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U.S. Citizenship and Immigration Services, Department of Homeland Security and Employment and Training Administration and Wage and Hour Division, Department of Labor.
Temporary rule.
The Secretary of Homeland Security, in consultation with the Secretary of Labor, has decided to increase the numerical limitation on H-2B nonimmigrant visas to authorize the issuance of up to, but not more than, an additional 30,000 visas through the end of Fiscal Year (FY) 2019. The Departments have determined that employers who attest that they are likely to suffer irreparable harm may request these supplemental visas only for workers who were issued an H-2B visa or otherwise granted H-2B status in FY 2016, 2017, or 2018. This increase is based on a time-limited statutory authority and does not affect the H-2B program in future fiscal years. The Departments are promulgating regulations to implement this determination.
This final rule is effective from May 8, 2019 through September 30, 2019, except for 20 CFR 655.67, which is effective from May 8, 2019 through September 30, 2022. The Office of Foreign Labor Certification within the U.S. Department of Labor will be accepting comments in connection with the new information collection Form ETA-9142B-CAA-3 associated with this rule until July 8, 2019.
You may submit comments on the new information collection Form ETA-9142B-CAA-3, identified by Regulatory Information Number (RIN) 1205-AB95, by any one of the following methods:
Individuals with hearing or speech impairments may access the telephone numbers above via TTY by calling the toll-free Federal Information Relay Service at 1-877-889-5627 (TTY/TDD).
The Immigration and Nationality Act (INA), as amended, establishes the H-2B nonimmigrant classification for a nonagricultural temporary worker “having a residence in a foreign country which he has no intention of abandoning who is coming temporarily to the United States to perform . . . temporary [non-agricultural] service or labor if unemployed persons capable of performing such service or labor cannot be found in this country.” INA section
DHS regulations provide that an H-2B petition for temporary employment in the United States must be accompanied by an approved temporary labor certification (TLC) from the Department of Labor (DOL) issued pursuant to regulations established at 20 CFR part 655, 8 CFR 214.2(h)(6)(iii)(A), (C)-(E), (h)(6)(iv)(A)
In order to determine whether to issue a temporary labor certification, the Departments have established regulatory procedures under which DOL certifies whether a qualified U.S. worker is available to fill the job opportunity described in the employer's petition for a temporary nonagricultural worker, and whether a foreign worker's employment in the job opportunity will adversely affect the wages or working conditions of similarly employed U.S. workers.
The INA also authorizes DHS to impose appropriate remedies against an employer for a substantial failure to meet the terms and conditions of employing an H-2B nonimmigrant worker, or for a willful misrepresentation of a material fact in a petition for an H-2B nonimmigrant worker. INA section 214(c)(14)(A), 8 U.S.C. 1184(c)(14)(A). The INA expressly authorizes DHS to delegate certain enforcement authority to DOL. INA section 214(c)(14)(B), 8 U.S.C. 1184(c)(14)(B);
The INA sets the annual number of aliens who may be issued H-2B visas or otherwise provided H-2B nonimmigrant status to perform temporary nonagricultural work at 66,000, to be distributed semi-annually beginning in October and April.
In FY 2005, 2006, 2007, and 2016, Congress exempted H-2B workers identified as returning workers from the annual H-2B cap of 66,000.
Because of the strong demand for H-2B visas in recent years, the statutorily limited semi-annual visa allocation, and the regulatory requirement that employers apply for temporary labor certification 75 to 90 days before the start date of work,
On February 15, 2019, the President signed the FY 2019 Omnibus which contains a provision, section 105 of Division H (section 105), permitting the Secretary of Homeland Security, under certain circumstances and after consultation with the Secretary of Labor, to increase the number of H-2B visas available to U.S. employers, notwithstanding the otherwise established statutory numerical limitation. Specifically, section 105 provides that “the Secretary of Homeland Security, after consultation with the Secretary of Labor, and upon the determination that the needs of American businesses cannot be satisfied in [FY] 2019 with U.S. workers who are willing, qualified, and able to perform temporary nonagricultural labor,” may increase the total number of aliens who may receive an H-2B visa in FY 2019 by not more than the highest number of H-2B nonimmigrants who participated in the H-2B returning worker program in any fiscal year in which returning workers were exempt from the H-2B numerical limitation.
In FY 2017, Congress enacted section 543 of Division F of the Consolidated Appropriations Act, 2017, Public Law 115-31, and, in FY 2018, Congress enacted section 205 of Division M of the Consolidated Appropriations Act, 2018, Public Law 115-141. Both statutory provisions were materially identical to section 105 of the FY 2019 Omnibus pertaining to the FY 2017 and FY 2018 H-2B visa allocations. In both FY 2017 and FY 2018, the Secretary of Homeland Security, after consulting with the Secretary of Labor, determined that the needs of some American businesses could not be satisfied in FY 2017 and FY 2018, respectively, with U.S. workers who were willing, qualified, and able to perform temporary nonagricultural labor. Based on these determinations, on July 19, 2017, and May 31, 2018, respectively, DHS and DOL jointly published temporary final rules allowing an increase of up to 15,000 additional H-2B visas for those businesses that attested to a level of need such that, if they did not receive all of the workers requested on the Petition for a Nonimmigrant Worker (Form I-129), they were likely to suffer irreparable harm,
As they did in implementing the FY 2017 and FY 2018 Omnibus H-2B supplemental caps,
Following consultation with the Secretary of Labor, the Secretary of Homeland Security has determined that the needs of some American businesses cannot be satisfied in FY 2019 with U.S. workers who are willing, qualified, and able to perform temporary nonagricultural labor. In accordance with section 105 of the FY 2019 Omnibus, the Secretary of Homeland Security has determined that it is appropriate, for the reasons stated below, to raise the numerical limitation on H-2B nonimmigrant visas by up to an additional 30,000 visas for the remainder of the fiscal year. Consistent with such authority, the Secretary of Homeland Security has decided to increase the H-2B cap for FY 2019 by up to 30,000 additional visas for those American businesses that attest to a level of need such that, if they do not receive all of the workers under the cap increase, they are likely to suffer irreparable harm, in other words, suffer a permanent and severe financial loss. These businesses must attest that they will likely suffer irreparable harm and must retain documentation, as described below, supporting this attestation. In addition, the Secretary has determined that employers may only request these supplemental visas for specified H-2B returning workers. Specifically, these individuals must be workers who were issued H-2B visas or were otherwise granted H-2B status in FY 2016, 2017, or 2018.
The Secretary of Homeland Security's determination to increase the numerical limitation is based, in part, on the conclusion that some businesses risk closing their doors in the absence of a cap increase. Some stakeholders have reported that access to additional H-2B visas is essential to the continued viability of some small businesses that play an important role in sustaining the economy in their states, while others
The decision to afford the benefits of this cap increase to businesses that need workers to avoid irreparable harm, rather than applying the cap increase to any and all businesses seeking temporary workers, is consistent with section 105. Specifically, section 105 provides that the Secretary of Homeland Security, upon satisfaction of the statutory business need standard, may increase the numerical limitation to meet such need.
First, DHS interprets section 105's reference to “the needs of American businesses” as describing a need different than the need required of employers in petitioning for an H-2B worker. Under the generally applicable H-2B program, each individual H-2B employer must demonstrate that it has a temporary need for the services or labor for which they seek to hire H-2B workers.
Second, the approach set forth in this rule limits the increase in a way that is similar to the implementation of the FY 2017 and FY 2018 supplemental caps, and provides protections against adverse effects on U.S. workers that may result from a larger cap increase. Although there is not enough time remaining in FY 2019 to conduct more formal analysis of such effects and the calendar does not lend itself to such additional efforts, the Secretary of Homeland Security has determined that in the particular circumstances presented here, it is appropriate, within the limits discussed below, to tailor the availability of this temporary cap increase to those businesses likely to suffer irreparable harm,
To address the increased, and, in some cases, imminent need for H-2B workers, for FY 2019, the Secretary has determined that employers may only petition for supplemental visas on behalf of workers who were issued an H-2B visa or were otherwise granted H-2B status in FY 2016, 2017, or 2018. The last-three-fiscal-years temporal limitation in the returning worker definition in this temporary rule mirrors the temporal limitation Congress imposed in previous returning worker statutes.
Limiting the supplemental cap to returning workers is beneficial because these workers have generally demonstrated the willingness to return home after they have completed their temporary labor or services or their period of authorized stay, which is a condition of H-2B status. The returning workers condition therefore provides a basis to believe that H-2B workers under this cap increase will likely return home again after another temporary stay in the United States. That same basis does not exist for non-returning workers, not all of whom have a track record of returning home. Although the returning worker requirement limits the flexibility of employers, the requirement provides an important safeguard, which DHS deems paramount.
Employers must also establish, among other requirements, that insufficient qualified U.S. workers are available to fill the petitioning H-2B employer's job opportunity and that the foreign worker's employment in the job opportunity will not adversely affect the wages or working conditions of similarly employed U.S. workers. INA section 214(c)(1), 8 U.S.C. 1184(c)(1); 8 CFR 214.2(h)(6)(iii)(A) and (D); 20 CFR 655.1. To meet this standard, and therefore, in order to be eligible for additional visas under this rule, employers must have applied for and
In sum, this rule increases the FY 2019 numerical limitation by up to 30,000 visas to ensure a sufficient number of visas to allow for increased need for H-2B workers, but also restricts the availability of such additional visas by prioritizing only the most significant business needs and limiting eligibility to H-2B returning workers. These provisions are each described in turn below.
DHS expects the increase of up to 30,000 visas
Section 105 of the FY 2019 Omnibus sets the highest number of H-2B returning workers
Available data indicates that need for supplemental H-2B visas in FY 2019 will exceed the previous supplemental caps. In FY 2018, USCIS received petitions for approximately 29,000 beneficiaries during the first 5 business days of filing for the 15,000 supplemental cap. USCIS therefore conducted a lottery on June 7, 2018, to randomly select petitions that would be accepted under the supplemental cap. Of the petitions that were selected, USCIS issued approvals for 15,672 beneficiaries.
Given indications of increased demand in the H-2B program overall and the FY 2018 supplemental cap relative to prior year supplemental caps, the Secretary of Homeland Security has considered both FY 2007 data in which the highest number of returning workers approved was 64,716, and the previous cap determinations. The Secretary has determined that authorizing up to 30,000 additional visas, which is approximately half of the highest number of returning worker visas approved for H-2B beneficiaries in FY 2007 as well as almost half of the regular H-2B cap, will better ensure that additional H-2B visas will be available to businesses that need H-2B workers.
Although the increase of up to 30,000 additional workers is higher than previous years, the Secretary has determined that the supplemental visas should only be granted to returning workers from the past three fiscal years, in order to meet the immediate need for H-2B workers. The Secretary has determined that for purposes of this program, H-2B returning workers include those individuals who were issued an H-2B visa or were otherwise granted H-2B status in FY 2016, 2017, or 2018. As discussed above, the Secretary determined that limiting returning workers to those who were issued an H-2B visa or granted H-2B status in the past three fiscal years is appropriate as it mirrors the previous standard that Congress designated in previous returning worker provisions. As also discussed above, returning workers have previously obtained H-2B visas and therefore been vetted by DOS, would have departed the United States after their authorized period of stay as generally required by the terms of their nonimmigrant admission, and therefore may obtain their new visas through DOS and begin work more expeditiously.
To ensure compliance with the requirement that additional visas only be made available to returning workers,
To file an H-2B petition during the remainder of FY 2019, petitioners must meet all existing H-2B eligibility requirements, including having an approved, valid, and unexpired TLC.
The attestation will serve as prima facie initial evidence to DHS that the petitioner's business is likely to suffer irreparable harm. Any petition received lacking the requisite attestation may be denied in accordance with 8 CFR 103.2(b)(8)(ii). Although this regulation does not require submission of evidence at the time of filing of the petition, other than an attestation, the employer must have such evidence on hand and ready to present to DHS, DOL, or DOS at any time starting with the date of filing, through the prescribed document retention period discussed below.
In addition to the statement regarding the irreparable harm standard, the attestation will also state that the employer: Meets all other eligibility criteria for the available visas, including the returning worker requirement; will comply with all assurances, obligations, and conditions of employment set forth in the
It is the view of the Secretaries of Homeland Security and Labor that requiring a post-TLC attestation to USCIS is sufficiently protective of U.S. workers given that the employer, in completing the TLC process, has already made one unsuccessful attempt to recruit U.S. workers. In addition, the employer is required to retain documentation, which must be provided upon request, supporting the new attestations, including a recruitment report for any additional recruitment required under this rule. Although the employer must have such documentation on hand at the time it files the petition, the Departments have determined that if employers were required to submit the attestations to DOL before seeking a petition from DHS or to complete any additional recruitment required before submitting a petition, the attendant delays would render any visas unlikely to satisfy the needs of American businesses given processing timeframes and the time remaining in this fiscal year. USCIS may issue a notice of intent to revoke and request additional evidence, or issue a revocation notice, based on such documentation, and DOL's OFLC and WHD will be able to review this documentation and enforce the attestations during the course of an audit examination or investigation.
In accordance with the attestation requirement, under which petitioners attest that they meet the irreparable harm standard and that they are seeking to only employ returning workers, and the document retention requirements at 20 CFR 655.67, the petitioner must retain documents and records meeting their burden to demonstrate compliance with this rule for 3 years, and must provide the documents and records upon the request of DHS or DOL, such as in the event of an audit or investigation. Supporting evidence may include, but is not limited to, the following types of documentation:
(1) Evidence that the business is or would be unable to meet financial or contractual obligations without H-2B workers, including evidence of contracts, reservations, orders, or other business arrangements that have been or would be cancelled absent the requested H-2B workers, and evidence demonstrating an inability to pay debts/bills;
(2) Evidence that the business has suffered or will suffer permanent and severe financial loss during the period of need, as compared to the period of need in prior years, such as financial statements (including profit/loss statements) comparing the present period of need to prior years; bank statements, tax returns, or other documents showing evidence of current and past financial condition; and relevant tax records, employment records, or other similar documents showing hours worked and payroll comparisons from prior years to current year;
(3) Evidence showing the number of workers needed in previous seasons to meet the employer's temporary need as compared to those currently employed, including the number of H-2B workers requested, the number of H-2B workers actually employed, the dates of their employment, and their hours worked (for example, payroll records), particularly in comparison to the weekly hours stated on the TLC. In addition, for employers that obtain authorization to employ H-2B workers under this rule, evidence showing the number of H-2B workers requested under this rule, the number of workers actually employed, including H-2B workers, the dates of their employment, and their hours worked (for example,
(4) Evidence that the business is dependent on H-2B workers, such as documentation showing the number of H-2B workers compared to U.S. workers needed prospectively or in the past; business plan or reliable forecast showing that, due to the nature and size of the business, there is a need for a specific number of H-2B workers; and
(5) Evidence that the employer requested and/or instructed that each of the workers petitioned by the employer in connection with this temporary rule were issued H-2B visas or otherwise granted H-2B status in FY 2016, 2017, or 2018. Such evidence would include, but is not limited to, a date-stamped written communication from the employer to its agent(s) and/or recruiter(s) that instructs the agent(s) and/or recruiter(s) to only recruit and provide instruction regarding an application for an H-2B visa to those foreign workers who were previously issued an H-2B visa or granted H-2B status in FY 2016, 2017, or 2018.
This temporary rule does not apply to workers who have already been counted under the fiscal year 2019 H-2B (66,000) cap. Further, this rule does not apply to persons who are exempt from the fiscal year 2019 H-2B cap, including those who are extending their stay in H-2B status. Accordingly, petitioners who are filing on behalf of such workers are not subject to the attestation requirement.
These examples are not exclusive, nor will they necessarily establish that the business meets the irreparable harm or returning worker standards; petitioners may retain other types of evidence they believe will satisfy these standards. If an audit or investigation occurs, DHS or DOL will review all evidence available to it to confirm that the petitioner properly attested to DHS that their business would likely suffer irreparable harm and that they petitioned for and employed only returning workers. If DHS subsequently finds that the evidence does not support the employer's attestation, DHS may deny or, if the petition has already been approved, revoke the petition at any time consistent with existing regulatory authorities. DHS may also, or alternatively, notify DOL. In addition, DOL may independently take enforcement action, including by, among other things, debarring the petitioner from the H-2B program generally for not less than one year or more than 5 years from the date of the final agency decision which also disqualifies the debarred party from filing any labor certification applications or labor condition applications with DOL for the same period set forth in the final debarment decision.
To the extent that evidence reflects a preference for hiring H-2B workers over U.S. workers, an investigation by other agencies enforcing employment and labor laws, such as the Immigrant and Employee Rights Section (IER) of the Department of Justice's Civil Rights Division, may be warranted.
DHS, in exercising its statutory authority under INA section 101(a)(15)(H)(ii)(b), 8 U.S.C. 1101(a)(15)(H)(ii)(b), and section 105 of the FY 2019 Omnibus, is responsible for adjudicating eligibility for H-2B classification. As in all cases, the burden rests with the petitioner to establish eligibility by a preponderance of the evidence. INA section 291, 8 U.S.C. 1361. Accordingly, as noted above, where the petition lacks initial evidence, such as a properly completed attestation, DHS may deny the petition in accordance with 8 CFR 103.2(b)(8)(ii). Further, where the initial evidence submitted with the petition contains inconsistencies or is inconsistent with other evidence in the petition and underlying TLC, DHS may issue a Request for Evidence, Notice of Intent to Deny, or Denial in accordance with 8 CFR 103.2(b)(8). In addition, where it is determined that an H-2B petition filed pursuant to the FY 2019 Omnibus was granted erroneously, the H-2B petition approval may be revoked.
Because of the particular circumstances of this regulation, and because the attestation plays a vital role in achieving the purposes of this regulation, DHS and DOL intend that the attestation requirement be non-severable from the remainder of the regulation. Thus, in the event the attestation requirement is enjoined or held invalid, the remainder of the regulation, with the exception of the retention requirements being codified in 20 CFR 655.67, is also intended to cease operation in the relevant jurisdiction, without prejudice to workers already present in the United States under this regulation, as consistent with law.
To petition for H-2B workers under this rule, the petitioner must file a Form I-129 in accordance with applicable regulations and form instructions, an unexpired TLC, and the attestation described above.
To encourage timely filing of any petition seeking a visa under the FY 2019 Omnibus, DHS is notifying the public that the petition may not be approved by USCIS on or after October 1, 2019.
USCIS's current processing goals for H-2B petitions that can be adjudicated without the need for further evidence (
As with other Form I-129 filings, DHS encourages petitioners to provide a duplicate copy of Form I-129 and all supporting documentation at the time of filing if the beneficiary is seeking a nonimmigrant visa abroad. Failure to submit duplicate copies may cause a delay in the issuance of a visa to otherwise eligible applicants.
All employers are required to have an approved and valid TLC from DOL in order to file a Form I-129 petition with DHS.
In addition to the recruitment already conducted in connection with a valid TLC, in order to ensure the recruitment does not become stale, employers with current TLCs must conduct a fresh round of recruitment for U.S. workers if they file an I-129 petition 45 or more days after the certified start date of work on the TLC. As noted in the 2015 H-2B Interim Final Rule, U.S. workers seeking employment in temporary non-agricultural jobs typically do not search for work months in advance, and cannot make commitments about their availability for employment far in advance of the work start date.
Therefore, only those employers with still-valid TLCs with a start date of work that is 45 or more days before the date they file a petition will be required to conduct additional recruitment, and attest that the recruitment will be conducted, as follows. The employer must place a new job order for the job opportunity with the State Workforce Agency (SWA), serving the area of intended employment. The job order must contain the job assurances and contents set forth in 20 CFR 655.18 for recruitment of U.S. workers at the place of employment, and remain posted for at least 5 days beginning not later than the next business day after submitting a petition for H-2B workers to USCIS. The employer must also follow all applicable SWA instructions for posting job orders and receive applications in all forms allowed by the SWA, including online applications. In addition, eligible employers will also be required to place one newspaper advertisement, which may be published online or in print on any day of the week, meeting the advertising requirements of 20 CFR 655.41, during the period of time the SWA is actively circulating the job order for intrastate clearance. Employers must retain the additional recruitment documentation, including a recruitment report that meets the requirements for recruitment reports set forth in 20 CFR 655.48(a)(1), (2), and (7), together with a copy of the attestation and supporting documentation, as described above, for a period of 3 years from the date that the TLC was approved, consistent with the document retention requirements under 20 CFR 655.56. These requirements are similar to those that apply to certain seafood employers who stagger the entry of H-2B workers under 20 CFR 655.15(f).
The employer must hire any qualified U.S. worker who applies or is referred for the job opportunity until 2 business days after the last date on which the job order is posted. The 2 business day requirement permits a brief additional period of time to enable U.S. workers to contact the employer following the job order or newspaper advertisement. Consistent with 20 CFR 655.40(a), applicants can be rejected only for lawful job-related reasons.
DOL's WHD has the authority to investigate the employer's attestations, as the attestations are a required part of the H-2B petition process under this rule and the attestations rely on the employer's existing, approved TLC. Where a WHD investigation determines that there has been a willful misrepresentation of a material fact or a substantial failure to meet the required terms and conditions of the attestations, WHD may institute administrative proceedings to impose sanctions and remedies, including (but not limited to) assessment of civil money penalties, recovery of wages due, make whole relief for any U.S. worker who has been improperly rejected for employment, laid off or displaced, and/or debarment for 1 to 5 years.
DHS has the authority to verify any information submitted to establish H-2B eligibility at any time before or after the petition has been adjudicated by USCIS.
DOL's OFLC already has the authority under 20 CFR 655.70 to conduct audit examinations on adjudicated
Petitioners must also comply with any other applicable laws, such as avoiding unlawful discrimination against U.S. workers based on their citizenship status or national origin. Specifically, the failure to recruit and hire qualified and available U.S. workers on account of such individuals' national origin or citizenship status may violate INA section 274B, 8 U.S.C. 1324b.
This rule is issued without prior notice and opportunity to comment and with an immediate effective date pursuant to the Administrative Procedure Act (APA). 5 U.S.C. 553(b) and (d).
The APA, 5 U.S.C. 553(b)(B), authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” The good cause exception for forgoing notice and comment rulemaking “excuses notice and comment in emergency situations, or where delay could result in serious harm.”
In this case, the Departments are bypassing advance notice and comment because of the exigency created by section 105 of Div. H of the Consolidated Appropriations Act, 2019 (FY 2019 Omnibus), which went into effect on February 15, 2019, and expires on September 30, 2019. USCIS received more than enough petitions to meet the H-2B visa statutory cap for the second half of FY 2019 on February 19, 2019, which is 8 days earlier than when the cap for the second half of FY 2018 was reached, and is the earliest date the cap for the second half of the fiscal year has been reached since FY 2016. USCIS conducted a lottery on February 21, 2019, to randomly select a sufficient number of petitions to meet the cap. USCIS rejected and returned the petitions and associated filing fees to petitioners that were not selected, as well as all cap-subject petitions received after February 19, 2019. Given high demand by American businesses for H-2B workers, and the short period of time remaining in the fiscal year for U.S. employers to avoid the economic harms described above, a decision to undertake notice and comment rulemaking would likely delay final action on this matter by weeks or months, and would therefore complicate and likely preclude the Departments from successfully exercising the authority in section 105.
Courts have found “good cause” under the APA when an agency is moving expeditiously to avoid significant economic harm to a program, program users, or an industry. Courts have held that an agency may use the good cause exception to address “a serious threat to the financial stability of [a government] benefit program,”
Consistent with the above authorities, the Departments have bypassed notice and comment to prevent the “serious economic harm to the H-2B community,” including associated U.S. workers, that could result from ongoing uncertainty over the status of the numerical limitation,
The APA also authorizes agencies to make a rule effective immediately, upon a showing of good cause, instead of imposing a 30-day delay. 5 U.S.C. 553(d)(3). The good cause exception to the 30-day effective date requirement is easier to meet than the good cause exception for foregoing notice and comment rulemaking.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility. Executive Order 13771 (“Reducing Regulation and Controlling Regulatory Costs”) directs agencies to reduce regulation and control regulatory costs.
The Office of Management and Budget (OMB) has determined that this rule is a “significant regulatory action” although not an economically significant regulatory action. Accordingly, OMB has reviewed this regulation. This final rule is considered an Executive Order 13771 deregulatory action. Details on the estimated cost savings of this temporary rule are discussed in the rule's economic analysis.
With this final rule, DHS is authorizing up to an additional 30,000 visas for the remainder of FY 2019, pursuant to the FY 2019 Omnibus, to be available to certain H-2B workers for certain U.S. businesses under the H-2B visa classification. By the authority given under the FY 2019 Omnibus, DHS is increasing the H-2B cap for the remainder of FY 2019 for those businesses that: (1) Show that there are an insufficient number of qualified U.S. workers to meet their needs in FY 2019; (2) attest that their businesses are likely to suffer irreparable harm without the ability to employ the H-2B workers that are the subject of their petition; and (3) petition for returning H-2B workers who were issued an H-2B visa or were otherwise granted H-2B status in FY 2016, 2017, or 2018. DHS estimates that the total cost of this rule ranges from $9,360,053 (rounded) to $11,949,369 (rounded) depending on the combination of petitions filed by each type of filer.
The H-2B visa classification program was designed to serve U.S. businesses that are unable to find a sufficient number of qualified U.S. workers to perform nonagricultural work of a temporary or seasonal nature. For an H-2B nonimmigrant worker to be admitted into the United States under this visa classification, the hiring employer is required to: (1) Receive a TLC from DOL and (2) file a Form I-129 with DHS. The temporary nature of the services or labor described on the approved TLC is subject to DHS review during adjudication of Form I-129.
The H-2B cap for the second half of FY 2019 was reached on February 19, 2019. Normally, once the H-2B cap has been reached, petitioners must wait until the next half of the fiscal year, or the beginning of the next fiscal year, for additional cap-subject visas to become available. However, on February 15, 2019, the President signed the FY 2019 Omnibus that contains a provision (Sec. 105 of Div. H) authorizing the Secretary of Homeland Security, under certain circumstances, to increase the number of H-2B visas available to U.S. employers, notwithstanding the established statutory numerical limitation. After consulting with the Secretary of Labor, the Secretary of Homeland Security has determined it is appropriate to raise the H-2B cap by up to an additional 30,000 visas for the remainder of FY 2019 for certain H-2B workers who would be employed with certain businesses.
This temporary rule would impact those employers who file Form I-129 on behalf of the nonimmigrant worker(s) they seek to hire under the H-2B visa program. More specifically, this rule would impact those employers who could establish that their business is likely to suffer irreparable harm because they cannot employ the H-2B returning workers requested on their petition in this fiscal year. Due to the temporary nature of this rule and the limited time left for these additional visas to be available, DHS believes it is more reasonable to assume that eligible petitioners for these additional 30,000 visas will be those employers that have already completed the steps to receive an approved TLC prior to the issuance of this rule.
According to DOL OFLC's certification data for FY 2019, as of March 25, 2019, about 6,183 H-2B certification applications were received with expected work start dates between April 1 and September 30, 2019. DOL OFLC has approved 4,687 certifications for 82,539 H-2B positions and is still reviewing the remaining 863 TLC requests for 13,701 H-2B positions. However, many of these certified worker positions have already been filled under the semi-annual cap of 33,000. Of the 4,687 certified Applications for Temporary Employment Certification, USCIS data shows that 1,774 were already filed with H-2B petitions toward the second semi-annual cap of 33,000 visas. We believe that approximately up to 3,776 Applications for Temporary Employment Certification may be filed under this rule and the FY 2019 supplemental cap. This number is based on the sum of the remaining 2,913 certified H-2B Applications for Temporary Employment Certification (4,687 (total certified)−1,774 (certified and already submitted under the second semi-annual cap) and 863 Applications for Temporary Employment Certification that are still being processed by DOL, and therefore represents a reasonable estimate of the pool of potential petitions that may request additional H-2B workers under this rule;
The costs for this form include filing costs and the opportunity costs of time to complete and file the form. The current filing fee for Form I-129 is $460 and the estimated time needed to complete and file Form I-129 for H-2B classification is 4.26 hours.
To estimate the total opportunity cost of time to petitioners who complete and file Form I-129, DHS uses the mean hourly wage rate of HR specialists of $31.84 as the base wage rate.
Calculation if an in-house lawyer files: $99.60 × (4.26 hours to file Form I-129 H-2B + 0.5 hour to file Form G-28) = $474.10;
Calculation if an outsourced lawyer files: $170.55 × (4.26 hours to file Form I-129 H-2B + 0.5 hour to file Form G-28) = $811.82.
Calculation if an in-house lawyer files: $474.10 + $460 (filing fee) = $934.10;
Calculation if outsourced lawyer files: $811.82 + $460 (filing fee) = $1,271.82.
As mentioned in Section III.B.3., the population impacted by this rule is the 3,776 petitioners who may apply for up to 30,000 additional H-2B visas for the remainder of FY 2019. Based on the previously presented total filing costs per petitioner, DHS estimates the total cost to file Form I-129 is $2,484,797 (rounded) if HR specialists file, $3,527,162 (rounded) if in-house lawyers file, and $4,802,392 (rounded) if outsourced lawyers file.
Calculation if an in-house lawyer files: $934.1 × 3,776 (population applying for H-2B visas) = $3,527,161.60 = $3,527,162 (rounded);
Calculation if an outsourced lawyer files: $1,271.82 × 3,776 (population applying for H-2B visas) = $4,802,392.32 = $4,802,392 (rounded).
Employers may use
Calculation if an in-house lawyer files: $99.60 × (0.58 hours) = $57.77;
Calculation if an outsourced lawyer files: $170.55 × (0.58 hours) = $98.92.
Calculation if an in-house lawyer files: $57.77 + $1,410 = 1,467.77;
Calculation if outsourced lawyer files: $98.92 + $1,410 = $1,508.92.
The attestation form includes recruiting requirements, the irreparable harm standard, and document retention obligations. DOL estimates the time burden for completing and signing the form is 0.25 hour and 0.5 hour for notifying third parties and retaining records relating to the returning worker requirements. Using the total per hour wage for an HR specialist ($46.49), the opportunity cost of time for an HR specialist to complete the attestation form and notifying third parties and retaining records relating to the returning worker requirements, is $34.87.
Additionally, the form requires that the petitioner assess and document supporting evidence for meeting the irreparable harm standard, and retain those documents and records, which we assume will require the resources of a financial analyst (or another equivalent occupation). Using the same methodology previously described for wages, the total per hour wage for a financial analyst is $69.79.
As discussed previously, we believe that the estimated 3,776 remaining unfilled certifications for the latter half of FY 2019 would include all potential employers who might request to employ H-2B workers under this rule. This number of certifications is a reasonable proxy for the number of employers who may need to review and sign the attestation. Using this estimate for the total number of certifications, DOL estimates that the cost for HR specialists is $131,660 and for financial analysts is $1,317,635 (rounded).
DHS anticipates some additional costs in adjudicating the additional petitions submitted as a result of the increase in cap limitation for H-2B visas. However, DHS expects these costs to be covered by the fees associated with the forms.
The inability to access H-2B workers for these entities may cause their businesses to suffer irreparable harm. Temporarily increasing the number of available H-2B visas for this fiscal year may result in a cost savings, because it will allow some businesses to hire the additional labor resources necessary to avoid such harm. Preventing such harm may ultimately rescue the jobs of any other employees (including U.S. employees) at that establishment. Additionally, returning workers are most likely very familiar with the H-2B process and requirements and may be positioned to more expeditiously begin work with these employers. In addition, employers may already be familiar with returning workers as they have trained, vetted, and worked with some of these returning workers in past years. As such, limiting the supplemental visas to returning workers would assist employers who are facing irreparable harm.
The Regulatory Flexibility Act, 5 U.S.C. 601
The Unfunded Mandates Reform Act of 1995 (UMRA) is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and tribal governments. Title II of the Act requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed rule, or final rule for which the agency published a proposed rule that includes any Federal mandate that may result in $100 million or more expenditure (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector. This
In addition, this rule does not exceed the $100 million expenditure in any 1 year when adjusted for inflation ($165 million in 2018 dollars), and this rulemaking does not contain such a mandate. The requirements of Title II of the Act, therefore, do not apply, and the Departments have not prepared a statement under the Act.
This temporary rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Act of 1996, Public Law 104-121, 804, 110 Stat. 847, 872 (1996), 5 U.S.C. 804(2). This rule has not been found to result in an annual effect on the economy of $100 million or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic or export markets.
This rule does 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. Therefore, in accordance with section 6 of Executive Order No. 13132, 64 FR 43255 (Aug. 4, 1999), this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
This rule meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order No. 12988, 61 FR 4729 (Feb. 5, 1996).
DHS analyzes actions to determine whether the National Environmental Policy Act (NEPA) applies to them and if so what degree of analysis is required. DHS Directive (Dir) 023-01 Rev. 01 establishes the procedures that DHS and its components use to comply with NEPA and the Council on Environmental Quality (CEQ) regulations for implementing NEPA, 40 CFR parts 1500 through 1508. The CEQ regulations allow federal agencies to establish, with CEQ review and concurrence, categories of actions (“categorical exclusions”) which experience has shown do not individually or cumulatively have a significant effect on the human environment and, therefore, do not require an Environmental Assessment (EA) or Environmental Impact Statement (EIS). 40 CFR 1507.3(b)(1)(iii), 1508.4. DHS Instruction 023-01 Rev. 01 establishes such Categorical Exclusions that DHS has found to have no such effect. Dir. 023-01 Rev. 01 Appendix A Table 1. For an action to be categorically excluded, DHS Instruction 023-01 Rev. 01 requires the action to satisfy each of the following three conditions: (1) The entire action clearly fits within one or more of the Categorical Exclusions; (2) the action is not a piece of a larger action; and (3) no extraordinary circumstances exist that create the potential for a significant environmental effect. Inst. 023-01 Rev. 01 section V.B (1)-(3).
This rule temporarily amends the regulations implementing the H-2B nonimmigrant visa program to increase the numerical limitation on H-2B nonimmigrant visas for the remainder of FY 2019 based on the Secretary of Homeland Security's determination, in consultation with the Secretary of Labor, consistent with the FY 2019 Omnibus. Generally, DHS believes that NEPA does not apply to a rule which changes the number of visas which can be issued because any attempt to analyze its impact would be largely, if not completely, speculative. The Departments cannot estimate with reasonable certainty which employers will successfully petition for employees in what locations and numbers. At most, it is reasonably foreseeable that an increase of up to 30,000 visas may be issued for temporary entry into the United States in diverse industries and locations. For purposes of the cost estimates contained in the economic analysis above, DHS bases its calculations on the assumption that all 30,000 will be issued. However, estimating the cost of document filings is qualitatively different from analyzing environmental impacts. Being able to estimate the costs per filing and number of filings at least allows a calculation. Even making that assumption, analyzing the environmental impacts of 30,000 visa recipients among a current U.S. population in excess of 323 million and across a U.S. land mass of 3.794 million square miles, would require a degree of speculation that causes DHS to conclude that NEPA does not apply to this action.
DHS has determined that even if NEPA were to apply to this action, this rule would fit within one categorical exclusion under Environmental Planning Program, DHS Instruction 023- 01 Rev. 01, Appendix A, Table 1 and does not individually or cumulatively have a significant effect on the human environment. Specifically, the rule fits within Categorical Exclusion number A3(d) for rules that interpret or amend an existing regulation without changing its environmental effect.
This rule maintains the current human environment by helping to prevent irreparable harm to certain U.S. businesses and to prevent a significant adverse effect on the human environment that would likely result from loss of jobs and income. With the exception of recordkeeping requirements, this rulemaking terminates after September 30, 2019; it is not part of a larger action and presents no extraordinary circumstances creating the potential for significant environmental effects. No further NEPA analysis is required.
The Paperwork Reduction Act (PRA), 44 U.S.C. 3501
Moreover, this rule includes a new form,
In addition to the request for an emergency approval, DOL is seeking comments on this information collection pursuant to 5 CFR 1320.10. Comments must be received by July 8, 2019. This process of engaging the public and other Federal agencies helps ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The PRA provides that 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 it is approved by OMB under the PRA and displays a currently valid OMB Control Number. See 44 U.S.C. 3501
In accordance with the PRA, DOL is affording the public with notice and an opportunity to comment on the new information collection, which is necessary to implement the requirements of this temporary rule. The information collection activities covered by this rule are required under Section 105 of Division H of the Consolidated Appropriations Act, which provides that “the Secretary of Homeland Security, after consultation with the Secretary of Labor, and upon the determination that the needs of American businesses cannot be satisfied in [FY] 2019 with U.S. workers who are willing, qualified, and able to perform temporary nonagricultural labor,” may increase the total number of aliens who may receive an H-2B visa in FY 2019 by not more than the highest number of H-2B nonimmigrants who participated in the H-2B returning worker program in any fiscal year in which returning workers were exempt from the H-2B numerical limitation. As previously discussed in the preamble of this rule, the Secretary of Homeland Security in consultation with the Secretary of Labor has decided to increase the numerical limitation on H-2B nonimmigrant visas to authorize the issuance of up to, but not more than, an additional 30,000 visas through the end of FY 2019 for certain H-2B workers.
The agencies are particularly interested in comments that:
• 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,
The aforementioned information collection requirements are summarized as follows:
The Paperwork Reduction Act (PRA), 44 U.S.C. 3501
Administrative practice and procedure, Aliens, Cultural exchange programs, Employment, Foreign officials, Health professions, Reporting and recordkeeping requirements, Students.
Administrative practice and procedure, Employment, Employment and training, Enforcement, Foreign workers, Forest and forest products, Fraud, Health professions, Immigration, Labor, Longshore and harbor work, Migrant workers, Nonimmigrant workers, Passports and visas, Penalties, Reporting and recordkeeping requirements, Unemployment, Wages, Working conditions.
For the reasons discussed in the joint preamble, part 214 of chapter I of title
6 U.S.C. 202, 236; 8 U.S.C. 1101, 1102, 1103, 1182, 1184, 1186a, 1187, 1221, 1281, 1282, 1301-1305 and 1372; sec. 643, Pub. L. 104-208, 110 Stat. 3009-708; Public Law 106-386, 114 Stat. 1477-1480; section 141 of the Compacts of Free Association with the Federated States of Micronesia and the Republic of the Marshall Islands, and with the Government of Palau, 48 U.S.C. 1901 note and 1931 note, respectively; 48 U.S.C. 1806; 8 CFR part 2.
(h) * * *
(6) * * *
(x)
(B) In order to file a petition with USCIS under this paragraph (h)(6)(x), the petitioner must:
(
(
(
(
(
(C) USCIS will reject petitions filed pursuant to this paragraph (h)(6)(x) that are received after the numerical limitation has been reached or after September 16, 2019, whichever is sooner. USCIS will not approve a petition filed pursuant to this paragraph (h)(6)(x) on or after October 1, 2019.
(D) This paragraph (h)(6)(x) expires on October 1, 2019.
(E) The requirement to file an attestation under paragraph (h)(6)(x)(B)(
Accordingly, for the reasons stated in the joint preamble, 20 CFR part 655 is amended as follows:
Section 655.0 issued under 8 U.S.C. 1101(a)(15)(E)(iii), 1101(a)(15)(H)(i) and (ii), 8 U.S.C. 1103(a)(6), 1182(m), (n) and (t), 1184(c), (g), and (j), 1188, and 1288(c) and (d); sec. 3(c)(1), Pub. L. 101-238, 103 Stat. 2099, 2102 (8 U.S.C. 1182 note); sec. 221(a), Pub. L. 101-649, 104 Stat. 4978, 5027 (8 U.S.C. 1184 note); sec. 303(a)(8), Pub. L. 102-232, 105 Stat. 1733, 1748 (8 U.S.C. 1101 note); sec. 323(c), Pub. L. 103-206, 107 Stat. 2428; sec. 412(e), Pub. L. 105-277, 112 Stat. 2681 (8 U.S.C. 1182 note); sec. 2(d), Pub. L. 106-95, 113 Stat. 1312, 1316 (8 U.S.C. 1182 note); 29 U.S.C. 49k; Pub. L. 107-296, 116 Stat. 2135, as amended; Pub. L. 109-423, 120 Stat. 2900; 8 CFR 214.2(h)(4)(i); 8 CFR 214.2(h)(6)(iii); and sec. 6, Pub. L. 115-218, 132 Stat. 1547 (48 U.S.C. 1806).
Subpart A issued under 8 CFR 214.2(h).
Subpart B issued under 8 U.S.C. 1101(a)(15)(H)(ii)(a), 1184(c), and 1188; and 8 CFR 214.2(h).
Subparts F and G issued under 8 U.S.C. 1288(c) and (d); sec. 323(c), Pub. L. 103-206, 107 Stat. 2428; and 28 U.S.C. 2461 note, Pub. L. 114-74 at section 701.
Subparts H and I issued under 8 U.S.C. 1101(a)(15)(H)(i)(b) and (b)(1), 1182(n) and (t), and 1184(g) and (j); sec. 303(a)(8), Pub. L. 102-232, 105 Stat. 1733, 1748 (8 U.S.C. 1101 note); sec. 412(e), Pub. L. 105-277, 112 Stat. 2681; 8 CFR 214.2(h); and 28 U.S.C. 2461 note, Pub. L. 114-74 at section 701.
Subparts L and M issued under 8 U.S.C. 1101(a)(15)(H)(i)(c) and 1182(m); sec. 2(d), Pub. L. 106-95, 113 Stat. 1312, 1316 (8 U.S.C. 1182 note); Pub. L. 109-423, 120 Stat. 2900; and 8 CFR 214.2(h).
An employer filing a petition with USCIS under 8 CFR 214.2(h)(6)(x) to employ H-2B workers from May 8, 2019 through September 16, 2019, must meet the following requirements:
(a) The employer must attest on Form ETA-9142-B-CAA-3 that without the ability to employ all of the H-2B workers requested on the petition filed pursuant to 8 CFR 214.2(h)(6)(x), its business is likely to suffer irreparable harm (that is, permanent and severe financial loss), and that the employer will provide documentary evidence of this fact to DHS or DOL upon request.
(b) The employer must attest on Form ETA-9142-B-CAA-3 that each of the workers requested and/or instructed to apply for a visa, on a petition filed pursuant to 8 CFR 214.2(h)(6)(x), have been issued an H-2B visa or otherwise granted H-2B status during one of the last three (3) fiscal years (Fiscal Years 2016, 2017, or 2018).
(c) An employer that files Form ETA-9142B-CAA-3 and the I-129 petition 45 or more days after the certified start date of work, as shown on its approved
(1) The employer must place a new job order for the job opportunity with the State Workforce Agency, serving the area of intended employment. The employer must follow all applicable State Workforce Agency instructions for posting job orders and receive applications in all forms allowed by the State Workforce Agency, including online applications (sometimes known as “self-referrals”). The job order must contain the job assurances and contents set forth in § 655.18 for recruitment of
(2) The employer must place one newspaper advertisement using an online or print format on any day of the week meeting the advertising requirements of § 655.41, during the period of time the State Workforce Agency is actively circulating the job order for intrastate clearance; and
(3) The employer must hire any qualified U.S. worker who applies or is referred for the job opportunity until 2 business days after the last date on which the job order is posted under paragraph (c)(1) of this section. Consistent with § 655.40(a), applicants can be rejected only for lawful job-related reasons.
(d) This section expires on October 1, 2019.
(e) The requirement to file an attestation under paragraph (a) of this section is intended to be non-severable from the remainder of this section; in the event that paragraph (a) is enjoined or held to be invalid by any court of competent jurisdiction, the remainder of this section is also intended to be enjoined or held to be invalid in such jurisdiction, without prejudice to workers already present in the United States under this part, as consistent with law.
(a) An employer who files a petition with USCIS to employ H-2B workers in fiscal year 2019 under authority of the temporary increase in the numerical limitation under section 105 of Division H, Public Law 116-6 must maintain for a period of 3 years from the date of certification, consistent with § 655.56 and 29 CFR 503.17, the following:
(1) A copy of the attestation filed pursuant to regulations governing that temporary increase;
(2) Evidence establishing that employer's business is likely to suffer irreparable harm (that is, permanent and severe financial loss), if it cannot employ H-2B nonimmigrant workers in fiscal year 2019; and
(3) Documentary evidence establishing that each of the workers the employer requested and/or instructed to apply for a visa, whether named or unnamed, had been issued an H-2B visa or otherwise granted H-2B status during one of the last three (3) fiscal years (Fiscal Years 2016, 2017 or 2018), as attested to pursuant to 8 CFR 214.2(h)(6)(x).
(4) If applicable, evidence of additional recruitment and a recruitment report that meets the requirements set forth in § 655.48(a)(1), (2), and (7).
DOL or DHS may inspect these documents upon request.
(b) This section expires on October 1, 2022.
Federal Aviation Administration (FAA), DOT.
Final special conditions.
These amended special conditions are issued for Embraer Model EMB-550 airplanes. This airplane will have novel or unusual design features when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. This design feature is associated with an electronic flight control system that prevents the pilot from inadvertently or intentionally exceeding the positive or negative airplane limit load factor. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Effective May 8, 2019.
Joe Jacobsen, Airplane & Flight Crew Interface Section, AIR-671, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone and fax 206-231-3158; email
On August 9, 2016, Embraer applied for a change to Type Certificate No. TC00062IB to include additional flexibility to the normal load factor limit on the Embraer Model EMB-550 airplane, by requesting an amendment to the existing Embraer Model EMB-550 Special Conditions No. 25-520-SC as a result of harmonization efforts in the Flight Test Harmonization Working Group (FTHWG). The Embraer Model EMB-550 airplane, currently approved under Type Certificate No. TC00062IB, is a twin-engine, transport category airplane with a maximum takeoff weight of 42,857 pounds. The Embraer Model EMB-550 has a maximum seating capacity of 12 passengers.
Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Embraer must show that the Embraer Model EMB-550 airplane, as changed, continues to meet the applicable provisions of the regulations listed in Type Certificate No. TC00062IB or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, the Embraer Model EMB-550 airplane must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.
The Embraer Model EMB-550 airplane will incorporate the following novel or unusual design features:
The Embraer Model EMB-550 airplane flight control system design incorporates normal load factor limiting on a full-time basis that will prevent the pilot from inadvertently or intentionally exceeding the positive or negative airplane limit load factor. This feature is considered novel and unusual in that the current regulations do not provide standards for maneuverability and controllability evaluations for such systems.
The normal load factor limit on the Embraer Model EMB-550 airplane is unique in that traditional airplanes with conventional flight control systems (mechanical linkages) are limited in the pitch axis only by the elevator surface area and deflection limit. The elevator control power is normally derived for adequate controllability and the maneuverability at the most critical longitudinal pitching moment. The result is that traditional airplanes have a significant portion of the flight envelope where maneuverability in excess of limit structural design values is possible. The Embraer Model EMB-550 airplane because of the normal load factor limit does not have this excess maneuverability.
Title 14, Code of Federal Regulations (14 CFR) part 25 does not specify requirements for demonstrating maneuver control that impose any handling qualities requirements beyond the design limit structural loads. Nevertheless, some pilots are accustomed to the availability of this excess maneuver capacity in case of extreme emergency such as upset recoveries or collision avoidance.
As a result of harmonization efforts with other civil aviation authorities through the Flight Test Harmonization Working Group (FTHWG) and Embraer's request to incorporate them into Special Conditions No. 25-520-SC, the FAA is including additional flexibility in maneuverability limits by amending the existing Embraer Model EMB-550 airplane Special Conditions No. 25-520-SC. This additional flexibility allows for reduced maneuverability limits beyond V
The special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
The FAA issued Notice of Proposed Special Conditions No. 25-19-01-SC for the Embraer Model EMB-550 airplane, which was published in the
As discussed above, these special conditions are applicable to the Embraer Model EMB-550 airplane. Should Embraer apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.
Under standard practice, the effective date of final special conditions would be 30 days after the date of publication in the
This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.
1. To meet the intent of adequate maneuverability and controllability required by § 25.143(a), and in addition to the requirements of § 25.143(a) and in the absence of other limiting factors, the following special conditions are based on § 25.333(b):
a. The positive limiting load factor must not be less than:
(1) 2.5g for the normal state of the electronic flight control system with the high lift devices retracted up to V
(2) 2.0g for the normal state of the electronic flight control system with the high lift devices extended.
b. The negative limiting load factor must be equal to or more negative than:
(1) Minus 1.0g for the normal state of the electronic flight control system with the high lift devices retracted.
(2) 0.0g for the normal state of the electronic flight control system with high lift devices extended.
c. Maximum reachable positive load factor wings level may be limited by the characteristics of the electronic flight control system or flight envelope protections (other than load factor protection) provided that:
(1) The required values are readily achievable in turns, and
(2) Wings level pitch up responsiveness is satisfactory.
d. Maximum achievable negative load factor may be limited by the characteristics of the electronic flight control system or flight envelope protections (other than load factor protection) provided that:
(1) Pitch down responsiveness is satisfactory, and
(2) From level flight, 0g is readily achievable or alternatively, a satisfactory trajectory change is readily achievable at operational speeds. For the FAA to consider a trajectory change as satisfactory, the applicant should propose and justify a pitch rate that provides sufficient maneuvering capability in the most critical scenarios.
e. Compliance demonstration with the above requirements may be performed without ice accretion on the airframe.
f. These special conditions do not impose an upper bound for the normal load factor limit, nor does it require that the limiter exist. If the limit is set at a value beyond the structural design limit maneuvering load factor “n” of §§ 25.333(b), 25.337(b) and 25.337(c), there should be a very obvious positive tactile feel built into the controller so that it serves as a deterrent to inadvertently exceeding the structural limit.
Drug Enforcement Administration, Department of Justice.
Final rule; correcting amendment.
The Drug Enforcement Administration is correcting a final order that appeared in the
Effective Date: May 8, 2019.
Lynnette M. Wingert, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
On May 29, 1987, the Drug Enforcement Administration (DEA) placed six substances, including 3-methylthiofentanyl, into schedule I of the Controlled Substances Act. 52 FR 20070. At that time, the introductory text was revised to clearly indicate that optical and geometric isomers of 3-methylthiofentanyl were controlled. On January 8, 1988, paragraph (b)(34), the listing for 3-methylthiofentanyl, was redesignated to (b)(35), but the introductory text was not revised. 53 FR 500. On May 16, 2016, paragraph (b)(35), the listing for 3-methylthiofentanyl, was redesignated to (b)(36), but the introductory text was not revised. 81 FR 22023. On June 7, 2017, paragraph (b)(36), the listing for 3-methylthiofentanyl, was redesignated to (b)(37), but the introductory text was not revised. 82 FR 26349. On April 20, 2018, paragraph (b)(37), the listing for 3-methylthiofentanyl, was redesignated to (b)(38), but the introductory text was not revised. 83 FR 17486. On November 29, 2018, paragraph (b)(38), the listing for 3-methylthiofentanyl, was redesignated to (b)(41), the present listing for 3-methylthiofentanyl, and a further error was introduced by modifying the reference to (b)(34) in the preamble to (b)(39), due to a drafting fault. 83 FR 61320.
Previously, the prefatory language has identified 3-methylthiofentanyl by paragraph number. However, the paragraph numbers have changed frequently over time, as new substances are identified and added to the list of schedule I substances in § 1308.11(b). In order to avoid similar oversights or confusion in the future, this correction changes the designation to reference 3-methylthiofentanyl by name rather than by paragraph number.
Because this final rule is limited to a technical correction for accuracy and does not substantively alter any regulation, and is therefore insignificant in nature and impact, and inconsequential to the public, the Agency finds good cause that notice and public procedure are unnecessary to the promulgation of this correction. 5 U.S.C. 553(b)(B). The Agency also finds that this technical correction merely clarifies or explains the existing regulation and is therefore an interpretive rule that does not require notice and comment rulemaking. 5 U.S.C. 553(b)(A);
Because, as described above, this final rule is limited to a technical correction for accuracy and does not substantively alter any regulation, and is therefore insignificant in nature and impact, and inconsequential to the public, the Agency finds good cause to make this final rule effective upon the date of publication and to forego thirty days prior notice.
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, 21 CFR part 1308 is amended as follows:
21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.
(b)
Drug Enforcement Administration, Department of Justice.
Final rule.
With the issuance of this final rule, the Drug Enforcement Administration places
This final rule is effective May 8, 2019.
Lynnette M. Wingert, Regulatory Drafting and Policy Support Section, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
The Controlled Substances Act (CSA) provides that proceedings for the issuance, amendment, or repeal of the scheduling of any drug or other substance may be initiated by the Attorney General (1) on his own motion; (2) at the request of the Secretary of the Department of Health and Human Services (HHS),
On May 12, 2016, the DEA published a final order in the
On April 27, 2018, the HHS provided the DEA with a scientific and medical evaluation and scheduling recommendation for
After a review of the available data, including the scientific and medical evaluation and the scheduling recommendation from the HHS, the former Acting Administrator of the DEA published a NPRM entitled “Schedules of Controlled Substances: Placement of
The DEA received 25 comments on the proposed rule to control
Ten commenters supported controlling
One commenter stated that
One commenter expressed concerns about the roles of phones in classroom and wants smart phones out of public schools. Another commenter highlighted the gap in medical education system and emphasized the need for physicians to handle difficulties associated with prescription drug abuse. Another commenter stated that words matter when handling complex issues like powerful prescription drugs. Three commenters misinterpreted
With regard to the gap in medical education system and the need to educate physicians to tackle prescription drug abuse, the DEA has worked aggressively to improve its communication and cooperation with registrant medical professionals by maintaining an open dialogue with national associations such as the American Medical Association, Federation of State Medical Boards, and other groups to address diversion problems and educate the medical community on improving prescribing practices. In May 2018, the DEA initiated a nationwide program to train individual practitioners through Practitioner Diversion Awareness Conferences (PDACs) throughout the country. In addition to the PDAC training, the DEA has also sent correspondence to 1.3 million prescribers nationwide, alerting them of the Centers for Disease Control and Prevention (CDC) recommendation (part of CDC's Prescribing Guideline for Chronic Pain) for opioid prescribing for acute pain and alerted practitioners to a free training webinar available from CDC. The DEA is also working on similar correspondence to alert these same practitioners about resources available from the Substance Abuse and Mental Health Services Administration (SAMHSA) to locate substance abuse treatment providers in their state.
This rule will not affect patient access to FDA-approved fentanyl medications (such as the fentanyl transdermal patch) because the rule is limited to
Based on consideration of all comments, the scientific and medical evaluation and accompanying recommendation of the HHS, and the DEA's consideration of its own eight-factor analysis, the DEA finds that these facts and all other relevant data constitute substantial evidence of potential for abuse of
The CSA establishes five schedules of controlled substances known as schedules I, II, III, IV, and V. The CSA also outlines the findings required to place a drug or other substance in any particular schedule. 21 U.S.C. 812(b). After consideration of the analysis, recommendation of the Assistant Secretary for HHS, and review of all other available data, the Acting Administrator of the DEA, pursuant to 21 U.S.C. 811(a) and 21 U.S.C. 812(b)(1), finds that:
1.
2.
3. There is a lack of accepted safety for use of
Based on these findings, the Acting Administrator of the DEA concludes that
Upon the effective date of this final rule,
1.
2.
3.
4.
5.
6.
After the initial inventory, every DEA registrant must take a new inventory of all stocks of controlled substances (including
In accordance with 21 U.S.C. 811(a), this scheduling action is subject to formal rulemaking procedures done “on the record after opportunity for a hearing,” which are conducted pursuant to the provisions of 5 U.S.C. 556 and 557. The CSA sets forth the criteria for scheduling a drug or other substance. Such actions are exempt from review by the Office of Management and Budget (OMB) pursuant to section 3(d)(1) of Executive Order 12866 and the principles reaffirmed in Executive Order 13563.
This final rule does not meet the definition of an Executive Order 13771 regulatory action. OMB has previously determined that formal rulemaking actions concerning the scheduling of controlled substances, such as this rule, are not significant regulatory actions under Section 3(f) of Executive Order 12866.
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate drafting errors and ambiguity, minimize litigation, provide a clear legal standard for affected conduct, and promote simplification and burden reduction.
This rulemaking does not have federalism implications warranting the application of Executive Order 13132. The rule does not have substantial direct effects on the States, on the relationship between the national government and the States, or the distribution of power and responsibilities among the various levels of government.
This rule does not have tribal implications warranting the application of Executive Order 13175. It does not have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
The Acting Administrator, in accordance with the Regulatory Flexibility Act, 5 U.S.C. 601-602, has reviewed this final rule and by approving it, certifies that it will not have a significant economic impact on a substantial number of small entities. On May 12, 2016, the DEA published a final order to temporarily place
A review of the 20 registrations indicates that all entities that currently handle
In accordance with the Unfunded Mandates Reform Act (UMRA) of 1995, 2 U.S.C. 1501
This action does not impose a new collection of information under the Paperwork Reduction Act of 1995. 44 U.S.C. 3501-3521. This action will not impose recordkeeping or reporting requirements on State or local governments, individuals, businesses, or organizations. 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.
This final rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Congressional Review Act (CRA)). This rule will not result in: An annual effect on the economy of $100,000,000 or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets. However, pursuant to the CRA, the DEA has submitted a copy of this final rule to both Houses of Congress and to the Comptroller General.
The DEA is making the rule effective on the date of publication in the
Administrative practice and procedure, Drug traffic control, Reporting and recordkeeping requirements.
For the reasons set out above, the DEA amends 21 CFR part 1308 as follows:
21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise noted.
The addition reads as follows:
(b) * * *
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the special local regulation on the Black River in South Haven, Michigan for the Harborfest Dragon Boat Race on June 15, 2019. This action is necessary and intended to protect the safety of life and property on navigable waters prior to, during, and immediately after the boat race. During the enforcement period listed below vessels and persons are prohibited from transiting through, mooring, or anchoring within the special local regulation unless authorized by the Captain of the Port Lake Michigan or a designated representative. The operator of any vessel in the regulated area must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign.
The regulations in 33 CFR 100.903 will be enforced from 7 a.m. through 6 p.m. on June 15, 2019.
If you have questions about this notice of enforcement, call or email marine event coordinator MSTC Kaleena Carpino, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI; telephone (414) 747-7148, email
The Coast Guard will enforce the special local regulation in 33 CFR 100.903 from 7 a.m. through 6 p.m. on June 15, 2019. This special local regulation encompasses the waters of the Black River in South Haven, MI within the following coordinates starting at 42°24′13.6″ N, 086°16′41″ W; then southeast 42°24′12.6″ N, 086°16′40″ W; then northeast to 42°24′19.2″ N, 086°16′26.5″ W; then northwest to 42°24′20.22″ N, 086°16′27.4″ W; then back to point of origin. (NAD 83). As specified in 33 CFR 100.901, no vessel may enter, transit through, or anchor within the regulated area without the permission of the Coast Guard Patrol Commander. This action is being taken to provide for the safety of life and property on navigable waterways prior to, during, and immediately after the boat race.
Pursuant to 33 CFR 100.903, Harborfest Dragon Boat Race; South Haven, MI, entry into, transiting, or anchoring within the special local regulation during an enforcement period is prohibited unless authorized by the Captain of the Port Lake Michigan, or a designated on-scene representative. Those seeking permission to enter the special local regulation may request permission from the Captain of Port Lake Michigan via channel 16, VHF-FM or at (414) 747-7182. If you are the operator of a vessel in the regulated area during the enforcement period you must comply with directions from the Patrol
This notice of enforcement is issued under the authority of 33 CFR 100.903 and 5 U.S.C. 552(a). In addition to this notice of enforcement in the
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the special local regulation for the Washburn Board Across the Bay event in Washburn, WI from 7:30 a.m. through 12:30 p.m. on July 27, 2019. This action is necessary to protect participants and spectators during the Board Across the Bay event. During the enforcement period, vessels transiting within the regulated area shall travel at a no-wake speed except as may be permitted by the Captain of the Port Duluth or a designated on-scene representative. Additionally, vessels shall yield right-of-way for event participants and event safety craft and shall follow directions given by event representatives during the event.
The regulations in 33 CFR 100.169 will be enforced from 7:30 a.m. through 12:30 p.m. on July 27, 2019.
If you have questions on this document, call or email LT Abbie Lyons, Chief of Waterways Management, Coast Guard; telephone (218) 725-3818, email
The Coast Guard will enforce the special local regulation for the annual Washburn Board Across the Bay event in 33 CFR 100.169 from 7:30 a.m. through 12:30 p.m. on July 27, 2019 on all waters of the Chequamegon Bay within 100 yards of either side of an imaginary line beginning in Washburn, WI at position 46°36′52″ N, 090°54′24″ W; thence southwest to position 46°38′44″ N, 090°54′50″ W; thence southeast to position 46°37′02″ N, 090°50′20″ W; and ending southwest at position 46°36′12″ N, 090°51′51″ W.
Vessels transiting within the regulated area shall travel at a no-wake speed except as may be permitted by the Captain of the Port Duluth or a designated on-scene representative. Additionally, vessels shall yield right-of-way for event participants and event safety craft and shall follow directions given by event representatives during the event.
This document is issued under authority of 33 CFR 100.169 and 5 U.S.C. 552(a). In addition to this publication in the
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the temporary safety zone for the Hemingway Sunset Run & Paddleboard Race, Key West, Florida on July 20, 2019. Our regulation for Recurring Safety Zones in Captain of the Port Key West Zone identifies the regulated area for this event. This action is necessary to ensure the safety of event participants and spectators. During the enforcement period, no person or vessel may enter, transit through, anchor in, or remain within the regulated area without approval from the Captain of the Port Key West or a designated representative.
The regulations in 33 CFR 165.786, Table to § 165.786, Item 7.1 will be enforced from 5 p.m. until 6:30 p.m. on July 20, 2019.
If you have questions about this notice of enforcement, call or email Gregory Bergstrom, Sector Key West Waterways Management Department, Coast Guard; telephone (305) 292-8772; email
The Coast Guard will enforce the safety zones in 33 CFR 165.786, for the Hemingway Sunset Run and Paddleboard Race regulated area from 5 p.m. to 6:30 p.m. on July 20, 2019. This action is being taken to provide for the safety of life on navigable waterways during this event. Our regulation for recurring marine events within Sector Key West, Table to § 165.786, Item 7.1, specifices the location of the regulated area. During the enforcement period, no person or vessel may enter, transit through, anchor in, or remain within the established regulated areas without approval from the Captain of the Port Key West or designated representative. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.
