Agricultural Marketing Service
Forest Service
Economic Analysis Bureau
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Army Department
Federal Energy Regulatory Commission
Agency for Healthcare Research and Quality
Food and Drug Administration
Health Resources and Services Administration
Coast Guard
Federal Emergency Management Agency
U.S. Immigration and Customs Enforcement
Fish and Wildlife Service
Drug Enforcement Administration
Employment and Training Administration
Federal Aviation Administration
Federal Motor Carrier Safety Administration
Federal Railroad Administration
Internal Revenue Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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In Rule Document C1-2023-19269, appearing on page 69873 in the issue of Tuesday, October 10, 2023, make the following correction:
Office of the Secretary, USDA.
Final rule.
This document revises the delegations of authority from the Secretary of Agriculture and general officers of the U.S. Department of Agriculture (USDA) to reflect changes and additions to the delegations as summarized below.
Effective October 12, 2023.
Melissa McClellan, Office of the General Counsel, (202) 720-5565,
This rule amends the delegations of authority in 7 CFR part 2 to reflect changes to the organizational structure of the Office of Partnerships and Public Engagement (OPPE). This includes removing the delegations of authority by the Director, OPPE to the Director, Office of Advocacy and Outreach (OAO) at section 2.700, as OAO is no longer a separate entity within OPPE. In addition, this rule reflects the transfer of oversight of the 1994 Tribal Scholars Program from the Director of OPPE (section 2.38) to the Director of the Office of Tribal Relations (section 2.39) and the transfer of oversight of the Centers for Faith Based and Neighborhood Partnerships from the Director of OPPE to the Assistant Secretary for Congressional Relations (section 2.23).
This rule also amends the delegations of authority to reflect the transfer of responsibility for USDA's Controlled Unclassified Information Program from the Assistant Secretary for Administration (section 2.24) and the Executive Director of the Office of Homeland Security (section 2.95) to the Chief Information Officer (section 2.32).
Finally, this rule amends the delegations to the Under Secretary for Natural Resources and Environment (section 2.16) and the Chief of the Forest Service (section 2.60) to authorize the Forest Service's Law Enforcement and Investigations staff to enforce and investigate violations of the Lacey Act, 16 U.S.C. 3371-3378, involving timber and timber products. These delegations do not affect the existing delegations of authority under the Lacey Act to the Under Secretary for Marketing and Regulatory Programs and the Administrator of the Animal and Plant Health Inspection Service.
This rule relates to internal agency management. Accordingly, pursuant to 5 U.S.C. 553, notice of proposed rulemaking and opportunity for comment are not required, and this rule may be made effective less than 30 days after publication in the
Authority delegations (Government agencies).
Accordingly, as discussed in the preamble, 7 CFR part 2 is amended as follows:
7 U.S.C. 6912(a)(1); 5 U.S.C. 301; Reorganization Plan No. 2 of 1953, 3 CFR 1949-1953 Comp., p. 1024.
(a) * * *
(2) * * *
(xliii) Enforce and conduct investigations of violations of the Lacey Act, which prohibits importing or exporting any plant or plant product in interstate or foreign commerce in violation of any Federal, State, Tribal, or foreign law regulating plants or plant products (16 U.S.C. 3371-3378).
(a) * * *
(2) * * *
(v) Oversee the Center for Faith Based and Neighborhood Partnerships.
(a) * * *
(14) Administer the Controlled Unclassified Information (CUI) Program for the Department pursuant to E.O. 13556, “Controlled Unclassified Information” (75 FR 68675, 3 CFR, 2011 Comp., p. 267) and 32 CFR part 2002.
(a) * * *
(9) Administer the USDA/1994 Land Grant Institutions (Tribal Colleges) Programs.
(a) * * *
(45) Enforce and conduct investigations of violations of the Lacey Act, which prohibits importing or exporting any plant or plant product in interstate or foreign commerce in violation of any federal, state, Tribal, or foreign law regulating plants or plant products (16 U.S.C. 3371-3378).
The Secretary of Agriculture, Thomas J. Vilsack, having reviewed and approved this document, is delegating the authority to electronically sign this document to Mary Beth Schultz, Acting General Counsel, for purposes of publication in the
In rule document 2023-20343, appearing on pages 66966 through 67041 in the issue of Thursday, September 28, 2023, make the following correction:
On page 66967, in Table I.1, in the fifth column, on the third line, “September 28, 2025” should read “September 28, 2027”.
U.S. Small Business Administration.
Final rule.
SBA is adopting with changes the interim final rule published in the
The effective date of this final rule is November 13, 2023.
Gregorius Suryadi, Senior Financial and Loan Specialist, 504 Program Branch, Office of Financial Assistance, Small Business Administration, 409 3rd Street SW, Washington, DC 20416; telephone: (202) 205-6806; email:
The 504 Loan Program is an SBA financing program authorized under title V of the Small Business Investment Act of 1958, 15 U.S.C. 695
In addition, the 504 Loan Program may be used to refinance debt under two options authorized under section 502(7)(B) and (C) of the Small Business Investment Act of 1958. First, if a 504 Project involves the expansion of the small business, any amount of existing indebtedness that does not exceed 50 percent of the project cost of the expansion may be refinanced and added to the project's cost (Debt Refinancing with Expansion) under the conditions set forth in section 502(7)(B) and the implementing regulations.
Section 328(a) of the Economic Aid to Hard-Hit Small Businesses, Nonprofits, and Venues Act (Economic Aid Act), enacted December 27, 2020, Public Law 116-260, revised the conditions and requirements for refinancing debt in the 504 Loan Program as follows:
(1) With respect to Debt Refinancing with Expansion, 13 CFR 120.882(e), the Economic Aid Act increased the amount of existing indebtedness that may be refinanced as part of a 504 Project from not more than 50 percent of the project cost of the expansion to not more than 100 percent of the project cost;
(2) With respect to Debt Refinancing without Expansion, 13 CFR 120.882(g), the Economic Aid Act:
(a) Eliminated the condition that this program shall only be in effect in any fiscal year during which the cost to the Federal Government of making guarantees under 13 CFR 120.882(g) and under the 504 Loan Program is zero;
(b) Eliminated the requirement that a CDC limit its financing under the 504 Loan Program so that, during any Federal fiscal year, new financings under 13 CFR 120.882(g) do not exceed 50% of the dollars the CDC loaned under the 504 Loan Program, including under 13 CFR 120.882(g), during the previous fiscal year, unless otherwise waived;
(c) Eliminated the prohibition against Premier Certified Lender Program (PCLP) CDCs using delegated authority to approve loan applications for Debt Refinancing without Expansion;
(d) Reinstated an alternate job retention standard that was previously removed from the Debt Refinancing without Expansion Program by section 521 of division E of the Consolidated Appropriations Act, 2016 (2016 Consolidated Appropriations Act), enacted on December 18, 2015, Public Law 114-113;
(e) Revised the definition of “qualified debt” to mean debt that was incurred not less than six months before the date of application instead of two years before the date of application;
(f) Removed from the definition of “qualified debt” condition that the debt not be subject to a guarantee by a Federal agency; and
(g) Eliminated from the definition of “qualified debt” the requirement that the borrower be current on all payments for not less than one year before the date of the application for refinancing.
As described in the section-by-section analysis below, SBA is issuing this final rule to adopt the previously published interim final rule and to conform the current rules to the requirements of the Economic Aid Act.
On July 29, 2021, SBA published in the
In its place SBA inserted a provision that set forth the conditions and requirements that apply to the refinancing of a loan that is subject to a guarantee by a Federal agency or department. As indicated above, the Economic Aid Act removed the prohibition against refinancing a loan that is subject to a guarantee by a Federal agency or department. Although these loans may now be refinanced if the refinancing project does not involve expansion, the loan must comply with the following conditions and requirements:
(1) for an existing 504 loan, either both the Third Party Loan and the 504 loan must be refinanced, or the Third Party Loan must have been paid in full; and
(2) for an existing 7(a) loan, the CDC must verify in writing that the present lender is either unwilling or unable to modify the current payment schedule. In addition, in the case of same institution debt, if the Third Party Lender or the CDC affiliate as authorized under 13 CFR 120.820 is the 7(a) lender, the loan will be eligible for 504 refinancing only if the lender is unable to modify the terms of the existing loan because a secondary market investor will not agree to modified terms.
(3) the refinancing of any federally-guaranteed loan must provide a substantial benefit to the borrower. “Substantial benefit” means that the portion of the new installment amount attributable to the debt being refinanced must be at least 10 percent less than the existing installment amount(s). Prepayment penalties (including any subsidy recoupment fee), financing fees, and other financing costs must be added to the amount being refinanced in calculating the percentage reduction in the new installment payment. The portion of the new installment amount attributable to Eligible Business Expenses will not need to be included in this calculation. The rule allows the Director, Office of Financial Assistance (D/FA) or designee, to approve an exception to the 10 percent reduction requirement for good cause and does not allow PCLP CDCs to use their delegated authority to approve a loan requiring this exception.
SBA received 66 comments on this rule change, of which 50 supported the rule change with modifications. There were no comments opposing the rule change.
A national trade association and its member CDCs requested that SBA not include in regulation any conditions or requirements that restrict or limit the ability to refinance a loan that is subject to a guarantee by a Federal agency or department as no such conditions or restriction exists in statute or in the Economic Aid Act (EAA) update.
The national trade association and its member CDCs also recommended that SBA remove the requirement that CDCs obtain written verification of the existing 7(a) lender's inability or unwillingness to modify the current payment schedule as a requirement to allowing the refinance of an existing 7(a) loan. The national trade association
Another national trade association proposed safeguards of increasing the substantial benefit requirement for both 7(a) and 504 programs, which include, but are not limited to, the SBA issuing specific guidance on the underwriting for both programs. In addition, to protect the borrower from paying additional and significant fees, the national trade association recommended the SBA limit fees for new 504 loans. SBA feels that increasing the substantial benefit requirement as requested in a rising interest rate environment would not be in the best interest of the small business borrower.
Based on the public comments received, SBA is revising this rule to remove the requirement that CDCs and 7(a) lenders be given the opportunity to modify existing debt. Instead, SBA is transferring the burden of contacting the CDC or 7(a) lender whose debt is being refinanced from the borrower to the CDC that will be packaging the 504 loan for the borrower. The revised rule requires the CDC to notify in writing (by email or letter) the existing CDC or 7(a) lender to advise them in advance when a government guaranteed loan is being refinanced.
The alternate job retention standard provides that the number of employees of a borrower is equal to the sum of:
(1) the number of full-time employees of the borrower on the date on which the borrower applies for a loan under this subparagraph; and
(2) the product obtained by multiplying:
(a) the number of part-time employees of the borrower on the date on which the borrower applies for a loan under this subparagraph, by
(b) the quotient obtained by dividing the average number of hours each part-time employee of the borrower works each week by 40.
An example of how this standard is calculated is included in the text of the rule.
SBA did not receive any comments on this adjustment. The final rule adopts the interim final rule with one change, namely an increase in the amount per Job Opportunity that a 504 Loan Project must create from $75,000 to $90,000 as per SBA's announcement in the
Second, paragraph (i) of the definition of “Qualified debt” (redesignated as paragraph (A)) previously allowed a loan that was refinanced within the two years before the date of application (the most recent loan) to be deemed incurred not less than two years before the date of the application provided that the effect of the most recent loan was to extend the maturity date without advancing any additional proceeds. With the minimum age of the qualified debt shortened from two years to six months, SBA believed that it was no longer necessary to address this situation and therefore SBA removed the second and third sentences of paragraph (i) (redesignated as paragraph (A)).
Third, paragraph (ii) of the definition of “Qualified debt” previously excluded debt that was subject to a guarantee by a Federal agency or department. As stated above, section 328(a) of the Economic Aid Act removed this statutory exclusion and SBA consequently removed this paragraph and renumbered the remaining paragraphs accordingly. The conditions and requirements that apply to the refinancing of a loan that is subject to a Federal guarantee are set forth in paragraph (g)(3).
Fourth, paragraph (vi) of the definition of “Qualified debt” previously excluded a Third Party Loan that is part of an existing 504 Project. However, under the new paragraph (g)(3), an existing 504 loan may be refinanced when both the Third Party Loan and the 504 loan are being refinanced. Accordingly, SBA revised this paragraph, which was redesignated as paragraph (E), to incorporate this exception to the general prohibition against a qualified debt including a Third Party Loan.
Fifth, paragraph (vii) of the definition of “Qualified debt” previously reflected the statutory requirement that, for the debt to qualify for refinancing, the applicant had to be current on all payments due for not less than one year preceding the date of application. Because section 328(a) of the Economic Aid Act removed this requirement from section 502(7)(C) of the Small Business Investment Act, SBA removed this paragraph from the regulations. In accordance with prudent lending standards, SBA expects CDCs to consider whether the applicant is current on all payments due, and the applicant's history of delinquency, in its credit analysis. SBA did not receive any comments on these specific revisions and is adopting the revisions as set forth in the interim final rule.
SBA did however receive comments from a national trade association and its member CDCs requesting that SBA lower the Qualified debt definition's standard of “substantially all (85% or
Finally, the phrase “Same institution debt” was previously used with Debt Refinancing without Expansion only in reference to the Third Party Loan,
Since the publication of the interim final rule SBA conducted a series of roundtable discussions with CDCs and lenders at annual and regional events. In alignment with the adjustment with jobs created/retained due to the CPI, SBA received multiple comments during the regional roundtables for an inflation adjustment also to update § 120.883, Eligible administrative costs for 504 loans, in paragraph (e) which currently limits of the amount of CDC closing fees allowed to be included in 504 financing portion of a project to be capped at $2,500. In alignment with these changes and in an attempt to keep the limit of CDC closing costs relevant to administrative costs, SBA is proposing an increase to the legal fees. According to the public comments, this cap does not reflect current administrative costs and creates a burden on the borrower to pay for closing expenses from its own account. In the final rule, SBA increases the amount from $2,500 to $10,000.
The Office of Management and Budget (OMB) has determined that this rule constitutes a “significant regulatory action” for purposes of Executive Orders 12866 and 13563. SBA, however, is proceeding under the emergency provision at Executive Order 12866, section 6(a)(3)(D), based on the need to move expeditiously to mitigate the current conditions arising from the COVID-19 pandemic.
As shown in Table 1 below, during the five-year period spanning fiscal year (FY) 2018 and FY 2022, a total of 38,022 504 loans were approved for a total gross approval amount as of September 30, 2022, of $32,965,182,830. In addition, during this five-year period, SBA approved 247 debt refinance with expansion loans on average per year with an average annual dollar volume of $309,165,400, and approved 451 debt refinance without expansion loans on average per year with an average annual dollar volume of $469,596. The Economic Aid Act passage increased the debt refinance with expansion from 50 percent of a project to 100 percent of a project. Prior to this change, of the debt refinance with expansion loans, only 16 refinanced a debt that equaled 50 percent of the expansion costs; if these borrowers had been able to refinance 100 percent of the expansion costs instead of 50 percent, and assuming that all these borrowers did so, these borrowers would have been able to borrow $15 million more over five years, or about $3 million more annually. Since the passage of the Economic Aid Act, and the issuance of the interim final rule, there have been 746 504 loan refinancing with expansion projects approved for a total of $1,030,563,000 approved. This legislative change has expanded the access to capital to small business for expansion projects that also need debt refinancing.
Data as of 9/15/2023, total dollar volume is lifetime gross approval amount including increases.
This rule was necessary to implement the Economic Aid Act and provide economic relief to small businesses adversely impacted by COVID-19. SBA anticipates that finalizing these changes to the 504 debt refinancing programs will continue to result in benefits to
To assess the impact of the interim final rule, SBA evaluated 504 loan activity (including the number of loans and dollar volume of both debt refinance with and without expansion) between August 2018 and July 2023. Because the interim final rule was published on July 29, 2021, with immediate effectiveness, the first full month during which the modifications to 504 debt refinancing were available was August 2021, with August 2021 through July 2022 being the first 12-month period during which the modifications to 504 debt refinancing were available to 504 applicants. SBA divided the data into five cohorts of 12 months each, with the first cohort beginning in August 2018 and the last cohort beginning August 2023. See Table 2.
As an appropriate baseline for evaluation of the impacts of the interim final rule that would be made permanent in this rule, SBA considers the state of 504 lending for debt refinance with expansion and without expansion before July 2021. SBA examines the 12-month periods from August 1, 2018, through July 31, 2019, to the period from August 1, 2022, to July 31, 2023, noting that external influences from the pandemic and from the payments made on behalf of borrowers by SBA under section 1112 of the Coronavirus Aid Recovery, and Economic Security Act (Section 1112 Payments) that ended in September 2021 occurred. The Section 1112 Payments required SBA to make principal and interest payments on 504 loans for certain periods of time depending on the when the 504 loan was approved, which would have made a 504 loan an attractive option for small businesses and consequently would have increased 504 loan volume. Further, interest rates on 504 loans in these two periods differ, from a range of approximately 4.0 to 5.0 percent in the earlier period to rates up to 7.0 percent in the later period, as do rates on alternatives to 504 loans. These changes mean that lending total volume comparisons may not be appropriate for assessment of impact. Because the major changes in the interim final rule were the increases in the amounts of existing indebtedness that may be refinanced for both 504 debt involving expansions and 504 debt not involving expansions, SBA examined the percentages of 504 lending that were for these two types of debt refinancing. The chart below shows these percentages for five August-July cohorts.
As indicated in the chart, the percentages of 504 debt refinancing loans with and without expansion are in the recent period returning to the levels seen prior to the publication of the interim final rule in July 2021. For debt refinancing without expansion, the August 2020-July 2021 period was elevated and the August 2021-July 2022 cohort was an outlier, but the next 12 months settled to a percentage that at a level consistent with the periods before the interim final rule and not indicative of a significant impact. These two cohorts with higher percentages were during the pandemic and were covered, at least in part, by Section 1112 Payments. The 12-month percentages of 504 debt refinancing with expansion did not vary widely.
The interim final rule increased the amounts on 504 debt refinancing with and without expansion. Aggregate 504 lending over the period in question ranged from approximately $5 billion to almost $9.25 billion, with total 504 lending in the latest 12-month cohort at about $6.6 billion. Even in the unlikely scenario of the interim final rule as the sole cause of an increase in total 504 lending from the low volume in the examined period of $5 billion (in 2018-19) to the latest 12-month total of $6.6 billion, the incremental impact, as indicated by changes in the percentage of total lending accounted for by each, is under $100 million.
OMB's Office of Information and Regulatory Affairs has determined that this rule is not a major rule under Subtitle E of the Small Business Regulatory Enforcement Fairness Act of 1996 (also known as the Congressional Review Act), 5 U.S.C. 804(2). Per the above cost benefit analysis, the annual effect on the economy is less than $100 million.
This action meets applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden. The action does not have preemptive effect or retroactive effect.
This rule does not have federalism implications as defined in Executive Order 13132. 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, as specified in the Executive order. As such it does not warrant the preparation of a Federalism Assessment.
In order to implement the Act, SBA determined that it was necessary to modify SBA Form 1244,
(a) The information collection previously required PCLP CDCs to process all applications for debt refinancing without expansion through the Sacramento Loan Processing Center (SLPC) and not through the PCLP CDC's delegated authority. As discussed above, this requirement was removed by the Economic Aid Act and, accordingly, SBA removed the requirement from the information collection when the interim final rule (IFR) was released in 2021. The final rule would result in no further changes. This revision did not change the information the PCLP CDC is required to collect, only how the application is processed. In addition, consistent with the changes made by the
(b) With respect to the question regarding whether the Applicant creates or retains the required number of jobs per debenture amount, an option has been added for the Applicant to indicate whether the project is eligible under the 504 debt refinance alternate job standard reinstated by the Economic Aid Act.
(c) Of the exhibits that are required, Exhibit 20 required that if the debt had been refinanced within two years of the date of application, non-PCLP CDCs had to submit with the application (and PCLP CDCs had to retain in the loan file) copies of the current debt and lien instruments as well as copies of the debt and lien instruments for the debt that was replaced by the current debt. With the minimum age of the qualified debt shortened from two years to six months by the Economic Aid Act, SBA revised the form to remove the requirement that these debt and lien instruments be included as part of Exhibit 20.
In addition to the changes resulting from this rule, SBA made the following technical corrections and clarifying changes to Form 1244: (1) SBA corrected the description of which exhibits the CDC must retain and which the CDC must submit with the loan application; (2) SBA added a separate entry to facilitate disclosure of the use of refinancing proceeds involving land purchases only (the previous format of “Land/Building” did not clearly indicate how information is to be reported); and (3) under the list of economic development objectives met by the project, SBA added references to “base closures” and “minority-owned business”.
When an agency issues a rulemaking, the Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612, requires the agency to “prepare and make available for public comment an initial regulatory analysis” which will “describe the impact of the proposed rule on small entities.” Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the proposed rulemaking is not expected to have a significant economic impact on a substantial number of small entities.
The changes in the final rule are a codification of new legislation and will involve changes to regulations at 13 CFR 120.882, however there will be no changes to SBA Form 1244, and the burden hours to the small business concern and the Certified Development Company will remain the same. There are no anticipated additional compliance costs. Furthermore, SBA does not anticipate that any changes to the Eligible Project costs for 504 loans regulations would have a significant impact to a substantial number of small businesses. This is because only a small percentage of each year's 504 loans involve debt refinancing without expansion. Each loan represents a unique small business borrower because these borrowers are only eligible to refinance their debt once in a fiscal year with the 504 Loan Program, and therefore do not have multiple 504 debt refinancing without expansion loans in any given year. Based on the average number of 504 loans from FY 2021-2023, only 13% involved debt refinancing without expansion. Specifically, in FY 2021, out of 9,676 loans, 693 loans or 7% were for debt refinancing without expansion. In FY 2022, this figure was 829 out of 9,254 or 9% 504 loans, while in FY 2023, 1,005 out of 4,451 or 23% of 504 loans were for debt refinancing without expansion. While the percentage of the 504 loan portfolio involving debt refinancing without expansion increased by 20% from FY 2021 to 2023, this increase was due in part to the Section 1112 Payments, and in part to a rapidly increasing interest rate environment. The Section 1112 Payments have sunset and SBA anticipates some adjustment due to the continued interest rate increases planned by the Federal Reserve. Because Section 1112 Payments have sunset, SBA believes that the 504 debt refinancing without expansion volume will return to the pre-section 1112 level of less than 10% of small entities. As such, SBA concludes that the rule will not impact a substantial number of small entities.
While the economic implications of the final rule are small and the data do not reveal a significant economic impact on a substantial number of small entities, SBA anticipates a refinancing growth rate more in alignment with pre-pandemic levels, with some adjustment to the economic impact because the final rule will expand program eligibility. SBA analyzed potential growth scenarios of up to 30% growth in the 504 loan program, and even using this impact model (actual growth has never exceeded 15% in any prior fiscal year) the total of 504 debt refinance without expansion projects as a percentage of either number of loans or dollar volume of loans is not estimated to exceed 16% of the overall portfolio. When this percentage is applied to the estimated number of loans (small businesses impacted), this would result in less than 1,100 small businesses impacted. SBA estimates that the average monthly savings for small businesses that refinance their existing loans through the 504 loan program would be between $7,000 to $8,300 per month, with a total estimated savings over the life of the loan of between $180,000 to $205,000. SBA determined this estimate based on the historical average of a 504 debt refinancing without expansion loan averaging $1,000,000 for each small business applicant. SBA used the 504 July 2023 interest rates to calculate both the monthly and total loan savings to each small business concern. The lower end of the $180,000 to $205,000 range reflects the economic impact if a small business concern refinanced for 20 years, while the higher end reflects the economic impact of a small business concern refinanced for 25 years. Small business concerns do not use 10 year 504 loans for debt refinancing without expansion, as their goal is to lower their payments by not only taking advantage of the 504 loan program's fixed interest rate, but also the longer 20 and 25-year loan terms available.
For the reasons stated above, SBA certifies that this action would not have a significant economic impact on a substantial number of small entities.
Loan programs-business, Reporting and recordkeeping requirements, Small businesses.
Accordingly, the interim rule amending 13 CFR part 120, which was published at 86 FR 40775 on July 29, 2021, is adopted as final with the following changes:
15 U.S.C. 634(b) (6), (b) (7), (b) (14), (h), and note, 636(a), (h) and (m), 650, 687(f), 696(3) and (7), and 697(a) and (e); sec. 521, Pub. L. 114-113, 129 Stat. 2242; sec. 328(a), Pub. L. 116-260, 134 Stat. 1182.
The revisions read as follows:
(g) * * *
(3) A loan that is subject to a guarantee by a Federal agency or department may be refinanced under the following conditions and requirements:
(i) An existing 504 loan may be refinanced if both the Third Party Loan and the 504 Loan are being refinanced or the Third Party Loan has been paid in full. If the 504 Loan being refinanced received approval through another CDC, the CDC working on the current refinancing must provide advance notice to the other CDC in writing (by email or letter).
(ii) An existing 7(a) loan may be refinanced if the CDC notifies the 7(a) lender in advance in writing (by email or letter).
(iii) The refinancing will provide a substantial benefit to the borrower. For purposes of this paragraph (g)(3)(iii), “substantial benefit” means that the portion of the new installment amount attributable to the debt being refinanced must be at least 10 percent less than the existing installment amount(s). Prepayment penalties (including subsidy recoupment fees), financing fees, and other financing costs must be added to the amount being refinanced in calculating the percentage reduction in the new installment payment, but the portion of the new installment amount attributable to Eligible Business Expenses (as described in paragraph (g)(6)(ii) of this section) is not included in this calculation. Exceptions to the 10 percent reduction requirement may be approved by the Director, Office of Financial Assistance (D/FA) or designee for good cause. PCLP CDCs may not use their delegated authority to approve a loan requiring the exception in this paragraph (g)(3)(iii).
(15) Notwithstanding § 120.860, a debt may be refinanced under this paragraph (g) if it does not meet the job creation or other economic development objectives set forth in § 120.861 or § 120.862. In such case, the 504 loan may not exceed the product obtained by multiplying the number of employees of the Borrower by $90,000. The number of employees of the Borrower is equal to the sum of:
(i) The number of full-time employees of the Borrower on the date of the application; and
(ii) The product obtained by multiplying:
(A) The number of part-time employees of the Borrower on the date of the application; by
(B) The quotient obtained by dividing the average number of hours each part-time employee of the Borrower works each week by 40.
(e) CDC Closing Fee (see § 120.971(a)(2)) up to a maximum of $10,000; and
Executive Office for Immigration Review, Department of Justice.
Interim final rule; request for comment.
The Department of Justice (“Department”) is revising its regulations to provide that the Attorney General may, in his discretion, review decisions and orders of Administrative Law Judges (“ALJs”) in the Office of the Chief Administrative Hearing Officer (“OCAHO”) in cases arising under section 274B of the Immigration and Nationality Act (“INA” or “the Act”). This revision will ensure that the adjudicatory process for section 274B cases is consistent with the Supreme Court's decision in the 2021 case
If you wish to provide comment regarding this rulemaking, you must submit comments, identified by the agency name and reference RIN 1125-AB28 or EOIR Docket No. 022-0010, by one of the two methods below.
•
•
Raechel Horowitz, Chief, Immigration Law Division, Office of Policy, Executive Office for Immigration Review, 5107 Leesburg Pike, Suite 1800, Falls Church, VA 22041, telephone (703) 305-0289 (not a toll-free call).
Interested persons are invited to participate in this rulemaking by submitting written data, views, or arguments on all aspects of this interim final rule (“IFR”) via one of the methods and by the deadline stated above. The Department also invites comments that relate to the economic, environmental, or federalism effects that might result from this IFR. Comments that will provide the most assistance to the
Please note that all comments received are considered part of the public record and made available for public inspection at
If you want to submit personally identifying information (such as your name, address, etc.) as part of your comment, but do not want it to be posted online, you must include the phrase “PERSONALLY IDENTIFYING INFORMATION” in the first paragraph of your comment and identify what information you want redacted.
If you want to submit confidential business information as part of your comment, but do not want it to be posted online, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You also must prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted on
Personally identifying information located as set forth above will be placed in the agency's public docket file, but not posted online. Confidential business information identified and located as set forth above will not be placed in the public docket file. The Department may withhold from public viewing information provided in comments that it determines may impact the privacy of an individual or is offensive. For additional information, please read the Privacy Act notice that is available via the link in the footer of
OCAHO is a component of the Department's Executive Office for Immigration Review (“EOIR”).
The INA provides instruction regarding the finality of and available appellate procedures for OCAHO ALJ orders under sections 274A, 274B, and 274C of the Act, 8 U.S.C. 1324a, 1324b, and 1324c.
The Supreme Court's decision in
The Appointments Clause of the Constitution sets out the manner in which “Officers of the United States” who exercise significant governmental authority must be appointed. U.S. Const. art. II, sec. 2, cl. 2;
In
The Department has examined its current regulation governing cases arising under section 274B of the Act, 8 U.S.C. 1324b, in light of the principles outlined in
The Department's current regulation provides that, in cases arising under section 274B of the Act, 8 U.S.C. 1324b, an ALJ's decision “becomes the final agency order on the date the order is issued” and does not expressly provide for administrative review. 28 CFR 68.52(g). This regulation could be read to prevent further review by the Attorney General, which would make it comparable to the statutory scheme in
Following the Supreme Court's decision in
Specifically, this understanding of section 274B of the Act, 8 U.S.C. 1324b, is most consonant with general administrative law principles. As the Office of Legal Counsel has previously explained, “[u]nder the APA, `final agency action' is generally understood to mean that action which is necessary and sufficient for judicial review.”
Indeed, throughout the Executive Branch, including in other Department components that utilize ALJs, ALJs render “initial decisions,” sometimes called “recommended decisions,” in certain cases that the agency can review further or, if there is no appeal or referral, become final agency decisions.
In addition to the above conclusion that this reading of the term “final agency action” is most consonant with general administrative law practices, the analysis in
Relatedly, ensuring that the Attorney General has the opportunity to review ALJ decisions is informed by the remedy that the Supreme Court prescribed in
Given the general principles of administrative law, the well-settled meaning of the word “final” in this context, the fact that head-of-agency review of ALJ decisions is the APA norm, and possible constitutional concerns with granting ALJs final decision-making authority not subject to further agency review, the Department declines to read the statute as precluding Attorney General review.
Consequently, the Department concludes that section 274B(g)(1) of the Act, 8 U.S.C. 1324b(g)(1), should not be read to preclude all further administrative review of an ALJ's decision. The typical understanding of the word “final” in Administrative Procedure Act cases, the fact that head-of-agency review of ALJ decisions is the APA norm, and possible constitutional avoidance concerns make this IFR's new provisions implementing procedures related to section 274B of the Act, 8 U.S.C. 1324b, including section 274B(g)(1) of the Act, 8 U.S.C. 1324b(g)(1), most appropriate to ensure a constitutionally sound review procedure for claims arising under this section.
Accordingly, to effectuate the Department's new interpretation and avoid potential constitutional issues raised by the
The Department is amending OCAHO's rules of practice and procedure to implement a review procedure for ALJ decisions in cases arising under section 274B of the Act, 8 U.S.C. 1324b, that aligns with the agency review procedures set forth in the APA, is consistent with general administrative law principles, and is constitutionally sound. These changes will provide the Attorney General with an opportunity to review all OCAHO ALJ final orders consistent with the Attorney General's position as the head of the Department with responsibility for oversight of inferior officers at the Department. The decision whether to review an OCAHO ALJ decision would be within the sole discretion of the Attorney General, and no party will have the right to seek or request such review.
First, consistent with the overall intent of this IFR to ensure the opportunity for Attorney General review of ALJ decisions in cases under section 274B of the Act, 8 U.S.C. 1324b, this IFR amends the definitions of “entry” and “final agency order” in 28 CFR 68.2. With respect to the definition of “entry,” this IFR removes the separate definition of “entry” for cases arising under section 274B(i)(1) of the Act, 8 U.S.C. 1324b(i)(1).
Second, the IFR amends 28 CFR 68.55 to specify the procedures for Attorney General review of ALJ decisions and orders in cases arising under section 274B of the Act, 8 U.S.C. 1324b, including by providing a time frame for referral of such cases.
Third, the IFR amends 28 CFR 68.57 regarding the procedures for seeking judicial review of a final agency order in cases arising under section 274B of the Act, 8 U.S.C. 1324b, to include final agency orders issued under 28 CFR 68.55(d).
Finally, the IFR also revises the authority citation for 28 CFR part 68 to include citations to 28 U.S.C. 509 (“Functions of the Attorney General”), 28 U.S.C. 510 (“Delegation of Authority”), and 5 U.S.C. 557(b) to ensure clarity regarding the basis for the Attorney General's authority to review OCAHO cases.
The Department has determined that this rule is not subject to the general requirements of notice and comment and a 30-day delay in the effective date. The requirements of 5 U.S.C. 553 do not apply to these regulatory changes because this IFR is a rule of “agency organization, procedure, or practice.” 5 U.S.C. 553(b)(A). This IFR, as with prior OCAHO procedural rulemakings, pertains solely to agency procedures and practices regarding the processing of cases before OCAHO and does not diminish or reduce any substantive
The Department has reviewed this regulation in accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)) and has determined that this IFR will not have a significant economic impact on a substantial number of small entities. Further, a regulatory flexibility analysis is not required when the agency is not required to publish a general notice of proposed rulemaking, as is the case here. 5 U.S.C. 604(a) (“When an agency promulgates a final rule under section 553 of this title, after being required by that section or any other law to publish a general notice of proposed rulemaking . . . the agency shall prepare a final regulatory flexibility analysis.”);
This IFR will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This IFR is not a major rule as defined by section 804 of the Congressional Review Act. See 5 U.S.C. 804(2). Moreover, this action is a rule of agency organization that does not substantially affect the rights or obligations of non-agency parties. Accordingly, it is not a “rule” as that term is used in 5 U.S.C. 804(3). Therefore, the reports to Congress and the Government Accountability Office specified by 5 U.S.C. 801 are not required.
Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (Sept. 30, 1993), Executive Order 13563, Improving Regulation and Regulatory Review, 76 FR 3821 (Jan. 18, 2011), and Executive Order 14094, Modernizing Regulatory Review, 88 FR 21879 (Apr. 6, 2023), direct agencies to assess all 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 also emphasizes the importance of using the best available methods to quantify costs and benefits, and of reducing costs, harmonizing rules, and promoting flexibility.
Because this IFR is limited to agency organization, management, or personnel matters, it is not subject to review by the Office of Management and Budget pursuant to section 3(d)(3) of Executive Order 12866. Further, because this IFR is one of internal organization, management, or personnel, it is not subject to the requirements of Executive Order 13563.
This IFR 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. Therefore, in accordance with section 6 of Executive Order 13132, Federalism, 64 FR 43225, 43257-58 (Aug. 4, 1999), it is determined that this IFR does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
This IFR meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988, 61 FR 4729, 4730-32 (Feb. 5, 1996).
This IFR does not propose new or revisions to existing “collection[s] of information” as that term is defined under the Paperwork Reduction Act of 1995, Public Law 104-13, 109 Stat. 163 (May 22, 1995), codified at 44 U.S.C. 3501
Administrative practice and procedure, Aliens, Citizenship and naturalization, Civil Rights, Employment, Equal employment opportunity, Immigration.
Accordingly, for the reasons set forth in the preamble and by the authority vested in me as Attorney General by law, part 68 of title 28 of the Code of Federal Regulations is amended as follows:
5 U.S.C. 301, 554, 557(b); 8 U.S.C. 1103, 1324a, 1324b, and 1324c; 28 U.S.C. 509, 510, and 2461 note.
(g)
(1) In a case arising under section 274A or 274C of the INA, the Chief Administrative Hearing Officer modifies, vacates, or remands the Administrative Law Judge's final order pursuant to § 68.54; or
(2) In a case arising under section 274A, 274B, or 274C of the INA, the order is referred to the Attorney General pursuant to § 68.55.
(a)
(c) * * * When a final order of an Administrative Law Judge or the Chief Administrative Hearing Officer is referred to the Attorney General pursuant to paragraph (a) of this section, or a referral is accepted in accordance with paragraph (b)(3) of this section, the Attorney General shall review the final order in accordance with the provisions of this section. * * *
In cases arising under section 274A or 274C of the INA, a person or entity adversely affected by a final agency order issued under § 68.52(c) or (e), § 68.54(e), or § 68.55(d) may file, within forty-five (45) days after the date of the final agency order, a petition in the United States Court of Appeals for the appropriate circuit for review of the final agency order. * * *
In cases arising under section 274B of the INA, any person aggrieved by a final agency order issued under § 68.52(d) or § 68.55(d) may, within sixty (60) days after entry of the order, seek review of the final agency order in the United States Court of Appeals for the circuit in which the violation is alleged to have occurred or in which the employer resides or transacts business. If a final agency order is not appealed, the Special Counsel (or, if the Special Counsel fails to act, the person filing the charge, other than the Department of Homeland Security) may file a petition in the United States District Court for the district in which the violation that is the subject of the final agency order is alleged to have occurred, or in which the respondent resides or transacts business, requesting that the order be enforced.
Coast Guard, DHS.
Final rule.
The Coast Guard is altering the operating schedule that governs the US 23 Highway Bridge, mile 0.92, across the Cheboygan River—Part of the Inland Route, at Cheboygan, Michigan. The Cheboygan County Road Commission requested we extend the winter advance notice for the bridge.
This rule is effective November 13, 2023.
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 Mr. Lee D. Soule, Bridge Management Specialist, Ninth Coast Guard District; telephone 216-902-6085, email
On April 5, 2023, the Coast Guard published an NPRM titled Drawbridge Operation Regulation; Cheboygan River at Cheboygan, MI in the
The Coast Guard is issuing this rule under authority 33 U.S.C. 499.
The Cheboygan County Road Commission requested we extend the winter advance notice for the bridge due to ice coverage which continues beyond the period requiring advance notice as set forth in the prior rule.
The Coast Guard provided a comment period of 60 days and no comments were received.
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.
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. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on the ability that vessels can still transit the bridge given advanced notice.
The Regulatory Flexibility Act of 1980 (RFA), 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 received no comments from the Small Business Administration on this rule. 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 bridge 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 calls for no 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.
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 Management Directive 023-01, Rev.1, associated implementing instructions, and Environmental Planning Policy COMDTINST 5090.1 (series) which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f). The Coast Guard has 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 promulgates the operating regulations or procedures for drawbridges and is categorically excluded from further review, under paragraph L49, of Chapter 3, Table 3-1 of the U.S. Coast Guard Environmental Planning Implementation Procedures.
Neither a Record of Environmental Consideration nor a Memorandum for the Record are required for this rule.
Bridges.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; and DHS Delegation No. 00170.1, Revision No. 01.3.
The draw of the US 23 highway bridge, mile 0.9 at Cheboygan shall operate as follows:
(a) From May 1 through November 31—
(1) Between the hours of 7 a.m. and 11 p.m., the draw need only open from three minutes before to three minutes after the quarter-hour and three-quarter hour.
(2) Between the hours of 11 p.m. and 7 a.m., no drawtender is required to be at the bridge and the bridge need not open unless a request to open the draw
(b) From December 1 through April 31, no drawtender is required to be at the bridge and the bridge need not open unless a request to open the draw is given at least 12-hours in advance of a vessels intended time of passage through the draw.
(c) At all times, the draw shall open as soon as possible for the passage of vessels if carrying public safety or public utility vehicles and persons to or from the island.
(d) The owner of the bridge shall provide and keep in good legible condition two board gauges painted white with black figures not less than six inches high to indicate the vertical clearance under the closed draw at all water levels. The gauges shall be placed on the bridge so that they are plainly visible to operators of vessels approaching the bridge either up or downstream.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for navigable waters within a 0.25 nautical miles radius around the Motor Vessel (M/V) BONNIE G grounded near the coast of Saint Thomas, U.S.V.I. This action is necessary to protect personnel, vessels, and the marine environment from potential hazards created by the M/V BONNIE G grounding. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port San Juan.
This temporary final rule is effective without actual notice from October 12, 2023 through October 20, 2023. For the purposes of enforcement, actual notice will be used from October 6, 2023 until October 12, 2023.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rule, call or email Lieutenant Commander Carlos M. Ortega-Perez, Waterways Management Division Chief, U.S. Coast Guard; telephone 787-729-2380, 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 TFR because doing so would be impracticable. The M/V BONNIE G grounded near the coast of Saint Thomas, U.S.V.I, and immediate action is needed to respond to the potential safety hazards associated with the emergency response and salvage operations. It is impracticable to publish an NPRM because we must establish this safety zone by October 6, 2023.
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. The Captain of the Port San Juan (COTP) has determined that there are potential hazards associated with the response and salvage operations regarding the M/V BONNIE G grounding. There will be a safety concern for anyone within a 0.25 nautical miles radius around the M/V BONNIE G grounded near the coast of Saint Thomas, U.S.V.I. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone during response and salvage operations.
This rule establishes a safety zone on certain waters of the Caribbean Sea off the coast of Saint Thomas, U.S.V.I. The safety zone will be enforced from October 6, 2023 through October 20, 2023. The safety zone will cover all navigable waters within 0.25 nautical miles radius of 18°19′27″ N 64°58′25″ W, the current location of the M/V BONNIE G. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters while the Owning company of the vessel completes their salvage plan.
No person or vessel will be permitted to enter, transit through, anchor in, or remain within the safety zone without first obtaining permission from the COTP or a designated representative. If authorization to enter, transit through, anchor in, or remain within the safety zone is granted by the COTP or a designated representative, all persons and vessels receiving such authorization must comply with the instructions of the COTP or a designated representative. The Coast Guard will provide notice of the safety zone by Broadcast Notice to Mariners, and/or by on-scene designated representatives.
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. This rule has not been designated a “significant regulatory action,” under section 3(f) of Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, this rule has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on following reasons: (1) the temporary safety zone will only be enforced for 15 consecutive days and may be removed earlier if the response and salvage operations are completed prior October 20, 2023; (2) although persons and vessels may not enter, transit through, anchor in, or remain within the safety zone without authorization from the COTP or a designated representative, they may operate in the surrounding area during the enforcement period; (3) persons and vessels may still enter, transit through, anchor in, or remain within the areas during the enforcement period if authorized by the COTP or a designated representative.
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. 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 call or email 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.
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, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), 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 .25 nautical mile perimeter safety zone, lasting the duration of response and salvage operations or a maximum of 15 consecutive days and thus limited in scope. This zone will prohibit entry while in effect. It is categorically excluded from further review under paragraph L60(d) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email 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, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.
(a)
(b)
(c)
(2) Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the COTP San Juan by telephone at (787) 289-2041, or a designated representative via VHF-FM radio on channel 16 to request authorization. If authorization is granted, all persons and vessels receiving such authorization must comply with the instructions of the COTP San Juan or a designated representative.
(3) The Coast Guard will provide notice of the regulated area by Local Notice to Mariners, Broadcast Notice to Mariners via VHF-FM channel 16, or the COTP's designated representative.
(d)
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is finalizing an update to the current ozone absorption cross-section to the recommended consensus-based cross-section value of 1.1329x10
This final rule is effective on November 13, 2023.
The EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2022-0007. All documents in the docket are listed on the
Ms. Joann Rice, Office of Air Quality Planning and Standards, Air Quality Assessment Division, Ambient Air Monitoring Group (C304-06), Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-3372; email address:
In 1961, the ozone absorption cross-section was measured to be 1.1476 x10
The Gas Analysis Working Group of the Consultive Committee for Metrology in Chemistry and Biology (CCQM-GAWG) of the Bureau of Weights and Measures in France (BIPM) convened a task group in 2016 to review all published measurements of the ozone cross-section since 1950. This task group was also charged with recommending a consensus-based cross-section value and associated uncertainty for adoption in measurements of ozone concentrations by standard UV photometric instruments, including the SRP. (Hodges et al., 2019).
After publication in Hodges et al., 2019, the CCQM-GAWG
40 CFR part 50, appendix D, “Reference Measurement Principle and Calibration Procedure for the Measurement of Ozone in the Atmosphere,” currently provides EPA's ozone calibration procedure with a stated value of 308 ± 4 atm
The updated value reduces the uncertainty to 0.31% from the current 1.4%. The value is also 1.2% lower than the current value of 308 atmosphere atm
Design values, the metric used to compare ambient ozone concentrations measured at a monitor to the National Ambient Air Quality Standard (NAAQS) to determine compliance, are determined using the data reporting, data handling, and computation procedures provided in 40 CFR part 50, appendix U, “Interpretation of the Primary and Secondary National Ambient Air Quality Standards for Ozone.”
Multiple factors can contribute to variability in monitoring data and ultimately design values, including, but not limited to, the precision of the monitoring method, the acceptance criteria for Standard Reference Photometer (SRP) calibration and verification, the acceptance criterion for bench and field standards used to calibrate ozone monitors in the field, how agencies perform calibration and adjust analyzer response, the precision and bias acceptance criteria in EPA's Quality Assurance (QA) Handbook,
The inherent precision (variability) of the measurements from analyzers used to measure ozone is about ±1 ppb, or ±0.001 ppm. The variability in the measurement in either the positive or negative direction should be considered relative to the change in monitoring data due to the new cross-section value.
When the new cross-section value is implemented, all SRPs maintained by BIPM, NIST, and the EPA will be updated to incorporate the new value. The update will be achieved through software/firmware modification and will not require any hardware changes. The EPA is planning to update all Agency's SRPs simultaneously, instead of through a phased approach, to minimize disruption of the SRP network. To establish and maintain traceability, the readings of an ozone analyzer are compared through a hierarchy of standards to a NIST ozone SRP. The process of using NIST-traceable standards to verify the ozone concentrations is implemented for all regulatory network ozone analyzers used for comparison to the NAAQS. There are 12 SRPs within the EPA's network: three at EPA's Office of Research and Development (ORD) and nine at various EPA Regional offices and the California Air Resources Board (CARB). One of ORD's SRPs is sent to NIST to be re-verified against the NIST SRP annually. That SRP serves as the reference for the two other ORD SRPs. Each SRP in the U.S. is re-verified against one of ORD's three SRPs annually. Under normal verification operations, implementing the ozone standards traceability process for the entire SRP network could take 2 or more years starting from when the SRP software/firmware is updated. During this time, the implementation progress and monitoring data collected with the new cross-section will need to be tracked.
The acceptance criteria used in comparing the SRPs (Level 1 standards) to each other is a slope of 1.00 ± 0.01 (or 1%) and an intercept 0.00 ± 1 ppb. Field and bench standards (Level 2 standard) used to calibrate ozone analyzers in the field have acceptance criteria for the slope of 1.00 ± 0.03 (or 3%) and an intercept of 0 ± 3 ppb. The 1.2% change in cross-section value is well within the 3% acceptance for Level 2 standards.
The goal for annual measurement uncertainty for ozone in 40 CFR part 58, “Ambient Air Quality Surveillance,” is an upper 90 percent confidence limit for the coefficient of variation of 7% for precision and for bias an upper 95 percent confidence limit of 7%. Bias and precision estimates are determined using data obtained from the comparison of the ozone analyzer response to one-point Quality Control (QC) checks using a Level 2 calibration standard. The 1.2% change in cross-section value is well within the bias and precision goal of 7%. Data reported to the EPA's Air Quality System by state, local, and tribal monitoring agencies is used to assess bias and precision. The 2021 national average precision for all ozone analyzers in the U.S. is 2.3% and the national average bias is 1.6%.
The QA Handbook, Volume II, Appendix D Validation Template
Ozone analyzers are calibrated or verified every 182 days if one-point zero and span checks are performed every 14 days, and every 365 days if one-point zero and span checks are done daily. The acceptance criteria for multi-point calibration are all points < ±2.1% or ≤ ±1.5 ppb difference of the best fit straight line, whichever is greater, and a slope of 1 ± 0.05 or 5%. The 1.2% change is also well within this acceptance criteria for ozone monitor calibration.
Ozone design values are computed as the 3-year average of the annual 4th highest daily maximum 8-hour value
Taking these factors into consideration, the EPA believes it is unlikely that the cross-section change will have a measurable, predictable influence on any given ozone design value or monitoring data set.