The Coast Guard will provide notice of the regulated area by Local Notice to Mariners and Broadcast Notice to Mariners. If the Captain of the Port Key West determines that the regulated area need not be enforced for the full duration stated in this publication, he or she may use a Broadcast Notice to Mariners to grant general permission to enter the regulated area.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone in 33 CFR 165.943 for the Bridgefest Regatta Fireworks in Houghton, MI from 9:30 p.m. through 11:30 p.m. on June 15, 2019. This action is necessary to protect participants and spectators prior to, during, and immediately after the fireworks display. During the enforcement period listed below, entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Duluth or a designated on-scene representative.
The regulations in 33 CFR 165.943(a)(1) will be enforced as listed in Table 165.943 from 9:30 p.m. through 11:30 p.m. on June 15, 2019.
If you have questions about this notice of enforcement, call or email LT Abbie Lyons, Chief of Waterways Management, Coast Guard; telephone (218) 725-3818, email
The Coast Guard will enforce the Bridgefest Regatta Fireworks safety zone listed as item (1) in Table 165.943 of 33 CFR 165.943 from 9:30 p.m. through 11:30 p.m. on June 15, 2019 on all waters of the Keweenaw Waterway bounded by the arc of a circle with a 100-yard radius from the fireworks launch site with its center in approximate position 47°07′28″ N, 088°35′02″ W. This action is being taken to provide for the safety of life and property on a navigable waterway during the fireworks display.
Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Duluth or a designated on-scene representative. The Captain of the Port Duluth or an on-scene representative may be contacted via VHF Channel 16 or at (906) 635-3217.
This notice of enforcement is issued under authority of 33 CFR 165.943 and 5 U.S.C. 552 (a). In addition to this publication in the
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the safety zone for the Pointe to La Pointe Swim event in Bayfield, WI from 5:30 a.m. through 10:30 a.m. on August 03, 2019. This action is necessary to protect participants and spectators during the event. During the enforcement period, entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Duluth or a designated on-scene representative.
The regulation listed in 33 CFR 165.943(a)(9) will be enforced as listed in Table 1 to § 33 CFR 165.943 from 5:30 a.m. through 10:30 a.m. on August 3, 2019.
If you have questions on this document, call or email LT Abbie Lyons, Chief of Waterways Management, Coast Guard; telephone (218) 725-3818, email
The Coast Guard will enforce the special local regulation for the annual Pointe to La Pointe Swim event in 33 CFR 165.943(a)(9) from 5:30 a.m. through 10:30 a.m. on August 3, 2019 on all waters between Bayfield, WI and Madeline Island, WI within an imaginary line created by the following coordinates: 46°48′50.97″ N, 090°48′44.28″ W, moving southeast to 46°46′44.90″ N, 090°47′33.21″ W, then moving northeast to 46°46′52.51″ N 090°47′17.14″ W, then moving northwest to 46°49′03.23″ N 090°48′25.12″ W and finally running back to the starting point.
Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Duluth or a designated on-scene representative.
This notice of enforcement is issued under authority of 33 CFR 165.943 and 5 U.S.C. 552 (a). In addition to this publication in the
Coast Guard, DHS.
Final rule.
The Coast Guard is updating its recurring safety zones regulations in the Captain of the Port Detroit. This rule updates 51 safety zones locations, dates, and sizes, adds three safety zones, removes six established safety zones, and reformats the regulations into an easier to read table format. These amendments will protect spectators, participants, and vessels from the hazards associated with annual marine events and firework shows, and improve the clarity and readability of the regulation.
This rule is effective June 7, 2019.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Tracy Girard, Prevention Department, Sector Detroit, Coast Guard; telephone (313) 568-9564, email
On March 25, 2019 the Coast Guard published an NPRM in the
Included in the NPRM was an invitation to make comments on the proposed regulatory action for updating the safety zones in § 165.941. During the comment period that ended April 25, 2019, the Coast Guard received no comments.
The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034, 70051, 33 CFR 1.05.1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1. The Captain of the Port Detroit (COTP) has determined these regulations are necessary to ensure vessels and persons are protected from the specific hazards related to the aforementioned events. These specific hazards include obstructions in the waterway that may cause marine casualties; collisions among vessels maneuvering at a high speed within a channel; the explosive dangers involved in pyrotechnics and hazardous cargo; and flaming/falling debris into the water that may cause injuries. Therefore, the COTP is establishing a safety zone around the event locations listed in the table under § 165.941 to help minimize risks to safety of life and property during this event.
As noted above, we received no comments on our NPRM published March 25, 2019. There are no changes in the regulatory text of this rule from the proposed rule in the NPRM.
This rule updates 51 safety zone locations, dates, and sizes, adds three safety zones, removes six established safety zones and reformat the regulations into an easier to read table format. These amendments will protect spectators, participants, and vessels from the hazards associated with annual marine events and firework shows, and improve the clarity and readability of the regulation.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the rule has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the size, location, duration, and time of day of the safety zones. The safety zones created by this rule will be relatively small and effective during the time to ensure safety of spectator and participants for the listed triggering or marine events. Moreover, the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM about the zone, and the rule will allow vessels to seek permission to enter the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section IV.A above, this rule will not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule updates 51 safety zone locations, dates, and sizes, adds three safety zones, removes six established safety zones and reformat the regulations into an easier to read table format. It is categorically excluded from further review under paragraph L[60] of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR 165.941 as follows:
46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a) Regulations. The following regulations apply to the safety zones listed in Table 1 to § 165.941 of this section, coordinates listed in table are North American Datum of 1983 (NAD 83).
(1) In accordance with the general regulations in § 165.23 of this part, entry into, transiting, or anchoring within any of the safety zones listed in this section is prohibited unless authorized by the Captain of the Port Detroit or a designated representative.
(2) These safety zones are closed to all vessel traffic, except as may be permitted by the Captain of the Port Detroit or his designated on-scene representative.
(3) Vessel operators desiring to enter or operate within the safety zone must contact the Captain of the Port Detroit or an on-scene representative to obtain permission to do so. The Captain of the Port Detroit or an on-scene representative may be contacted via VHF Channel 16. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port Detroit, or an on-scene representative.
(4) The enforcement dates and times for each of the safety zones listed in Table 1 to § 165.941 are subject to change, but the duration of enforcement would remain the same or nearly the same total number of hours as stated in the table. In the event of a change, the Captain of the Port Detroit will provide notice to the public by publishing a Notice of Enforcement in the
(b)
(1) Designated or on scene representative means any Coast Guard commissioned, warrant, or petty officers designated by the Captain of the Port Detroit to monitor a safety zone, permit entry into a safety zone, give legally enforceable orders to persons or vessels within a safety zone, and take other actions authorized by the Captain of the Port Detroit.
(2) Public vessel means a vessel that is owned, chartered, or operated by the United States, or by a State or political subdivision thereof.
(3) Rain date refers to an alternate date and/or time in which the safety zone would be enforced in the event of inclement weather.
(c)
(d)
(e)
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce a safety zone for the St. Joseph Fourth of July Fireworks display on the St. Joseph River and Lake Michigan in St. Joseph, MI from 9 p.m. through 11 p.m. on July 3, 2019. This action is necessary and intended to ensure safety of life on navigable waters immediately prior to, during, and after the fireworks display. During the enforcement period, entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan or a designated representative.
The regulations in 33 CFR 165.929 will be enforced for safety zone (e)(5), Table 165.929, from 9 p.m. through 11 p.m. on July 3, 2019.
If you have questions on this notice of enforcement, call or email marine event coordinator MST1 Kaleena Carpino, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI; telephone (414) 747-7148, email
The Coast Guard will enforce the St. Joseph Fourth of July Fireworks display safety zone listed as item (e)(5) in Table 165.929 of 33 CFR 165.929 from 9 p.m. through 11:00 p.m. on July 3, 2019 on all waters of Lake Michigan and the St. Joseph River within the arc of a circle with a 1,000-foot radius from the fireworks launch site in position 42°06.867′ N, 086° 29.463′ W. (NAD 83). Entry into, transiting, or anchoring within the safety zone is prohibited unless
This notice of enforcement is issued under authority of 33 CFR 165.929, Safety Zones; Annual events requiring safety zones in the Captain of the Port Lake Michigan zone, and 5 U.S.C. 552(a). In addition to this publication in the
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for all navigable waters of the Fox River, in the vicinity of Green Bay Metropolitan Sewerage District, De Pere facility and the Northern pier of the Perkofski Boat Launch. This action is needed to protect personnel and vessels from potential hazards created by the outfall of a fireworks display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Lake Michigan.
This rule is effective from 9 p.m. through 11 p.m. on May 26, 2019.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email the marine event coordinator, MSTC Kaleena Carpino, Prevention Department, Coast Guard Sector Lake Michigan, Milwaukee, WI; telephone (414) 747-7148, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because doing so would be impracticable and contrary to the public interest. The final details for this event were not known to the Coast Guard until there was insufficient time remaining before the event to publish an NPRM. Thus, delaying the effective date of this rule to wait for a comment period to run would be both impracticable and contrary to the public interest because it would inhibit the Coast Guard's ability to protect the public, vessels, mariners, and property from the hazards associated with a fireworks display on May 26, 2019.
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 46 U.S.C. 70034 (previously 33 U.S.C. 1231); 33 CFR 1.05-1, 160.5; Department of Homeland Security Delegation No. 0170.1.
A fireworks display will take plan on Fox River in De Pere, WI on May 26, 2019 from 9 p.m. through 11 p.m. The Captain of the Port Lake Michigan has determined that this fireworks display will pose a significant risk to public safety and property. Such hazards include premature and accidental detonations, falling and burning debris, and collisions among spectator vessels.
With the aforementioned hazards in mind, the Captain of the Port Lake Michigan has determined that this temporary safety zone is necessary to protect persons and vessels during the fireworks display in the waters of the Fox River, in De Pere, WI. This zone is effective and will be enforced from 9 p.m. through 11 p.m. on May 26, 2019. The safety zone will be enforced for all navigable waters of the Fox River, in the vicinity of Green Bay Metropolitan Sewerage District, De Pere facility and the Northern pier of the Perkofski Boat Launch within an area bounded by the following coordinates; at 44°27′43.26″ N 88°03′34.86″ W (NAD 83) continuing east across the Fox River to 44°27′41.18″ N 88°03′24.32″ W (NAD 83) then south along the riverbank to 44°27′18.10″ N 88°03′40.79″ W (NAD 83) then west across the Fox River to 44°27′32.12″ N 88°04′06.21″ W (NAD 83) then north returning to the point of origin.
Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan or his or her designated on-scene representative. The Captain of the Port or his or her designated on-scene representative may be contacted via VHF Channel 16.
We developed this rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This rule has not been designated a
We conclude that this rule is not a significant regulatory action because we anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. This regulatory action determination is based on the size, location, duration, and time-of-year of the safety zone. The safety zone created by this rule will be relatively small and enforced for only two hours. Under certain conditions, vessels may still transit through the safety zone when permitted by the Captain of the Port. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting only 2 hours that will prohibit entry within the established safety zone for the firework display. It is categorically excluded from further review under paragraph L60a of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A Record of Environmental Consideration supporting this determination is available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port Lake Michigan or a designated on-scene representative.
(3) The “on-scene representative” of the Captain of the Port Lake Michigan is any Coast Guard commissioned, warrant or petty officer who has been designated by the Captain of the Port Lake Michigan to act on his or her behalf.
(4) Vessel operators desiring to enter or operate within the safety zone must contact the Captain of the Port Lake Michigan or an on-scene representative to obtain permission to do so. The Captain of the Port Lake Michigan or an on-scene representative may be contacted via VHF Channel 16. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port Lake Michigan or an on-scene representative.
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes tolerances for residues of the insecticide cyflumetofen in or on tea, dried. OAT Agrio. Ltd., Tokyo, Japan c/o Landis International, Inc. requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
This regulation is effective May 8, 2019. Objections and requests for hearings must be received on or before July 8, 2019 and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2017-0532, is available at
Michael L. Goodis, P.E., Director, Registration Division (750P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2017-0532 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing and must be received by the Hearing Clerk on or before July 8, 2019. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2017-0532, by one of the following methods:
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•
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In the
Based upon review of the data supporting the referenced petition, EPA is establishing a tolerance for residues of cyflumetofen on tea, dried.
Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . .”
Consistent with FFDCA section 408(b)(2)(D), and the factors specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for cyflumetofen including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with cyflumetofen follows.
EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.
Cyflumetofen has a low acute toxicity via the acute oral, dermal, and inhalation routes of exposure. It is minimally irritating to the eyes but not to the skin. Cyflumetofen is a skin sensitizer. The major target organ in rats, mice, and dogs following short- and long-term oral administration of cyflumetofen is the adrenal glands characterized by increased organ weight and histopathology (vacuolation and hypertrophy of the adrenal cortical cells).
There is no evidence of increased qualitative or quantitative susceptibility in the rat 2-generation reproduction study; however, the rat and rabbit developmental studies indicate susceptibility in the pups. There is evidence of increased quantitative susceptibility in the rabbit developmental toxicity study, since developmental effects at the limit dose were observed where no maternal toxicity was present. There is evidence of increased qualitative susceptibility in the rat developmental toxicity study as developmental effects were seen at the same dose that caused an increase in adrenal weights and organ-to-body weight ratio in the maternal animals.
There is no evidence of neurotoxicity in any of the submitted studies for cyflumetofen.
Cyflumetofen has been classified as having “Suggestive Evidence of Carcinogenic Potential” in accordance with the EPA's Final Guidelines for Carcinogen Risk Assessment (March 2005). This classification is based on the presence of a single tumor type (thyroid c-cell) in one sex (male) and one species (rat), and the lack of concern for mutagenicity. When there is suggestive evidence of carcinogenicity, the Agency does not attempt a dose-response assessment as the nature of the data generally would not support one. Therefore, the Agency has determined that quantification of risk using a non-linear approach (
More detailed information on the studies received and the nature of the adverse effects caused by cyflumetofen as well as the NOAEL and the LOAEL from the toxicological studies can be found in the document entitled, “Cyflumetofen. Human Health Risk Assessment to Support New Uses on Imported Tea,” dated March 4, 2019, by going to
Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level—generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD)—and a safe margin of exposure (MOE). For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, see
A summary of the toxicological endpoints for cyflumetofen used for human risk assessment is shown in the Table of this unit.
More detailed information on the toxicological endpoints for cyflumetofen can be found in the document entitled, “Cyflumetofen. Human Health Risk Assessment to Support New Uses on Imported Tea,” dated March 4, 2019, by going to
1.
i.
ii.
iii.
iv.
More detailed information on the acute and chronic dietary (food only) exposure and risk assessment for cyflumetofen can be found in the document entitled, “Cyflumetofen. Human Health Risk Assessment to Support New Uses on Imported Tea,” dated March 4, 2019, by going to
2.
The estimated drinking water concentrations (EDWCs) previously used in the dietary risk assessment were incorporated directly into this dietary assessment. The Pesticide Root Zone Model/Exposure Analysis Modeling System (PRZM/EXAMS) simulations of a NY grapes scenario produced the highest surface-water EDWCs (0.33 ppb for chronic dietary exposure) and an updated EDWC was not required for this assessment since the proposed use on imported tea will not impact the previously provided estimates.
Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 0.33 ppb was used to assess the contribution to drinking water.
3.
4.
EPA has not found cyflumetofen to share a common mechanism of toxicity with any other substances, and cyflumetofen does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that cyflumetofen does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website at
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2.
3.
i. The toxicity database for cyflumetofen is complete and adequate to characterize potential pre- and/or post-natal risk for infants and children.
ii. There are acute and subchronic neurotoxicity studies available. There is no indication that cyflumetofen is a neurotoxic chemical in any of the submitted studies for cyflumetofen, and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. While there is evidence of increased susceptibility in the rabbit and rat developmental studies, these studies have clearly defined NOAEL/LOAELs based on the explanation in Unit III.D.2. above.
iv. There are no residual uncertainties identified in the exposure database. Since the dietary and residential exposure estimates were based on conservative assumptions, EPA is confident that this assessment does not underestimate dietary (food and water) or residential exposure.
EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.
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2.
3.
Since no dermal hazard was identified for cyflumetofen in the toxicological database, only inhalation exposure assessments were conducted for residential handlers. The most conservative residential exposure scenario was chosen for the adult population which reflects inhalation exposure from mixing/loading/applying the liquid cyflumetofen formulation with a backpack sprayer. For background dietary exposure, the adult sub-population with the highest exposure (adults 50-99) was chosen since this is protective for all other adult sub-populations. There are no residential exposures expected for children; therefore, a short-term aggregate risk assessment for children is equal to the chronic food and drinking water exposure and risk estimates and is not of concern. Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures result in aggregate MOEs above the LOC of 100 for all scenarios assessed and are not of concern.
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An adequate enforcement methodology is available to enforce the HED-recommended tolerances for cyflumetofen in plant commodities. The high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) method has been adequately validated, has undergone a successful ILV (independent laboratory validation), is considered adequately radio-validated and has been reviewed by the Agency for appropriateness as an enforcement method. The method limit of detection (LOD) for residues of cyflumetofen in tea is 0.01 ppm. Cyflumetofen has also been subjected to analysis by the Food and Drug Administration (FDA) multi-residue method (MRM) protocols. Cyflumetofen is not adequately recovered through any of the FDA multi-residue protocols.
The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; email address:
In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint United Nations Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.
Codex has not established maximum residue limits (MRLs) for residues of cyflumetofen in tea commodities; therefore, there are no harmonization issues.
To conform with to the Agency's preferred commodity vocabulary, EPA is establishing the tolerance for tea on “tea, dried”, which will cover residues on all tea commodities.
Therefore, a tolerance is established for residues of the insecticide cyflumetofen, (2-methoxyethyl α-cyano-α-[4-(1,1-dimethylethyl)phenyl]-β-oxo-2-(trifluoromethyl)benzenepropanoate), in or on tea at 40 ppm.
This action establishes a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), nor is considered a regulatory action under Executive Order 13771, entitled “Reducing Regulations and Controlling Regulatory Costs” (82 FR 9339, February 3, 2017). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
This action directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of FFDCA section 408(n)(4). As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000) do not apply to this action. In addition, this action does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1501
This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 note).
Pursuant to the Congressional Review Act (5 U.S.C. 801
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
21 U.S.C. 321(q), 346a and 371.
(a) * * *
Agricultural Marketing Service, USDA.
Proposed rule.
This proposed rule would implement a recommendation from the Cherry Industry Administrative Board (Board) to establish free and restricted percentages for the 2018-19 crop year under the Marketing Order for tart cherries grown in the states of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin. This action would establish the proportion of tart cherries from the 2018-19 crop which may be handled in commercial outlets. This action would also revise the regulations regarding grower diversion. This action should stabilize marketing conditions by adjusting supply to meet market demand and help improve grower returns.
Comments must be received by June 7, 2019.
Interested persons are invited to submit written comments concerning this proposal. Comments must be sent to the Docket Clerk, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Fax: (202) 720-8938; or internet:
Jennie M. Varela, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-2491, Fax: (202) 720-8938, or Email:
This action, pursuant to 5 U.S.C. 553, proposes an amendment to regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposed rule is issued under Marketing Agreement and Order No. 930, both as amended (7 CFR part 930), regulating the handling of tart cherries produced in the states of Michigan, New York, Pennsylvania, Oregon, Utah, Washington and Wisconsin. Part 930 (referred to as the “Order”) is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The Board locally administers the Order and is comprised of producers and handlers of tart cherries operating within the production area, and a public member.
The Department of Agriculture (USDA) is issuing this proposed rule in conformance with Executive Orders 13563 and 13175. This proposed rule falls within a category of regulatory action that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review. Additionally, because this proposed 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).
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. Under the Order provisions now in effect, free and restricted percentages may be established for tart cherries handled during the crop year. This proposed rule would establish free and restricted percentages for tart cherries for the 2018-19 crop year, beginning July 1, 2018, through June 30, 2019.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
This proposed rule invites comments on the establishment of free and restricted percentages for the 2018-19 crop year. This proposal would establish the proportion of tart cherries from the 2018-19 crop which may be handled in commercial outlets at 73 percent free and 27 percent restricted. This action would also revise the regulations regarding grower diversion to codify the Board's definition of marketable fruit. The Secretary of Agriculture (Secretary) has determined that designating free and restricted percentages of tart cherries for the 2018-2019 crop year would effectuate the declared policy of the Act to stabilize marketing conditions by adjusting supply to meet market demand and help improve grower returns. These recommendations were made by the Board at meetings on September 13, 2018, and October 23, 2018.
Section 930.51(a) provides the Secretary authority to regulate volume by designating free and restricted percentages for any tart cherries acquired by handlers in a given crop year. Section 930.50 prescribes procedures for computing an optimum supply based on sales history and for calculating these free and restricted percentages. Free percentage volume may be shipped to any market, while restricted percentage volume must be held by handlers in a primary or secondary reserve, or be diverted or used for exempt purposes as prescribed in §§ 930.159 and 930.162. Exempt purposes include, in part, the development of new products, sales into new markets, the development of export markets, and charitable contributions. Sections 930.55 through 930.57 prescribe procedures for inventory reserve. For cherries held in reserve, handlers would be responsible for storage and would retain title of the tart cherries.
Under § 930.52, only districts with an annual average production over the prior three years of at least six million pounds are subject to regulation, and any district producing a crop that is less than 50 percent of its annual average of the previous five years is exempt. The regulated districts for the 2018-19 crop year would be: District 1—Northern Michigan; District 2—Central Michigan; District 3—Southern Michigan; District 4—New York; District 7—Utah; District 8—Washington; and District 9—Wisconsin. Districts 5 and 6 (Oregon and Pennsylvania, respectively) would not be regulated for the 2018-19 season.
Section 930.58 of the Order provides authority for voluntary grower diversion. When volume regulation is in effect, growers can divert all or a portion of their cherries which otherwise, upon delivery to a handler, would be subject to regulation. This section also authorizes the Board, with the approval of the Secretary, to establish terms and conditions for grower diversion. Section 930.158 prescribes the rules and regulations for grower diversion, including a requirement that diverted cherries be marketable.
Demand for tart cherries and tart cherry products tends to be relatively stable from year to year. Conversely, annual tart cherry production can vary greatly. In addition, tart cherries are processed and can be stored and carried over from crop year to crop year, further impacting supply. As a result, supply and demand for tart cherries are rarely in balance.
Because demand for tart cherries is inelastic, total sales volume is not very responsive to changes in price. However, prices are very sensitive to changes in supply. As such, an oversupply of cherries would have a sharp negative effect on prices, driving down grower returns. Aware of this economic relationship, the Board focuses on using the volume control provisions in the Order to balance supply and demand to stabilize industry returns.
Pursuant to § 930.50, the Board meets on or about July 1 to review sales data, inventory data, current crop forecasts, and market conditions for the upcoming season and, if necessary, to recommend preliminary free and restricted percentages if anticipated supply would exceed demand. After harvest is complete, but no later than September 15, the Board meets again to update its calculations using actual production data, consider any necessary adjustments to the preliminary percentages, and determine if final free and restricted percentages should be recommended to the Secretary.
The Board uses sales history, inventory, and production data to determine whether there is a surplus and, if so, how much volume should be restricted to maintain optimum supply. The optimum supply represents the desirable volume of tart cherries that should be available for sale in the coming crop year. Optimum supply is defined as the average free sales of the prior three years plus desirable carry-out inventory. Desirable carry-out is the amount of fruit needed by the industry to be carried into the succeeding crop year to meet market demand until the new crop is available. Desirable carry-out is set by the Board after considering market circumstances and needs. Section 930.151(b) specifies that desirable carry-out can range from zero to a maximum of 100 million pounds.
In addition, USDA's “Guidelines for Fruit, Vegetable, and Specialty Crop Marketing Orders” (
After the Board determines optimum supply, desirable carry-out, and market growth factor, it must examine the current year's available volume to determine whether there is an oversupply situation. Available volume includes carry-in inventory (any inventory available at the beginning of the season) along with that season's production. If production is greater than the optimum supply minus carry-in, the difference is considered surplus. This surplus tonnage is divided by the sum of production in the regulated districts to reach a restricted percentage. This percentage must be held in reserve or used for approved diversion activities, such as exports.
The Board met on July 6, 2018, and computed an optimum supply of 303 million pounds for the 2018-19 crop year using the average of free sales for the three previous seasons and desirable carry-out. To determine the carry-out figure, the Board discussed and considered a range of alternatives. One member suggested a carry-out value of 100 million pounds to maximize the amount of fruit on the market and to compete with imports. Another member indicated both free and restricted product could be used to compete with imports and proposed a 50 million pound carry-out. Another attendee noted excessive carryout puts downward pressure on prices. After the consideration of the alternatives, the Board determined a carry-out of 80 million pounds would supply the industry's needs at the beginning of the next season.
The Board subtracted the estimated carry-in of 125.1 million pounds from the optimum supply to calculate the production quantity needed from the 2018-19 crop to meet optimum supply. This number, 177.9 million pounds, was subtracted from the Board's estimated 2018-19 total production (from regulated and unregulated districts) of 344.5 million pounds to calculate a surplus of 166.6 million pounds of tart cherries. The Board also complied with the market growth factor requirement by removing 22.3 million pounds (average sales for prior three years of 223 million times 10 percent) from the surplus. The adjusted surplus of 144.3 million pounds was then divided by the expected production in the regulated districts (338.5 million pounds) to reach a preliminary restricted percentage of 43 percent for the 2018-19 crop year.
The Board then discussed whether this calculation would provide sufficient supply to grow sales and fulfil orders that have not yet shipped. Some members and attendees expressed concern that some existing inventory is old enough that it is difficult to sell and thus more of the current season's fruit should be made available. Some also reported there may be poor fruit yield in
The Board met again on September 13, 2018, to consider final volume regulation percentages for the 2018-19 season. The final percentages are based on the Board's reported production figures and the supply and demand information available in September.
The total production for the 2018-19 season was 299.2 million pounds, 45.3 million pounds below the Board's July estimate. In addition, growers diverted 12.4 million pounds in the orchard, about half of what had been anticipated. As a result 286.8 million pounds would be available to market, 282.3 million pounds of which are in the restricted districts. Using the actual production numbers, and accounting for the recommended desirable carry-out and economic adjustment, as well as the market growth factor, the restricted percentage was recalculated.
The Board subtracted the carry-in figure used in Julyof 125.1 million pounds, from the optimum supply of 303 million pounds to determine 177.9 million pounds of 2018-19 production would be necessary to reach optimum supply. The Board subtracted the 177.9 million pounds from the actual production of 299.2 million pounds, resulting in a surplus of 121.3 million pounds of tart cherries.
The Board also revisited its earlier decision regarding an economic adjustment. Many in attendance expressed that the previously recommended economic adjustment should be revisited to avoid placing excess fruit on the market. One member indicated the fruit quality in Michigan was better than anticipated in July. Other attendees indicated the adjustment for additional sales had been overstated. As a result, the Board recommended lowering the economic adjustment to 24 million pounds.
The recalculated surplus was reduced by subtracting the revised economic adjustment of 24 million pounds and the market growth factor of 22.3 million pounds, resulting in an adjusted surplus of 75 million pounds. The Board then divided this final surplus by the available production of 282.3 million pounds in the regulated districts (294.7 million pounds minus 12.4 million pounds of in-orchard diversion) to calculate a restricted percentage of 27 percent with a corresponding free percentage of 73 percent for the 2018-19 crop year, as outlined in the following table:
The final restriction of 27 percent is lower than the preliminary restriction percentage of 31 percent. The largest factor affecting this change was the final production numbers that came in below the Board's July estimate. Additionally, less fruit was diverted in orchard than anticipated and the Board revised its economic adjustment to 24 million pounds. The desired carry-out remained the same at 80 million pounds.
In discussing the calculation, several members indicated they believed the recommendation was too restrictive. They supported maintaining the economic adjustment at the original level, which would have resulted in a lower calculated restriction. Other members stated that reducing the economic adjustment was reflective of industry conditions and expressed concern about putting too much fruit into the market.
Establishing free and restricted percentages is an attempt to bring supply and demand into balance. If the primary market is oversupplied with cherries, grower prices decline substantially. Restricted percentages have benefited grower returns and helped stabilize the market as compared to those seasons prior to the implementation of the Order. The Board, based on its discussion of this issue and the result of the above calculations, believes the available information indicates a restricted percentage should be established for the 2018-19 crop year to avoid oversupplying the market with tart cherries.
Consequently, the Board recommended final percentages of 73 percent free and 27 percent restricted by a vote of 13 in favor, 4 opposed, and 1 abstention. The Board could meet and recommend the release of additional volume during the crop year if conditions so warranted. The Secretary finds, from the recommendation and supporting information supplied by the Board, that designating final percentages of 73 percent free and 27 percent restricted would tend to effectuate the
Additionally, the Board reviewed its rules regarding grower diversion, as this diversion option has become more of a common practice over the past few seasons. To receive grower diversion credit, the Order requires that the fruit left in the orchard must be marketable. With no definition of marketable in the Order, the Board had defined fruit as unmarketable if insects were found in any of the fruit sampled from the acreage marked for diversion.
In 2016, the Board formed a committee to investigate updating this policy based on recent infestations of spotted wing drosophila. The industry was concerned growers would not qualify for diversion if a zero-tolerance policy remained in effect, but also wanted to ensure orchards were properly maintained to prevent the spread of infestation. The Board modified its working definition of marketable to reflect aspects of the tolerances in an FDA Compliance Policy Guide (CPG Sec. 550.225 Cherries—Brined, Fresh, Canned and Frozen—Adulteration Involving Rot and Insect). Specifically, the Board recommended using a 5 percent tolerance for insects and a 7 percent tolerance for rot when sampling cherries for diversion. After applying the two tolerances for insects and rot over two harvests, the Board found these levels were effective. The Board discussed this issue at its meetings on September 13, 2018, and October 23, 2018, and unanimously recommended incorporating this change into the Order's rules and regulations.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this proposed rule on small entities. Accordingly, AMS has prepared this initial regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 600 producers of tart cherries in the regulated area and approximately 40 handlers of tart cherries who are subject to regulation under the Order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000, and small agricultural service firms have been defined as those whose annual receipts are less than $7,500,000 (13 CFR 121.201).
According to the National Agricultural Statistics Service (NASS) and Board data, the average annual grower price for tart cherries utilized for processing during the 2017-18 season was approximately $0.224 per pound. With total utilization at approximately 254 million pounds for the 2017-18 season, the total 2017-18 value of the crop utilized for processing is estimated at $56.9 million. Dividing the crop value by the estimated number of producers (600) yields an estimated average receipt per producer of $94,833. This is well below the SBA threshold for small producers.
A free on board (FOB) price of $0.82 per pound for frozen tart cherries was reported by the Food Institute during the 2017-2018 season. Based on utilization, this price represents a good estimate of the price for processed cherries. Multiplying this FOB price by total utilization of 254.1 million pounds results in an estimated handler-level tart cherry value of $208 million. Dividing this figure by the number of handlers (40) yields estimated average annual handler receipts of $5.2 million, which is below the SBA threshold for small agricultural service firms. Assuming a normal distribution, the majority of producers and handlers of tart cherries may be classified as small entities.
The tart cherry industry in the United States is characterized by wide annual fluctuations in production. According to NASS, the pounds of tart cherry production for the years 2012 through 2017 were 85 million, 294 million, 304 million, 253 million, 329 million, and 260 million, respectively. Because of these fluctuations, supply and demand for tart cherries are rarely in balance.
Demand for tart cherries is inelastic, meaning changes in price have a minimal effect on total sales volume. However, prices are very sensitive to changes in supply, and grower prices vary widely in response to the large swings in annual supply. Grower prices per pound for processed utilization have ranged from a low of $0.073 in 1987 to a high of $0.588 per pound in 2012.
Because of this relationship between supply and price, oversupplying the market with tart cherries would have a sharp negative effect on prices, driving down grower returns. Aware of this economic relationship, the Board focuses on using the volume control authority in the Order to align supply with demand and stabilize industry returns. This authority allows the industry to set free and restricted percentages as a way to bring supply and demand into balance. Free percentage cherries can be marketed by handlers to any outlet, while restricted percentage volume must be held by handlers in reserve, diverted, or used for exempted purposes.
This proposal would control the supply of tart cherries by establishing percentages of 73 percent free and 27 percent restricted for the 2018-19 crop year. These percentages should stabilize marketing conditions by adjusting supply to meet market demand and help improve grower returns. The proposal would regulate tart cherries handled in Michigan, New York, Utah, Washington, and Wisconsin. This proposal would also revise the regulations regarding grower diversion to codify the Board's definition of marketable fruit. The authority for this proposed action is provided in §§ 930.50, 930.51(a), 930.52, and 930.58. The Board recommended this action at meetings on September 13, 2018, and October 23, 2018.
This proposal would result in some fruit being diverted from the primary domestic markets. However, as mentioned earlier, the USDA's “Guidelines for Fruit, Vegetable, and Specialty Crop Marketing Orders” (
In addition, there are secondary uses available for restricted fruit, including the development of new products, sales into new markets, the development of export markets, and being placed in reserve. While these alternatives may provide different levels of return than the sales to primary markets, they play an important role for the industry. The areas of new products, new markets, and the development of export markets utilize restricted fruit to develop and expand the markets for tart cherries. In 2017-18, these activities accounted for over 82 million pounds in sales, 27 million of which were exports. These numbers represent increases of 45 million pounds and 11.4 million pounds respectively.
Placing tart cherries into reserves is also a key part of balancing supply and demand. Although handlers bear the handling and storage costs for fruit in reserve, reserves stored in large crop
The Board recommended a carry-out of 80 million pounds and made a demand adjustment of 24 million pounds in order to make the regulation less restrictive. With 125.1 million pounds of carry-in, 4.5 million pounds of production in the unregulated districts, and 207.3 million pounds of free tonnage from the regulated districts, 336.9 million pounds of fruit would be available for the domestic market. This is nearly 50 million pounds greater than the tonnage made available in the previous season. Even with the recommended restriction, the domestic market would have an ample supply of tart cherries. Further, should marketing conditions change, and market demand exceed existing supplies, the Board could meet and recommend the release of an additional volume of cherries. Consequently, it is not anticipated that this proposal would unduly burden growers or handlers.
While this proposal could result in some additional costs to the industry, these costs are outweighed by the benefits. The purpose of setting restricted percentages is to attempt to bring supply and demand into balance. If the primary market (domestic) is oversupplied with cherries, grower prices decline substantially. Without volume control, the primary market would likely be oversupplied, resulting in lower grower prices. In addition, the industry could start to build large amounts of unwanted inventories, which would also have a depressing effect on grower returns.
An econometric model has been developed to assess the impact volume control has on the price growers receive for their product. Based on the model, the use of volume control would have a positive impact on grower returns for this crop year. With volume control, grower prices are estimated to be approximately $0.04 per pound higher than without restrictions. In addition, absent volume control, the industry could start to build large amounts of unwanted inventories. These inventories would have a depressing effect on grower prices.
Retail demand is assumed to be highly inelastic, which indicates changes in price do not result in significant changes in the quantity demanded. Consumer prices largely do not reflect fluctuations in cherry supplies. Therefore, this proposal should have little or no effect on consumer prices and should not result in a reduction in retail sales.
The incorporation of a tolerance for insects and rot in diverted fruit would align the Order's grower diversion rules and regulations with current industry practices. The tolerances should make it possible for more growers to participate in diversion during periods of oversupply, while encouraging proper pest management. Proper pest management helps reduce costs by decreasing incidences of infestation. Further, the use of grower diversion removes excess supply from the market without incurring the costs of harvesting, processing, and storage.
The proposed tolerance for insects and rot for cherries diverted in the orchard would provide clear guidance for compliance with Order provisions, encourage proper pest management, and align the Order's rules with industry standards. Growers, regardless of size, would benefit from the addition of these tolerances.
The free and restricted percentages established by this proposal would provide the market with optimum supply and would apply uniformly to all regulated handlers in the industry, regardless of size. As the restriction represents a percentage of a handler's volume, the costs, when applicable, are proportionate and should not place an extra burden on small entities as compared to large entities.
The stabilizing effects of this proposal would benefit all handlers by helping them maintain and expand markets, despite seasonal supply fluctuations. Likewise, price stability positively impacts all growers and handlers by allowing them to better anticipate the revenues their tart cherries would generate. Growers and handlers, regardless of size, would benefit from the stabilizing effects of the volume restriction.
The Board had extensive discussions on carry-out inventory alternatives. The alternatives included five motions that failed to pass, ranging from 50 million pounds to 100 million pounds. The Board determined that if the carry-out number was too large, it could have a negative impact on grower returns. Some attendees indicated excess carry-in over the past few seasons has had a negative effect on returns and that growers are seeking relief. After consideration of the alternatives, the Board recommended a carry-out of 80 million pounds.
The Board also weighed alternatives when discussing the economic adjustment. At its July meeting, the Board recommended a 48 million pound adjustment to account for fruit quality concerns and expected sales. One member proposed an additional 40-million-pound adjustment to counter imports of dried and frozen cherries, while other members favored a lower amount.
When the final production numbers were reviewed in September, the Board revisited the economic adjustment. Members indicated fruit quality was still an issue, but yields were better than initially anticipated. Members also stated that with tough international markets, the additional sales may have been overstated. Members from the Western states in particular were concerned that a large shift in the restriction percentage following harvest would disrupt the overall market and petitioned the Board to reconsider the adjustment. After discussion, the Board adopted an adjustment of 24 million pounds determining this amount would best meet the industry's sales needs. Thus, the alternatives were rejected.
Regarding grower diversion requirements, the Board initially proposed a broader set of requirements including spray protocols and destruction of diverted fruit in order to better control infestation. The original proposal called for annual determination of which steps would be required in each district. As research is still evolving on how best to deal with spotted wing drosophila infestations, preferred methods of dealing with the diverted fruit were also subject to change. Thus, the Board voted to codify only the tolerance for marketability.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the Order's information collection requirements have been previously approved by OMB and assigned OMB No. 0581-0177, Tart Cherries Grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin. No changes are necessary in those requirements as a result of this action. Should any changes become necessary, they would be submitted to OMB for approval.
This proposal would not impose any additional reporting or recordkeeping requirements on either small or large tart cherry handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
AMS is committed to complying with the E-Government Act, 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.
USDA has not identified any relevant Federal rules that duplicate, overlap or conflict with this proposed rule.
In addition, the Board's meetings were widely publicized throughout the tart cherry industry, and all interested persons were invited to attend the meetings and participate in Board deliberations on all issues. Like all Board meetings, the July 6, 2018, September 13, 2018, and October 23, 2018, meetings were public meetings, and all entities, both large and small, were able to express views on this issue. Finally, interested persons are invited to submit comments on this proposed rule, including the regulatory and information collection impacts of this proposal on small businesses.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
A 30-day comment period is provided to allow interested persons to respond to this proposal. All written comments timely received will be considered before a final determination is made on this matter.
Marketing agreements, Reporting and recordkeeping requirements, Tart cherries.
For the reasons set forth in the preamble, 7 CFR part 930 is proposed to be amended as follows:
7 U.S.C. 601-674.
(a)
The percentages for tart cherries handled by handlers during the crop year beginning on July 1, 2018, which shall be free and restricted, respectively, are designated as follows: Free percentage, 73 percent and restricted percentage, 27 percent.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Extension of public comment period.
On March 18, 2019, the U.S. Department of Energy (DOE) published a request for information (RFI) on the measurement of average cycles or periods of use in DOE test procedures in the
The comment period for the RFI published on March 18, 2019 (84 FR 9721) is extended. DOE will accept comments, data, and information regarding this RFI received no later than May 31, 2019.
Interested persons are encouraged to submit comments using the Federal eRulemaking Portal at
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No telefacsimilies (faxes) will be accepted.
The docket web page can be found at
Ms. Jennifer Tiedeman, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW, Washington, DC 20585-0121. Telephone: (202) 287-6111. Email:
On March 18, 2019, DOE published a notice in the
Bureau of Consumer Financial Protection.
Advance notice of proposed rulemaking.
The Bureau of Consumer Financial Protection (Bureau) is issuing this Advance Notice of Proposed Rulemaking (ANPR) to solicit comments relating to whether to make changes to the data points that the Bureau's October 2015 final rule implementing the Home Mortgage Disclosure Act (HMDA) added to Regulation C or revised to require additional information. Additionally, the Bureau is issuing this ANPR to solicit comments relating to the requirement that institutions report certain business- or commercial-purpose transactions under Regulation C.
Comments must be received by July 8, 2019.
You may submit responsive information and other comments, identified by Docket No. CFPB-2019-0020, by any of the following methods:
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You are not required to answer all questions to receive consideration of your comments. The Bureau encourages the early submission of comments. All submissions must include the document title and docket number.
Because paper mail in the Washington, DC area and at the Bureau is subject to delay, commenters are encouraged to submit comments electronically. In general, all comments received will be posted without change to
All submissions, including attachments and other supporting materials, will become part of the public record and subject to public disclosure. Sensitive personal information, such as account numbers or Social Security numbers, or names of other individuals, should not be included. Submissions will not be edited to remove any identifying or contact information.
The Bureau invites comment on all aspects of the ANPR from all interested parties. In the event that a respondent may have concerns about revealing proprietary or personal information, the Bureau welcomes comments from attorneys, consumer advocacy organizations, trade associations, or other representatives that do not identify their clients.
Jaydee DiGiovanni or Shaakira Gold-Ramirez, Counsels; or Amanda Quester or Alexandra Reimelt, Senior Counsels, Office of Regulations, at 202-435-7700 or
The Bureau is issuing this ANPR to solicit information relating to whether to make changes to the data points that the Bureau's October 2015 final rule implementing HMDA (2015 HMDA Rule) added to Regulation C or revised to require additional information. The Bureau also seeks comments relating to the requirement that institutions report certain business- or commercial-purpose transactions under Regulation C.
HMDA requires certain depository institutions and for-profit nondepository institutions to collect, record, and report data about originations and purchases of mortgage loans, as well as mortgage loan applications that do not result in originations (for example, applications that are denied or withdrawn).
In 2010, Congress enacted the Dodd-Frank Act, which amended HMDA and transferred HMDA rulemaking authority and other functions from the Board of Governors of the Federal Reserve System (Board) to the Bureau.
In October 2015, the Bureau issued the 2015 HMDA Rule.
The Bureau added the following data points to Regulation C to implement specific provisions added by the Dodd-Frank Act in HMDA section 304(b)(4), (5)(A) through (C), and (6)(A) through (I): ULI;
The Bureau also re-adopted certain data points in the 2015 HMDA Rule that are substantially similar or identical to pre-existing data points added to Regulation C by the Board. These data points include the following: Application date; loan type; whether the application or covered loan involved a request for a preapproval of a home purchase loan under a preapproval program; construction method for the dwelling related to the subject property;
In other instances, the 2015 HMDA Rule revised pre-existing Regulation C data points established by the Board to require additional information be reported for those data points. Such revised data points include the following: The purpose of the loan or application; occupancy type; ethnicity; race; and legal entity identifier (LEI).
Additionally, the Bureau added the following new data points in the 2015 HMDA Rule pursuant to its discretionary authority under HMDA section 304(b)(5) and (6): Reasons for denial of a loan application, which were optionally reported under the Board's rule but became mandatory in the 2015 HMDA Rule;
The 2015 HMDA Rule also requires reporting of applications for, and originations of, dwelling-secured business- or commercial-purpose closed-end mortgage loans and open-end lines of credit for home purchase, refinancing, or home improvement purposes.
Before institutions had to comply with the new and revised data reporting requirements in 2015 HMDA Rule, the Bureau in September 2017 issued a final rule amending certain aspects of the 2015 HMDA Rule (2017 HMDA Rule).
The Bureau issued a statement in December 2017 (December 2017 Statement) in which it indicated that it intended to engage in a rulemaking to reconsider various aspects of the 2015 HMDA Rule, such as the institutional and transactional coverage tests and the rule's discretionary data points.
On May 24, 2018, the President signed the Economic Growth, Regulatory Relief, and Consumer Protection Act (EGRRCPA) into law.
Since issuing the 2015 HMDA Rule and 2017 HMDA Rule, the Bureau has heard concerns about the burden associated with reporting certain of the new or revised data points relative to the value of the information in serving HMDA's purposes. The Bureau has also heard continuing concerns about Regulation C's coverage of certain business- or commercial-purpose loans. In addition, although the 2015 HMDA Rule was outside the scope of the Bureau's Call for Evidence series of Requests for Information (RFIs)
Among other things, some industry stakeholders have advised the Bureau that it is more burdensome to report information about whether a borrower owns or leases the land on which a manufactured home is located
The 2015 HMDA Rule also requires financial institutions to complete free-form text fields for certain data points if certain circumstances are met. For example, the 2015 HMDA Rule made reporting of reasons for denial mandatory and provides various reporting options from which financial institutions may choose.
Additionally, in the past year the Bureau has heard from several industry stakeholders requesting that the Bureau should exclude from Regulation C's coverage business- or commercial-purpose loans made to a non-natural person and secured by a multifamily dwelling. For example, in response to the Bureau's RFIs a few industry commenters stated that requiring reporting of such transactions is not necessary to fulfilling the purposes of HMDA and that the burden of reporting them does not outweigh the benefits of doing so.
The Bureau is issuing this ANPR to solicit comments relating to whether to make changes to (1) the data points that the 2015 HMDA Rule added to Regulation C or revised to require additional information, and (2)
The Bureau is soliciting comment, data, and information from the public relating to whether to make changes to the data points that the 2015 HMDA Rule added to Regulation C or revised to require additional information.
The Bureau encourages commenters to be specific and, where possible, to include any relevant empirical evidence. Comment is requested from all interested parties on the following four topics:
1. Please identify any new data point or any data point revised to require additional information from the table above for which the cost of collecting and reporting the information does not justify the benefit that the information collected and reported provides in furthering the purposes of HMDA. For each such data point:
i. Please describe the nature and magnitude of any operational challenges in collecting and reporting the required information.
ii. What ongoing costs are incurred in collecting and reporting the required information? Has the Bureau's new web-based data submission and edit-check system affected ongoing costs of collecting and reporting the required information? If so, how and how much? To what extent are the data point's requirements aligned with industry standards, and how does that affect ongoing costs of collecting and reporting the required information?
iii. Would financial institutions generally collect the required information in the ordinary course of business absent Regulation C requirements? If so, what are the incremental costs associated with reporting the required information? If not, what are the costs associated with collecting and reporting the required information?
iv. How much value does the data point provide in furthering the purposes of HMDA?
2. The 2015 HMDA Rule requires financial institutions to complete free-form text fields for certain data points when certain circumstances are met. For each free-form text field required by the 2015 HMDA Rule:
i. What are the costs of providing information through the free-form text field?
ii. What are the benefits of providing information through the free-form text field?
iii. Are there better alternatives to providing information than through the free-form text field?
3. Are there other considerations the Bureau should take into account in deciding whether to propose to eliminate or revise any new data point or revised data point from the 2015 HMDA Rule?
4. Are there new or revised data points under the 2015 HMDA Rule for which more explanation is needed to clarify the collection and reporting requirements? If so, please identify any data point for which additional clarity could reduce the costs associated with collecting and reporting the data and improve the value of the data in furthering the purposes of HMDA.
The Bureau seeks to assess the extent to which requiring reporting of information on business- or commercial-purpose loans made to a non-natural person and secured by a multifamily dwelling imposes burdens on financial institutions and furthers HMDA's purposes.
The Bureau seeks information that might assist the Bureau in deciding whether to propose to exclude such transactions from HMDA's requirements, including information about the following:
5. The value that data on such transactions provides in serving HMDA's purposes;
6. Other benefits associated with reporting such transactions; and
7. The burden imposed by the requirement to report data on such transactions.
Federal Aviation Administration (FAA), DOT.
Notice of proposed special conditions.
This action proposes special conditions for The Boeing Company (Boeing) Model 777-9 airplane. This airplane will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport-category airplanes. This design feature is an electronic flight-control system requiring control-surface-position awareness. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Send comments on or before June 24, 2019.
Send comments identified by Docket No. FAA-2018-1016 using any of the following methods:
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Joe Jacobsen, Airplane & Flight Crew Interface Section, AIR-671, Transport Standards Branch, Policy and Innovation Division, Aircraft Certification Service, Federal Aviation Administration, 2200 South 216th Street, Des Moines, Washington 98198; telephone: 206-231-3158; email:
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data.
We will consider all comments we receive by the closing date for comments. We may change these special conditions based on the comments we receive.
On December 6, 2013, Boeing applied for an amendment to Type Certificate No. T00001SE to include the new 777-9 airplane. This airplane, which is a derivative of the Boeing Model 777 airplane currently approved under Type Certificate No. T00001SE, is a twin-engine, transport-category airplane with seating for 495 passengers and a maximum takeoff weight of 775,000 pounds.
Under the provisions of title 14, Code of Federal Regulations (14 CFR) 21.101, Boeing must show that the Model 777-9 airplane meets the applicable provisions of the regulations listed in Type Certificate No. T00001SE, or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, the Boeing Model 777-9 airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type certification basis under § 21.101.
The Boeing Model 777-9 airplane will incorporate the following novel or unusual design feature:
An electronic flight-control system requiring control-surface-position awareness.
With a response-command type of flight-control system and no direct coupling from the cockpit controller to control surface, such as on the Boeing Model 777 and 787 airplanes, the pilot is not aware of the actual surface-deflection position during flight maneuvers. This feature of this design is novel and unusual when compared to the state of technology envisioned in the airworthiness standards for transport-category airplanes. These special conditions are intended to contain the additional safety standard.
Some unusual flight conditions, arising from atmospheric conditions, or airplane or engine failures, or both, may result in full or nearly full control-surface deflection. Unless the flightcrew is made aware of excessive deflection or impending control-surface deflection limiting, piloted or the automated flight-control system control of the airplane could be inadvertently continued in a way that would cause loss of control, or other unsafe handling or performance situations.
The special conditions require that suitable annunciation be provided to the flightcrew when a flight condition exists in which nearly full control-surface deflection occurs. Suitability of such an annunciation must take into account that some pilot-demanded maneuvers, such as a rapid roll, are necessarily associated with intended full or nearly full control-surface deflection. Simple alerting systems, which would function in both intended and unexpected control-limiting situations, must be properly balanced between providing needed crew awareness and avoiding nuisance warnings.
The special conditions are derived initially from standardized requirements the Aviation Rulemaking Advisory Committee (ARAC) developed, a committee comprising representatives of the FAA, Europe's Joint Aviation Authorities (now replaced by the European Aviation Safety Agency), and industry representatives. In the case of some of these requirements, a draft notice of proposed rulemaking has been prepared but no final rule has yet been issued.
The proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
As discussed above, these proposed special conditions are applicable to the Boeing Model 777-9 airplane. Should Boeing apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, these special conditions would apply to that model as well.
This action affects only a certain novel or unusual design feature on one model of airplane. It is not a rule of general applicability.
Aircraft, Aviation safety, Reporting and recordkeeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(f), 106(g), 40113, 44701, 44702, 44704.
Accordingly, the Federal Aviation Administration (FAA) proposes the following special conditions as part of the type certification basis for Boeing Model 777-9 airplanes.
In addition to compliance with §§ 25.143, 25.671, and 25.672, the following proposed special conditions apply.
1. The system design must ensure that the flightcrew is made suitably aware whenever the primary control means nears the limit of control authority. This indication should direct the pilot to take appropriate action to avoid the unsafe condition in accordance with appropriate airplane flight manual (AFM) instructions. Depending on the application, suitable annunciations may include flight-deck control position, annunciator light, or surface position indicators. Furthermore, this requirement applies at limits of control authority, not necessarily at limits of any individual surface travel.
2. Suitability of such a display or alerting must take into account that some pilot-demanded maneuvers are necessarily associated with intended full performance, which may require full surface deflection. Therefore, simple alerting systems, which would function in both intended or unexpected control-limiting situations, must be properly balanced between needed flightcrew awareness and nuisance factors. A monitoring system, which might compare airplane motion, surface deflection, and pilot demand, could be useful for eliminating nuisance alerting.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Airbus SAS Model A318 and A319 series airplanes, Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes, and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. This proposed AD was prompted by a report that cracks were detected on frame (FR) 16 and FR 20 web holes and passenger door intercostal fitting holes at the door stop fitting locations. This proposed AD would require repetitive rototest inspections of the holes at the door stop fittings for any cracking, and corrective actions if necessary, as specified in an European Aviation Safety Agency (EASA) AD, which will be incorporated by reference. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by June 24, 2019.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
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For the incorporation by reference (IBR) material described in the “Related IBR material under 1 CFR part 51” section in
You may examine the AD docket on the internet at
Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3223.
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2018-0289, dated December 21, 2018 (“EASA AD 2018-0289”) (also referred to as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus SAS Model A318 and A319 series airplanes, Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes, and Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes. The MCAI states:
During accomplishment of airworthiness limitations item (ALI) task 531103-01-1 on an aeroplane, a crack was found in an affected area. At the time of the inspection, the affected aeroplane had accumulated 27[,]340 flight cycles (FC) since first flight, which is significantly below the FC threshold required for that ALI task.
This condition, if not detected and corrected, could affect the structural integrity of FR16 and FR20 of the aeroplane.
To address this potential unsafe condition, Airbus developed a[n optional] modification (cold working), which reinforces the affected area and allows accomplishment of the next inspection at extended threshold. Airbus also revised the threshold for the inspection of the affected area for pre-mod aeroplanes, and published these thresholds in new ALI tasks 531103-01-2 and 531103-01-3. EASA published AD 2017-0231 [which corresponds to FAA AD 2018-25-02, Amendment 39-19513 (83 FR 62690, December 6, 2018) (“AD 2018-25-02”)], requiring, among others, accomplishment of those ALI tasks.
Since that [EASA] AD was issued, it was decided to replace the applicable ALI tasks with the inspection SB [service bulletin] and modification SB. Consequently, both ALI tasks 531103-01-2 and 531103-01-3 will be deleted at the next opportunity of the applicable Airbus airworthiness limitations section document for the aircraft models affected by this [EASA] AD.
For the reason stated above, this [EASA] AD requires repetitive [rototest] inspections of the affected areas and, depending on findings, accomplishment of applicable corrective action(s). This [EASA] AD also includes reference to the applicable [optional] modification SB which provides an optional terminating action for the repetitive inspections [which includes a visual inspection of the intercostal fitting and frame web for damage (including corrosion) and corrective action if necessary] required by this [EASA] AD, or allows deferral of the next inspection, depending on the timing of modification embodiment.
EASA AD 2018-0289 describes procedures for repetitive rototest inspections of the holes at the door stop fittings for any cracking, and corrective actions if necessary. This material 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 our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
This proposed AD would require accomplishing the actions specified in EASA AD 2018-0289 described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this AD.
In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA worked with Airbus and EASA to develop a process to use certain EASA ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. As a result, EASA AD 2018-0289 will be incorporated by reference in the FAA final rule. This proposed AD would, therefore, require compliance with the provisions specified in EASA AD 2018-0289, except for any differences identified as exceptions in the regulatory text of this proposed AD. Service information specified in EASA AD 2018-0289 that is required for compliance with EASA AD 2018-0289 will be available on the internet at
Table 1 of EASA AD 2018-0289 refers to a compliance time “after 31 May 2017,” which EASA stated is the
We estimate that this proposed AD affects 1,229 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary on-condition actions that would be required based on the results of any required actions. We have no way of determining the number of aircraft that might need this on-condition action:
We have received no definitive data that would enable us to provide cost estimates for the on-condition repairs specified in this proposed 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.
We are 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.
We 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. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. 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.
We must receive comments by June 24, 2019.
None.
This AD applies to the Airbus SAS airplanes specified in paragraphs (c)(1) through (c)(4) of this AD, certificated in any category, as identified in European Aviation Safety Agency (EASA) AD 2018-0289, dated December 21, 2018 (“EASA AD 2018-0289”).
(1) Model A318-111, -112, -121, and -122 airplanes.
(2) Model A319-111, -112, -113, -114, -115, -131, -132, and -133 airplanes.
(3) Model A320-211, -212, -214, -216, -231, -232, and -233 airplanes.
(4) Model A321-111, -112, -131, -211, -212, -213, -231, and -232 airplanes.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by a report that cracks were detected on frame (FR) 16 and FR 20 web holes and passenger door intercostal fitting holes at the door stop fitting locations. We are issuing this AD to address such cracking, which could adversely affect the structural integrity of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, EASA AD 2018-0289.
(1) For purposes of determining compliance with the requirements of this AD: Where EASA AD 2018-0289 refers to its effective date, this AD requires using the effective date of this AD.
(2) The “Remarks” section of EASA AD 2018-0289 does not apply to this AD.
(3) Where Table 1 of EASA AD 2018-0289 refers to a compliance time “after 31 May 2017,” this AD requires using a compliance time after May 31, 2018 (the effective date of task 531103-01-1 in “ALS Part 2 rev. 6”).
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) For information about EASA AD 2018-0289, contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 89990 6017; email
(2) For more information about this AD, contact Sanjay Ralhan, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-3223.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Airbus SAS Model A330-200 Freighter, -200 and -300 series airplanes; and certain Airbus SAS Model A340-200, -300, -500, and -600 series airplanes. This proposed AD was prompted by a determination that certain wing slat tracks that were inadvertently indicated as eligible for installation on all Model A330 and A340 series airplanes are unable to sustain the ultimate loads relative to the weight variant of certain airplane configurations. This proposed AD would require inspecting any affected part for cracking, and replacing with a serviceable part, as specified in an European Aviation Safety Agency (EASA) AD, which will be incorporated by reference. We are proposing this AD to address the unsafe condition on these products.
We must receive comments on this proposed AD by June 24, 2019.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
•
•
•
•
For the incorporation by reference (IBR) material described in the “Related IBR material under 1 CFR part 51” section in
You may examine the AD docket on the internet at
Vladimir Ulyanov, Aerospace Engineer, International Section, Transport Standards Branch, FAA, 2200 South 216th St, Des Moines, WA 98198; telephone and fax: 206-231-3229.
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
The EASA, which is the Technical Agent for the Member States of the European Union, has issued EASA AD 2019-0026, dated February 4, 2019 (“EASA AD 2019-0026”) (also referred to as the Mandatory Continuing Airworthiness Information, or “the MCAI”), to correct an unsafe condition for certain Airbus SAS Model A330-200 Freighter, -200 and -300 series airplanes; and certain Airbus SAS Model A340-200, -300, -500, and -600 series airplanes. The MCAI states:
It was recently determined that, since June 2010, the affected parts were inadvertently indicated as eligible for installation on all A330 and A340 aeroplanes in the applicable Illustrated Part Catalogue (IPC), although in fact, those parts are not valid for some aeroplane configurations (weight variants), because they are unable to sustain ultimate load. Investigation demonstrated that affected parts were never delivered as spare part. However, it cannot be excluded that an affected part was removed in-service from an aeroplane and installed on another.
This condition, if not detected and corrected, could lead to slat detachment in flight, possibly resulting in reduced control of the aeroplane.
To address this potential unsafe condition, Airbus published the applicable SB [service bulletin] to provide instructions to identify affected parts, and instructions to inspect [for cracking of] those affected parts found installed.
For the reasons described above, this [EASA] AD requires a one-time detailed (DET) and special detailed inspection (SDI) of the aft lug of each affected part and replacement of each affected part. This [EASA] AD also prohibits installation of affected parts.
EASA AD 2019-0026 describes procedures for one-time detailed and special detailed (high frequency eddy current) inspections for cracking of the aft lug of each affected wing slat track (including an inspection to first determine if an affected part is installed), and replacing any affected part with a serviceable part. This material 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 our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
This proposed AD would require accomplishing the actions specified in EASA AD 2019-0026 described previously, as incorporated by reference, except for any differences identified as exceptions in the regulatory text of this AD.
In the FAA's ongoing efforts to improve the efficiency of the AD process, the FAA worked with Airbus and EASA to develop a process to use certain EASA ADs as the primary source of information for compliance with requirements for corresponding FAA ADs. As a result, EASA AD 2019-0026 will be incorporated by reference in the FAA final rule. This proposed AD would, therefore, require compliance with the provisions specified in EASA AD 2019-0026, except for any differences identified as exceptions in the regulatory text of this proposed AD. Service information specified in EASA AD 2019-0026 that is required for compliance with EASA AD 2019-0026 will be available on the internet at
We estimate that this proposed AD affects 104 airplanes of U.S. registry. We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary on-condition action that would be required based on the results of any required actions. We have no way of determining the number of aircraft that might need this on-condition action:
According to the manufacturer, some or all of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all known costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I,
We are 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.
We 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. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska; and
4. 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.
We must receive comments by June 24, 2019.
None.
This AD applies to the airplanes identified in paragraphs (c)(1), (c)(2), (c)(3), (c)(4), (c)(5), and (c)(6) of this AD, certificated in any category, as identified in European Aviation Safety Agency (EASA) AD 2019-0026, dated February 4, 2019 (“EASA AD 2019-0026”).
(1) Airbus SAS Model A330-223F and -243F airplanes.
(2) Airbus SAS Model A330-201, -202, -203, -223, and -243 airplanes.
(3) Airbus SAS Model A330-301, -302, -303, -321, -322, -323, -341, -342, and -343 airplanes.
(4) Airbus SAS Model A340-211, -212, and -213 airplanes.
(5) Airbus SAS Model A340-311, -312, and -313 airplanes.
(6) Airbus SAS Model A340-541 and -642 airplanes.
Air Transport Association (ATA) of America Code 57, Wings.
This AD was prompted by a determination that certain wing slat tracks that had been inadvertently indicated as eligible for installation on all Model A330 and A340 series airplanes are unable to sustain the ultimate loads relative to the weight variant of certain airplane configurations. We are issuing this AD to address installation of affected parts, which could result in slat detachment in flight and consequent reduced control of the airplane.
Comply with this AD within the compliance times specified, unless already done.
Except as specified in paragraph (h) of this AD: Comply with all required actions and compliance times specified in, and in accordance with, EASA AD 2019-0026.
(1) For purposes of determining compliance with the requirements of this AD: Where EASA AD 2019-0026 refers to its effective date, this AD requires using the effective date of this AD.
(2) The “Remarks” section of EASA AD 2019-0026 does not apply to this AD.
The following provisions also apply to this AD:
(1)
(2)
(3)
(1) For information about EASA AD 2019-0026, contact the EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221 89990 6017; email
(2) For more information about this AD, contact Vladimir Ulyanov, Aerospace
Food and Drug Administration, HHS.
Notification of petition.