Because the EPA believes that adoption of the new cross-section will improve the accuracy of measured ozone values and is unlikely to have a measurable, predictable influence on any given monitor or design value, the EPA is finalizing its proposal to revise the current ozone absorption cross-section to the recommended international consensus-based cross-section value of 304.39 atm
Ozone analyzers are traceable to a NIST standard reference UV-based photometer with a specified ozone UV absorption cross-section value. The absorption cross-section value stated this appendix (304.39 atm
The EPA is including an additional published reference for the research done to support the cross-section change in 40 CFR part 50, appendix D, section 6.0
On February 24, 2023, the EPA proposed to update the current ozone absorption cross-section (88 FR 11835) and solicited comment on the proposed update. The EPA received two comments by the close of the public comment period on March 27, 2023. One commenter expressed concern that the proposed target date of January 1, 2024, provides insufficient time to implement the new cross-section value and noted that monitoring equipment that is no longer supported by manufacturers would require monitoring agencies to purchase new ozone monitoring equipment.
In further consideration of global implementation of the updated cross-section value, the international task group leading implementation and the EPA recognize the challenges, complexity, and time it will take to implement the updated value and are accordingly delaying the implementation start date from January 2024 until January 2025 with an additional year (to January 2026) to complete implementation. Regarding the assertion that some monitoring agencies will be required to purchase new equipment, existing equipment will be adjusted by firmware updates if available. Where firmware updates are not available for certain monitors, those monitors may instead be calibrated against ozone transfer standards, which are calibrated directly back to a Standard Reference Photometer (SRP) using the updated cross-section value. Therefore, the purchase of new equipment should not be required.
A second comment on the proposed cross-section value assumed that the percentage increase in monitoring data would be 0.00086 ppm at the current level of the standard (0.070 ppm). The commenter noted that, if that increase had been applied to the health studies upon which the current NAAQS is based, “a NAAQS closer to 71 ppb very well could have been chosen based on the monitoring data.” The commenter also noted that under the current ozone reconsideration, the Clean Air Science Advisory Committee (CASAC) and EPA “must” consider the ozone cross-section change on monitoring data and health effect studies and, if not considered, the NAAQS may be “artificially lowered” or more stringent.
The EPA disagrees that this change will make the NAAQS ozone standard more stringent. As described in the proposed action, at the current level of the standard (0.070 ppm), 0.00086 ppm is within the current precision of the measurement method which is +/- 0.001 ppm. Moreover, when viewed in conjunction with the current monitor calibration acceptance criteria
No other comments were received. The EPA is finalizing this action as proposed.
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action as defined by Executive Order 12866, as amended by
This action does not impose an information collection burden under the PRA. This action revises the ozone absorption cross-section and revise and amend relevant references. It does not contain any information collection activities.
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 EPA concludes that the impact of concern for this rule is any significant adverse economic impact on small entities and that the agency is certifying that this rule will not have a significant economic impact on a substantial number of small entities if the rule has no net burden on the small entities subject to the rule. This action updates the ozone absorption cross-section value for surface ozone monitoring under 40 CFR part 50, and we anticipate that there will be minimal costs associated with this change. We have, therefore, concluded that this action will have no net regulatory burden for all directly regulated 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. This action imposes no enforceable duty on any state, local, or tribal governments, or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175. This action updates a reference measurement principle and calibration procedure for the measurement of ambient ozone under 40 CFR part 50. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This rulemaking involves technical standards. The EPA used voluntary consensus standards in the preparation of this measurement principle and procedure; it is the benchmark against which all ambient ozone monitoring methods are compared. This action is simply updating the reference measurement principle in light of updated information.
Executive Order 12898 (59 FR 7629, Feb.16, 1994) directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations (people of color) and low-income populations.
The EPA believes that this type of action does not concern human health or environmental conditions and, therefore, cannot be evaluated with respect to potentially disproportionate and adverse effects on people of color, low-income populations and/or indigenous peoples. This regulatory action is an update to a previously promulgated analytical method and does not have any impact on human health or the environment.
This action is subject to the CRA, and the EPA will submit a rule report to each house of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Environmental protection, Air pollution control, Ozone.
For the reasons set forth in the preamble, the EPA amends title 40, chapter I of the Code of Federal Regulations as follows:
42 U.S.C. 7401,
The revisions and addition read as follows:
2.0
2.2 The measurement system is calibrated by referencing the instrumental chemiluminescence measurements to certified O
4.0
4.1
A stable O
The calculated O
4.5
4.5.3.10. Calculate the O
Some commercial photometers may automatically evaluate all or part of equation 4. It is the operator's responsibility to verify that all of the information required for equation 4 is obtained, either automatically by the photometer or manually. For “automatic” photometers which evaluate the first term of equation 4 based on a linear approximation, a manual correction may be required, particularly at higher O3 levels. See the photometer instruction manual and Reference 13 for guidance.
6.0
13. Technical Assistance Document for the Calibration of Ambient Ozone Monitors, EPA publication number EPA-454/B-22-003, January 2023.
14. QA Handbook for Air Pollution Measurement Systems—Volume II. Ambient Air Quality Monitoring Program. EPA-454/B-17-001, January 2017.
15. Hodges, J.T., Viallon, J., Brewer, P.J., Drouin, B.J., Gorshelev, V., Janssen, C., Lee, S., Possolo, A., Smith, M.A.H., Walden, and Wielgosz, R.I., Recommendation of a consensus value of the ozone absorption cross-section at 253.65 nm based on a literature review,
7.0
Environmental Protection Agency (EPA).
Final rule.
In this final action, the Environmental Protection Agency (EPA) is amending its reformulated gasoline (RFG) regulations to reflect the reclassification of several ozone nonattainment areas as Severe for the 2008 ozone national ambient air quality standard (NAAQS). The subject areas are the Dallas-Fort Worth, TX area (Dallas), the Denver-Boulder-Greeley-Fort Collins-Loveland, CO area (Denver), and the Eastern Kern County, CA area (Eastern Kern). The reclassification of the Dallas and Denver areas as Severe for the 2008 ozone NAAQS was effective on November 7, 2022, and results in the prohibition of the sale of conventional gasoline throughout the entire nonattainment area under the Clean Air Act (CAA) eon November 7, 2023. Similarly, the reclassification of the Eastern Kern area was effective on July 7, 2021, and the Federal RFG requirement applied to the area on July 7, 2022.
This final rule is effective November 13, 2023.
Mark Coryell, Office of Transportation and Air Quality, U.S. Environmental Protection Agency, 2000 Traverwood, Ann Arbor, MI 48105; email address:
The contents of this preamble are listed in the following outline:
Entities potentially affected by this final action are fuel producers and distributors who do business in the Dallas-Fort Worth, TX area, the Denver-Boulder-Greeley-Fort Collins-Loveland, CO area, and the Eastern Kern County, CA area.
The above table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. The table lists the types of entities of which EPA is aware that potentially could be affected by this final action. Other types of entities not listed on the table could also be affected. To determine whether your organization could be affected by this final action, you should carefully examine the regulations in 40 CFR part 1090. If you have questions regarding the applicability of this action to a particular entity, see the
EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2023-0289. All documents in the docket are listed on the
In this final action, the Environmental Protection Agency (EPA) is amending its reformulated gasoline (RFG) regulations at 40 CFR 1090.285(b) and (c) to reflect the reclassification of several ozone nonattainment areas as Severe for the 2008 ozone national ambient air quality standard. The subject areas are the Dallas-Fort Worth, TX area, the Denver-Boulder-Greeley-Fort Collins-Loveland, CO area, and the Eastern Kern County, CA area. The reclassification of the Dallas and Denver areas was effective on November 7, 2022, and results in the prohibition of the sale of conventional gasoline throughout the entire nonattainment area under CAA section 211(k)(10)(D) and section 211(k)(5) effective 1 year after the effective date of the reclassification, which is November 7, 2023.
The CAA prohibits the sale of conventional gasoline in any ozone nonattainment area that is reclassified as Severe and requires that Federal RFG must instead be sold. The prohibition on the sale of conventional gasoline takes effect 1 year after the effective date of the reclassification (see CAA section 211(k)(10)(D)). For areas that are reclassified as Severe for the 2008 ozone NAAQS, States would not promulgate State fuel rules for implementing Federal RFG because the CAA requirements would be implemented as written. Air agencies are thus not required to submit a State Implementation Plan (SIP) revision addressing Federal RFG requirements. Areas already subject to Federal RFG requirements are listed in 40 CFR 1090.285(a)-(d). Federal RFG is already sold in four counties in the Dallas area because Texas opted those counties into RFG under CAA section 211(k)(6)(A). The reclassification of the Dallas area as Severe for the 2008 ozone NAAQS results in Federal RFG being required in all 10 counties in the nonattainment area for the 2008 ozone NAAQS.
EPA is issuing this final action without prior notice and comment. The rulemaking procedures provided in CAA section 307(d) do not apply when the Agency for good cause finds that notice-and-comment procedures are impracticable, unnecessary, or contrary to the public interest pursuant to section 553(b)(B) of the Administrative Procedure Act, 5 U.S.C. 553(b)(B). This is a ministerial action that amends 40 CFR 1090.285(b) and (c) to reflect that the Dallas, Denver, and Eastern Kern ozone nonattainment areas have been reclassified as Severe for the 2008 ozone NAAQS and that CAA section 211(k)(10)(D) requires that such reclassified areas become Federal RFG covered areas 1 year after the effective date of their reclassification. For this reason, EPA finds that notice-and-comment procedures under CAA section 307(d)(1) are unnecessary.
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action as defined in Executive Order 12866, as amended by Executive Order 14094, and was therefore not subject to a requirement for Executive Order 12866 review.
This action does not impose any information collection burden under the PRA, because it does not contain any information collection activities.
This action is not subject to the RFA. The RFA applies only to rules subject to notice-and-comment rulemaking requirements under the Administrative Procedure Act (APA), 5 U.S.C. 553, or any other statute. This rule is not subject to notice-and-comment requirements because the Agency has invoked the APA “good cause” exemption under 5 U.S.C. 553(b).
This final rule does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action amends the reformulated gasoline (RFG) regulations at 40 CFR 1090.285(b) and (c) to reflect the reclassification of several ozone nonattainment areas as Severe for the 2008 ozone NAAQS, which results in the prohibition of the sale of conventional gasoline throughout the entire nonattainment area under CAA section 211(k)(10)(D) and section 211(k)(5) effective 1 year after the effective date of the reclassification.
This action does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
This action does not have Tribal implications, as specified in Executive Order 13175. This final rule affects only those refiners, importers or blenders of gasoline that chose to produce or import gasoline that meets Federal RFG program requirements for sale in the Dallas, Denver, and Kern County areas and gasoline distributers and retail stations in those areas. Thus, Executive Order 13175 does not apply to this action.
EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk. EPA has no reason to believe that this action will disproportionately affect children since the RFG program results in lower emissions of ozone precursors in the Dallas, Denver, and Kern County areas.
This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.
This rule does not involve technical standards.
Executive Order 12898 (59 FR 7629, February 16, 1994) directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations (people of color and/or Indigenous peoples) and low-income populations.
The EPA believes that the requirement to sell RFG is likely to reduce existing disproportionate and adverse effects on people of color, low-income populations and/or Indigenous peoples. This requirement in the areas referenced in this action will result in area-wide emission reductions for ozone precursors and provide clean air benefits. Therefore, disproportionately high and adverse human health or environmental effects on minority or low-income populations are not an anticipated result.
This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. The CRA allows the issuing agency to make a rule effective sooner than otherwise provided by the CRA if the agency makes a good cause finding that notice-and-comment rulemaking procedures are impracticable, unnecessary, or contrary to the public interest (5 U.S.C. 808(2)). The EPA has made a good cause finding for this rule as discussed in section IV, including the basis for that finding.
The statutory authority for this action is granted to EPA by sections 211(k) and 301(a) of the Clean Air Act, as amended; 42 U.S.C. 7545(h) and 7601(a).
Environmental protection, Administrative practice and procedures, Air pollution control, Fuel additives, Gasoline, Motor vehicle and motor vehicle engines, Motor vehicle pollution, Penalties, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, EPA amends 40 CFR part 1090 as follows:
42 U.S.C. 7414, 7521, 7522-7525, 7541, 7542, 7543, 7545, 7547, 7550, and 7601.
The additions read as follows:
(b) * * *
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS closes the General category fishery for large medium and giant (
Effective 11:30 p.m., local time, October 9, 2023, through November 30, 2023.
Lisa Crawford,
Atlantic HMS fisheries, including BFT fisheries, are managed under the authority of the Atlantic Tunas Convention Act (ATCA; 16 U.S.C. 971
As described in § 635.27(a), the current baseline U.S. BFT quota is 1,316.14 metric tons (mt) (not including the 25 mt ICCAT allocated to the United States to account for bycatch of BFT in pelagic longline fisheries in the Northeast Distant Gear Restricted Area). The current baseline quota for the General category is 710.7 mt. The General category baseline quota is suballocated to different time periods. Relevant to this action, the baseline subquota for the October through November time period is 92.4 mt. Effective September 28, 2023, NMFS transferred 25 mt from the Reserve category to the General category, resulting in an adjusted October through November time period subquota of 117.4 and 87.2 mt for the Reserve
Under § 635.28(a)(1), NMFS files a closure action with the Office of the Federal Register for publication when a BFT quota (or subquota) is reached or is projected to be reached. Retaining, possessing, or landing BFT under that quota category is prohibited on or after the effective date and time of a closure notice for that category until the opening of the relevant subsequent quota period or until such date as specified.
To date, reported landings for the General category October through November time period total approximately 60.1 mt. Based on these landings, NMFS has determined that the adjusted October through November time period subquota of 117.4 mt is projected to be reached and exceeded shortly. Therefore, retaining, possessing, or landing large medium or giant (
On May 25, 2023 (88 FR 33839), NMFS published a final rule implementing RFDs every Tuesday, Friday, and Saturday from July 1 through November 30, 2023. Since the fishery will be closed for the remainder of the October through November time period, NMFS waives the previously-scheduled RFDs for the remainder of that time period.
With the RFDs waived during the closure, consistent with § 635.23(a)(4), fishermen aboard General category permitted vessels and HMS Charter/Headboat permitted vessels may tag and release BFT of all sizes, subject to the requirements of the catch-and-release and tag-and-release programs at § 635.26. All BFT that are released must be handled in a manner that will maximize their survival, and without removing the fish from the water, consistent with requirements at § 635.21(a)(1). For additional information on safe handling, see the “Careful Catch and Release” brochure available at
NMFS will continue to monitor the BFT fisheries closely. Dealers are required to submit landing reports within 24 hours of a dealer receiving BFT. Late reporting by dealers compromises NMFS' ability to timely implement actions such as quota and retention limit adjustments, as well as closures, and may result in enforcement actions. Additionally, and separate from the dealer reporting requirement, General and HMS Charter/Headboat category vessel owners are required to report the catch of all BFT retained or discarded dead within 24 hours of the landing(s) or end of each trip, by accessing
After the fishery reopens on December 1, depending on the level of fishing effort and catch rates of BFT, NMFS may determine that additional adjustments are necessary to ensure available subquotas are not exceeded or to enhance scientific data collection from, and fishing opportunities in, all geographic areas. If needed, subsequent adjustments will be published in the
NMFS issues this action pursuant to section 305(d) of the Magnuson-Stevens Act and regulations at 50 CFR part 635 and is exempt from review under Executive Order 12866.
The Assistant Administrator for NMFS (AA) finds that pursuant to 5 U.S.C. 553(b)(B), there is good cause to waive prior notice and opportunity to provide comment on this action, as notice and comment would be impracticable and contrary to the public interest for the following reasons. Specifically, the regulations implementing the 2006 Consolidated HMS FMP and amendments provide for inseason retention limit adjustments and fishery closures to respond to the unpredictable nature of BFT availability on the fishing grounds, the migratory nature of this species, and the regional variations in the BFT fishery. Providing for prior notice and an opportunity to comment is impracticable and contrary to the public interest as this fishery is currently underway and, based on landings information, the available time period subquota is projected to be reached shortly. Delaying this action could result in BFT landings exceeding the October through November time period subquota. Taking this action does not raise conservation or management concerns. NMFS notes that the public had an opportunity to comment on the underlying rulemakings that established the U.S. BFT quota and the inseason adjustment criteria.
For all of the above reasons, the AA also finds that pursuant to 5 U.S.C. 553(d), there is good cause to waive the 30-day delay in effective date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; in-season adjustment.
This action decreases the possession and trip limits for Gulf of Maine (GOM) cod for Northeast multispecies common pool vessels for the remainder of the 2023 fishing year, through April 30, 2024. The National Marine Fisheries Service projects that, at its current trajectory, the common pool will exceed its 2023 sub-Annual Catch Limit for GOM cod. This decrease in the possession and trip limit for Gulf of Maine cod is intended to prevent the common pool fishery from exceeding its
This action is effective October 12, 2023, through April 30, 2024.
Spencer Talmage, Fishery Policy Analyst, (978) 281-9232.
The regulations at § 648.86 (o) provide that NMFS may adjust the possession and trip limits for common pool vessels in order to help prevent the overharvest or underharvest of the common pool quotas. The fishing year 2023 common pool sub-annual catch limit (ACL) for Gulf of Maine GOM cod is 10.6 metric tons (mt). Catch through Trimester 1, which ended on August 31, 2023, was 8.5 mt, or 80.2 percent of the sub-ACL. As a result, as of September 1, 2023, 2.1 mt remained of the common pool sub-ACL of GOM cod. Common pool catch of GOM cod triggered a closure of the Trimester 1 Total Allowable Catch Area for the stock on July 27, 2023 (88 FR 50065), which was effective through August 31, 2023, the end of Trimester 1.
An analysis was conducted to project common pool catch from the start of Trimester 2 on September 1, 2023, through the end of the fishing year on April 30, 2024. Fishing history during this time period from fishing years 2020, 2021, and 2022 was used to estimate common pool catch under a range of different trip limit options, including the 150-pound (lb) (68-kilogram (kg)) per Day-at-Sea (DAS)/300-lb (136.1-kg) per trip limit currently in place. The resulting estimates were compared to the amount of quota remaining in the common pool sub-ACL of GOM cod on September 1, 2023.
Based on this analysis, NMFS projects that, at the current trip limit of 150 lb (68 kg) per DAS/300 lb (136.1 kg) per trip, the common pool will exceed its fishing year 2023 sub-ACL. If this occurs, regulations require that the overage must be deducted from the common pool's fishing year 2024 sub-ACL for GOM cod, which would have a negative economic impact on common pool vessels. Therefore, we are implementing a decrease to the possession and trip limits for GOM cod to help prevent the common pool fishery from exceeding its fishing year 2023 sub-ACL for GOM cod.
Effective October 12, 2023, the GOM cod possession and trip limits are decreased to 50 lb (22.7 kg) per DAS, up to 100 lb (45.4 kg) per trip, as summarized in Table 1 below.
Since the analysis on which this action was based was conducted, additional catch has been landed. Catch data reported through September 12, 2023, showed that the common pool has now caught 8.7 mt of GOM cod, 82.5 percent of the sub-ACL, leaving 1.9 mt of catch available from that date until the sub-ACL is achieved.
Weekly quota monitoring reports for the common pool fishery are on our website at:
Common pool groundfish vessels that have declared their trip through the VMS or the interactive voice response system, and crossed the VMS demarcation line prior to October 12, 2023, are not subject to the new possession and trip limits for that trip.
This action is authorized by 50 CFR part 648 and is exempt from review under Executive Order 12866.
The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(b)(B) and 5 U.S.C. 553(d)(3) to waive prior notice and the opportunity for public comment and the 30-day delayed effectiveness period because it would be impracticable and contrary to the public interest.
Regulations at § 648.86 (o) provide that NMFS may adjust the Northeast multispecies possession and trip limits for common pool vessels in order to prevent the overharvest or under-harvest of the pertinent common pool quotas. We have projected that the 150-lb (68-kg) per DAS, up to 300-lb (136.1-kg) per trip limits for GOM cod will result in the common pool exceeding its fishing year 2023 sub-ACL for this stock. This action reduces these trip limits to help prevent the common pool exceeding its fishing year 2023 sub-ACL.
The time necessary to provide for prior notice and comment, and a 30-day delay in effectiveness, would prevent these reductions from being implemented in a timely manner. This action could not have taken place sooner because the catch data and analysis used as the basis for this action have only recently become available on September 21, 2023. Delays in implementation increase the probability of an overage of the common pool sub-ACL for this stock, which would undermine the conservation objectives of the Northeast Multispecies Fishery Management Plan and trigger the implementation of accountability measures that would require deduction of the overage from common pool's quota for the next fishing year. These deductions would have negative economic impacts to the common pool fishery. The regulations authorizing this action have been in effect for many years, and the fishing industry expects NMFS to take timely in-season action to prevent overages and their payback requirements.
16 U.S.C. 1801
Agricultural Marketing Service, USDA.
Proposed rule.
This proposed rule would suspend the Federal marketing order regulating dried prunes produced in California (Order) effective at the beginning of the 2023-2024 crop year. After operating for 18 years without handling regulations, the Prune Administrative Committee (Committee) recommended the Agricultural Marketing Service (AMS) indefinitely suspend the Order. After reviewing the Committee's recommendation, AMS determined that regulatory suspension with a sunset provision of seven years is appropriate. This suspension period would extend through the end of the 2029-2030 crop year and would provide industry sufficient time to assess whether the Order's reinstatement is beneficial. If no recommendation is made by the Committee to reinstate the Order by the end of the 2029-2030 crop year, AMS would proceed to terminate the Order.
Comments must be received by November 13, 2023 to be assured consideration.
Interested persons are invited to submit written comments concerning this proposed rule. Comments may be sent to the Docket Clerk, Market Development Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237. Comments may also be sent to the Docket Clerk electronically by Email:
Jeremy Sasselli, Marketing Specialist, or Gary Olson, Chief, West Region Branch, Market Development Division, Specialty Crops Program, AMS, USDA; Telephone: (559) 487-5901, or Email:
Small businesses may request information on complying with this regulation by contacting Richard Lower, Market Development Division, Specialty Crops Program, AMS, USDA, 1400 Independence Avenue SW, STOP 0237, Washington, DC 20250-0237; Telephone: (202) 720-8085, or Email:
This proposed action, pursuant to 5 U.S.C. 553, proposes to amend regulations issued to carry out a marketing order as defined in 7 CFR 900.2(j). This proposed rule is issued under Marketing Agreement No. 110 and Marketing Order No. 993, both as amended (7 CFR part 993), regulating the handling of dried prunes produced in California. Part 993 (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 Prune Administrative Committee (Committee) locally administers the Order and is comprised of producers and handlers of dried prunes operating within the area of production, and one public member.
The Agricultural Marketing Service (AMS) is issuing this proposed rule in conformance with Executive Orders 12866, 13563, and 14094. Executive Orders 12866 and 13563 direct agencies to assess all 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 14094 reaffirms, supplements, and updates Executive Order 12866 and further directs agencies to solicit and consider input from a wide range of affected and interested parties through a variety of means. This action falls within a category of regulatory actions that the Office of Management and Budget (OMB) exempted from Executive Order 12866 review.
This proposed rule has been reviewed under Executive Order 13175—Consultation and Coordination with Indian Tribal Governments, which requires agencies to consider whether their rulemaking actions would have Tribal implications. AMS has determined that this proposed rule is unlikely to 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.
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. This proposed rule is not intended to have retroactive effect, prior to crop year 2023-2024.
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 the United States Department of Agriculture (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. Such 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 would suspend the Order's regulatory provisions. The Committee recommended this action at its March 22, 2023, meeting. Section
The Committee meets regularly to consider recommendations for modification, suspension, or termination of the Order, and such meetings are open to the public where interested persons may express their views at these meetings. AMS reviews Committee recommendations, including information provided by the Committee and from other available sources, and determines whether such recommendations would tend to effectuate the declared policy of the Act.