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by CooperVision, Inc., proposing that the color additive regulations be amended to provide for the safe use of disperse orange 3 methacrylamide to color contact lenses. The color additive is intended to be copolymerized with various monomers to produce colored contact lens materials.
The color additive petition was filed on March 28, 2019.
For access to the docket to read background documents or comments received, go to
Molly A. Harry, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1075.
Under section 721(d)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379e(d)(1)), we are giving notice that we have filed a color additive petition (CAP 9C0315), submitted by CooperVision, Inc., 5870 Stoneridge Dr., Suite 1, Pleasanton, CA 94588. The petition proposes to amend the color additive regulations in 21 CFR part 73,
The petitioner has claimed that this action is categorically excluded under 21 CFR 25.32(l) because disperse orange 3 methacrylamide is intended for use in contact lenses. In addition, the petitioner has stated that, to their knowledge, no extraordinary circumstances exist. If FDA determines a categorical exclusion applies, neither an environmental assessment nor an environmental impact statement is required. If FDA determines a categorical exclusion does not apply, we will request an environmental assessment and make it available for public inspection.
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard is proposing to establish a temporary special local regulation for a designated area of the Duluth Harbor entrance to Superior Bay on Lake Superior during the Festival of Sail 2019 event in Duluth, MN. This action is necessary to provide for the safety of life on these navigable waters around the port of Duluth, MN during a parade of sail event on August 11, 2019. This proposed rulemaking would prohibit persons and vessels from being in the designated region unless authorized by the Captain of the Port Duluth or a designated representative. We invite your comments on this proposed rulemaking.
Comments and related material must be received by the Coast Guard on or before June 7, 2019.
You may submit comments identified by docket number USCG-2019-0300 using the Federal eRulemaking Portal at
If you have questions about this proposed rulemaking, call or email Lieutenant Abbie Lyons, Waterways Management, MSU Duluth, U.S. Coast Guard; telephone 218-725-3818, email
On December 11, 2018, Draw Events LLC notified the Coast Guard that it will be conducting a Parade of Sail from 7 a.m. through 1 p.m. on August 11, 2019, as part of the 2019 Festival of Sail event in Duluth, MN from August 11 through August 13, 2019. Hazards from spectator vessels and the limited maneuverability of the sailing vessels exist. The Captain of the Port Duluth (COTP) has determined that potential hazards associated with the parade of sail would be a safety concern for anyone within the route of the parade.
The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters within the parade route before, during, and immediately after the scheduled event. The legal basis for this proposed rule is the Coast Guard's authority under 46 U.S.C. 70041; 33 CFR 1.05-1.
The COTP is proposing to establish a special local regulation from 7 a.m. through 1 p.m. on August 11, 2019. The special local regulation would cover all navigable waters encompassed within the following boundaries: Beginning at position 46°46′48.36″ N, 092°05′16.44″ W, across Duluth Harbor to 46°47′02.76″ N, 092°05′17.88″ W, turning north toward the Duluth Lift Bridge at to 46°47′19.32″ N, 092°04′04.80″ W, to 46°46′50.88″ N, 092°05′17.88″ W, out
The duration of the zone is intended to protect the safety of vessels and these navigable waters before, during, and immediately after the scheduled 7 a.m. through 1 p.m. Parade of Sail. Only the designated sailing vessels associated with the event are permitted within the zone. No other vessels or persons will be permitted to enter the zone without obtaining permission from the COTP or a designated representative. The COTP or a designated representative may be contacted via VHF Channel 16 or by telephone at (218) 428-9357. The regulatory text proposed appears at the end of this document.
We developed this proposed rule after considering numerous statutes and Executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and Executive orders and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13771 directs agencies to control regulatory costs through a budgeting process. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB), and pursuant to OMB guidance it is exempt from the requirements of Executive Order 13771.
This regulatory action determination is based on the availability of the Superior Harbor entrance as an alternate entry into Superior Bay, the short time frame of the special local regulation, and the estimated number of spectator vessels around the Duluth Harbor entrance for the event. We anticipate that it will have minimal impact on the economy, will not interfere with other agencies, will not adversely alter the budget of any grant or loan recipients, and will not raise any novel legal or policy issues. The Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine Channel 16 about the zone, and the rule would allow vessels to seek permission to enter the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed rule would not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the restricted area may be small entities, for the reasons stated in section IV.A above, this proposed rule would not have a significant economic impact on any vessel owner or operator.
If you think that your business, organization, or governmental jurisdiction qualifies as a small entity and that this rule would have a significant economic impact on it, please submit a comment (see ADDRESSES) explaining why you think it qualifies and how and to what degree this rule would economically affect it.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this proposed rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
This proposed rule would not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has 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. We have analyzed this proposed rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this proposed rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it would not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this proposed rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this proposed rule would not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this proposed rule under Department of Homeland Security Directive 023-01 and Commandant Instruction M16475.1D, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made a preliminary determination that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This proposed rule involves a special local regulation lasting 6 hours that would prohibit entry within a designated area around the Duluth Harbor entrance. Normally such actions are categorically excluded
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this NPRM as being available in the docket, and all public comments, will be in our online docket at
Marine safety, Navigation (water), Reporting and recordkeeping requirements, Waterways.
For the reasons discussed in the preamble, the Coast Guard is proposing to amend 33 CFR part 100 as follows:
46 U.S.C. 70041; 33 CFR 1.05-1.
(a)
(b)
(2) Vessels and persons receiving COTP Duluth or on-scene representative authorization to enter the area of this special local regulation must do so in accordance with the following restrictions:
(i) Vessels and persons must transit at a speed not exceed six (6) knots or at no wake speed, whichever is less. Vessels proceeding under sail will not be allowed in this Area unless also propelled by machinery, due to limited maneuvering ability around numerous other spectator craft viewing the Festival of Sail.
(ii) Vessels and persons will not be permitted to impede the parade of sail once it has commenced, as the tall ships are extremely limited in their ability to maneuver.
(3) The Coast Guard will provide notice of the regulated area prior to the event through Local Notice to Mariners and Broadcast Notice to Mariners. Notice will also be provided by on-scene representatives.
(4) The “on-scene representative” of the COTP Duluth is any Coast Guard commissioned, warrant, or petty officer and any Federal, State, or local officer designated by the COTP to act on his or her behalf.
(5) Vessel operators desiring to enter or operate within the regulated area shall contact the COTP Duluth by telephone at (218) 428-9357, or on-scene representative via VHF radio on Channel 16, to obtain permission to do so. Vessel operators given permission to enter, operate, transit through, anchor in, or remain within the regulated areas must comply with all instructions given by COTP Duluth or on-scene representatives.
(c)
Environmental Protection Agency (EPA).
Petition for rulemaking; denial.
This document provides the reasons for EPA's response to a January 31, 2019, petition it received under section 21 of the Toxic Substances Control Act (TSCA) from the Attorneys General of Massachusetts, California, Connecticut, Hawaii, Maine, Maryland, Minnesota, New Jersey, New York, Oregon, Pennsylvania, Rhode Island, Vermont, Washington, and the District of Columbia (“petitioners”). Generally, the petitioners requested that EPA initiate a rulemaking proceeding under TSCA section 8(a) for the reporting of the manufacture (including import) and processing of asbestos. After careful consideration, EPA denied the petition for the reasons discussed in this document.
EPA's response to this TSCA section 21 petition was signed April 30, 2019.
This action is directed to the public in general. This action may, however, be of particular interest to those persons who manufacture (which includes import) or process or may manufacture or process the chemical asbestos (general CAS No. 1332-21-4). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
The docket for this TSCA section 21 petition, identified by docket identification (ID) number EPA-HQ-OPPT-2019-0038, is available at
Under TSCA section 21, (15 U.S.C. 2620), any person can petition EPA to initiate a rulemaking proceeding for the issuance, amendment, or repeal of a rule under TSCA sections 4, 6, or 8, or an order under TSCA sections 4, 5(e), or 5(f). A TSCA section 21 petition must set forth the facts which it is claimed establish that it is necessary to initiate the action requested. EPA is required to grant or deny the petition within 90 days of its filing. If EPA grants the petition, the Agency must promptly commence an appropriate proceeding. If EPA denies the petition, the Agency must publish its reasons for the denial in the
TSCA section 21(b)(1) requires that the petition “set forth the facts which it is claimed establish that it is necessary to issue, amend or repeal a rule.” 15 U.S.C. 2620(b)(1). TSCA section 8(a)(1), the section under which petitioners request the EPA to act here, authorizes the EPA Administrator to promulgate rules under which manufacturers (including importers) and processors of chemical substances must maintain such records and submit such information as the EPA Administrator may reasonably require (15 U.S.C. 2607). TSCA section 8(a)(2) outlines the information that the EPA Administrator may require under TSCA section 8(a)(1), insofar as it is known to the person making the report or insofar as reasonably ascertainable. Under TSCA section 8(a), EPA has promulgated several data collection rules, such as the Chemical Data Reporting (CDR) rule at 40 CFR part 711, which covers asbestos.
On January 31, 2019, the Attorneys General of Massachusetts, California, Connecticut, Hawaii, Maine, Maryland, Minnesota, New Jersey, New York, Oregon, Pennsylvania, Rhode Island, Vermont, Washington, and the District of Columbia (petitioners) petitioned EPA to initiate a rulemaking proceeding under TSCA section 8(a) for the reporting of the manufacture, import, and processing of asbestos (Ref. 1).
The petitioners requested specific TSCA section 8(a) reporting requirements for asbestos in order to collect information for the ongoing asbestos risk evaluation being conducted under TSCA section 6(b), which is to be completed by December 22, 2019 (15 U.S.C. 2605(b)(4)(G)(i)) and no later than June 22, 2020 if EPA exercises a six-month extension (15 U.S.C. 2605(b)(4)(G)(ii)), and, if necessary, for any subsequent risk management decisions under TSCA section 6(a). The petitioners specifically requested that EPA:
• Eliminate any applicability of the “naturally occurring substance” (NOCS) exemption in the CDR for asbestos reporting;
• Apply the CDR reporting requirements to processors of asbestos, as well as manufacturers (including importers) of the chemical substance;
• Eliminate any applicability of the impurities exemption in the CDR for asbestos reporting; and
• Eliminate any applicability of the articles exemption in the CDR with respect to imported articles that contain asbestos.
The petitioners request that EPA initiate a rulemaking proceeding under TSCA section 8(a) “to address infirmities in asbestos reporting” under EPA's CDR rule at 40 CFR 711. In support of their request, the petitioners state that “[r]obust reporting of the importation and use of asbestos in the U.S. is necessary for EPA to satisfy its statutory mandate under TSCA section 6(a) to establish requirements to ensure that asbestos does not present an unreasonable risk of injury to health or the environment and for states and the public to have access to data necessary to themselves evaluate such risks” (Ref. 1).
The petitioners present their views as to EPA's need for “comprehensive data with respect to the manufacture (including import) and use of asbestos in the U.S.” when conducting the asbestos risk evaluation and undertaking any potential subsequent risk management actions. The petitioners conclude that such data are not being collected under the current CDR rule. Several times in their request, the petitioners cite EPA's response to a previous petition filed under TSCA section 21 by the Asbestos Disease Awareness Organization (ADAO) and five other non-governmental organizations. In that petition, which EPA received on September 27, 2018, ADAO and others requested that EPA initiate rulemaking proceedings under TSCA section 8(a) to amend the CDR rule to increase reporting of asbestos to CDR (Ref. 2). EPA denied the petition on December 21, 2018, on the grounds that the petitioners did not demonstrate that it is necessary to amend the CDR rule (84 FR 3396, February 12, 2019) (FRL-9988-56). The petition from ADAO et al. and EPA's response are in Docket ID
The CDR rule, which is one of several reporting rules promulgated under TSCA section 8(a), requires manufacturers (including importers) to provide EPA with information on the production and use of chemicals in commerce, generally 25,000 pounds or more of a chemical substance at any single site, with a reduced reporting threshold (2,500 pounds) applying to chemical substances subject to certain TSCA actions, including, as applicable here, actions taken under TSCA section 6.
While asbestos is already required to be reported under the CDR rule by manufacturers (including importers) meeting certain criteria, the petitioners point out that CDR exempts from reporting chemicals, like asbestos, that are naturally occuring chemical substances, present as an impurity, or incorporated into an article. Additionally, the petitioners note that CDR does not require reporting from processors of chemical substances.
The petitioners assert that “[a]ny TSCA risk evaluation that EPA conducts without access to accurate and complete asbestos data cannot satisfy TSCA's risk evaluation criteria, including TSCA's requirement that EPA use the `best available science' in carrying out TSCA's mandate to eliminate unreasonable risk of injury to health or the environment presented by the manufacture (including importation), processing, distribution in commerce, use, or disposal of a toxic chemical substance” (Ref. 1).
Petitioners contend that the requested action under TSCA section 8(a) “would enable EPA to present and rely on a complete set of domestic data about the amount, and uses, of asbestos, is consistent with those goals and with the statute's requirements” (Ref. 1).
In their request, the petitioners state that “[a]sbestos is a known human carcinogen and there is no safe level of exposure to this highly toxic material ubiquitous in our built environment” (Ref. 1). The petitioners cite research finding dangers from asbestos and provide a review of asbestos assessments and regulations under federal and state law.
In their petition, they state that in 1989, EPA concluded that “asbestos is a highly potent carcinogen regardless of the type of asbestos or the size of the fiber” and assert that “EPA has long possessed an abundance of information that supports aggressive regulatory actions to protect the public from asbestos disease risks” (Ref. 1).
The petitioners restate their belief that EPA has “chos[en] to put on blinders and ignore some of the most meaningful data with respect to risks of exposure to the chemical substance” (Ref. 1), a view which many of the petitioning Attorneys General first expressed in comments on EPA's Problem Formulation of the Risk Evaluation for Asbestos (83 FR 26998, June 11, 2018) (FRL-9978-40). Moreover, the petitioners cite language in the Problem Formulation that states that “import volumes of products containing asbestos is [sic] unknown” (Ref 1). The petitioners assert that EPA's response to the ADAO Petition directly contradicts what EPA stated in the Problem Formulation.
To understand EPA's reasons for denying the petitioners' requests, it is important to first review the details of EPA's ongoing risk evaluation of asbestos, existing TSCA section 8(a) rules including the CDR rule, general exemptions for TSCA section 8(a) rules, and past reporting of asbestos under TSCA section 8(a). These details are explained in the following units.
On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Pub. L. 114-182) amended TSCA (15 U.S.C. 2601
EPA is currently evaluating the risks of asbestos under its conditions of use, pursuant to TSCA section 6(b)(4)(A). Through scoping and subsequent research for the asbestos risk evaluation, EPA identified the conditions of use of asbestos, including imported raw bulk chrysotile asbestos for the fabrication of diaphragms for use in chlorine and sodium hydroxide production; several imported chrysotile asbestos-containing materials, including sheet gaskets in chemical manufacturing where extremely high temperatures are needed; brake blocks for oil drilling; aftermarket automotive brakes/linings; other vehicle friction products; and other gaskets (Ref. 3). In identifying the conditions of use for asbestos and the rest of the first 10 chemicals undergoing risk evaluation under amended TSCA, EPA included use information reported under the CDR rule. In addition to using CDR data to identify the current conditions of use of asbestos, EPA conducted extensive research and outreach. This included EPA's review of published literature and online databases including Safety Data Sheets (SDSs), the United States Geological Survey's Mineral Commodities Summary and Minerals Yearbook, the U.S. International Trade Commission's Dataweb, and government and commercial trade databases. (See Docket ID No. EPA-HQ-OPPT-2016-0736). EPA's review of these data sources served as the basis for the conditions of use of asbestos. Additionally, EPA worked with its Federal partners, such as Customs and Border Protection, to enhance its understanding of import information on asbestos-containing products in support of the risk evaluation.
EPA also reviewed company websites of potential manufacturers, importers, distributors, retailers, or other users of asbestos and received public comments (1) during the February 2017 public meeting on the scoping efforts for the risk evaluations for the first ten chemicals, (2) when EPA published the Scope of the Risk Evaluation for Asbestos in June 2017, and (3) when EPA published the Problem Formulation of the Risk Evaluation for Asbestos in June 2018, all of which were used to identify the conditions of use. (See Docket ID No. EPA-HQ-OPPT-2016-0736). In addition, to inform EPA's understanding of the universe of conditions of use for asbestos for the scope document published in June 2017, EPA convened meetings with companies, industry groups, chemical users, and other stakeholders (Ref. 3). Lastly, on June 11, 2018 (83 FR 26922; FRL-9978-76), EPA proposed a significant new use rule (SNUR) under TSCA section 5, in an administrative proposal separate and apart from the ongoing risk evaluation process under TSCA section 6, for certain uses of asbestos (including asbestos-containing products) and specifically asked for public comment or information on ongoing uses of asbestos. In the public comments submitted on the SNUR, EPA received no new information on any ongoing uses. (See Docket ID No. EPA-HQ-OPPT-2018-0159).
In the Asbestos Problem Formulation document, based on the aforementioned outreach and research, EPA did not identify any conditions of use of
The purpose of EPA's risk evaluation is to determine whether a chemical substance presents an unreasonable risk to health or the environment, under the conditions of use, including an unreasonable risk to a relevant potentially exposed or susceptible subpopulation (15 U.S.C. 2605(b)(4)(A)). As part of this process, EPA must evaluate both hazard and exposure, excluding consideration of costs or other non-risk factors, use scientific information and approaches in a manner that is consistent with the requirements in TSCA section 26 for the best available science, and ensure decisions are based on the weight of scientific evidence. EPA intends to finalize the risk evaluation for asbestos by December 2019, the deadline that Congress set in TSCA. EPA acknowledges the statute provides that EPA may extend the deadline to complete a risk evaluation by six months (15 U.S.C. 2605(b)(4)(G)(ii)). As discussed in Unit V.A., even if EPA were to exercise this extension authority in the case of the ongoing asbestos risk evaluation, that would not affect the Agency's reasons for denying this petition.
On April 17, 2019, EPA signed the SNUR for asbestos and asbestos-containing products (84 FR 17345, April 25, 2019; FRL-9991-33). Section 5(a)(2) of TSCA, as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, authorizes EPA to determine that a use of a chemical substance is a “significant new use.” Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture (including import) or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA prohibits the manufacturing (including importing) or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). Those actions could include a prohibition on a use of that chemical substance.
For that SNUR, the significant new use of asbestos is manufacturing (including importing) or processing for uses that are neither ongoing nor already prohibited under TSCA. The following uses are subject to the SNUR: Adhesives, sealants, and roof and non-roof coatings; arc chutes; beater-add gaskets; cement products; extruded sealant tape and other tape; filler for acetylene cylinders; friction materials (with certain exceptions); high-grade electrical paper; millboard; missile liner; packings; pipeline wrap; reinforced plastics; roofing felt; separators in fuel cells and batteries; vinyl-asbestos floor tile; woven products; any other building material; and any other use of asbestos that is neither ongoing nor already prohibited under TSCA.
The asbestos SNUR prohibits these discontinued uses of asbestos from restarting without EPA having an opportunity to evaluate each intended use (
Section 8(a)(1) of TSCA authorizes the EPA Administrator to promulgate rules under which manufacturers and processors of chemical substances must maintain such records and submit such information as the EPA Administrator may “reasonably require.” 15 U.S.C. 2607. The Agency is prohibited by TSCA section 8(a)(5)(A) from requiring reporting that is “unnecessary or duplicative” and must apply the reporting obligations under TSCA section 8(a) to those persons who are likely to have the relevant information. 15 U.S.C. 2607(a)(5).
EPA has promulgated several data reporting rules under TSCA section 8(a); the CDR rule is the largest data collection rule, in terms of the number of entities subject to reporting under the rule.
The CDR rule requires U.S. manufacturers (including importers) of chemicals on the TSCA Chemical Substance Inventory, with some exceptions, to report to EPA every four years the identity of chemical substances manufactured (including imported) for all years since the last principal reporting year (40 CFR 711.8(a)(2)). Generally, reporting is required for substances with production volumes of 25,000 pounds or more at any single site during any of the calendar years since the last principal reporting year. However, a lower threshold (2,500 pounds) applies for chemical substances that are the subject of certain TSCA actions (see 40 CFR 711.8(b)). The CDR regulation generally exempts several groups of chemical substances from its reporting requirements,
EPA has specified general reporting and recordkeeping provisions for TSCA section 8(a) information gathering rules at 40 CFR 704 and has promulgated general exemptions to reporting at 40 CFR 704.5 using the Agency's broad discretion in TSCA section 8(a) to fashion reporting schemes “as the Administrator may reasonably require.” (15 U.S.C. 2607(a)(1)(A)). However, also utilizing this discretion, EPA can revise, remove, or add to these exemptions. The exemptions at 40 CFR 704.5 are for articles, byproducts, impurities, non-isolated intermediates, research and development, and small manufacturers and importers.
If the chemical substance is imported solely as part of an article, the chemical substance is generally exempt from being reported under TSCA section 8(a). An article is defined in 40 CFR 704.3 as “a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end-use function(s) dependent in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design.”
Impurities are also generally exempt from reporting under rules promulgated pursuant to TSCA section 8(a). An impurity is defined as a chemical substance unintentionally present with another chemical substance (40 CFR 704.3). Impurities are not manufactured for distribution in commerce as chemical substances per se and have no commercial purpose separate from the substance, mixture, or article of which they are a part.
The exemption from reporting naturally occurring chemical substances under the CDR rule, found at 40 CDR 711.6(b), is one example of an exemption that has been added to TSCA section 8(a) reporting requirements under EPA's broad discretion to fashion reporting schemes “as the Administrator may reasonably require”.
While TSCA section 8(a) provides EPA with the authority to collect information from processors, EPA has used its discretion to not require processors to report under the CDR rule. Processing information is reported by the manufacturers: If a manufacturer reports a chemical under the CDR rule, it must also report processing and use information for the chemical substance unless it is exempted from this reporting by 40 CFR 711.6(b).
Two companies, both from the chloro-alkali industry, reported importing raw asbestos during the 2016 CDR reporting cycle (Ref. 4) and did not claim the exemption for naturally occurring chemical substances. Both companies claimed their reports as confidential business information. Because asbestos has not been mined or otherwise produced in the United States since 2002 (Ref. 5), all raw asbestos currently in commerce in the U.S. is imported.
After careful consideration, EPA has denied the petition. A copy of the Agency's response, which consists of a letter to the signatory petitioner from the State of California (Ref. 6), is available in the docket for this TSCA section 21 petition. In accordance with TSCA section 21, the reasons for the denial are set forth in this
EPA agrees that knowledge of which entities are importing and using asbestos and asbestos-containing products, where and how these activities occur, and the quantities of asbestos involved is important for identifying exposed populations, and characterizing pathways of exposure. EPA already has this information, which it has obtained through reporting, voluntary submission, and modeling. EPA has used information currently reported under the CDR rule and other sources of data to identify and characterize the conditions of use for asbestos, and is using this information as part of the ongoing risk evaluation for asbestos under TSCA section 6(b).
EPA does not believe that petitioners have demonstrated that it is necessary to initiate a rulemaking proceeding under TSCA section 8(a) to obtain additional information in order to conduct its risk evaluation on asbestos and any potential subsequent risk management. While the petitioners assert that EPA's response to the ADAO Petition directly contradicts what EPA stated in the Problem Formulation regarding EPA's acknowledgement of a lack of certain data, EPA disagrees. EPA believes that the Agency is aware of all ongoing uses of asbestos and already has the essential information that EPA would receive if EPA were to grant the petition. Since asbestos was announced in December 2016 as one of the first ten chemicals for evaluation under TSCA, the Agency has conducted market research, public outreach, voluntary data collection, collaborative work with other Federal and State agencies, and stakeholder engagement. Given EPA's understanding of asbestos and reporting under TSCA section 8(a), as a result of implementation of the CDR rule and other TSCA section 8(a) rules, EPA does not believe that the requested reporting requirements would collect the data the petitioners believe the Agency lacks. Where EPA lacks information, the Agency has relied on models. This use of modeled data is in line with EPA's final Risk Evaluation Rule (Ref. 7) and EPA's risk assessment guidelines. Furthermore, EPA will provide opportunity for peer and public review of the draft Asbestos Risk Evaluation, which EPA will use to refine the risk evaluation of asbestos.
Further, even if EPA believed that the requested reporting requirements would collect new and useful information, EPA would not complete the rulemaking proceeding in time to collect data to inform the ongoing risk evaluation. The petitioners' request does not factor in the necessary timeframes for any rulemaking proceeding that would be required to propose and then finalize such amendments. To allow for the notice and comment period for the public and regulated community required under the Administrative Procedure Act (5 U.S.C. 553) and for appropriate internal deliberation prior to proposal and after the close of the comment period, EPA typically needs at least 18 months to finalize the promulgation, amendment, or repeal of a rule. EPA would then need to provide time for implementation, data collection, and data review prior to making use of the reported information. EPA intends to finalize the risk evaluation for asbestos in December 2019, but EPA notes that it has statutory authority to extend that deadline by up to six months. If EPA finds unreasonable risk for a condition of use, risk management must promptly be initiated with a proposed rule issued one year after EPA makes such a determination.
While it is possible that the requested rulemaking proceeding itself could be completed prior to any potential subsequent risk management decision(s) being finalized, EPA does not believe that the requested section 8(a) reporting requirements on asbestos would collect information useful for any necessary risk management, for the reasons explained in Unit V.B. Given the statutorily required timing for finalizing the asbestos risk evaluation and initiating risk management, if unreasonable risk exists for a condition of use, the requested TSCA section 8(a) reporting requirements on asbestos would not provide timely or useful information to inform either the ongoing asbestos risk evaluation or any potential subsequent risk management action. EPA believes that this would still be the case even were it to exercise its statutory authority to extend the deadline to complete the asbestos risk evaluation for six months, because the requested section 8(a) reporting requirements would likely not collect that would further inform the risk evaluation beyond the information EPA already has, as explained in Unit V.B.
This unit provides the reasons for EPA's decision to deny the petition asking EPA to initiate rulemaking proceedings under TSCA section 8(a) for the reporting of the manufacture, import, and processing of asbestos.
a.
b.
Any naturally occurring chemical substance, as described in 40 CFR 710.4(b). The applicability of this exclusion is determined in each case by the specific activities of the person who manufactures the chemical substance in question. Some chemical substances can be manufactured both as described in 40 CFR 710.4(b) and by means other than those described in 40 CFR 710.4(b). If a person described in § 711.8 manufactures a chemical substance by means other than those described in 40 CFR 710.4(b), the person must report regardless of whether the chemical substance also could have been produced as described in 40 CFR 710.4(b). Any chemical substance that is produced from such a naturally occurring chemical substance described in 40 CFR 710.4(b) is reportable unless otherwise excluded.
A chemical substance qualifies as naturally occurring only if it is: (1)(i) Unprocessed or (ii) processed only by manual, mechanical, or gravitational means; by dissolution in water; by flotation; or by heating solely to remove water; or (2) extracted from air by any means (40 CFR 710.4(b)). Articles containing asbestos would not be considered a naturally occurring chemical substance, given the processing required to create the article.
EPA does not believe that the requested elimination of the exemption for naturally occurring chemical substances would result in the reporting of any information that is not already known to EPA, for several reasons. EPA's understanding is that the chloro-alkali industry is the only importer of raw bulk asbestos, and the Agency has sufficient volume, import, use, and hazard data from that industry to conduct the risk evaluation. EPA has no reason to believe there are other importers of raw asbestos. Raw asbestos generally refers to asbestos as a naturally occuring chemical substance. Implementing TSCA section 8(a) asbestos reporting requirements for manufacturers (including importers) of asbestos as a naturally occuring chemical substance, therefore, would not provide any additional useful or timely information to EPA on the use of raw asbestos.
Because the purpose of domestic manufacturing or importing of raw asbestos is to make asbestos diaphragms, for which EPA already has use and exposure information, the request to require reporting on naturally occurring substances for asbestos would not provide any additional data to EPA. EPA already has this information obtained through extensive outreach and research (as described in Unit IV.A.), and the Agency is prohibited by TSCA section 8(a)(5)(A) from requiring reporting that is unnecessary or duplicative.
EPA disagrees that there is a contradiction between what EPA stated in the Asbestos Problem Formulation and what EPA stated in the petition response to ADAO. While EPA did state in the problem formulation that the imported volumes of products containing asbestos are unknown, the requested reporting of naturally occurring substances would not provide imported volumes of products containing asbestos, given that articles are not considered naturally occurring substances. As used in the asbestos Problem Formulation, the term “products containing asbestos” refers to asbestos articles. For more information on the data availability and evaluation of asbestos in articles, see Unit V.B.iii. for EPA's response to the request for reporting of imported asbestos articles.
EPA finds that petitioners have failed to set forth sufficient facts to establish that it is necessary for the Agency to use its discretion to no longer exempt naturally occurring asbestos from reporting requirements under TSCA section 8(a).
a.
b.
To support a claim that there is ongoing processing of articles that EPA is unaware of, the petitioners cite the export and reexport of articles described in the USGS Minerals Yearbook for 2016 (Ref. 5). The petitioners, however, neglect to note that the same report states that these shipments were likely misclassified and that “[s]hipments reported under these categories may have been reexports and (or) exports of products that were similar but did not contain asbestos.” In identifying the conditions of use for asbestos during the TSCA risk evaluation process, EPA reviewed the U.S. International Trade Commission's Dataweb and other government and commercial trade databases. EPA was unable to confirm any processing of asbestos beyond processing of raw asbestos into diaphragms and the fabrication of gaskets from imported asbestos-containing sheets.
Since asbestos is not mined in the United States, raw asbestos is imported solely by the chlor-alkali industry; because sheet gaskets are the only imported asbestos-containing products that may involve processing, EPA does not believe there are additional, unknown processors of asbestos in the United States. Accordingly, EPA does not believe that requiring reporting from processors of asbestos under TSCA section 8(a) will provide useful information not already in the Agency's possession. The petitioners have failed to indicate what additional information EPA would collect by requiring asbestos processors to report under section 8(a) and the Agency is prohibited by TSCA section 8(a)(5)(A) from requiring
a.
b.
EPA has sufficient information on imported articles containing asbestos to conduct the risk evaluation and inform any potential risk management decisions based on the risk determination. The only asbestos-containing articles that EPA has identified that are currently imported into the United States are asbestos-containing sheet gaskets, other gaskets, aftermarket automotive brakes/linings, other vehicle friction products, and brake blocks. Furthermore, the final Asbestos SNUR, published on April 25, 2019, ensures that no significant new uses of asbestos, including as an article, can begin without EPA first evaluating the significant new use and then, if necessary, taking action to prohibit or limit the activity.
The petitioners state that EPA lacks information on the quantity of asbestos contained in articles and assert that the Agency “lack[s] this information despite” communication with Chemours, a company that uses asbestos-containing gaskets, and Branham Corporation, the gasket supplier to Chemours (Ref. 1). Yet, as stated in the Asbestos Problem Formulation, Chemours notified EPA of their current use of imported gaskets from China (Comment identified by Document ID No. EPA-HQ-OPPT-2016-0736-0067). Chemours stated that these sheet gaskets are composed of 80% (minimum) chrysotile asbestos, encapsulated in Styrene Butadiene Rubber, and used to create tight chemical containment seals during the production of titanium dioxide. Furthermore, as stated in the Asbestos Problem Formulation, on October 30, 2017, EPA met with Chemours and Branham Corporation, who provided EPA with additional information on the fabrication and use of the gaskets (Ref. 3).
Similarly, the petitioners stated that EPA lacks information on asbestos-containing brake blocks, even though a domestic brake block manufacturer confirmed the continued import of these products (Ref. 1). However, EPA believes that it is able to conduct scientifically rigorous risk evaluations even without the information to which petitioners refer. For the asbestos risk evaluation, in instances where the specific use information on asbestos is unknown, EPA has made use of best available science. EPA's assumptions, uncertainty factors, and models or screening methodologies used when assessing risks associated with the conditions of use of asbestos-containing articles will be peer and publicly reviewed. It is standard practice for EPA to make conservative assumptions in the absence of complete information. Considering the extensive outreach and research conducted since December 2016, EPA has no reason to believe there are ongoing imports of articles containing asbestos that are unknown to EPA.
Additionally, information reported under TSCA section 8(a) is limited to that which is “known to or reasonably ascertainable” by the reporter. Thus, even if EPA were to require the reporting of asbestos-containing articles under TSCA section 8(a), importers would rely on information readily available to them, such as Safety Data Sheets or other documentation provided by their foreign supplier. As a result, EPA does not believe that the requested reporting requirement would result in importers reporting articles that are not already known to EPA because the Agency has conducted its own research to analyze Safety Data Sheets and other evidence in order to determine the conditions of use of asbestos for the risk evaluation. Requiring importers of asbestos-containing articles to report under TSCA section 8(a), therefore, would not provide any new use information that would inform the ongoing risk evaluation or any subsequent risk management decisions, if needed, and the Agency is prohibited by TSCA section 8(a)(5)(A) from requiring reporting that is unnecessary or duplicative.
For these reasons, EPA believes that the petitioners have failed to set forth sufficient facts to establish that it is necessary for the Agency to use its discretion to require reporting from importers of asbestos-containing articles under section 8(a).
a.
EPA does not believe that issuing the requested TSCA section 8(a) reporting requirements would result in reporting of asbestos as an impurity, to the extent that the presence of asbestos as an impurity in these articles generally is not known or reasonably ascertainable to the importer. EPA finds that the petitioners have failed to set forth sufficient facts to establish that it is necessary for the Agency to use its discretion to require manufacturers (including importers) of asbestos as an impurity to report under section 8(a).
a.
b.
Additionally, in the final Risk Evaluation Rule, EPA defined weight of scientific evidence as a systematic review method, applied in a manner suited to the nature of the evidence or decision, that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance (Ref. 7 at pg. 33733). EPA sees weight of the scientific evidence approach as an interrelated part of systematic review, and further believes that integrating systematic review into the TSCA risk evaluations is critical to meet the statutory requirements of TSCA.
TSCA section 26(k) (15 U.S.C. 2625(k)) states that in carrying out risk evaluations, EPA shall consider information that is “reasonably available,” but the statute does not further define this phrase. In the final Risk Evaluation Rule (Ref. 7), EPA defined “reasonably available information” to mean information that EPA possesses, or can reasonably obtain and synthesize for use in risk evaluations, considering the deadlines for completing the evaluation. While EPA prefers high quality data, where available, EPA recognized in the Risk Evaluation Rule that data is not always necessary to reach a scientifically grounded conclusion on the potential risks of a chemical substance, within the timeframes dictated by the statute (Ref. 7 at pg. 33739).
As outlined in the previous units, EPA does not believe that the requested asbestos reporting requirements would collect information that is either new or useful in informing the ongoing asbestos risk evaluation. EPA believes that it already has sufficient information to conduct the risk evaluation. Moreover, even if EPA were to initiate the requested action, EPA would not collect information in a timely manner to inform the ongoing risk evaluation nor any potentially subsequent risk management activities, if unreasonable risk for the asbestos uses being evaluated is determined. EPA intends to finalize the risk evaluation for asbestos no later than December 2019, EPA acknowledges the statute provides that EPA may extend the deadline to complete a risk evaluation by six months (15 U.S.C. 2605(b)(4)(G)(ii)). As discussed in Unit V.A., even if EPA were to exercise this extension authority in the case of the ongoing asbestos risk evaluation, that would not affect the Agency's reasons for denying this petition. If EPA finds unreasonable risk for a condition of use, risk management must promptly be initiated with a proposed rule issued one year after EPA makes such a determination.
Thus, EPA finds that the petitioners have failed to set forth sufficient facts to establish that it is necessary to grant their request in order to meet its obligations under TSCA section 26 to make its decision under TSCA section 6 based on the weight of the scientific evidence, using reasonably available information, and using the best available science.
The following is a listing of the documents that are specifically referenced in this document. The docket includes these documents and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under
Environmental protection, Asbestos, Flame retardants, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve portions of a state implementation plan (SIP) submission from Maryland for the 2010 sulfur dioxide (SO
Written comments must be received on or before June 7, 2019.
Submit your comments, identified by Docket ID No. EPA-R03-OAR-2018-0042 at
Marilyn Powers, Planning & Implementation Branch (3AD30), Air & Radiation Division, U.S. Environmental Protection Agency, Region III, 1650 Arch Street, Philadelphia, Pennsylvania 19103. The telephone number is (215) 814-2308. Ms. Powers can also be reached via electronic mail at
On June 22, 2010 (75 FR 35520), EPA promulgated a revised NAAQS for SO
On August 17, 2016, Maryland, through the Maryland Department of the Environment (MDE) formally submitted a SIP revision to satisfy the infrastructure requirements of section 110(a) of the CAA for the 2010 SO
Based on EPA guidance issued on September 13, 2013 (2013 Infrastructure Guidance),
EPA is proposing to approve Maryland's August 17, 2016 infrastructure SIP submittal for the 2010 SO
EPA's review of this material indicates that MDE's August 17, 2016 infrastructure SIP submittal for CAA section 110(a)(2)(A), (B), (C), (D)(i)(II), D(ii), (E), (F), (G), (H), (J), (K), (L), and (M) for the 2010 SO
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” 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);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866.
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is 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
• Does 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);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to 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 the CAA; and
• Does 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).
In addition, this proposed approval of Maryland's infrastructure SIP submittal for the 2010 SO
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Sulfur oxides.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve revisions to the Calaveras County Air Pollution Control District (CCAPCD) portion of the California State Implementation Plan (SIP). This revision concerns reporting of emissions of volatile organic compounds (VOCs) and oxides of nitrogen (NO
Any comments must arrive by June 7, 2019.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2019-0147 at
Nancy Levin, EPA Region IX, 75 Hawthorne Street, San Francisco, CA 94105. By phone: (415) 972-3848 or by email at
Throughout this document, “we,” “us” and “our” refer to the EPA.
Table 1 lists the rule addressed by this proposal with the dates that it was adopted by the local air agency and submitted by the California Air Resources Board (CARB).
On April 19, 2019, the submittal for CCAPCD Rule 513 was deemed by operation of law to meet the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.
We approved an earlier version of Rule 513, then numbered Rule 408 “Source Recordkeeping and Reporting,” into the SIP on May 11, 1977 (42 FR 23804). The CCAPCD renumbered and adopted revisions to Rule 408 on June 26, 2018, and CARB submitted Rule 513 “Source Recordkeeping and Emission Statement” on November 21, 2018. Submitted Rule 513 reorganizes the information contained in SIP-approved Rule 408. It also removes a requirement for sources to retain emissions reports submitted to the District.
Emissions of VOCs and NO
Rules in the SIP must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193). Areas classified as Marginal nonattainment or higher, such as the Calaveras County nonattainment area, are subject to the requirements of CAA section 182(a)(3)(B).
Guidance and policy documents that we used to evaluate enforceability, revision/relaxation, and CAA requirements for the applicable criteria pollutants include the following:
• “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988 (the Bluebook, revised January 11, 1990).
• “Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001 (the Little Bluebook).
• “(Draft) Guidance on the Implementation of an Emission Statement Program,” EPA, July 1992.
This rule is consistent with CAA requirements and relevant guidance regarding enforceability and SIP revisions. The TSD has more information on our evaluation.
The TSD includes recommendations for the next time the local agency modifies the rule.
As authorized in section 110(k)(3) of the Act, the EPA proposes to fully approve the submitted rule because it fulfills all relevant requirements. We will accept comments from the public on this proposal until June 7, 2019. If we take final action to approve the submitted rule, our final action will incorporate this rule into the federally enforceable SIP.
In this document, the EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by reference the CCAPCD rule described in Table 1 of this preamble. The EPA has made, and will continue to make, these materials available through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this proposed action merely proposes to approve state law as meeting federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a “significant regulatory action” 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);
• Is not an Executive Order 13771 (82 FR 9339, February 2, 2017) regulatory action because SIP approvals are exempted under Executive Order 12866;
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is 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
• Does 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);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to 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 the Clean Air Act; and
• Does not provide the EPA with the discretionary authority to address disproportionate human health or environmental effects with practical, appropriate, and legally permissible methods under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to 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. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency.
Proposed rule; notice of intent.
The Environmental Protection Agency Region 4 is issuing a Notice of Intent to Delete the Tennessee Products Superfund Site (Site) located in Chattanooga, Tennessee, from the National Priorities List (NPL) and requests public comments on this proposed action. 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 Tennessee (State), through the Tennessee Department of Environment and Conservation (TDEC), have determined that all appropriate response actions under CERCLA, other than Five-Year Reviews, have been completed. However, this deletion does not preclude future actions under Superfund.
Comments must be received by June 7, 2019.
Submit your comments, identified by Docket ID no. EPA-HQ-SFUND-1995-0005, by one of the following methods:
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Craig Zeller, Remedial Project Manager, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia 30303; phone: 404-562-8827; email:
EPA Region 4 announces its intent to delete the Tennessee Products Superfund Site from the National Priorities List (NPL) and requests public comment on this proposed action. The NPL constitutes Appendix B of 40 CFR part 300, which is the National Oil and Hazardous Substances Pollution Contingency Plan (NCP), which EPA promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA) of 1980, as amended. EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). As described in 40 CFR 300.425(e)(3) of the NCP, sites deleted from the NPL remain eligible for Fund-financed remedial actions if future conditions warrant such actions.
EPA will accept comments on the proposal to delete this site for thirty (30) days after publication of this document in the
Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses the Tennessee Products Superfund Site and demonstrates how it meets the deletion criteria.
The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate. In making such a determination pursuant to 40 CFR 300.425(e), EPA will consider, in consultation with the State, whether any of the following criteria have been met:
• Responsible parties or other persons have implemented all appropriate response actions required;
• All appropriate Fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or
• The remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, the taking of remedial measures is not appropriate.
Pursuant to CERCLA section 121(c) and the NCP, EPA conducts Five-Year Reviews to ensure the continued protectiveness of remedial actions where hazardous substances, pollutants, or contaminants remain at a site above levels that allow for unlimited use and unrestricted exposure (see Operation and Maintenance and Five-Year Review section below). EPA conducts such Five-Year Reviews even if a site is deleted from the NPL. EPA may initiate further action to ensure continued protectiveness at a deleted site if new information becomes available that indicates it is appropriate. 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.
The following procedures apply to deletion of the Site:
A. EPA consulted with the State before developing this Notice of Intent to Delete;
B. EPA has provided to the State 30 working days for review of this notice prior to publication of it today;
C. In accordance with the criteria discussed above, EPA has determined that no further response is appropriate;
D. The State, through its Department of Environment and Conservation, has concurred with deletion of the Site from the NPL (letter to EPA dated May 21, 2018);
E. Concurrently with the publication of this Notice of Intent to Delete in the
F. The EPA placed copies of documents supporting the proposed deletion in the deletion docket and made these items available for public inspection and copying at the Site information repositories identified above.
If comments are received within the 30-day public comment period on this document, EPA will evaluate and respond appropriately to the comments before making a final decision to delete. If necessary, EPA will prepare a Responsiveness Summary to address any significant public comments received. After the public comment period, if EPA determines it is still appropriate to delete the Site, the Regional Administrator will publish a final Notice of Deletion in the
Deletion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for future response actions, should future conditions warrant such actions.
The following information provides EPA's rationale for deleting the Site from the NPL.
The Tennessee Products Superfund Site (TPS) is located in south Chattanooga, Hamilton County, Tennessee and is defined as 2.5-mile section of Chattanooga Creek that contained sediments contaminated primarily with polycyclic aromatic hydrocarbons (PAHs). During the early decades of the 20th Century, a coal carbonization (Coke) plant complex (named Tennesee Products) was responsible for waste disposal practices that led to the contamination of Chattanooga Creek sediments. Numerous discharges of contaminated water to Chattanooga Creek via tributaries, were documented. Results of previous investigations and subsequent evaluations indicated that existing conditions posed a potential unacceptable risk to human health, if exposure to the contaminated sediments were to occur.
The TPS Site was proposed for inclusion on the NPL in January 1994 (59 FR 2568) after completion of a multi-media investigation of Chattanooga Creek by the EPA and the issuance of a Health Advisory by the Agency for Toxic Substances and Disease Registry (ATSDR) in 1993. The Health Advisory concluded that “the presence of the coal tar in-and-around the creek poses a health and safety hazard.” The TPS Site was placed on the NPL on September 29, 1995 (60 FR 50435). The EPA CERCLIS ID Number for this Site is TND071516959.
Based on the ATSDR Health Advisory, the EPA initiated a non-time-critical removal of the most accessible coal tar deposits along the upper reach of the Creek and behind the former Southern Coke and Chemical plant site (the Coke Plant area). On September 26, 1996, the EPA issued an Action Memorandum approving a non-time-critical removal action (Phase I removal action) as described in the 1996 Engineering Evalaution/Cost Analysis (EE/CA). The Action Memorandum was amended on September 24, 1997, and on December 5, 1998, authorizing the expenditure of additional funding to address a larger volume of contaminated sediments in the Creek than previously estimated. Over the course of the eighteen months of the Phase I removal action, a total of 4,235 linear feet of Chattanooga Creek was excavated, along with three isolated tar pits located in the flood plain and adjacent to the former coke plant. The total material excavated was 25,350 cubic yards, of which 22,934 cubic yards came from the excavation of Chattanooga Creek. The removal action was completed in December, 1998.
The purpose of a remedial investigation is to determine the nature and extent of contamination at a site and the threat to public health and the environment from a release, or potential release of hazardous substances from a site. The remedial investigation for the TPS Site included reviewing historical information and collecting samples from the air, water, soil, sediment and waste. The remedial investigation focused on the plant site, although a number of samples were also collected from areas surrounding the creek. EPA decided not to collect many creek sediment samples for this investigation because the EPA had conducted a comprehensive study of the creek in 1992
The purpose of the Feasibility Study was to determine the best cleanup remedy. The EPA conducted a Feasibility Study focused on cleanup alternatives for the portion of the contaminated creek not addressed during the Phase I Removal. Other much smaller areas in the flood plain that were contaminated with coal-tar and its related chemicals were also addressed with the creek sediments.
The former plant property was not considered in the cleanup strategy for the Site, because the property was removed from the Tennessee Products NPL listing by Federal Courts. See the November 12, 1996, decision of the U.S. Court of Appeals for the D.C. Circuit in
Based on the remedial investigation and the risk assessment, the remedy objectives were:
• Prevent human exposure to contaminated soil along the Northeast Tributary and contaminated sediment in Chattanooga Creek; and,
• Eliminate risks to aquatic life in Chattanooga Creek from exposure to contaminated sediment.
Six remedial action alternatives were considered for evaluation in the Focused Feasibility Study Report. They were: (1) Taking no action; (2) Re-routing the creek and encapsulating (solidifying) the contaminated sediment; (3) Excavating contaminated sediment and disposing of it in an on-site landfill; (4) Excavating contaminated sediment and treatment with on-site thermal desorption; (5) Excavating with on-site incineration; and (6) Excavating with off-site disposal and recycling.
In September 2002, EPA Region 4 issued the Final Record of Decision (ROD) for the TPS Site. The ROD selected the remedial action for the Middle Reach of Chattanooga Creek and a portion of the Northeast Tributary. The Middle Reach includes the bed and banks of Chattanooga Creek beginning 1,354 feet north of the 38th Street Bridge and extending to the confluence of Chattanooga Creek and Dobbs Branch, an approximate 1.9-mile section (the previous Non-Time Critical Removal Action addressed the upstream portion of the creek). Remediation of a dredged spoil pile located along the Northeast Tributary was also included in the ROD. The six remedial alternatives, including the no action alternative, were evaluated using nine criteria for remedy selection. Based on this evaluation, the EPA determined that excavating with off-site disposal and recycling (Alternative 6) was its preferred alternative for the Site. It provided the best balance of tradeoffs among the nine evaluation criteria and met the remedial goals by preventing future human contact with the coal-tar constituents and contaminated sediment in Chattanooga Creek. This remedy was used during the first phase of the cleanup (Non-Time Critical Removal) and was proven to be effective and efficient. Also, this was the only alternative considered to completely remove the waste material from the site. The remedy selected involved excavating coal-tar constituent waste and contaminated sediment beginning where the Phase 1 Cleanup ended (at 38th Street), to the confluence with Dobbs Branch. All of the contaminated sediment and waste in this segment of the creek was removed from the creek sides and bottom. Since the coal-tar contamination was easily identified by visual inspection, it was unnecessary to establish numerical cleanup standards. The cleanup was confirmed after a visual inspection of the work areas of the creek was performed. The scope of the remedy did not include groundwater, soil (other than specific areas containing tar waste), or surface water. The RI did not find contamination in those media requiring a remedial action.
In August of 2004, the EPA issued an Explanation of Significant Difference (ESD) to explain a change to a portion of the selected remedy. The remedy selected in the ROD was excavating with off-site disposal and recycling. The ESD changed the remedy to off-site disposal at the Bradley County Landfill. The recycling component of the remedy was eliminated due to the remedy encountering a larger volume of waste and the accompanying increase in costs.
The remedial action was implemented by dividing the creek into five segments, or creek channel reaches. In general, excavation of contaminated sediment and restoration activities occurred starting at the upstream segment and working downstream. The strategy for removal of sediments in the work area involved excavation in the dry. The creek dewatering process included installation of temporary coffer dams and pumping systems (large pumps and pipes) to route the creek water around the active reaches of excavation. The dams were constructed of clay and/or clean fill. The pumping systems were maintained twenty-four hours per day, seven days per week to keep the work areas dewatered. Contact between creek water and contaminated sediments in an active reach of excavation was minimized. However, water within the active stream reach that came in contact with excavated sediment was treated using an oil/water separator prior to discharge back into the creek.
Contaminated sediment from the creek channel was excavated until the remaining sediments were visually clean. Excavation activities began in October 2005 in Reach 1. Contaminated sediment was excavated from bank-to-bank, which was defined as the vegetative line at the edge of the creek; and, since limestone bedrock was not always present to define the vertical extent, all visual signs of sediment contamination were removed, and test pits were excavated to confirm that no other visual contamination existed. Where visible contamination extended beyond the creek bank, a maximum of three feet was removed horizontally from the original bank. The bank was then backfilled with clean fill and stabilized. When these efforts were completed, the EPA, or the designated representative, inspected the work area and verified that the performance standard was achieved. The excavated reach was then approved by the EPA before restoration activities were completed and water was pumped back into that portion of the creek.
Excavation of the contaminated creek sediments was conducted in a manner to minimize handling and to contain the contaminated sediment within the creek before direct transfer to trucks for transport to a drying bed for stabilization. Typically, two excavators were in the creek reach working to transport sediment to a common area for load-out. Lime kiln dust (LKD) was added to the sediment in the creek to stabilize sediment that contained significant free liquids prior to loading into the truck. The mixture was allowed to cure for a period of time that was sufficient to promote drying before the sediment was loaded in trucks. These activities were performed as necessary to reduce spillage during loading of the trucks. The excavated sediments were then transported to drying beds located on the former Southern Wood Piedmont facility. Additional LKD was mixed into the sediment prior to transport to the Bradley County, Tennessee, landfill for final disposal. Approval by the TDEC Division of Solid Waste Management was required for disposal of special waste (contaminated sediment mixed with lime kiln dust) at the Bradley County Landfill. Disposal of the special waste from the Site was approved on October 10, 2005. Recertifications for the 2006 and 2007 construction seasons were submitted and approved as well.
During excavation of a portion of the creek oxbow in January 2006, a black liquid was observed infiltrating the bottom of the excavation. Twelve inches of clay was placed in the first 250-foot section of the oxbow in an attempt to seal off the liquid. The seal did not work. This section of the creek is on property owned by Southern Wood Piedmont Company, which treated railroad cross-ties with creosote from 1924 to 1988. The black liquid resembled creosote and differed in physical characteristics from the coal-tar impacted sediments that were encountered in the upper reaches of the creek channel remediation. While the project was temporarily shut down because of high water conditions, the EPA performed a field investigation in March 2006 within and adjacent to Chattanooga Creek to evaluate this Non Aqueous Phase Liquid (NAPL). The general objectives of the investigation were to:
• Determine the horizontal and vertical extent of the NAPL in the oxbow section;
• Evaluate whether the presence of NAPL in the oxbow creates a potential for re-contamination;
• Assess NAPL transport pathways and potential sources of NAPL; and
• Evaluate the potential risks to human health and the environment posed by the NAPL.
The results of the EPA investigation were presented in a June 2006 document titled
The design for the isolation barrier included the use of AquaBlok®, which is a patented solid aggregate that is coated with a clay polymer that expands when hydrated. For the isolation barrier, a minimum 12-inch prepared subgrade soil layer was placed over the creek bed and banks to a level that was a minimum of three feet above the highest point of observed NAPL intrusion. The creek banks were graded or maintained at a maximum 3:1 slope. The protective isolation barrier was placed from where the creek crosses the Southern Wood Piedmont property to the confluence of Dobbs Branch, or approximately 5,750 linear feet of restored creek channel. A total of 308,878.3 square feet of isolation barrier, or approximately 7.1 acres, was installed. A combination of placing riprap and seeding was performed for creek bank stabilization. Restoration was consistent with the previous removal action at the upper reach of Chattanooga Creek. Areas of the creek bank where excavation of the bank had occurred or potential eroding locations (specifically on outer radius of curves) were stabilized by one of two methods. The first method included placement of a 6-oz non-woven geotextile covered by 6-inch riprap. The riprap was obtained from the temporary coffer dams or imported as required. Other locations requiring stabilization were seeded for a
A final total of 107,292 tons of contaminated sediment and debris were transported to the landfill for disposal over the course of the project in a total of 4,338 truck loads. The last load of stabilized sediment was transported from the Site to the landfill on September 4, 2007. Discarded tires found in the creek were removed and pressure washed. A total of 15.01 tons of tires were sent to a recycler in Nashville, Tennessee.
No long-term operation and maintenance or monitoring activities under CERCLA are required by the ROD or the RD/RA Consent Decree. Discretionary Five-Year Reviews will be conducted by the EPA to assess whether the protective isolation barrier continues to function as an effective engineering control to isolate the creek from the nearby NAPL source in the oxbow area. Operation and Maintenance and monitoring are the responsibility of the Southern Wood Piedmont facility under the Resource Conservation and Recovery Act (RCRA) through the Final RCRA Post-Closure Permit for the Southern Wood Piedmont facility, which is delegated to the TDEC. The triggering date for the discretionary Five-Year Review is five years from the formal authorization to proceed on October 12, 2005. There have been two FYRs in 2011 and 2016. EPA is conducting Discretionary Five-Year Reviews because a protective isolation barrier was installed to isolate the CERCLA remedy from adjacent areas where hazardous substances, pollutants or contaminants could remain above levels that allow for unlimited use and unrestricted exposure as defined by CERCLA. The most recent Five-Year Review was completed on September 26, 2016, and reported no issues or recommendations. The 2016 Five-Year Review concluded that the remedy at the Tennessee Products Site remains protective of human health and the environment, both in the short term and long term. The site inspections and sampling events concluded that the AquaBlok® cap is functioning as intended. These reviews will continue until the NAPL under the creek is addressed through the September 2005 RCRA Post-Closure Permit for the Southern Wood Piedmont facility. No institutional controls were required by the ROD.
Community involvement activities were conducted throughout the Non-Time Critical Removal and Remedial Action. Public notices and meetings were routinely held. An administrative record and information repository was placed in the community to provide accessible information about the activities at the Site. An advertisement will be placed in the
Region 4 has followed the procedures required by 40 CFR 300.425(e), and the implemented remedy achieves the degree of cleanup specified in the ROD for all pathways of exposure. The EPA confirmed that the sediment remedial action objectives and performance criteria were achieved. All cleanup actions specified in the ROD have been implemented. All selected remedial and removal action objectives and associated cleanup levels are consistent with agency policy and guidance, and are summarized in the Final Close-Out Report. This Site meets all the site completion requirements as specified in Office of Solid Waste and Emergency Response (OSWER) Directive 9320.22,
Environmental protection, Chemicals, Hazardous substances, Hazardous waste, Intergovernmental relations, Reporting and recordkeeping requirements, Superfund, Water pollution control.
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.
Federal Communications Commission.
Proposed rule; proposed auction procedures.
In this document, the Commission announces auctions of Upper Microwave Flexible Use Service licenses in the Upper 37 GHz (37.6-38.6 GHz), 39 GHz (38.6-40 GHz), and 47 GHz (47.2-48.2 GHz) bands, designated as Auction 103. This document proposes and seeks comment on competitive bidding procedures to be used for Auction 103.
Comments are due on or before May 15, 2019, and reply comments are due on or before May 30, 2019.
Comments may be filed using the Commission's Electronic Comment Filing System (ECFS) or by filing paper copies.
All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW, Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of before entering the building.
Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.
U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW, Washington, DC 20554.
For auction legal questions, Mark Montano or Erik Beith in the Auctions Division of the Office of Economics and Analytics at (202) 418-0660. For general auction questions, the Auctions Hotline at (717) 338-2868. For Upper Microwave Flexible Use Service questions, Simon Banyai in the Wireless Telecommunications Bureau's Broadband Division at (202) 418-2487.
This is a summary of the
1. By the
2. Auction 103 will offer UMFUS licenses for all available spectrum in the Upper 37 GHz (37.6-38.6 GHz), 39 GHz (38.6-40 GHz), and 47 GHz (47.2-48.2 GHz) bands. The Commission will offer 100 megahertz blocks of spectrum licensed by Partial Economic Area (PEA) service area. In combination, the Upper 37 GHz and the 39 GHz bands offer the largest amount of contiguous spectrum in the millimeter wave bands for flexible-use wireless services—a total of 2,400 megahertz—and the 47 GHz band will provide an additional 1,000 megahertz of millimeter wave spectrum for such services. The Commission proposes to limit Auction 103 to only these bands because licenses for no other UMFUS spectrum bands are ready and/or suitable to be auctioned at this same time.
3. The specific number of Upper 37 and 39 GHz licenses to be auctioned in each PEA will be determined by the reconfiguration process, which concludes with the Initial Commitments of 39 GHz incumbents as described in the
4. It is possible that an incumbent that chooses to receive modified licenses will decide to retain its partial PEA holding (
5. Each of the bands available in Auction 103 will be licensed on an unpaired basis in 100 megahertz channel blocks by PEA. A licensee in these bands may provide any services permitted under a fixed or mobile allocation, as set forth in the non-Federal Government column of the Table of Frequency Allocations in section 2.106 of the Commission's rules.
6. In the
7.
8.
9. The Commission seeks comment on establishing reasonable caps on the total amount of bidding credits that an eligible small business or rural service provider may be awarded for Auction 103.
10. In the
11. The Commission, in the
12. The Commission proposes to adopt the same bidding credit caps for Auction 103. Like Auction 101 and Auction 102, Auction 103 will offer licenses in the millimeter wave spectrum, and the Commission anticipates that the range of potential use cases suitable for the UMFUS bands, including localized fiber replacement and IoT, combined with the small license areas in these bands, may permit deployment of smaller scale networks with lower total costs. Further, based on past auction data, the Commission expects that a $25 million cap on small business bidding credits will allow the substantial majority of small businesses in the auction to take full advantage of the bidding credit program. The Commission therefore believes that its proposed cap will promote the statutory goals of providing meaningful opportunities for
13. The Commission proposes to adopt a $10 million cap on the total amount of bidding credits that may be awarded to an eligible rural service provider in Auction 103. The Commission anticipates that a $10 million cap on rural service provider bidding credits will not constrain the ability of any rural service provider to participate fully and fairly in Auction 103. In addition, to create parity in Auction 103 among eligible small businesses and rural service providers competing against each other in smaller markets, the Commission proposes a $10 million cap on the overall amount of bidding credits that any winning small business bidder may apply to winning licenses in markets with a population of 500,000 or less.
14. The Commission seeks comment on these proposed caps. Specifically, do the expected capital requirements associated with operating in the UMFUS bands, the potential number and value of UMFUS licenses, past auction data, or any other considerations justify a higher or lower cap for either type of bidding credit? Moreover, are there convincing reasons why the Commission should not achieve parity with the bidding credit caps in Auctions 101 and 102? Commenters are encouraged to identify unique circumstances and characteristics of this millimeter wave auction that should guide the Commission in establishing bidding credit caps, and to provide specific, data-driven arguments in support of their proposals.
15. The Commission reminds applicants applying for designated entity bidding credits that they should take due account of the requirements of the Commission's rules and implementing orders regarding
16. As with most recent Commission spectrum license auctions, the Commission proposes to limit information available in Auction 103 in order to prevent the identification of
17. Once the bidding in Auction 103 starts, under these proposed limited information procedures (sometimes also referred to as anonymous bidding), information to be made public after each round of bidding would include for each category of license in each geographic area, the supply, the aggregate demand, the price at the end of the last completed round, and the price for the next round. However, the identities of bidders placing specific bids and the net bid amounts (reflecting bidding credits) would not be disclosed until after the close of bidding.
18. Bidders would have access through the bidding system to additional information related to their own bidding and bid eligibility. For example, bidders would be able to view their own level of eligibility, before and during the auction, through the FCC auction bidding system.
19. After the close of bidding, bidders' PEA selections, upfront payment amounts, bidding eligibility, bids, and other bidding-related actions would be made publicly available.
20. The Commission seeks comment on the details of its proposal for implementing limited information procedures, or anonymous bidding, in Auction 103. Commenters opposing the use of anonymous bidding in Auctions 103 should explain their reasoning and propose alternative information rules.
21. Each potential bidder is solely responsible for investigating and evaluating all technical and marketplace factors that may have a bearing on the value of the licenses that it is seeking in Auction 103. Each bidder is responsible for assuring that, if it wins a license, it will be able to build and operate facilities in accordance with the Commission's rules. The Commission makes no representations or warranties about the use of this spectrum for particular services. Each applicant should be aware that a Commission auction represents an opportunity to become a Commission licensee, subject to certain conditions and regulations. This includes the established authority of the Commission to alter the terms of existing licenses by rulemaking, which is equally applicable to licenses awarded by auction. A Commission auction does not constitute an endorsement by the Commission of any particular service, technology, or product, nor does a Commission license constitute a guarantee of business success.
22. An applicant should perform its due diligence research and analysis before proceeding, as it would with any new business venture. Each potential bidder should perform technical analyses and/or refresh any previous analyses to assure itself that, should it become a winning bidder for any Auction 103 license, it will be able to build and operate facilities that will comply fully with all applicable technical and regulatory requirements. For example, licensees operating in the Upper 37 GHz band near specific Federal sites must coordinate with those Federal operations. The Commission strongly encourages each applicant to inspect any prospective sites for communications facilities located in, or near, the geographic area for which it plans to bid; confirm the availability of such sites; and familiarize itself with the Commission's rules regarding the National Environmental Policy Act.