On May 27, 2005, following a recommendation from the Committee, AMS indefinitely suspended handling and reporting requirements under the Order, extended the temporary suspension of outgoing inspection and volume control regulations, and extended the temporary suspension of the Prune Import Regulation (70 FR 30610). Since 2005, the Committee has continued to perform the administrative duties prescribed under the Order, including the collection of assessments, conducting Committee nominations, and assessing whether to recommend a marketing policy, which may include handling regulations.
On March 22, 2023, the Committee held a public meeting to consider the future of regulation under the Order. The Committee determined that the 2005 suspension of handling and volume regulations did not adversely impact the marketing of California prunes and that there is no value in funding the administrative duties prescribed under the Order when the handling regulations and reserve control provisions are not in effect. The Committee discussed terminating the Order but rejected the idea because its members believe the sector of industry is not yet ready to terminate, given the length of time and expense that would be required to establish a new marketing order should regulation again be deemed necessary in the future. In addition, several Committee members expressed the opinion that future market conditions may warrant regulation, particularly volume control, and urged the Committee not to terminate the Order at this time. After much deliberation, the Committee voted unanimously to indefinitely suspend the Order with the expectation that the Order would either remain indefinitely suspended or AMS would at a future time act to terminate the Order if no recommendation for reinstatement is submitted by industry. In the event of no such recommendation for reinstatement, the Committee would take the necessary steps to ensure an orderly and complete termination of the Order.
The Committee recommended to AMS the Order's suspension for an indefinite period to allow for the reinstatement of regulation to remain an option and to provide industry time to assess the market environment and other external factors affecting California prunes. Under the proposed suspension, handlers would no longer be required to pay assessments. The Committee believes this cost savings would benefit both small and large handlers, and that producers would also be relieved of some costs because such payments are often passed onto them by handlers.
After reviewing the Committee's recommendation and supporting materials, AMS included a sunset provision that if no recommendation is received by July 31, 2030, AMS would then issue a rule proposing termination of the Order. The Committee agreed that a suspension period of seven years is adequate time for the California prune industry to assess future market conditions and reestablishment of the Order, if warranted. This proposed rule would lift the portions of the Order currently under suspension and then suspend the entire Order for seven years, beginning with the 2023-2024 crop year and ending with the 2029-2030 crop year, which ends on July 31, 2030. If industry does not recommend reinstating the Order by the end of the proposed suspension period, AMS will issue a proposal to terminate the Order.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), 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 the 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 dried prunes in the production area and 27 handlers subject to regulation under the Order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts less than $3,500,000, and small agricultural service firms are defined as those whose annual receipts are less than $34,000,000 (13 CFR 121.201).
According to the National Agricultural Statistics Service (NASS), the average producer price for California dried prunes for the 2021 crop was $2,000 per ton. NASS further reported 2021 crop year production for California dried prunes was 74,000 tons. The estimated total 2021-22 crop year value of California dried prunes is $148,000,000 (74,000 tons times $2,000 per ton equals $148,000,000). Dividing the estimated total crop value by the estimated number of producers (600) yields an estimated average receipt per producer of $246,667, which is considerably lower than the $3,500,000 SBA small agricultural producer threshold.
In addition, according to USDA Market News data, the reported average terminal market price for 2022 for California dried prunes was $39.04 per carton. Dividing the average carton price by the 28-pound carton size yields an estimated price per pound of $1.39. ($39.04 average price divided by 28 pounds). Multiplying $1.39 per pound by 2,000 pounds yields $2,780 per ton, which, when multiplied by total estimated 2021 production of 74,000 tons, yields estimated total handler receipts of $205,720,000. Dividing this figure by the 27 regulated handlers yields estimated average annual handler receipts of $7,619,259, well below the $34 million SBA threshold for small agricultural service firms. Therefore, using the above data, the majority of producers and handlers of California dried prunes may be classified as small entities.
This proposed rule would suspend all provisions of the Order starting with the 2023-2023 crop year, through the 2029-2030 crop year. On March 22, 2023, the Committee voted unanimously to indefinitely suspend the Order after determining that the 2005 suspension of handling regulations, volume control and reporting requirements did not negatively impact the marketing of California prunes and that the costs to continue the Order outweighs its benefit to industry. The Committee believes that such suspension would provide a cost savings to large and small handlers and producers.
After reviewing the Committee's recommendation and other supporting material, AMS included a sunset provision that if no recommendation for reinstatement is received during the proposed suspension period, AMS
This action would suspend the Federal marketing order regulating dried prunes produced in California though July 31, 2030. Authority for this action is provided in section 993.90(a) of the Order.
Committee meetings are widely publicized throughout the production area. The California dried prune industry and all interested persons are invited to attend the meetings and participate in Committee deliberations on all issues. Similarly, the March 22, 2023, meeting was a public meeting and all entities, both large and small, were able to express views on this issue.
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. 0581-0178, Vegetable Crops. OMB's three-year approval of the forms in the Vegetable Crops package expire March 31, 2024. AMS' submission of the renewal package prior to its expiration will retain prune forms but will drawdown the information collection burden to zero during the time when respondents will not be completing and submitting the forms during the seven-year suspension. Should any changes become necessary, they would be submitted to OMB for approval.
This proposed rule would not impose any additional reporting or recordkeeping requirements on either small or large California dried prune 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.
AMS has not identified any relevant Federal rules that duplicate, overlap, or conflict with this proposed rule.
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 proposed rule. All written comments timely received will be considered before a final determination is made on this rule.
Marketing agreements, Plum, Prunes, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, the Agricultural Marketing Service proposes to amend 7 CFR part 993 as follows:
7 U.S.C. 601-674.
Drug Enforcement Administration, Department of Justice.
Advanced notice of proposed rulemaking.
The Drug Enforcement Administration finds that propionyl chloride is used in the illicit manufacture of the controlled substance fentanyl, as well as fentanyl analogues, and fentanyl-related substances and is important to the manufacture of these substances because it is often used in synthetic pathways to illicitly manufacture fentanyl, fentanyl analogues, and fentanyl-related substances. Prior to proposing to list propionyl chloride as a list I chemical, DEA is soliciting information on the current uses of propionyl chloride (other than for the synthesis of fentanyl) in order to properly determine the effect such a proposed action would have on legitimate industry.
Comments must be submitted electronically or postmarked on or before November 13, 2023. Commenters should be aware that the electronic Federal Docket Management System will not accept any comments after 11:59 p.m. Eastern Time on the last day of the comment period.
To ensure proper handling of comments, please reference “Docket No. DEA-1189” on all electronic and written correspondence, including any attachments.
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Terrence L. Boos, Drug and Chemical Evaluation Section, Diversion Control Division, Drug Enforcement Administration; Telephone: (571) 362-3249.
Please note that all comments received in response to this docket are considered part of the public record. They will, unless reasonable cause is
If you want to submit confidential business information as part of your comment, but do not want it to be made publicly available, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. You must also prominently identify the confidential business information to be redacted within the comment.
Comments containing personal identifying information or confidential business information identified as directed above will be made publicly available in redacted form. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be made publicly available. Comments posted to
An electronic copy of this advanced proposed rule is available at
The Controlled Substances Act (CSA) gives the Attorney General the authority to specify, by regulation, chemicals as list I chemicals.
The clandestine manufacture of fentanyl, fentanyl analogues, and fentanyl-related substances remains extremely concerning as the distribution of illicit fentanyl, fentanyl analogues, and fentanyl-related substances continues to drive drug-related overdose deaths in the United States. Fentanyl is a synthetic opioid and was first synthesized in Belgium in the late 1950s. Fentanyl was introduced into medical practice and is approved for medical practitioners in the United States to prescribe lawfully for anesthesia and analgesia. Yet, due to its pharmacological effects, fentanyl can be used as a substitute for heroin, oxycodone, and other opioids in opioid dependent individuals. Therefore, despite its accepted medical use in treatment in the United States, DEA controls fentanyl as a schedule II controlled substance due to its high potential for abuse and dependence.
The unlawful trafficking of fentanyl, fentanyl analogues, and fentanyl-related substances in the United States continues to pose an imminent hazard to the public safety. Since 2012, fentanyl has shown a dramatic increase in the illicit drug supply as a single substance, in mixtures with other illicit drugs (
DEA has noted a significant increase in overdoses and overdose fatalities from fentanyl, fentanyl analogues, and fentanyl-related substances in the United States in recent years. According to the Centers for Disease Control and Prevention (CDC), opioids, mainly synthetic opioids (which includes fentanyl), are predominantly responsible for drug overdose deaths in recent years. According to CDC WONDER,
Fentanyl, fentanyl analogues, and fentanyl-related substances are not naturally occurring substances. As such, the manufacture of these substances requires them to be produced through synthetic organic chemistry. Synthetic organic chemistry is the process in which a new organic molecule is created through a series of chemical reactions, which involve precursor chemicals. Through chemical reactions, the chemical structures of precursor chemicals are modified in a desired fashion. These chemical reaction sequences, also known as synthetic pathways, are designed to create a desired substance. Several synthetic pathways to fentanyl, fentanyl analogues, and fentanyl-related substances have been identified in clandestine laboratory settings; these include the original “Janssen method,” the “Siegfried method,” and the “Gupta method.” In response to the illicit manufacture of fentanyl, fentanyl analogues, and fentanyl-related substances using these methods, DEA controlled
In 2017, the United Nations Commission on Narcotic Drugs placed NPP and ANPP in Table I of the Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances of 1988 (1988 Convention) in response to the international reintroduction of fentanyl on the illicit drug market. As such, member states of the United Nations are required to regulate these precursor chemicals at the national level. Importantly, the People's Republic of China regulated NPP and ANPP on February 1, 2018.
The original published synthetic pathway to fentanyl, known as the Janssen method, involves the list I chemical benzylfentanyl and schedule II immediate precursor norfentanyl. In this synthetic pathway, benzylfentanyl, a list I chemical under the CSA,
Propionyl chloride also serves as a precursor chemical in the Siegfried method. In this synthetic pathway, propionyl chloride is reacted with ANPP,
In addition to the Janssen and Siegfried methods, clandestine manufacturers are using other methods to synthesize fentanyl, one of which is known as the Gupta method. In this synthetic pathway, 4-piperidone, a list I chemical under the CSA, is used to synthesize 4-anilinopiperidine, another list I chemical under the CSA,
Propionyl chloride is attractive to illicit manufacturers because of the lack of regulations on this chemical, it is readily available from chemical suppliers, and it can be easily used in many known synthetic pathways used in the illicit manufacture of fentanyl, fentanyl analogues, and fentanyl-related substances.
With this advanced notice of proposed rulemaking, DEA is soliciting information on any possible legitimate uses of propionyl chloride unrelated to fentanyl production (including industrial uses) in order to assess the potential economic impact of controlling propionyl chloride as a list I chemical. DEA seeks to document any unpublicized use(s) and other proprietary use(s) of propionyl chloride that are not in the public domain. Therefore, DEA is soliciting comment on the uses of propionyl chloride in the legitimate marketplace.
DEA is soliciting input from all potentially affected parties regarding: (1) The types of legitimate industries using propionyl chloride; (2) the legitimate uses, legitimate needs and quantity produced, used, and distributed of propionyl chloride; (3) the size of the domestic market for propionyl chloride; (4) the number of manufacturers of propionyl chloride; (5) the number of distributors of propionyl chloride; (6) the level of import and export of propionyl chloride; (7) the potential burden that controlling propionyl chloride as a list I chemical may have on any legitimate industry and trade; (8)
Such information may be submitted electronically to the address listed above and is requested by November 13, 2023. This information will be used to properly determine the effect that proposed regulations to make propionyl chloride a list 1 chemical under the CSA would have on industry.
Confidential or proprietary information may be submitted as part of a comment regarding this advanced notice of proposed rulemaking. Please see the “POSTING OF PUBLIC COMMENTS” section above for a discussion of the identification and redaction of confidential business information and personally identifying information.
This ANPRM was developed in accordance with the principles of Executive Order (E.O.) 12866, “Regulatory Planning and Review” and E.O. 13563, “Improving Regulation and Regulatory Review.” Since this action is an ANPRM, the requirement of E.O. 12866 to assess the costs and benefits of this action does not apply.
Furthermore, the requirements of the Regulatory Flexibility Act do not apply to this action because, at this stage, it is an ANPRM and not a “rule” as defined in 5 U.S.C. 601. Following review of the comments received in response to this ANPRM, if DEA proceeds with a notice of proposed rulemaking regarding this matter, DEA will conduct all relevant analyses as required by statute or E.O.
This document of the Drug Enforcement Administration was signed on October 5, 2023, by Administrator Anne Milgram. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard is proposing to establish a temporary safety zone for certain waters of the Potomac River. This action is necessary to provide for the safety of life on these navigable waters at the old Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge, during demolition operations from November 8, 2023 through January 30, 2024. This proposed rulemaking would prohibit persons and vessels from being in the safety zone unless authorized by the Captain of the Port, Sector Maryland-National Capital Region 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 October 27, 2023.
You may submit comments identified by docket number USCG-2023-0795 using the Federal Decision-Making Portal at
If you have questions about this proposed rulemaking, call or email LCDR Kate Newkirk, Sector Maryland-NCR, Waterways Management Division, U.S. Coast Guard: telephone 410-576-2519, email
Skanska-Corman-McLean, Joint Venture notified the Coast Guard that it will be conducting demolition of the old Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge, which will occur from 12:01 a.m. on November 8, 2023, to 11:59 p.m. on January 30, 2024. The bridge is located on the Potomac River, at mile 43.3, between Charles County, MD and King George County, VA. The segment of the old bridge over waters that include the bridge piers sections between Piers 14 and the east riverbank of the Potomac River requires the use of explosives, and debris removal and hydrographic surveying equipment. Marine equipment, including barges, positioned in the Potomac River will be used to support the bridge demolition and debris removal operation. This operation also requires the use of a temporary commercial mooring buoy in the Potomac River south of the old bridge where the explosives barge will be kept. Hazards from the demolition and debris removal work include accidental discharge of explosives, dangerous projectiles, hanging ropes or cables, and falling objects or debris. The Captain of the Port, Maryland-National Capital Region (COTP) has determined that potential hazards associated with the demolition and removal of the old Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge would be a safety concern for anyone within or near project area.
The purpose of this rulemaking is to ensure the safety of vessels and the navigable waters within or near the Federal navigation channel at the old Governor Harry W. Nice/Senator Thomas “Mac” Middleton Memorial (US-301) Bridge before, during, and after the scheduled event. The Coast Guard is proposing this rulemaking under authority in 46 U.S.C. 70034.
The COTP is proposing to establish a safety zone from 12:01 a.m. on November 8, 2023, to 11:59 p.m. on
Area 1. All navigable waters of the Potomac River, encompassed by a line connecting the following points beginning at 38°21′49.10″ N, 076°59′32.46″ W, thence south to 38°21′40.04″ N, 076°59′30.62″ W, thence east to 38°21′43.52″ N, 076°59′15.22″ W, thence south along the shoreline to 38°21′52.49″ N, 076°58′59.70″ W, and west back to the beginning point, located between Charles County, MD and King George County, VA.
Area 2. All navigable waters of the Potomac River, within 1,500 feet of the explosives barge located in approximate position 38°21′21.47″ N, 076°59′45.40″ W.
The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled demolition and debris removal. Except for marine equipment and vessels operated by Skanska-Corman-McLean, Joint Venture, or its subcontractors, no vessel or person would be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative. The term designated representative also includes an employee or contractor of Skanska-Corman-McLean, Joint Venture for the sole purposes of designating and establishing safe transit corridors, to permit passage into or through the safety zone, or to notify vessels and individuals that they have entered the safety zone and are required to leave.
The COTP will notify the public that the safety zone will be enforced by all appropriate means to the affected segments of the public, as practicable, in accordance with 33 CFR 165.7(a). Such means of notification will also include, but are not limited to, Broadcast Notice to Mariners. Vessels or persons violating this rule are subject to the penalties set forth in 46 U.S.C. 70036 and 46 U.S.C. 70052. The regulatory text we are proposing 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. This NPRM has not been designated a “significant regulatory action,” under Executive Order 12866, as amended by Executive Order 14094 (Modernizing Regulatory Review). Accordingly, the NPRM has not been reviewed by the Office of Management and Budget (OMB).
This regulatory action determination is based on the size, location and time of year of the safety zone. The temporary safety zone comprises two separate geographic areas which total a maximum of approximately 900 yards in width and 350 yards in length. This safety zone would impact a small, designated area of the Potomac River for a maximum 84 total days, but we anticipate that there would be no vessels that are unable to conduct business because of the safety zone. Excursion vessels and commercial fishing vessels are not impacted by this rulemaking. Excursion vessels do not operate in this area, and commercial fishing vessels are not impacted because of their draft. Some towing vessels may be impacted, but bridge project personnel have been conducting outreach throughout the project to coordinate with those vessels. This safety zone would be established outside the normal recreational boating season for this area, which occurs during the summer. Moreover, the Coast Guard would issue Local Notices to Mariners and a Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone on days it is being enforced.
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 safety zone 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 proposed rule would have a significant economic impact on it, please submit a comment (see
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 call or email 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
We have analyzed this proposed rule under Department of Homeland Security Directive 023-01, Rev. 1, associated implementing instructions, and Environmental Planning COMDTINST 5090.1 (series), 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 safety zone lasting 84 total days that would prohibit entry within a portion of the Potomac River. Normally such actions are categorically excluded from further review under paragraph L60(a) of Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1. A preliminary Record of Environmental Consideration supporting this determination is available in the docket. For instructions on locating the docket, see the
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to call or email 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 review all comments received, but we will only post comments that address the topic of the proposed rule. We may choose not to post off-topic, inappropriate, or duplicate comments that we receive.
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard is proposing to amend 33 CFR part 165 as follows:
46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 00170.1, Revision No. 01.3.
(a)
(1)
(2)
(b)
(c)
(2) Mariners wishing to transit any of these safety zone areas must first contact the Skanska-Corman-McLean, Joint
(3) The Coast Guard will publish a notice in the Fifth Coast Guard District Local Notice to Mariners and issue marine information broadcasts on VHF-FM marine band radio announcing specific enforcement dates and times.
(d)
(e)
Environmental Protection Agency (EPA).
Proposed rule; extension of comment period.
The Environmental Protection Agency (EPA) is extending the comment period for the proposed revisions to the Air Emissions Reporting Requirements (AERR), published in the
The comment period for the proposed rule and ICR published on August 9, 2023, at 88 FR 54118 is extended. Comments must be received on or before November 17, 2023.
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2004-0489, by one of the following methods:
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Mr. Marc Houyoux, Office of Air Quality Planning and Standards, Air Quality Assessment Division, Emission Inventory and Analysis Group (C339-02), U.S. Environmental Protection Agency, Research Triangle Park, NC 27711; telephone number: (919) 541-3649; email:
On Wednesday, August 9, 2023, the EPA published proposed revisions to the Air Emissions Reporting Requirements along with an associated ICR in the
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a revision to the South Coast Air Quality Management District (SCAQMD or “the District”) portion of the California State Implementation Plan (SIP) as SIP strengthening. This revision concerns emissions of oxides of nitrogen (NO
Comments must be received on or before November 13, 2023.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2023-0494 at
La Kenya Evans-Hopper, EPA Region IX, 75 Hawthorne St., San Francisco, CA 94105. By phone: (415) 972-3245 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 February 13, 2022, the submittal for SCAQMD Rule 2305 was deemed complete by operation of law with respect to the completeness criteria in 40 CFR part 51, appendix V, which must be met before formal EPA review.
SCAQMD Rule 2305 is a new rule. There are no previously approved versions of the rule in the applicable SIP.
Emissions of NO
The purpose of SCAQMD Rule 2305 is to reduce local and area-wide emissions of NO
Also, through adoption of the 2016 South Coast Air Quality Management Plan (AQMP), the SCAQMD committed to assess and identify potential actions to further reduce emissions associated with emission sources operating in and out of warehouse distribution centers,
The EPA has taken several actions on the 2016 South Coast AQMP. With certain exceptions not relevant here, the EPA approved portions of the 2016 South Coast AQMP addressing the Serious Area requirements for the 2006 24-hour PM
Rule 2305 applies to owners and operators of warehouses located in the SCAQMD with greater than 100,000 square feet of indoor floor space in a single building and who operate at least 50,000 square feet of the warehouse for warehousing activities. Warehouse operators are required either to earn points, as discussed below, from emission reducing activities, or to pay a mitigation fee. Warehouse facility owners or warehouse land owners may opt in to earn Warehouse Actions and Investments to Reduce Emissions Points (“WAIRE Points”) and transfer these points to a warehouse operator at the same site. Both warehouse facility owners and operators must comply with certain recordkeeping and reporting requirements under the rule. Warehouse facility owners were required to submit initial Warehouse Operations Notifications to the SCAQMD by September 1, 2021, and then again within certain prescribed periods thereafter if certain conditions occur. Warehouse operators are also required to submit their Initial Site Information Reports (ISIR) and Annual WAIRE Reports to the SCAQMD. All of the notifications and reports are to be submitted through the WAIRE Program Online Portal (WAIRE POP). In addition, records which document the accuracy and validity of all information submitted to the SCAQMD as required by the rule must be kept by the warehouse owner, or operator as applicable, for a minimum of seven years from the reporting deadline. Records must be made available upon request to the SCAQMD during normal business hours.
The principal substantive requirement in the rule is the requirement that each warehouse operator meet an annual compliance obligation by earning WAIRE Points. The annual compliance obligation, referred to as the WAIRE Points Compliance Obligation (WPCO), for each warehouse operator is calculated based on Weighted Annual Truck Trips (WATTs) multiplied by a stringency factor (0.0025 points per WATT) and an annual variable (which accounts for the phased implementation of the rule).
The requirement to earn WAIRE points to meet a WPCO does not apply to warehouse operators who use less than 50,000 square feet for warehousing activities of a warehouse that is greater than or equal to 100,000 square feet.
In situations where investments or actions that were completed by a warehouse owner or operator perform significantly lower than anticipated due to unforeseen circumstances beyond the control of the warehouse owners or operators resulting in lower than anticipated earned WAIRE Points, the warehouse owner or operator may apply to the Executive Officer
Warehouse owners (who opt in) and operators are required to earn WAIRE Points either: through the completion of specified actions from the list of actions in the WAIRE Menu,
Rule 2305 specifies the number of points for the different types of actions or investments, ranging from 1 point (per 165,000 kilowatt-hours) from the use of onsite solar panels to 1,680 points for installation of a 700-kilogram-per-day hydrogen (H
Based on the most current information contained in the first Annual Report for the WAIRE Program, the average WPCO per warehouse operator was rounded to 80 points for the 2022 compliance period.
Under the rule, the Custom WAIRE Plan is a second option that allows warehouse owners or operators to earn WAIRE Points through a customized plan specific for a warehouse facility.
Warehouse owners or operators have a third option to meet the annual compliance obligation that involves payment of a mitigation fee in the amount of $1,000 for each WAIRE Point.
As noted above, warehouse operators have three basic options, or any combination of these options, through which to earn or obtain points sufficient to meet their WPCO. Warehouse owners may also earn WAIRE Points using the same methods or options available to warehouse operators and may transfer these WAIRE Points to any warehouse operator at the site where the WAIRE Points were earned within a three-year period.
In the SCAQMD's first Annual Report for the WAIRE Program, the SCAQMD compiled information from 380 ISIR's that had been submitted by warehouse operators through September 30, 2022. The first Annual Report suggests that warehouse operators expect to meet their WPCOs, at least in the early years of the program, primarily through ZE hostler usage, (
The SCAQMD developed emissions reduction estimates for various scenarios representing different compliance approaches to Rule 2305.