23. The Commission strongly encourages each applicant to conduct its own research prior to Auction 103 in order to determine the existence of pending administrative, rulemaking, or judicial proceedings that might affect its decisions regarding participation in the auction.
24. The Commission also strongly encourages participants in Auction 103 to continue such research throughout the auction. The due diligence considerations mentioned in the document do not constitute an exhaustive list of steps that should be undertaken prior to participating in this auction. As always, the burden is on the potential bidder to determine how much research to undertake, depending upon the specific facts and circumstances related to its interests.
25. The Commission also reminds bidders of the Commission's mobile spectrum holding policies applicable to the millimeter wave bands. Specifically, for purposes of reviewing proposed secondary market transactions, the Commission adopted a threshold of 1850 megahertz of combined millimeter wave spectrum in the 24 GHz, 28 GHz, 37 GHz, 39 GHz, and 47 GHz bands. In addition, the Commission found that it is in the public interest to review applications for initial licenses filed post-auction on a case-by-case basis using this same 1850 megahertz threshold.
26. The Commission will conduct Auction 103 using an ascending clock auction design that will offer licenses for spectrum held by the Commission and for spectrum relinquished by incumbent licensees, and which will also determine incentive payments for relinquishing licensees. The first phase of the incentive auction will consist of successive clock bidding rounds in which bidders indicate their demands for categories of generic license blocks in specific partial economic areas (PEAs), followed by a second phase with bidding for frequency-specific license assignments, as the Commission decided in the
27. As in the clock auction used in the forward auction portion of the Broadcast Incentive Auction (Auction 1002) and the auction of licenses in the 24 GHz Band (Auction 102), the clock auction for Auction 103 will incorporate bidding for categories of generic spectrum blocks. The auction will proceed in a series of rounds, with bidding being conducted simultaneously for all spectrum blocks available in the auction. During the clock phase, the FCC auction bidding system will announce prices for blocks in each category in each PEA, and qualified bidders will submit quantity bids for the number of blocks they seek. Bidding rounds will be open for predetermined periods of time, during which bidders will indicate their demands for blocks at the clock prices associated with the current round. As in SMR auctions, bidders will be subject to activity and eligibility rules that govern the pace at which they participate in the auction.
28. Under the ascending clock auction format adopted by the Commission, in each PEA, the clock price for a license category will increase from round to round if bidders indicate total demand that exceeds the number of blocks
29. Following the clock phase, the assignment phase will offer clock phase winners the opportunity to bid an additional amount for licenses with specific frequencies. All winning bidders, regardless of whether they bid in the assignment phase, will be assigned licenses for contiguous blocks within a category in a PEA.
30. The Commission seeks comment on specific procedures to implement this ascending clock auction and on alternative procedures for conducting, in a timely manner, an auction of Upper 37 GHz, 39 GHz, and 47 GHz licenses.
31. The
32. The Commission proposes that the first category will consist of the available blocks between 37.6-40 GHz. This category, designated Category M/N, will comprise a total of twenty-four blocks: Ten in the Upper 37 GHz band (Blocks M1-M10) and 14 in the 39 GHz band (Blocks N1-N14). These 24 blocks represent a continuous swath of spectrum, and including them in a single bidding category should speed up the auction and give bidders greater flexibility to aggregate multiple contiguous spectrum blocks. A second category, Category P, will consist of the ten blocks between 47.2-48.2 GHz (Blocks P1-P10).
33. In each bidding round, a bidder will have the opportunity to bid for the quantity of generic blocks it demands in each of the two bidding categories. Bidding in the clock phase will determine a single price for all the generic blocks in each category in each PEA.
34. If an incumbent, in the Initial Commitment phase, chooses to accept a reconfigured license (full or partial) in one or more PEAs, the number of generic blocks available for bidding in the M/N category in those PEAs will be reduced accordingly. As a result, under this proposed procedure, there may be fewer than 24 blocks available for bidding in some PEAs in the M/N category. The Commission proposes to announce the full auction inventory—
35. The Commission's proposal for bidding on generic blocks in two categories is based on the close similarity of the blocks within each bidding category. To the extent a bidder has a preference for specific frequency licenses, the bidder may bid for its preferred blocks in the assignment phase. However, a bidder for a generic block cannot be assured that it will be assigned, or not be assigned, any particular frequency block. The Commission asks that commenters explain any concerns they may have about the interchangeability of generic blocks within the two proposed categories of generic blocks, bearing in mind potential tradeoffs between the number of categories and auction length, the ability of the auction system to assign contiguous blocks to winners of multiple blocks, and bidder manageability.
36. The final clock phase price for a generic licensing block in Category M/N in a given PEA will determine the incentive payment associated with 100 megahertz of relinquished spectrum rights in that PEA. Further, an incumbent that relinquishes spectrum rights equivalent to fewer than 100 megahertz in the full geography of the PEA will be entitled to an incentive payment equal to the final clock phase price for a Category M/N block times the fraction of its relinquished rights, measured in MHz-pops, relative to the full number of MHz-pops in the PEA.
37. An incumbent that both relinquishes the equivalent of a full block of spectrum rights in Category M/N in a PEA and wins a generic block in the category in the same PEA will, in effect, receive an incentive payment credit equal to the final clock phase price and incur an obligation in the same amount, for a net clock phase payment of zero. If an incumbent chooses to bid for specific frequencies in the assignment phase, the incumbent will be obligated to pay any additional payment.
38. An incumbent that is eligible for bidding credits and that both relinquishes spectrum and bids for new licenses will receive a bidding credit discount only on its net cash payment for new licenses.
39. Under this proposal, Auction 103 will consist of sequential bidding rounds, each followed by the release of round results. The initial bidding schedule will be announced in a public notice to be released at least one week before the start of bidding.
40. Auction 103 will be conducted over the internet using the FCC auction bidding system. Bidders will also have the option of placing bids by telephone through a dedicated auction bidder line. The toll-free telephone number for the auction bidder line will be provided to qualified bidders prior to the start of bidding in the auction.
41. The Commission proposes that the initial bidding schedule may be adjusted in order to foster an auction pace that reasonably balances speed with the bidders' need to study round results and adjust their bidding strategies. Such changes may include the amount of time for bidding rounds, the amount of time between rounds, or the number of rounds per day, depending upon bidding activity and other factors. The Commission seeks comment on this proposal. Commenters on this issue should address the role of the bidding schedule in managing the pace of the auction, specifically discussing the tradeoffs in managing auction pace by bidding schedule changes, by changing the activity requirement or the increment percentage, or by using other means.
42. The Commission proposes an aggregate net revenue requirement to ensure that the proceeds from Auction 103, net of bidding credits, are sufficient to cover incentive payment obligations to incumbents relinquishing spectrum. Under this proposal, the Commission will consider revenues from licenses in the Upper 37 GHz, 39 GHz, and the 47 GHz bands in determining whether the net revenue requirement has been met. The Commission proposes to make available to bidders an estimate of the current shortfall for meeting the net revenue requirement, updated after each round of bidding, until the requirement is met. The Commission proposes to indicate on the Public Reporting System (PRS) whether the requirement has been met. The Commission further proposes to consider only clock phase revenues in determining whether the net revenue requirement is met.
43. Under this proposal, the shortfall figure the Commission makes available prior to the close of bidding in the clock
44. The Commission proposes to consider only clock phase revenues—not assignment phase revenues—in determining whether the net revenue requirement is met. Revenues from assignment phase payments are expected to be small relative to those from the clock phase and therefore less likely to contribute significantly to meeting the revenue requirement. Because assignment phase payments are determined using a second-price rule, an individual bidder wishing to boost revenues intentionally will have little ability to do so. In addition, the Commission is mindful of the additional time required to conduct assignment rounds, and it does not wish to require bidders or Commission staff to invest the additional time in the assignment phase if ultimately no licenses will be assigned.
45. If the net revenue requirement has been satisfied at the time that the clock phase bidding stops for both categories of blocks, the auction system will determine the winning bidders of generic blocks, and the auction will proceed to the assignment phase. If the net revenue requirement has not been satisfied at the time bidding stops in the clock phase, the auction will end, and no new licenses will be assigned. Incumbents in the 39 GHz band will retain their original licenses pending further decisions by the Commission.
46. The Commission seeks comment on its proposed net revenue requirement and on its proposals to make available a conservative estimate of the shortfall after each round and to consider only clock phase revenues in determining whether the requirement has been met.
47. The Commission proposes a simultaneous stopping rule for the clock phase of Auction 103, under which both categories of licenses in all PEAs will remain available for bidding until the bidding stops on both categories. Specifically, the Commission proposes that the clock phase of bidding will end for both categories of blocks after the first round in which there is no excess demand in any category in any PEA. Consequently, under this approach, it is not possible to determine in advance how long Auction 103 would last.
48. The Commission seeks comment on its proposed simultaneous stopping rule.
49. In keeping with the Commission's usual practice in spectrum license auctions, the Commission proposes that applicants be required to submit upfront payments as a prerequisite to becoming qualified to bid. The upfront payment is a refundable deposit made by an applicant to establish its eligibility to bid on licenses. Upfront payments that are related to the inventory of licenses being auctioned protect against frivolous or insincere bidding and provide the Commission with a source of funds from which to collect payments owed at the close of bidding.
50. The Commission proposes to assign each PEA a specific number of bidding units, equal to one bidding unit per $10 of the upfront payment. The number of bidding units for a given PEA is fixed and does not change during the auction as prices change. The bidding unit amount assigned to a specific PEA will apply to a single generic block for that PEA. Bidding units will be used for purposes of measuring bidder eligibility and bidding activity. The Commission further proposes to determine the bidding units for a PEA based on the same weights it will use in the reconfiguration process and in Round Zero to quantify the weighted MHz-pops of an incumbent's spectrum holdings. Since weights are not yet determined, Attachment A to the document lists the MHz-pops of each PEA, and the Commission will update Attachment A with bidding units and upfront payment amounts when the weights are available.
51. Taking into account the various purposes of upfront payments, the Commission proposes to use a tiered approach, under which upfront payment amounts will vary by market population. The Commission proposes upfront payments for a generic block in a PEA based on $0.001 per weighted MHz-pop for PEAs 1-50, $0.0002 per weighted MHz-pop for PEAs 51-100, and $0.0001 per weighted MHz-pop in other PEAs. The proposed upfront payments equal approximately half the proposed minimum opening bids. The Commission seeks comment on the proposed method for calculating upfront payment amounts. For informational purposes, Attachment A shows the unweighted MHz-pops per each PEA and the result of multiplying the unweighted MHz-pops by $0.001, $0.0002, or $0.0001 depending on the PEA.
52. The Commission further proposes that the amount of the upfront payment submitted by a bidder will determine its initial bidding eligibility in bidding units. To the extent that bidders wish to bid on multiple generic blocks simultaneously, they will need to ensure that their upfront payment provides enough eligibility to cover multiple blocks. Under the proposed approach to calculating bidding units, the generic Category M/N and Category P blocks in a PEA will be assigned the same number of bidding units, which will facilitate bidding across categories.
53. Under the proposed approach, a bidder's upfront payment will not be attributed to blocks in a specific PEA or PEAs. If an applicant is found to be qualified to bid on more than one block being offered in Auction 103, such a bidder may place bids on multiple blocks, provided that the total number of bidding units associated with those blocks does not exceed its current eligibility. A bidder cannot increase its eligibility during the auction; it can only maintain its eligibility or decrease its eligibility. Thus, in calculating its upfront payment amount and hence its initial bidding eligibility, an applicant must determine the maximum number of bidding units on which it may wish to bid in any single round and submit an upfront payment amount covering that total number of bidding units. The Commission seeks comment on these proposals.
54. In connection with the proposed upfront payment amounts and corresponding bidding eligibility, the Commission tentatively concludes that
55. In order to ensure that the auction closes within a reasonable period of time, an activity rule requires bidders to bid actively throughout the auction, rather than wait until late in the auction before participating. For a clock auction, a bidder's activity in a round for purposes of the activity rule will be the sum of the bidding units associated with the bidder's demands as applied by the auction system during bid processing. Bidders are required to be active on a specific percentage of their current bidding eligibility during each round of the auction. Failure to maintain the requisite activity level will result in a reduction in the bidder's eligibility, possibly curtailing or eliminating the bidder's ability to place additional bids in the auction.
56. The Commission proposes to require that bidders maintain a fixed, high level of activity in each round of Auction 103 in order to maintain bidding eligibility. Specifically, the Commission proposes to require that bidders be active on between 90 and 100% of their bidding eligibility in all clock rounds, with an initial activity requirement of 95%. Thus, the activity rule would be satisfied when a bidder has bidding activity on blocks with bidding units that total 90 to 100% of its current eligibility in the round. If the activity rule is met, then the bidder's eligibility does not change in the next round. The Commission proposes to calculate bidding activity based on the bids that are applied by the FCC auction bidding system. That is, if a bidder requests a reduction in the quantity of blocks it demands in a category, but the FCC auction bidding system does not apply the request because demand for the category would fall below the available supply, the bidder's activity will reflect its unreduced demand. If the activity rule is not met in a round, a bidder's eligibility automatically would be reduced. The activity requirements may be changed during the auction.
57. The Commission invites comment on this proposal, in particular on whether to set the activity requirement between 90% and 100%. Commenters may wish to address the relationship between the proposed activity rule and the ability of bidders to switch their demands across PEAs or across categories of blocks within a PEA. The Commission encourages any commenters that oppose an activity rule in this range to explain their reasons with specificity.
58. The Commission points out that under its proposed clock auction, bidders are required to indicate their demands in every round, even if their demands at the new round's prices are unchanged from the previous round. Missing bids—bids that are not reconfirmed—are treated by the auction bidding system as requests to reduce to a quantity of zero blocks for the category. If these requests are applied, or applied partially, a bidder's bidding activity, and hence its bidding eligibility for the next round, will be reduced.
59. For Auction 103, the Commission does not propose to provide for activity rule waivers to preserve a bidder's eligibility. This proposal is consistent with the ascending clock auction procedures adopted for Auctions 1002 and 102. In previous Commission multiple round auctions, when a bidder's eligibility in the current round was below a required minimum level, the bidder was able to preserve its current level of eligibility with a limited number of activity rule waivers. The clock auction, however, relies on precisely identifying the point at which demand falls to equal supply to determine winning bidders and final prices. Allowing waivers would create uncertainty with respect to the exact level of bidder demand, interfering with the basic clock price-setting and winner determination mechanisms. Moreover, uncertainty about the level of demand would affect the way bidders' requests to reduce demand are processed by the FCC auction bidding system. The Commission seeks comment on this proposal.
60. The Commission seeks comment on the use of a minimum opening bid amount and/or reserve price for Auction 103, as it does prior to the start of each auction.
61. A reserve price is an absolute minimum price below which a construction permit or license will not be sold in a given auction. A minimum opening bid, on the other hand, is the minimum bid price set at the beginning of the auction below which no bids are accepted. In Auction 103, if there are any PEAs in which demand for blocks never exceeds the supply of blocks, the minimum opening bid will serve as the basis for determining incentive payments to incumbents relinquishing spectrum in a PEA (because the final clock phase price will be equal to the minimum opening bid).
62. The Commission proposes to establish minimum opening bid amounts for Auction 103. Based on the Commission's experience in past auctions, a minimum opening bid amount is an effective bidding tool for accelerating the competitive bidding process. At the beginning of the clock phase, a bidder will indicate how many blocks in a generic license category in a PEA it demands at the minimum opening bid price. For Auction 103, the Commission proposes to establish initial clock prices, or minimum opening bids, as set forth in the following paragraph. The Commission does not propose to establish license-specific reserve prices that are different from minimum opening bid amounts for the licenses to be offered in Auction 103.
63. For Auction 103, the Commission proposes to calculate minimum opening bid amounts using a formula based on bandwidth and license area population, incorporating the same weights it will use in the reconfiguration process and Round Zero to quantify the weighted MHz-pops of an incumbent's spectrum holdings. This is similar to the Commission's approach in many previous spectrum auctions of weighting by an index of relative prices from prior auctions. Since weights are not yet determined, Attachment A of the document lists the MHz-pops of each PEA, and the Commission will update Attachment A with bidding units and upfront payment amounts when the weights are available.
64. The Commission proposes to use a tiered approach, under which minimum opening bid amounts will vary by market population. The Commission proposes minimum
65. In establishing minimum opening bid amounts, the Commission particularly seeks comment on factors that could reasonably have an impact on bidders' valuation of the spectrum, including the type of service offered, market size, population covered, any other relevant factors.
66. Commenters may also wish to address the general role of minimum opening bids in managing the pace of the auction. For example, commenters could compare using minimum opening bids—
67. Under the proposed clock auction format for Auction 103, after bidding in the first round and before each subsequent round, the FCC auction bidding system will announce a clock price for the next round, which is the highest price to which bidders can respond during the round. The Commission proposes to set the clock price for each category in each specific PEA for a round by adding a fixed percentage increment to the price for the previous round. As long as total demand for blocks in a category exceeds the supply of blocks, the percentage increment will be added to the clock price from the prior round. If demand equaled supply at an intra-round bid price in a previous round, then the clock price for the next round will be set by adding the percentage increment to the intra-round bid price.
68. The Commission proposes to apply an increment that is between 5% and 20% and generally to apply the same increment percentage to all categories in all PEAs. The Commission proposes to set the initial increment within this range, and to adjust the increment as rounds continue. The proposed 5-20% increment range will allow the FCC to set a percentage that manages the auction pace, taking into account bidders' needs to evaluate their bidding strategies while moving the auction along quickly. The Commission also proposes that increments may be changed during the auction on a PEA-by-PEA or category-by-category basis based on bidding activity to assure that the system can offer appropriate price choices to bidders.
69. The Commission proposes to permit a bidder to make intra-round bids by indicating a point between the previous round's price and the new clock price at which its demand for blocks in a category changes. In placing an intra-round bid, a bidder would indicate a specific price and a quantity of blocks it demands if the price for blocks in the category should increase beyond that price.
70. Intra-round bids would be optional; a bidder may choose to express its demands only at the clock prices. This proposal to permit intra-round bidding would allow the auction system to use relatively large clock increments, thereby speeding the clock phase, without running the risk that a jump in the clock price will overshoot the market clearing price—the point at which demand for blocks equals the available supply.
71. The Commission proposes that the FCC auction bidding system not apply a bidder's request to reduce the quantity of blocks it demands in a category if the reduction will result in aggregate demand falling below the available supply of blocks in the category.
72. Under the ascending clock format proposed for Auction 103, a bidder will indicate in each round the quantity of blocks in each category in each PEA that it demands starting at a given price, indicating that at prices above the bid price it is willing to get the changed quantity. A bidder can express its demands at the clock price or at an intra-round price, and bid quantities can represent an increase or a decrease over the bidder's previous demands for blocks in a category.
73. If a bidder demands fewer blocks in a category than it did in the previous round, the FCC auction bidding system will treat the bid as a request to reduce demand that will be implemented only if aggregate demand would not fall below the available supply of blocks in the category. In addition, if a bidder demands more blocks in a category than it did in the previous round, the FCC auction bidding system will treat the bid as a request to increase demand that will be implemented only if the bidder has sufficient bidding eligibility to cover the increase.
74. The Commission also proposes to process bids after a round ends in order of price point, where the price point represents the percentage of the bidding interval for the round. Under this proposal, once a round ends, the FCC auction bidding system will process bids in ascending order of price point, first considering intra-round bids in order of price point and then bids at the clock price. The system will consider bids at the lowest price point for all categories in all PEAs, then look at bids at the next price point in all areas, and so on. In processing the bids submitted in the round, the FCC auction bidding system will determine the extent to which there is excess demand for each category in each PEA in order to determine whether a bidder's requested reduction in demand can be implemented.
75. For a given category in a given PEA, the uniform price for all blocks in the category will stop increasing when aggregate demand no longer exceeds the available supply of blocks in the category. If no further bids are placed, the final clock phase price for the category will be the stopped price.
76. In order to facilitate bidding for multiple blocks in a PEA, the Commission proposes that bidders will be permitted to make two types of bids: Simple bids and switch bids.
77. A “simple” bid indicates a desired quantity of licenses in a category at a price (either the clock price or an intra-round price). Simple bids may be applied partially. A simple bid that involves a reduction from the bidder's previous demands may be implemented partially if aggregate excess demand is insufficient to support the entire reduction. A simple bid to increase a bidder's demand in a category may be applied partially if the total number of bidding units associated with the bidder's demand, given all changes in demand that have been applied so far in the bid processing, exceeds the bidder's bidding eligibility for the round.
78. A “switch” bid allows the bidder to request to move its demand for a quantity of licenses from the M/N category to the P category, or vice versa, within the same PEA. A switch bid may be applied partially, but the increase in demand in the “to” category will always match in quantity the reduction in the “from” category.
79. The proposed bid types will allow bidders to express their demand for blocks in the next clock round without running the risk that they will be forced to purchase more spectrum at a higher price than they wish. When a bid to reduce demand can be applied only partially, the uniform price for the category will stop increasing at that point, since the partial application of the bid results in demand falling to equal supply. Hence, a bidder that makes a simple bid or a switch bid that cannot be fully applied will not face a price for the remaining demand that is higher than its bid price.
80. Because in any given round some bidders may increase demands for licenses in a category while others may request reductions, the price point at which a bid is considered by the auction bidding system can affect whether it is applied. In addition to proposing that bids be considered by the system in order of increasing “price point,” the Commission further proposes that bids not applied because of insufficient aggregate demand or insufficient eligibility be held in a queue and considered, again in order, if there should be excess demand (in the case of a bid to reduce demand) or if the bidder's demand in other categories and PEAs is reduced (in the case of a bid to increase demand) later in the processing after other bids are processed.
81. More specifically, under the proposed procedures, once a round closes, the FCC auction bidding system will process the bids by first considering the bid submitted at the lowest price point and determine whether it can be applied given aggregate demand as determined most recently and given the associated bidder's eligibility. If the bid can be applied, or partially applied, the number of licenses the bidder demands will be adjusted, and aggregate demand will be recalculated accordingly. If the bid cannot be applied in part or in full, the unfulfilled bid, or portion thereof, will be held in a queue to be considered later during bid processing for that round. The FCC auction bidding system will then consider the bid submitted at the next highest price point, accepting it in full, in part, or not at all, given recalculated aggregate demand and given the associated bidder's eligibility. Any unfulfilled requests will again be held in a queue, and aggregate demand will again be recalculated. Every time a bid or part of a bid is applied and aggregate demand has been recalculated, the unfulfilled bids held in queue will be reconsidered, in the order of their original price points (and by pseudo-random number, in the case of tied price points). The auction bidding system will not carry over unfulfilled bid requests to the next round, however. The bidding system will advise bidders of the status of their bids when round results are released.
82. After the bids are processed in each round, the FCC auction bidding system will announce new clock prices to indicate a range of acceptable bid prices for the next round. Each bidder will be informed of the number of blocks in a category on which it holds bids, the aggregate demand for each category in a PEA, and, if demand fell to equal supply during the round, the intra-round price point at which that occurred.
83.
84. The Commission seeks comment on its proposals regarding reducing demand, bid types, and bid processing for Auction 103.
85. Under the proposed clock auction format for Auction 103, as long as the net revenue requirement has been satisfied, bidders that are still expressing demand for a quantity of blocks in a category in a PEA at the time the stopping rule is met will become the winning bidders and will be assigned specific frequencies in the assignment phase.
86. The FCC auction bidding system allows each bidder to remove any of the bids it placed in a round before the close of that round. By removing a bid placed within a round, a bidder effectively “unsubmits” the bid. Once a round closes, a bidder may no longer remove a bid.
87. Unlike an SMR auction, there are no provisionally winning bids in a clock auction. As a result, the concept of bid withdrawals is inapplicable to a clock auction. As proposed, however, bidders in Auction 103 may request to reduce demand for generic blocks.
88. The Commission proposes to sequence assignment rounds to make it easier for bidders to incorporate frequency assignments from previously assigned areas into their bid preferences for other areas, recognizing that bidders winning multiple blocks of licenses generally will prefer contiguous blocks across adjacent PEAs. The Commission proposes to conduct rounds for the largest markets first to enable bidders to establish a “footprint” from which to work.
89. Specifically, the Commission proposes to conduct a separate assignment round for each of the top 20 PEAs and to conduct these assignment rounds sequentially, beginning with the largest PEAs. Once the top 20 PEAs have been assigned, the Commission proposes to conduct, for each Regional Economic Area Grouping (REAG), a series of assignment rounds for the remaining PEAs within that region. The Commission further proposes, where feasible, to group into a single market for assignment any non-top 20 PEAs within a region in which the supply of blocks is the same in each category, the same entities (winning bidders and incumbents keeping modified licenses) need to be assigned the same number of blocks in each category, and all are subject to the small markets bidding cap or all are not subject to the cap, which will also help maximize contiguity across PEAs. The Commission proposes to sequence the assignment rounds within a REAG in descending order of population for a PEA group or individual PEA. The Commission further proposes to conduct the bidding for the different REAGs in parallel in order to reduce the total amount of time required to complete the assignment phase.
90. The Commission seeks comment on these proposals for sequencing assignment rounds, including conducting separate rounds for the top 20 PEAs, and on the proposal to group PEAs for bidding under some circumstances within REAGs.
91. In each assignment round, a bidder will be asked to assign a price to one or more possible frequency assignments for which it wishes to express a preference, consistent with its winnings for generic blocks in the clock phase. The price will represent a maximum payment that the bidder is willing to pay, in addition to the base price established in the clock phase for the generic blocks, for the frequency-specific license or licenses in its bid. The Commission proposes that a bidder will submit its preferences for blocks it won in the Upper 37 and 39 GHz bands and the 47 GHz band separately, rather than submitting bids for preferences that include blocks in both categories. That is, if a bidder won one block in category M/N and two blocks in category P, it would not be able to submit a single bid amount for an assignment that included all three blocks. Instead, it would submit its bid or bids for assignments in category M/N separately from its bid or bids for assignments in category P.
92. The Commission proposes to use an optimization approach to determine the winning frequency assignment for each category in each PEA or PEA group. The Commission proposes that the auction system will select the assignment that maximizes the sum of bid amounts among all assignments that satisfy the contiguity requirements. The Commission proposes that the additional price a bidder will pay for a specific frequency assignment (above the base price) will be calculated consistent with a generalized “second price” approach—that is, the winner will pay a price that would be just sufficient to result in the bidder receiving that same winning frequency assignment while ensuring that no group of bidders is willing to pay more for an alternative assignment that satisfies the contiguity restrictions. This price will be less than or equal to the price the bidder indicated it was willing to pay for the assignment. The Commission proposes to determine prices in this way because it facilitates bidding strategy for the bidders, encouraging them to bid their full value for the assignment, knowing that if the assignment is selected, they will pay no more than would be necessary to ensure that the outcome is competitive.
93. The Commission seeks comment on these proposed procedures. In particular, the Commission asks whether bidders would find it useful to be able to submit a single bid for assignments that include frequencies in both categories, in cases where the bidder won blocks in both category M/N and category P.
94. Any winning bidder that defaults or is disqualified after the close of an auction (
95. The Commission's rules provide that, in advance of each auction, it will establish a percentage between 3% and 20% of the applicable winning bid to be assessed as an additional default payment. As the Commission has indicated, the level of this additional payment in each auction will be based on the nature of the service and the licenses being offered.
96. For Auction 103, the Commission proposes to establish an additional default payment of 15%, which is consistent with that adopted for Auctions 101 and 102. As noted in the
97. In case they are needed for post-auction administrative purposes, the bidding system will calculate individual per-license prices that are separate from final auction payments, which are calculated on an aggregate basis. The bidding system will apportion to individual licenses any assignment phase payments and any capped bidding credit discounts, since in both cases, a single amount may apply to multiple licenses.
98. The Commission intends to provide additional information on the bidding system and to offer demonstrations and other educational opportunities for applicants in Auction 103 to familiarize themselves with the FCC auction application system and the auction bidding system. For example, the Commission intends to release an online tutorial that will help applicants understand the procedures to be followed in the filing of their auction short-form applications (FCC Form 175) for Auction 103.
99.
100.
101. The proposed procedures for the conduct of Auction 103 constitute the more specific implementation of the competitive bidding rules contemplated by Parts 1 and 30 of the Commission's rules and the underlying rulemaking orders, including the
102.
103.
104. As noted above, Regulatory Flexibility Analyses were incorporated into the
105. Based on the information available in the Commission's public Universal Licensing System (ULS), the Commission estimates there are currently 16 incumbent 39 GHz licensees. Of these incumbent 39 GHz licensees, the Commission estimates that up to 8 could be considered a “small entity” under the RFA.
106.
107. The Commission does not expect the processes and procedures proposed in the document will require small entities to hire attorneys, engineers, consultants, or other professionals to participate in Auction 103 and comply with the procedures the Commission ultimately adopts because of the information, resources, and guidance the Commission makes available to potential and actual participants. For example, the Commission intends to release an online tutorial that will help applicants understand the procedures for filing of the auction short-form applications (FCC Form 175). The Commission also intends to make information on the bidding system available and offer demonstrations and other educational opportunities for applicants in Auction 103 to familiarize themselves with the FCC auction application system and the auction bidding system. By providing these resources, the Commission expects small business entities who utilize the available resources to experience lower participation and compliance costs.
108.
109. The Commission has taken steps to minimize any economic impact of its auction procedures on small businesses
110. The Commission also makes various databases and other sources of information, including the Auctions program websites, and copies of Commission decisions, available to the public without charge, providing a low-cost mechanism for small businesses to conduct research prior to and throughout the auction. Prior to and at the close of Auction 103, the Commission will post public notices on the Auctions website, which articulate the procedures and deadlines for the auction. The Commission makes this information easily accessible and without charge to benefit all Auction 103 applicants, including small businesses, thereby lowering their administrative costs to comply with the Commission's competitive bidding rules.
111. Prior to the start of bidding, eligible bidders are given an opportunity to become familiar with auction procedures and the bidding system by participating in a mock auction. Further, the Commission intends to conduct Auction 103 electronically over the internet using its web-based auction system that eliminates the need for bidders to be physically present in a specific location. Qualified bidders also have the option to place bids by telephone. These mechanisms are made available to facilitate participation in Auction 103 by all eligible bidders and may result in significant cost savings for small business entities who use these alternatives. Moreover, the adoption of bidding procedures in advance of the auction, consistent with statutory directive, is designed to ensure that the auction will be administered predictably and fairly for all participants, including small businesses.
112. For Auction 103, the Commission proposes a $25 million cap on the total amount of bidding credits that may be awarded to an eligible small business and a $10 million cap on the total amount of bidding credits that may be awarded to a rural service provider. In addition, the Commission proposes a $10 million cap on the overall amount of bidding credits that any winning small business bidder may apply to winning licenses in markets with a population of 500,000 or less. Based on the technical characteristics of the UMFUS bands and the Commission's analysis of past auction data, the Commission anticipates that the proposed caps will allow the majority of small businesses to take full advantage of the bidding credit program, thereby lowering the relative costs of participation for small businesses.
113. These proposed procedures for the conduct of Auction 103 constitute the more specific implementation of the competitive bidding rules contemplated by Parts 1 and 30 of the Commission's rules and the underlying rulemaking orders, including the
114.
115.
Federal Communications Commission.
Proposed rule.
In this document, the Commission's Office of Engineering and Technology (OET) sought comment on updating the Commission's rules and procedures to reflect recent changes to two standards: (1) ANSI C63.4a-2017 “American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz, Amendment 1: Test Site Validation;” and (2) ISO/IEC 17025:2017(E) “General requirements for the competence of testing and calibration laboratories.”
Submit comments on or before June 7, 2019 and reply comments on or before June 24, 2019.
Pursuant to sections 1.415 and 1.419 of the Commission's rules, 47 CFR 1.415 and 1.419, interested parties
Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW, Room TW-A325, Washington, DC 20554. The filing hours are 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of
Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9050 Junction Drive, Annapolis Junction, MD 20701.
U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW, Washington DC 20554.
Documents are available for public inspection and copying during business hours at the FCC Reference Information Center, Portals II, 445 12th Street SW, Room CY-A257, Washington, DC 20554.
Mr. Brian Butler at
This is a summary of the Office of Engineering and Technology's Public Notice in ET Docket No 19-48, released April 2, 2019. The full text of this document is available at
ANSI C63.4a-2017 can be purchased from the Institute of Electrical and Electronic Engineers (IEEE), 3916 Ranchero Drive, Ann Arbor, MI 48108, 1-800-699-9277,
ISO/IEC publications can be purchased from the American National Standards Institute (ANSI) through its NSSN operation (
As background, the Commission's rules incorporate references to measurement and technical standards that have been established by standards-setting bodies such as American National Standards Institute, Accredited Standards Committee C63SC (ASC63), International Organization for Standardization (ISO), and International Electrotechnical Commission (IEC). The Commission's equipment authorization program for radiofrequency (RF) devices, for example, incorporates such references in § 2.910 of the Commission's rules, 47 CFR. These organizations periodically update their standards to maintain best practices in response to advancements in technologies and measurement capabilities. When these changes are of a substantive nature, the Commission uses the rulemaking process to evaluate whether the changes should be effectuated in its rules.
By the Public Notice (Notice), OET sought comment on updating the Commission's rules and procedures to reflect recent changes to two standards: ANSI C63.4a-2017 “American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz, Amendment 1: Test Site Validation” and ISO/IEC 17025:2017(E) “General requirements for the competence of testing and calibration laboratories.” As detailed below, the Notice discussed the role of these standards in the Commission's rules and it noted the recent changes made by the respective standards bodies.
Additionally, ISO and International Laboratory Accreditation Cooperation (ILAC) recently issued a joint communique that re-confirms that a three-year transition period will be allowed for accredited laboratories to transition to the 2017 version of ISO/IEC 17025. While both ISO/IEC 17025:2005(E) and ISO/IEC 17025:2017(E) will be valid during this three-year transition period, accreditations to ISO/IEC 17025:2005(E) will become invalid after November 30, 2020. OET sought comment on incorporating ISO/IEC 17025:2017(E) into the Commission's rules and adopting a three-year transition period, consistent with the ISO and ILAC joint communique.
Coreworks, LLC (Coreworks) submitted a notification of proposed production activity to the FTZ Board for its facility in Katy, Texas. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on April 30, 2019.
The applicant indicates that it will be submitting a separate application for FTZ designation at the Coreworks facility under FTZ 84. The facility is used for the production of brazed aluminum heat exchangers and cryogenic equipment. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt Coreworks from customs duty payments on the foreign-status components used in export production. On its domestic sales, for the foreign-status materials/components noted below, Coreworks would be able to choose the duty rates during customs entry procedures that apply to: Brazed aluminum heat exchangers; brazed aluminum heat exchanger parts; and, steel and aluminum cryogenic cold boxes (duty rate ranges from duty-free to 4.2%). Coreworks would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The components and materials sourced from abroad include: Aluminum fin stock; hollow aluminum end bars for core blocks; custom-shape, alloy aluminum end bars for core blocks; aluminum tubing structural shapes and supports; aluminum parting sheets for cores; aluminum braze foils; aluminum header and nozzle pipes; aluminum flanges; stainless steel skid cold box heat exchanger piping; stainless steel skid cold box structures; stainless steel fittings; steel flanges; stainless steel threaded fittings; butt welded fittings; steel forged fittings; vacuum braze furnace vacuum pumps; induction and resistance vacuum braze furnaces; seals, gaskets, pumps, filters and condenser panels for vacuum braze furnaces; die stamping presses; steel process separator drums; and, steel process vessel columns (duty rate ranges from duty-free to 6.5%). The request indicates that certain materials/components are subject to special duties under Section 232 of the Trade Expansion Act of 1962 (Section 232) or Section 301 of the Trade Act of 1974 (Section 301), depending on the country of origin. The applicable Section 232 and Section 301 decisions require subject merchandise to be admitted to FTZs in privileged foreign status (19 CFR 146.41).
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary and sent to:
A copy of the notification will be available for public inspection in the “Reading Room” section of the Board's website, which is accessible via
For further information, contact Elizabeth Whiteman at
STIHL, Incorporated (STIHL) submitted a notification of proposed production activity to the FTZ Board for its facility in Virginia Beach, Virginia. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on May 1, 2019.
STIHL already has authority to produce outdoor power equipment and their parts within Subzone 20E. The current request would add foreign status materials/components to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status materials/components described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt STIHL from customs duty payments on the foreign-status materials/components used in export production. On its domestic sales, for the foreign-status materials/components noted below, STIHL would be able to choose the duty rates during customs entry procedures that apply to: Blowers, trimmers, sprayers, cutters, cultivators, and chainsaws (duty rate ranges from duty-free to 4.7%). STIHL would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The materials/components sourced from abroad include portable sprayers, tool holders, lithium battery primary cells, recorded media, electronic modules, and apparatus for measuring voltage (duty rate ranges from duty-free to 3.9%). The request indicates that lithium battery primary cells will be admitted to the zone in privileged foreign status (19 CFR 146.41), thereby precluding inverted tariff benefits on such items. The request also indicates that certain materials/components are subject to special duties under Section 301 of the Trade Act of 1974 (Section
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary and sent to:
A copy of the notification will be available for public inspection in the “Reading Room” section of the Board's website, which is accessible via
For further information, contact Juanita Chen at
An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the Chattanooga Chamber Foundation, grantee of FTZ 134, requesting production authority on behalf of Wacker Polysilicon North America, LLC (Wacker), located in Charleston, Tennessee. The application conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.23) was docketed on May 2, 2019.
Wacker's facility (700 employees, 564 acres) is located within Subzone 134B. The facility is used for the production of polysilicon. Production under FTZ procedures could exempt Wacker from customs duty payments on the foreign components used in export production. The company anticipates that some 90 percent of the plant's shipments will be exported. On its domestic sales, Wacker would be able to choose the duty rates during customs entry procedures that apply to hyperpure polysilicon (duty-free) for the foreign-status input noted below. Wacker would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment. The request indicates that the savings from FTZ procedures would help improve the plant's international competitiveness.
Material sourced from abroad (representing 10-20% of the value of the finished product) is silicon metal (5.3% duty rate). Wacker is requesting authority subject to a restriction prohibiting the admission of foreign status silicon metal subject to an antidumping or countervailing duty order.
In accordance with the FTZ Board's regulations, Elizabeth Whiteman of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the FTZ Board.
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary and sent to:
A copy of the application will be available for public inspection in the “Reading Room” section of the FTZ Board's website, which is accessible via
For further information, contact Elizabeth Whiteman at Elizabeth
Hitachi Automotive Systems Americas, Inc. (Hitachi) submitted a notification of proposed production activity to the FTZ Board for its facilities in Harrodsburg and Berea, Kentucky. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on May 2, 2019.
Hitachi already has authority to produce automotive components within Subzone 29F. The current request would add foreign status materials/components to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status materials/components described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt Hitachi from customs duty payments on the foreign-status materials/components used in export production. On its domestic sales, for the foreign-status materials/components noted below, Hitachi would be able to choose the duty rates during customs entry procedures that apply to the finished products described and approved in prior requests, including: Electric-hybrid drive systems; mass air sensors; throttle bodies and chambers; starter motors; motor/generator units; alternators; distributors; static converters; inverter modules; rotors/stators; batteries; ignition coils; sensors and modules; fuel injectors; emissions control equipment; valves; pumps; automotive battery management systems; fuel rail Assemblies; and, electronic control units for engines and transmissions (duty rate ranges from duty-free to 4.4%). Hitachi would be able to avoid duty on foreign-status components which become scrap/waste. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The materials/components sourced from abroad include cooling sheets and wire harnesses (duty rate ranges from 5 to 5.8%). The request indicates that certain materials/components are subject to special duties under Section 301 of the Trade Act of 1974 (Section 301), depending on the country of origin. The applicable Section 301 decisions require subject merchandise to be admitted to FTZs in privileged foreign status (19 CFR 146.41).
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary and sent to:
A copy of the notification will be available for public inspection in the “Reading Room” section of the Board's website, which is accessible via
For further information, contact Elizabeth Whiteman at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) preliminarily determines that countervailable subsidies are being provided to producers and exporters of magnesium from Israel. The period of investigation (POI) is January 1, 2017, through December 31, 2017. Interested parties are invited to comment on this preliminary determination.
Effective May 8, 2019.
Ethan Talbott or Dana Mermelstein, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-1030 or (202) 482-1391, respectively.
This preliminary determination is made in accordance with section 703(b) of the Tariff Act of 1930, as amended (the Act). Commerce published the notice of initiation of this investigation on November 20, 2018.
For a complete description of the events that followed the initiation of this investigation,
The product covered by this investigation is magnesium from Israel. For a full description of the scope of this investigation,
In accordance with the preamble to Commerce's regulations,
Commerce is conducting this investigation in accordance with section 701 of the Act. For each of the subsidy programs found countervailable, Commerce preliminarily determines that there is a subsidy,
As noted in the Preliminary Decision Memorandum, in accordance with section 705(a)(1) of the Act and 19 CFR 351.210(b)(4), Commerce is aligning the final countervailing duty (CVD) determination in this investigation with the final determination in the companion antidumping duty (AD) investigation of Magnesium from Israel based on a request made by the petitioner.
Sections 703(d) and 705(c)(5)(A) of the Act provide that, in the preliminary determination, Commerce shall determine an estimated all-others rate for companies not individually examined. This rate shall be an amount equal to the weighted average of the estimated subsidy rates established for those companies individually examined, excluding any zero and
Commerce calculated an individual estimated countervailable subsidy rate for Dead Sea Magnesium, Ltd. (DSM),
Commerce preliminarily determines that the following estimated countervailable subsidy rates exist:
In accordance with section 703(d)(1)(B) and (d)(2) of the Act,
Commerce intends to disclose its calculations and analysis performed to interested parties in this preliminary determination within five days of its public announcement, or if there is no public announcement, within five days of the date of this notice in accordance with 19 CFR 351.224(b).
As provided in section 782(i)(1) of the Act, Commerce intends to verify the information relied upon in making its final determination.
Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the last verification report is issued in this investigation. 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, limited to issues raised in the case and rebuttal briefs, must submit a written request to the Assistant Secretary for Enforcement and Compliance, U.S. Department of Commerce within 30 days after the date of publication of this notice. Requests should contain the party's name, address, and telephone number, the number of participants, whether any participant is a foreign national, and a list of the issues to be discussed. If a request for a hearing is made, Commerce intends to hold the hearing at the U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230, at a time and date to be determined. Parties should confirm by telephone the date, time, and location of the hearing two days before the scheduled date.
In accordance with section 703(f) of the Act, Commerce will notify the International Trade Commission (ITC) of its determination. If the final determination is affirmative, the ITC will determine before the later of 120 days after the date of this preliminary determination or 45 days after the final determination.
This determination is issued and published pursuant to sections 703(f) and 777(i) of the Act and 19 CFR 351.205(c).
The products covered by this investigation are primary and secondary pure and alloy magnesium metal, regardless of chemistry, raw material source, form, shape, or size. Magnesium is a metal or alloy containing by weight primarily the element magnesium. Primary magnesium is produced by decomposing raw materials into magnesium metal. Secondary magnesium is produced by recycling magnesium-based scrap into magnesium metal. The magnesium covered by this investigation also includes blends of primary magnesium, scrap, and secondary magnesium.
The subject merchandise includes the following pure and alloy magnesium metal products made from primary and/or secondary magnesium, including, without limitation, magnesium cast into ingots, slabs, t-bars, rounds, sows, billets, and other shapes, and magnesium ground, chipped, crushed, or machined into raspings, granules, turnings, chips, powder, briquettes, and other shapes: (1) products that contain at least 99.95 percent magnesium, by weight (generally referred to as “ultra-pure” or “high purity” magnesium); (2) products that contain less than 99.95 percent but not less than 99.8 percent magnesium, by weight (generally referred to as “pure” magnesium); and (3) chemical combinations of magnesium and other material(s) in which the magnesium content is 50 percent or greater, but less than 99.8 percent, by weight, whether or not conforming to an “ASTM Specification for Magnesium Alloy.”
The scope of this investigation excludes: (1) magnesium that is in liquid or molten form; and (2) mixtures containing 90 percent or less magnesium in granular or powder form by weight and one or more of certain non-magnesium granular materials to make magnesium-based reagent mixtures, including lime, calcium metal, calcium silicon, calcium carbide, calcium carbonate, carbon, slag coagulants, fluorspar, nephaline syenite, feldspar, alumina (A1203), calcium aluminate, soda ash, hydrocarbons, graphite, coke, silicon, rare earth metals/mischmetal, cryolite, silica/fly ash, magnesium oxide, periclase, ferroalloys, dolomite lime, and colemanite.
The merchandise subject to this investigation is classifiable under items 8104.11.00, 8104.19.00, and 8104.30.00 of the Harmonized Tariff Schedule of the United States (“HTSUS”). Although the HTSUS items are provided for convenience and customs purposes, the written description of the merchandise under investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable April 30, 2019.
Michael J. Heaney, Heather Lui, and William Thompson II, at (202) 482-4475, (202) 482-0016, and (202) 482-7459, respectively, AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.
On April 10, 2019, the U.S. Department of Commerce (Commerce) received an antidumping duty (AD) petition concerning imports of ceramic tile from the People's Republic of China (China), filed in proper form on behalf of the Coalition for Fair Trade in Ceramic Tile (the petitioner).
Between April 15 and April 24, 2019, Commerce requested supplemental information pertaining to certain aspects of the Petition.
In accordance with section 732(b) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that imports of ceramic tile from China are being, or are likely to be, sold in the United States at less than fair value (LTFV) within the meaning of section 731 of the Act, and that such imports are materially injuring, or threatening material injury to, the domestic industry producing ceramic tile in the United States. Consistent with section 732(b)(1) of the Act, the Petition is accompanied by information reasonably available to the petitioner supporting its allegations.
Commerce finds that the petitioner filed the Petition on behalf of the domestic industry because the petitioner is an interested party as defined in section 771(9)(E) of the Act. Commerce also finds that the petitioner demonstrated sufficient industry support with respect to the initiation of the requested AD investigation.
Because the Petition was filed on April 10, 2019, the period of investigation (POI) is October 1, 2018, through March 31, 2019.
The merchandise covered by this investigation is ceramic tile from China. For a full description of the scope of this investigation,
During our review of the Petition, we contacted the petitioner regarding the proposed scope to ensure that the scope language in the Petition is an accurate reflection of the products for which the domestic industry is seeking relief.
As discussed in the
Commerce requests that any factual information the parties consider relevant to the scope of the investigation be submitted during this time period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party may contact Commerce and request permission to submit the additional information. All such comments must also be filed on the record of the concurrent CVD investigation.
All submissions to Commerce must be filed electronically via ACCESS.
Commerce is providing interested parties an opportunity to comment on the appropriate physical characteristics of ceramic tile to be reported in response to Commerce's AD questionnaires. This information will be used to identify the key physical characteristics of the subject merchandise in order to report the relevant factors of production (FOPs) accurately, as well as to develop appropriate product-comparison criteria.
Interested parties may provide any information or comments that they feel are relevant to the development of an accurate list of physical characteristics. In order to consider the suggestions of interested parties in developing and issuing the AD questionnaire, all comments must be filed by 5:00 p.m. ET on May 20, 2019, which is 20 calendar days from the signature date of this notice.
Section 732(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 732(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 732(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, Commerce shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”
Section 771(4)(A) of the Act defines the “industry” as the producers as a whole of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs Commerce to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both Commerce and the ITC must apply the same statutory definition regarding the domestic like product,
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (
With regard to the domestic like product, the petitioner does not offer a definition of the domestic like product distinct from the scope of the Petition.
In determining whether the petitioner has standing under section 732(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in the Appendix to this notice. To establish industry support, the petitioner provided its own 2018 shipments of the domestic like product and compared this to the estimated total shipments of the domestic like product for the entire domestic industry.
Our review of the data provided in the Petition, the General Issues Supplement, the Second General Issues Supplement, and other information readily available to Commerce indicates that the petitioner has established industry support for the Petition.
The petitioner alleges that the U.S. industry producing the domestic like product is being materially injured, or is threatened with material injury, by reason of the imports of the subject merchandise sold at LTFV. In addition, the petitioner alleges that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.
The petitioner contends that the industry's injured condition is illustrated by a significant and increasing volume of subject imports; reduced market share; adverse impact on the domestic industry's production, capacity utilization, U.S. shipments, employment variables, and financial
The following is a description of the allegation of sales at LTFV upon which Commerce based its decision to initiate an AD investigation on imports of ceramic tile from China. The sources of data for the deductions and adjustments relating to U.S. price and normal value (NV) are discussed in greater detail in the AD Initiation Checklist.
The petitioner based the U.S. price on export price (EP) using average unit values (AUVs) of publicly available import data.
With respect to China, Commerce considers China to be a non-market economy (NME) country.
The petitioner contends that Mexico is an appropriate surrogate country for China because it is a market economy country that is at a level of economic development comparable to that of China, it is a significant producer of comparable merchandise, and public information from Mexico is available to value all material input factors.
Interested parties will have the opportunity to submit comments regarding surrogate country selection and, pursuant to 19 CFR 351.301(c)(3)(i), will be provided an opportunity to submit publicly available information to value FOPs within 30 days before the scheduled date of the preliminary determination.
Because information regarding the volume of inputs consumed by the Chinese producers/exporters was not reasonably available, the petitioner relied on the production experience for one of the members of the petitioning coalition as a surrogate to estimate the Chinese manufacturers' FOPs.
Based on the data provided in the Petition, there is reason to believe that imports of ceramic tile from China are being, or are likely to be, sold in the United States at LTFV. Based on comparisons of EP to NV in accordance with sections 772 and 773 of the Act, the estimated dumping margin for ceramic tile from China range from 127.33 to 356.02 percent.
Based upon the examination of the Petition on ceramic tile from China, we find that the Petition meets the requirements of section 732 of the Act. Therefore, we are initiating an AD investigation to determine whether imports of ceramic tile from China are being, or are likely to be, sold in the United States at LTFV. In accordance with section 733(b)(1)(A) of the Act and 19 CFR 351.205(b)(1), unless postponed, we will make our preliminary determination no later than 140 days after the date of this initiation.
The petitioner named 197 producers/exporters of ceramic tile in China.
On April 30, 2019, Commerce released CBP data under Administrative Protection Order (APO) to all parties with access to information protected by APO and indicated that interested parties wishing to comment on the CBP data must do so within three business days of the publication date of the notice of initiation of this investigation.
In addition, Commerce will post the Q&V questionnaire along with filing instructions on the Enforcement and Compliance website at
Producers/exporters of ceramic tile from China that do not receive Q&V questionnaires by mail may still submit a response to the Q&V questionnaire and can obtain a copy from the Enforcement & Compliance website. The Q&V response must be submitted by the relevant China exporters/producers no later than 5:00 p.m. ET on May 20, 2019. All Q&V responses must be filed electronically via ACCESS.
In order to obtain separate-rate status in an NME investigation, exporters and producers must submit a separate-rate application.
Commerce will calculate combination rates for certain respondents that are eligible for a separate rate in an NME investigation. The Separate Rates and Combination Rates Bulletin states:
In accordance with section 732(b)(3)(A) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to China via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petition to each exporter named in the Petition, as provided under 19 CFR 351.203(c)(2).
We will notify the ITC of our initiation, as required by section 732(d) of the Act.
The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of ceramic tile from China are materially injuring, or threatening material injury to, a U.S. industry.
Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). Any party, when submitting factual information, must specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted
Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in a letter or memorandum of the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Parties should review
Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, Commerce published
This notice is issued and published pursuant to sections 732(c)(2) and 777(i) of the Act, and 19 CFR 351.203(c).
The merchandise covered by this investigation is ceramic flooring tile, wall tile, paving tile, hearth tile, porcelain tile, mosaic tile, flags, finishing tile, and the like (hereinafter ceramic tile). Ceramic tiles are articles containing a mixture of minerals including clay (generally hydrous silicates of alumina or magnesium) that are fired so the raw materials are fused to produce a finished good that is less than 3.2 cm in actual thickness. All ceramic tile is subject to the scope regardless of end use, surface area, and weight, regardless of whether the tile is glazed or unglazed, regardless of the water absorption coefficient by weight, regardless of the extent of vitrification, and regardless of whether or not the tile is on a backing. Subject merchandise includes ceramic tile with decorative features that may in spots exceed 3.2 cm in thickness and includes ceramic tile “slabs” or “panels” (tiles that are larger than 1 meter
Subject merchandise includes ceramic tile that undergoes minor processing in a third country prior to importation into the United States. Similarly, subject merchandise includes ceramic tile produced that undergoes minor processing after importation into the United States. Such minor processing includes, but is not limited to, one or more of the following: Beveling, cutting, trimming, staining, painting, polishing, finishing, additional firing, or any other processing that would otherwise not remove the merchandise from the scope of the investigation if performed in the country of manufacture of the in-scope product.
Subject merchandise is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under the following subheadings of heading 6907: 6907.21.1005, 6907.21.1011, 6907.21.1051, 6907.21.2000, 6907.21.3000, 6907.21.4000, 6907.21.9011, 6907.21.9051, 6907.22.1005, 6907.22.1011, 6907.22.1051, 6907.22.2000, 6907.22.3000, 6907.22.4000, 6907.22.9011, 6907.22.9051, 6907.23.1005, 6907.23.1011, 6907.23.1051, 6907.23.2000, 6907.23.3000, 6907.23.4000, 6907.23.9011, 6907.23.9051, 6907.30.1005, 6907.30.1011, 6907.30.1051, 6907.30.2000, 6907.30.3000, 6907.30.4000, 6907.30.9011, 6907.30.9051, 6907.40.1005, 6907.40.1011, 6907.40.1051, 6907.40.2000, 6907.40.3000, 6907.40.4000, 6907.40.9011, and 6907.40.9051. Subject merchandise may also enter under subheadings of headings 6914 and 6905: 6914.10.8000, 6914.90.8000, 6905.10.0000, and 6905.90.0050. The HTSUS subheadings are provided for convenience and customs purposes only. The written description of the scope of this investigation is dispositive.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that producers/exporters subject to this review made sales of subject merchandise at less than normal value during the May 10, 2016, through October 31, 2017, period of review (POR).
Effective May 8, 2019.
Laurel LaCivita or Stephanie Berger, AD/CVD Operations, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-4243 and (202) 482-2483, respectively.
Commerce published the
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 this order is circular welded austenitic stainless pressure pipe not greater than 14 inches in outside diameter. For purposes of this scope, references to size are in nominal inches and include all products within tolerances allowed by pipe specifications. This merchandise includes, but is not limited to, the American Society for Testing and Materials (ASTM) A-312 or ASTM A-778 specifications, or comparable domestic or foreign specifications. ASTM A-358 products are only included when they are produced to meet ASTM A-312 or ASTM A-778 specifications, or comparable domestic or foreign specifications.
The subject imports are normally classified in subheadings 7306.40.5005, 7306.40.5040, 7306.40.5062, 7306.40.5064, and 7306.40.5085 of the Harmonized Tariff Schedule of the United States (HTSUS). They may also enter under HTSUS subheadings 7306.40.1010, 7306.40.1015, 7306.40.5042, 7306.40.5044, 7306.40.5080, and 7306.40.5090. The HTSUS subheadings are provided for convenience and customs purposes only; the written description of the scope of this order is dispositive.
As no parties submitted comments on the
Commerce determines that the following weighted-average dumping
Pursuant to the final results of this review, Commerce determines, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with section 751(a)(2)(C) of the Act and 19 CFR 351.212(b).
For the mandatory respondents (
For the companies which were not selected for individual review, we will assign an assessment rate based on the weighted average of the cash deposit rates calculated for the companies selected for individual review (
In accordance with Commerce's “automatic assessment” practice, for entries of subject merchandise during the POR produced by each respondent for which they did not know that their merchandise was destined for the United States, we will instruct CBP to liquidate entries not reviewed at the all-others rate of 8.35 percent if there is no rate for the intermediate company(ies) involved in the transaction.
We intend to issue instructions to CBP 15 days after publication of these final results of this review in the
The following deposit requirements will be effective upon publication of this notice of final results of administrative review in the
This notice serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping and/or countervailing duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of the antidumping and/or countervailing duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under the APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
We are issuing and publishing these final results of administrative review in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.221(b)(5).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (Commerce) determines that JBF RAK LLC (JBF) made sales of subject merchandise at less than normal value during the period of review (POR), November 1, 2016, through October 31, 2017.
May 8, 2019.
Andrew Huston, 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) 482-4261.
Commerce published the preliminary results of this administrative review on December 7, 2018.
The products covered by the order are all gauges of raw, pre-treated, or primed polyethylene terephthalate film (PET Film), whether extruded or co-extruded. Excluded are metallized films and other finished films that have had at least one of their surfaces modified by the application of a performance-enhancing resinous or inorganic layer more than 0.00001 inches thick. Also excluded is roller transport cleaning film which has at least one of its surfaces modified by application of 0.5 micrometers of SBR latex. Tracing and drafting film is also excluded. PET Film is classifiable under subheading 3920.62.00.90 of the Harmonized Tariff Schedule of the United States (HTSUS). While HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope of the order is dispositive.
All issues raised in the sole case brief filed in this review are addressed in the Issues and Decision Memorandum.
Based on our analysis of the comments received, we made changes to our margin calculations for JBF. Specifically, we revised our calculation of per-unit cost adjustments for direct labor, variable overhead and fixed overhead costs.
As a result of this review, we determine that the following weighted-average dumping margin for the manufacturer/exporter listed below exists for the period of November 1, 2016, through October 31, 2017:
Pursuant to section 751(a)(2)(A) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.212(b)(1), Commerce shall determine, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review.
For JBF, we will calculate importer-specific
The final results of this review shall be the basis for the assessment of antidumping duties on entries of merchandise covered by the final results of this review and for future deposits of estimated duties, were applicable.
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of these final results, as provided by section 751(a)(2)(C) of the Act: (1) For JBF, the cash deposit rate will be equal to the weighted-average dumping margin listed above in the “Final Results of Review” section; (2) for merchandise exported by producers or exporters not covered in this review but covered in a previously completed segment of this proceeding, the cash deposit rate will continue to be the company-specific rate published in the final results for the most recent period in which that producer or exporter participated; (3) if the exporter is not a firm covered in this review or in any previous segment of this proceeding, but the producer is, then the cash deposit rate will be that established for the producer of the merchandise in these final results of review or in the final results for the most recent period in which that producer participated; and
We will disclose to interested parties the calculations performed in connection with these final results within five days of the publication of this notice, consistent with 19 CFR 351.224(b).
This notice serves as a final 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 Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of doubled antidumping duties.
This notice is the only reminder to parties subject to the administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under the APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a violation subject to sanction.
We are issuing and publishing these final results and this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.213(h).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
Applicable April 30, 2019.
Yasmin Bordas at (202) 482-3813; Moses Song at (202) 482-7885; John McGowan at (202) 492-3019, respectively; AD/CVD Operations, Office VI, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230.
On April 10, 2019, the U.S. Department of Commerce (Commerce) received a countervailing duty (CVD) Petition concerning imports of ceramic tile from the People's Republic of China (China), filed in proper form on behalf of the Coalition for Fair Trade in Ceramic Tile (the petitioner).
Between April 15 and 24, 2019, Commerce requested supplemental information pertaining to certain aspects of the Petition.
In accordance with section 702(b)(1) of the Tariff Act of 1930, as amended (the Act), the petitioner alleges that the Government of China is providing countervailable subsidies, within the meaning of sections 701 and 771(5) of the Act, to producers of ceramic tile in China, and that such imports are materially injuring, or threatening material injury to, the domestic industry producing ceramic tile in the United States. Consistent with section 702(b)(1) of the Act and 19 CFR 351.202(b), for those alleged programs on which we are initiating a CVD investigation, the Petition is accompanied by information reasonably available to the petitioner supporting its allegations.
Commerce finds that the petitioner filed this Petition on behalf of the domestic industry, because the petitioner is an interested party, as defined in section 771(9)(E) of the Act. Commerce also finds that the petitioner demonstrated sufficient industry
Because the Petition was filed on April 10, 2019, the period of investigation (POI) is January 1, 2018, through December 31, 2018.
The merchandise covered by this investigation consists of ceramic tile from China. For a full description of the scope of this investigation,
During our review of the Petition, we contacted the petitioner regarding the proposed scope to ensure that the scope language in the Petition is an accurate reflection of the products for which the domestic industry is seeking relief.
As discussed in the
Commerce requests that any factual information the parties consider relevant to the scope of the investigation be submitted during this period. However, if a party subsequently finds that additional factual information pertaining to the scope of the investigation may be relevant, the party may contact Commerce and request permission to submit the additional information. All such submissions must be filed on the records of the concurrent AD investigation.
All submissions to Commerce must be filed electronically using Enforcement and Compliance's Antidumping Duty and Countervailing Duty Centralized Electronic Service System (ACCESS).
Pursuant to sections 702(b)(4)(A)(i) and (ii) of the Act, Commerce notified China of the receipt of the Petition and provided it the opportunity for consultations with respect to the CVD Petition.
Section 702(b)(1) of the Act requires that a petition be filed on behalf of the domestic industry. Section 702(c)(4)(A) of the Act provides that a petition meets this requirement if the domestic producers or workers who support the petition account for: (i) At least 25 percent of the total production of the domestic like product; and (ii) more than 50 percent of the production of the domestic like product produced by that portion of the industry expressing support for, or opposition to, the petition. Moreover, section 702(c)(4)(D) of the Act provides that, if the petition does not establish support of domestic producers or workers accounting for more than 50 percent of the total production of the domestic like product, Commerce shall: (i) Poll the industry or rely on other information in order to determine if there is support for the petition, as required by subparagraph (A); or (ii) determine industry support using a statistically valid sampling method to poll the “industry.”
Section 771(4)(A) of the Act defines the “industry” as the producers, as a whole, of a domestic like product. Thus, to determine whether a petition has the requisite industry support, the statute directs Commerce to look to producers and workers who produce the domestic like product. The International Trade Commission (ITC), which is responsible for determining whether “the domestic industry” has been injured, must also determine what constitutes a domestic like product in order to define the industry. While both Commerce and the ITC must apply the same statutory definition regarding the domestic like product,
Section 771(10) of the Act defines the domestic like product as “a product which is like, or in the absence of like, most similar in characteristics and uses with, the article subject to an investigation under this title.” Thus, the reference point from which the domestic like product analysis begins is “the article subject to an investigation” (
With regard to the domestic like product, the petitioner does not offer a definition of the domestic like product distinct from the scope of the investigation.