Lastly, the rule includes recordkeeping and reporting requirements. The three types of reports that are due under Rule 2305 include: (1) the Warehouse Operations Notification (WON), which is the responsibility of the warehouse owner, (2) the ISIR, and (3) the Annual WAIRE Report, both of which are the responsibility of warehouse operators. The rule also specifies a sunset date after the EPA finds that all air basins within the SCAQMD have attained the
The EPA has evaluated SCAQMD Rule 2305 against the applicable procedural and substantive requirements of the CAA for SIPs and SIP revisions and has concluded that, with certain exceptions discussed below, Rule 2305 meets the applicable requirements and would strengthen the SIP. Generally, SIPs must include enforceable emission limitations and other control measures, means, or techniques, as well as schedules and timetables for compliance, as may be necessary to meet the requirements of the Act (see CAA section 110(a)(2)(A)); must provide necessary assurances that the State will have adequate personnel, funding, and authority under State law to carry out such SIP (and is not prohibited by any provision of Federal or State law from carrying out such SIP) (see CAA section 110(a)(2)(E)); must be adopted by a State after reasonable notice and public hearing (see CAA section 110(a)(1); section 110(a)(2); section 110(l)); and must not interfere with any applicable requirement concerning attainment and reasonable further progress, or any other applicable requirement of the Act (see CAA section 110(l)).
The SCAQMD jurisdiction covers all the South Coast Air Basin, and portions of the Salton Sea and Mojave Desert Air Basins, and includes air quality planning areas that are designated as nonattainment for the 1-hour ozone NAAQS and the 1997, 2008 and 2015 8-hour ozone NAAQS (South Coast and Coachella Valley areas); the 1997 24-hour and annual PM
CAA section 172(c)(1) requires States with ozone nonattainment areas to implement all reasonably available control measures (RACM), including such reductions in emissions from existing sources in the area as may be obtained through the adoption, at a minimum, of reasonably available control technology (RACT), as expeditiously as practicable. CAA sections 182(b)(2) and 182(f) specify that implementation of RACT under CAA section 172(c)(1) is required for all major stationary sources of NO
With respect to rule stringency, the EPA is prohibited by the CAA from requiring States and local air agencies to submit indirect source review (ISR) programs as a condition to approving a SIP.
Under CAA section 110(l), SIP revisions must be adopted by the State, and the State must provide for reasonable public notice and hearing prior to adoption. Pursuant to 40 CFR 51.102, States must provide at least 30-days' notice of any public hearing to be held on a proposed SIP revision. States must provide the opportunity to submit written comments and allow the public the opportunity to request a public hearing within that period. Rule 2305 was adopted by SCAQMD on May 7, 2021, through Resolution 21-9, following a public hearing held on the same day. Prior to adoption, the SCAQMD published notice of the May 7, 2021 public hearing on March 31, 2021, and provided more than 30 days for submission of written comments. The CARB subsequently adopted the rule as a revision to the SIP on August 13, 2021, through Executive Order S-21-012. The CARB then submitted SCAQMD Rule 2305 to the EPA on August 13, 2021, as an attachment to a letter with the same date. Various other materials comprising the SIP submission package were submitted as well, including copies of public comments received during the comment period, District responses to comments, and environmental and socioeconomic impact assessments.
Based on the materials provided in the August 13, 2021 SIP submission summarized above, we propose to find that the District and the CARB have met the procedural requirements for adoption and submission of SIPs and SIP revisions under CAA section 110(l) and 40 CFR 51.102.
The SCAQMD has been granted both general and specific authority under the California Health & Safety Code (CH&SC) to adopt and implement Rule 2305.
Moreover, the EPA knows of no obstacle under State or Federal law in the SCAQMD's ability to implement Rule 2305. With respect to State law, the EPA notes that, during the rule development phase, certain commenters challenged the mitigation fee option in Rule 2305 on the grounds that it imposes an unlawful tax under State law. However, CARB's August 13, 2021 SIP submission package includes a legal analysis from the State Attorney General's Office
With respect to Federal law, the EPA is aware of an ongoing legal challenge by the California Trucking Association (CTA), among others, to the SCAQMD's legal authority to implement Rule 2305 in litigation to which the EPA is not a party.
With respect to the CAA, the EPA's evaluation of Rule 2305 indicates that the SCAQMD is authorized to adopt this program for inclusion into the California SIP. CAA section 110(a)(5) authorizes States to include any ISR program in their SIPs. Under CAA section 110(a)(5), the EPA may not require a State to adopt an ISR program as part of its SIP, but the EPA may approve an ISR program that a State chooses to adopt and submit for inclusion into its approved SIP. In this context, “indirect source” means a facility, building, structure, installation, real property, road, or highway that attracts, or may attract, mobile sources of pollution.
• Exceeding any national primary ambient air quality standard for a mobile source-related air pollutant after the primary standard attainment date; or
• Preventing maintenance of any such standard after such date.
Rule 2305 involves the facility-by-facility review of existing and new warehouses, which are facilities that attract mobile sources of air pollution. Based on this review, the rule provides a list of specific measures that, when implemented by the warehouse operator, will reduce or offset the related mobile source emissions that contribute to the exceedances of the NAAQS for PM
To earn or obtain WAIRE points, warehouse owners and operators have the option of: (i) taking various types of actions or making variety types of investments specified in the WAIRE menu; (ii) following an approved Custom WAIRE Plan; (iii) paying a mitigation fee; (iv) or any combination of such options (see section I.D of this document). The SCAQMD anticipates that the same types of actions and investments that are specified in Rule 2305 will also occur under the WAIRE Mitigation Program funded by the mitigation fee option under the rule (see section I.D of this document). As such, Rule 2305 is designed to reduce, offset, or mitigate the emissions generated by mobile sources attracted to warehouses in the SCAQMD. This includes the associated contribution to area-wide exceedances of the NAAQS and to the local pollutant burden on communities in the vicinities of warehouses.
Rule 2305 is similar to the ISR review program previously adopted by the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD) to reduce or offset emissions of NO
Commenters, objecting to Rule 2305 during its adoption, contended that an ISR program, for the purposes of CAA section 110(a)(5), is limited to new or modified indirect sources and that, therefore, Rule 2305 is not authorized under the CAA, at least as it applies to existing warehouses. This contention is based on the clause in the definition of the term “indirect source review program” describing such programs as “including such measures as are necessary to assure, or assist in assuring, that a new or modified indirect source will not attract mobile sources of air pollution.”
In its own rulemaking process, the SCAQMD responded to this issue by noting that the SCAQMD's authority derives from State law, not Federal law. State law does not limit the authority of the SCAQMD to regulating only new or modified (as opposed to existing) indirect sources.
In reviewing Rule 2035, the EPA has specifically evaluated whether it is consistent with the requirements of CAA section 110(a)(5). When taking action on any SIP submission, the EPA must evaluate whether the SIP provisions as issue meet applicable statutory and regulatory requirements. The EPA acknowledges that there are ambiguities in the language of section 110(a)(5). For example, section 110(a)(5)(D) superficially appears to define the term “indirect source review program” in terms of “new or modified” indirect sources. That provision in relevant part defines an indirect source program as one “including” such measures at new or modified sources. The EPA does not, however, interpret this definition to restrict States from having such programs that extend to existing sources if they elect to do so. Instead, the use of “including” preceding the reference to “new or modified indirect source” indicates that regulation of new or modified indirect sources is illustrative of the scope of this provision, not limiting.
Other provisions support this interpretation. Section 110(a)(5)(C) defines the term “indirect source” itself to include many things such as a building “which attracts, or may attract, mobile sources of pollution.” This definition could encompass both existing and future structures. By contrast, with respect to parking, section 110(a)(5)(C) expressly states that an indirect source program can include “existing off-street parking” but not “new or existing on-street parking.” If such an “indirect source program” could apply to existing off-street parking, then it is unclear why this conceptually would not extend to other existing sources such as existing buildings, notwithstanding the reference to new or modified sources in the definition of “indirect source program.” At most, there is a small degree of ambiguity with respect to whether Congress actually intended the definition of “indirect source program” to function as a restriction on the EPA's authority to approve a State indirect source program that extends to existing buildings into the State's SIP. The EPA does not consider such a restrictive reading of the provision to be reasonable or logical, absent a clearer prohibition.
As further support for this interpretation, the EPA notes that CAA section 116 explicitly provides that States retain authority to regulate more stringently in SIP provisions than otherwise required by Federal law, except where preempted from doing so. Even if Congress anticipated that States might typically elect to adopt such programs that would include new or modified sources, Congress did not explicitly appear to preclude States from adopting indirect source programs that extend to existing sources as well, except with respect to “new or existing on street parking.” In other words, by defining the term “indirect source program” in CAA section 110(a)(5)(D), Congress was not diminishing existing State authority under CAA section 116 to adopt such programs that apply to existing sources, such as existing warehouses, if they elect to do so. Thus, the EPA concludes that the State is not precluded from regulating both existing and new warehouses in Rule 2305, and thus this poses no issue with respect to the EPA proposing approval of the rule into the SIP.
During the rule development process, the SCAQMD received comments objecting to Rule 2305 on the grounds that the rule, while structured as an ISR program, represents a de facto purchase mandate for ZE or NZE trucks and is thus preempted under CAA section 209(a). These adverse comments cited to the Supreme Court decision in
As noted above, the question of whether an ISR program is preempted under Section 209 of the CAA was squarely addressed by the Ninth Circuit in
The EPA has previously acknowledged the possibility that a rule styled as an ISR program may in effect be a regulation of direct sources, including motor vehicles or nonroad sources. In other words, the EPA is not obligated merely to accept at face value a State or local authority's characterization, but may consider how the program will work in practice. In its 2011 final approval action on the SJVUAPCD ISR, the EPA noted factors that might indicate a rule ostensibly measuring emissions from a site was a
As explained in section I.D above, Rule 2305 applies to warehouse operators and provides multiple options for meeting the annual WPCO. As noted by the SCAQMD in response to comments on proposed Rule 2305, “the WPCO is not based on truck
Commenters objecting to the SCAQMD's adoption of Rule 2305 contended that the requirements are preempted under the ADA and F4A. Under the ADA, with certain exceptions not applicable here, a State or political subdivision of a State may not enact or enforce a law, regulation, or other provision having the force and effect of law related to a price, route, or service of an air carrier or carrier affiliated with a direct air carrier through common controlling ownership when such carrier is transporting property by aircraft or by motor vehicle (whether or not such property has had or will have a prior or subsequent air movement).
The EPA does not consider the requirements under Rule 2305 as relating directly to the “price, route, or service” of any air carrier or common carrier but do recognize that an indirect effect on price is a foreseeable consequence of the additional costs borne by warehouse owners or operators to comply with the annual WAIRE points compliance obligation. However, the EPA proposes to find that Rule 2305 is not preempted under either the ADA or F4A because any price effect is indirect and remote. Moreover, the District is acting under its delegated police powers to protect public health in a way that is explicitly authorized under CAA section 110(a)(5) and CAA section 116. Any incremental increase in price for delivery services due to compliance with Rule 2305 internalizes costs otherwise borne by the public, particularly members of the public living and working in the vicinities of warehouses, through the types of health effects associated with elevated concentrations of PM.
The EPA has evaluated the enforceability of Rule 2305 with respect to applicability and exemptions; standard of conduct; compliance dates; sunset provisions; discretionary provisions; and test methods, recordkeeping and reporting,
First, with respect to applicability, the EPA generally finds that Rule 2305 is sufficiently clear as to which entities are subject to the requirements in the regulation and which entities are exempt.
Second, with respect to compliance dates, the EPA notes that all warehouses subject to the rule will be required to meet their WAIRE points annual compliance obligation requirements beginning with calendar year 2024. This is consistent with achieving emission reductions in advance of the July 20,
Third, Rule 2305 includes a sunset provision.
The EPA notes that Rule 2305 includes provisions that allow for discretion on the part of the SCAQMD's Executive Officer. Such “director's discretion” provisions can undermine enforceability of a SIP regulation, and thus prevent full approval by EPA. In the case of Rule 2305, it allows for director's discretion in connection with the determination of whether WAIRE Points from a Custom WAIRE Plan are quantifiable, verifiable, and real and the determination of whether the warehouse owner or operator is making adequate progress to complete an approved Custom WAIRE Plan.
Lastly, Rule 2305 includes recordkeeping and reporting requirements that are sufficient to ensure compliance with the applicable requirements.
The SCAQMD adopted Rule 2305 in part to meet a commitment in the 2016 South Coast AQMP to assess and identify potential actions to further reduce emissions associated with emission sources operating in and out of warehouse distribution centers. While the EPA is not proposing to credit Rule 2305 with achieving a specific amount of emissions reductions, the EPA's evaluation of Rule 2305 indicates that the rule will achieve additional emission reductions. These additional reductions will incrementally contribute to the overall reductions needed to attain the NAAQS in the South Coast Air Basin and Coachella Valley air quality planning areas.
However, as discussed previously, we find that the sunset clause in Rule 2305 could interfere with attainment or reasonable further progress by foregoing emissions reductions that may be needed for attainment or maintenance of the NAAQS. Thus, the EPA recommends that the SCAQMD remove the sunset clause and follow the normal course of action in rescinding rules from the SIP,
The SCAQMD adopted a specific rule, Rule 316 (“Fees for Rule 2305”), for the purpose of recovering the SCAQMD's costs associated with implementing Rule 2305. In light of the adoption of Rule 316, the EPA finds that the SCAQMD will have adequate personnel and funding to implement Rule 2305.
Based on the above discussion, the EPA believes Rule 2305 is consistent with the relevant CAA requirements, policies, and guidance, except as otherwise noted. As an ISR program under CAA section 110(a)(5), Rule 2305 is not a required submission. The EPA proposes to find that the District has the authority to implement and enforce Rule 2305 and is not prohibited from doing so by any State or Federal law. While Rule 2305, as stated previously, will reduce emissions associated with warehouses, the EPA proposes to find that the rule is not fully enforceable, and that the amount of associated emissions reductions is not sufficiently quantifiable for credit at the present time. The EPA proposes to find that Rule 2305 is SIP-strengthening and proposes to approve it on this basis. A recent decision by the Ninth Circuit upheld the EPA's approval of a SIP submission for the San Joaquin Valley on SIP strengthening grounds.
As authorized in section 110(k)(3) of the Act, the EPA proposes to approve the submitted rule. The EPA concludes that, while SCAQMD Rule 2305 does not meet all the evaluation criteria for enforceability, we are proposing approval because the submitted rule is not a required SIP element and would strengthen the SIP. In light of the deficiencies identified above, however, the EPA concludes that the submitted rule should not be credited in any attainment and rate of progress/reasonable further progress demonstrations.
We will accept comments from the public on the proposed action, the rationale and basis for the proposed action, and other relevant matters until November 13, 2023. If the EPA takes final action to approve the submitted rule, the final action will incorporate this rule into the federally enforceable SIP.
In this rule, 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 SCAQMD Rule 2305, adopted on May 7, 2021, that establishes an ISR program for certain warehouse owners and operators, as described in section I 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), 13563 (76 FR 3821, January 21, 2011) and 14094 (88 FR 21879, April 11, 2023);
• 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); and
• 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.
Executive Order 12898 (Federal Actions To Address Environmental Justice in Minority Populations and Low-Income Populations, 59 FR 7629, Feb. 16, 1994) directs Federal agencies to identify and address “disproportionately high and adverse human health or environmental effects” of their actions on minority populations and low-income populations to the greatest extent practicable and permitted by law. The EPA defines environmental justice (EJ) as “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” The EPA further defines the term fair treatment to mean that “no group of people should bear a disproportionate burden of environmental harms and risks, including those resulting from the negative environmental consequences of industrial, governmental, and commercial operations or programs and policies.”
The SCAQMD did not evaluate environmental justice considerations as part of its SIP submittal; the CAA and applicable implementing regulations neither prohibit nor require such an evaluation. However, the Community Steering Committees for four environmental justice communities admitted into the State's AB 617 program in the affected area requested development of a warehouse ISR rule due to concerns regarding air pollution impacts from trucks and DPM.
Lastly, 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 proposed 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, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements.
Environmental Protection Agency (EPA).
Advanced notice of proposed rulemaking.
The Environmental Protection Agency (EPA) is soliciting public
Comments must be received on or before December 11, 2023.
The docket for this action, identified under docket identification (ID) number EPA-HQ-OPP-2023-0420, is available online at
Susan Bartow, Chemical Review Manager, Pesticide Reevaluation Division, Office of Chemical Safety and Pollution Prevention (7508M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; phone: 202-566-2280; email address:
You may be affected by this action if you manufacture, distribute, sell, treat, or use pesticide-treated seed or treated paint products. EPA has promulgated several exemptions for pesticide products of a character not requiring regulation under FIFRA, including for treated articles and substances; EPA is now considering modifying the treated article exemption. This exemption is codified in 40 CFR 152.25(a). The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, rather it provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Pesticide and other agricultural chemical manufacturers (NAICS codes 325320 and 325311).
• Manufacturers who may also be distributors of these products, which includes farm supplies merchant wholesalers (NAICS code 424910).
• Retailers of pesticide products (some of which may also be manufacturers), which includes nursery, garden center, and farm supply stores (NAICS code 444220).
• Government establishments engaged in regulation, licensing, and inspection (NAICS code 926150).
• Users of treated seed products and persons involved in crop production (NAICS code 111).
• Persons involved in support activities for crop production (NAICS code 1151).
If you have questions regarding the applicability of this action to a particular entity, consult the person listed under
This advance notice of proposed rulemaking (ANPRM) is issued under the authority of FIFRA, 7 U.S.C. 136
EPA is requesting comments on specific issues related to seed treated with conventional pesticides (“treated seed”) and paint treated with conventional or antimicrobial pesticides (“treated paint”). As to treated seed products, EPA has typically included on the label of the treating pesticide labeling instructions regarding both the use of the treating pesticide and the distribution, sale, and use of the treated seed product, and EPA's exposure assessments and registration decisions take those instructions into consideration. However, states and other stakeholders have raised questions about the clarity and enforceability of instructions specifically relating to use of the treated seed products (
For treated paint products, pesticide labeling requirements do not currently exist. EPA is exploring the option of requiring labeling instructions on treated paint products to address potential risks of concern for professional painters exposed to the pesticide in the treated paint without the use of personal protection equipment (PPE), such as respirators, when applying the paint using a spray method. Thus far, labeling for treated paint has been proposed for only one active ingredient (
EPA will consider comments and information to determine whether to amend its approach for allowing treated
This ANPRM does not impose or propose any requirements, and instead seeks comments and suggestions that will help the Agency identify whether and to what extent there is a potential need for a FIFRA section 3(a) rule and/or other regulatory or administrative action. If EPA decides to propose changes to the regulations, it will conduct the appropriate assessments of the costs and benefits of those changes and provide opportunities for further public comment.
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Do not submit CBI to EPA through
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When preparing and submitting your comments, see the commenting tips at
Applications for registration of a pesticide may be submitted to EPA and must meet the requirements in FIFRA sections 3(c) and 33. 7 U.S.C. 136a and 136w-8. Those requirements include, among other things, submission of complete labeling of the pesticide, including claims made for the pesticide and instructions on use; complete data in support of that registration request; and requisite fees in support of that application. 7 U.S.C. 136a(c); 7 U.S.C.136a(b); and 7 U.S.C. 136w-8;
To grant a pesticide registration, FIFRA requires EPA to consider whether the pesticide meets the FIFRA standard that use of the pesticide has no “unreasonable adverse effects” to human health and the environment. 7 U.S.C. 136a(c)(5). FIFRA section 2(bb) defines “unreasonable adverse effects on the environment” to mean, among other things, “any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide” or “a human dietary risk from residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 408 of the Federal, Food, Drug, and Cosmetic Act” (FFDCA). 7 U.S.C. 136(bb). EPA is required to review each pesticide registration every 15 years to determine whether the pesticide continues to satisfy the FIFRA standard for registration. 7 U.S.C. 136a(g) and 40 CFR Part 155, subpart C.
It is a violation under FIFRA to sell or distribute an unregistered pesticide or to use a registered pesticide in a manner inconsistent with its labeling. 7 U.S.C. 136j(a)(1)(A) and 136j(a)(2)(G). FIFRA section 12 does not make it a violation to use an unregistered pesticide. However, under FIFRA section 3(a), EPA may, by regulation, impose limits on the distribution, sale, and use of any pesticide that is not registered “to the extent necessary to prevent unreasonable adverse effects on the environment,” and compliance with such regulation is enforceable under FIFRA section 12(a)(2)(S). 7 U.S.C. 136a(a) and 136j(a)(2)(S).
FIFRA section 25(b)(2) provides that the Administrator may, by regulation, exempt from the requirements of FIFRA, including the registration requirements, any pesticide which the Administrator determines to be of “a character which is unnecessary” to be subject to FIFRA “in order to carry out the purposes” of FIFRA. 7 U.S.C. 136w(b)(2). Several exemptions under FIFRA section 25(b)(2) were adopted in 1988 and included a “treated articles and substances” exemption at 40 CFR 152.25(a).
The regulation at 40 CFR 152.25 provides that “the pesticides or classes of pesticides listed in this section have been determined to be of character not requiring regulation under FIFRA and are therefore exempt from all provisions of FIFRA when intended for use, only in the manner specified.” The regulation in 40 CFR 152.25 identifies the types of pesticides and conditions applicable for an exemption to apply. 40 CFR 152.25(a) identifies treated articles or substances and defines them as “an article or substance treated with, or containing, a pesticide to protect the article or substance itself (for example, paint treated with a pesticide to protect the paint coating, or wood products treated to protect the wood against insect or fungus infestation), if the pesticide is registered for such use.”
It has been EPA's longstanding position that FIFRA section 25(b)(2) authorized the 1988 final rule exempting pesticide-treated articles or substances because EPA's assessment of the treating pesticide comprehensively addresses the use of and exposure to the treating pesticide and to the article or substance that is permissibly treated and distributed, sold, and used consistent with labeling instructions. The FIFRA finding to grant the
It has also been EPA's longstanding position that treated seed products meeting the regulatory conditions at 40 CFR 152.25(a) are exempt from FIFRA requirements. Those conditions include that a pesticide “registered for such use” is used, which EPA has interpreted to require compliance with labeling instructions relating to distribution, sale, and use of the pesticide registered under FIFRA to treat seed and the distribution, sale, and use of the treated seed product itself. If distribution, sale, and/or use of the treating pesticide or treated seed product is not consistent with such labeling for the treating pesticide or treated seed product, then the “registered for such use” criterion is not met and the exemption does not apply. For example, if the treating pesticide requires that the treated seed bag tag include specific labeling information and instructions, but such bag tag does not include the required labeling or instructions, the “registered for such use” condition is not met. In such a case, the exemption does not apply and the treated seed product must be registered under FIFRA and must comply with other FIFRA requirements, such as the requirement in FIFRA section 7 to register the establishment in which the pesticide is produced and the requirements in FIFRA section 17(c) and 19 CFR 2.110 through 2.117 to file an EPA Notice of Arrival of Pesticides and Devices (EPA Form 3540-1) or its electronic equivalent for importation of treated seed product (Ref. 1). Similarly, if the treated seed product is not used consistent with the instructions on treating pesticide labeling as communicated on the seed bag tag, the condition that a pesticide “registered for such use” is not met and use of the treated seed product would be use of an unregistered pesticide. The required labeling information and instructions are helpful to farmers who use the treated seed and may be considered in EPA risk assessments. As a result, compliance with the requirements for such labeling and the instructions relating to distribution, sale, and use may be necessary to protect against unreasonable risks to the environment.
A more thorough discussion of EPA's approach for evaluating pesticides for use in treating seeds, which includes an evaluation of the use of the treated seed product itself, and the treated article exemption is discussed in EPA's Treated Seed Petition Response which is discussed in the next section.
In April 2017, the Center for Food Safety (CFS or the Petitioner) filed a petition with EPA seeking a rulemaking or a formal agency interpretation relating to pesticide treated seed (hereinafter Treated Seed Petition) (Ref. 2). Specifically, CFS petitioned EPA to take the following actions: (1) Amend 40 CFR 152.25(a) to clarify that it does not apply to seeds for planting coated with systemic pesticides, such as the neonicotinoids, that are intended to kill pests of the plant instead of pests of the seed itself; (2) Alternatively, publish a final, formal, Agency interpretation in the
EPA responded to the petition on September 27, 2022 (hereinafter Treated Seed Petition Response) (Ref. 1). In that response, EPA explained the history of the regulatory treated article exemption, the comprehensive nature of assessments of pesticides that are intended for use in treating seeds which includes assessment of the impact with use of the treated seed, and the regulatory conditions for the article exemption to apply. EPA noted that if the conditions for the exemption are met, the exemption applies; no new assessment or risk finding is necessary and no new FIFRA section 25(b)(2) finding specific to the article or substance treated is required. EPA also noted that it has been reviewing and will continue to review labeling instructions for pesticides registered for seed treatment use(s) in registration and registration review to verify the completeness of these instructions for both use of the treating pesticide and the distribution, sale, and use of the treated seed products. Finally, EPA acknowledged that use of the treated seed product in a manner contrary to labeling instructions is not generally enforceable under FIFRA. As a result, while the Agency did not grant the petition requests, it noted that it intends to issue this ANPRM to seek additional information on pesticide seed treatment, including use and usage information and whether treated seed products are being used contrary to labeling instructions, and to explore the option of issuing a rule pursuant to FIFRA section 3(a) to regulate the use of treated seed products. As explained in the petition response, plant-incorporated protectants (PIPs) are not subject to the treated article exemption for reasons articulated at 40 CFR 174.1 (because the characteristics of PIPs “distinguish them from traditional chemical pesticides,” PIPs are subject to “different regulatory requirements, criteria, and procedures than traditional chemical pesticides”). As a result, PIPs are not within the scope of this ANPRM. For further information, please see docket ID number EPA-HQ-OPP-2018-0805 at
In August 2022, SFIREG provided EPA with the “Treated Seed Issue Paper” for consideration and response (Ref. 3). Shortly following the submittal of this issue paper by SFIREG, EPA released the Treated Seed Petition Response discussed in Unit II.C., which addressed many of the issues raised in the SFIREG issue paper in full or in part. In June 2023, the Agency responded to the SFIREG issue paper, based on its understanding of the issues that were raised (Ref. 4). Part of that response included EPA's intention to include in this ANPRM the issues that were raised and to particularly focus on those not fully addressed in the Treated Seed Petition Response. Some of the issues raised in the SFIREG issue paper that are included in this ANPRM include use of treated seed products and available data systems to track the active ingredients used for seed treatments, change in use patterns of other pesticides due to availability of treated seeds, and label language on seed treatment products and treated seed products (
Paint and coating products are often treated with pesticides for a variety of reasons, such as to increase the longevity of the products by controlling microbial contamination of the paint applied to a surface. Pesticide labeling requirements for treated paint or coatings do not currently exist. However, recent EPA risk assessments on paint preservative pesticides suggest that there may be risks of concern for professional painters exposed to treated paint without use of PPE such as respirators when applying paint using a spray method. The concept of adding labeling requirements for treated paint on the paint container has, thus far, only been proposed for one active ingredient (
EPA invites public feedback on the questions posed in this document regarding use and usage of treated seed products and whether there are cases of use contrary to treating pesticide or treated seed product (
As explained in the Treated Seed Petition Response, EPA's assessments for treating pesticides are based on all reasonably available and reliable information, including exposure assessments based on the treating pesticide labeling instructions defining the maximum amount of active ingredient that may be used on the seed. These assessments and labeling instructions are subject to public comment during the registration and registration review processes. In addition, outside of the registration and registration review processes, EPA recently solicited further public comment on proposed updates to all treated seed labeling on treating pesticide products and on treated seed products, to reduce exposures to non-target organisms, which might include federally listed threatened or endangered species. EPA has updated the labeling language for such products for future active ingredients undergoing registration review in response to comments and in anticipation of seeking further comment in response to this ANPRM. In addition, its public processes under registration and registration review for specific pesticide products intended for use in treating seed, EPA will continue to consider further updates to treated seed product label language to take into account additional public comments and new information, if any submitted.
This ANPRM is a separate effort to consider whether to amend its approach for regulation of treated seed products (
This ANPRM is also intend to explore the option of adding instructions on the labels of pesticides used to treat paint, similar to the approach take for labeling of treated seed, and/or whether to amend its approach for allowing treated paint to be exempt from FIFRA requirements (
EPA is specifically requesting comment and information on the following topics:
• Effectiveness of instructions on treated seed product labeling (
• Use, usage, and tracking of treated seed products;
• Management of spilled or excess treated seed;
• Treated paint; and
• Administrative action, amendment of the treated article exemption, and/or FIFRA section 3(a) Rule.
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EPA currently is reviewing labeling instructions for pesticides registered for seed treatment use(s) in registration and registration review. EPA intends to ensure that treating pesticide labeling instructions include: (1) the requirement that seed bag tag labeling accompany the treated seed when distributed and sold; (2) that such labeling include specified clear and effective instructions on use of the treated seed, including the name of the active ingredient and pesticide product used (including the EPA product registration number), and instructions on the storage, planting, and/or management of spilled or excess treated seed, as appropriate; and, (3) that the distribution or sale of the treated seed products without such labeling is the distribution or sale of an unregistered pesticide.
The Treated Seed Petition raised a number of issues with the potential for harm from the planting of treated seed or with the planting process used to plant treated seed. The Treated Seed Petition Response discusses each of the issues, including how EPA assessments of the treating pesticide address these issues. The response also discusses the regulatory conditions for application of the treated article exemption and how those conditions apply to treated seed products, including, among other things, the need for use of the treating pesticide and treated seed products to be consistent with the treating pesticide and related seed product labeling instructions. Examples of such labeling are in the document “Labeling Instructions for Pesticide-Treated Seed and Pesticide-Treated Paint Products” (referred to as the “Labeling Instructions” document from hereon) (Ref. 5), which can be found in the
EPA is requesting comment on the following:
• Labeling instructions presented in the Labeling Instructions document (Ref. 5) and whether there are any necessary improvements to such language.
• Are the examples of current instructions for storage, planting, and management of treated seed clear, generally achievable,
• Are there other recommendations to increase the clarity of instructions on treated seed product (
• Are there additional or alternative instructions that would be effective in reducing dust-off?
2.
EPA's exposure estimates reflect both use and usage information. Use information is focused on the maximum amount of particular pesticide that may be applied based on the treating pesticide labeling instructions (
The Treated Seed Petition noted the lack of pesticide usage data collected by EPA but acknowledged that one EPA assessment assumed nearly 100% of one crop is treated with the referenced pesticide and in another case identified the percentage of the pesticide use that is on treated seed. In response, EPA acknowledged the lack of usage data but more recently, data from two sources (
The SFIREG issue paper sought additional information on the general use of treated seed and data systems to track use of active ingredients to treat seed. The SFIREG issue paper also sought more information on the impact of the use of treated seed on the other types of applications such as soil or foliar applications (
EPA is seeking comment on the certain issues summarized below as raised in the SFIREG issue paper and the Treated Seeds Petition.
• Information on the use and usage of treated seed.
• Given the scope of EPA assessments, whether the potential for tracking of treated seed distribution, sale, and/or use would provide any meaningful improvements in the assessment of the risks of pesticides used to treat seeds.
• Are there available data detailing the replacement or reduction of other types of pesticides with increasing use of treated seed, since this issue is of interest to states and other stakeholders? EPA would normally address replacement and use reduction on an individual chemical basis, taking into account alternative control strategies to seed treatment (
• Are there additional data sets available that may serve to complement the recently acquired data sources (
• EPA requests information on the volume of imported treated seed products and whether amending the treated article exemption so that importers of treated seed products must comply with FIFRA section 17(c) and 19 CFR 12.110 through 2.117, including filing an EPA Notice of Arrival of Pesticides and Devices (EPA Form 3540-1) or its electronic equivalent would assist in tracking the import and distribution of treated seed products (
• Should the treated article exemption be amended so that treated seed manufacturers would be subject to FIFRA section 7 registration and reporting requirements (Ref. 11)? Would this information help track use of seed treatment pesticides or provide any helpful treated seed usage information?
3.
EPA included additional labeling instructions for management of spilled and excess treated seed in the registration review Proposed Interim Decisions (PIDs) and Interim Decisions (IDs) of several chemicals (see for example Ref. 12 and Ref. 13) as appropriate. This labeling included instructions on the collection and burial
Comments on the ESA Workplan Update (Ref. 14) raised concerns with disposal of treated seed, particularly for use in ethanol production. The proposed labeling instructions that are presented in Labeling Instructions document (Ref. 5) are intended to address concerns relating to disposal of treated seed, exposure to wildlife, contamination of ground and surface water, sufficiency of current disposal instructions on both the registered treating pesticide product and treated seed product labeling, and disposal by way of ethanol production (for oil seed crops such as corn and soybeans). The concern regarding disposal of treated seeds stems from the possibility of a buildup of pesticide material as a byproduct of ethanol production.
The Agency previously approved labels for oil seed crops that allowed for the use of excess treated seeds in ethanol production. EPA became aware of the potential for the use of excess, unmarketable treated seeds of oilseed crops in ethanol production and was concerned about the potential for pesticide residues found in the ethanol production by-products getting into food or feed. The byproducts of the process (
EPA requests comment on the following:
• Are additional instructions for collection of spilled seed needed?
• What is currently done with excess treated seed if not used in a planting season? For example, what do farming operations do with excess seed; can that seed be returned to the distributor or seed company?
• Similarly, what do distributors and seed companies do with excess treated seed that is not sold or delivered to or is returned from farming operations?
4.
Paints and coatings are often treated with pesticides for a variety of reasons, such as to increase the longevity of the products by controlling microbial contamination of the paint applied to a surface. Pesticide labeling requirements for treated paint do not currently exist. However, recent EPA risk assessments on paint preservative pesticides suggest that some treated paints may pose risks of concern to professional painters when applying paint using a spray method, without use of PPE such as respirators. The concept of adding labeling requirements for treated paint on the paint container has, thus far, only been proposed for one active ingredient (
EPA assesses risks to Do-It-Yourself painters as well as professional painters (
a.
EPA is considering requiring certain treated paint products to include labeling instructions relating to precautionary label language and proper use. See Ref. 5. Distribution and sale of the treated paint products with such instructions would be an exempted treated substance and thus registration of the treated paint would not be required. For the exemption to apply, and similar to treated seed, the registration and labeling for the treating pesticide will make clear that specified instructions and precautionary language must appear on the treated paint labeling. If more than one pesticide is used to treat the paint, the registration and labeling for the treating pesticides will also likewise make clear that the exemption will only apply if the most restrictive label language is used on the paint label. If the appropriate instructions and precautionary language are not on the paint product labeling, the treated paint would not qualify as an exempt treated article, making it an unexempt, unregistered pesticide that may not be sold or distributed under FIFRA section 3 and subject to enforcement under FIFRA section 12(a)(1)(A).
EPA is also considering adding specific use instructions for professional painters based on recent risk assessments for paint preservatives that have identified risks for professional painters. EPA may propose a FIFRA section 3(a) rule to apply to certain treated paint, making certain use instructions enforceable under FIFRA section 12(a)(2)(S). Similar to the discussion on treated seed, other administrative actions may also be considered (
EPA requests specific comment on the following topics:
• If EPA were to establish label requirements for treated paint products, what should be included to increase the clarity of the labeling and its safe use for the end user and the environment?
• Is there evidence that the lack of label or labeling requirements on treated paint has resulted in harm to human health or the environment? This may include harm experienced by professional painters from use of treated paint, improper disposal of treated paint,
• Would requiring on the treated paint label the EPA registration number for each treating pesticide and the appropriate use instructions relating to painter protection be effective in reducing the identified risk concerns? If not, what additional information or requirements should EPA consider?
• Should the treated article exemption be amended so that paint manufacturing establishments producing pesticide-treated paint would be subject to FIFRA section 7 registration and reporting requirements (Ref. 11)? If so, should the establishment registration number be included on the label of the treated paint? How many paint manufacturers might be subject to such a requirement?
• If EPA were to establish enforceable use requirements for professional painters using treated paint, what additional information or requirements should EPA consider in this rulemaking to ensure effective enforcement? This may include information on additional resources, processes,
b.
As noted previously, the condition in the exemption that the treating pesticide be “registered for such use” specifies that the exemption only applies to treated paint that is formulated with a FIFRA-registered pesticide product. EPA requests information on the volume of imported treated paint and whether amending the treated article exemption so that importers of treated paint must comply with FIFRA section 17(c) and 19 CFR 12.110 through 2.117, including filing an EPA Notice of Arrival of Pesticides and Devices (EPA Form 3540-1) or its electronic equivalent would assist in tracking the import and distribution of treated paint (
5.
EPA's assessments for seed and paint treatment uses are comprehensive, and EPA processes allow for comment on those assessments. As noted in the Treated Seed Petition Response, amending the regulatory exemption for treated articles to require registration of pesticide-treated seed where there is general compliance with labeling instructions for the FIFRA registered pesticides and treated seed products would provide little to no human health or environmental benefits. This is based on the comprehensive nature of EPA assessments for treating pesticides and treated seed and given EPA has no information suggesting that users of treated seed products are distributing, selling, or using the seed products contrary to labeling instructions. This is the same case for other treated articles and substances, including treated paint. However, concerns were raised by the Treated Seed Petition and the SFIREG issue paper regarding a lack of enforceability relating to use of treated seeds contrary to label instructions and possible effects of such use on human health and the environment. The same concerns also apply to treated paint products. Thus, EPA is requesting comment from stakeholders on whether or to what extent there might be use of treated seed and paint products contrary to labeling instructions for the treated seed and paint.
EPA will take into consideration comments and information submitted in response to this ANPRM to determine whether to amend its approach for regulation of treated seed and treated paint (
EPA requests comment on the following:
• Is a FIFRA section 3(a) rule and/or other regulatory or administrative action necessary or appropriate to prevent unreasonable adverse effects on human health and the environment, considering the concerns raised regarding enforceability of any particular type of labeling instructions on use of treated seed and paint products? Is a FIFRA section 3(a) rule and/or other regulatory or administrative action the best way of ensuring use consistent with instructions on the treating pesticide labeling relating to use of the treated seed or paint?
• Are there examples of use of treated seed contrary to labeling instructions, and whether adopting a FIFRA section 3(a) rule or the other options noted are the best means of ensuring appropriate use of treated seed?
• Would there be any impacts that might result to states if such a FIFRA section 3(a) rule is finalized? Are there existing tools that would be impacted, or are new ones needed for state investigation and enforcement? For example, state statutes or rules may need to be amended, new standard operating procedures developed, additional personnel hired, or some form of record keeping added.
• Are there specific examples of misuse by seed treatment applicators or from on-farm seed treatments and what type of evidence has been collected to support this claim?
• What are the enforcement measures that are used in regions and individual states for misuse of pesticides and are there barriers to applying such measures to treated articles, such as treated seed and treated paint?
• What are some examples of state statutory authority concerning treated seed and/or paint, and successful enforcement measures that have been exercised regarding treated seed and/or paint?
• What are some considerations, including enforcement considerations, that need to be included in EPA's approach for assessment and management of pesticide-treated seed and paint?
Under EPA policy, environmental justice is “the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income, with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.” See
1.
It is estimated that there are 2.5-3 million agricultural workers in the United States. The Department of Labor conducted a National Agricultural Workers Survey in 2019-2020. In this survey, more than 2,100 farmworkers were interviewed in person. Approximately 78% of those workers identified themselves as Hispanic and 62% said that Spanish was the language in which they were most comfortable conversing. Among U.S.-born farmworkers, 32% were Hispanic. Ten percent of farmworkers were self-identified as indigenous. EPA requests specific comment on the following topic:
• Are there any sources of data that could address whether exposure to treated seeds may be an environmental justice concern (
2.
EPA has limited sources of data to address whether there could be disproportionate impact to certain demographics that might be more likely to be exposed to treated paint. The Bureau of Labor Statistics (BLS) data from 2021 include demographics on “painting workers” and “painters and paperhangers.” For both categories, the BLS data suggest that the majority of workers are Hispanic or Latino. According to 2021 U.S. Census data, Hispanics/Latinos make up 18.9% of the population. However, according to BLS, 32.3% of “painting workers” and 59.3% of “painter and paperhangers” are Hispanic or Latino. EPA requests specific comment on the following topics:
• Are there any sources of data that could address whether exposure to treated paint may be an environmental justice concern?
• Does either, or both, of the BLS categories (
In addition to the statutory obligations in FIFRA and FFDCA to consider children's health in registration decisions, EPA's 2021 Policy on Children's Health (Ref. 16) states that protecting children's health from environmental risks is fundamental to EPA's mission because varying behavioral and physiological characteristics can affect children's exposure and health risks, children's health should be viewed through the lens of a sequence of “lifestages” (from conception, infancy, early childhood, and adolescence through until 21 years of age).
Children may be more susceptible to environmental exposures and/or the associated health effects, and therefore more at risk than adults. These risks arise because children generally eat more food, drink more water, and breathe more air relative to their body size than adults do, and consequently may be exposed to relatively higher amounts of contaminants. Normal childhood activity, such as putting hands and objects in mouths, playing on the ground, or crawling, can result in exposures to contaminants that adults do not face. In addition, environmental contaminants may affect children disproportionately because they are still developing; for example, their immune system defenses are not fully developed, and their growing organs are more easily harmed.
The Agency welcomes public comment and information regarding the consideration of potential children's health concerns in the context of the issues raised in this ANPRM. If and when the Agency proposes regulatory options regarding exemptions under FIFRA, other actions or the related procedures, EPA will seek additional input from the public to facilitate the Agency's consideration of potential children's health concerns related to those actions.
EPA intends to review all the comments and information received in response to this ANPRM, as well as previously collected and assembled information, to help determine whether to propose a FIFRA section 3(a) rule or take other regulatory or administrative action to adjust its approach for treated seed or treated paint. In addition to comments received in response to this ANPRM, EPA may seek additional information from states, industry or other stakeholders. Should EPA decide to move forward with changes to the program, the next step would be to identify, develop and evaluate specific options, including whether amendment to the current regulation in 40 CFR 152.25(a) is appropriate, and if so, to develop a proposed rule for public review and comment. During the development of the proposed rule, the Agency may also engage stakeholders or provide other opportunities for public engagement and comment before issuing a final action.
The following is a list of the documents that are specifically referenced in this document. The docket includes these references and other information considered by EPA, including documents that are referenced within the documents that are included in the docket, even if the reference is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action as defined in Executive Order 12866 (58 FR 51735, October 4, 1993), as amended by Executive Order 14094 (88 FR 21879, April 11, 2023), and was therefore not subject to a requirement for Executive Order 12866 review.
Because this action does not impose or propose any requirements, and instead seeks comments and suggestions for the Agency to consider in possibly developing a subsequent proposed rule, the various other review requirements in statutes and Executive Orders that apply when an agency imposes requirements do not apply to this ANPRM. Should EPA subsequently determine to pursue a rulemaking, EPA will address the requirements in the statutes and Executive Orders as applicable to that rulemaking.
Nevertheless, the Agency welcomes comments and/or information that would help the Agency to assess any of the following:
• Potential economic impacts of a rulemaking on small entities pursuant to the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
• Potential impacts on Federal, state, or local governments pursuant to the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531-1538);
• Potential federalism implications pursuant to Executive Order 13132, entitled
• Potential Tribal implications pursuant to Executive Order 13175, entitled
• As discussed in Unit III.C., potential human health or environmental effects on minority or low-income populations pursuant to Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994);
• As discussed in Unit III.D., potential disproportionate environmental health or safety effects on children pursuant to Executive Order 13045, entitled
• Potential availability of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA) (15 U.S.C. 272).
• Potential energy effects pursuant to Executive Order 13211, entitled
• Potential impacts in terms of costs and burdens associated with regulation options that the Agency may consider in developing a proposed rulemaking or other requirements, including potential activities and burdens associated with potential paperwork burdens pursuant to the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
The Agency will consider such comments and information in developing options as it considers appropriate steps to address any applicable requirements.
Administrative practice and procedure; Agricultural commodities; Environmental protection; Exemptions from pesticide regulation; Pesticides and pests; Reporting and recordkeeping requirements.
Fish and Wildlife Service, Interior.
Notification of petition findings and initiation of status review.
We, the U.S. Fish and Wildlife Service (Service), announce two 90-day findings on petitions to reclassify the West Indian manatee (
The findings announced in this document were made on October 12, 2023.
(1)
(2)
We request that you send information only by the methods described above. Any information we receive during the course of our status review will be considered, and we will post all information we receive on
Nicole Rankin, Division of Conservation and Classification Manager, telephone: 404-679-7089, email:
You may submit your comments and materials concerning the status of, or threats to, the West Indian manatee, its subspecies or populations, including the Puerto Rico population of Antillean manatee, or their habitats, by one of the methods listed above in
If you submit information via
Comments and materials we receive, as well as supporting documentation we used in preparing these findings, will be available for public inspection on
Section 4 of the Act (16 U.S.C. 1533
Our regulations establish that substantial scientific or commercial information with regard to a 90-day petition finding refers to credible scientific or commercial information in support of the petition's claims such that a reasonable person conducting an impartial scientific review would conclude that the action proposed in the petition may be warranted (50 CFR 424.14(h)(1)(i)).
A species may be determined to be an endangered species or a threatened species because of one or more of the five factors described in section 4(a)(1) of the Act (16 U.S.C. 1533(a)(1)). The five factors are:
(a) The present or threatened destruction, modification, or curtailment of its habitat or range (Factor A);
(b) Overutilization for commercial, recreational, scientific, or educational purposes (Factor B);
(c) Disease or predation (Factor C);
(d) The inadequacy of existing regulatory mechanisms (Factor D); and
(e) Other natural or manmade factors affecting its continued existence (Factor E).
These factors represent broad categories of natural or human-caused actions or conditions that could have an effect on a species' continued existence. In evaluating these actions and conditions, we look for those that may have a negative effect on individuals of the species, as well as other actions or conditions that may ameliorate any negative effects or may have positive effects.
We use the term “threat” to refer in general to actions or conditions that are known to, or are reasonably likely to, affect individuals of a species negatively. The term “threat” includes actions or conditions that have a direct impact on individuals (direct impacts), as well as those that affect individuals through alteration of their habitat or required resources (stressors). The term “threat” may encompass—either together or separately—the source of the action or condition, or the action or condition itself. However, the mere identification of any threat(s) may not be sufficient to compel a finding that the information in the petition is substantial information indicating that the petitioned action may be warranted. The information presented in a petition must include evidence sufficient to suggest that these threats may be affecting the species to the point that the species may meet the definition of an endangered species or threatened species under the Act.
If we find that a petition presents such information, our subsequent status review will evaluate all identified threats by considering the individual-, population-, and species-level effects and the expected response by the species. We will evaluate individual threats and their expected effects on the species, then analyze the cumulative effect of the threats on the species as a whole. We also consider the cumulative effect of the threats in light of those actions and conditions that are expected to have positive effects on the species—such as any existing regulatory mechanisms or conservation efforts that may ameliorate threats. It is only after conducting this cumulative analysis of threats and the actions that may ameliorate them, and the expected effect on the species now and in the foreseeable future, that we can determine whether the species meets the definition of an endangered species or threatened species under the Act. If we find that a petition presents substantial scientific or commercial information indicating that the petitioned action may be warranted, the Act requires that we promptly commence a review of the status of the species, and we will subsequently complete a status review in accordance with our prioritization methodology for 12-month findings (81 FR 49248; July 27, 2016).
We note that designating critical habitat is not a petitionable action under the Act. Petitions to designate critical habitat (for species without existing critical habitat, including a potential DPS of the Puerto Rico population of Antillean manatee) are reviewed under the Administrative Procedure Act (5 U.S.C. 1531
The West Indian manatee (
On October 21, 2021, we received a petition from Julio C. Colón requesting that the Puerto Rico population of the Antillean manatee be listed as an endangered distinct population segment (DPS) and that critical habitat be designated for this entity under the Act. On November 21, 2022, we received a petition from the Center for Biological Diversity, Brooks McCormick Jr. Animal Law & Policy Program at Harvard Law School, Miami Waterkeeper, Save the Manatee Club, and Frank S. González García requesting that the West Indian manatee, including its subspecies Florida manatee and Antillean manatee, be reclassified as endangered. Both petitions clearly identified themselves as such and included the requisite identification information for the petitioner, required at 50 CFR 424.14(c). This finding addresses both of those petitions.