In determining whether the petitioner has standing under section 702(c)(4)(A) of the Act, we considered the industry support data contained in the Petition with reference to the domestic like product as defined in the “Scope of the Investigation,” in the Appendix to this notice. To establish industry support, the petitioner provided its own 2018 shipments of the domestic like product and compared this to the estimated total shipments of the domestic like product for the entire domestic industry.
Our review of the data provided in the Petition, the General Issues Supplement, the Second General Issues Supplement, and other information readily available to Commerce indicates that the petitioner has established industry support for the Petition.
Because China is a “Subsidies Agreement Country” within the meaning of section 701(b) of the Act, section 701(a)(2) of the Act applies to this investigation. Accordingly, the ITC must determine whether imports of the subject merchandise from China materially injure, or threaten material injury to, a U.S. industry.
The petitioner alleges that imports of the subject merchandise are benefitting from countervailable subsidies and that such imports are causing, or threaten to cause, material injury to the U.S. industry producing the domestic like product. In addition, the petitioner alleges that subject imports exceed the negligibility threshold provided for under section 771(24)(A) of the Act.
The petitioner contends that the industry's injured condition is illustrated by a significant and increasing volume of subject imports; reduced market share; adverse impact on the domestic industry's production, capacity utilization, U.S. shipments, employment variables, and financial performance; underselling and price depression or suppression; lost sales and revenue; negative impact on the domestic industry's return on investments; the cancellation or postponement of expansion projects for U.S. production facilities; reduced spending on research and development; and an increase in end-of-year production inventories.
Based on the examination of the Petition, we find that the Petition meets the requirements of section 702 of the Act. Therefore, we are initiating a CVD investigation to determine whether imports of ceramic tile from China benefit from countervailable subsidies conferred by the Government of China. Based on our review of the Petition, we find that there is sufficient information to initiate a CVD investigation, in whole or part, on each of the alleged programs. For a full discussion of the basis for our decision to initiate on each program,
The petitioner named 197 companies as producers/exporters of ceramic tile in China.
On April 30, 2019, Commerce released CBP data on imports of ceramic tile from China under Administrative Protective Order (APO) to all parties with access to information protected by APO and indicated that interested parties wishing to comment regarding the CBP data and respondent selection must do so within three business days of the publication date of the notice of initiation of this investigation.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305(b). Instructions for filing such applications may be found on the Commerce's website at
Comments must be filed electronically using ACCESS. An electronically filed document must be received successfully, in its entirety, by ACCESS no later than 5:00 p.m. ET on the date noted above. We intend to finalize our decisions regarding respondent selection within 20 days of publication of this notice.
In accordance with section 702(b)(4)(A)(i) of the Act and 19 CFR 351.202(f), a copy of the public version of the Petition has been provided to China via ACCESS. To the extent practicable, we will attempt to provide a copy of the public version of the Petition to each exporter named in the Petition, as provided under 19 CFR 351.203(c)(2).
We will notify the ITC of our initiation, as required by section 702(d) of the Act.
The ITC will preliminarily determine, within 45 days after the date on which the Petition was filed, whether there is a reasonable indication that imports of ceramic tile from China are materially injuring, or threatening material injury to, a U.S. industry.
Factual information is defined in 19 CFR 351.102(b)(21) as: (i) Evidence submitted in response to questionnaires; (ii) evidence submitted in support of allegations; (iii) publicly available information to value factors under 19 CFR 351.408(c) or to measure the adequacy of remuneration under 19 CFR 351.511(a)(2); (iv) evidence placed on the record by Commerce; and (v) evidence other than factual information described in (i)-(iv). Any party, when submitting factual information, must specify under which subsection of 19 CFR 351.102(b)(21) the information is being submitted
Parties may request an extension of time limits before the expiration of a time limit established under 19 CFR 351.301, or as otherwise specified by the Secretary. In general, an extension request will be considered untimely if it is filed after the expiration of the time limit established under 19 CFR 351.301. For submissions that are due from multiple parties simultaneously, an extension request will be considered untimely if it is filed after 10:00 a.m. ET on the due date. Under certain circumstances, we may elect to specify a different time limit by which extension requests will be considered untimely for submissions which are due from multiple parties simultaneously. In such a case, we will inform parties in a letter or memorandum of the deadline (including a specified time) by which extension requests must be filed to be considered timely. An extension request must be made in a separate, stand-alone submission; under limited circumstances we will grant untimely-filed requests for the extension of time limits. Parties should review
Any party submitting factual information in an AD or CVD proceeding must certify to the accuracy and completeness of that information.
Interested parties must submit applications for disclosure under APO in accordance with 19 CFR 351.305. On January 22, 2008, Commerce published
This notice is issued and published pursuant to sections 702 and 777(i) of the Act and 19 CFR 351.203(c).
The merchandise covered by this investigation is ceramic flooring tile, wall tile, paving tile, hearth tile, porcelain tile, mosaic tile, flags, finishing tile, and the like (hereinafter ceramic tile). Ceramic tiles are articles containing a mixture of minerals including clay (generally hydrous silicates of alumina or magnesium) that are fired so the raw materials are fused to produce a finished good that is less than 3.2 cm in actual thickness. All ceramic tile is subject to the scope regardless of end use, surface area, and weight, regardless of whether the tile is glazed or unglazed, regardless of the water absorption coefficient by weight, regardless of the extent of vitrification, and regardless of whether or not the tile is on a backing. Subject merchandise includes ceramic tile with decorative features that may in spots exceed 3.2 cm in thickness and includes
Subject merchandise includes ceramic tile that undergoes minor processing in a third country prior to importation into the United States. Similarly, subject merchandise includes ceramic tile produced that undergoes minor processing after importation into the United States. Such minor processing includes, but is not limited to, one or more of the following: Beveling, cutting, trimming, staining, painting, polishing, finishing, additional firing, or any other processing that would otherwise not remove the merchandise from the scope of the investigation if performed in the country of manufacture of the in-scope product.
Subject merchandise is currently classified in the Harmonized Tariff Schedule of the United States (HTSUS) under the following subheadings of heading 6907: 6907.21.1005, 6907.21.1011, 6907.21.1051, 6907.21.2000, 6907.21.3000, 6907.21.4000, 6907.21.9011, 6907.21.9051, 6907.22.1005, 6907.22.1011, 6907.22.1051, 6907.22.2000, 6907.22.3000, 6907.22.4000, 6907.22.9011, 6907.22.9051, 6907.23.1005, 6907.23.1011, 6907.23.1051, 6907.23.2000, 6907.23.3000, 6907.23.4000, 6907.23.9011, 6907.23.9051, 6907.30.1005, 6907.30.1011, 6907.30.1051, 6907.30.2000, 6907.30.3000, 6907.30.4000, 6907.30.9011, 6907.30.9051, 6907.40.1005, 6907.40.1011, 6907.40.1051, 6907.40.2000, 6907.40.3000, 6907.40.4000, 6907.40.9011, and 6907.40.9051. Subject merchandise may also enter under subheadings of headings 6914 and 6905: 6914.10.8000, 6914.90.8000, 6905.10.0000, and 6905.90.0050. The HTSUS subheadings are provided for convenience and customs purposes only. The written description of the scope of this investigation is dispositive.
National Institute of Standards and Technology, 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.
Written comments must be submitted on or before July 8, 2019.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 1401 Constitution Avenue NW, Washington, DC 20230 (or via the internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Mary Clague, 301-975-4188,
NIST Associates (NA) will include guest researchers, research associates, contractors, and other non-NIST employees that require access to NIST campuses or NIST resources. The NIST Associates Information System (NAIS) information collection instrument(s) are completed by the incoming NAs. The NAs will be requested to provide personal identifying data including home address, date and place of birth, employer name and address, and basic security information. The data provided by the collection instruments will be input into NAIS, which automatically populates the appropriate forms, and is routed through the approval process. NIST's Office of Security receives security forms through the NAIS process and is able to allow preliminary access to NAs to the NIST campuses or resources. The data collected will also be the basis for further security investigations as necessary.
The information is collected in paper format.
NIST invites comments on: (a) 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; (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; they also will become a matter of public record.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application for regulations and Letters of Authorization extension; request for comments and information.
NMFS has received a request from the U.S. Navy (Navy) to extend the expiration date from December 2023 to December 2025 for Marine Mammal Protection Act (MMPA) regulations authorizing the take of marine mammals incidental to Navy training and testing activities conducted in the Hawaii-Southern California Training and Testing (HSTT) Study Area. In August 2018, the MMPA was amended by the John S. McCain National Defense Authorization Act (NDAA) for Fiscal Year 2019 to allow for seven-year authorizations for military readiness activities, as compared to the previously allowed five years. The Navy's activities qualify as military readiness activities pursuant to the MMPA as amended by the NDAA for Fiscal Year 2004. In making the request to extend the time period covered by the MMPA 2018 HSTT regulations from five to seven years, the Navy proposes no changes to their specified activities, the
Comments and information must be received no later than June 7, 2019.
Comments on the application should be addressed to Jolie Harrison, Chief, Permits and Conservation Division, Office of Protected Resources, National Marine Fisheries Service. Physical comments should be sent to 1315 East-West Highway, Silver Spring, MD 20910 and electronic comments should be sent to
Wendy Piniak, Office of Protected Resources, NMFS, (301) 427-8401. An electronic copy of the Navy's application may be obtained online at:
Sections 101(a)(5)(A) and (D) of the MMPA (16 U.S.C. 1361
An authorization for incidental takings shall be granted if NMFS finds that the taking will have a negligible impact on the species or stock(s), will not have an unmitigable adverse impact on the availability of the species or stock(s) for subsistence uses (where relevant), and if the permissible methods of taking and requirements pertaining to the mitigation, monitoring, and reporting of such takings are set forth.
NMFS has defined “negligible impact” in 50 CFR 216.103 as an impact resulting from the specified activity that cannot be reasonably expected to, and is not reasonably likely to, adversely affect the species or stock through effects on annual rates of recruitment or survival.
The MMPA states that the term “take” means to harass, hunt, capture, kill or attempt to harass, hunt, capture, or kill any marine mammal.
The NDAA for Fiscal Year 2004 (2004 NDAA) (Pub. L. 108-136) amended section 101(a)(5) of the MMPA to remove the “small numbers” and “specified geographical region” provisions indicated above and amended the definition of “harassment” as it applies to a “military readiness activity” to read as follows (Section 3(18)(B) of the MMPA): (i) Any act that injures or has the significant potential to injure a marine mammal or marine mammal stock in the wild (Level A Harassment); or (ii) Any act that disturbs or is likely to disturb a marine mammal or marine mammal stock in the wild by causing disruption of natural behavioral patterns, including, but not limited to, migration, surfacing, nursing, breeding, feeding, or sheltering, to a point where such behavioral patterns are abandoned or significantly altered (Level B Harassment). In addition, the 2004 NDAA amended the MMPA as it relates to military readiness activities such that least practicable adverse impact shall include consideration of personnel safety, practicality of implementation, and impact on the effectiveness of the military readiness activity.
More recently, section 316 of the NDAA for Fiscal Year 2019 (2019 NDAA) (Pub. L. 115-232), signed on August 13, 2018, amended the MMPA to allow incidental take rules for military readiness activities under section 101(a)(5)(A) to be issued for up to seven years. Prior to this amendment, all incidental take rules under section 101(a)(5)(A) were limited to five years.
On March 11, 2019, NMFS received an adequate and complete application from the Navy requesting that NMFS extend the 2018 HSTT regulations (83 FR 66846) and associated Letters of Authorization (LOAs) such that they would cover take incidental to seven years of training and testing activities instead of five, extending the expiration date from December 20, 2023 to December 20, 2025. The extension would be conducted through a proposed and final rulemaking analyzing seven years of activity, consistent with the requirements of section 101(a)(5)(A). Specifically, the activities include training and testing (all categorized as military readiness activities) including the use of active acoustic sonar systems and other transducers, in-water detonations, air guns, construction activities involving pile removal and installation, and the operation of a fleet of vessels throughout the HSTT Study Area. These activities may result in the incidental take of marine mammals in the form of Level B harassment (behavioral disruption or temporary hearing impairment), Level A harassment (permanent hearing impairment or tissue damage), or serious injury or mortality in a very small number of cases.
In its 2019 application, the Navy proposes no changes to the nature of the specified activities covered by the 2018 HSTT final rule, the level of activity within and between years would be consistent with that previously analyzed in the 2018 HSTT final rule and all activities would be conducted within the same boundaries of the HSTT Study Area identified in the 2018 HSTT final rule. Therefore, the training and testing activities (
Regarding the quantification of expected takes from acoustic and explosive sources (by Level A harassment and Level B harassment, as well as mortality resulting from exposure to explosives), the number of takes are based directly on the level of activities (days, hours, counts, etc., of different activities and events) in a given year. In the 2018 HSTT final rule, take estimates across the five-years were based on the Navy conducting three years of a representative level of activity and two years of maximum level of activity. Consistent with the pattern set forth in the 2017 application, the 2018 HSTT Final Environmental Impact Statement/Overseas Environmental Impact Statement (FEIS/OEIS,
The existing 2018 HSTT regulations authorize three serious injuries or mortalities from vessel strike in the HSTT Study Area over five years. Based on a revised vessel strike analysis encompassing seven years of activities, the Navy requests no change in the number of requested large whale mortalities due to vessel strike. The large whale stocks that are proposed to be taken by vessel strike are the same as those included in the 2018 HSTT final rule.
As noted above, the proposed extension of the rule would include mitigation, monitoring, and reporting measures that are identical to those included in the 2018 HSTT final rule. Mitigation would include procedural mitigation measures and mitigation areas. Procedural mitigation includes, but is not limited to, the use of trained Lookouts (protected species observers) to monitor for marine mammals in mitigation zones, requirements for Lookouts to immediately provide notification of sightings to the appropriate watch station, requirements for implementation of powerdown and shutdown mitigation measures (based on activity defined zones), pre- and post-monitoring requirements for explosive events, and measures to reduce the likelihood of ship strikes. Chapter 5 of the 2018 HSTT FEIS/OEIS and the
The Navy proposes to continue forward the implementation of the robust Integrated Comprehensive Monitoring Program and Strategic Planning Process outlined in the current regulations. The Navy's monitoring strategy, currently required by the 2018 HSTT regulations, is well-designed to work across Navy ranges to help better understand the impacts of the Navy's activities on marine mammals and their habitat by focusing on learning more about marine mammal occurrence in different areas and exposure to Navy stressors, marine mammal responses to different sound sources, and the consequences of those exposures and responses on marine mammal populations. Similarly, the proposed extension of regulations would include identical adaptive management provisions and reporting requirements as the existing regulations. Please refer to Chapter 13 of the Navy's application for full details on the monitoring and reporting proposed by the Navy.
Interested persons may submit information, suggestions, and comments concerning the Navy's request (see
Office for Coastal Management (OCM), National Ocean Service (NOS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of public meeting.
The National Oceanic and Atmospheric Administration (NOAA), Office for Coastal Management will hold a public meeting to solicit comments on the performance evaluation of the Rhode Island Coastal Management Program.
For specific dates, times, and locations of the public meetings, see
You may submit comments on the coastal program NOAA intends to evaluate by any of the following methods:
Carrie Hall, Evaluator, Planning and Performance Measurement Program, Office for Coastal Management, NOS/NOAA, 1305 East-West Highway, 11th Floor, N/OCM1, Silver Spring, Maryland 20910, by phone at (240) 533-0730 or email comments
Section 312 of the Coastal Zone Management
You may participate or submit oral comments at the public meeting scheduled as follows:
Written public comments must be received on or before June 28, 2019.
Federal Domestic Assistance Catalog 11.419.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; issuance of permit.
NMFS West Coast Region is announcing exempted fishing permits (EFP) issued to target highly migratory species (HMS) in Federal waters off the U.S. West Coast for 2019. NMFS renewed 21 standard deep-set buoy gear (standard DSBG) EFPs for 2019 and issued a new pelagic longline EFP valid for 24 months from the effective date. Ten linked deep-set buoy gear (linked DSBG) EFPs issued in 2018 remain valid for the 2019 calendar year. The permits are issued as exemptions from specific prohibitions under the Fishery Management Plan for U.S. West Coast Fisheries for Highly Migratory Species (HMS FMP). The general purpose of the EFPs is to allow novel fishing practices and gear types that are not otherwise authorized under a fishery management plan. Specifically, NMFS will collect data on the effects and efficacy of using these gears to fish for swordfish and other HMS off the West Coast.
See the
Copies of supporting documents are available via the Federal eRulemaking Portal:
Chris Fanning, NMFS West Coast Region, 562-980-4198, or
On July 2, 2014, the Pacific Fishery Management Council (Council) solicited EFP proposals to test alternative fishing gear as a substitute in the large mesh drift net (DGN) fishery, or test new approaches or methods of fishing DGN gear (
Standard and linked DSBG are not currently authorized gear types under the HMS FMP. Standard DSBG fishing trials occurred for the past eight years under research activity (2011 to 2015) and EFPs (2015 to 2018) in the U.S. West Coast EEZ off California. Linked DSBG research fishing trials included a total of 40 fishing days from 2015 through 2017. Data collected from these fishing activities have demonstrated that about 95 percent of fish species caught with standard DSBG and 90 percent of those caught with linked DSBG are marketable.
Longline fishing is currently prohibited within the U.S. West Coast EEZ; therefore, an EFP was needed to authorize the activity to take place in Federal waters. The longline EFP will provide data for fishery managers about the performance of the gear and the mitigation measures intended to minimize adverse environmental impacts in these waters.
NMFS considered all applicable Federal laws when issuing the standard and linked DSBG EFPs, including section 7(a)(2) of the Endangered Species Act (ESA) (16 U.S.C. 1531
NMFS considered all applicable Federal laws prior to issuing the longline EFP on April 29, 2019, including completing a consultation under section 7(a)(2) of the ESA. This resulted in a biological opinion that concluded the impacts of the EFP are not likely to jeopardize the continued existence of any listed species or result in the destruction or adverse modification of critical habitat (PCTS, WCR-2018-9553). NMFS also determined that the longline EFP is not likely to adversely affect short-tailed albatross, and the U.S. Fish and Wildlife Service concurred with this determination on February 3, 2017. Additionally, NMFS completed the appropriate analyses under the National Environmental Policy Act, in accordance with NOAA Administrative Order 216-6, prior to issuing the longline EFP described in Table 3.
As a result of Federal review, NMFS issued terms and conditions for this EFP that include more mitigation measures than those proposed in the original application. For example, to monitor and lower the risk of interactions with protected species, the terms and conditions require 100 percent observer coverage of the activities, night setting of shallow-set longlines, and specify no-fishing areas (
See the
16 U.S.C. 1801
Office of Elementary and Secondary Education (OESE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before July 8, 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 Amanda Ognibene, 202-453-6637.
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.
Applicants prepare and submit these applications through an e-application on ED's Impact Aid Grant System website. The e-application offers recurring LEA applicants significant advantages in preparing the application because it pre-populates much of the LEA's identifying information and Federal property data. The e-application automatically checks for completion of all necessary items and includes arithmetic checks for table subtotals and the application total. This software reduces the number of errors in applications submitted to ED.
Office of Elementary and Secondary Education (OESE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995, ED is proposing a revision of an existing information collection.
Interested persons are invited to submit comments on or before July 8, 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 Amanda Ognibene, 202-453-6637.
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.
The statute and regulations for this program require a variety of data from applicants annually to determine eligibility for the grants and the amount of grant payment under the statutory formula. The least burdensome method of collecting this required information is for each applicant to submit these data through a web-based electronic application hosted on the Impact Aid Grant System (IAGS) website.
The Impact Aid Program, authorized by Title VII of the Elementary and Secondary Education Act (ESEA), provides financial assistance to local educational agencies (LEAs) whose enrollment or revenues are adversely affected by Federal activities.
The statute and implementing regulations (34 CFR part 222) require information from applicants annually to determine eligibility for and the amount of payments. The least burdensome method of collecting this required information is for each applicant to submit it as part of its annual Impact Aid application, previously approved under OMB 1810-0687.
ED is now requesting to revise this collection. Previously, applicants submitted applications through ED's G5 website. Now, the Impact Aid Program is developing its own online grants management system to better serve the local educational agencies who receive Impact Aid funds. Grantees will now be able to submit the annual application through the Impact Aid Grant System. The program has revised the application to be more user-friendly and reduce burden. The data collected on the application is largely the same. All changes are summarized below.
• The program regulations at 34 CFR 222.33 require that LEAs survey their Federally connected children “no earlier than the fourth day of the regular school year.” In order to monitor this, we will have each applicant enter the first day of school for students.
• We now require first-time Charter School LEA applicants to submit their charter and their annual financial report at the time of application. The program has always required new charter school applicants to submit this information in order to verify that the school is financially independent and able to apply on its own behalf as an LEA, per the statutory definition in 20 U.S.C. 7713; however, they were requested after the charter school submitted the application. We are now asking for these documents with the application to speed the review process.
• Another change requires applicants to affirm they have enough children to qualify for categories F and G before being allowed to enter child counts in those categories. This is intended to save them effort in data entry. This does not require any additional submissions with the data collection.
• We no longer require the Housing Official Certification form. We ask only for the Housing Official's contact information so that we may obtain data required to calculate housing renovation claims directly from the official.
• We have eliminated the requirement to upload a signed cover page and assurances page, and will permit applicants to sign the required attestations and certifications electronically.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of decision and order.
The U.S. Department of Energy (“DOE”) gives notice of a Decision and Order (Case Number
The Decision and Order is effective on May 8, 2019. The Decision and Order will terminate upon the compliance date of any future amendment to the test procedure for room air conditioners located in 10 CFR part 430, subpart B, appendix F that addresses the issues presented in this waiver. At such time, LG must use the relevant test procedure for this product for any testing to demonstrate compliance with standards, and any other representations of energy use.
Ms. Lucy deButts, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW, Washington, DC 20585-0121. Email:
Ms. Sarah Butler, U.S. Department of Energy, Office of the General Counsel, Mail Stop GC-33, Forrestal Building, 1000 Independence Avenue SW, Washington, DC 20585-0103. Telephone: (202) 586-1777. Email:
In accordance with Title 10 of the Code of Federal Regulations (10 CFR 430.27(f)(2)), DOE gives notice of the issuance of its Decision and Order as set forth below. The Decision and Order grants LG a waiver from the applicable test procedure in 10 CFR part 430, subpart B, appendix F (“Appendix F”) for specified basic models of room air conditioners, if LG tests and rates such products using the alternate test procedure specified in the Decision and Order. LG's representations concerning the energy efficiency of the specified basic models must be based on testing according to the provisions and restrictions in the alternate test procedure set forth in the Decision and Order, and the representations must fairly disclose the test results. Distributors, retailers, and private labelers are held to the same requirements when making representations regarding the energy efficiency of these products. (42 U.S.C. 6293(c))
Consistent with 10 CFR 430.27(j), not later than July 8, 2019, any manufacturer currently distributing in commerce in the United States a product employing a technology or characteristic that results in the same need for a waiver from the applicable test procedure must submit a petition for waiver. Manufacturers not currently distributing such products in commerce in the United States must petition for and be granted a waiver prior to the distribution in commerce of those products in the United States. Manufacturers may also submit a request for interim waiver pursuant to the requirements of 10 CFR 430.27.
The Energy Policy and Conservation Act of 1975 (“EPCA”),
Under EPCA, DOE's energy conservation program consists essentially of four parts: (1) Testing, (2) labeling, (3) Federal energy conservation standards, and (4) certification and enforcement procedures. Relevant provisions of EPCA include definitions (42 U.S.C. 6291), energy conservation standards (42 U.S.C. 6295), test procedures (42 U.S.C. 6293), labeling provisions (42 U.S.C. 6294), and the authority to require information and reports from manufacturers (42 U.S.C. 6296).
The Federal testing requirements consist of test procedures that manufacturers of covered products must use as the basis for: (1) Certifying to DOE that their products comply with the applicable energy conservation standards adopted pursuant to EPCA (42 U.S.C. 6295(s)), and (2) making other representations about the efficiency of that product (42 U.S.C. 6293(c)). Similarly, DOE must use these test procedures to determine whether the product complies with relevant standards promulgated under EPCA. (42 U.S.C. 6295(s))
Under 42 U.S.C. 6293, EPCA sets forth the criteria and procedures DOE is required to follow when prescribing or amending test procedures for covered products. EPCA requires that any test procedures prescribed or amended under this section must be reasonably designed to produce test results which reflect energy efficiency, energy use or estimated annual operating cost of a covered product during a representative average use cycle or period of use and requires that test procedures not be unduly burdensome to conduct. (42 U.S.C. 6293(b)(3)) The test procedure for room air conditioners is contained in the Code of Federal Regulations (“CFR”) at 10 CFR part 430, subpart B, appendix F,
Under 10 CFR 430.27, any interested person may submit a petition for waiver from DOE's test procedure requirements. DOE will grant a waiver from the test procedure requirements if DOE determines either that the basic model for which the waiver was requested contains a design characteristic that prevents testing of the basic model according to the prescribed test procedures, or that the prescribed test procedures evaluate the basic model in a manner so unrepresentative of its true energy consumption characteristics as to provide materially inaccurate comparative data. 10 CFR 430.27(f)(2). DOE may grant the waiver subject to conditions, including adherence to alternate test procedures.
By letter dated April 6, 2018, LG submitted a petition for waiver and application for an interim waiver from the applicable room air conditioner test procedure set forth in Appendix F. LG requested relief for the following room air conditioner basic models: LW2217IVSM, LW1817IVSM, and LW1517IVSM.
LG stated that variable-speed room air conditioners use frequency controls to constantly adjust the compressor rotation speed to maintain the desired temperature in the home without turning the motor on and off; that the compressor responds automatically to surrounding conditions to operate in the most efficient possible manner; and that this results in both significant energy savings and faster cooling compared to a typical room air conditioner, which does not have a variable-speed compressor. LG further stated that variable-speed room air conditioners also have a higher/lower operating range (10 Hz to 120 Hz) than room air conditioners without variable-speed compressors. LG asserted that because the DOE test procedure does not account for part-load performance, the results of the test procedure are not representative of the actual energy consumption of variable-speed room air conditioners. DOE agrees that the current test procedure produces test results that are unrepresentative of actual energy use, and accordingly energy efficiency, for variable-speed room air conditioners. The current test procedure's single full-load test condition does not account for such products automatically adjusting compressor or fan speed during performance under part-load conditions. As a result, the current test procedure does not capture the relative efficiency gains of variable-speed technology under part-load conditions, as would be experienced during a representative average use cycle or period of use. Also, an alternate test procedure, similar to LG's requested approach but with modifications, will appropriately reflect operation under part-load conditions and provide results that are representative of actual energy efficiency for variable-speed room air conditioners during a representative average use cycle or period of use, as discussed further below.
In its petition, LG requested an alternate test procedure, which would provide for testing the specified basic models according to Appendix F, except that the variable-speed room air conditioners would be tested at four different outdoor temperature rating conditions
As discussed, the current test procedure relies on a single operating condition, defined by the dry-bulb and wet-bulb temperatures in the indoor and outdoor side test chambers. The suggested alternate approach for variable-speed room air conditioners involves measuring performance over a range of four operating conditions, including reduced outdoor temperature conditions at which variable-speed room air conditioners would perform more efficiently than single-speed room air conditioners, and that better reflect representative use. Although a single-speed air conditioner also would operate more efficiently at reduced outdoor temperatures, the marginal improvement of a variable-speed room air conditioner exceeds that of a single-speed room air conditioner. There are several reasons for this: Unlike single-speed room air conditioners, variable-speed units match the load, avoid cycling losses, and use condition-specific control strategies. Because the current test procedure tests only under a single operating condition, comparing variable-speed room air conditioner performance based on testing at four operating conditions against a single-speed room air conditioner tested at the highest-temperature operating condition would not provide an appropriate comparison.
A performance adjustment factor allows a more appropriate comparison between a variable-speed room air conditioner tested according to the alternate test procedure and a single-speed room air conditioner tested according to the current test procedure. The performance adjustment factor represents the average relative benefit of variable-speed units over single-speed units across the range of operating conditions. It represents the benefit compared to a theoretical comparable single-speed room air conditioner. It is applied to the measured variable-speed room air conditioner performance only at the high-temperature operating condition (the same operating condition under which single-speed room air conditioners are tested) to provide a more appropriate comparison to the existing CEER metric for single-speed room air conditioners.
On June 29, 2018, DOE published a notice that announced its receipt of the petition for waiver and granted LG an interim waiver. 83 FR 30717 (“June 2018 notice”). In the June 2018 notice, DOE presented LG's claim that the results of the test procedure in Appendix F are not representative of the actual energy consumption of the variable-speed room air conditioners specified in LG's petition for waiver and the requested alternate test procedure described above.
In the June 2018 notice, DOE specified an alternate test procedure as suggested by LG that must be followed for testing and certifying the specific basic models for which LG requested a waiver. For the reasons explained here and in the Notice of Petition for Waiver,
By letter dated March 11, 2019, LG requested DOE extend the scope of the interim waiver to include an additional basic model, LW1019IVSM. LG stated that basic model LW1019IVSM employs the same technology as the basic models addressed by the interim waiver.
DOE has reviewed LG's waiver extension request and based on that review, determined that the room air conditioner basic model identified in LG's request incorporates the same design characteristics as those basic models covered under the interim waiver in Case Number 2018-003 such that the test procedure evaluates that basic model in a manner that is unrepresentative of its actual energy use. DOE has also determined that the alternate test procedure will evaluate the additional basic model, LW1019IVSM, in a manner that is representative of its actual energy use. As such, DOE is including LG's basic model LW1019IVSM in this Decision and Order along with the three basic models that were listed in the interim waiver.
Thus, DOE is requiring LG to test and rate the four room air conditioner basic models identified in today's Order according to the alternate test procedure in today's Order. The alternate test procedure in this Order is a modified version of the procedure in the interim waiver.
In the June 2018 notice, DOE also solicited comments from interested parties on all aspects of the petition.
Although ASAP agreed with LG's assertion that the current test procedure for room air conditioners does not capture part-load performance and the potential benefits of variable-speed technology, they believe that a test procedure waiver is not the appropriate approach to address the concern. They stated that, instead of granting a waiver for an alternate test with fixed temperature, humidity, and compressor speeds, DOE should amend the current test procedure to use a load-based testing approach. ASAP contended that room air conditioners likely spend a significant amount of time during the cooling season operating under part-load conditions, which require less cooling. ASAP stated that the existing full-load test at an external temperature of 95 °F both does not reflect these actual operating conditions and does not capture inefficiencies and performance degradation due to a single-speed unit's cycling on and off under part-load operating conditions. ASAP suggested that a load-based test would better reflect how both single-speed and variable-speed room air conditioners perform in the field and would capture not only the benefits of variable-speed compressors, in that they are able to provide cooling that matches the load, but also other important factors that affect efficiency, including the avoidance of cycling losses and condition-specific control strategies. ASAP referenced recent work by the CSA Group in developing a load-based test for residential central air conditioners and heat pumps that it suggested could serve as a model for a load-based test for room air conditioners. ASAP further believes that a load-based approach would provide better information to consumers, encourage the adoption of new technologies that may improve efficiency, and, while also providing additional benefits to consumers and the electric grid (
In response to ASAP's comments, LG noted that DOE's regulations specify that a granted waiver must be followed, as soon as practicable, by a test procedure rulemaking to amend DOE's regulations and eliminate any need for continuation of the waiver. LG asserted that a waiver is appropriate to address any misrepresentation of energy consumption immediately and expressed support for a subsequent rulemaking to establish such an approach in the DOE room air conditioner test procedure. LG also asserted that ASAP's preference for a dynamic load-based test would not be appropriate grounds for denying LG's petition for waiver, which it claimed has met all waiver criteria and is thereby warranted. (LG, No. 7 at pp. 2-3)
DOE agrees with the concept that a load-based test may be more representative of typical operation, where the conditions within a room vary and the room air conditioner operates based on the set point and monitored conditions. However, there are substantial issues with setting up and maintaining conditions in existing test chambers that are not designed for this type of test. These require significantly more technician involvement and time, thereby greatly increasing the test cost. In addition, because the specific equipment in the calorimeter chamber will affect the variation in chamber temperature as a function of the cooling load, ensuring the reproducibility of the test would substantially increase the test burden in relation to the potential improved representativeness of the test. As a result, DOE has decided not to establish a load-based test. This understanding is based in part on investigative room air conditioner testing that DOE recently conducted.
In addition to preferring a load-based test, ASAP expressed concern regarding the fixed compressor speeds in the LG-suggested alternate test procedure, stating that such test conditions do not reflect how variable-speed room air conditioners operate in the field. ASAP asserted that control strategies significantly impact efficiency and performance, and that by fixing the compressor speeds, the alternate test procedure would not capture the impact of a unit's control strategy for adjusting the compressor (and potentially fan) speed(s) in response to varying conditions. (ASAP, No. 5 at p. 2)
DOE agrees that variable-speed room air conditioners in the field are likely to adjust their compressor speed in real-time in response to variations in the cooling load. However, EPCA requires developing a test procedure that is reasonably designed to produce results that measure performance during a representative average use cycle or period of use, without undue burden. Because of the large variation in cooling loads, both for rooms within a house, and among different housing types and geographical areas, identifying a single or multiple representative cooling loads would not be feasible at this time. Furthermore, load-based testing would impose undue cost and burden on manufacturers and test laboratories due to the unique construction and capabilities of existing calorimeter chambers and unit response variability during load-based testing. In contrast, DOE concludes that the approach suggested by LG to measure performance for the full range of variable-speed operation (
Friedrich raised concerns about the suggested alternate test procedure. First, they questioned why the test conditions specified in the interim waiver were those suggested by LG instead of the full set of seasonal energy efficiency ratio (“SEER”) test conditions in American National Standards Institute (“ANSI”)/Air-Conditioning, Heating, and Refrigeration Institute “AHRI” 2017 Standard 210/240, “Performance Rating of Unitary Air-Conditioning & Air-Source Heat Pump Equipment” (“AHRI 210/240-2017”). According to Friedrich, the bin hours and test methodology in AHRI 210/240-2017 have been thoroughly vetted. (Friedrich, No. 4 at p. 1)
In response to Friedrich's comments, LG noted that, where appropriate, the test conditions in the waiver test procedure are based on those in AHRI 210/240-2017 considering that AHRI 210/240-2017 applies to central air conditioners, whereas the petition for waiver is for room air conditioners. LG stated, for example, that the required test conditions in AHRI 210/240-2017 for central air conditioners having variable-speed compressors include a fifth condition, the F
DOE reviewed the full set of five required and two optional test conditions in AHRI 210/240-2017 and concludes that those four selected by LG apply to room air conditioners, but the three remaining conditions do not. Specifically, the outdoor test conditions for the required F
Friedrich also questioned whether the capacity and power adjustment factors used to calculate the performance of a comparable single-speed room air conditioner are representative of the range of single-speed room air conditioners on the market. (Friedrich, No. 4 at p. 1) DOE conducted testing and modeling to estimate performance of room air conditioners at varying outdoor ambient conditions. DOE reviewed the capacity and power adjustment factors suggested by LG and notes that they largely align with the data from DOE's testing and modeling. Therefore, DOE is confident that the capacity and power adjustment factor values suggested by LG to estimate performance of a comparable single-speed room air conditioner at reduced ambient conditions are appropriate and representative of expected performance.
Friedrich also suggested that an alternate test for variable-speed room air conditioners should use a building load and operating hours at specific operating conditions, as is done for the SEER metric in AHRI 210/240-2017. Friedrich disagrees with LG's approach that instead assumes a room air conditioner operates for 750 hours in every condition. (Friedrich, No. 4 at p. 1) In response to Friedrich's comment, LG noted that DOE has previously determined that 750 operating hours is the representative average-use cycle per year for room air conditioners. (LG, No. 7 at pp. 6-7)
DOE reviewed Table 16 in AHRI 210/240-2017 and determined that the full set of conditions are likely not applicable to room air conditioner operation. Table 16 contains data describing the fraction of the cooling season during which the temperature is within each of eight temperature bins, with representative temperatures for each bin ranging from 67 °F to 102 °F in increments of 5 °F. Specifically, DOE agrees that only bins 4 through 7 of Table 16 are appropriate for room air conditioner operation because these are the ranges of temperatures that span the current indoor and outdoor temperature conditions of 80 °F and 95 °F, respectively. DOE notes that normalizing those fractional bin hours results in the weighting factors suggested in LG's petition for waiver, with each weighting factor representing the fraction of 750 hours during the cooling season that would be associated with each outdoor temperature bin. Therefore, DOE concludes that the weighting factors suggested by LG are appropriate for variable-speed room air conditioners.
Friedrich also stated that the alternate test procedure compares the weighted variable-speed CEER to the weighted single-speed CEER, which is higher than the CEER value at which the comparable single-speed unit would currently be rated (
DOE notes that only the final CEER metric calculated in section 5.4.9 of the waiver test procedure (
The California IOUs recommended that DOE deny LG's waiver request and rescind the interim waiver because the CEER weighting scheme in the alternate test procedure represents too significant a change to the CEER performance metric and its calculation methodology. The California IOUs noted that under 10 CFR 430.27, a waiver shall not be granted if it will “change the energy use or efficiency metric that the manufacturer must use to certify compliance with the applicable energy conservation standard.” They believe that the alternate testing procedure represents a change in the efficiency metric calculation because it incorporates a weighting approach. Instead of a waiver, the California IOUs suggested that DOE conduct a test procedure rulemaking to allow opportunities for proper consideration, evaluation, and review before a manufacturer conducts testing and certification using an alternate test procedure. The California IOUs noted that the proposed testing conditions could then be evaluated to determine whether they accurately capture the energy consumption of the listed and comparable models. They asserted that because LG did not submit any data to justify the chosen testing conditions or weighting factors, the validity of these values cannot be verified. The California IOUs further asserted that if the alternate test procedure in this waiver is granted, the CEER metric for the identified LG models would no longer be comparable to those of room air conditioners from other manufacturers, resulting in an unfair marketplace and misleading information for consumers. (California IOUs, No. 6 at pp. 1-2)
In response to the comment from the CA IOUs, LG stated that its suggested alternate test procedure does not change the metric, but rather maintains the CEER metric and would not alter the minimum standard applicable to these products. LG further stated that it is preferable to provide better information to consumers as soon as possible, rather than waiting until a new test procedure rulemaking is completed. (LG, No. 7 at pp. 3-4)
DOE notes that the LG interim waiver approach assesses the performance improvements associated with variable-speed room air conditioners as compared to single-speed room air conditioners, on the basis of adjusted operation at varying, reduced-temperature operating conditions and accounting for savings associated with eliminating cycling losses. DOE recognizes that neither the intermediate individual CEER values nor the weighted CEER value calculated for a variable-speed room air conditioner unit and comparable single-speed room air conditioner at the different operating conditions are comparable to the CEER determined using Appendix F. However, the alternate test procedure does not prescribe either of these values for determining compliance or for comparison with the CEER determined using Appendix F. Under the alternate test procedure, the intermediate CEER values are used to determine a performance adjustment factor that reflects the relative performance improvement associated with variable-speed operation. That performance adjustment factor is then applied to the Appendix F CEER metric. In that way, the efficiency metric for variable-speed room air conditioners remains comparable to the current CEER metric, which would continue to reflect performance of single-speed room air conditioners. Thus, consumers are informed of the relative efficiency improvements provided by variable-speed room air conditioners. As discussed above, the weighting factors and test conditions suggested by LG are based on the applicable values in Table 16 of AHRI 210/240-2017, which has been verified and validated and is an industry accepted standard.
Additionally, the California IOUs objected to DOE's assertion in the interim waiver that LG would suffer economic hardship and be at a competitive disadvantage if it were required to rate the identified models for which it requested a waiver according to the current room air conditioner test procedure. The California IOUs stated that following a review of product literature, they found that all three LG models listed in the interim waiver (LW2217IVSM, LW1817IVSM, and LW1517IVSM) currently exceed the minimum Federal standards for room air conditioners in their respective product classes, and would therefore not be precluded from entering the market. (California IOUs, No. 6 at p. 2)
LG stated that even though LG's products would not be barred from the market, it would suffer economic hardship and be at a competitive disadvantage without the waiver, because the DOE test procedure does not capture the relative efficiency improvements achieved by variable-speed room air conditioners over a range of operating conditions compared to single-speed room air conditioners. LG asserted that, without an alternate test procedure, the CEER values of variable-speed room air conditioners would be inaccurately low, despite the improved performance under part-load conditions. (LG, No. 7 at pp. 4-5)
For the reasons explained here and in the June 2018 notice, without a waiver, the basic models identified in the Order cannot be tested and rated for energy consumption on a basis representative of their true energy consumption characteristics. DOE has reviewed the recommended procedure suggested by LG and concludes that it will allow for generally accurate measurement of the energy use of the listed models, while alleviating the problems associated with testing these models following DOE's room air conditioner test procedure. LG must test and rate the four listed room air conditioner basic models according to the alternate test procedure specified in the Decision and Order. This alternate test procedure is substantively consistent with the interim waiver's alternate test procedure but makes some modifications.
Based on further review of the alternate test procedure required under the interim waiver order and subsequent investigative testing performed by DOE, the alternate test procedure required under today's Decision and Order: (1) Does not permit use of a psychrometric chamber instead of a calorimeter chamber, (2) provides definitions for each fixed compressor speed, and (3) specifies that compressor speeds will be set in accordance with instructions that LG will provide. DOE has determined that these changes are necessary to ensure better repeatability and reproducibility of the alternate test procedure, as well as representativeness of the results.
DOE is removing the option provided in the interim waiver order to test using the air-enthalpy method, which relies on use of a psychrometric chamber, as opposed to a calorimeter chamber. Use of a psychrometric chamber requires the installation of test ducts on the evaporator and condenser exhausts to measure the air-enthalpy and calculate cooling capacity, which may impact the air flow, particularly on the evaporator side where room air conditioners typically locate the inlet and outlet in close proximity. As such, the results from using a psychrometric chamber may not be representative of typical installations. Further, unlike the calorimeter method, the air-enthalpy method does not address heat loss through the chassis to the room, and may not capture possible heat transfer due to internal air leakage through the chassis between the indoor and outdoor test chambers. DOE's investigative testing of 9 room air conditioners suggested that the air-enthalpy and calorimeter methods are not interchangeable: DOE's results varied up to 11 percent in cooling capacity and efficiency between the two methods.
To capture the efficiency gains associated with variable-speed technology, the alternate test procedure requires testing variable-speed room air conditioners at different fixed compressor speeds under various reduced outdoor operating temperatures. To harmonize the alternate test procedure with industry standards and ensure the compressor speeds are representative of the expected load at each of the outdoor test conditions, DOE is providing definitions for the three compressor speeds outlined in the Interim Waiver Order and revising the nomenclature for these speeds based on AHRI 210/240-2017. To ensure that the low and intermediate compressor speeds result in adequate cooling capacity under reduced loads, the low compressor speed definition requires that the test unit's measured cooling capacity at the low temperature (82 °F) rating condition must be within 47 percent to 57 percent of the measured cooling capacity when operating with the full compressor speed at the 95 °F rating condition. DOE developed this range based on the building load calculation, equation 11.6, in AHRI 210/240-2017, which relates the building load to the unit full-load cooling capacity and the outdoor temperature. DOE normalized this equation for room ACs so that full load operation occurs at a 95 °F outdoor temperature, rather than 98 °F under the existing equation, and then used the normalized equation to estimate the cooling load as a percentage of the full-load cooling capacity at the 82 °F outdoor temperature rating condition. Based on this analysis, DOE expects that, if a variable-speed room AC's cooling capacity at low compressor speed is higher than 57 percent of the unit's cooling capacity at the 95 °F rating condition, the cooling capacity would exceed the cooling load when the outdoor temperature is 82 °F. Thus, such a unit in the field would cycle the compressor under a cooling load corresponding to the rating condition because more cooling than necessary would be provided to the room, thereby incurring cycling losses and not providing the full performance benefits associated with variable-speed operation. Conversely, if a variable-speed room AC's cooling capacity at the low compressor speed is significantly lower than 57 percent of the unit's cooling capacity at the 95 °F rating condition, the unit would not provide sufficient cooling (based on the expected cooling load at the 82 °F rating condition) and would thereby impact consumer acceptance of the product. For this reason, and because variable-speed room ACs may use compressors that vary speed in discrete steps without the capability to directly operate at a speed that meets the 57 percent requirement precisely, the low speed definition allows for a minimum cooling capacity at the low compressor speed of 47 percent of the cooling capacity at the 95 °F rating condition. This range ensures that the unit's cooling capacity at the representative low cooling load, as determined using the building load calculation in AHRI 210/240-2017, is achieved while maintaining the performance benefits of variable-speed compressors.
Setting and maintaining a specific room air conditioner compressor speed is not typically possible without specific control instructions from the manufacturer. Because fixed compressor speeds are critical to the repeatability of this alternate test procedure, DOE is requiring that the manufacturer provide DOE all necessary instructions to maintain the compressor speed required for each test condition.
DOE also recognizes that corresponding changes are needed to the calculation that provides the basis of the annual energy consumption and operating cost information presented to consumers on the EnergyGuide Label. These changes will allow for an appropriate comparison of the annual energy consumption and operating costs between single-speed room air conditioners and the four variable-speed room air conditioner basic models listed in today's Order. As such, the alternate test procedure specifies two values of electrical power input. One is used in calculating the average annual energy consumption in 10 CFR 430.23(f)(3), which in turn is used to calculate the combined annual energy consumption and estimated annual operating cost in 10 CFR 430.23(f)(4) and (f)(1), respectively. This value is the weighted average of the input power measured at each of the four test conditions plus the annual energy consumption in inactive mode or off mode. The second value is the value measured at the 95 °F rating condition and reported to DOE through certification reports, as required in 10 CFR 429.15(b)(2), and is used to calculate the unit's measured CEER value in 10 CFR 430.23(f)(5) before applying the performance adjustment factor. DOE concludes that, although a different value of electrical power input is appropriate for calculating the FTC EnergyGuide values, reporting of the electrical power input at the 95 °F rating condition ensures consistency with the cooling capacity measured under the same condition.
DOE further requires in today's Decision and Order testing of the specified basic models in accordance with the instructions submitted by LG on April 2, 2019, regarding the compressor frequencies and control
The Decision and Order applies only to the four basic models listed in the Order and does not extend to any other basic models. LG may request that DOE extend the scope of this waiver to include additional basic models that employ the same technology as those listed in the Order. 10 CFR 430.27(g). LG may also submit another petition for waiver from the test procedure for additional basic models that employ a different technology and meet the criteria for test procedure waivers. 10 CFR 430.27(a)(1).
DOE notes that it may rescind or modify the waiver at any time upon a determination that the factual basis underlying the petition for waiver is incorrect, or that the results from the alternate test procedure are unrepresentative of the basic models' true energy consumption characteristics. 10 CFR 430.27(k)(1). Likewise, LG may request that DOE rescind or modify the waiver if the company discovers an error in the information provided to DOE as part of its petition, determines that the waiver is no longer needed, or for other appropriate reasons. 10 CFR 430.27(k)(2).
In accordance with 10 CFR 430.27(f)(2), DOE consulted with the Federal Trade Commission (“FTC”) staff concerning the LG petition for waiver. The FTC staff did not have any objections to DOE's granting a waiver to LG for the four specified basic models.
After careful consideration of all the material that was submitted by LG and commenters in this matter, public facing materials, and the testing conducted by DOE, it is
(1) LG must, as of the date of publication of this Order in the
(2) The alternate test procedure for the LG basic models referenced in paragraph (1) of this Order is the test procedure for room air conditioners prescribed by DOE at appendix F to subpart B of 10 CFR part 430 (“Appendix F”) and 10 CFR 430.23(f), except: (i) Determine the combined energy efficiency ratio (“CEER”) as detailed below, and (ii) calculate the average annual energy consumption referenced in 10 CFR 430.23(f)(3) as detailed below. In addition, for each basic model listed in paragraph (1), maintain compressor speeds at each test condition and set control settings for the variable components, according to the instructions submitted to DOE by LG. All other requirements of Appendix F and DOE's regulations remain applicable.
In 10 CFR 430.23, in paragraph (f) revise paragraph (3)(i) to read as follows: The electrical power input in kilowatts as calculated in section 5.2.1 of appendix F to this subpart, and
In 10 CFR 430.23, in paragraph (f) revise paragraph (5) to read as follows:
(5) Calculate the combined energy efficiency ratio for room air conditioners, expressed in Btu's per watt-hour, as follows:
(i) Calculate the quotient of:
(A) The cooling capacity as determined at the 95 °F outdoor test condition, Capacity
(B) The combined annual energy consumption, in watt hours, which is the sum of the annual energy consumption for cooling mode, calculated in section 5.4.2 of appendix F to this subpart for test condition 1 in Table 1 of appendix F to this subpart, and the standby mode and off mode energy consumption, as determined in accordance with section 5.3 of appendix F to this subpart. The sum of the annual energy consumption in cooling mode and standby mode and off mode energy consumption is then multiplied by a conversion factor of 1,000 to convert kilowatt-hours to watt-hours.
(ii) Multiply the quotient calculated in paragraph (f)(5)(i) of this section by (1 + Fp), where Fp is the variable-speed room air conditioner performance adjustment factor as determined in section 5.4.8 of appendix F to this subpart.
(iii) Round the resulting value from paragraph (f)(5)(ii) of this section to the nearest 0.1 Btu per watt-hour.
In Appendix F:
Add in Section 1,
1.8 “Single-speed” means a type of room air conditioner that cannot automatically adjust the compressor speed based on detected conditions.
1.9 “Variable-speed” means a type of room air conditioner that can automatically adjust compressor speed based on detected conditions.
1.10 “Full compressor speed (full)” means the compressor speed specified by the manufacturer at which the unit operates at full load testing conditions.
1.11 “Intermediate compressor speed (intermediate)” means the compressor speed higher than the low compressor speed by one third of the difference between low compressor speed and full compressor speed with a tolerance of plus 5 percent (designs with non-discrete compressor speed stages) or the next highest inverter frequency step (designs with discrete compressor speed steps).
1.12 “Low compressor speed (low)” means the compressor speed specified by the manufacturer at which the unit operates at low load test conditions, such that the measured cooling capacity at Temperature Condition 4 in Table 1 of this appendix, Capacity
Add to the end of Section 2.1
For the purposes of this waiver, all units must conduct the cooling mode test a total of four times: One test at each of the test conditions listed in Table 1, consistent with section 3.1 of this appendix.
Revise Section 3.1,
Replace Section 5.1 to read as follows:
Calculate the condition-specific cooling capacity (expressed in Btu/hr), Capacity
Replace Section 5.2 to read as follows:
Determine the condition-specific electrical power input (expressed in watts), P
Insert a new Section 5.2.1:
5.2.1
Add a new Section 5.4, following Section 5.3,
5.4
5.4.1
5.4.2
5.4.3
5.4.4
5.4.5
5.4.6
5.4.7
5.4.8
(3)
(4) This waiver shall remain in effect according to the provisions of 10 CFR 430.27.
(5) This waiver is issued on the condition that the statements, representations, and documents provided by LG are valid. Any modifications to the controls or configurations of a basic model subject to this waiver will render the waiver invalid with respect to that basic model, and LG will either be required to use the current Federal test procedure or submit a new application for a test procedure waiver. DOE may revoke or modify this waiver at any time if it determines the factual basis underlying the petition for waiver is incorrect, or the results from the alternate test procedure are unrepresentative of the basic model's true energy consumption characteristics. 10 CFR 430.27(k)(1). Likewise, LG may request that DOE rescind or modify the waiver if LG discovers an error in the information provided to DOE as part of its petition, determines that the waiver is no longer needed, or for other appropriate reasons. 10 CFR 430.27(k)(2).
(6) LG remains obligated to fulfill the certification requirements set forth at 10 CFR part 429.
Signed in Washington, DC, on May 1, 2019.
Environmental Protection Agency (EPA).
Notice.
EPA has received specific exemption requests from the Virginia Department of Agriculture and Consumer Services (VDACS) to use the insecticide dinotefuran (CAS No. 165252-70-0) to treat up to 29,000 acres of pome fruits and stone fruits to control the brown marmorated stinkbug. The applicant proposes uses which are supported by the Interregional Research Project Number 4 (IR-4) and have been requested in 5 or more previous years, and petitions for tolerances have not yet been submitted to the Agency. Therefore, EPA is soliciting public comment before making the decision whether to grant the exemptions.
Comments must be received on or before May 23, 2019.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2019-0192, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Michael L. Goodis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
1.
2.
3.
Under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 U.S.C. 136p), at the discretion of the EPA Administrator, a Federal or State agency may be exempted from any provision of FIFRA if the EPA Administrator determines that emergency conditions exist which require the exemption. The VDACS has requested the EPA Administrator to issue specific exemptions for the use of dinotefuran on pome fruits and stone fruits to control the brown marmorated stinkbug. Information in accordance with 40 CFR part 166 was submitted as part of the requests. In addition to VDACS, several other states have previously requested specific exemptions for the same uses and are expected to submit similar requests.
As part of the requests, the applicant asserts that the rapid spread of large outbreaks of the brown marmorated stinkbug (a recent invasive species) resulted in an urgent and non-routine
This notice does not constitute a decision by EPA on the application itself. The regulations governing FIFRA section 18 at 40 CFR 166.24(a)(7), require publication of a notice of receipt of an application for a specific exemption proposing a use which is supported by the Interregional Research Project Number 4 (IR-4) and has been requested in 5 or more previous years, and a petition for tolerance has not yet been submitted to the Agency. The notice provides an opportunity for public comment on the application. The Agency will review and consider all comments received during the comment period in determining whether to issue the specific exemptions requested by the VDACS.
7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice.
EPA is required under the Toxic Substances Control Act (TSCA), as amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act, to make information publicly available and to publish information in the
Comments identified by the specific case number provided in this document must be received on or before June 7, 2019.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2019-0075, and the specific case number for the chemical substance related to your comment, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
This document provides the receipt and status reports for the period from 02/01/2019 to 02/28/2019. The Agency is providing notice of receipt of PMNs, SNUNs and MCANs (including amended notices and test information); an exemption application under 40 CFR part 725 (Biotech exemption); TMEs, both pending and/or concluded; NOCs to manufacture a new chemical substance; and a periodic status report on new chemical substances that are currently under EPA review or have recently concluded review.
EPA is also providing information on its website about cases reviewed under the amended TSCA, including the section 5 PMN/SNUN/MCAN and exemption notices received, the date of receipt, the final EPA determination on the notice, and the effective date of EPA's determination for PMN/SNUN/MCAN notices on its website at:
Under the TSCA, 15 U.S.C. 2601
Any person who intends to manufacture (including import) a new chemical substance for a non-exempt commercial purpose, or to manufacture or process a chemical substance in a non-exempt manner for a use that EPA has determined is a significant new use, is required by TSCA section 5 to provide EPA with a PMN, MCAN or SNUN, as appropriate, before initiating the activity. EPA will review the notice, make a risk determination on the chemical substance or significant new use, and take appropriate action as described in TSCA section 5(a)(3).
TSCA section 5(h)(1) authorizes EPA to allow persons, upon application and under appropriate restrictions, to manufacture or process a new chemical substance, or a chemical substance subject to a significant new use rule (SNUR) issued under TSCA section 5(a)(2), for “test marketing” purposes, upon a showing that the manufacture, processing, distribution in commerce, use, and disposal of the chemical will not present an unreasonable risk of injury to health or the environment. This is referred to as a test marketing
Under TSCA sections 5 and 8 and EPA regulations, EPA is required to publish in the
This action provides information that is directed to the public in general.
No.
1.
2.
In the past, EPA has published individual notices reflecting the status of TSCA section 5 filings received, pending or concluded. In 1995, the Agency modified its approach and streamlined the information published in the
For the PMN/SNUN/MCANs that have passed an initial screening by EPA during this period, Table I provides the following information (to the extent that such information is not subject to a CBI claim) on the notices screened by EPA during this period: The EPA case number assigned to the notice that indicates whether the submission is an initial submission, or an amendment, a notation of which version was received, the date the notice was received by EPA, the submitting manufacturer (
As used in each of the tables in this unit, (S) indicates that the information in the table is the specific information provided by the submitter, and (G) indicates that this information in the table is generic information because the specific information provided by the submitter was claimed as CBI. Submissions which are initial submissions will not have a letter following the case number. Submissions which are amendments to previous submissions will have a case number followed by the letter “A” (
In Table II. of this unit, EPA provides the following information (to the extent that such information is not claimed as CBI) on the NOCs that have passed an initial screening by EPA during this period: The EPA case number assigned to the NOC including whether the submission was an initial or amended submission, the date the NOC was received by EPA, the date of commencement provided by the submitter in the NOC, a notation of the type of amendment (
In Table III. of this unit, EPA provides the following information (to the extent such information is not subject to a CBI claim) on the test information that have passed an initial screening by EPA during this time period: The EPA case number assigned to the test information; the date the test information was received by EPA, the type of test information submitted, and chemical substance identity.
If you are interested in information that is not included in these tables, you may contact EPA's technical information contact or general information contact as described under
15 U.S.C. 2601
Environmental Protection Agency (EPA).
Notice of availability for comment; correction.
The Environmental Protection Agency (EPA) Region 8 is correcting the docket number for a notice of availability for comment that appeared in the
Comments must be received, in writing, on or before May 28, 2019.
Submit your comments, identified by Docket ID No. EPA-R08-OW-2019-0219, by the following method:
Once submitted, comments cannot be edited or removed from
Paul Garrison, Wastewater Program, U.S. Environmental Protection Agency, Region 8, Mailcode 8WD-CW-W, 1595 Wynkoop Street, Denver, Colorado 80202-1129, (303) 312-6016,
Please refer to the
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: 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; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before July 8, 2019. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
The FCC/MB-1 SORN, which was approved on November 28, 2016 (81 FR 72047), covers the collection, purpose(s), storage, safeguards, and disposal of the PII that individual respondents may submit on FCC Form 323, as required under the Privacy Act of 1974, as amended (5 U.S.C. 552a). FCC Form 323 includes a privacy statement to inform applicants (respondents) of the Commission's need to obtain the information and the protections that the Commission has in place to protect the PII.
FRNs are assigned to applicants who complete FCC Form 160 (OMB Control No. 3060-0917). Form 160 currently requires applicants for FRNs to provide their Taxpayer Information Number (TIN) and/or Social Security Number (SSN). The FCC's electronic Commission Registration System (CORES) then provides each registrant with a CORES FRN, which identifies the registrant in his/her subsequent dealings with the FCC. This is done to protect the individual's privacy.
FCC Form 160 also enables applicants to obtain a Restricted Use FRN, which may be used on Form 323 to identify an individual reported as an attributable interest holder. Form 160 requires applicants for Restricted Use FRNs to provide an alternative set of identifying information that does not include the individual's full SSN: His/her full name, residential address, date of birth, and only the last four digits of his/her SSN. Restricted Use FRNs may be used in lieu of CORES FRNs only on broadcast ownership reports and only for individuals (not entities) reported as attributable interest holders.
The Commission maintains a SORN, FCC/OMD-25, Financial Operations Information System (FOIS), to cover the collection, purpose(s), storage, safeguards, and disposal of the PII that individual respondents may submit on FCC Form 160. FCC Form 160 includes a privacy statement to inform applicants (respondents) of the Commission's need to obtain the information and the protections that the FCC has in place to protect the PII.
In addition, Licensees and Permittees of commercial AM, FM, and full power television broadcast stations must file Form 323 following the consummation of a transfer of control or an assignment of a commercial AM, FM, or full power television broadcast station license or construction permit; a Permittee of a new commercial AM, FM, or full power television broadcast station must file Form 323 within 30 days after the grant of the construction permit; and a Permittee of a new commercial AM, FM, or full power television broadcast station must file Form 323 to update the initial report or to certify the continuing accuracy and completeness of the previously filed report on the date that the Permittee applies for a license to cover the construction permit.
In the case of organizational structures that include holding companies or other forms of indirect ownership, a separate Form 323 must be filed for each entity in the organizational structure that has an attributable interest in the Licensee or Permittee.
The FCC/MB-1 SORN, which was approved on November 28, 2016 (81 FR 72047), covers the collection, purpose(s), storage, safeguards, and disposal of the PII that individual respondents may submit on FCC Form 323-E, as required under the Privacy Act of 1974, as amended (5 U.S.C. 552a). FCC Form 323-E includes a privacy statement to inform applicants (respondents) of the Commission's need to obtain the information and the protections that the Commission has in place to protect the PII.
FRNs are assigned to applicants who complete FCC Form 160 (OMB Control No. 3060-0917). Form 160 currently requires applicants for FRNs to provide their Taxpayer Information Number (TIN) and/or Social Security Number (SSN). The FCC's electronic Commission Registration System (CORES) then provides each registrant with a CORES FRN, which identifies the registrant in his/her subsequent dealings with the FCC. This is done to protect the individual's privacy.
FCC Form 160 also enables applicants to obtain a Restricted Use FRN, which may be used on Form 323-E to identify an individual reported as an attributable interest holder. Form 160 requires applicants for Restricted Use FRNs to provide an alternative set of identifying information that does not include the individual's full SSN: His/her full name, residential address, date of birth, and only the last four digits of his/her SSN. Restricted Use FRNs may be used in lieu of CORES FRNs only on broadcast ownership reports and only for individuals (not entities) reported as attributable interest holders.
The Commission maintains a SORN, FCC/OMD-25, Financial Operations Information System (FOIS), to cover the collection, purpose(s), storage, safeguards, and disposal of the PII that individual respondents may submit on FCC Form 160. FCC Form 160 includes a privacy statement to inform applicants (respondents) of the Commission's need to obtain the information and the protections that the FCC has in place to protect the PII.
In addition, Licensees and Permittees of noncommercial educational AM, FM, and television broadcast stations must file Form 323-E following the consummation of a transfer of control or an assignment of a noncommercial educational AM, FM, or television broadcast station license or construction permit; a Permittee of a new noncommercial educational AM, FM, or television broadcast station must file Form 323-E within 30 days after the grant of the construction permit; and a Permittee of a new noncommercial educational AM, FM, or television broadcast station must file Form 323-E to update the initial report or to certify the continuing accuracy and completeness of the previously filed report on the date that the Permittee applies for a license to cover the construction permit.
In the case of organizational structures that include holding companies or other forms of indirect ownership, a separate Form 323-E must be filed for each entity in the organizational structure that has an
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: 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; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before July 8, 2019. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection. Comments are requested concerning: 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; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written comments should be submitted on or before June 7, 2019. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the web page
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collection.
Comments are requested concerning: 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; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
On July 13, 2017, the Commission adopted an Order on Reconsideration in ET Docket Nos. 14-165 and 14-166, FCC 17-95, that addressed wireless microphone issues (2017 Wireless Microphone Order). Because the date the Commission specified in the 2015 White Spaces R&O for ending registration of unlicensed wireless microphones in the white space database had passed with the release of the Channel Reassignment Public Notice on April 13, 2017, the Order removed and reserved Section 15.713(j)(9) that had previously allowed such registrations.
The white space rules as amended by the 2015 White Spaces R&O require that each white space database administrator shall:
(a) Maintain a database that contains the information described in § 15.713 of the rules. The database must include information on protected entities and services, including TV stations, Broadcast Auxiliary Services, Private Land Mobile and Commercial Radio Service operations, part 74 Low Power Auxiliary Stations such as wireless microphones, the locations where part 27 600 MHz service licensees have commenced operation, and the locations of health care facilities that use WMTS equipment operating on channel 37. (Section 15.715(a));
(b) Establish a process for acquiring and storing in the database necessary and appropriate information from the Commission's databases and synchronizing the database with the current Commission databases at least once a week to include newly licensed facilities or any changes to licensed facilities (Section 15.715(b));
(c) Establish a process for registering fixed white space devices and registering and including in the database those facilities entitled to protection but not contained in a Commission database, including Multi-channel Video Programming Distributor (MVPD) receive sites. The database administrators must establish procedures to allow part 27 600 MHz service licensees to upload, modify and replace registration information for areas where they have commenced operations; allow health care facilities to register the locations of facilities where they operate WMTS networks on channel 37; and to allow unlicensed wireless microphone users in the 600 MHz band to register with the database and to provide lists of channels available for wireless microphones at a given location (Sections 15.715(n), (p) and (q)). Database administrators must remove from the database the registrations of fixed white space devices that have not checked the database for at least three months to update their channel lists (Section 15.715(o));
(d) Establish a process for registering facilities where part 74 low power auxiliary devices are used on a regular basis (Sections 15.713(j)(8) and 15.715(d));
(e) Provide accurate automated information regarding available channels to fixed and personal/portable white space devices that submit to the database the information required under § 15.713(e), (g) and (h) based on the geographic location of the device; and provide accurate automated information regarding available channels to fixed and Mode II devices requesting information regarding available channels for Mode I devices. Database administrators may allow prospective operators of white space devices to query the database and determine if there are vacant channels at a particular location (Section 15.715(e)); (f) Establish protocols and procedures to ensure that all automated communications and interactions between the database and white space devices are accurate and secure and that unauthorized parties cannot access or alter the database or the information regarding available channels sent to a white space device consistent with the provisions of Section 15.713(l) (Section 15.715(f));
(g) Make database services available to all unlicensed white space device users on a non-discriminatory basis (Section 15.715(g));
(h) Provide service for a five-year term. This term can be renewed at the Commission's discretion (Section 15.715(h));
(i) Respond in a timely manner to verify, correct and/or remove, as appropriate, data in the event that the Commission or a party brings a claim of inaccuracies in the database to the attention of the administrator. This requirement applies only to information that the Commission requires to be stored in the database (Section 15.715(i));
(j) Transfer the database, along with the IP addresses and URLs used to
(k) The database must have functionality such that upon request from the Commission it can indicate that no channels are available when queried by a specific white space devices or model of white space device (Section 15.715(k));
(l) If more than one database is developed, the database administrators must cooperate to develop a standardized process for providing on a daily basis or more often, as appropriate the data collected for the facilities listed in § 15.713(b)(2) to all other white space databases to ensure consistency in the records of protected facilities (Section 15.715(l));
(m) The database administrator may charge a fee for provision of lists of available channels to fixed and personal/portable devices and for registering fixed devices. This provision applies to devices that operate in the TV bands, 600 MHz service band, and the 600 MHz guard bands and duplex gap. A white space database administrator may also charge a fee for provision of lists of available channels to wireless microphone users. (Section 15.714).
To receive interference protection, 600 MHz licensees must notify one of the white space database administrators of the areas where they have commenced operation pursuant to §§ 15.713(j)(10) and 15.715(n) of this chapter (Section 27.1320).
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: 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; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees.
The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before July 8, 2019. If you anticipate that you will be submitting comments but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
The information collection requirements contained in 47 CFR 74.1251(c) require FM translator licensee to notify the FCC, in writing, of changes in the primary FM station being retransmitted.
10:00 a.m., Wednesday, May 22, 2019.
The Richard V. Backley Hearing Room, Room 511N, 1331 Pennsylvania Avenue NW, Washington, DC 20004 (enter from F Street entrance).
Open.
The Commission will hear oral argument in the matter
Any person attending this oral argument who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and 2706.160(d).
Emogene Johnson (202) 434-9935/(202) 708-9300 for TDD Relay/1-800-877-8339 for toll free.
1-(866) 867-4769, Passcode: 678-100.
10:00 a.m., Thursday, May 23, 2019.
The Richard V. Backley Hearing Room, Room 511N, 1331 Pennsylvania Avenue NW, Washington, DC 20004 (enter from F Street entrance).
Open.
The Commission will consider and act upon the following in open session:
Any person attending this meeting who requires special accessibility features and/or auxiliary aids, such as sign language interpreters, must inform the Commission in advance of those needs. Subject to 29 CFR 2706.150(a)(3) and 2706.160(d).
Emogene Johnson (202) 434-9935/(202) 708-9300 for TDD Relay/1-800-877-8339 for toll free.
1-(866) 867-4769, Passcode: 678-100.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection project titled Performance Progress and Monitoring Report (PPMR). This collection of information assists CDC in being responsible for the stewardship of funds provided via contracts, grants, and cooperative agreements, from CDC to partners throughout the world, while providing excellent, professional services to our partners and stakeholders.
CDC must receive written comments on or before July 8, 2019.
You may submit comments, identified by Docket No. CDC-2019-0035 by any of the following methods:
•
•
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact Jeffrey M. Zirger, Information Collection Review Office, Centers for Disease Control and
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. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
The OMB is particularly interested in comments that will help:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
5. Assess information collection costs.
Performance Progress and Monitoring Report (PPMR) (OMB Control No. 0920-1132, Expiration 08/31/2019)—Revision—Office of Science (OS), Centers for Disease Control and Prevention (CDC).
Each year, approximately 80% of the Centers for Disease Control and Prevention's (CDC) budget is distributed via contracts, grants and cooperative agreements, from the Office of Financial Resources (OFR) to partners throughout the world in an effort to promote health, prevent disease, injury and disability and prepare for new health threats. OFR is responsible for the stewardship of these funds while providing excellent, professional services to our partners and stakeholders.
Currently, CDC uses the Performance Progress and Monitoring Report (PPMR—OMB Control Number: 0920-1132, Expiration Date: 08/31/2019), a progress report form for Non-Research awards to collect information semi-annually from Awardees regarding the progress made over specified time periods on CDC funded projects. The PPMR was originally modified from SF-PPR (OMB Control Number: 0970-0406, Expiration Date: 10/31/2015), a similar progress report that was owned by the Administration for Children and Families (ACF) within the Department of Health and Human Services (HHS). The PPMR was created by CDC to provide an agency-wide collection tool that would be able to obtain data on the progress of CDC Awardees for the purposes of evaluation, and to bring the Awardee reporting procedure into compliance with the Paperwork Reduction Act (PRA).
The information collected enables the accurate, reliable, uniform, and timely submission to CDC of each Awardee's work plans and progress reports, including strategies, activities and performance measures. The information collected by the PPMR is designed to align with, and support the goals outlined for each of the CDC Awardees. Collection and reporting of the information will occur in an efficient, standardized, and user-friendly manner that will generate a variety of routine and customizable reports. The PPMR will allow each Awardee to summarize activities and progress towards meeting performance measures and goals over a specified time period specific to each award. CDC will also have the capacity to generate reports that describe activities across multiple Awardees. In addition, CDC will use the information collection to respond to inquiries from HHS, Congress and other stakeholder inquiries about program activities and their impact.
This Revision request is being submitted to allow CDC to continue collection of this valuable information from Awardees for an additional three years, and to amend the procedures by which the information can be collected. Currently, the submission process requires Awardees to submit a completed PDF version of the PPMR by uploading it to
Use of this mechanism and the ability of Awardees to submit information related to program evaluation directly to evaluators is expected to greatly increase the use of the PPMR and its associated forms. Centers, Institutes and Offices within CDC will use the PPMR with varying frequency, however with the opportunity to submit evaluation information directly, the total number of responses per year could be increased by 2,000. The total annual burden is estimated to increase to 13,014 hours. There is no cost to respondents other than their time.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of public meeting and request for comment.
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), announces the 2019 annual Vessel Sanitation Program (VSP) public meeting. The annual meeting serves as a forum for HHS/CDC to update cruise industry representatives and other interested persons on work completed in 2018 and plans for future activities. HHS/CDC is also opening a public docket so that written comments and materials regarding VSP's 2018 and future work may be submitted. The official record of this meeting will remain open through July 26, 2019, so that comments related to the topics discussed at the meeting may be submitted and made part of the record.
Written comments must be received on or before July 26, 2019.
The meeting will be held from 9:00 a.m. to 4:30 p.m. on June 27, 2019, in the Ballroom at the DoubleTree Grand Hotel Biscayne Bay, 1717 North Bayshore Drive, Miami, FL 33132. Information regarding logistics is available on the VSP website (
You may submit comments, identified by Docket No. CDC-2019-0039, by any of the following methods:
•
•
Commander Aimee Treffiletti, Vessel Sanitation Program, National Center for Environmental Health, Centers for Disease Control and Prevention, 4770 Buford Highway NE, MS F-58, Atlanta, Georgia 30341; phone: 954-356-6650 or 770-488-3141; email:
The purpose of the meeting is to inform the public of VSP's activities to help the cruise industry prevent the introduction and spread of gastrointestinal (GI) illness to U.S. ports from ships under VSP's jurisdiction. Ships under VSP jurisdiction have 13 or more passengers and an itinerary that includes foreign and U.S. ports.
The meeting will include a review of HHS/CDC's public health support activities from 2018, provide perspective on VSP's approach to vessel sanitation, and offer industry the opportunity to provide input regarding industry efforts to exceed VSP requirements. Presentations will clarify the roles and responsibilities of VSP, cruise line public health management, and shipyards constructing cruise ships. Presentations will also include initiatives for improved epidemiologic study of disease outbreaks and strategic approaches to public health risk reduction for 2020 and the future.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by June 7, 2019.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
This information collection supports Agency-sponsored research. Section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 353b) requires FDA to develop a list of bulk drug substances that may be used in compounding under that section (503B bulks list). Section 503B defines compounding to include the combining, admixing, mixing, diluting, pooling, reconstituting, or otherwise altering of a drug or bulk drug substance to create a drug. Compounded drugs are not FDA-approved. If the conditions under section 503B are met, drug products compounded by entities known as outsourcing facilities are exempt from the following requirements of the FD&C Act: requirements for FDA approval of drugs in section 505 of the FD&C Act (21 U.S.C. 355), labeling with adequate directions for use under section 502(f)(1) of the FD&C Act (21 U.S.C. 352(f)(1)), and drug supply chain security requirements under section 582 (21 U.S.C. 360eee-1). One of the conditions that must be met for a drug product compounded by an outsourcing facility to qualify for these exemptions is that the outsourcing facility may not compound a drug using a bulk drug substance unless (1) the bulk drug substance appears on a list established by the Secretary identifying bulk drug substances for which there is a clinical need (“bulks list”); or (2) the substance appears on the drug shortage list in effect under section 506E of the FD&C Act (21 U.S.C. 356e) at the time of compounding, distribution, and dispensing.
Many bulk drug substances have been nominated by the public for use in compounding by outsourcing facilities with adequate supporting information for FDA to evaluate them. The substances were nominated to treat a variety of conditions. To inform our evaluation of bulk drug substances for inclusion on the 503B bulks list, we have entered into a research study with the University of Maryland (UMD) Center of Excellence in Regulatory Science and Innovation (CERSI) and the Johns Hopkins University (JHU) CERSI.
FDA intends to use a two-part analysis in evaluating substances nominated for placement on the 503B bulks list to determine whether there is a clinical need. The collaboration with CERSI-UMD and CERSI-JHU pertains to part 2 of the analysis, which applies to bulk drug substances that are not components of FDA-approved drug products, as well as certain bulk drug substances that are components of FDA-approved drug products that have gone through part 1 and warrant further evaluation under part 2 of the analysis. One of the factors that FDA considers under part 2 is “current and historical use of the substance in compounded drug products, including information about the medical condition(s) that the substance has been used to treat and any references in peer-reviewed medical literature.”
Researchers may use surveys, interviews, focus groups, and other
1. What are the health condition(s) that the compounded drug is currently and has been historically used to treat? What is the patient population for which the compound drug has been used to treat?
2. What are the characteristics of the compounded drug(s) using the bulk drug substance (
3. Is the compounded drug considered standard therapy by healthcare practitioners, or is it recommended in clinical practice guidelines? If so, under what circumstances?
4. Does an approved drug exist for the health condition that the compounded drug product is used to treat? If so, what are the circumstances under which a compounded drug product using the bulk drug substance would be used in lieu of the approved drug product?
5. What is the historical use of the compounded drug to treat the health conditions identified, including the number of years during which the compounded drug has been prescribed for each use, and any change regarding its use over time?
6. To what extent do practitioners prescribe the compounded drug to treat each health condition identified? How many such prescriptions and/or orders have been written in the past 5 years? Have there been any notable changes in the number of prescriptions and/or orders written over this time?
7. How widespread is the use of the compounded drug product, including use in other countries?
8. Do practitioners order the compounded drug to maintain on hand before a patient presents with a need for the drug (“office stock”), or do practitioners typically write prescriptions for a patient after the patient presents with a need for the compounded drug? If the former, why (
In the
We estimate the burden of the collection of information as follows:
We base our estimate of the average burden per response on review activities familiar to the Agency. Since issuing the 60-day notice, FDA determined an additional burden estimate related to completion of questionnaires. We welcome additional comments regarding this estimate.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by June 7, 2019.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Under section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360) and part 807, subparts A through D (21 CFR part 807, subparts A through D), medical device establishment owners and operators are required to electronically submit establishment registration and device listing information.
Complete and accurate registration and listing information is necessary to accomplish a number of statutory and regulatory objectives, such as: (1) Identification of establishments producing marketed medical devices, (2) identification of establishments
Respondents to this information collection are owners or operators of establishments that engage in the manufacturing, preparation, propagation, compounding, or processing of a device or devices, who must register their establishments and submit listing information for each of their devices in commercial distribution. Notwithstanding certain exceptions, foreign device establishments that manufacture, prepare, propagate, compound, or process a device that is imported or offered for import into the United States must also comply with the registration and listing requirements. The number of respondents is based on data from the FDA Unified Registration and Listing System.
Burden estimates are based on recent experience with the existing medical device registration and listing program, electronic system operating experience, and previous data estimates.
In the
FDA estimates the burden of this collection of information as follows:
The following adjustments and program changes resulted in a 5,672-hour decrease to the overall total hour burden estimate for this information collection request.
• We adjusted the number of respondents based on updated registration and listing data.
• In the reporting burden table, we corrected the table footnotes to accurately indicate whether the information collection (IC) is a one-time or reoccurring burden.
• We also adjusted some of the IC descriptions in the table for increased clarity.
• We updated our estimate of Hours per Response for “807.22(a) Initial Registration and Listing” (+ 0.5 hours), “807.22(b)(1) Annual Registration” (− 0.25 hours), and “807.22(b)(3) Annual Update of Listing Information” (− 0.25 hours). Based on our review of the program, we believe these changes to the burden estimate will more accurately reflect the current preparation time for these ICs.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Laser Products—Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56).” This guidance describes the Agency's approach regarding compliance with FDA's performance standards for laser products. FDA believes that under the circumstances described in this guidance, conformance with certain International Electrotechnical Commission (IEC) standards would provide adequate protection of the public health and safety for laser products similar to performance standards in FDA's regulations. Accordingly, for laser product manufacturers that comply with the comparable clauses in IEC standards specified in the guidance, FDA does not intend to enforce the specified laser performance standards in FDA's regulations.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
An electronic copy of the guidance document is available for download from the internet. See the
Patrick Hintz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4228, Silver Spring, MD 20993-0002, 301-796-6927.
FDA recognizes that the IEC is a global organization that prepares and publishes international standards for electrical, electronic, and related technologies, including laser products. This means that manufacturers distributing products in the United States and other countries might have to ensure conformance of their products with IEC standards as well as comply with FDA regulatory requirements. Complying with FDA regulations and conforming to the identified IEC standards may cause manufacturers to duplicate their efforts.
FDA acknowledges the advantages of a universal set of device-specific criteria and requirements. Moreover, FDA believes that under the circumstances described in this guidance, conformance with certain IEC standards would provide adequate protection of the public health and safety for laser products similar to FDA's performance standards in §§ 1040.10 and 1040.11 (21 CFR 1040.10 and 1040.11). FDA eventually intends to amend its standards for laser products at §§ 1040.10 and 1040.11 to harmonize many of its requirements with those of the IEC because FDA acknowledges the advantages of one set of criteria and requirements worldwide. Until these requirements are harmonized, for laser product manufacturers that comply with the comparable clauses in IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1, FDA does not intend to enforce the comparable requirements in §§ 1040.10 and 1040.11.
On June 24, 2007, FDA's Center for Devices and Radiological Health (CDRH) published a guidance entitled “Laser Products—Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)” (
FDA considered comments received on the draft guidance that appeared in the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Laser Products—Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56).” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
This guidance refers to previously approved collections of information. 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 the following FDA regulations have been approved by OMB as listed in the following table:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by June 7, 2019.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
JonnaLynn Capezzuto, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St, North Bethesda, MD 20852, 301-796-3794,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Sponsors of approved or conditionally approved applications for new animal drugs containing an antimicrobial active ingredient are required by section 512 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360b) to submit to FDA an annual report on the amount of each such ingredient in the drug that is sold or distributed for use in food-producing animals. Sponsors are also required to maintain distribution records for their animal drug products, including separate information for each month of the calendar year, under section 512(l)(3) of the FD&C Act. These provisions were enacted to assist FDA in our continuing analysis of the interactions (including drug resistance), efficacy, and safety of antimicrobials approved for use in both humans and food-producing animals for the purpose of mitigating the public health risk associated with antimicrobial resistance.
Section 514.87 of our regulations (21 CFR 514.87) codifies the reporting requirements established in the FD&C Act. Sponsors submit antimicrobial animal drug sales and distribution reports to the Agency on Form FDA 3744. Each report must specify: (1) The amount of each antimicrobial active ingredient by container size, strength, and dosage form; (2) quantities distributed domestically and quantities exported; and (3) a listing of the target animals, indications, and production classes that are specified on the approved label of the product. The report must cover the period of the preceding calendar year and include separate information for each month of the calendar year. Each report must also provide a species-specific estimate of the percentage of each product that was sold or distributed domestically in the reporting year for use in cattle, swine, chickens, or turkeys for such species that appear on the approved label.
Collection of information on the amount of animal antimicrobials being distributed, including species-specific information, is necessary to support our ongoing efforts to encourage the judicious use of antimicrobials in food-producing animals to help ensure the continued availability of safe and effective antimicrobials for animals and humans. We intend to use these data to supplement existing information, including data collected under the National Animal Health Monitoring System and the National Antimicrobial Resistance Monitoring System programs. Data from multiple sources are needed to provide a comprehensive and science-based picture of antimicrobial drug use and resistance in animal agriculture.
In the
FDA estimates the burden of this collection of information as follows:
We base our estimate of the average burden per response on our recent experience with the existing antimicrobial animal drug distribution reports program. We base our estimate of the number of affected respondents reported in tables 1 and 2 and the average number of responses per respondent in table 1 on a review of our records of sponsors with active and inactive applications. We estimate that 20 sponsors will have active applications, and we assume that half of the respondents will report electronically, while the other half will report on paper. We estimate that 10 sponsors with active applications will spend 62 hours annually to assemble the necessary information, prepare, and submit an annual antimicrobial animal drug sales and distribution report on paper, and 10 sponsors with active applications will spend 52 hours annually to assemble the necessary information, prepare, and electronically submit an annual antimicrobial animal drug sales and distribution report. We estimate that seven sponsors will have inactive applications, and we assume that half of these respondents will report electronically, while the other half will report on paper. We estimate that sponsors with inactive applications will spend 2 hours to prepare their annual antimicrobial animal drug sales and distribution reports, whether electronically or on paper.
Animal drug manufacturers are already required to maintain distribution records for their animal drug products to comply with FDA's current good manufacturing regulations for periodic drug reports under § 514.80(b)(4)(i) (21 CFR 514.80(b)(4)(i)), approved under OMB control number 0910-0284. Section 512(l)(3) of the FD&C Act differs from § 514.80(b)(4)(i) in that it requires that records include separate information for each month of the calendar year. In addition, under 21 CFR 211.196 (approved under OMB control number 0910-0139), manufacturers currently are required to maintain distribution records that include dosage form and the date the drug is distributed. Based on these requirements, FDA believes that manufacturers already keep detailed records of the dates when antimicrobial drugs are distributed for marketing and recall purposes from which monthly reports can be prepared as part of usual and customary business practices. However, FDA estimates an additional recordkeeping burden of 54 hours for further compliance with section 512(l)(3) of the FD&C Act, as detailed in table 2.
Based on a review of the information collection since our last request for OMB approval, which was submitted with a final rule, we have made no adjustments to our burden estimates as reported in tables 1 and 2, other than to remove the one-time burden of 787 hours, which represented the time needed to review the provisions of the final rule and develop a compliance plan in the first year of compliance.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Classification and Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57).” This guidance describes FDA's policy with respect to certain LIPs that comply with International Electrotechnical Commission (IEC) standards during laser product classification under the Electronic Product Radiation Control provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to electronic products.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
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
• 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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
An electronic copy of the guidance document is available for download from the internet. See the
Patrick Hintz, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4228, Silver Spring, MD 20993-0002, 301-796-6927.
This guidance describes FDA's policy with respect to certain LIPs that comply with IEC standards during laser product classification under the Electronic Product Radiation Control provisions of the FD&C Act (Pub. L. 90-602, amended by Pub. L. 103-80) that apply to electronic products. For purposes of this guidance, the term “laser illuminated projector” refers to a type of demonstration laser product regulated under 21 CFR 1040.10(b)(13) that is designed to project a display image without the use of raster-scanned collimated laser beams. LIPs may be used in locations such as indoor or outdoor cinema theaters, laser shows, presentations at conventions, image/data projectors in office settings, or homes. Under 21 CFR 1040.10(c), FDA recognizes four major hazard classes (I to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb). Under this classification procedure higher laser classes correspond to more powerful lasers and a higher potential to pose serious danger if used improperly.
As demonstration laser products, LIPs and applications for LIPs cannot exceed class IIIa emission limits as specified in 21 CFR 1040.11(c) (which is comparable to IEC 60825-1 Ed. 3.0 Class 3R) unless granted a variance by FDA under 21 CFR 1010.4. Some LIPs and applications for LIPs will exceed the class IIIa limits and therefore require a variance to exceed those emission limits.
This guidance document describes FDA's intent to clarify the application of certain aspects of the performance standard requirements in 21 CFR 1040.11(c) for LIPs. Because the radiant emission levels produced by LIPs can be scientifically characterized by an alternative IEC standard, IEC 62471-5:Ed. 1.0, FDA does not intend to enforce the requirements under 21 CFR 1040.10(c)(1) and 21 CFR 1040.11(c) when LIP manufacturers conform to these standards under the situations outlined in sections III and IV of this guidance.
FDA considered comments received on the draft guidance that appeared in the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on classification and requirements for LIPs (Laser Notice No. 57). It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
This guidance refers to previously approved collections of information. 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
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Medical X-Ray Imaging Devices Conformance with IEC Standards.” This guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that is subject to the Federal Food, Drug and Cosmetic Act (FD&C Act) and FDA's regulations that apply to medical devices and electronic products.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
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
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
An electronic copy of the guidance document is available for download from the internet. See the
Robert Sauer, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5628, Silver Spring, MD 20993-0002, 301-796-3580.
This guidance describes FDA's policy regarding the regulation of medical x-ray imaging equipment that is subject to the FD&C Act and FDA's regulations that apply to medical devices and electronic products. In this guidance, FDA is seeking to harmonize performance standards prescribed pursuant to section 534 of Subchapter C (Electronic Product Radiation Control (EPRC)) of the FD&C Act (21 U.S.C. 360(kk)) with International Electrotechnical Commission (IEC) standards, where appropriate, to help to ensure streamlined regulatory review of submissions for these products. The guidance also provides recommendations to industry on how to comply with the applicable requirements. FDA has determined that industry conformance to certain IEC standards would provide, at a minimum, the same level of protection of the public health and safety from electronic radiation as certain EPRC regulatory standards. In addition, due to the recent publication of a proposed rule (84 FR 12147) on April 1, 2019, that would, if finalized, eliminate the reporting requirements for x-ray imaging devices, FDA determined that the proposed policy outlined in section 4 of the draft guidance, which stated that x-ray imaging devices that conform to IEC standards would be considered to have met the EPRC reporting requirements, should be removed from the guidance. This decision was made to avoid the confusion inherent in establishing an interim procedure that would shortly be superseded by the final rule. However, as stated in section V. of the guidance, FDA believes that submission of a declaration of conformity to the appropriate standards, and model identification as required by 21 CFR 1002.10(a) and (b), in a product report, would be sufficient to meet the requirements of a product report under 21 CFR 1002.10, thus reducing duplication.
FDA considered comments received on the draft guidance that appeared in the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Medical X-Ray Imaging Devices Conformance with IEC Standards.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
In the
This guidance refers to previously approved collections of information. 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 the following FDA regulations have been approved by OMB as listed in the following table:
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Policy Clarification for Certain Fluoroscopic Equipment Requirements.” This guidance document intends to clarify FDA's interpretation of certain aspects of the performance standard requirements in FDA's regulations for fluoroscopic equipment.
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
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.”
•
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
An electronic copy of the guidance document is available for download from the internet. See the
Donald Miller, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4318, Silver Spring, MD 20993-0002, 301-796-3299.
This guidance document intends to clarify FDA's interpretation of certain aspects of the performance standard requirements in §§ 1020.30 and 1020.32 (21 CFR 1020.30 and 1020.32) for fluoroscopic equipment. Specifically, it clarifies FDA's interpretation of fluoroscopic irradiation time (§ 1020.30(b)), the permissible duration of the activation of the x-ray tube in the fluoroscopic mode (§ 1020.32(c)), and on inclusion of an emergency fluoroscopy mode in fluoroscopes.
FDA considered comments received on the draft guidance that appeared in the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Policy Clarification for Certain Fluoroscopic Equipment Requirements.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
This guidance refers to previously approved collections of information. 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 the following FDA regulations have been approved by OMB as listed in the following table:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995 (PRA).
Fax written comments on the collection of information by June 7, 2019.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Section 1701(a)(4) of the Public Health Service Act (PHS Act) (42 U.S.C. 300u(a)(4)) authorizes FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA-regulated products in carrying out the provisions of the FD&C Act.
The mission of the Office of Prescription Drug Promotion (OPDP) is to protect the public health by helping to ensure that prescription drug information is truthful, balanced, and accurately communicated so that patients and healthcare providers can make informed decisions about treatment options. The OPDP's research program supports this mission by providing scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that we believe are most central to our mission, focusing in particular on three main topic areas: advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features, we assess how elements such as graphics, format, and disease and product characteristics impact the communication and understanding of prescription drug risks and benefits; focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience; and our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues. This study falls under the topic of advertising features (content and format).
Pursuant to section 506(c) of the FD&C Act (21 U.S.C. 356(c)) and 21 CFR part 314, subpart H (or 21 CFR part 601, subpart E for biological products), FDA may grant accelerated approval to a drug product under section 505(c) of the FD&C Act (21 U.S.C. 355(c)) or a biological product under section 351(a) of the PHS Act (42 U.S.C 262(a)). This pathway enables faster approval of prescription drugs intended to treat serious or life-threatening illnesses. Accelerated approval may be based on a determination that a drug product has an effect on a surrogate endpoint (for example, a blood test result) that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit (
The accelerated approval pathway is limited to certain products intended to treat serious or life-threatening illnesses as there can be “[u]ncertainty about whether clinical benefit will be verified and the possibility of undiscovered risks” (FDA 2014 guidance for industry entitled “Expedited Programs for Serious Conditions—Drugs and Biologics,” available at
Under FDA's regulations governing physician labeling for prescription drugs, the INDICATIONS AND USAGE section of the FDA-approved prescribing information (PI) for a drug approved under accelerated approval must include a succinct description of the limitations of usefulness of the drug and any uncertainty about anticipated clinical benefits, with reference to the clinical studies section for a discussion of the available evidence (21 CFR
• This indication is approved under accelerated approval based on [surrogate endpoint]. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial; or
• Approval is based on a reduction in [surrogate endpoint]. There are no controlled trials demonstrating a direct treatment benefit such as improvement in disease-related symptoms, functioning, or increased survival.
Despite its complexity, sponsors often use this language from the PI in direct-to-consumer (DTC) promotional materials for drugs approved under accelerated approval. In other cases, DTC promotion of accelerated approval products does not communicate the unique considerations and potential limitations inherent in the accelerated approval process.
Disclosures may be used to communicate information such as this to consumers. Disclosures can include information about scientific and clinical data, any residual uncertainty about clinical benefit, and the practical utility of scientific and clinical data. These disclosures may influence consumer comprehension and affect perception of drug risks and benefits. This study will examine the presence, wording, and prominence of a disclosure communicating information related to the drug's accelerated approval in DTC promotional materials. This information includes the use of surrogate or intermediate clinical endpoints to support approval, the uncertainty about the relationship of the surrogate or intermediate clinical endpoint to the predicted clinical benefit, and the need for confirmatory trials.
We plan to conduct one pretest not longer than 20 minutes, administered via internet panel, to test the experimental manipulations and pilot the main study procedures. After implementing any lessons learned from the pilot, we plan to conduct one main study not longer than 20 minutes, administered via internet panel. For the pretest and main study, we will randomly assign the participants to one of the test conditions (see table 1 for the study design). We have chosen to focus on oncology products because cancer is a life-threatening illness, and many oncology products are granted accelerated approval. Moreover, DTC promotion of oncology drugs is common. In the study, participants will view a website for a fictional oncology prescription drug. After viewing the website, participants will complete a questionnaire that assesses whether participants noticed the disclosure and their interpretation of it, as well as perceptions of the drug's risks and benefits. We will also measure covariates such as demographics and literacy. The questionnaire is available upon request from
We will vary the presence and prominence of the disclosure (
We will recruit a general population sample of adult volunteers 18 years of age or older. We will exclude individuals who work for the U.S. Department of Health and Human Services or work in the healthcare, marketing, advertising, or pharmaceutical industries. We will use health literacy quotas to ensure that our sample includes participants with a range of health literacy skills. With the sample sizes described below, we will have sufficient power to detect small-sized effects in the main study (table 2).
In the
(Comment 1) One comment suggested that the study does not evaluate the extent to which patients understand accelerated approval, “including the serious and life-threatening nature of the disease, the fact that FDA determined that the product is likely to provide a meaningful advantage over available therapy, the fact that the
(Response) We will begin the study by giving participants information about acute lymphoblastic leukemia, which includes its serious and life-threatening nature, to put the accelerated approval of the drug product in the appropriate context. Questions 3-9 assess participants' understanding of the accelerated approval concepts conveyed in the disclosure. The concepts in the disclosure align with the elements recommended by FDA to describe accelerated approval products and information currently seen in DTC promotion (Ref. 2). Questions 12, 13, and 18 are designed to measure participants' perceptions of the drug's risks.
(Comment 2) One comment suggested that the proposed disclosure language, “we currently do not know if Drug X helps people live longer or feel better” should be replaced with “we currently do not know if Drug X helps to minimize progression of disease and improve quality of life.” The comment noted that the proposed language may be simplistic and inaccurate because “feel better” is subjective and may be irrelevant for cancer treatments.
(Response) In many cases, the available data for accelerated approval products do provide information about disease progression, without providing information on overall survival (
(Comment 3) One comment stated that Q26 (Perspective Taking Scale) does not appear necessary.
(Response) We included the Perspective Taking Scale as a potential moderator. Participants will be drawn from the general public, and we will ask them to imagine that someone close to them was recently diagnosed with the relevant medical condition. Participants' ability to identify with a different perspective might affect how well they are able to do this. We will evaluate the usefulness of this measure in the pretest and drop it from the main study if it does not apply.
(Comment 4) One comment recommended studying another consumer-friendly disclosure in place of the physician labeling version of the disclosure. In addition, this comment recommended that the consumer-friendly disclosure not mention unknown outcomes (
(Response) We plan to study the physician labeling version of the disclosure because sponsors currently use this language to explain accelerated approval in DTC promotion (Ref. 2). We plan to include a statement about unknown outcomes in the disclosure because it is one of the elements recommended by FDA to describe accelerated approval products, and it is present in currently used accelerated approval disclosures (Ref. 2). We are in support of additional research that would study alternate consumer-friendly versions.
(Comment 5) One comment requested clarification on the execution of the prominence conditions, in particular regarding its proximity to the indication.
(Response) The disclosure will be presented in direct conjunction with the indication in both prominence conditions. In the high prominence condition, the disclosure will also be presented along with the largest claim.
(Comment 6) Three comments requested access to the study stimuli.
(Response) We have described the purpose of the study, the design, the population of interest, and have provided the questionnaire to numerous individuals upon request. We provided the disclosure language in the questionnaire. Our full stimuli are under development during the PRA process. We do not make draft stimuli public during this time because of concerns that this may contaminate our participant pool and compromise the research.
(Comment 7) One comment requested that we clarify the primary measure of the study.
(Response) Our hypotheses are based on noticing the disclosure (Q20), understanding the disclosure (Q3-Q9), and perceptions (Q10-Q17).
(Comment 8) One comment asked why items Q20 and Q21 come after items Q7-Q19.
(Response) Items Q7-Q19 are designed to measure participants' reaction to the experimental condition to which they were assigned. Items Q20 and Q21 show the disclosure to all participants (regardless of experimental condition) and ask them to respond to it.
(Comment 9) One comment questioned the utility of Q19-B.
(Response) We agree with this concern and have deleted this item.
(Comment 10) One comment stated a concern that an accelerated approval disclosure could cause undue apprehension and deter people who might otherwise benefit from seeking treatment advice about accelerated approval products. Based on this concern, the comment suggested adding questions about whether participants would seek information regarding potential risks or discuss the accelerated approval status with a healthcare professional.
(Response) The current study is intended to gather data that will help us understand how accelerated approval disclosures may impact consumer perception of an accelerated approval drug product. In a content analysis of accelerated approval product websites, we found that 73 percent currently include some form of a disclosure already (Ref. 2). Therefore, it is important to study what effect these disclosures may have. We will measure participants' perceptions of the drug's benefits and risks. In addition, we have expanded our intention question to also measure intentions to suggest a loved one ask their doctor about the drug's risks, benefits, and FDA approval.
(Comment 11) One comment suggested that promotional materials are not the best venue for providing information about prescription drugs, given the role of healthcare professionals in discussing and prescribing treatments. Based on this, the comment suggested modifying the study to focus on prescriber-patient interactions rather than DTC promotion.
(Response) Consumers often wish to participate in shared decision-making with healthcare professionals when selecting prescription drugs and may request specific prescription drugs from their healthcare professionals based on promotions they have seen in the marketplace. Because information consumers receive through DTC prescription drug promotion can impact these requests, it is important to investigate how the information in prescription drug promotional pieces impacts consumer attention, understanding, and perceptions.
(Comment 12) One comment noted that, in real-world conditions, consumers do not choose an accelerated approval product in a vacuum. This comment requested that we provide participants with information on the limited availability and/or effectiveness of alternative treatments.
(Response) We acknowledge that accelerated approval products often constitute the only treatment option or one of a limited number of treatment options available to patients. We revised the questionnaire to include information for participants in this study about the treatment landscape for the disease.
(Comment 13) One comment recommends enrolling a diversity of participants across demographic categories and geographic locations. They suggest screening for pretest participants, individuals who have recently participated in prescription drug research, and individuals with prior use of oncology products or accelerated approval products.
(Response) Participants will be internet panel members. We will use soft quotas to ensure recruitment of a low health literacy population as well as a demographically diverse set of participants. Pretest participants will not be allowed to participate in the main study. We added questionnaire items asking participants whether they have been diagnosed with cancer, and if so whether they have ever taken prescription drugs, and specifically accelerated approval products, for cancer.
(Comment 14) One comment noted that participants may pay more attention to information presented in a study, including claims designed to be intentionally misleading, and asked what efforts we will take to avoid response bias.
(Response) The study design does not include intentionally misleading claims. Based on previous research with DTC prescription drug websites, we expect the median time spent on the study stimuli to be under a minute to 2 minutes (Ref. 3). In general, we attempt to minimize response bias by following best practices, such as keeping the survey length short and cognitive-testing and pretesting the questions to make sure they are clearly written.
(Comment 15) One comment requested that the screener and consent form be made available.
(Response) The screener and consent form are available as part of the information collection submission to the OMB.
(Comment 16) One comment noted that the wording of Q4 and Q9 could lead participants toward a specific response.
(Response) These questions are designed to measure whether participants processed the information in the disclosure. Thus, Q4 asks about the unknown outcome information from the disclosure, and Q9 asks about the continuing research information from the disclosure. Because these are not meant to be questions about perceptions, we have changed the wording of Q4 to clarify that we are asking about what the website said, rather than what they might think. We will evaluate these items in cognitive interview and pretesting.
(Comment 17) One comment recommended adding intermediate response values for Q10-Q17 and Q24-Q26.
(Response) We have added intermediate response values for these items, with the exception of Q26, the Perspective Taking Scale, to be consistent with its previous use.
FDA estimates the burden of this collection of information as follows:
The following references are on display with the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; these are not available electronically at
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “Utilizing Animal Studies to Evaluate Organ Preservation Devices.” The intent of this guidance is to provide recommendations regarding best practices for utilizing animal
The announcement of the guidance is published in the
You may submit either electronic or written comments on Agency guidances at any time as follows:
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.”
•
You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)).
An electronic copy of the guidance document is available for download from the internet. See the
Carolyn Neuland, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G226, Silver Spring, MD 20993-0002, 301-796-6523.
FDA is announcing the availability of the leapfrog guidance “Utilizing Animal Studies to Evaluate Organ Preservation Devices.” The intent of this guidance is to provide recommendations regarding best practices for utilizing animal studies for the evaluation of organ preservation devices, while considering both regulatory least burdensome principles and ethical principles in animal testing. This guidance provides clarity on premarket recommendations to develop animal transplant models for organ preservation technologies, which will streamline initiation of clinical studies. Optimizing animal and clinical study designs for premarket submissions will allow us to bring novel, safe, and effective organ preservation devices to the market faster to increase the availability of organs for transplant for patients awaiting transplants. FDA recognizes that best practices for conducting animal studies to evaluate organ preservation devices are evolving with the rapid advancements in such technologies. This guidance is not intended to be comprehensive or prescriptive.
This guidance is a leapfrog guidance; leapfrog guidances are intended to serve as a mechanism by which the Agency can share initial thoughts regarding the content of premarket submissions for emerging technologies and new clinical applications that are likely to be of public health importance very early in product development. This leapfrog guidance represents the Agency's initial thinking, and our recommendations may change as more information becomes available. The Agency strongly encourages manufacturers to submit a Pre-Submission to obtain more detailed feedback regarding their organ preservation device. For more information on Pre-Submissions, please see “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” at (
Early stakeholder feedback was sought to inform the development of this guidance through the Center for Devices and Radiological Health's (CDRH's) notice on the fiscal year 2016 proposed guidance development issued
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Utilizing Animal Studies to Evaluate Organ Preservation Devices.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. This guidance is not subject to Executive Order 12866.
Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the internet. A search capability for all CDRH guidance documents is available at
This guidance refers to previously approved collections of information. 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 the following FDA regulations and guidance and the Federal Food, Drug, and Cosmetic Act (FD&C Act) have been approved by OMB as listed in the following table:
Health Resources and Services Administration (HRSA), HHS.
Notice; correction.
The Advisory Council on Blood Stem Cell Transplantation (ACBSCT) meeting has been rescheduled due to unforeseen circumstances and will now be held on Tuesday, July 2, 2019, from 10:00 a.m.-4:00 p.m. Eastern Time. The meeting will be held by webinar and conference call. The webinar link, conference call-in number, agenda, and instructions for registration will be posted 15 business days before the meeting on the ACBSCT website at
Robert Walsh, Designated Federal Officer, at the Healthcare Systems Bureau, Division of Transplantation, HRSA, 5600 Fishers Lane, 8W60, Rockville, Maryland 20857; 301-443-6839; or
Pursuant to the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) announces the following advisory committee program.
NCVHS advises the HHS Secretary on health data, statistics, privacy, national health information policy, and is mandated to report to Congress on the implementation status of HIPAA. Since mid-2017, the Subcommittee on Standards has been focused on developing a “predictability roadmap” through collaboration with industry to identify and evaluate barriers to the efficient and timely update and
One recommendation was specific to certain entities and processes related to the maintenance, modification, and recommendations to the Secretary for updated and new standards or transactions. Regarding this process, NCVHS urged HHS “to re-evaluate the function and purpose of the Designated Standards Maintenance Organizations (DSMO).”
In the HIPAA Transaction and Code Sets final rule of August 2000 (65 FR 50312), the Secretary named the six DSMOs. After the publication of the final rule, the six organizations and the Secretary of HHS signed a Memorandum of Understanding (MOU) establishing a steering committee and formalizing the processes for reviewing updated or new standards in advance of a recommendation to NCVHS and the Secretary.
Between 2001 and 2004, the DSMO steering committee received more than 150 change requests. Today, the DSMO receives fewer than 10 change requests per year. The DSMO appears to have accomplished the purposes for which it was established.
To support future work the HHS Secretary may undertake regarding the NCVHS recommendation to re-evaluate the DSMO, the Subcommittee will conduct a facilitated visioning session with a group of industry stakeholders. The goal of this session is to develop a set of viable options for a next-generation DSMO.
Following the meeting, the Subcommittee plans to draft additional recommendations for the full Committee to consider for submission to the HHS Secretary. These recommendations will take into account the input received during the facilitated visioning session.
The times and topic for this meeting are subject to change. Participation in the visioning session will be by invitation in order to maximize effectiveness. Members of the public are welcome to submit comments and suggestions through August 20, 2019, to
Should you require reasonable accommodation, please contact the CDC Office of Equal Employment Opportunity on (770) 488-3210 as soon as possible.
Office of the Secretary, HHS.
Notice.
The Department of Health and Human Services (HHS) is updating a portion of one office, the Office of the Assistant Secretary for Financial Resources (ASFR), which is located within the Office of the Secretary (OS). ASFR is modifying its structure to streamline and improve operational functionality by replacing the Office of Grants and Acquisition Policy and Accountability (AMT) and establishing in its place the Office of Acquisitions (AMV), and the Office of Grants (AMU).
Jen Moughalian, Acting Assistant Secretary for Financial Resources, 200 Independence Ave. SW, Washington, DC 20201, (202) 690-6061. Part A, Office of the Secretary, Statement of Organization, Functions and Delegations of Authority for the Department of Health and Human Services (HHS) is being amended at Chapter AM, Office of Financial Resources, as last amended at 76 FR 69741-42, dated November 9, 2011, 74 FR 57679-82, dated November 9, 2009, and 74 FR 18238-39, dated April 21, 2009. This reorganization will eliminate the Office of Grants and Acquisition Policy and Accountability (AMT) within the Office of Financial Resources (ASFR) and establish the Office of Grants (AMU) and Office of Acquisitions (AMV). This reorganization will make the following changes under Chapter AM, Office of Financial Resources:
I. Under Section AM.10 Organization, delete in its entirety and replace with the following:
Section AM.10 Organization: The Office of Financial Resources is headed by the Assistant Secretary for Financial Resources (ASFR). The Assistant Secretary for Financial Resources is the Departmental Chief Financial Officer (CFO), Chief Acquisition Officer (CAO) and Performance Improvement Officer (PIO), and reports to the Secretary. The office consists of the following components:
Immediate Office of the Assistant Secretary (AM).
Office of Budget (AML).
Office of Finance (AMS).
Office of Grants (AMU).
Office of Acquisitions (AMV).
II. Under Chapter AM, “Office of the Assistant Secretary for Financial Resources,” delete Chapter AMT, “Office of Grants and Acquisition Policy and Accountability,” in its entirety and replace with the following:
The Office of Grants (OG) provides Department-wide leadership, guidance, and oversight to constituent organizations, and coordinates long and short-range planning for HHS' grants management policies, practices, systems and workforce. OG provides technical assistance to the Department's OPDIVs and STAFFDIVs, evaluates effectiveness of the grants programs and processes; develops pertinent HHS-wide regulatory guidance, policies, and performance standards; maintains and reports
OG is headed by a Deputy Assistant Secretary for Grants who reports to the Assistant Secretary for Financial Resources. The Deputy Assistant Secretary also serves as the Department's Senior Grants Management Official. OG consists of the following components: Immediate Office of Grants (AMU); Division of Policy Oversight and Evaluation (AMU1); Division of Systems (AMU2; Division of Workforce Development (AMU3).
1. Immediate Office of Grants (AMU). The Immediate Office of Grants consists of the Deputy Assistant Secretary and support staff who assist in the management and administration of the Office's functions, and facilitate and coordinate government wide initiatives and activities on behalf of the grant community.
2. Division of Grants Policy Oversight and Evaluation (AMU1). The Division of Policy Oversight and Evaluation (OGPOE) is headed by a Director. The Division formulates, oversees, and evaluates Department-wide implementation of grants policies governing the award and management of grants throughout HHS, in support of existing laws, regulations, and OMB Circulars. Additionally, OGPOE: (a) Develops and implements HHS grants management regulations and publishes new policies and modifications in the HHS Grants Policy Directives (GPDs), including all directives necessary to implement new intergovernmental and HHS policies; (b) Represents the Department and serves as its liaison in interagency grants policy and management activities; maintains working relationships with OMB, U.S. General Services Administration (GSA), GAO and other Federal agencies to coordinate and assist in the development of proposed legislation and policy.
3. Division of Systems (AMU2). The Division of Systems (DS) is headed by a Director. The organization consists of the following components:
a.
b. Grants Management Systems (AMU22). The Grants Management Systems Branch (GMSB) is headed by a Branch Chief. This Branch plans, directs and coordinates the activities of the Office of Grants with respect to Departmental implementation of all electronic grants initiatives, such as: TAGGS, Government-wide Grants Management Line of Business, as well as management of select Grants internet and Intranet sites. GMSB represents the Department or the Office of Grants on matters of electronic assistance administration policy in dealing with recipients, OMB, other Federal agencies, and the public in general and leads Departmental coordination of grants system activities in support of the Federal Financial Accountability and Transparency Act including system interfaces with USASpending.gov.
4. Division of Workforce Development (DWD) (AMU3). Division of Workforce Development (DWD) develops strategy and related training opportunities to enhance the career development of grants management professionals both within the Department and Government-wide so as to facilitate the hiring and retention of a well-qualified and fully certified workforce of grants management professionals. DWD provides training and advice to the grants workforce across the Department and creates a training curriculum and certification program for the grants management officials across the Department. Additionally, DWD provides performance assessment Department-wide to improve workforce performance and enhance development opportunities within the workforce.
The Office of Acquisitions (OA) provides leadership, guidance, and oversight to constituent organizations, and coordinates long and short-range planning for HHS' acquisition practices, systems and workforce. The OA provides technical assistance to the Department's OPDIVs and STAFFDIVs; evaluates effectiveness of the acquisition programs and processes; develops pertinent HHS-wide regulatory guidance, policies, and performance standards; maintains Departmental contract award information; and conducts special Departmental initiatives related to acquisition. It also serves as the focal point for coordinating ASFR's response to cross-cutting Freedom of Information Act (FOIA) requests, audits, and reports. The OA provides input for coordinated Department positions on proposed legislation and Government regulations specific to acquisition related matters. The OA also manages activities
OA is headed by a Deputy Assistant Secretary for Acquisitions who reports to the Assistant Secretary for Financial Resources. The Deputy Assistant Secretary also serves as the Department's Senior Procurement Executive. OA consists of the following components: Immediate Office of Acquisitions (AMV); Division Acquisition Systems, Governance, Integration & Modernization (AMV1); Division of Acquisition Policy, Governance, & Process Transformation (AMV2); the Division of Acquisition Performance & Program Management Office (AMV3); administratively supports the Office of Small and Disadvantaged Business Utilization (AMV4); and The Office of Recipient Integrity and Compliance (AMV5).
1. Immediate Office of Acquisitions (AMV). The Immediate Office of Acquisitions consists of the Deputy Assistant Secretary and support staff who assist in the management and administration of the Office's functions, and facilitate and coordinate OA-wide initiatives and activities on behalf of the acquisition community.
2. Division of Acquisition Systems, Governance, Integration & Modernization (AMV1). The Division of Acquisition Systems, Governance, and Integration & Modernization (DASGIM) is headed by a Director. DASGIM plans, directs and coordinates the activities of the Office of Acquisition with respect to Departmental implementation of all electronic acquisitions initiatives. Ensures systems comply with Federal policy as set by the Senior Procurement Executive, the DATA ACT, Buy Smarter and Accelerate. Provides oversight & maintenance & facilitation of Buy Smarter and Accelerate. Coordinates micro services development. DASGIM manages the Acquisition systems roadmap and facilitates and improves the acquisition system by: (a) Developing innovative processes and tools; (b) Acquiring, adopting, tailoring and sharing best practices.
3. Division of Acquisition Policy, Governance, & Process Transformation (AMV2). The Division of Acquisition Policy, Governance, & Process Transformation (DAPGPT) is headed by a Director. The Division provides leadership in the area of acquisition through policy development and implementation and workforce planning, development, and training. The Division is responsible for formulating Department-wide acquisition policies governing acquisition activities, publishing and maintaining the HHS Acquisition Regulation (HHSAR), participating in government-wide acquisition rule-making through the Civilian Agency Acquisition Council, providing advice and technical assistance on matters related to HHS acquisition programs, managing workforce development issues for the Department's acquisition workforce, managing the Departmental Contract Information System; and monitoring the adoption of acquisition policies by the Department's OPDIVs and Staff Divisions (STAFFDIVs) to ensure consistent policy interpretation.
4. Division of Acquisition Performance & Program Management Office (AMV3). The Division of Acquisition Performance & Program Management Office (DAPPMO) is headed by a Director and provides advice, oversight and support regarding operational acquisition and business practices and issues. This Division conducts procurement management reviews, promotes consistent and standardized business practices. DAPPMO works with the other division within OA to develop innovative processes and tools acquiring, adopting, tailoring and sharing best practices. Leads the Department's Strategic Sourcing Program and the acquisition aspects of the environmental program. DAPPMO provides expert consultation services; and manages the Department's Government Purchase Card Program. Enables and implements category management, and risk monitoring. Establishes program performance metrics. The Office serves as the Department's liaison relating to acquisition issues for OMB, Congress, GAO and the Office of the Inspector General (OIG) when requested and acts as the Ombudsman.
5. Office of Small & Disadvantaged Business Utilization (AMV4). The Office of Small & Disadvantaged Business Utilization (OSDBU) is headed by a Director who reports directly to the Deputy Secretary and is administratively supported by OA. The OSDBU fosters the use of small business as Federal contractors pursuant to Public Law 95-507 and has responsibility within the Department for policy, plans, and oversight to execute the functions under Sections 8 & 15 of the Small Business Act. The OSDBU provides leadership, policy, guidance and supervision, as well as coordinating short- and long-range strategic planning to assure that small business vendors have a fair opportunity to compete for and receive business with the Department. The Office also provides technical assistance to the Department's OPDIVs and STAFFDIVs; reviews and evaluates planned procurements to ensure that small businesses are given thorough consideration; evaluates effectiveness of the small business programs and processes; develops pertinent HHS-wide policies, guidance, and performance standards; maintains Departmental small business reports; and conducts special Departmental initiatives related to small and socioeconomic business concerns. The OSDBU manages the development and implementation of appropriate outreach programs aimed at heightening the awareness of the small business community to the contracting opportunities available within HHS. The OSDBU provides input for coordinated Department positions on proposed legislation and Government regulations on matters affecting cognizant small socioeconomic business programs. It also serves as the focal point for coordinating ASFR's response to cross-cutting Freedom of Information Act (FOIA) requests, audits, and activities related to small business related efforts and programs.
6. Office of Recipient Integrity and Compliance (AMV5). The Office of Recipient Integrity and Compliance (ORIC) provides leadership, guidance, and oversight of the Department suspension and disbarment program, and coordinates long and short-range planning for HHS' suspension and disbarment efforts. The ORIC provides technical assistance to the Department's OPDIVs and STAFFDIVs; evaluates effectiveness of the programs and processes; develops pertinent HHS-wide regulatory guidance, policies, and performance standards; maintains Departmental suspension and disbarment information; and conducts special Departmental initiatives related to recipient integrity. The ORIC processes suspension and debarment cases, issues agency protest decisions, and handles task order and metrication Ombudsmen complaints, justification and approval requests, sole source approvals, requests for waivers and organizational conflict of interest issues. The Division also handles a variety of special projects as assigned by Chief Acquisition Officer. The ORIC processes suspension and debarment cases and provides direct support to the Suspension and Debarment Official (SDO). The SDO reviews recommendations made by the ORIC, makes present responsibility
Delegations of Authority. All delegations and re-delegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further re-delegation, provided they are consistent with this reorganization.
Section 30.18 of the Department of Health and Human Services' claims collection regulations (45 CFR part 30) provides that the Secretary shall charge an annual rate of interest, which is determined and fixed by the Secretary of the Treasury after considering private consumer rates of interest on the date that the Department of Health and Human Services becomes entitled to recovery. The rate cannot be lower than the Department of Treasury's current value of funds rate or the applicable rate determined from the “Schedule of Certified Interest Rates with Range of Maturities” unless the Secretary waives interest in whole or part, or a different rate is prescribed by statute, contract, or repayment agreement. The Secretary of the Treasury may revise this rate quarterly. The Department of Health and Human Services publishes this rate in the
The current rate of 10
Office of the Assistant Secretary for Housing- Federal Housing Commissioner, HUD.
Corrected notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW, Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Josh Geyer, Office of Environment and Energy, Department of Housing and Urban Development, 451 7th Street SW, Washington, DC 20410; email
Copies of available documents submitted to OMB may be obtained from Ms. Pollard.
This notice informs the public that HUD is seeking approval from OMB for the information collection described in Section A.
• Form HUD-2530, Previous Participation Certification, is completed by the Intermediary. The Intermediary submits the form to HUD via
• SF-424 family of forms (SF-424A-D, as applicable), Application for Federal Assistance and Assurances, is completed by the Intermediary. The Intermediary submits this family of forms to HUD via
• Form HUD-2880, Applicant/Recipient Disclosure/Update Report, is completed by the Intermediary. The Intermediary submits the from to HUD via the
• Form HUD 424-CBW (excel spreadsheet), Detailed Budget Worksheet, is completed by the Intermediary. The Intermediary submits this form to HUD via email or US mail for approval. The type of information collected includes a detailed description of budget as it pertains to each participating property. The Intermediary submits this form to HUD in program phases for completion of the retrofits in all participating properties in the PFS program.
• Form HUD-9250, Funds Authorization, is completed by the Owner. The Owner submits this form by email or by US mail to HUD for approval. The type of information collected includes Owner's name, address, mortgagee, etc. Owners are required to submit this form to HUD to request withdrawal from the Reserve for Replacements or Residual Receipts Funds.
• Certification of Owner Eligibility, Owner must complete this form to be eligible to participate in the Pay for Success pilot. Owner submits certification to HUD for approval via email or by US mail. The type of information collected includes Owner's name, iREMS number, address, signature, etc. Owners must provide a certification to HUD that they and the property meet HUD eligibility requirements in order to be able to participate in the Pilot.
• Cooperative Agreement is administered by HUD's Office of Multifamily Housing Programs, which will have oversight of the Intermediaries, ensuring compliance with all included provisions and authorizing payments when and if required conditions are met. The type of information collected includes Date agreement was entered with Intermediary, total of units HUD awarded intermediary, signature and HUD official. The form is submitted to HUD/Intermediary via email or by US mail.
• Site-Specific Environment Review (Part 1 of 2), this form should be used only to initiate site-specific reviews for individual HUD-assisted properties undertaking energy and water conservation retrofits under the Multifamily Energy and Water Conservation Pay for Success Pilot. Intermediary completes the form and any relevant documents for each site identified to participate in the PFS Pilot and submits it to HUD to upload in the HUD Environmental Review Online System (HEROS).
• Office of Multifamily Housing Pay for Success Program Narrative Template is completed by the Intermediary and is submitted to HUD via grants.gov. The type of information collected includes the Intermediary's name, EIN, organization name, etc. The narrative template is provided to Applicants under the Pay for Success Pilot program and will be evaluated by HUD.
HUD is authorized under this legislation to establish a competitive process for selecting one or more qualified applicants to serve as Intermediaries who will, per agreements with HUD, be responsible for initiating and managing an energy and water conservation retrofit program at eligible properties. For the purpose of this program, applicants are defined as entities applying to participate. The documents that are the subject of this notice are those used by applicants applying to participate in this program. This information will allow applicants to submit their proposal and for the government to evaluate this information.
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This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in Section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. Chapter 35.
Fish and Wildlife Service, Interior.
Notice of availability; reopening of the public comment period.
We, the U.S. Fish and Wildlife Service (Service), are announcing a new deadline for submittal of public comments on draft documents prepared in accordance with the National Environmental Policy Act (NEPA) and the Endangered Species Act (ESA). The Service received an application from the City of Tumwater Public Works Department for an incidental take permit pursuant to the ESA. The applicant has requested a permit that would authorize “take” of the threatened Olympia pocket gopher incidental to construction of safety and infrastructure improvements in Thurston County, Washington. The application includes a HCP that describes the actions the applicant will take to minimize and mitigate the impacts of the taking on the covered species. A
To ensure consideration, please submit written comments by May 23, 2019.
To request further information or submit written comments, please use one of the following methods:
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Tim Romanski, Conservation Planning and Hydropower Branch Manager, Washington Fish and Wildlife Office (see
We are announcing a new deadline for submittal of public comments on two draft documents prepared in accordance with the National Environmental Policy Act (NEPA; 42 U.S.C. 4321
We provide this notice in accordance with the requirements of section 10 of the ESA and NEPA and their implementing regulations (50 CFR 17.22 and 40 CFR 1506.6, respectively).
U.S. Geological Survey, Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Geological Survey (USGS) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before July 8, 2019.
Send your comments on this information collection request (ICR) by mail to U.S. Geological Survey, Information Collections Officer, 12201 Sunrise Valley Drive MS 159, Reston, VA 20192; or by email to
To request additional information about this ICR, contact Kristi Wallace 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.
We are soliciting comments on the proposed 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 USGS; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the USGS enhance the quality, utility, and clarity of the information to be collected; and (5) how might the USGS 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. We will include or summarize each comment in our request to OMB to approve this ICR. 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 USGS provides notifications and warnings to the public of volcanic activity in the US in order to reduce the loss of life, property, and economic and societal impacts. Ash fallout to the ground can pose significant disruption and damage to buildings, transportation, water and wastewater, power supply, communications equipment, agriculture, and primary production leading to potentially substantial societal impacts and costs, even at thicknesses of only a few millimeters or inches. Additionally, fine-grained ash, when ingested can cause health impacts to humans and animals. USGS will use reports entered in real time by respondents of ashfall in their local area to correct or refine ashfall forecasts as the ash cloud moves downwind. Retrospectively these reports will enable USGS to improve their ashfall models and further research into eruptive processes.
This project is a database module and web interface allowing the public and Alaska Volcano Observatory (AVO) staff to enter reports of ashfall in their local area in real time and retrospectively following an eruptive event. Users browsing the AVO website during eruptions will be directed towards a web form allowing them to fill in ashfall information and submit the information to AVO.
Compiled ashfall reports are available in real-time to AVO staff through the AVO internal website. A pre-formatted summary report or table that distills information received online will show ashfall reports in chronological order with key fields including (1) date and time of ashfall, (2) location, (3) positive or negative ashfall (4) name of observer, and (5) contact information is easily viewable internally on the report so that calls for clarification can be made by AVO staff quickly and Operations room staff can visualize ashfall information quickly.
Ashfall report data will also be displayed on a dynamic map interface and show positive (yes ash) and negative (no ash) ashfall reports by location. Ashfall reports (icons) will be publicly displayed for a period of 24 hours and shaded differently as they age so that the age of reports is obvious.
The ashfall report database will help AVO track eruption clouds and associated fallout downwind. These reports from the public will also give scientists a more complete record of the amount and duration and other conditions of ashfall. Getting first-hand accounts of ashfall will support model ashfall development and interpretation of satellite imagery. AVO scientists will—as time allows—be able to contact the individuals using their entered contact information for clarification and details. Knowing the locations from which ashfall reports have been filed will improve ashfall warning messages, AVO Volcanic Activity Notifications, and make fieldwork more efficient. AVO staff will be able to condense and summarize the various ashfall reports and forward that information on to emergency management agencies and the wider public. The online form will also free up resources during exceedingly busy times during an eruption, as most individuals currently phone AVO with their reports.
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
U.S. Geological Survey (USGS), Interior.
Notice of information collection; request for comment.
In accordance with the Paperwork Reduction Act of 1995, we, the U.S. Geological Survey (USGS) are proposing to renew an information collection.
Interested persons are invited to submit comments on or before July 8, 2019.
Send your comments on this information collection request (ICR) by mail to U.S. Geological Survey, Information Collections Officer, 12201 Sunrise Valley Drive MS 159, Reston, VA 20192; or by email to
To request additional information about this ICR, contact Joseph East, Eastern Energy Resources Science Center, U.S. Geological Survey 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.