Because the West Indian manatee includes two recognized subspecies, the Florida manatee (
The petition from the Center for Biological Diversity, Brooks McCormick Jr. Animal Law & Policy Program at Harvard Law School, Miami Waterkeeper, Save the Manatee Club, and Frank S. González García requests that we reclassify the West Indian manatee, including its subspecies Florida manatee and Antillean manatee, as an endangered species under the Act. We find the petition presents substantial information that seagrass loss (Factor A) may be a threat to the species such that it may meet the definition of an endangered species under the Act. Therefore, we find that the petition presents substantial information that the petitioned action, reclassifying the West Indian manatee as endangered, may be warranted and we will commence a status review to determine if the action is warranted.
The petition also presented information suggesting other activities may be threats to the West Indian manatee, including loss of warm-water refugia, loss of freshwater access, coastal development, and boating and recreational disturbance (Factor A); harassment (Factor B); bacterial infections (Factor C); and boat strikes, marine debris, contaminants, invasive species, and climate change (Factor E). Our status review will evaluate all relevant threats and conservation actions in detail based on the best scientific and commercial data available, including whether these threats towards the listed or listable entities may be ameliorated or exacerbated by any existing regulatory mechanisms or conservation efforts to support a finding that the West Indian manatee, Florida manatee, or Antillean manatee is in danger of extinction throughout all or a significant portion of its range.
We reviewed the petitions, sources cited in the petitions, and other readily available information. We considered the factors under section 4(a)(1) of the Act and assessed the effect that the threats identified within the factors may have on the Puerto Rico population of Antillean manatee and the West Indian manatee now and in the foreseeable future. We also considered existing regulatory mechanisms or conservation efforts that may ameliorate, reduce, or exacerbate the threats. Based on our review of the petitions and readily available information regarding boat collisions, genetic diversity loss, and seagrass loss, we find that these two petitions present credible and substantial information that the petitioned actions may be warranted. We will fully evaluate these and all other potential threats for the listed and listable entities, as well as the validity of the Puerto Rico DPS, in detail based on the best scientific and commercial data available when we conduct a status assessment and make the 12-month findings.
In accordance with the requirements of the statute, our 12-month findings on these two petitions to identify and reclassify a DPS in Puerto Rico, as well as reclassify (uplist) the West Indian manatee and its subspecies, the Florida manatee and Antillean manatee, will be based upon the best scientific and commercial data available and will not be limited to the information presented in the petitions. Similarly, if we make one or more “warranted” 12-month findings, we may identify a DPS in that finding based on the best scientific and commercial data available; we will not be limited to the possible DPS described in the petition. If we do identify and propose to uplist a DPS, we will consider that proposal in the context of the ongoing recovery for the rest of the population in the larger currently listed entity.
The basis for our finding on these petitions, and other information regarding our review of the petitions, including the 2017 reclassification and 2007 5-year status review, can be found at
On the basis of our evaluation of the information presented in the petitions under sections 4(b)(3)(A) and 4(b)(3)(D)(i) of the Act, we have determined that the two petitions summarized above for the Puerto Rico population of Antillean manatee, as well as the West Indian manatee, present substantial scientific or commercial information indicating that the petitioned actions may be warranted. We are, therefore, initiating a status review of the West Indian manatee rangewide. This status review will include a determination on whether a Puerto Rico DPS for the Antillean manatee has the same or a different status than the Antillean manatee rangewide. This status review will determine whether the petitioned actions are warranted under the Act. At the conclusion of the status review, we will issue a finding, in accordance with section 4(b)(3)(B) of the Act, as to whether the petitioned actions are not warranted, warranted, or warranted but precluded by pending proposals to determine whether other species are an endangered or threatened species.
The primary authors of this document are staff members of the Division of Conservation and Classification, Ecological Services Program, U.S. Fish and Wildlife Service.
The authority for these actions is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Forest Service, USDA.
Notice; request for comment.
In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking public comment on reapproval of a currently approved information collection request,
Comments must be received in writing by December 11, 2023.
Comments concerning this notice should be addressed to Kenli Kim via mail at USDA Forest Service, Yates Building, 201 14th Street SW, Washington, DC 20520 or email at
All timely comments, including names and addresses, will be placed in the record and will be available for public inspection and copying. The public may inspect comments received at USDA Forest Service, Yates Building, 201 14th Street SW, Washington, DC 20520, during normal business hours. Visitors are encouraged to call ahead to 202-205-0925 to facilitate entry into the building.
Kenli Kim, USDA Forest Service,
Individuals who use telecommunication devices for the hearing impaired (TDD) may call the Federal Relay Service at 800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Time, Monday through Friday.
Visitor feedback allows the FLMAs to enhance customer service by establishing and revising objectives for FLMA recreational services and facilities and recreation-related transportation programs and systems; inform FLMA land use plans; and facilitate interagency coordination across FLMA jurisdictions. This feedback augments the ability of FLMAs to meet the recreational needs of the public and more effectively utilize the resources under FLMA management. In addition, this generic, interagency information collection request saves visitor and agency time and costs by allowing multiple FLMAs in an area to work jointly on data collection. The information collected may also help FLMAs respond to queries from the public, Congressional staffs, the media, and transportation and recreation organizations.
The authorities for the FLMAs to conduct public surveys on recreation and supporting transportation programs and systems include:
• Forest Service Organic Administration Act of 1897.
• Forest Service Multiple Use-Sustained Yield Act.
• National Park Service Act of 1916.
• National Wildlife Refuge System Administration Act of 1966.
• National Wildlife Refuge System Centennial Act.
• Federal Land Policy and Management Act of 1976.
• Government Performance and Results Act of 1993.
Respondents include visitors and potential visitors to FLMA-managed lands and residents of communities in or near those lands, as well as state, local, or Tribal agency staff who are involved with public land management and businesses operating on or near FLMA-managed lands. Many of the FLMA information collections may be similar in terms of the populations surveyed, types of questions asked, research methods, and data applications. The information collection may occur at one location, several locations, across FLMA units, across regions, or nationally and may be multi-jurisdictional at any of these levels. The information collection may occur once, multiple times over a short time period, or periodically over a long period. Individual, organizational, agency, or business feedback could be collected through facilitated focus groups, in-person or telephonic interviews, or electronic or handwritten comment cards or questionnaires. Potential participants may be contacted at pertinent sites, including FLMA access points, or pre- or post-visit.
In general, questions relate to recreational use of one or more specific locations on FLMA-managed lands and may address one or more of the following:
• Mobility and access, such as different transportation modes used to access sites; satisfaction with transportation-related services and facilities; use and satisfaction with traveler information; reasons for non-visitation.
• Resource management, such as support for different management approaches.
• Safety, for example, safety-related incidents that have occurred.
• Environment, including for example visitor priorities with respect to natural and cultural resources and perceptions related to sound.
• Economic development, such as the amount of money visitors spend in an area.
• Trip characteristics, for example, length of trip and trip purpose, activities, and destinations.
• Visitor or user demographics and use data, such as city and state of residence, age group, gender, race, and number of people or vehicles in a party.
All results are aggregated so that specific responses cannot be connected to specific respondents. If any names, addresses, or telephone numbers are collected, FLMAs will not store that information with responses. Contact information will be purged from FLMAs' files once data collections are completed.
Participation in the FLMA surveys, interviews, focus groups, and other data collections under this information collection is strictly voluntary. The information may be collected and analyzed by FLMA personnel, private contractors, other federal agencies, or universities or other educational institutions conducting the information collection on behalf of the FLMAs. All results will be aggregated so specific responses cannot be connected to specific respondents.
Without coordinated information collections on recreation and supporting transportation programs and systems on federal land, the FLMAs will lack the information necessary to identify and implement improvements in recreational services and facilities and supporting transportation programs and systems that address public needs, protect federal land and resources, and enhance the visitor experience. These information collections will become more important as demand for access to FLMA recreation sites and opportunities continues to grow.
Comment is invited on (1) whether this information collection request is necessary for the stated purposes and the proper performance of the functions of the FLMAs, including whether the information collected will have practical or scientific utility; (2) the accuracy of the Forest Service's estimate of the burden of the information collection request, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the information collection request on respondents, including the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the submission request for Office of Management and Budget approval.
The Department of Commerce will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance, in accordance with the Paperwork Reduction Act of 1995 (PRA) on or after the date of publication of this notice. We invite the general public and other Federal agencies to comment on proposed and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. Public comments were previously requested via the
This information collection request may be viewed at
Written comments and recommendations for the proposed information collection should be submitted within 30 days of the publication of this notice on the following website
On June 8, 2023, GE Vernova Operations, LLC submitted a notification of proposed production activity to the FTZ Board for its facility within FTZ 121, in Schenectady, New York.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
On June 8, 2023, Puerto Rico Steel Products Corporation submitted a notification of proposed production activity to the FTZ Board for its facility within Subzone 163L, in Coto Laurel, Puerto Rico.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
On June 8, 2023, the Board of County Commissioners of Washington County, Maryland, grantee of FTZ 255, submitted a notification of proposed production activity to the FTZ Board on behalf of Lenox Corporation, within FTZ 255, in Hagerstown, Maryland.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the Port of South Louisiana, grantee of FTZ 124, requesting an expansion of Subzone 124A on behalf of Valero Refining—New Orleans L.L.C. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the FTZ Board (15 CFR part 400). It was formally docketed on October 5, 2023.
The applicant is requesting authority to expand Subzone 124A to include a new site located at 11842 River Road in St. Rose (Site 2, 2.63 acres). No authorization for additional production activity has been requested at this time.
In accordance with the FTZ Board's regulations, Camille Evans of the FTZ Staff is designated examiner to review the application and make 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 “Online FTZ Information Section” section of the FTZ Board's website, which is accessible via
For further information, contact Camille Evans at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) finds that certain producers/exporters subject to this administrative review made sales of subject merchandise at less than normal value during the period of review (POR) March 1, 2021, through February 28, 2022.
Applicable October 12, 2023.
Lilit Astvatsatrian or Caroline Carroll, AD/CVD Operations, Office IX, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-6412 or (202) 482-4948, respectively.
On April 6, 2023, Commerce published the
The merchandise subject to the
All issues raised in the case and rebuttal briefs are addressed in the Issues and Decision Memorandum. A list of the issues that parties raised, and to which we responded in the Issues and Decision Memorandum, is attached to this notice in Appendix I. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Based on a review of the record and comments received from interested parties regarding our
Generally, Commerce looks to section 735(c)(5) of the Act, which provides instructions for calculating the all-others rate in an investigation, for guidance for calculating the rate for companies which were not selected for individual examination in an administrative review. Under section 735(c)(5)(A) of the Act, the all-others rate is normally “an amount equal to the weighted-average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero or
In this review, we calculated weighted-average dumping margins of 2.29 percent and 8.57 percent for ATC and ATF, respectively. With two respondents under individual examination, Commerce normally calculates: (A) a weighted-average of the estimated dumping rates calculated for the examined respondents; (B) a simple average of the estimated dumping rates calculated for the examined respondents; and (C) a weighted-average of the estimated dumping rates calculated for the examined respondents using each company's publicly-ranged U.S. sale values for the merchandise under consideration. Commerce then compares (B) and (C) to (A) and selects the rate closest to (A) as the most appropriate rate for all other producers and exporters.
Consistent with our practice, we have determined that 2.56 percent, which is the weighted average of ATC and ATF's margins based on publicly ranged data, will be assigned to the non-examined companies under section 735(c)(5)(A) of the Act.
As a result of this review, we determine the following estimated weighted-average dumping margins for the period March 1, 2021, through February 28, 2022:
Commerce intends to disclose the calculations performed for ATC and ATF in connection with these final results to interested parties within five days of the date of publication of this notice, in accordance with 19 CFR 351.224(b).
Pursuant to section 751(a)(2)(C) of the Act, and 19 CFR 351.212(b)(1), Commerce has determined, 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.
Pursuant to 19 CFR 351.212(b)(1), because ATC reported the entered value of its U.S. sales, we calculated importer-specific
For the companies not selected for individual review, we used an assessment rate based on the weighted average of the cash deposit rates calculated for ATC and ATF. 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 the future deposits of estimated duties where applicable.
Commerce's “automatic assessment” practice will apply to entries of subject merchandise during the POR produced by ATC or ATF for which the reviewed companies did not know that the merchandise they sold to the intermediary (
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for the companies covered in this review will be equal to the weighted-average dumping margin that is established in the final results of this review, except if the rate is less than 0.50 percent and, therefore,
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 review period. Failure to comply with this requirement could result in Commerce's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under 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 return/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 sanctionable violation.
This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that the sole mandatory respondent under review, Taizhou Qingsong Refrigerant New Material Co., Ltd./Taixing Meilan New Materials Co., Ltd. (collectively, Qingsong), made sales of subject merchandise at prices below normal value during the period of review (POR) August 27, 2020, through February 28, 2022. Additionally, we are rescinding this review with respect to Zhejiang Sanmei Chemical Ind. Co., Ltd. (Zhejiang Sanmei).
Applicable October 12, 2023.
Paul Gill, AD/CVD Operations, Office IX, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-5673.
On April 6, 2023, Commerce published the
The merchandise covered by the
We addressed all the issues raised in the case and rebuttal briefs in the Issues and Decision Memorandum. A list of the issues that parties raised is provided in the appendix to this notice. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Based on a review of the record and comments received from interested parties regarding the
In the
As a result of this review, we are assigning the following dumping margin to the respondent for the period August 27, 2020, through February 28, 2022:
Commerce intends to disclose the calculations performed in connection with these final results to interested parties within five days of the date of publication of this notice, in accordance with 19 CFR 351.224(b).
Pursuant to section 751(a)(2)(C) of the Act and 19 CFR 351.212(b), Commerce determined, 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. Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of these final results. If a timely summons is filed at the U.S. Court of International Trade, the assessment instructions will direct CBP not to liquidate relevant entries until the time for parties to file a request for a
Pursuant to Commerce's assessment practice,
The following cash deposit requirements will be effective upon publication of the final results of administrative review for all shipments of subject merchandise entered, or withdrawn from warehouse, for consumption on, or after, the publication date of the final results of review, as provided for by section 751(a)(2)(C) of the Act: (1) the cash deposit rate for Qingsong will be equal to the dumping margin established in the final results of this review; (2) for a previously investigated or reviewed exporter of subject merchandise not listed in the final results of review that has a separate rate, the cash deposit rate will continue to be the exporter's existing cash deposit rate; (3) for all Chinese exporters of subject merchandise that do not have a separate rate, the cash deposit rate will be the cash deposit rate established for the China-wide entity, 221.06 percent;
This notice also 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 double antidumping duties.
This notice also serves as the final reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of 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 sanctionable violation.
We are issuing and publishing these final results of administrative review and notice 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.
On September 28, 2023, the U.S. Court of International Trade (CIT) issued its final judgment in
Applicable October 8, 2023.
Laurel LaCivita, 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.
On July 7, 2021, Commerce published its
List Industries, Inc. (the petitioner) appealed Commerce's
In its final results of redetermination, issued in August 2023, Commerce provided further explanation for its treatment of shipping revenue, incentive income, interest income, and rental income in the determination of the SG&A expense ratio using Ayes' audited financial statements.
On September 28, 2023, the CIT sustained Commerce's final results of redetermination.
In its decision in
Because there is now a final court judgment, Commerce is amending its
Commerce will issue revised cash deposit instructions to U.S. Customs and Border Protection.
This notice is issued and published in accordance with sections 516A(c) and (e) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On July 14, 2023, the U.S. Court of International Trade (CIT) issued its final judgment in
Applicable July 24, 2023.
Adam Simons, AD/CVD Operations, Office IX, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-6172.
On November 30, 2020, Commerce published its final results in the 2017-2018 antidumping duty administrative review of WLP from Korea.
Husteel, Hyundai Steel, NEXTEEL, and SeAH appealed Commerce's
In its
The CIT sustained Commerce's
In its decision in
Because there is now a final court judgment, Commerce is amending its
Because NEXTEEL, SeAH, and the non-selected companies Husteel and Hyundai Steel have a superseding cash deposit rate,
Because the CIT's ruling has not been appealed, Commerce intends to instruct CBP to assess antidumping duties on unliquidated entries of subject merchandise produced and/or exported by NEXTEEL, SeAH, and the non-selected companies, Husteel and Hyundai Steel, in accordance with 19 CFR 351.212(b). We will instruct CBP to assess antidumping duties on all appropriate entries covered by this review when the importer-specific
This notice is issued and published in accordance with sections 516A(c) and (e) and 777(i)(1) of the Act.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The U.S. Department of Commerce (Commerce) determines that Suzano S.A. made sales of subject merchandise at prices below normal value during the period of review (POR) March 1, 2021, through February 28, 2022. Commerce also determines that Sylvamo do Brasil Ltda. and Sylvamo Exports Ltda. (collectively, Sylvamo) did not make sales of subject merchandise at prices below normal value during the POR.
Applicable October 12, 2023.
Christopher Maciuba or Nathan James, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone: (202) 482-0413 or (202) 482-5305, respectively.
On April 6, 2023, Commerce published the
The product covered by this
We addressed the issue raised in the case and rebuttal brief in the Issues and Decision Memorandum. The issue that parties raised, and to which we responded in the Issues and Decision Memorandum, is attached to this notice as an appendix. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Following a review of the record and comments received from interested parties, we have made no changes to the
Commerce determines that the following estimated weighted-average dumping margins exist for the period March 1, 2021, through February 28, 2022:
Because we made no changes to the calculations performed in connection with the
Pursuant to section 751(a)(2)(A) of the Act and 19 CFR 351.212(b)(1), Commerce has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries covered by this review.
Because Suzano's weighted-average dumping margin is not zero or
Consistent with Commerce's assessment practice, for entries of subject merchandise during the POR produced by Suzano or Sylvamo for which they did not know their merchandise was destined for the United States, we will instruct CBP to liquidate unreviewed entries at the all-others rate if there is no rate for the intermediate company(ies) involved in the transaction.
Commerce intends to issue assessment instructions to CBP no earlier than 35 days after the date of publication of the final results of this review in the
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) the cash deposit rates for Suzano and Sylvamo will be the rates established in the final results of this administrative review; (2) for previously reviewed or investigated companies not listed above, the cash deposit rate will continue to be the company-specific rate published for the most recently completed segment of this proceeding; (3) if the exporter is not a firm covered in this review, a prior review, or the original less-than-fair-value (LTFV) investigation, but the producer is, the cash deposit rate will be the rate established for the most recently completed segment of this proceeding for the producer of the subject merchandise; and (4) the cash deposit rate for all other manufacturers or exporters will continue to be 27.11 percent, the all-others rate established in the LTFV investigation.
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 has 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 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 the terms of an APO is a sanctionable violation.
We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i)(1) of the Act, and 19 CFR 351.221(b)(5) and 19 CFR 351.213(h)(1).
Commodity Futures Trading Commission.
Notice.
The Commodity Futures Trading Commission (CFTC or Commission) is requesting nominations for Associate Members of the Energy and Environmental Markets Advisory Committee (EEMAC or Committee). The EEMAC is an advisory committee established by the Dodd-Frank Wall Street Reform and Consumer Protection Act.
The deadline for the submission of nominations is October 19, 2023.
Nominations should be emailed to
Lauren Fulks, EEMAC Secretary, (816) 960-7719 or email:
The EEMAC was established to conduct public meetings; submit reports and recommendations to the Commission; and otherwise serve as a vehicle for discussion and communication on matters of concern to exchanges, trading firms, end users, energy producers, and regulators regarding energy and environmental markets and their regulation by the Commission.
Pursuant to the EEMAC's authorizing statute, the EEMAC must have nine members. In addition, the EEMAC Charter requires that the Committee have approximately 9-20 Associate Members. With several Associate Members' terms recently expiring, Commissioner Summer K. Mersinger, the EEMAC's Sponsor, seeks additional Associate Members of the EEMAC.
Accordingly, the Commission invites the submission of nominations for EEMAC Associate Members who represent a wide diversity of opinions and a broad spectrum of interests related to the energy and environmental markets and their regulation by the Commission. To advise the Commission effectively, EEMAC Associate Members must have a high level of expertise and experience in the energy and/or environmental markets and the Commission's regulation of such markets, including from a historical perspective. To the extent practicable, the Commission will strive to select members reflecting wide ethnic, racial, gender, and age representation. All EEMAC Associate Members must be willing to participate in a public forum.
Each nomination submission must provide relevant information about the proposed Associate Member: the individual's name, title, organizational affiliation and address, email address and telephone number, as well as information that supports the individual's qualifications to serve as an Associate Member of the EEMAC (
Submission of a nomination is not a guarantee of selection as an Associate Member of the EEMAC. As noted in the EEMAC's Charter, the CFTC identifies Associate Members of the EEMAC through a variety of methods. Such methods may include public requests for nominations for membership; recommendations from existing advisory committee members; consultations with knowledgeable persons outside the CFTC (industry, consumer groups, other state or federal government agencies, academia, etc.); requests to be represented received from individuals and organizations; and Commissioners' and CFTC staff's professional knowledge of those experienced in the energy and environmental markets. The office of the Commissioner primarily responsible for the EEMAC plays a primary, but not exclusive, role in this process and makes recommendations regarding membership to the Commission. The Commission, by vote, authorizes Associate Members to serve on the EEMAC.
Associate Members may be appointed as representatives, special government employees, or regular government employees. Associate Members serve at the pleasure of the Commission, and may be appointed to serve for one, two, or three-year terms. As required by the EEMAC Charter, Associate Members provide their reports and recommendations directly to the EEMAC and not the Commission. Associate Members do not have the right to vote on matters before the EEMAC and may not sign or otherwise formally approve reports or recommendations made by the EEMAC to the Commission. Associate Members do not receive compensation for their services, and are not reimbursed for travel and per diem expenses. The EEMAC meets at such intervals as are necessary to carry out its functions and must meet at least two times per year. Associate Members are expected to provide their advice and recommendations to EEMAC members during these meetings.
Notwithstanding any other provisions of the law, no person is required to respond to, nor shall any person be subjected to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid OMB Control Number. For this collection, OMB has issued control number 3038-0119.
The information we collect about you is covered by the Privacy Act of 1974. The CFTC is providing this statement to you as required by 5 U.S.C. 552a(e)(3). We are authorized to collect information from you pursuant to the Federal Advisory Committee Act, 5 U.S.C. 1001
Department of the Army, DOD.
Notice of intent.
The Department of the Army (Army) announces its intent to conduct public scoping under the National Environmental Policy Act (NEPA) to gather information to prepare an Environmental Impact Statement (EIS) for proposed near-term real property actions and the update of the Real Property Master Plan (RPMP) for Military Ocean Terminal Sunny Point (MOTSU). MOTSU is a 16,435-acre installation located on the banks of the Cape Fear River between the towns of Boiling Spring Lakes and Southport, North Carolina. The scoping process will help identify reasonable alternatives, potential environmental impacts, and key issues of concern to be analyzed in the EIS. The Army intends to comply with the requirements of section 106 of the National Historic Preservation Act in parallel with this NEPA process and invites federally recognized Tribes and the State Historic Preservation Office (SHPO) of North Carolina to participate in the consultation process.
Scoping comments must be submitted/sent on or before November 11, 2023. There will be a public meeting, as discussed below.
Please send written comments to James A. Rupkalvis, Installation Manager, 6280 Sunny Point Road, Southport, NC 28461-7800 or via email to
Stephen C Herring, Legislative Affairs Officer, Public and Congressional Affairs Office, Military Surface Deployment and Distribution Command; telephone (618) 220-6119; email:
MOTSU is the Military Surface Deployment and Distribution Command's East Coast strategic ammunition port and is the Department of Defense's primary ammunition seaport supporting the European, African, and Middle Eastern areas of operation. The proposed action includes barricade safety, waterfront maintenance, Pleasure Island Explosive Safety Clear Zone security, linear infrastructure (
The EIS will evaluate the potential impacts associated with implementing the proposed RPMP activities, to include analyzing Full-Plan Implementation, a Partial Implementation Alternative, and a No-Action Alternative. Any other reasonable alternatives identified during the scoping process will be considered for evaluation in the EIS. The EIS will assess the impacts of the alternatives on resources and identify mitigation measures. Resource areas to be addressed include land use and coastal zone management, cultural resources, socioeconomics and environmental justice, transportation and utilities infrastructure, hazardous materials, hazardous waste, toxic substances, and contaminated sites. The proposed action could result in significant adverse effects to endangered species, 100-year floodplains, wetlands, and waters of the Cape Fear River. Anticipated permits and other authorizations include findings of no practicable alternatives for actions proposed in floodplains and wetlands per Executive Orders 11988 and 11990 respectively, Endangered Species Act consultations and take permits, National Historic Preservation Act consultations, Clean Water Act section 401 water quality certifications and section 404 permits, Rivers and Harbors Act section 10 permits, Sediment Pollution Control Act permits, and North Carolina Coastal Area Management Act federal consistency determinations. Actual permits and other authorizations will be determined for each project following that project's final design.