We are soliciting comments on the proposed 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 USGS; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the USGS enhance the quality, utility, and clarity of the information to be collected; and (5) how might the USGS 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. We will include or summarize each comment in our request to OMB to approve this ICR. 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 USGS will issue a call for proposals to support researchers from State Geological Surveys and associated accredited universities that can provide geologic data to support NCRDS and other energy assessment projects being conducted by the USGS.
Data submitted to NCRDS by external cooperators constitute more than two-thirds of the USGS point-source stratigraphic database (USTRAT) on coal occurrence. This program is conducted under various authorities, including 30 U.S.C. 208-1, 42 U.S.C. 15801, and 43 U.S.C. 31
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.
The State of Oklahoma entered into a compact amendment with the Shawnee Tribe governing certain forms of class III gaming; this notice announces the approval of the Non-House-Banked Table Games Supplement to the compact between the Shawnee Tribe and the State of Oklahoma.
The compact amendment takes effect on May 8, 2019.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Office of the Deputy Assistant Secretary—Policy and Economic Development, Washington, DC 20240, (202) 219-4066.
Under section 11 of the Indian Gaming Regulatory Act (IGRA) Public Law 100-497, 25 U.S.C. 2701
Office of Natural Resources Revenue, Interior.
Notice.
Final regulations for valuing gas produced from Indian leases, published August 10, 1999, require the Office of Natural Resources Revenue (ONRR) to determine major portion prices and notify industry by publishing the prices in the
The due date to pay additional royalties based on the major portion prices is July 8, 2019.
Calculation of Prices Information: Robert Sudar, Manager, Market & Spatial Analytics, ONRR, at (303) 231-3511, or email to
On August 10, 1999, ONRR's predecessor, the Minerals Management Service, published a final rule titled “Amendments to Gas Valuation Regulations for Indian Leases” effective January 1, 2000 (64 FR 43506). The gas valuation regulations apply to all gas production from Indian (Tribal or allotted) oil and gas leases, except leases on the Osage Indian Reservation.
The regulations require ONRR to publish major portion prices for each designated area not associated with an index zone for each production month beginning January 2000, as well as the due date for additional royalty payments.
For information on how to report additional royalties due to major portion prices, please refer to our Dear Payor letter dated December 1, 1999, on the ONRR website at
Mineral Leasing Act of 1920, 30 U.S.C. 181
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 13) of the presiding administrative law judge (“ALJ”), granting complainant's motion for summary determination of violation of section 337 of the Tariff Act of 1930, by the defaulting respondents. The Commission is requesting written submissions on remedy, bonding, and the public interest.
Clint Gerdine, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 708-2310. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at
The Commission instituted this investigation on June 11, 2018, based on a complaint filed on behalf of Bear Archery, Inc. (“Bear Archery”) of Evansville, Indiana. 83 FR 27021-22 (June 11, 2018). The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain full-capture arrow rests and components thereof by reason of infringement of certain claims of U.S. Patent No. 6,978,775 (“the '775 patent”). The Commission's notice of investigation named as respondents 2BULBS Technology Co. Ltd. of Jiangsu, China; Ningbo Linkboy Outdoor Sports Co., Ltd. of Zhejiang, China; Shenzhen Keepmyway Tech. Co., Ltd., Wenqing Zhang, Tingting Ye, and Tao Li, all of Guangdong, China; Zhengzhou IRQ Outdoor Sports Co., Ltd. of Henan, China; and Sean Yuan of Shandong, China. The Office of Unfair Import Investigations (“OUII”) is also a party to the investigation. All respondents in the investigation have been found in default.
On October 26, 2018, Bear Archery moved for summary determination of violation of section 337 by the defaulting respondents and requested a general exclusion order (“GEO”). On November 21, OUII filed a response supporting the motion.
The ALJ issued the subject ID on March 19, 2019, granting the motion for summary determination and finding a violation of section 337 for the '775 patent. Specifically, the ALJ found that Bear Archery established infringement of claims 1-2 and 32 of the '775 patent with respect to each defaulting respondent's accused product by substantial, reliable, and probative evidence. The ALJ recommended that the Commission issue a GEO if it finds a violation of section 337. No party petitioned for review of the subject ID.
Having examined the record of this investigation, the Commission has determined not to review the subject ID.
As noted above, all eight respondents were found in default. Section 337(g) and Commission Rule 210.16(c) authorize the Commission to issue relief against respondents found in default unless, after considering the public interest, it finds that such relief should not issue. Before the ALJ, Bear Archery sought a GEO under section 337(g)(2).
In connection with the final disposition of this investigation, the Commission may issue an order that could result in the exclusion of the subject articles from entry into the United States. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for
If the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors the Commission will consider include the effect that an exclusion order and/or cease and desist orders would have on (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.
If the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve or disapprove the Commission's action.
Complainant and OUII are also requested to submit proposed remedial orders for the Commission's consideration. Complainant is also requested to state the date that the patent expires, the HTSUS numbers under which the accused products are imported, and to supply the names of known importers of the products at issue in this investigation. The written submissions and proposed remedial orders must be filed no later than close of business on [two weeks from the date of this notice], 2019. Reply submissions must be filed no later than the close of business on [one week later], 2019. No further submissions on these issues will be permitted unless otherwise ordered by the Commission.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit eight true paper copies to the Office of the Secretary pursuant to Section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the investigation number (“Inv. No. 337-TA-1117”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment unless the information has already been granted such treatment during the proceedings. All such requests should be directed to the Secretary of the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in Part 210 of the Commission's Rules of Practice and Procedure, 19 CFR part 210.
By order of the Commission.
On the basis of the record
The Commission, pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)), instituted these reviews on January 2, 2018 (83 FR 142) and determined on April 9, 2018 that it would conduct full reviews (83 FR 17446, April 19, 2018). Notice of the scheduling of the Commission's reviews and of a public hearing to be held in connection therewith was given by posting copies of the notice in the Office of the Secretary, U.S. International Trade Commission, Washington, DC, and by publishing the notice in the
The Commission made these determinations pursuant to section 751(c) of the Act (19 U.S.C. 1675(c)). It
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the presiding administrative law judge (“ALJ”) has issued a Final Initial Determination on Violation of Section 337 and Recommended Determination on Remedy and Bond in the above-captioned investigation. The Commission is soliciting comments on public interest issues raised by the recommended relief should the Commission find a violation of section 337. This notice is soliciting public interest comments from the public only. Parties are to file public interest submissions pursuant to Commission rules.
Clint A. Gerdine, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 708-2310. Copies of non-confidential documents filed in connection with this investgation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW, Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at
Section 337 of the Tariff Act of 1930 provides that if the Commission finds a violation it shall exclude the articles concerned from the United States unless, after considering the effect of such exclusion upon the public health and welfare, competition conditions in the United States economy, the production of like or directly competitive articles in the United States consumers, it finds that such articles should not be excluded from entry. 19 U.S.C. 1337(d)(1).
The Commission is soliciting comments on public interest issues raised by the recommended relief. The ALJ recommended, should the Commission find a violation, that the Commission issue a limited exclusion order directed against certain electrical connectors, components thereof, and products containing the same imported, sold for importation, and/or sold after importation by respondents Robert Bosch GmbH of Baden-Wuertemberg, Germany; Bosch Automotive Products (Suzhou) Co., Ltd. of Jiangsu, China; Robert Bosch LLC of Broadview, Illinois; Robert Bosch, Sistemas Automatrices, S.A. de C.V. of Chihuahua, Mexico; Robert Bosch, Ltda. of Sao Paulo, Brazil; and Hon Hai Precision Industry Co., Ltd. and Foxconn Interconnect Technology, Ltd., both of New Tapei City, Taiwan.
The Commission is interested in further development of the record on the public interest in its investigations. Accordingly, parties are to file public interest submissions pursuant to 19 CFR 210.50(a)(4). In addition, members of the public are invited to file submissions of no more than five (5) pages, inclusive of attachments, concerning the public interest in light of the administrative law judge's Recommended Determination on Remedy and Bond issued in this investigation on April 12, 2019. Comments should address whether issuance of a remedial order in this investigation would affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the recommended order are used in the United States;
(ii) identify any public health, safety, or welfare concerns in the United States relating to the recommended orders;
(iii) indicate the extent to which like or directly competitive articles are produced in the United States or are otherwise available in the United States, with respect to the articles potentially subject to the recommended orders;
(iv) indicate whether Complainant, Complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to the recommended orders within a commercially reasonable time; and
(v) explain how the recommended order would impact consumers in the United States.
Written submissions must be filed by the close of business on Tuesday, May 21, 2019.
Persons filing written submissions must file the original document electronically on or before the deadline stated above and submit eight true paper copies to the Office of the Secretary pursuant to Commission Rule 210.4(f), CFR part 210.4(f). Submissions should refer to the investigation number (“Inv. No. 337-TA-1043”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment unless the information has already been granted such treatment during the proceedings. All such requests should be directed to the Secretary of the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under authority of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
Drug Enforcement Administration, Department of Justice.
30-Day notice.
The Department of Justice, Drug Enforcement Administration (DEA), is submitting the following information collection request to the Office of Management and Budget for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the
Comments are encouraged and will be accepted for 30 days until June 7, 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 Lynnette M. Wingert, Diversion Control Division, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812. Written comments and/or suggestions may also be sent to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503, or sent to OIRA_submission@omb.eop.gov.
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:
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DEA Form 251: CSOS DEA Registrant Certificate Application.
DEA Form 252: CSOS Principal Coordinator/Alternate Coordinator Certificate Application.
DEA Form 253: CSOS Power of Attorney Certificate Application.
DEA Form 254: CSOS Certificate Application Registrant List Addendum.
The Department of Justice component is the Drug Enforcement Administration, Diversion Control Division.
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If additional information is required, please 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, Suite 3E.405B, Washington, DC 20530.
National Archives and Records Administration (NARA).
Notice of availability of proposed records schedules; request for comments.
The National Archives and Records Administration (NARA) publishes notice of certain Federal agency requests for records disposition authority (records schedules). We publish notice in the
NARA must receive comments by June 24, 2019.
You may submit comments by either of the following methods. You must cite the control number, which appears on the records schedule in parentheses after the name of the agency that submitted the schedule.
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Records Management Operations by email at
We are publishing notice of records schedules in which agencies propose to dispose of records they no longer need to conduct agency business. We invite public comments on these records schedules, as required by 44 U.S.C. 3303a(a), and list the schedules at the end of this notice by agency and subdivision requesting disposition authority.
In addition, this notice lists the organizational unit(s) accumulating the records or states that the schedule has agency-wide applicability. It also provides the control number assigned to each schedule, which you will need if you submit comments on that schedule. We have uploaded the records schedules and accompanying appraisal memoranda to the
We will post comments, including any personal information and attachments, to the public docket unchanged. Because comments are public, you are responsible for ensuring that you do not include any confidential or other information that you or a third party may not wish to be publicly posted. If you want to submit a comment with confidential information or cannot otherwise use the
We will consider all comments submitted by the posted deadline and consult as needed with the Federal agency seeking the disposition authority. After considering comments, we will post on
We will post schedules on our website in the Records Control Schedule (RCS) Repository, at
Each year, Federal agencies create billions of records. To control this accumulation, agency records managers prepare schedules proposing retention periods for records and submit these schedules for NARA's approval. Once approved by NARA, records schedules provide mandatory instructions on what happens to records when no longer needed for current Government business. The records schedules authorize agencies to preserve records of continuing value in the National Archives or to destroy, after a specified period, records lacking continuing administrative, legal, research, or other value. Some schedules are comprehensive and cover all the records of an agency or one of its major subdivisions. Most schedules, however, cover records of only one office or program or a few series of records. Many of these update previously approved schedules, and some include records proposed as permanent.
Agencies may not destroy Federal records without the approval of the Archivist of the United States. The Archivist grants this approval only after thorough consideration of the records' administrative use by the agency of origin, the rights of the Government and of private people directly affected by the Government's activities, and whether or not the records have historical or other value. Public review and comment on these records schedules is part of the Archivist's consideration process.
1. Department of the Air Force, Agency-wide, Sexual Assault Prevention and Response Program (DAA-AFU-2018-0006).
2. Department of Agriculture, Agency-wide, Management Improvement Program Records (DAA-0016-2019-0003).
3. Department of Agriculture, Food and Nutrition Service, Supplemental Nutrition Assistance Program (SNAP) Waivers (DAA-0462-2019-0001).
4. Department of Agriculture, Food Safety and Inspection Service, Lab Decommissioning Records (DAA-0584-2019-0003).
5. Department of Agriculture, Forest Service, Interpretive Service (DAA-0095-2018-0042).
6. Department of Agriculture, Forest Service, Water Uses and Development (DAA-0095-2018-0056).
7. Department of Agriculture, Forest Service, Minerals and Geology Certification (DAA-0095-2018-0066).
8. Department of Agriculture, Forest Service, Invasive Species (DAA-0095-2018-0067).
9. Department of Agriculture, Forest Service, State Tribal and County and Local Agencies, Public and Private Organizations (DAA-0095-2018-0079).
10. Department of Agriculture, Forest Service, Appeals and Litigation (DAA-0095-2018-0080).
11. Department of Agriculture, Forest Service, Public Involvement Programs (DAA-0095-2018-0081).
12. Department of Agriculture, Forest Service, Library Administration (DAA-0095-2018-0083).
13. Department of Agriculture, Forest Service, Direct Programs (DAA-0095-2018-0087).
14. Department of Commerce, U.S. Patent and Trademark Office, Office of the Ombudsman Records (DAA-0241-2018-0005).
15. Department of Health and Human Services, Centers for Disease Control, Technology Transfer and Intellectual Property (DAA-0442-2018-0003).
16. Department of Health and Human Services, Food and Drug Administration, Polio Files (DAA-0088-2018-0007).
17. Department of Health and Human Services, National Institutes of Health, Animal Husbandry and Veterinary Services Records (DAA-0443-2018-0003).
18. Department of Health and Human Services, National Institutes of Health, Intramural Research Clinical Care Services Records (DAA-0443-2019-0001).
19. Department of Homeland Security, Bureau of Customs and Border Protection, Administrative and Management Records-General Enterprise Support (DAA-0568-2017-0012).
20. Department of Homeland Security, United States Citizenship and Immigration Services, I-862 Notice to Appear (DAA-0566-2019-0020).
21. Department of the Treasury, Internal Revenue Service, Competent Authority Arrangement Case Files (DAA-0058-2017-0015).
22. Department of the Treasury, Internal Revenue Service, Office of Professional Responsibility Disciplinary Files (DAA-0058-2019-0002).
23. Administrative Office of the United States Courts, Judicial Services Office, Legislative Files (DAA-0116-2019-0006).
24. Federal Motor Carrier Safety Administration, Agency-wide, Commercial Driver's License Drug and Alcohol Clearinghouse Database (DAA-0557-2019-0004).
25. Federal Retirement Thrift Investment Board, Office of Enterprise
26. Federal Retirement Thrift Investment Board, Office of External Affairs, External Affairs Records (DAA-0474-2017-0004).
27. Government Publishing Office, Agency-wide, Revisions to the Comprehensive Schedule (DAA-0149-2018-0001).
28. Surface Transportation Board, Office of Proceedings, Finance Dockets (DAA-0134-2013-0025).
1:00 p.m., Tuesday, May 21, 2019.
NTSB Conference Center, 429 L'Enfant Plaza SW, Washington, DC 20594.
The one item is open to the public.
Telephone: (202) 314-6100.
The press and public may enter the NTSB Conference Center one hour prior to the meeting for set up and seating.
Individuals requesting specific accommodations should contact Rochelle McCallister at (202) 314-6305 or by email at
The public may view the meeting via a live or archived webcast by accessing a link under “News & Events” on the NTSB home page at
Schedule updates, including weather-related cancellations, are also available at
Candi Bing at (202) 314-6403 or by email at
Terry Williams at (202) 314-6100 or by email at
Pension Benefit Guaranty Corporation.
Notice of request for OMB approval.
The Pension Benefit Guaranty Corporation (PBGC) is requesting that the Office of Management and Budget (OMB) approve, under the Paperwork Reduction Act, a collection of information necessary for PBGC to determine whether a plan is covered under title IV of the Employee Retirement Security Income Act of 1974. This notice informs the public of PBGC's request and solicits public comment on the collection.
Comments must be submitted by June 7, 2019.
Comments should be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Pension Benefit Guaranty Corporation, via electronic mail at
A copy of the request will be posted on PBGC's website at:
Melissa Rifkin (
PBGC insures defined benefit pension plans covered under title IV of the Employee Retirement Income Security Act of 1974 (ERISA). A plan is covered if it is described in section 4021(a) of ERISA and does not meet one of the exemptions from coverage listed in section 4021(b)(1)-(13). If a question arises about whether a plan is covered under title IV, PBGC may make a coverage determination.
The proposed form and instructions would be used by a plan sponsor or plan administrator to request a coverage determination and would be suitable for all types of requests. The proposed form would highlight the four plan types for which coverage determinations are most frequently requested: (1) Church plans as listed in section 4021(b)(3) of ERISA; (2) plans that are established and maintained exclusively for the benefit of plan sponsors' substantial owners as listed in section 4021(b)(9); (3) plans covering, since September 2, 1974, no more than 25 active participants that are
PBGC needs this information collection to determine whether a plan is covered or not covered under title IV. Information provided to PBGC would be confidential to the extent provided in the Freedom of Information Act and the Privacy Act.
On December 4, 2018, PBGC published in the
PBGC is requesting that OMB approve of the collection for three years. 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.
PBGC estimates that 425 forms would be submitted each year. PBGC estimates that each form would require approximately 20 hours to complete by a combination of plan office staff (50%) and outside professionals (attorneys and actuaries) (50%). PBGC estimates an annual hour burden of 4,250 hours (based on plan office time). The estimated dollar equivalent of this hour burden, based on an assumed hourly rate of $75 for administrative, clerical, and supervisory time is $318,750. PBGC estimates an annual cost burden of $1,487,500 (based on 4,250 professional hours assuming an average hourly rate of $350).
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposed rule change to list and trade under BZX Rule 14.11(d)(2)(K)(i) shares of the iPath S&P MLP ETN (the “Notes”) issued by Barclays Bank PLC (“Barclays” or the “Issuer”), which are currently listed on NYSE Arca, Inc. (“Arca”). The Exchange has designated this proposal as non-controversial and provided the Commission with the notice required by Rule 19b-4(f)(6)(iii) under the Act.
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 list and trade the Notes
Specifically, the Exchange submits this rule filing because the Index exceeds the concentration limitation for initial listing on the Exchange included in Rule 14.11(d)(2)(K)(i)(a)(2)(C) by less than 3%. The Notes will meet the continued listing standards applicable to Equity Index-Linked Securities under Rule 14.11(d)(2)(K)(i)(b)(1)(A)
As such, the Exchange is submitting this proposal in order to allow the Notes to list and trade on the Exchange pursuant to Rule 14.11(d)(2)(K)(i) in a manner identical to the way that the Notes are currently listed on Arca—pursuant to the generic listing standards applicable to Equity Index-Linked Securities with the obligation to comply with all continued listing obligations under that rule. In the event that the Index does not meet the requirements of Rule 14.11(d)(2)(K)(i)(b)(1)(B) upon rebalance or the Index or Notes fail to meet any other continued listing obligation under Rule 14.11(d), the Exchange will initiate delisting proceedings pursuant to Rule 14.12.
All statements and representations made in this filing regarding (a) the description of the Index, (b) limitations on Index or portfolio holdings or reference assets, (c) the dissemination and availability of the Index, and reference assets; or (d) the applicability of Exchange rules and surveillance procedures shall constitute continued listing requirements for listing the Notes on the Exchange. The issuer has represented to the Exchange that it will advise the Exchange of any failure by the Notes to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will surveil for compliance with the continued listing requirements.
The Index is designed to provide exposure to leading partnerships that trade on major U.S. exchanges and are classified in the GICS Energy Sector and GICS Gas Utilities Industry according to the Global Industry Classification Standard. It includes both MLPs and publicly traded limited liability companies which have a similar legal structure to MLPs and share the same tax benefits as MLPs. The Index is calculated, maintained and published by S&P Dow Jones Indices LLC. The composition of the Index is rebalanced annually after the market close of the third Friday of October.
To qualify for membership in the Index, a stock must satisfy the following criteria: (i) Be a publicly traded partnership with either a master limited partnership or a limited liability company structure; (ii) be listed on the NYSE (including NYSE Arca), the NYSE MKT, the NASDAQ Global Select Market, the NASDAQ Select Market or the NASDAQ Capital Market; and (iii) belong to the GICS Energy Sector (GICS Code 10) or Gas Utilities Industry (GICS Code 551020).
At each annual rebalancing, a company in the qualifying universe is added to the Index if it meets the following requirements: (i) Float-adjusted market capitalization of at least US $300 million as of the rebalancing reference date; and (ii) average daily value traded above US $2 million for the three months prior to the rebalancing reference date. No additions are made to the Index between rebalancing.
The Index methodology employs a modified market capitalization-weighting scheme, using the divisor methodology used in most S&P Dow Jones equity indices. At each annual rebalancing, no stock can have a weight of more than 15% in the Index and all stocks with a weight greater than 4.5%, based on float-adjusted market capitalization, are not allowed, as a group, to exceed 45% of the Index.
The website for the Notes,
With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Notes. The Exchange will halt trading in the Notes under the conditions specified in BZX Rule 11.18. Trading may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Notes inadvisable. These may include: (1) The extent to which trading is not occurring in the securities composing the Index; or (2) whether other unusual conditions or circumstances detrimental to the maintenance of a fair and orderly market are present.
The Exchange deems the Notes to be equity securities, thus rendering trading in the Notes subject to the Exchange's existing rules governing the trading of equity securities. The Exchange will allow trading in the Notes from 8:00 a.m. until 5:00 p.m. Eastern time and has the appropriate rules to facilitate transactions in the Notes during all trading sessions. As provided in BZX Rule 11.11(a), the minimum price variation for quoting and entry of orders in securities traded on the Exchange is
Prior to the commencement of listing on the Exchange, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Notes. Such Information Circular will include information related to: (a) The special risks of trading the Notes; (b) the Exchange Rules that will apply to the Notes, including Rule 3.7, which imposes suitability obligations on Exchange members with respect to recommending transactions in the Shares to customers; (c) information about the dissemination of the value of the Index; and (d) the risks involved in trading the Shares during the Pre-Opening
The Exchange believes that its surveillance procedures are adequate to properly monitor the trading of the Notes on the Exchange during all trading sessions and to deter and detect violations of Exchange rules and the applicable federal securities laws. Trading of the Notes through the Exchange will be subject to the Exchange's surveillance procedures for derivative products, including Linked Securities. The issuer has represented to the Exchange that it will advise the Exchange of any failure by the Notes to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Exchange Act, the Exchange will surveil for compliance with the continued listing requirements. If the Notes are not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures for the Notes under Exchange Rule 14.12. The Exchange or the Financial Industry Regulatory Authority (“FINRA”), on behalf of the Exchange, or both, will communicate as needed regarding trading in the Notes and the Index Constituents with other markets or other entities that are members of the Intermarket Surveillance Group (“ISG”) or with which the Exchange has in place a comprehensive surveillance sharing agreement, and may obtain trading information regarding trading in the Notes from such markets or entities.
The Exchange believes that the proposal is consistent with Section 6(b) of the Act
Further, the Exchange believes that its surveillance procedures are adequate to properly monitor the trading of the Notes on the Exchange during all trading sessions and to deter and detect violations of Exchange rules and the applicable federal securities laws. Trading of the Notes through the Exchange will be subject to the Exchange's surveillance procedures for derivative products, including Linked Securities. The issuer has represented to the Exchange that it will advise the Exchange of any failure by the Notes to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Exchange Act, the Exchange will surveil for compliance with the continued listing requirements. If the Notes are not in compliance with the continued listing requirements, the Exchange will commence delisting procedures for the Notes under Exchange Rule 14.12. FINRA conducts certain cross-market surveillances on behalf of the Exchange pursuant to a regulatory services agreement. The Exchange is responsible for FINRA's performance under the regulatory services agreement.
The Exchange or FINRA, on behalf of the Exchange, or both, will communicate as needed regarding trading in the Notes and the Index Constituents with other markets or other entities that are members of the ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement, and may obtain trading information regarding trading in the Notes from such markets or entities. The Exchange prohibits the distribution of material non-public information by its employees. The Index Provider is not a registered broker-dealer and is not affiliated with a broker-dealer. In the event that the Index Provider becomes a broker-dealer or becomes affiliated with a broker-dealer, the Index Provider will implement and maintain a fire wall with respect to its relevant personnel regarding access to information concerning the composition and/or changes to the Index. In addition, the Index Provider has implemented and will maintain procedures around the relevant personnel that are designed to prevent the use and dissemination of material, non-public information regarding the Index. The Index value, calculated and disseminated at least every 15-seconds, as well as the components of the Index and their percentage weighting, will be available from major market data vendors.
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest. In addition, a large amount of information is publicly available regarding the Notes, thereby promoting market transparency. Information regarding market price and
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 transfer of the listing of an exchange-traded product that will enhance competition among market participants, to the benefit of investors and the marketplace. As noted above, the Exchange has in place surveillance procedures relating to trading in the Notes and may obtain information via ISG from other exchanges that are members of ISG or with which the Exchange has entered into a comprehensive surveillance sharing agreement.
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 purpose of the Act. The Exchange notes that the proposed rule change, rather, will facilitate the transfer from Arca and listing of an additional exchange-traded product on the Exchange, which will enhance competition among listing venues, to the benefit of issuers, investors, and the marketplace more broadly.
The Exchange has neither solicited nor received written 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
A proposed rule change filed under Rule 19b-4(f)(6)
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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
FINRA is proposing to update the FINRA Manual to reflect FINRA's new subsidiary, FINRA CAT, LLC. Specifically, the proposed rule change would codify the delegation of specific responsibilities and functions to FINRA CAT, LLC under the Plan of Allocation and Delegation of Functions by FINRA (“Delegation Plan”); make conforming amendments to the Delegation Plan to reflect FINRA CAT, LLC; amend the By-Laws of FINRA Regulation, Inc. (“FINRA Regulation By-Laws”) to make relevant conforming amendments; and make conforming amendments to FINRA rules.
The text of the proposed rule change is available on FINRA's website at
In its filing with the Commission, FINRA 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. FINRA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
FINRA and the national securities exchanges (collectively, the “Participants”)
Unless otherwise specified, capitalized terms used in this rule filing are defined as set forth herein or in the CAT NMS Plan.
The Participants jointly own and operate CAT NMS, LLC, a company formed by the Participants to arrange for and oversee the creation, implementation, and maintenance of the consolidated audit trail (“CAT”) as required under Rule 613, and the CAT is a facility of each Participant.
The Plan requires the Participants to select a Plan Processor to perform the CAT processing functions required by SEC Rule 613 and as set forth in the Plan.
In addition to serving in its capacity as Plan Processor of the CAT, FINRA is required to fulfill its obligations as a Participant of the Plan. To that end, FINRA CAT, LLC will further FINRA's compliance with its regulatory obligations under SEC Rule 613 with respect to the creation, operation and maintenance of a central repository. FINRA will fulfill its obligations as a Participant of the Plan, including among others, enforcing FINRA rules requiring its members to comply with the CAT NMS Plan, through FINRA (and FINRA Regulation, Inc.) and not through FINRA CAT, LLC.
FINRA believes that significant resources are required in order to meet its obligations as Plan Processor of the CAT. For example, FINRA has dedicated staff and financial resources in connection with serving as the Plan Processor and believes that it will be required to continue to allot resources to the CAT in this capacity. In addition, certain functions of the Plan Processor require consultation with or are subject to approval by the CAT NMS Plan Operating Committee. FINRA created FINRA CAT, LLC as a subsidiary of FINRA in order to dedicate resources solely to carrying out its obligations as Plan Processor and to underscore that FINRA CAT, LLC, while part of the self-regulatory organization (“SRO”), is separate and distinct from the other FINRA entities.
FINRA notes that as a subsidiary of FINRA, FINRA CAT, LLC is part of the registered securities association. As such, for purposes of SEC Regulation Systems Compliance and Integrity (“Regulation SCI”), FINRA CAT, LLC is an SCI SRO and therefore an SCI entity.
To account for the new subsidiary and codify the delegation by FINRA of certain regulatory responsibilities and functions to it, FINRA is proposing to make conforming amendments to the Delegation Plan to include FINRA CAT, LLC in the Delegation Plan; amend FINRA Regulation By-Laws to make relevant conforming amendments; and make conforming amendments to FINRA rules.
FINRA is proposing to rename the Delegation Plan as the “Plan of Allocation and Delegation of Functions by FINRA to Subsidiaries.” FINRA also is proposing to make conforming amendments throughout the Delegation Plan to replace references to “FINRA Regulation” with references to “the Subsidiaries” or “Subsidiary” to indicate that both FINRA Regulation, Inc. and FINRA CAT, LLC are subsidiaries of FINRA. In addition, the proposed rule change would reference FINRA Regulation, Inc. and FINRA CAT, LLC individually and define them collectively as “the Subsidiaries.” Finally, FINRA is proposing to amend Section I.B of the Delegation Plan to include a reference to new Section III pertaining to FINRA CAT, LLC.
Section I of the Delegation Plan provides that FINRA shall have responsibility for the rules and regulations of the Association (defined in the FINRA Manual as FINRA and its Subsidiaries) and its operation and administration. Under Section I.B, the proposed rule change would include subsection 10 to provide that FINRA expressly retains authority and functions to resolve any disputes among the Subsidiaries. This subsection was included in the Delegation Plan prior to the merger of FINRA Dispute Regulation, Inc. into and with FINRA Regulation, Inc.,
FINRA is proposing to expressly provide in amended Section I.E of the Delegation Plan that, notwithstanding the delegation of authority to FINRA CAT, LLC, the staff, books, records, and premises of FINRA CAT, LLC are the staff, books, records, and premises of FINRA subject to oversight pursuant to the Act, and all officers, directors, employees, and agents of FINRA CAT, LLC are officers, directors, employees, and agents of FINRA for purposes of the Act, subject to applicable provisions of the CAT NMS Plan.
FINRA is proposing to amend the Delegation Plan to include Section III of the Delegation Plan to delegate responsibilities and functions to FINRA CAT, LLC. Specifically, FINRA is proposing to delegate to FINRA CAT, LLC the following responsibilities and functions: (1) To act as a Plan Processor under the CAT NMS Plan in accordance with SEC Rule 613 and the provisions
FINRA also proposes to provide that the responsibilities and functions delegated by FINRA to FINRA CAT, LLC in Section III include, but are not limited to, those specified above. FINRA notes that the specific responsibilities and functions of the Plan Processor are set forth in Section 6.1 of the CAT NMS Plan, many of which require consultation with or approval by the CAT NMS Plan Operating Committee. As such, FINRA is proposing to expressly provide that all action taken by FINRA CAT, LLC pursuant to authority delegated pursuant to the Delegation Plan shall be taken in accordance with the terms of the Plan and SEC Rule 613, and in consultation with the CAT NMS Plan Operating Committee, as applicable.
Finally, FINRA is proposing to include language providing that capitalized terms that are not defined in Section III shall have the meanings ascribed to them in the Plan.
FINRA is proposing to make conforming amendments to the FINRA Regulation By-Laws. Specifically, FINRA is proposing to amend the definition of “Delegation Plan” in section (i) of Article I to replace “FINRA Regulation” with “Subsidiaries” to account for the fact that pursuant to the proposed rule change, the Delegation Plan also would pertain to FINRA CAT, LLC. In addition, FINRA is proposing to include reference to FINRA CAT, LLC in the last sentence of Section 4.14(b) (Conflicts of Interest; Contracts and Transactions Involving Directors) to indicate that the provisions in that subsection shall not apply to contracts or transactions between FINRA Regulation, Inc. and FINRA CAT, LLC.
FINRA also is proposing to amend several FINRA rules to reflect FINRA CAT, LLC as a FINRA subsidiary. The proposed rule change would amend Rule 0160 (Definitions) to include FINRA CAT, LLC in the definition of FINRA. In addition, FINRA is proposing a conforming amendment to Rule 0170 (Delegation, Authority and Access) to replace references to “FINRA Regulation” with the “Subsidiaries.”
FINRA notes that the proposed rule change would not amend the Rule 6800 Series (Consolidated Audit Trail Compliance Rule), pursuant to which FINRA requires its members to comply with the provisions of the CAT NMS Plan. FINRA is not delegating any of its responsibilities or functions pertaining to the Rule 6800 Series to FINRA CAT, LLC.
FINRA has filed the proposed rule change for immediate effectiveness. The effective date will be the date of filing.
FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act,
FINRA believes that the proposed amendments to include its subsidiary, FINRA CAT, LLC, in the FINRA Manual would reflect and bring transparency to FINRA's corporate organizational structure, and, in the process, would make the organization more efficient. In addition, FINRA believes that delegating regulatory responsibilities and functions to FINRA CAT, LLC to meet its CAT-related obligations enables FINRA to efficiently direct resources to ensure that it properly carries out its contractual obligations in its capacity as Plan Processor and its regulatory obligations under SEC Rule 613.
FINRA notes that the proposed rule change would not affect public investors, the goals of the Plan or fees associated with the CAT. FINRA believes that the proposed rule change reflects its commitment to serve as Plan Processor of the CAT and to comply with the provisions of the Plan. Thus, FINRA believes that the creation of FINRA CAT, LLC and inclusion of FINRA CAT, LLC in the FINRA Manual would ensure that FINRA continues to protect investors and the public interest in an efficient manner.
FINRA does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. FINRA believes that the proposed amendments account for FINRA's subsidiary, FINRA CAT, LLC, and would align FINRA's corporate organizational structure with its organizational practice. The proposed rule change would allow FINRA to update its Manual to include FINRA CAT, LLC and make changes to its Manual to reflect the current corporate structure. Further, FINRA intends to allocate staff and financial resources directly to FINRA CAT, LLC to meet its obligations as Plan Processor. FINRA notes that the proposed rule change would not alter member and industry obligations related to the Plan, including regarding fees. FINRA believes that the proposed rule change demonstrates its commitment to fulfilling its contractual obligations in its capacity as Plan Processor and its regulatory obligations under SEC Rule 613.
Written comments were neither solicited nor received.
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.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to delete and relocate the Exchange's current Registration, Qualification and Continuing Education rules (“Exchange Registration Rules” and, generally, “Registration Rules”) under the 1200 Series (Rules 1210 through 1260), and incorporate by reference The Nasdaq Stock Market LLC's (“Nasdaq”) rules at General 4 (“Nasdaq Registration Rules”), into General 4 of the Exchange's rulebook's (“Rulebook”) shell structure.
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 recently amended, reorganized, and enhanced certain of its membership, registration, and qualification requirement rules partly in response to rule changes by the Financial Industry Regulatory Authority (“FINRA”), and also in order to conform the Exchange's rules more closely to those of its Affiliated Exchanges in the interest of uniformity and to facilitate compliance with membership, registration and qualification regulatory requirements by members of multiple Affiliated Exchanges including the Exchange.
The Exchange now proposes to delete the Exchange Registration Rules 1210, 1220, 1230, 1240, and 1250, currently under the 1200 Series; and incorporate by reference the Nasdaq Registration Rules at General 4 of Nasdaq's rulebook into General 4 of the Exchange's Rulebook. Relatedly, the Exchange will make necessary cross-reference updates throughout the Rulebook. Specifically, the Exchange will amend the cross-references in Exchange Rules 1, 3202, 9630, the Pricing Schedule at Options 7, Section 9, C and the Options Floor Trading Rules at Options 8, Sections 8 and 12.
The incorporation by reference of Nasdaq Registration Rules at General 4 into the Exchange's General 4 title and
The Exchange notes that as a condition of an exemption, which the Exchange will request and will need to be approved by the Commission pursuant to Section 36 of the Act,
The Exchange proposes that this rule change becomes operative at such time as it receives approval for an exemption from the Securities and Exchange Commission, pursuant to its authority under Section 36 of the Act and Rule 0-12
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
Incorporating by reference the Nasdaq Registration Rules at General 4 into the Exchange's General 4 title will provide an easy reference for Exchange members seeking to comply with registration and qualification requirements on multiple markets. As noted, the Exchange intends to file similar proposed rule changes for other Affiliated Exchanges so that Nasdaq General 4 is the source document for all Registration Rules. The Exchange notes that the current rule is not changing and that Exchange members will be required to continue to comply with the Nasdaq Registration Rules as though such rules are fully set forth in Exchange's Rulebook. The Exchange desires to conform its rules and locate those rules within the same location in each Rulebook to provide Exchange members the ability to quickly locate rules.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that this rule change does not impose an undue burden on competition because the Exchange is merely incorporating by reference the Nasdaq Registration Rules at General 4 into its own Rulebook. The Exchange Registration Rules are not being amended and therefore no member is impacted.
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)(iii) 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 shall institute proceedings to determine whether the proposed rule 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 (“Act”),
The proposed rule change will extend the onboarding fee waiver and introduce a fee rebate scheme for CDSClear Index Swaptions clearing activities to be effective upon filing with the Commission.
In its filing with the Commission, LCH SA 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. LCH SA has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
As specified in the table below, the current CDSClear Index Swaptions fee grid includes an onboarding fee and offers both General Members and Select Members a choice between the Introductory Tariff and the Unlimited Tariff.
The purpose of the proposed rule change is to:
(1) Extend the waiver period for the onboarding fee for both General Members and Select Members that register to the CDSClear Index Swaptions clearing service, and
(2) introduce a clearing fee rebate applicable to the Index Swaptions Unlimited Tariff for both General Members and Select Members.
As a reminder, under the Unlimited Tariff, Clearing Members pay a fixed amount annually that covers all clearing fees for their Index Swaptions House activity for the activity of all the Affiliates of their Clearing Member group.
In order to incentivize the Clearing Members to build liquidity in the CDSClear Index Swaptions clearing service, LCH SA has decided to make the following changes to its Index Swaptions fee grid:
(1) Extend the waiver period for the onboarding fee from 31 March 2019 to 20 December 2019 for both General Members and Select Members that register to the CDSClear Index Swaptions clearing service, and
(2) implement a fee rebate scheme, applicable to the Unlimited Tariff for both General Members and Select Members, in which discounts to the fixed fee will apply depending on the Index Swaptions notional cleared by each Clearing Member group as detailed hereinafter.
The fee rebate scheme will be valid for 2019 only and apply equally to all Clearing Members that register to the CDSClear Index Swaptions clearing service.
In order to determine the relevant discount rate to apply, LCH SA will consider the total Index Swaptions notional cleared in 2019 starting from the date on which the fee rebate is deemed effective in accordance with any relevant regulatory review and approval process.
Section 17A(b)(3)(D) of the Act requires that the rules of a clearing agency provide for the equitable allocation of reasonable dues, fees, and other charges.
LCH SA has determined that the proposed fees are reasonable and appropriate to offer and grow CDSClear Index Swaptions clearing services.
Regarding the CDClear Index Swaptions service, LCH SA has already rule filed with the SEC the relevant fee grid and believes that the proposed discounts for CDSClear Index Swaptions clearing activities have been set up at an appropriate level given the costs, expenses and revenues to be generated to LCH SA in providing such services.
All clearing members will have the same opportunity to equally benefit from the proposed incentive rebate according to the specified conditions.
LCH SA believes that proposing such clearing fees and rebate are consistent with the requirements of Section 17A of the Act
Section 17A(b)(3)(I) of the Act requires that the rules of a clearing agency not impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
As noted above, LCH SA believes that the fees amount and related discounts have been set up at an appropriate level given the costs and expenses to LCH SA in offering and maintaining the relevant CDSClear Index Swaptions clearing services.
Additionally, the fee waiver and rebate will apply equally to all CDSClear Clearing Members and their Affiliates.
Further, LCH SA does not believe that the proposed rule change would have a burden on competition because it does not adversely affect the ability of such Clearing Members or other market participants generally to engage in cleared transactions or to access clearing services as the clearing of Index Swaptions remains not mandatory.
Written comments relating to the proposed rule change have not been solicited or received. LCH SA will notify the Commission of any written comments received by LCH SA.
The foregoing proposed rule change has become effective upon filing pursuant to Section 19(b)(3)(A)
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 of request for public comment and submission to OMB of proposed collection of information.
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Submit comments directly to the Office of Management and Budget (OMB) up to June 7, 2019.
Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to Alice Kottmyer, who may be reached at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
The form created by this information collection (DS-4282) will be used to present complaints of discrimination under Title VI of the Civil Rights Act of 1964; or Sections 504 or 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794 and 794d).
The form can be downloaded from
Federal Transit Administration (FTA), DOT.
Notice.
This notice announces final environmental actions taken by the Federal Transit Administration (FTA) for projects in Spokane, Washington, and Portland and Gresham, Oregon. The purpose of this notice is to announce publicly the environmental decisions by FTA on the subject projects and to activate the limitation on any claims that may challenge these final environmental actions.
By this notice, FTA is advising the public of final agency actions subject to 23 U.S.C. 139(l). A claim seeking judicial review of FTA actions announced herein for the listed public transportation projects will be barred unless the claim is filed on or before October 7, 2019.
Nancy-Ellen Zusman, Assistant Chief Counsel, Office of Chief Counsel, (312) 353-2577 or Juliet Bochicchio, Environmental Protection Specialist, Office of Environmental Programs, (202) 366-9348. FTA is located at 1200 New Jersey Avenue SE, Washington, DC 20590. Office hours are from 9:00 a.m. to 5:00 p.m., Monday through Friday, except Federal holidays.
Notice is hereby given that FTA has taken final agency actions by issuing certain approvals for the public transportation projects listed below. The actions on the projects, as well as the laws under which such actions were taken, are described in the documentation issued in connection with the projects to comply with the National Environmental Policy Act (NEPA) and in other documents in the FTA environmental project file for the projects. Interested parties may contact either the project sponsor or the relevant FTA Regional Office for more information. Contact information for FTA's Regional Offices may be found at
This notice applies to all FTA decisions on the listed projects as of the
Federal Transit Administration (FTA), U.S. Department of Transportation (USDOT).
Notice of funding opportunity.
The Federal Transit Administration's (FTA) Integrated Mobility Innovation (IMI) Demonstration program's primary purpose is to fund projects that demonstrate innovative, effective approaches, practices, partnerships, and technologies to enhance public transportation effectiveness, increase efficiency, expand quality, promote safety, and improve the traveler's experience. This notice announces the availability of up to $15 million in Fiscal Year (FY) 2017 and FY 2018 FTA research funds in the form of cooperative agreements for eligible projects. FTA may award additional funds, if available.
This IMI Notice of Funding Opportunity (NOFO) brings together three distinct areas of inquiry: Mobility on Demand (MOD) Sandbox demonstrations; FTA's Strategic Transit Automation Research (STAR); and Mobility Payment Integration (MPI). These areas are integrated in this NOFO to allow applicants to comprehensively plan multiple areas of mobility research. FTA requests that all applicants identify the specific area(s) for which they are applying.
The Integrated Mobility Innovation Demonstration program will also leverage FTA's leadership of the Accessible Transportation Technologies Research Initiative (ATTRI) to ensure that all activities conducted under this NOFO advance the vision of a Complete Trip for All. The Complete Trip concept reflects the understanding that a person's travel comprises a chain of steps beginning with an often-spontaneous decision to make a trip, through to planning an itinerary, traversing the built environment and its transportation networks (with or without a vehicle); navigating streets, intersections, facilities, stations, and stops to their destination—safely, efficiently, and carefree. The Complete Trip is the realization that if any part of the trip-making chain is broken, the trip cannot be completed, and an opportunity is lost.
Applications must be submitted by 11:59 p.m. Eastern Time August 6, 2019 through
Please send any questions regarding this notice to Mr. Hendrik Opstelten, Program Manager, Office of Research, Demonstration and Innovation, (202) 366-8094, or
Each section of this notice contains information and instructions relevant to the application process for IMI Demonstration projects, and all applicants should read this notice in its entirety so that they have the information required to submit eligible and competitive applications.
FTA's Public Transportation Innovation program is authorized by Federal public transportation law at 49 U.S.C. 5312. Under this authority, FTA may make grants, or enter into contracts, cooperative agreements, and other agreements for research, development, demonstration, deployment, and evaluation projects of national significance to public transportation that the Secretary determines will improve public transportation. The Integrated Mobility Innovation (IMI) Demonstration program was developed under this authority.
The IMI Demonstration program and its constituent areas of inquiry advance the Secretary's strategic goal to lead the development and deployment of
The IMI Demonstration program's goals include:
• Exploring new business approaches and emerging technology solutions that support transformational mobility services;
• Enabling communities to adopt innovative mobility solutions that enhance transportation efficiency and effectiveness; and
• Facilitating the widespread deployment of proven mobility solutions that foster expanded personal mobility.
All applicants are expected to suggest performance measures in their applications to gauge the success of the proposed solutions within the above goals. Applicants are also required to note the data that will be provided to the Department to evaluate performance as well as provide an overview of how a public data access plan will be developed.
This NOFO announces the availability of $15 million in Fiscal Year (FY) 2017 and 2018 FTA research funds. The $15 million will fund solutions in one or more of the three areas: Mobility on Demand (MOD), Transit Automation, and Mobility Payment Integration. FTA may make multiple awards (
FTA's Mobility on Demand (MOD) initiative envisions improved mobility through a traveler-centric approach that leverages innovations in technologies, service methods, and business models. FTA's MOD Sandbox Demonstrations provide a venue for integrated MOD concepts and solutions—supported through local partnerships—demonstrated in real-world settings.
In support of the Mobility on Demand vision, the Sandbox Demonstration program seeks to:
• Advance the transit industry's adoption of MOD;
• Enhance the transit industry's ability to formulate and implement MOD practices, with existing transit service as the backbone of an integrated mobility ecosystem;
• Validate the technical and institutional feasibility of innovative MOD business models and document best practices emerging from the demonstrations;
• Measure the impacts of MOD on travelers and transportation systems; and
• Examine requirements, regulations, and policies supporting the adoption of MOD.
The 2016 MOD Sandbox program (
The state of practice for MOD has evolved since 2016. FTA is aware that a growing number of transit agencies and communities have partnered with private mobility providers to integrate new mobility options for transit users. Some agencies transformed their own operational and business practices to better meet passenger needs with new or enhanced services, such as new trip planning tools and applications; on-demand bus and microtransit operations; and other flexible service models.
The 2016 Sandbox projects are yielding valuable insights into how agencies can take advantage of new mobility options. These insights include the potential value for travelers, and some of the challenges or potential pitfalls in using these methods of service.
Some initial lessons learned include:
• Well-functioning first-mile/last-mile connections are essential to implementing effective MOD projects regardless of the MOD technology or business model demonstrated;
• Though MOD technologies and approaches can provide new and enhanced transportation options for all travelers and all communities, the benefits and impacts of new MOD service models may vary across different communities;
• Access to data and information on demonstration projects is essential to understanding the impacts of MOD, validating new MOD-focused metrics, and enabling transit agencies to make effective operational decisions. However, potential hurdles exist to accessing MOD pilot project data, including privacy concerns, the protection of proprietary business information, and data accuracy issues;
• Business models must be sustainable for all project partners, throughout the pilot and beyond; and
• The flexibility inherent in research authority allows project adjustments to respond to changing realities or changing business priorities, minimizing risk to project participants.
To build on these initial findings, and to continue to advance the state of the practice, the MOD Sandbox Demonstration component of this NOFO will focus on the three key areas below, while encouraging other innovative models and ideas that may not fall into any one category.
Key MOD Sandbox Demonstration Areas:
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New MOD Sandbox demonstration projects selected and funded from this NOFO will be subject to current regulations and policies, the applicability of which is explained by FTA's Shared Mobility Frequently Asked Questions document at
FTA developed the five-year Strategic Transit Automation Research (STAR) Plan (
The goal of STAR is to advance transit readiness for automation by:
• Conducting enabling research to achieve safe and effective transit automation deployments;
• Identifying and resolving barriers to deployment of transit automation;
• Leveraging technologies from other sectors to move transit automation forward;
• Demonstrating market-ready technologies in real-world settings; and
• Transferring knowledge to the transit stakeholder community.
This NOFO solicits specific automation projects noted in the STAR plan roadmap, including:
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All automation projects must address a range of factors related to transit, including:
• System performance, capabilities, limitations, and effectiveness;
• Transit operations and maintenance;
• Service quality;
• Safety and security, including cybersecurity;
• Passenger experience, comfort, acceptance, and willingness to use;
• Communication and equipment needs and costs;
• Overall cost-effectiveness; and
• Transferability.
Additional factors that should be included are noted for each of the specific demonstration areas.
In support of the STAR Plan's goal to demonstrate ADAS for Transit Buses (defined as a rubber-tired automotive vehicle used for the provision of public transportation service) projects are sought that will demonstrate use cases including, but not limited to:
• Smooth acceleration and deceleration;
• Automatic emergency braking and pedestrian collision avoidance;
• Curb avoidance;
• Object avoidance;
• Precision docking;
• Narrow lane/shoulder operations; and
• Platooning.
A project team may demonstrate one or more use cases. Applicants may also propose other ADAS use cases not identified above.
In addition to the factors related to automation demonstrations, generally, ADAS demonstrations must address:
• Human factors, including training drivers in ADAS operation, establishing understanding to avoid over-reliance on or under-utilization of ADAS, and evaluating the driver-vehicle interface; and
• Bus operator experience and acceptance.
FTA will fund one or more projects that demonstrate the integration of automated shuttles into a transit system (
Demonstrations will utilize nearly market-ready automated shuttles to support transit automation (SAE Level 4). Preference will be given to projects operating in revenue service. Existing automated shuttle projects in the United States and abroad have demonstrated basic functionality and user acceptance, so appropriate projects should seek to demonstrate operations in more complex operating environments (
Projects can include one or more automated shuttle use case including, but not limited to, circulator service and/or feeder service.
In addition to the factors related to automation demonstrations, generally, automated shuttle demonstrations must address:
• Human factors, including communicating shuttle intent and human-machine interface;
• Accessibility for people with disabilities, at a level which complies with the Americans with Disabilities Act, and beyond, ensuring contribution to an accessible Complete Trip;
• On-board attendant experience and acceptance; and
• Perceptions and acceptance by other road users, such as bicyclists and pedestrians.
Applicants should also provide information showing that any automated shuttles comply with the National Highway Safety Administration's (NHTSA) Federal Motor Vehicle Safety Standards (FMVSS) or are operating consistent with an exemption from those standards issued by NHTSA. If, conversely, an applicant wishes to use a vehicle that is not compliant and does not have an applicable exemption, the applicant should provide information concerning its plan to apply for the necessary exemption.
In addition, FTA may also select the Automated Shuttles Demonstration project for “twinning,” which is an ongoing knowledge exchange, with a relevant European Commission-funded automated road transport research project.
The Mobility Payment Integration (MPI) research area was developed from FTA's recognition of the emergence and rapid evolution of the mobility payment marketplace, its importance in managing and integrating mobility, and ultimately, its overall influence on mobility outcomes. Integrating payment for different types of transportation services in a region can facilitate seamless travel across a variety of modes, including public transportation, transportation network companies, car and bike sharing services, micro-transit providers, and even private vehicles. Payment integration will enable the full use and coordination of public-sector and private-sector mobility resources to expand mobility options in communities across America. In keeping with FTA's commitment to equity and accessibility, payment integration solutions funded under this NOFO will address universal usability by all people, including those with disabilities as well as those who are under-banked or unbanked.
Convenient, useful payment systems are a key provision of FTA's Mobility Innovation goals. To advance the state of the practice in this area, FTA seeks to assess the feasibility of different payment integration technologies and strategies through the MPI demonstrations. Key areas to explore will include back-office operational models (including financial and accounting systems), institutional collaboration and experience, user experience, and interoperability and sustainability of such systems. Furthermore, MPI is also structured to explore the feasibility and impact of integrating payment services beyond the traditional mobility ecosystem, such as retail, banking, and health care industries.
This NOFO solicits demonstration projects in MPI with a focus on two topical areas:
An informal assessment of data suggests that between 10 and 50% of transit riders use cash as their primary method of payment, to include on-vehicle payment and at transit ticket vending machines. Reasons for cash only payments range from personal preference to lack of access to non-cash payment products or services. In addition, some American households do not have relationships with traditional financial institutions (
a. Unbanked and underbanked populations;
b. Populations without access to mobile devices and/or mobile data access; and
c. Human service transportation users.
Projects selected under this MPI focus area will plan, develop, demonstrate, evaluate, and refine solutions to ensure equitable access to transit and mobility systems by: Unbanked or underbanked populations; the technology disadvantaged; and vulnerable groups (low-income, minority, older adults, students and young travelers, and people with disabilities). Furthermore, projects should seek to validate payment integration's ability to enhance the experience of travelers from the targeted groups, thus enabling them to more effectively use the mobility system to connect them with more economic, healthcare, educational, social, and recreational opportunities. This demonstration aims to uncover and showcase how public transportation agencies and mobility providers can ensure equity and accessibility when deploying integrated payment solutions.
Multi-modal and multi-provider payment integration requires enabling technologies and institutional partnerships. Demonstration(s) in this topical area will focus on operationalizing an integrated single payment account across multiple public and private mobility services (
• Transportation adjacencies (
• Specialized and demand-response transportation (
• Multiple non-transit/non-mobility services (
• Social programs (
• Access and authorization (
Applicants wishing to pursue an integrated mobility demonstration should address practical and sustainable partnership models among multiple agencies and providers. Applicants will investigate effective system-wide mobility and business or technology partnerships. These partnerships should be supported by scalable and sustainable back-office procedures and operations. Institutional collaboration should address harmonization of business rules and fare policies, as well as collaborative incentivization strategies.
Due to the anticipated complexity of structuring and developing a multi-agency, multi-modal, multi-provider system, FTA recognizes that most applicants will plan and implement their respective mobility payment integration projects in phases beyond the scope of this demonstration. Phases can be structured to capture different aspects such as incremental expansion of service areas or regions, layering of different service providers (transportation, mobility, retail, government, etc.) over a period, expansion of interregional operations, or geography-agnostic interoperability, etc. This incremental approach can leverage lessons learned in each phase to refine and optimize subsequent strategies.
FTA requires that all applicants describe their vision and phased planning and implementation plan toward an integrated mobility payment system, and clearly indicate which phase(s) the requested funding will address.
This notice makes available $15 million under the Public Transportation Innovation program (49 U.S.C. 5312(b)), which FTA intends to award in the form of cooperative agreements, to support the research, development, demonstration, deployment, and evaluation of research and technology of national significance to public transportation that the Secretary determines will improve public transportation.
There is no minimum or maximum award amount. Rather, project scale will be bounded by each project's ability to complete all proposed planning and development activities and launch the demonstration within 12 months of project award. FTA intends to fund as many meritorious projects as possible. Only proposals from eligible recipients for eligible activities will be considered for funding. Due to funding limitations, applications that are selected for funding may receive less than the amount originally requested. In those cases, applicants must be able to demonstrate that the proposed projects are still viable and can be completed with the amount awarded.
Projects funded through this NOFO will be structured as cooperative agreements in which the federal government will have substantial involvement. The federal role will include active participation in the project activities by attending review meetings, commenting on technical reports, and maintaining frequent contact with the local project manager. FTA reserves the right to re-direct project activities and funding for projects supported under this NOFO and their related activities.
Recipients of funding under the 2016 Mobility on Demand Sandbox demonstration program may apply for funding to support additional projects or enhancements to previously developed activities. To be competitive, the applicant should demonstrate the extent to which the newly proposed project is indeed a new effort, and not a continuation of a prior project.
Projects funded under the IMI Demonstration program will be allowed a maximum of 12 months for project planning. A minimum of 12 months of demonstration activity is required.
The IMI Demonstration program is a research and development effort and, as such, FTA Research Circular 6100.1E (available at
To be selected for the IMI Demonstration program, an applicant must be an
• Private for-profit and not-for-profit organizations, including shared-use mobility providers, technology system suppliers and integrators, automated vehicle technology providers, property managers and developers, and others;
• private operators of transportation services, such as employee shuttle services, airport connector services, university transportation systems, or parking and tolling authorities;
• bus manufacturers;
• state or local government entities, including multi-jurisdictional partnerships, and organizations such as a Metropolitan Planning Organization; or
• other organizations including consultants, research consortia or not-for-profit industry organizations, and institutions of higher education.
The project team should include all project partners necessary to successfully carry out the prospective project, and structured to efficiently leverage Federal funds.
The applicant must be able to carry out the proposed agreement and procurements, if needed, with project partners in compliance with all applicable Federal, state, and local laws.
Eligible activities include all activities leading to the demonstration, such as planning and developing business models, obtaining equipment and service, acquiring or developing software and hardware interfaces to
FTA continues to seek bold and innovative ideas to advance the vision of MOD: Complete trips for all travelers using emerging technologies, applications, practices, and service models in concert with existing public transportation systems and resources.
Where applicable, eligible projects should consider how to address accessibility for persons with disabilities, including persons who use wheelchairs, and for older riders, affordability for individuals with lower incomes, impacts on the local community, broad access to mobility options for all travelers, as well as payment options that can accommodate all users, including the unbanked and underbanked. Planning activities should ensure that all stakeholders are involved, including people with disabilities. Eligible demonstrations will consist of a minimum 12-month field test and must be implemented and operational within 12 months of project award.
It should be noted that the program description section of this NOFO contains additional eligibility information with respect to the transit automation programmatic area. All applicants should closely review the Program Description section of this NOFO.
The Federal share of project costs under this program is limited to 80 percent. Applicants may seek a lower Federal contribution. The applicant must provide the local share of the net project cost in cash, or in-kind, and must document in its application the source of the local match. Eligible sources of local match are detailed in FTA Research Circular 6100.1E. (available at
Applications must be submitted electronically through
The application must include the Standard Form 424 (Application for Federal Assistance), cover page, and the Project Narrative, with the Applicant and a Proposal Profile supplemental form attached. The application must include responses to all sections of the SF-424 mandatory form and the supplemental form unless a section is designated as optional. FTA will use the information on the supplemental form to determine applicant and project eligibility for the program and to evaluate the proposal against the selection criteria described in part E of this notice. FTA will accept only one supplemental form per SF-424 submission. FTA encourages applicants to consider submitting a single supplemental form that includes multiple activities to be evaluated as a consolidated proposal. If an applicant chooses to submit separate proposals for individual consideration by FTA, it must submit each proposal with a separate SF-424 and supplemental form.
An applicant may attach additional supporting information to the SF-424 submission and supplemental form submission, including but not limited to letters of support, project budgets, fleet status reports, or excerpts from relevant planning documents. Supporting documentation must be described and referenced by file name in the appropriate response section of the supplemental form, or it may not be reviewed.
Information such as applicant name, Federal amount requested, local match amount, description of areas served, etc., may be requested in varying degrees of detail on both the SF-424 form and supplemental form. An applicant must fill in all fields unless stated otherwise on the forms. If copying information into the supplemental form from another source, the applicant should verify that the supplemental form has fully captured pasted text and that it has not truncated the text due to character limits built into the form. An applicant should use both the “Check Package for Errors” and the “Validate Form” validation buttons on both forms to check all required fields on the forms. An applicant should also ensure that the Federal and local amounts specified are consistent throughout the application.
The SF-424 Mandatory Form and the supplemental form will prompt applicants for the required information, including:
a. Applicant name.
b. Dun and Bradstreet (D&B) Data Universal Numbering System (DUNS) number.
c. Key contact information (including contact name, address, email address, and phone).
d. Congressional districts where the project will be carried out.
e. A description of the technical, legal, and financial capacity of the applicant.
f. A discussion of the overall goals of the proposed project, with proposed performance measures including the current state of mobility innovation in the community or service area of the proposed project, current challenges in providing robust, flexible, and accessible transportation options, integration challenges or gaps, and how the proposed project will address those needs. The discussion should include demographics for the areas expected to be served, a description of the current opportunities and need to improve mobility choices for all, and if applicable, recent local and/or national trends or developments that make this proposed project particularly timely. Additionally, all proposals should describe the extent to which the project builds, if applicable, on past research, innovation, or development efforts, and how this project will further advance innovative practices.
g. A description of the project partners, both technical and institutional, their roles, and their anticipated contributions. Indicate which of the project partners are “key partners” essential to the success of the proposed project. Additionally, the project team is encouraged to provide letters of commitment or support from each of the project partners as well as any agreements among the project partners. Describe the business model, service model, or approach that will be used to implement the demonstration project and any public-private partnerships formed to achieve the project objectives. Specify any unique or innovative approaches used to
h. A discussion of the expected outcomes and benefits of the proposed project to the individual travelers and the community; and how the goals and outcomes will be measured.
i. A description of the extent to which the proposed project is replicable in other communities, and the national significance of the project, if any.
j. A description of how, and the extent to which, the proposed project addresses accessible and equitable mobility service for all travelers, including persons with disabilities, older individuals, school age populations, and individuals with lower incomes or in underserved communities.
k. A description of any Federal, state, or local requirements or policies that the project team expects to present challenges to successfully implementing the proposed project.
l. A preliminary data management plan (DMP) which details the types of data that will be generated, and how the project team will provide access for FTA or its designee to this project-related data for purposes of evaluation, and a subset to the public.
m. A detailed description and supporting evidence (
n. A timeline of project implementation detailing all significant milestones and the roles of the responsible project partners. The timeline should include elements such as when the project will start, when it will be fully operational, and the length of time for anticipated data collection activities.
o. Financials and Budget
• Identify funding requirements for the proposed project, noting the specific sources and uses for the funds proposed, with enough detail to indicate the various key components of the project.
• Document the matching funds, including amount and source of the match (may include local or private sector financial participation in the project), or documents supporting the commitment of non-Federal funding to the project, or a timeframe upon which those commitments would be made.
Applicants may attach to the supplemental form supporting materials and documentation as appropriate. Applicants are encouraged to clearly reference all attachments in the Applicant and Proposal supplemental form. Suggested attachments include graphics, maps, letters of support, and other documents to support the proposal.
Each applicant is required to: (i) Be registered in SAM before submitting its application; (ii) provide a valid DUNS number in its application; and (iii) continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application under consideration by FTA. FTA may not make a grant award to an applicant until the applicant has complied with all applicable DUNS and SAM requirements. FTA will review an applicant's SAM registration status to make responsibility determination.