Members of the public, federally recognized Native American Tribes, and Federal, state, and local agencies are invited to participate in the scoping process for the preparation of this EIS by attending the virtual public meeting and/or submitting written comments. The Army requests input on identification of potential alternatives, information, and analyses relevant to the proposed action.
Written comments must be sent within 30 days of publication of this NOI in the
Under Secretary of Defense for Acquisition and Sustainment (USD(A&S)), Department of Defense (DoD).
Notice of Federal Advisory Committee meeting.
The DoD is publishing this notice to announce that the following Federal Advisory Committee meeting of the Strategic Environmental Research and Development Program (SERDP) Scientific Advisory Board (SAB) will take place.
SERDP SAB will hold a meeting open to the public. Day 1—Wednesday, October 11, 2023 from 9:00 a.m. to 4:15 p.m. (EST). Day 2—Thursday, October 12, 2023 from 9:00 a.m. to 2:35 p.m. (EST). Day 3—Friday, October 13, 2023 from 9:00 a.m. to 11:45 a.m. (EST).
The meeting will be accessible in person or by videoconference. The in-person meeting will be held at the Hilton Garden Inn, Reagan National Airport, 2020 Richmond Highway, Arlington, VA 22202. Information for accessing the videoconference is provided in
Dr. Kimberly Spangler, 571-372-6565 (voice),
Due to circumstances beyond the control of the Designated Federal Officer, the Strategic Environmental Research and Development Program Scientific Advisory Board was unable to provide public notification required by 41 CFR 102-3.150(a) concerning its October 11-13, 2023 meeting. Accordingly, the Advisory Committee Management Officer for the Department of Defense, pursuant to 41 CFR 102-3.150(b), waives the 15-calendar day notification requirement.
This meeting is being held under the provisions of chapter 10 of title 5 United States Code (U.S.C.) (commonly known as the “Federal Advisory Committee Act” or “FACA”), 5 U.S.C. 552b (commonly known as the “Government in the Sunshine Act”), and 41 CFR 102-3.140 and 102-3.150.
Institute of Education Sciences, Department of Education.
Request for information.
The National Center for Education Research (NCER), a center within the Institute of Education Sciences (IES), is seeking insight to guide its efforts to fund quick-turnaround high-reward, scalable solutions intended to improve education outcomes for all students.
We must receive your comments by November 13, 2023.
Comments must be submitted via the Federal eRulemaking Portal at
Erin Higgins, Education Research Analyst, National Center for Education Research, Institute of Education Sciences, U.S Department of Education, 400 Maryland Avenue SW, Washington, DC 20202-7240. Telephone: (202) 987-1531. You may also email your questions to
If you are deaf, hard of hearing, or have a speech disability and wish to access telecommunications relay services, please dial 7-1-1.
Our education system is tasked with helping Americans across their entire lifespan to successfully engage in civic activity and participate in an ever-evolving workforce, building the foundation for the Nation's future.
In the Explanatory Statement accompanying the fiscal year (FY) 2023 Consolidated Appropriations Act (P.L. 117-328), Congress directed IES to invest in quick-turnaround high-reward, scalable solutions intended to improve education outcomes for all students.
ATS will pilot efforts modeled on the advanced research projects agencies (ARPAs) found throughout the Federal government. ARPAs leverage insights from traditional/basic research to develop and scale breakthrough solutions and capabilities in focused areas that research or industry do not traditionally support. Many domains of R&D are primed for breakthrough advances that can make inroads on long standing education goals, such as personalizing student and educator learning, dramatically increasing learners' motivation and engagement, transforming the implementation and usefulness of assessments, and supporting successful transitions from school to career and between careers.
To advance ARPA-style efforts in education, the ATS initiative will build on several existing IES investments, including the Leveraging Evidence to Accelerate Recovery Nationwide (LEARN) Research Network, the Small Business Innovation Research (SBIR) program, the Standards for Excellence in Educational Research (SEER) Research Network for Digital Learning Platforms, prize challenges, and the Transformative Research in the Education Sciences research program. ATS will also support new activities that emphasize creating scalable, high impact solutions, such as going from idea to prototype and preparing existing tools, techniques, and products with evidence of effectiveness for scaling.
This RFI is focused on a proposed new program within ATS we are calling “From Seedlings to Scale” (S2S). IES is considering a three-phase investment strategy for S2S to support transformative ideas as they grow from seedlings to scalable solutions. As proposed, S2S would focus on high quality research, robust product development, and sustainability and scaling in the education marketplace. The performance goals below highlight how, at a high-level, each of those elements could be combined into a successful project.
Across the three proposed phases of funding, the Department envisions that successful performers would:
• Develop a full product or a broadly-applicable, new capability.
• Foster collaboration between product developers, researchers, and
• Challenge what is currently possible by pursuing breakthroughs, not incremental improvements or “point solutions.”
• Maintain an unwavering focus on improving learner outcomes, continuous improvement, and rigorously evaluating performance.
• Define from the beginning a credible path to significant impact and commercial success (including free and open-source pathways).
• Catalyze new areas of interest and investment.
Through the specific questions in the next section, IES is soliciting public comment on the two topics described below, Focus Areas and Program Design, to inform the development of the S2S program.
IES is currently considering four focus areas:
• Developing approaches that can be used to help learners build skills throughout their life spans to gain broadly applicable competencies and domain-specific skills in growing areas critical for international competitiveness in the jobs of the future.
• Creating tools and systems that can accurately identify and determine the unique needs of individual neurodiverse learners and propose a custom suite of instructional and technological supports to guide their learning.
• Creating next-generation tools for educators for feedback, recommendations, and supports that leverage artificial intelligence to augment teaching and planning. These efforts should support educators and coaches to reflect holistically on the elements of daily practice, including learning environment, instructional strategies, and student performance.
• Creating new techniques and approaches to help educators and learners implement strategies to support behavior and emotion regulation and to support learners' interactions with others in ways that build and maintain caring environments, strong relationships, and robust mental health.
We have also developed a list of potential cross-cutting areas that would be listed alongside the focus areas as “additional topics of interest.” We do not anticipate that these additional topics would become requirements for potential performers; rather, they would be strongly recommended as areas to consider. The additional topics of interest include:
• Data modernization (including transferability, interoperability, and common measures).
• Human-centered design for education innovation.
• Open, fair, and transparent research.
• Data privacy and security.
IES is
IES proposes to leverage a tiered investment model to spur R&D to accelerate the creation of tools, techniques, and products that can lead to breakthrough solutions for any stage of the education system: pre-K, K-12, postsecondary (including community colleges and technical training institutes), and adult education. We envision that this investment model will use a three-phase process to support developing transformative solutions. We offer a brief sketch of the proposed model below. Advancement from one stage to the next would not be automatic but would be contingent on performance and available funds. We anticipate that the timeline for completing all three phases would take an average of six years. However, it is possible that phase three awards focused on scaling may not follow-on directly from a phase two award if IES chooses to structure this phase similar to the Department of Energy's ARPA (ARPA-E) SCALEUP program (
For the first phase of funding, teams would have approximately one year to demonstrate that their proposed solution could meet four essential milestones: (1) serve a set of education providers, educator, or learner needs; (2) define and refine the key performance indicators (KPIs) for the solution; (3) create a prototype that can demonstrate elements of the core functionality at a “demo day”; and (4) conduct one or more successful studies providing evidence of the promise of the proposed solution for improving learner outcomes relative to traditional approaches, should the solution be fully developed.
Projects that demonstrate a compelling use case(s) and promising prototype would be able to move to the second phase. This stage would be approximately two years. The second phase would focus on rapid, iterative development to turn the prototype into a functional solution, answering key research questions about its design, establishing product-market fit, and gathering initial evidence of promise. In this second stage, awardees should also be looking for opportunities to forge strong external partnerships that can function together to improve learner outcomes.
The third phase of funding would last approximately three years. This stage would focus on leveraging strategic partnerships to support continuous improvement, expanding the user base, and independently and rigorously evaluating the impacts of the solutions that showed evidence of promise and strong product-market fit. In this stage, it would be critical to evaluate whether this new solution improves education outcomes and reduces persistent achievement and attainment gaps relative to existing solutions, and to determine cost, implementation ease, and other important measures that reflect both effectiveness and product-market fit. It is also possible that this phase may not follow directly from the previous two phases, allowing time to further develop the partnerships necessary for scaling.
This is a request for information only. This RFI is not a request for proposals (RFP), a request for applications (RFA), or a promise to issue an RFP or a notice inviting applications (NIA). This RFI does not commit the Department to contract for any supply or service whatsoever. Further, we are not seeking proposals and will not accept unsolicited proposals that align to this potential program. The Department will not pay for any information or administrative costs that you may incur in responding to this RFI. The documents and information submitted in response to this RFI will not be returned.
(1) Are the focus areas and cross cutting topics described well suited to advanced development R&D?
(a) Are these areas already adequately covered by existing funding mechanisms? If not, why not?
(b) Are there other topics that you think would yield more promise for identifying and developing breakthrough solutions? If so, what do you find more compelling about that topic?
(2) To successfully develop products and ecosystems that make a major impact on learners' education outcomes, teams will need a variety of supports. IES may require support from private industry in areas such as providing consultation and coaching to teams, convening potential partners for research and scaling.
(a) What would an ideal team look like to maximize the likelihood of success? For example, what role would researchers, education agencies (at the state or local level), and private companies play in the team?
(b) How can we ensure community engagement and input?
(c) What kind of experience does your organization have with supporting ARPA-style R&D efforts, especially those related to the education sciences? What case studies can you share from your experience?
(d) Particularly in the areas of fair, open, and transparent research and data privacy and security, what kind of programing or resources would you recommend providing teams?
(3) With a focus on developing quick-turn around, high-reward and scalable solutions, what would you propose are the core activities and/or benchmarks for success for a project in each of the phases? What examples can you provide around past successes in social science domains or specifically related to education R&D?
(4) Could you provide any estimates of the costs, assets, and contributions required for a team to successfully complete each phase?
(5) As a part of this effort, IES may seek support in establishing a technical working group (TWG) to inform the activities that will guide research teams for the S2S competition. If we were to establish a TWG related to the S2S competition, what kind of expertise would you propose is essential to a TWG in this area? Are there specific organizations or individuals that you suggest be included in the TWG?
You may also access documents of the Department published in the
Grid Deployment Office, Department of Energy.
Notice of application.
New Brunswick Energy Marketing Corporation (the Applicant or NBEMC) has applied for renewed authorization to transmit electric energy from the United States to Canada pursuant to the Federal Power Act.
Comments, protests, or motions to intervene must be submitted on or before November 13, 2023.
Comments, protests, motions to intervene, or requests for more information should be addressed by electronic mail to
Christina Gomer, (240) 474-2403,
The United States Department of Energy (DOE) regulates electricity exports from the United States to foreign countries in accordance with section 202(e) of the Federal Power Act (FPA) (16 U.S.C. 824a(e)) and regulations thereunder (10 CFR 205.300
Section 202(e) of the FPA provides that an entity which seeks to export electricity must obtain an order from DOE authorizing that export. (16 U.S.C. 824a(e)). On April 10, 2023, the authority to issue such orders was delegated to the DOE's Grid Deployment Office (GDO) by Delegation Order No. S1-DEL-S3-2023 and Redelegation Order No. S3-DEL-GD1-2023.
On December 5, 2008, DOE issued Order No. EA-345, authorizing NBEMC (f/k/a New Brunswick Power Generation Corporation) to transmit electric energy from the United States to Canada as a power marketer. This authority was renewed on December 6, 2013, (Order No. EA-345-A) and on December 5, 2018 (Order No. EA-345-B). On August 23, 2023, NBEMC filed an application with DOE (Application or App) for renewal of their export authority for an additional five-year term. App at 2.
In its Application, NBEMC states that it will purchase power to be exported to Canada from electric utilities in the U.S., federal power marketing agencies, qualifying cogeneration and small power production facilities, independent power producers, and other sellers. App. at 5. NBEMC notes it “does not own any electric generation or transmission facilities and, as a power marketer, does not hold a franchise or service territory or native load obligation.”
The existing international transmission facilities to be utilized by the Applicant have been previously authorized by Presidential permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.
Comments and other filings concerning NBEMC's Application should be clearly marked with GDO Docket No. EA-345-C. Additional copies are to be provided directly to Tyler S. Johnson, Bracewell LLP, 701 5th Avenue, Suite 3400, Seattle, Washington 98104,
A final decision will be made on the requested authorization after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after DOE evaluates whether the proposed action will have an adverse impact on the sufficiency of supply or reliability of the United States electric power supply system.
Copies of this Application will be made available, upon request, by accessing the program website at
This document of the Department of Energy was signed on October 6, 2023, by Maria Robinson, Director, Grid Deployment Office, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
Grid Deployment Office, Department of Energy.
Notice of application.
Saavi Energy Solutions, LLC (the Applicant or Saavi Energy Solutions) has applied for renewed authorization to transmit electric energy from the United States to Mexico pursuant to the Federal Power Act.
Comments, protests, or motions to intervene must be submitted on or before November 13, 2023.
Comments, protests, motions to intervene, or requests for more information should be addressed by electronic mail to
Christina Gomer, (240) 474-2403,
The United States Department of Energy (DOE) regulates electricity exports from the United States to foreign countries in accordance with section 202(e) of the Federal Power Act (FPA) (16 U.S.C. 824a(e)) and regulations thereunder (10 CFR 205.300
Section 202(e) of the FPA provides that an entity which seeks to export electricity must obtain an order from DOE authorizing that export. (16 U.S.C. 824a(e)). On April 10, 2023, the authority to issue such orders was delegated to the DOE's Grid Deployment Office (GDO) by Delegation Order No. S1-DEL-S3-2023 and Redelegation Order No. S3-DEL-GD1-2023.
On November 19, 2018, DOE issued Order No. EA-461 authorizing Saavi Energy Solutions to transmit electric energy from the United States to Mexico as a power marketer. On August 18, 2023, Saavi Energy Solutions filed an application with DOE (Application or App.) for renewal of their export authority for an additional five-year term. App. at 1.
In its Application, Saavi Energy Solutions states that it “does not own any electric generation or transmission facilities and, as a power marketer, does not hold a franchise or service territory or native load obligation.” App. at 5. Moreover, the Applicant notes that none of its “affiliates owns any electric transmission facilities other than the limited and discrete interconnection facilities described [in its Application], and Saavi Energy Solutions is not affiliated with an entity that holds a franchise or service territory.”
The existing international transmission facilities to be utilized by the Applicant have been previously authorized by Presidential permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.
Comments and other filings concerning Saavi Energy Solutions' Application should be clearly marked with GDO Docket No. EA-461-A. Additional copies are to be provided directly to Daniel Delgado and Liliana Gonzalez, Saavi Energy Solutions, LLC, 24 Greenway Plaza, Suite 1205, Houston, Texas 77046,
A final decision will be made on the requested authorization after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after DOE evaluates whether the proposed action will have an adverse impact on the sufficiency of supply or reliability of the United States electric power supply system.
Copies of this Application will be made available, upon request, on the program website at
This document of the Department of Energy was signed on October 6, 2023, by Maria Robinson, Director, Grid Deployment Office, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
Grid Deployment Office, Department of Energy.
Notice of application.
Mercuria Energy America, LLC (the Applicant or Mercuria) has applied for renewed authorization to transmit electric energy from the United States to Mexico pursuant to the Federal Power Act.
Comments, protests, or motions to intervene must be submitted on or before November 13, 2023.
Comments, protests, motions to intervene, or requests for more information should be addressed by electronic mail to
Christina Gomer, (240) 474-2403,
The United States Department of Energy (DOE) regulates electricity exports from the United States to foreign countries in accordance with section 202(e) of the Federal Power Act (FPA) (16 U.S.C. 824a(e)) and regulations thereunder (10 CFR 205.300
Section 202(e) of the FPA provides that an entity which seeks to export electricity must obtain an order from DOE authorizing that export. (16 U.S.C. 824a(e)). On April 10, 2023, the authority to issue such orders was delegated to the DOE's Grid Deployment Office (GDO) by Delegation Order No. S1-DEL-S3-2023 and Redelegation Order No. S3-DEL-GD1-2023.
On November 19, 2018, DOE issued Order No. EA-459 authorizing Mercuria to transmit electric energy from the United States to Mexico as a power marketer. On August 18, 2023, Mercuria filed an application with DOE (Application or App.) for renewal of their export authority for an additional five-year term. App. at 1.
In its Application, Mercuria states that neither it “nor any of its affiliates owns or controls any generation or transmission facilities.” App. at 2. Further, the Applicant notes “neither Mercuria nor any of its affiliates is a franchised utility or affiliated with any franchised utilities in North America.”
The existing international transmission facilities to be utilized by the Applicant have been previously authorized by Presidential permits issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.
Comments and other filings concerning Mercuria's Application should be clearly marked with GDO Docket No. EA-459-A. Additional copies are to be provided directly to Steven Bunkin, Mercuria Energy America, LLC, 33 Benedict Place, Greenwich, CT 06830,
A final decision will be made on the requested authorization after the environmental impacts have been evaluated pursuant to DOE's National Environmental Policy Act Implementing Procedures (10 CFR part 1021) and after DOE evaluates whether the proposed action will have an adverse impact on the sufficiency of supply or reliability of the United States electric power supply system.
Copies of this Application will be made available, upon request, by accessing the program website at
This document of the Department of Energy was signed on October 6, 2023, by Maria Robinson, Director, Grid Deployment Office, pursuant to delegated authority from the Secretary of Energy. That document with the original signature and date is maintained by DOE. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DOE Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of the Department of Energy. This administrative process in no way alters the legal effect of this document upon publication in the
This is a supplemental notice in the above-referenced proceeding of Talen Keystone LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is October 24, 2023.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
This is a supplemental notice in the above-referenced proceeding of Nova Power, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is October 24, 2023.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and
This is a supplemental notice in the above-referenced proceeding of Talen Conemaugh LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is October 24, 2023.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically may mail similar pleadings to the Federal Energy Regulatory Commission, 888 First Street NE, Washington, DC 20426. Hand delivered submissions in docketed proceedings should be delivered to Health and Human Services, 12225 Wilkins Avenue, Rockville, Maryland 20852.
In addition to publishing the full text of this document in the
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Take notice that the Commission received the Compliance filings in EL Dockets:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system (
Any person desiring to intervene, to protest, or to answer a complaint in any of the above proceedings must file in accordance with Rules 211, 214, or 206 of the Commission's Regulations (18 CFR 385.211, 385.214, or 385.206) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
On September 29, 2023, EONY Generation Limited submitted to the Federal Energy Regulatory Commission (Commission) a copy of its application for a Clean Water Act section 401(a)(1) water quality certification filed with New York State Department of Environmental Conservation (New York DEC), in conjunction with the above captioned project. Pursuant to 40 CFR 121.6 and section 4.34(b)(5) of the Commission's regulations,
If New York DEC fails or refuses to act on the water quality certification request on or before the above date, then the agency certifying authority is deemed waived pursuant to section 401(a)(1) of the Clean Water Act, 33 U.S.C. 1341(a)(1).
On August 1, 2023, ANR Pipeline Company (ANR) filed an application in Docket No. CP23-523-000 requesting a Certificate of Public Convenience and Necessity pursuant to section 7(c) and Authorization pursuant to section 7(b) of the Natural Gas Act to construct, operate, and abandon certain natural gas pipeline facilities. The proposed project is known as the Oak Grove Enhancement Project (Project). The Project would include construction of 34.1 miles of new 30-inch-diameter natural gas pipeline to replace 33.6 miles of existing 30-inch-diameter natural gas pipeline in Richland and West Carroll Parishes, Louisiana. According to ANR, its project would improve the integrity and reliability of ANR's system by replacing vintage pipeline facilities installed in the 1950's with new pipeline facilities.
On August 11, 2023, the Federal Energy Regulatory Commission (Commission or FERC) issued its Notice of Application for the Project. Among other things, that notice alerted agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a federal authorization
This notice identifies Commission staff's intention to prepare an environmental assessment (EA) for the Project and the planned schedule for the completion of the environmental review.
If a schedule
The Oak Grove Enhancement Project would consist of the following facilities:
• Installation of 34.1 miles of new 30-inch-diameter segment of natural gas pipeline, which will begin at ANR's existing Delhi Compressor Station (CS) in Richland Parish, Louisiana and primarily parallel the existing Line 0-501, 1-501, and 2-501 pipelines before the new segment ties into the existing route just south of State Route 586 in West Carroll Parish, Louisiana at the terminus of the existing Line 0-501 segment to be abandoned.
• Abandonment in place and by removal of 33.6 miles of existing 30-inch-diameter natural gas pipeline, which begins at ANR's existing Delhi CS in Richland Parish and terminates just south of State Route 586 in West Carroll Parish. Approximately one percent (0.25 mile) of the existing Line 0-501 segment would be abandoned by removal, while the remaining existing pipeline segments (totaling 33.35 miles) would be abandoned in place.
The Oak Grove Enhancement Project would not increase or reduce service to any existing ANR customer and no changes to system capacity are proposed. ANR's Project design would allow the existing segment to remain in operation until the replacement pipeline is placed into service.
On August 23, 2023, the Commission issued a
In order to receive notification of the issuance of the EA and to keep track of formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This service provides automatic notification of filings made to subscribed dockets, document summaries, and direct links to the documents. Go to
The Commission's Office of Public Participation (OPP) supports meaningful public engagement and participation in Commission proceedings. OPP can help members of the public, including landowners, environmental justice communities, Tribal members and others, access publicly available information and navigate Commission processes. For public inquiries and assistance with making filings such as interventions, comments, or requests for rehearing, the public is encouraged to contact OPP at (202) 502-6595 or
Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC website (
Tuesday, October 17, 2023 at 10:30 a.m. and its continuation at the conclusion of the open meeting on October 19, 2023.
1050 First Street NE, Washington, DC and virtual (this meeting will be a hybrid meeting).
This meeting will be closed to the public.
Compliance matters pursuant to 52 U.S.C. 30109.
Investigatory records compiled for law enforcement purposes and production would disclose investigative techniques.
Information the premature disclosure of which would be likely to have a considerable adverse effect on the implementation of a proposed Commission action.
Matters concerning participation in civil actions or proceedings or arbitration.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
The notificants listed below have applied under the Change in Bank Control Act (Act) (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the applications are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551-0001, not later than October 27, 2023.
1.
Board of Governors of the Federal Reserve System.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The public portions of the applications listed below, as well as other related filings required by the Board, if any, are available for immediate inspection at the Federal Reserve Bank(s) indicated below and at the offices of the Board of Governors. This information may also be obtained on an expedited basis, upon request, by contacting the appropriate Federal Reserve Bank and from the Board's Freedom of Information Office at
Comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors, Ann E. Misback, Secretary of the Board, 20th Street and Constitution Avenue NW, Washington, DC 20551-0001, not later than November 13, 2023.
1.
Board of Governors of the Federal Reserve System.
Agency for Healthcare Research and Quality (AHRQ), HHS.
Request for supplemental evidence and data submission.
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on
Kelly Carper, Telephone: 301-427-1656 or Email:
The Agency for Healthcare Research and Quality has commissioned the Evidence-based Practice Centers (EPC) Program to complete a review of the evidence for
The EPC Program is dedicated to identifying as many studies as possible that are relevant to the questions for each of its reviews. In order to do so, we are supplementing the usual manual and electronic database searches of the literature by requesting information from the public (
This is to notify the public that the EPC Program would find the following information on