These requirements do not apply if the applicant: (1) Is an individual; (2) is excepted from the requirements under 2 CFR 25.110(b) or (c); or (3) has an exception approved by FTA under 2 CFR 25.110(d). FTA may not make an award until the applicant has complied with all applicable unique entity identifier and SAM requirements. If an applicant has not fully complied with the requirements by the time FTA is ready to make an award, FTA may determine that the applicant is not qualified to receive an award and use that determination as a basis for making a Federal award to another applicant. All applicants must provide a unique entity identifier provided by SAM. Registration in SAM may take as little as 3-5 business days, but there can be unexpected steps or delays. For example, the applicant may need to obtain an Employer Identification Number. FTA recommends allowing ample time, up to several weeks, to complete all steps. For additional information on obtaining a unique entity identifier, please visit
Project proposals must be submitted electronically through
FTA urges applicants to submit applications at least 72 hours prior to the due date to allow time to correct any problems that may have caused either
Applicants are encouraged to begin the process of registration on the
The regulations effectuating Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities apply to this NOFO.
Funds under this NOFO cannot be used to reimburse projects for otherwise eligible expenses incurred prior to FTA award of a Cooperative Agreement unless FTA has issued a “Letter of No Prejudice” for the project before the expenses are incurred.
The Integrated Mobility Innovation Demonstration program is a research, development, and demonstration effort and as such FTA Research Circular 6100.1E rules will apply in administering the program.
FTA encourages applicants to identify scaled funding options in case
Project proposals will be evaluated by FTA per the following five selection criteria. FTA strongly encourages each applicant to demonstrate the responsiveness of a project to all criteria shown below with the most relevant information that the applicant can provide.
The five selection criteria are:
Applications should indicate how they expect to use the data they collect to evaluate the impact of their project, recognizing that ultimately this will involve collaboration between the applicant and an independent evaluator. Specifically, an essential element of all applications is a set of performance measures that clearly notes how success with the goals of the proposal will be measured and how the data will be collected.
Each selection criterion will be judged in the frame of the Area of Inquiry identified by the applicant. Therefore, applicants should clearly reference how their proposal advances the specific goals, objectives, and other intents of the applicable Area of Inquiry as they address the selection criteria.
A technical evaluation panel comprising FTA, other Departmental, and/or Federal agency staff will review project proposals against the selection criteria listed above. The technical evaluation committee may seek clarification from any applicant about any statement made in a proposal. FTA may also request additional documentation or information to be considered during the evaluation process. After the evaluation of all eligible proposals, the technical evaluation committee will provide project recommendations to the FTA Administrator. The FTA Administrator will determine the final list of project selections, and the amount of funding for each project. Geographic diversity, diversity of project type, the applicant's receipt of other Federal funding, and projects located in or that support public transportation service in a qualified opportunity zone designated pursuant to 26 U.S.C. 1400Z-1 may be considered in FTA's award decisions. FTA may prioritize projects proposed with a higher local share.
In addition to the criteria and considerations outlined in this section, the FTA Administrator will consider the following key Departmental objectives:
• Supporting economic vitality at the national and regional level;
• Leveraging Federal funding to attract other, non-Federal sources of investment, including value capture;
• Using innovative approaches to improve safety and expedite project delivery; and
• Holding grant recipients accountable for their performance and achieving specific, measurable outcomes with supporting data.
The FTA Administrator will announce the final project selections on the FTA website.
Projects funded under this announcement will be subject to evaluation by an independent evaluator selected and funded separately by FTA. Recipients will be required to coordinate with the independent evaluator to assist in developing an evaluation plan; and collecting, storing, and managing data required to fulfill that evaluation plan.
Projects funded under this announcement will be required to support the efforts of FTA or its designee to evaluate the project and its outcomes against a set of in-development Mobility Metrics, which will be shared with selected project teams upon award.
Projects funded under this announcement will be required to gather and share all relevant and required data with the FTA within appropriate and agreed-upon timelines, to support project evaluation.
The Department may make available a secure data system to store data for evaluation (more information available at
In response to the White House Office of Science and Technology Policy memorandum dated February 22, 2013, entitled
The FTA expects Recipients to remove CBI and PII before providing public access to project data. Recipients must ensure the appropriate data are accessible to the FTA and/or the public for a minimum of five years after the award period of performance expires.
Additionally, information submitted as part of or in support of an IMI Demonstration program-funded project shall make every attempt to use publicly available data or data that can be made public and methodologies that are accepted by industry practice and standards, to the extent possible. FTA recognizes that certain partnerships may pose a challenge to data sharing and will work with each recipient to develop an appropriate data management plan (DMP) building upon the preliminary DMP submitted in the application.
Recipients must make available to the Department copies of all work developed in performance of a project funded under this announcement, including but not limited to software and data. Data rights shall be in accordance with 2 CFR 200.315, Intangible property.
If the submission includes information the applicant considers to be trade secret or confidential commercial or financial information, the applicant should do the following: (1) Note on the front cover that the submission “Contains Confidential Business Information (CBI)”; (2) mark each affected page “CBI”; and (3) highlight or otherwise denote the CBI portions. FTA protects such information from disclosure to the extent allowed under applicable law. If FTA receives a Freedom of Information Act (FOIA) request for the information, FTA will follow the procedures described in the Department's FOIA regulations at 49 CFR part 7.
Project teams may be asked to participate in information exchange meetings, webinars, or outreach events to support FTA's goal of advancing the state of the practice. Project teams will be required to work with FTA to support knowledge transfer by participating in a relevant community of practice or similar activity. Applicants should allocate a portion of their budgets to support such work, which may include travel or presentations at key industry gatherings, such as conferences of the American Public Transportation Association (APTA), Community Transportation Association of America (CTAA), American Association of State Highway and Transportation Officials (AASHTO), Intelligent Transportation Society of America (ITSA) America, Transportation Research Board (TRB), and the Department, among others.
Projects with significant potential impacts on the mobility of persons with disabilities will be specifically encouraged to participate in FTA-supported cross-program coordination efforts. Such collaboration will bring together experts from the public, private, government, and academic sectors who share information and lessons learned from the development of technologies and business models with the potential to reduce the mobility barrier facing those with disabilities. The intent of this participation is to promote the success of projects funded under this NOFO, and to transfer knowledge and practices specific to accessibility.
Funded projects will be required to produce, within 4 months of award, a draft equity and accessibility plan. Such plans will clearly identify the steps to be taken to ensure the usability of the proposed service or technology by people with disabilities, as well as those who are unbanked or have lower incomes. As part of these plans, projects will be required to engage a stakeholder group comprised of representatives of impacted communities, and to clearly identify how stakeholder input will be garnered and utilized in the project's development.
FTA will issue specific guidance to recipients regarding pre-award authority at the time of selection. FTA does not provide pre-award authority for discretionary funds until projects are selected, and even then, there are Federal requirements that must be met before costs are incurred. For more information about FTA's policy on pre-award authority, please see the FY 2018 Apportionment Notice published on July 16, 2018.
FTA encourages applicants to notify the appropriate State Departments of Transportation and Metropolitan Planning Organizations (MPO) in areas likely to be served by the project funds made available under these initiatives and programs.
The applicant assures that it will comply with all applicable Federal statutes, regulations, executive orders, directives, FTA circulars, and other Federal administrative requirements in carrying out any project supported by the FTA agreement. The applicant acknowledges that it is under a continuing obligation to comply with the terms and conditions of the grant or cooperative agreement issued for its project with FTA. The applicant understands that Federal laws, regulations, policies, and administrative practices might be modified from time to time and may affect the implementation of the project. The applicant agrees that the most recent Federal requirements will apply to the project, unless FTA issues a written determination otherwise. The applicant must submit the Certifications and Assurances before entering into a grant or cooperative agreement if it does not have current certifications on file.
FTA requires that all capital procurements meet FTA's Buy America requirements per 49 U.S.C. 5323(j), which require that all iron, steel, or manufactured products be produced in the United States. Federal public transportation law provides for a phased increase in the domestic content for rolling stock. For FY 2019, the cost of components and subcomponents produced in the United States must be more than 65 percent of the cost of all components. For FY 2020 and beyond, the cost of components and subcomponents produced in the United States must be more than 70 percent of the cost of all components. There is no change to the requirement that final assembly of rolling stock must occur in the United States. FTA issued guidance on the implementation of the phased increase in domestic content on September 1, 2016 (81 FR 60278). Applicants should read the policy guidance carefully to determine the applicable domestic content requirement for their project. Any proposal that will require a waiver must identify in the application the items for which a waiver will be sought. Applicants should not proceed with the expectation that waivers will be granted, nor should applicants assume that selection of a project under the Low-No Program that includes a partnership with a manufacturer, vendor, consultant, or other third party constitutes a waiver of the Buy America requirements applicable at the time the project is undertaken. Consistent with Executive Order 13858 Strengthening Buy-American Preferences for Infrastructure Projects, signed by President Trump on January 31, 2019, applicants should maximize the use of goods, products, and materials produced in the United States, in Federal procurements and through the terms and conditions of Federal financial assistance awards. Additional information on Buy America requirements can be found at
For further information concerning this NOFO, please contact Mr. Hendrik Opstelten by phone at 202-366-8094, or by email at
Issued in Washington, DC.
Thank you for your letter supporting the application submitted by
The IMI Demonstration program is administered by the Federal Transit Administration (FTA), and funded under Federal public transportation law (49 U.S.C. 5312) through the Federal Public Transportation Innovation program. FTA expects to award several cooperative agreements up to a total of $15 million under this program.
The IMI Demonstration program's primary purpose is to fund projects that demonstrate innovative, effective approaches, practices, partnerships, and technologies to enhance public transportation effectiveness, increase efficiency, expand quality, promote safety, and improve the traveler's experience. The program will fund solutions in one or more of the three areas identified in the notice of funding opportunity: Mobility on Demand, Transit Automation, and Mobility Payment Integration.
All properly submitted applications for this funding will receive full and careful consideration. FTA will announce final project selections after the review process is complete.
Your interest in this program is appreciated.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 7, 2019.
You may submit comments identified by DOT Docket Number MARAD-2019-0078 by any one of the following methods:
•
•
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, email
As described by the applicant the intended service of the vessel ALLANA is:
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121 * * *.
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 7, 2019.
You may submit comments identified by DOT Docket Number MARAD-2019-0075 by any one of the following methods:
•
•
If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel ARIEL is:
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121 * * *.
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 7, 2019.
You may submit comments identified by DOT Docket Number MARAD-2019-0074 by any one of the following methods:
•
•
If you mail or hand-deliver your comments, we recommend that you include your name and a mailing address, an email address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel ROGUE ANGEL is:
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121 * * *.
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 7, 2019.
You may submit comments identified by DOT Docket Number MARAD-2019-0077 by any one of the following methods:
•
•
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel FURY is:
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 7, 2019.
You may submit comments identified by DOT Docket Number MARAD-2019-0073 by any one of the following methods:
•
•
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, email
As described by the applicant the intended service of the vessel PANACHE is:
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible,
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121 * * *.
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 7, 2019.
You may submit comments identified by DOT Docket Number MARAD-2019-0071 by any one of the following methods:
•
•
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel TRES SUENOS is:
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121 * * *.
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 7, 2019.
You may submit comments identified by DOT Docket Number MARAD-2019-0076 by any one of the following methods:
•
•
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, email
As described by the applicant the intended service of the vessel DUTY SERVED is:
The complete application is available for review identified in the DOT docket as MARAD-2019-0076 at
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121 * * *.
By Order of the Maritime Administrator.
Maritime Administration, DOT.
Notice.
The Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirements of the coastwise trade laws to allow the carriage of no more than twelve passengers for hire on vessels, which are three years old or more. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before June 7, 2019.
You may submit comments identified by DOT Docket Number MARAD-2019-0072 by any one of the following methods:
•
•
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE, Room W23-453, Washington, DC 20590. Telephone 202-366-9309, email
As described by the applicant the intended service of the vessel GETAWAY is:
Please submit your comments, including the attachments, following the instructions provided under the above heading entitled
Go to the docket online at
Yes. Be aware that your entire comment, including your personal identifying information, will be made publicly available.
If you wish to submit comments under a claim of confidentiality, you should submit three copies of your complete submission, including the information you claim to be confidential business information, to the Department of Transportation, Maritime Administration, Office of Legislation and Regulations, MAR-225, W24-220, 1200 New Jersey Avenue SE, Washington, DC 20590. Include a cover letter setting forth with specificity the basis for any such claim and, if possible, a summary of your submission that can be made available to the public.
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the public to better inform its rulemaking process. DOT posts these comments, without edit, to
49 CFR 1.93(a), 46 U.S.C. 55103, 46 U.S.C. 12121 * * *.
By Order of the Maritime Administrator.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice of actions on special permit applications.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein.
Comments must be received on or before June 7, 2019.
Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Ryan Paquet, Director, Office of Hazardous Materials Approvals and Permits Division, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC, or at
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of applications for modification of special permits.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.
Comments must be received on or before May 23, 2019.
Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Ryan Paquet, Director, Office of Hazardous Materials Approvals and Permits Division, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington DC or at
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of applications for special permits.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations, notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger-carrying aircraft.
Comments must be received on or before June 7, 2019.
Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Ryan Paquet, Director, Office of Hazardous Materials Approvals and Permits Division, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC, or at
This notice of receipt of applications for special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Department of the Treasury, Office of the Comptroller of the Currency (OCC).
Notice of Federal Advisory Committee meeting.
The OCC announces a meeting of the Mutual Savings Association Advisory Committee (MSAAC).
A public meeting of the MSAAC will be held on Thursday, May 23, 2019, beginning at 8:30 a.m. Eastern Daylight Time (EDT).
The OCC will hold the May 23, 2019 meeting of the MSAAC at the OCC's offices at 400 7th Street SW, Washington, DC 20219.
Michael R. Brickman, Designated Federal Officer, (202) 649-5420, Office of the Comptroller of the Currency, Washington, DC 20219.
By this notice, the OCC is announcing that the MSAAC will convene a meeting on Thursday, May 23, 2019, at the OCC's offices at 400 7th Street SW, Washington, DC 20219. The meeting is open to the public and will begin at 8:30 a.m. EDT. The purpose of the meeting is for the MSAAC to advise the OCC on regulatory or other changes the OCC may make to ensure the health and viability of mutual savings associations. The agenda includes a discussion of current topics of interest to the industry.
Members of the public may submit written statements to the MSAAC. The OCC must receive written statements no later than 5:00 p.m. EDT on Thursday, May 16, 2019. Members of the public may submit written statements to
Members of the public who plan to attend the meeting should contact the OCC by 5:00 p.m. EDT on Thursday, May 16, 2019, to inform the OCC of their desire to attend the meeting and to provide information that will be required to facilitate entry into the meeting. Members of the public may contact the OCC via email at
Attendees should provide their full name, email address, and organization, if any. For security reasons, attendees will be subject to security screening procedures and must present a valid government-issued identification to enter the building.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Internal Revenue Service, 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 information collections, as required by the Paperwork Reduction Act of 1995. The IRS is soliciting comments concerning the Annual Return/Report of Employee Benefit Plan.
Written comments should be received on or before July 8, 2019 to be assured of consideration.
Direct all written comments to Laurie Brimmer, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224.
Requests for additional information or copies of the forms and instructions should be directed to Martha R. Brinson, at (202) 317-5753, or at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet at
The number of filing and wage rates are unchanged from the 2019 5500/5500-SF submission Approved on April 26, 2019.
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS) Treasury.
Notice of meeting: Correction.
In the
The meeting will be held Thursday, May 30, 2019.
Gilbert Martinez at 1-888-912-1227 or (737) 800-4060.
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Taxpayer Advocacy Panel Joint Committee will be held Thursday, May 30, 2019, at 1:30 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. For more information please contact Gilbert Martinez at 1-888-912-1227 or (737-800-4060), or write TAP Office 3651 S. IH-35, STOP 1005 AUSC, Austin, TX 78741, or post comments to the website:
The agenda will include various committee issues for submission to the IRS and other TAP related topics. Public input is welcomed.
Internal Revenue Service (IRS), Treasury.
Notice of meeting: Correction.
In the
The meeting will be held Thursday, April 25, 2019.
Gilbert Martinez at 1-888-912-1227 or (737) 800-4060.
Notice is hereby given pursuant to Section 10(a)(2) of the Federal Advisory Committee Act, 5 U.S.C. App. (1988) that an open meeting of the Taxpayer Advocacy Panel Joint Committee will be held Thursday, April 25, 2019, at 1:30 p.m. Eastern Time via teleconference. The public is invited to make oral comments or submit written statements for consideration. For more information please contact Gilbert Martinez at 1-888-912-1227 or (737-800-4060), or write TAP Office 3651 S. IH-35, STOP 1005 AUSC, Austin, TX 78741, or post comments to the website:
The agenda will include various committee issues for submission to the IRS and other TAP related topics. Public input is welcomed.
Veterans Experience Office, Department of Veterans Affairs.
Notice.
The Veterans Experience Office (VEO), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before July 8, 2019.
Submit written comments on the collection of information through Federal Docket Management System (FDMS) at
Danny S. Green at (202) 421-1354.
Under the PRA of 1995, Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VEO invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VEO's functions, including whether the information will have practical utility; (2) the accuracy of VEO's estimate of the burden of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or the use of other forms of information technology.
The Veteran Benefits Administration (VBA) oversees numerous government programs supporting Veterans, including those furthering their education or filing for pension benefits. These programs engage Veterans through the National Call Center (NCC) or other benefit-specific call centers. The Veterans Experience Office (VEO) was procured by VBA to measure the customer satisfaction of persons contacting the following call centers: NCC, Pension, and Education.
Customer experience and satisfaction are usually measured at three levels: the enterprise level, the service level patterns, and point-of-service feedback. This measurement may bring insights and value to all stakeholders at VA. Front-line VA leaders can resolve individual feedback from Veterans and take steps to improve the customer experience; meanwhile VA executives can receive real-time updates on systematic trends that allow them to make changes.
(1) To collect continuous customer experience data that make or break the service experience.
(2) To help field staff and the national office identify areas of improvement.
(3) To understand emerging drivers and detractors of customer experience.
To accomplish this task, the VEO will invite random samples of recent callers to these call centers via email to complete a brief transactional online survey. Samples will be drawn three times a week to ensure that callers can accurately respond to their most recent call. The selected callers are given two weeks to respond to the survey, receiving an email reminding them about the survey invitation if they did not respond one week after the initial email. Sampled callers will report their experiences through Likert-scale questions designed to measure the customer experience driver metrics published by OMB in the A-11 Budget Directive. Sampled callers will also be asked to respond to an open-ended question about their experience with the VBA Contact Centers that will allow them to provide any further information about their experience that was not captured in the previous questions. Once data collection is completed, the participant responses in the online survey will be weighted so that the samples represent the caller population. Weighting models will rely on the following: Call Center Type and Subsidiary Call Center (NCC only). Weighted estimates will be published through dashboards on the Veteran Signals (VSignals) system for interactive reporting and data visualization.
This data collection was previously approved and conducted under the VA Generic Clearance Number 2900-0770: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery. Under this clearance, the VEO could collect and report this data to stakeholders internal to VA for program and procedure improvement. However, the stakeholders directed VEO to present the results that are statistically rigorous and generalizable to the target population from this survey to the public, which was not allowed under Generic Clearance Number 2900-0770.
Therefore, the VEO is creating a new information collection request to be able to meet the quantitative goals of the VBA Contact Center Survey of 1) being representative of the VBA Contact Center population and 2) allow for accurate statistical analysis and to allow it to be released to the public.
By direction of the Secretary.
Veterans Health Administration, Department of Veterans Affairs.
Notice.
In compliance with the Paperwork Reduction Act (PRA) of 1995, this notice announces that the Veterans Health Administration, Department of Veterans Affairs, will submit the collection of information abstracted below to the Office of Management and Budget (OMB) for review and comment. The PRA submission describes the nature of the information collection and its expected cost and burden and it includes the actual data collection instrument.
Comments must be submitted on or before June 7, 2019.
Submit written comments on the collection of information through
Danny S. Green, Office of Quality, Performance and Risk (OQPR), Department of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, (202) 421-1354 or email
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
By direction of the Secretary.
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 Engine Test Cells/Stands. We found risks due to emissions of air toxics from this source category to be acceptable and determined that the current NESHAP provides an ample margin of safety to protect public health. We identified no new cost-effective controls under the technology review to achieve further emission reductions. We are proposing no revisions to the numerical emission limit based on the risk analysis and technology review. We are proposing to amend provisions addressing periods of startup, shutdown, and malfunction (SSM), to amend provisions regarding electronic reporting and to make clarifying and technical corrections.
You may send comments, identified by Docket ID No. EPA-HQ-OAR-2018-0753, by any of the following methods:
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For questions about this proposed action, contact Jim Eddinger, Sector Policies and Programs Division (Mail Code 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-2018-0753).
A. What is the statutory authority for this action?
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 Engine Test Cells/Stands source category was promulgated on May 27, 2003 (68 FR 28774), and codified at 40 CFR part 63, subpart PPPPP. As promulgated in 2003, the Engine Test Cells/Stands NESHAP applies to engine test cells/stands located at major sources of HAP emissions. An engine test cell/stand is any apparatus used for testing uninstalled stationary or uninstalled mobile engines. That is, the NESHAP regulates the testing of engines, not the testing of any final product (
The NESHAP covers four subcategories of engine test cells/stands: (1) Cells/stands used for testing internal combustion engines with rated power of 25 horsepower (hp) or more; (2) cells/stands used for testing internal combustion engines with rated power of less than 25 hp; (3) cells/stands used for testing combustion turbine engines; and (4) cells/stands used for testing rocket engines. The first two subcategories cover facilities where reciprocating engines are tested, such as automobile engines and emergency generators. The combustion turbine subcategory includes jet engines, turboprops, and gas turbines.
The affected source is further classified as either an existing, new, or reconstructed source. An affected source is said to be “existing” if its construction began on or before May 14, 2002, and no reconstruction of the source occurred after that date. An affected source is considered “new” or “reconstructed” if it was constructed or reconstructed after May 14, 2002. The distinction between “existing” and “new/reconstructed” affected sources is important as existing affected sources testing engines are not subject to emission limits. However, new and reconstructed affected sources testing internal combustion engines with a rated power of 25 hp or more are subject to emission limits.
The typical engine test cell consists of one or more stands for mounting engines, storage tanks, and piping for fuels and cooling fluids, an electronic control system, data acquisition instrumentation for monitoring and recording engine parameters during testing, blast panels, fire suppression equipment, and spill collection systems. Most engine testing is performed indoors in a purpose-built enclosure equipped with ventilation systems with hoods, ducts, and fans. However, testing of jet engines, turboprops, large turbines, and rocket engines is sometimes conducted on outdoor test stands. Some test cells/stands include climate control systems that enable testing to be completed under a variety of temperature, humidity, and pressure conditions. Test cells used for aircraft engines and rockets sometimes include specially designed air handling systems that simulate high altitude conditions. Most sources have between two and 10 engine test cells/stands. However, a few larger sources have over 100 test cells.
Engine test cells/stands emit HAP in the exhaust gases from combustion of gaseous and liquid fuels in the engines tested. The emission rates and annual emissions vary based on the size and design of the engines tested, the types of fuels burned, and the number, type, and duration of tests performed. A wide range of engines are tested in the U.S., including two- and four-stroke reciprocating engines used in boats, automobiles, buses, and trucks; combustion turbines used for power generation; jet and turboprop engines used in military and civilian aircraft; and rocket engines used in a variety of military and civilian applications. Fuels
The sources of emissions are the exhaust gases from combustion of fuels in the engines being tested in the test cells/stands. The primary HAP present in the exhaust gases from engine test cells/stands are formaldehyde, benzene, acetaldehyde, and 1,3-butadiene.
The Engine Test Cells/Stands NESHAP provides the owner or operator of a new or reconstructed affected source used in whole or in part for testing internal combustion engines with rated power of 25 hp or more and located at a major source of HAP emissions two compliance options: (1) Reduce carbon monoxide (CO) or total hydrocarbons (THC) emissions in the exhaust from the new or reconstructed affected source to 20 parts per million by volume dry basis (ppmvd) or less, at 15-percent oxygen (O
During the development of 40 CFR part 63, subpart PPPPP, the EPA collected information on the emissions, operations, and location of engine test cells/stands. Since this information was collected prior to the 2003 promulgation of 40 CFR part 63, subpart PPPPP, the EPA prepared a questionnaire in 2016 in order to collect current information on the location and number of engine test cells/stands, types and quantities of emissions, number and type of engines tested, length and purpose of tests, annual operating hours, types and quantities of fuels burned, and information on air pollution control devices and emission points. Ten companies completed the 2016 questionnaire for which they reported data for 15 major source facilities. The EPA used data from the 2016 questionnaires to develop the modeling dataset for the 40 CFR part 63, subpart PPPPP risk modeling.
The list of facilities that are subject to 40 CFR part 63, subpart PPPPP was developed using EPA's Enforcement and Compliance History Online (ECHO) database, the 2014 National Emissions Inventory (2014 NEI) and the facility list developed for the 2003 promulgation of 40 CFR part 63, subpart PPPPP. Facilities with engine test cells/stands were identified in the 2014 NEI records by either the source classification codes (SCCs) or NAICS codes. The facility list was then refined using air permit information to determine whether the facility was a major source of HAP and subject to 40 CFR part 63, subpart PPPPP. The initial list of facilities and their engine test cells/stands was posted to the EPA's
In addition to the ECHO and NEI databases, the EPA reviewed the additional information sources listed below and consulted with stakeholders regulated under the Engine Test Cells/Stands NESHAP to determine whether there have been developments in practices, processes, or control technologies by engine testing 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 engine testing industry from the reasonably available control technology/best available control technology/lowest achievable emission rate Clearinghouse (RBLC);
• Information on the most effective ways to control emissions of volatile organic compounds (VOC) and organic HAP from sources in various industries; 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 proposal.
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 proposal. 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 describe how we estimated emissions and conducted the risk assessment. The docket for this rulemaking contains the following document which provides more information on the risk assessment inputs and models:
The list of facilities that are subject to 40 CFR part 63, subpart PPPPP, was developed using the ECHO database, the 2014 NEI and the facility list developed for the promulgation of the 2003 NESHAP. Facilities with engine test cells/stands were identified in the 2014 NEI records by their SCC or NAICS codes. The facility list was then refined using air permit information to determine whether the facility was a major source of HAP and subject to 40 CFR part 63, subpart PPPPP. The EPA emailed the list to several trade organizations as part of an outreach effort to the industry. The EPA Regional offices and state and local air pollution control agencies were asked to review the list and provide corrections as necessary. The DoD and NASA were also consulted and provided information for engine testing facilities located at research sites and military bases. Changes to the facility list were made based on the new information received. The final risk modeling datafile included 59 facilities, each with one or more engine test cell/stand. We are interested in your comments on the development of the facility list used in our analysis. For more details on the facility list development, see the memorandum titled
To determine which HAP should be modeled, we reviewed NEI emissions data and several other relevant sources to identify the principal HAP emitted.
We compiled the actual emissions data using the following four-step approach. Step 1—where possible, the actual emissions from the 2014 NEI and the 2016 questionnaires were used for the very few facilities that reported HAP emissions to either NEI or in their completed 2016 questionnaires. For facilities where HAP data were not available from these sources, we proceeded to step 2 (for facilities that submitted 2016 questionnaires) and step 3 for all others.
Step 2—As noted above, facilities that completed the 2016 questionnaire were asked to provide information on the types and quantities of each fuel consumed during engine testing. HAP emissions for these facilities, when not directly reported to NEI or in the questionnaire, were calculated by multiplying the fuel usage reported in the questionnaire by an emission factor. The emission factors used to calculate emissions were obtained from three sources.
Step 3—For those facilities that either reported VOC emissions to the 2014 NEI or for which we were able to calculate VOC emissions using fuel data from the 2016 questionnaire, we calculated organic HAP emissions by multiplying the VOC emissions by a speciation factor. Similarly, the metal HAP emissions were calculated by multiplying the PM
Step 4—Where data needed for steps 1 through 3 were not available, we based the HAP emissions on either:
(1) The HAP emissions from other similar test cells/stands located at the same facility and operating under the same SCC; or
(2) The HAP emissions from other similar test cells/stands located at a different facility that operate under the same SCC.
An average annual emissions value was used where emissions data for more than one test cell/stand was available.
Mercury emissions were modeled as three different species: Gaseous elemental mercury, gaseous divalent mercury, and particulate divalent mercury. Chromium emissions were modeled as hexavalent chromium and trivalent chromium. We used emissions for total mercury and total chromium determined by using the methods outlined above, in combination with speciation factors from the EPA's SPECIATE, to calculate the emissions of each species. The SPECIATE database contains source-specific, weight-fraction emission speciation profiles. The total mercury emissions were multiplied by the speciation factors of 0.5 for elemental mercury, 0.30 for gaseous divalent mercury, and 0.20 for particulate divalent mercury. The total chromium emissions were multiplied by speciation factors of 0.18 for hexavalent chromium and 0.82 for trivalent chromium.
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.)
Generally, allowable emissions for risk modeling are set equal to the current emission limits included in the rule. For this NESHAP, however, there are no emission limits for existing engine test cells/stands or for new test cells/stands used for testing combustion turbines, rockets, and internal combustion engines with rated power less than 25 hp. Although there are limits for new and reconstructed engine test cells/stands used to test internal combustion engines rated at 25 hp and above, only seven engine test cells/stands facilities have been constructed or reconstructed since the NESHAP was proposed in 2002. Thus, 52 of the 59 affected facilities are not subject to emission limits. Because most engine test cells/stands are not subject to emission limits and the emissions from engine test cells/stands can be variable, we have taken a conservative approach to estimating the allowable emissions for this source category. We estimated the allowable emissions at 4.5 times the actual emissions that were determined using the methods as described in section III.C.1 of this preamble. The 4.5 multiplier was determined based on data provided by facilities responding to our 2016 questionnaire that showed most facilities operate their engine test cells/stands at slightly less than 50 percent of their maximum potential. By setting the allowable multiplier at half the acute multiplier of 9.5, the estimated allowable emissions included in the modeling datafile are conservative estimates that take into consideration the potential variability in emissions from this source category.
Both long-term and short-term inhalation exposure concentrations and health risk from the source category addressed in this proposal 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 each source in the source category. The HAP air concentrations at each nearby census block centroid located within 50 km of the facility are a surrogate for the chronic inhalation exposure concentration for all the people who reside in that census block. A distance of 50 km is consistent with both the analysis supporting the 1989 Benzene NESHAP (54 FR 38044, September 14, 1989) and the limitations of Gaussian dispersion models, including AERMOD.
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. We use the peak hourly emission rate,
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
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 the Engine Test Cells/Stands source category, annual actual emission values were multiplied by a conservative factor of 9.5 instead of the default emissions multiplier of 10. This source category specific factor was developed using activity data collected from the 2016 questionnaire. A further discussion of why this factor was chosen can be found in the memorandum,
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 (even under the conservative assumptions of the screening assessment), and no further analysis is performed for these HAP. In cases where an acute HQ from the screening step is greater than 1, we consider additional site-specific data to develop a more refined estimate of the potential for acute exposures of concern. For this source category, the data refinements employed consisted of looking at the impact of acute risks at only off source category property locations. These refinements are discussed more fully in the
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 Engine Test Cells/Stands source category, we identified PB-HAP emissions of lead compounds, cadmium compounds, arsenic compounds, mercury compounds, and polycyclic organic matter (POM) (of which polycyclic aromatic hydrocarbons is a subset), so we proceeded to the next step of the evaluation. In this step, we determine whether the facility-specific emission rates of the emitted PB-HAP are large enough to create the potential for significant human health risk through ingestion exposure under reasonable worst-case conditions. To facilitate this step, we use 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
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 and farmer exposure scenarios at that facility. 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 U.S. Geological Survey (USGS) database to identify actual waterbodies within 50 km of each facility. 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 USGS waterbody data. If the PB-HAP emission rates for a facility exceed the Tier 2 screening threshold emission rates and data are available, we may conduct a Tier 3 screening assessment. If PB-HAP emission rates do not exceed a Tier 2 screening value of 1, we consider those PB-HAP emissions to pose risks below a level of concern.
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 lakes are fishable, 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. If the Tier 3 screening assessment indicates that risks above levels of concern cannot be ruled out, 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.
For further information on the multipathway assessment approach, see the
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, dioxins/furans, POM, mercury (both inorganic mercury and methyl mercury), and lead compounds. The acid gases included in the screening assessment are hydrochloric acid (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 HAP, we identified the available ecological benchmarks for each assessment endpoint. We identified, where possible, ecological benchmarks at the following effect levels: Probable effect levels, lowest-observed-adverse-effect level, and no-observed-adverse-effect level. In cases where multiple effect levels were available for a particular PB-HAP and assessment endpoint, we use all of the available effect levels to help us to determine whether ecological risks exist and, if so, whether the risks could be considered significant and widespread.
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 Engine Test Cells/Stands source category emitted any of the environmental HAP (cadmium, dioxins, POM, mercury [both inorganic mercury and methylmercury], arsenic, and lead). For the Engine Test Cells/Stands source category, we identified emissions of arsenic, cadmium, HCl, HF, lead, mercury, and POMs. Because one or more of the environmental HAP evaluated 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, dioxins/furans, 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 of pollutant 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. The source category records of that NEI 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 from the NEI 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 proposal. 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 an emission adjustment factor 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 the population in the blocks. We also add additional receptor locations where the population of a block is not well represented by a single location.
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 humans at the location of the maximum concentration. In the acute screening assessment that we conduct under the RTR program, we assume that peak emissions from the source category and worst-case meteorological conditions co-occur, thus, resulting in maximum ambient concentrations. These two events are unlikely to occur at the same time, making these assumptions conservative. We then include the additional assumption that a person is located at this point during this same time period. For this source category, these assumptions would tend to be worst-case actual exposures, as it is unlikely that a person would be located at the point of maximum exposure during the time when peak emissions and worst-case meteorological conditions occur simultaneously.
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 from models—TRIM.FaTE and AERMOD—that estimate environmental pollutant concentrations and human exposures for five PB-HAP (dioxins, POM, mercury, cadmium, and arsenic) and two acid gases (HF and HCl). For lead, we use AERMOD to determine ambient air concentrations, which are then compared to the secondary NAAQS standard for lead. Two important types of uncertainty associated with the use of these models in RTR risk assessments and inherent to any assessment that relies on environmental modeling are model uncertainty and input uncertainty.
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 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, dioxins/furans, 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.
Table 2 of this preamble provides a summary of the results of the inhalation risk assessment for the source category. More detailed information on the risk assessment can be found in the risk document, available in the docket for this action.
Results from the inhalation risk assessment using the MACT-allowable emissions indicate that the cancer MIR could be as high as 70-in-1 million with benzene, 1,3-butadiene, formaldehyde, and acetaldehyde emissions from
Table 2 of this preamble provides the worst-case acute HQ (based on the REL) of 9, driven by actual emissions of acrolein. To better characterize the potential health risks associated with estimated worst-case acute exposures to HAP, and in response to a key recommendation from the SAB's peer review of the EPA's RTR risk assessment methodologies, we examined a wider range of available acute health metrics than we do for our chronic risk assessments. This is in acknowledgement that there are generally more data gaps and uncertainties in acute reference values than there are in chronic reference values. By definition, the acute REL represents a health-protective level of exposure, with effects not anticipated below those levels, even for repeated exposures. However, the level of exposure that would cause health effects is not specifically known. Therefore, when an REL is exceeded and an AEGL-1 or ERPG-1 level is available (
The highest refined screening acute HQ value was 9 (based on the acute REL for acrolein). This value includes a refinement of determining the highest HQ value that is outside facility boundaries. In this case the highest value (9) occurs adjacent to the property boundary in a remote wooded location. HQ values at any nearby residential location are below 1. As noted previously, the highest HQ assumes that the primary source of the acrolein emissions from turbine engine testing operations was modeled with an hourly emissions multiplier of 9.5 times the annual emissions rate. As presented in Table 2, no facilities are estimated to have an HQ based on an AEGL or an EPRG greater than 1.
Of the 59 facilities in the source category, 21 facilities reported emissions of carcinogenic PB-HAP (arsenic and POM), and 23 facilities reported emissions of non-carcinogenic PB-HAP (cadmium and mercury). Of the facilities included in the assessment, three facilities reported emissions of a carcinogenic PB-HAP (arsenic) that exceeded a Tier 1 cancer screening threshold emission rate, and one facility reported emissions of non-carcinogenic PB-HAP (cadmium and mercury) that exceeded a Tier 1 noncancer screening threshold emission rate. For facilities that exceeded the Tier 1 multipathway screening threshold emission rate for one or more PB-HAP, we used additional facility site-specific information to perform a Tier 2 assessment and determine the maximum chronic cancer and noncancer impacts for the source category. Based on the Tier 2 multipathway cancer assessment, the arsenic emissions exceeded the Tier 2 screening threshold emission rate by a factor of 2.
An exceedance of a screening threshold emission rate in any of the tiers cannot be equated with a risk value or an HQ (or HI). Rather, it represents a high-end estimate of what the risk or hazard may be. For example, a screening threshold emission rate of 2 for a non-carcinogen can be interpreted to mean that we are confident that the HQ would be lower than 2. Similarly, a tier screening threshold emission rate of 30 for a carcinogen means that we are confident that the risk is lower than 30-in-1 million. Our confidence comes from the conservative, or health-protective, assumptions encompassed in the screening tiers: We choose inputs from the upper end of the range of possible values for the influential parameters used in the screening tiers, and we assume that the exposed individual exhibits ingestion behavior that would lead to a high total exposure.
The Tier 2 noncancer screening threshold emission rate for both mercury and cadmium emissions were below 1. Thus, based on the Tier 2 results presented above, additional screening or site-specific assessments were not deemed necessary.
As described in section III.A of this document, we conducted an environmental risk screening assessment for the Engine Test Cells/Stands source category for the following pollutants: Arsenic, cadmium, HCl, HF, lead, mercury (methyl mercury and mercuric chloride), and POMs.
In the Tier 1 screening analysis for PB-HAP (other than lead, which was evaluated differently), arsenic and POM emissions had no exceedances of any of the ecological benchmarks evaluated. Divalent mercury, methyl mercury and cadmium emissions had Tier 1 exceedances at one facility of surface soil benchmarks by a maximum screening value of 3.
A Tier 2 screening analysis was performed for divalent mercury, methyl mercury, and cadmium 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 facility-wide chronic MIR and TOSHI are based on emissions from all sources at the identified facilities (both MACT and non-MACT sources). The results of the facility-wide assessment for cancer risks indicate that 23 facilities have a facility-wide cancer MIR greater than or equal to 1-in-1 million, and 10 of those facilities have a facility-wide cancer MIR greater than or equal to 10-in-1-million. The maximum facility-wide cancer MIR is 70-in-1 million, mainly driven by emissions of chromium (VI) compounds from organic solvent (miscellaneous VOC) evaporation. The total estimated cancer incidence from the whole facility is 0.03 excess cancer cases per year, or about one excess case in every 33 years. Approximately 190,000 people are estimated to have cancer risks above 1-in-1 million from exposure to HAP emitted from both MACT and non-
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 Engine Test Cells/Stands 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 Engine Test Cells/Stands source category demographic analysis indicate that emissions from the source category expose approximately 2,700 people to a cancer risk at or above 1-in-1 million and no people to a chronic noncancer TOSHI greater than 1. Regarding cancer risk, the specific demographic results indicate that the percentage of the population potentially impacted by engine test cells/stands emissions is greater than its corresponding nationwide percentage for the following demographics: Above Poverty Level (87 percent for the source category compared to 86 percent nationwide), and Over 25 and with a High School Diploma (91 percent for the source category compared to 86 percent nationwide). The remaining demographic group percentages are the same or less than the corresponding nationwide percentages.
The methodology and the results of the demographic analysis are presented in a technical report,
As noted in section III 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” (see 54 FR 38045, September 14, 1989). In this proposal, the EPA estimated risks based on actual and allowable emissions from engine test cells/stands located at major sources of HAP, and we considered these in determining acceptability.
The estimated inhalation cancer risk to the individual most exposed to actual or allowable emissions from the source category is 70-in-1 million. The estimated incidence of cancer due to inhalation exposures is 0.02 excess cancer cases per year, or one excess case every 50 years. Approximately 190,000 people face an increased cancer risk at or above 1-in-1 million due to inhalation exposure to actual or allowable HAP emissions from this source category. The estimated maximum chronic noncancer TOSHI from inhalation exposure for this source category is 0.5. The screening assessment of worst-case inhalation impacts indicates a worst-case maximum acute HQ of 9 for acrolein based on the 1-hour REL and concentrations that are only 30 percent of the 1-hour AEGL-1 and ERPG-1.
Potential multipathway human health risks were estimated using a 3-tier screening assessment of the PB-HAP emitted by facilities in this source category. The only pollutant with elevated Tier 1 and Tier 2 screening values was arsenic, which is a carcinogen. The Tier 2 screening value for arsenic was 2. For noncancer, the Tier 2 screening values for all pollutants were less than 1.
In determining whether risks are acceptable for this source category, the EPA considered all available health information and risk estimation uncertainty as described above. The risk results indicate that both the actual and allowable inhalation cancer risks to the individual most exposed are well below 100-in-1 million, which is the presumptive limit of acceptability. In addition, the highest chronic noncancer TOSHI is well below 1, indicating low likelihood of adverse noncancer effects from inhalation exposures. The maximum acute HQ for all pollutants is 9 based on the REL for acrolein. As discussed in section III.C.3.c of this preamble, exceeding the REL does not automatically indicate an adverse health impact. Because of the conservative nature of the acute inhalation screening assessment (concurrent maximum emissions from all emission points, worst-case meteorology, and an exposed person at the location of highest concentration for a full hour), there is low probability that the maximum HQ of 9 is associated with adverse health effects. Further, the highest 1-hour acrolein concentration is only 30 percent of the 1-hour AEGL-1 and ERPG-1. There are also low risks associated with ingestion via multipathway exposure, with the highest cancer risk being 2-in-1 million and the highest noncancer HI being less than 1, based on a Tier 2 multipathway assessment.
Considering all the health risk information and factors discussed above, including the uncertainties discussed in section III of this preamble, the EPA proposes that the risks are acceptable for this source category.
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, the EPA considers all health factors evaluated in the risk assessment and evaluates 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 identified in our risk assessment. 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 emission reduction measures necessary to provide an ample margin of safety with respect to the risks associated with these emissions.
Our risk analysis indicated the risks from the source category are low for both cancer and noncancer health effects, and, therefore, any risk reductions from further available control options would result in minimal health benefits. Moreover, as noted in our discussion of the technology review in section IV.C of this preamble, no additional cost-effective measures were identified for reducing HAP emissions from affected sources in the Engine Test Cells/Stands source category. Thus, we are proposing that the current Engine Test Cells/Stands NESHAP provides an ample margin of safety to protect public health.
Based on the results of our environmental risk screening assessment, we conclude that there is not an adverse environmental effect from the Engine Test Cells/Stands source category. 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.
Section 112(d)(6) of the CAA requires a review of “developments in practices, processes and control technologies” in each source category as part of the technology review process. For this technology review, the “developments” we consider include:
• Add-on control technology that was not identified during the current NESHAP development;
• Improvement to an existing add-on control technology resulting in significant additional HAP emissions reductions;
• Work practice or operational procedure that was not previously identified during the current NESHAP development; or
• Process change or pollution prevention alternative that was not identified and considered during the current NESHAP development.
Developments in practices, processes, and control technologies were investigated through discussions with industry representatives, reviews of available construction and operating permits, searches of the EPA's RBLC, site visits, and literature searches. We also included questions on developments in practices, processes, and control technology in this source category in the 2016 questionnaire that was completed by 10 companies. The questionnaire, along with the responses received, are included in the docket.
Our review of the practices, processes, and control technology for the Engine Test Cells/Stands source category did
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 63.9305, 40 CFR 63.9340, and in Table 7 to subpart PPPPP of 40 CFR 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 Engine Test Cells/Stands 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 63.9350). Facilities will no longer need to develop an SSM plan or keep it current (Table 7, 40 CFR part 63, subpart PPPPP). We are specifically seeking comment on whether we have successfully removed the SSM exemption.
In proposing the standards in this rule, the EPA has taken into account startup and shutdown periods and, for the reasons explained below, is not proposing alternate standards for those periods. For add-on control systems, the Engine Test Cells/Stands NESHAP requires the measurement of thermal oxidizer operating temperature or catalytic oxidizer average temperature across the catalyst bed as well as the measurement of the emission capture system volumetric flow rate or facial velocity. Operating limits apply at all times (40 CFR 63.9302), including during periods of startup and shutdown. The Engine Test Cells/Stands NESHAP requires thermal oxidizer or catalytic oxidizer operating temperature and other add-on control device operating parameters to be recorded at least once every 15 minutes. The Engine Test Cells/Stands NESHAP specifies in 40 CFR 63.9340(b) that if an operating parameter is out of the allowed range, this is a deviation from the operating limit and must be reported as specified in 40 CFR 63.9350(d). Review of permits of facilities using add-on controls indicated that they were required by permit to operate the add-on controls at all times the engine test cells are being operated.
In proposing these rule amendments, the EPA has taken into account startup and shutdown periods and, for the reasons explained below, has not proposed alternate standards for those periods. Startups and shutdowns are part of normal operations for the Engine Test Cells/Stands source category. As currently specified in 40 CFR 63.9302(a), any new or reconstructed affected source for which you use add-on control option must meet operating limits “at all times.” This means that during startup and shutdown periods, in order for a facility using add-on controls to meet the emission and operating standards, the control device for an engine test cell/stand facility needs to be turned on and operating at specified levels before the facility begins engine testing operations, and the control equipment needs to continue to be operated until after the facility ceases engine testing operations.
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 7) entry for 40 CFR 63.6(e)(1)-(2) by redesignating it as 40 CFR 63.6(e)(1)(i) and changing the “yes” in column 3 to a “no.” Section 63.6(e)(1)(i) describes the general duty to minimize emissions. Some of the language in that section is no longer necessary or appropriate in light of the elimination of the SSM exemption. We are proposing instead to add general duty regulatory text at 40 CFR 63.9305 that reflects the general duty to minimize emissions while eliminating the reference to periods covered by an SSM exemption. The current language in 40 CFR 63.6(e)(1)(i) characterizes what the general duty entails during periods of SSM. With the elimination of the SSM exemption, there is no need to differentiate between normal operations and SSM events in describing the general duty. Therefore, the language the EPA is proposing for 40 CFR 63.9305 does not include that language from 40 CFR 63.6(e)(1).
We are also proposing to revise Table 7 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 63.9305.
We are also proposing to revise Table 7 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 7 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 PPPPP.
We are proposing to revise Table 7 to add an entry 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,
We are proposing to revise Table 7 entry for 40 CFR 63.6(f)(1) by changing the “yes” in column 3 to a “no.” 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 7 entry for 40 CFR 63.7(e)(1) by changing the “yes” in column 3 to a “no.” Section 63.7(e)(1) describes performance testing requirements. The EPA is instead proposing to revise the performance testing requirement at 40 CFR 63.9321 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 63.9321(a) of the current rule specifies that performance testing must be conducted when the emission capture system and add-on control device are operating at a representative flow rate, and the add-on control device is operating at a representative inlet concentration. Section 63.9321(a) also specifies that the performance test be conducted under representative operating conditions for the engine test cell/stand. Operations during periods of SSM, and during periods of nonoperation do not constitute representative operating conditions. The EPA is proposing to add language that requires the owner or operator to record the process information that is necessary to document operating conditions during the test and include in such record an explanation to support that such conditions represent normal operation. 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 7 entries for 40 CFR 63.8(c)(1)(i) and 40 CFR 63.8(c)(1)(iii) by changing the “yes” in column 3 to a “no.” 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 7 entry for 40 CFR 63.10(b)(2)(i) by changing the “yes” in column 3 to a “no.” Section 63.10(b)(2)(i) describes the recordkeeping requirements during startup and shutdown. These recording provisions are no longer necessary because the EPA is proposing that recordkeeping and reporting applicable to normal operations will apply to startup and shutdown. In the absence of special provisions applicable to startup and shutdown, such as a startup and shutdown plan, there is no reason to retain additional recordkeeping for startup and shutdown periods.
We are proposing to revise the Table 7 entry for 40 CFR 63.10(b)(2)(ii) by changing the “yes” in column 3 to a “no.” Section 63.10(b)(2)(ii) describes the recordkeeping requirements during a malfunction. A similar record is already required in 40 CFR 63.9350(c). The regulatory text in 40 CFR 63.9350(c) 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 63.9350(c) 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 63.9350(c) a requirement that sources keep records that include a list of the affected source or equipment and actions taken to minimize emissions, an estimate of the quantity of each regulated pollutant emitted over the standard for which the source failed to meet the standard, 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 to require that sources keep records of this information to ensure that there is adequate information to allow the EPA to determine the severity of any failure to meet a standard, and to provide data that may document how the source met the general duty to minimize emissions when the source has failed to meet an applicable standard.
We are proposing to revise the Table 7 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 63.9355(a).
We are proposing to revise Table 7 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 Table 7 entry for 40 CFR 63.10(c)(1)-(6), (9)-(15) by re-designating it as 40 CFR 63.10(c)(1)-(6), (9)-(14) and adding an entry for 40 CFR 63.10(c)(15) and including a “no” in column 3. The EPA is proposing that 40 CFR 63.10(c)(15) no longer apply. When applicable, the provision allows an owner or operator to use the affected source's SSM plan or records kept to satisfy the recordkeeping requirements of the SSM plan, specified in 40 CFR 63.6(e), to also satisfy the requirements of 40 CFR 63.10(c)(10) through (12). The EPA is proposing to eliminate this requirement because SSM plans would no longer be required, and, therefore, 40 CFR 63.10(c)(15) no longer serves any useful purpose for affected units.
We are proposing to revise Table 7 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 63.9350. The replacement language differs from the General Provisions
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 owners and operators of engine test cells/stands submit electronic copies of required performance test reports, performance evaluation reports, and semiannual compliance reports through the EPA's Central Data Exchange (CDX) using the Compliance and Emissions Data Reporting Interface (CEDRI). A description of the electronic data submission process is provided in the memorandum,
For the semiannual compliance reports the proposed rule requires that owners and operators use the appropriate spreadsheet template to submit information to CEDRI. A draft version of the proposed template for these reports is included in the docket for this rulemaking.
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 beyond their control. The situation where an extension may be warranted due to outages of either the EPA's CDX or CEDRI which precludes an owner or operator from accessing the system and submitting required reports is addressed in proposed 40 CFR 63.9350(i). The situation where an extension may be warranted 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 proposed 40 CFR 63.9350(j). Examples of such events are acts of nature, acts of war or terrorism, or equipment failure or safety hazards beyond the control of the facility.
The electronic submittal of the reports addressed in this proposed rulemaking, when finalized, 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 correction:
• Revising the monitoring requirements in 40 CFR 63.9307 to add THC as a continuous emission monitoring option and to add Performance Specification 8A and EPA Method 25A;
• Revising the initial compliance requirements in 40 CFR 63.9320 to include a provision for the performance test to be used to demonstrate compliance;
• Revising Tables 3 and 4 to 40 CFR part 63, subpart PPPPP, to add alternative compliance option; and
• Revising section 40 CFR 63.9350 to address the reporting of performance tests and performance evaluations.
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 May 8, 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 PPPPP, 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 PPPPP. 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 timeframe 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 59 engine test cells/stands facilities operating in the United States that conduct engine testing operations and are subject to the Engine Test Cells/Stands NESHAP. The 40 CFR part 63, subpart PPPPP, affected source is the collection of all equipment and activities associated with engine test cells/stands used for testing uninstalled stationary or uninstalled mobile engines located at a major source of HAP emissions. A new or reconstructed affected source is a completely new engine testing source that commenced construction after May 14, 2002, or meets the definition of reconstruction and commenced reconstruction after May 14, 2002.
At the current level of control, emissions of total HAP are estimated to be approximately 163 tpy. This represents a reduction in HAP emissions of about 80 tpy due to the current (2003) Engine Test Cells/Stands NESHAP. The proposed amendments will require all affected sources subject to the emission standards in the Engine Test Cells/Stands NESHAP to operate without the SSM exemption. We do not expect that eliminating the SSM exemption will result in reduced emissions since the NESHAP requires that the operating limits established during the performance test for demonstrating continuous compliance must be met at all times.
Indirect or secondary air emissions impacts are impacts that would result from the increased electricity usage associated with the operation of control devices (
We estimate that each facility in the source category will experience costs as a result of these proposed amendments that are estimated as part of the reporting and recordkeeping costs. 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. The recordkeeping and reporting costs are presented in section VIII.C of this preamble.
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 associated with the proposed requirements 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.
Based on the costs associated with the elimination of the SSM exemption and the costs associated with the requirement to electronically submit compliance reports presented in section VIII.C of this preamble, there are no significant economic impacts from these proposed amendments
The EPA did not propose changes to the emission limit requirements and estimates the proposed changes to SSM, recordkeeping, reporting, and monitoring are not economically significant. Because these proposed amendments are not considered economically significant, as defined by Executive Order 12866, and because no emission reductions were estimated, we did not estimate any benefits from reducing emissions.
We solicit comments on 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.
We specifically solicit comment on an additional issue under consideration that could reduce regulatory burden for owners or operators of certain engine test cells/stands facilities. Currently, if an affected source owner or operator elects to comply with the percent reduction emission limitation, an initial performance test must be conducted to determine the capture and control efficiencies of the equipment and to establish the operating limits to be achieved on a continuous basis. Performance tests are to be conducted under representative operating conditions and the source is required to document the operating conditions during the test and explain why the conditions represent normal operation. Industry stakeholders have raised the issue that, for facilities with multiple test cells/stands, it is difficult to define “normal” operation due to the several types of engine tests conducted, the varying operation conditions for the engine tests, the number of cells/stands, different kinds of test fuels, and the complex emission capture system. Thus, affected sources have felt the need to request approval on the testing protocol prior to conducting the performance tests to limit tests to representative cells. We are requesting comment on whether this process of requesting prior approval for determining what is considered “normal” operation for a specific affected facility is reasonable and appropriate for the one-time required performance test.
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-2018-0753 (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 Information Collection Request (ICR) document that the EPA prepared has been assigned EPA ICR number 2066.08. 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 Engine Test Cells/Stands 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 part 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. During the original rulemaking, an ICR was sent to over 100 companies representing over 300 individual facilities. Using that information, along with discussion with industry stakeholders, it was determined that there were no major sources that were also small businesses. 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. The action affects private industry and does not impose economic costs on state or local governments.
This action does not have tribal implications as specified in Executive Order 13175. The EPA does not know of any engine test cell/stand 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 significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
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, Engine test cells/stands, Hazardous substances, Incorporation by reference, 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
(a)
(2) If you start up your new or reconstructed affected source on or after May 27, 2003, you must comply with the emission limitations in this subpart upon startup; except that if the initial startup of your new or reconstructed affected source occurs after May 27, 2003, but on or before May 8, 2019, the compliance date for the revised requirements promulgated at §§ 63.9295, 63.9305, 63.9340, 63.9350, 63.9355, 63.9375, and Table 7 of this subpart published on [DATE OF PUBLICATION OF FINAL RULE IN THE
(3) If the initial startup of your new or reconstructed affected source occurs after May 8, 2019, the compliance date is [DATE OF PUBLICATION OF FINAL RULE IN THE
(a) Prior to [DATE 181 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(b) If you must comply with the emission limitation, you must operate and maintain your engine test cell/stand, air pollution control equipment, and monitoring equipment in a manner consistent with safety and good air pollution control practices for minimizing emissions at all times. The general duty to minimize emissions does not require the owner or operator to make any further efforts to reduce emissions if levels required by the applicable standard have been achieve. Determination of whether a source is operating in compliance with operation and maintenance requirements will be based on information available to the Administrator that may include, but is not limited to, monitoring results, review of operation and maintenance procedures, review of operation and maintenance records, and inspection of the affected source.
(c) For affected sources until [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(c) To comply with either emission limitations, the CEMS must be installed and operated according to the requirements described in paragraphs (c)(1) through (4) of this section.
(1) You must install, operate, and maintain each CEMS according to the applicable Performance Specification (PS) of 40 CFR part 60, appendix B (PS- 3, PS-4A, or PS-8).
(2) You must conduct a performance evaluation of each CEMS according to the requirements in 40 CFR 63.8 and according to PS-3 of 40 CFR part 60, appendix B, using Reference Method 3A or 3B for the O
(4) All CEMS data must be reduced as specified in § 63.8(g)(2) and recorded as CO or THC as carbon concentration in parts per million by volume, dry basis (ppmvd), corrected to 15 percent O
(b) You must conduct an initial performance evaluation of each capture and control system according to §§ 63.9321, 63.9322, 63.9323 and 63.9324, and each CEMS according to the requirements in 40 CFR 63.8 and according to the applicable Performance Specification of 40 CFR part 60, appendix B (PS- 3, PS-4A, or PS-8).
(c) The initial demonstration of compliance with the carbon monoxide (CO) or total hydrocarbon (THC) concentration limitation consists of either the first 4-hour rolling average CO or THC concentration recorded after completion of the CEMS performance evaluation if CEMS are installed or the average of the test run averages during the initial performance test. You must correct the CO or THC concentration at the outlet of the engine test cell/stand or the emission control device to a dry basis and to 15 percent O
(a) You must demonstrate initial compliance with the emission limitation that applies to you according to Table 4 to this subpart.
(c)
(2) The Administrator will determine whether deviations that occur during a period you identify as an SSM of control devices and associated monitoring equipment are violations, according to the provisions in § 63.6(e).
The revisions and additions read as follows:
(a) * * *
(6) For affected sources until [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN
(7) Beginning on [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN
(c) For each deviation from an emission limit, the semiannual compliance report must include the information in paragraphs (b)(1) through (3) of this section and the information included in paragraphs (c)(1) through (4) of this section, except that after [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN
(5) 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.
(d) For each CEMS or CPMS deviation, the semiannual compliance report must include the information in paragraphs (b)(1) through (3) of this section and the information included in paragraphs (d)(1) through (10) of this section, except that after [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN
(11) The total operating time of each new or reconstructed engine test cell/stand during the reporting period.
(e) Until [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN THE
(f) Within 60 days after the date of completing each performance test or performance evaluation required by this subpart, you must submit the results of the performance test following the procedures specified in paragraphs (f)(1) through (3) of this section.
(1) Data collected or performance evaluations of CMS measuring relative accuracy test audit (RATA) pollutants using test methods supported by the EPA's Electronic Reporting Tool (ERT) as listed on the EPA's ERT website (
(2) Data collected or performance evaluations of CMS measuring relative accuracy test audit (RATA) pollutants using test methods that are not supported by the EPA's ERT as listed on the EPA's ERT website at the time of the test. The results of the performance test or performance evaluation must be included as an attachment in the ERT or an alternate electronic file consistent with the XML schema listed on the EPA's ERT website. Submit the ERT generated package or alternative file to the EPA via CEDRI.
(3)
(g) If you are required to submit reports following the procedure specified in this paragraph, you must submit reports to the EPA via CEDRI, which can be accessed through the EPA's Central Data Exchange (CDX) (
(h) If you are required to electronically submit a report through CEDRI in the EPA's CDX, you may assert a claim of EPA system outage for failure to timely comply with the reporting requirement. To assert a claim of EPA system outage, you must meet the requirements outlined in paragraphs (h)(1) through (7) of this section.
(1) You must have been or will be precluded from accessing CEDRI and submitting a required report within the time prescribed due to an outage of either the EPA's CEDRI or CDX systems.
(2) The outage must have occurred within the period of time beginning five business days prior to the date that the submission is due.
(3) The outage may be planned or unplanned.
(4) You must submit notification to the Administrator in writing as soon as possible following the date you first knew, or through due diligence should have known, that the event may cause or has caused a delay in reporting.
(5) You must provide to the Administrator a written description identifying:
(i) The date(s) and time(s) when CDX or CEDRI was accessed and the system was unavailable;
(ii) A rationale for attributing the delay in reporting beyond the regulatory deadline to EPA system outage;
(iii) Measures taken or to be taken to minimize the delay in reporting; and
(iv) The date by which you propose to report, or if you have already met the reporting requirement at the time of the notification, the date you reported.
(6) The decision to accept the claim of EPA system outage and allow an extension to the reporting deadline is solely within the discretion of the Administrator.
(7) In any circumstance, the report must be submitted electronically as soon as possible after the outage is resolved.
(i) If you are required to electronically submit a report through CEDRI in the EPA's CDX, you may assert a claim of force majeure for failure to timely comply with the reporting requirement. To assert a claim of force majeure, you must meet the requirements outlined in paragraphs (i)(1) through (5) of this section.
(1) You may submit a claim if a force majeure event is about to occur, occurs, or has occurred or there are lingering effects from such an event within the period of time beginning five business days prior to the date the submission is due. For the purposes of this section, a force majeure event is defined as an event that will be or has been caused by circumstances beyond the control of the affected facility, its contractors, or any entity controlled by the affected facility that prevents you from complying with the requirement to submit a report electronically within the time period prescribed. Examples of such events are acts of nature (
(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) You must keep the records as described in paragraphs (a)(1) through (5) of this section. After [DATE OF PUBLICATION OF FINAL RULE IN
(3) Records of the occurrence and duration of each malfunction of the air pollution control equipment, if applicable, as required in § 63.9355.
(6) In the event that an affected unit fails to meet an applicable standard, record the number of failures. For each failure record the date, time and duration of each failure.
(7) For each failure to meet an applicable standard, record and retain a list of the affected sources or equipment, an estimate of the quantity of each regulated pollutant emitted over any emission limit, and a description of the method used to estimate the emissions.
(8) Record actions taken to minimize emissions in accordance with § 63.9305, and any corrective actions taken to return the affected unit to its normal or usual manner of operation.
(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.
(3) Until [DATE 180 DAYS AFTER DATE OF PUBLICATION OF FINAL RULE IN
As stated in § 63.9321, you must demonstrate initial compliance with each emission limitation that applies to you according to the following table:
As stated in § 63.9330, you must demonstrate initial compliance with each emission limitation that applies to you according to the following table:
As stated in § 63.9340, you must demonstrate continuous compliance with each emission limitation that applies to you according to the following table:
As stated in 63.9365, you must comply with the General Provisions in §§ 63.1 through 63.15 that apply to you according to the following table: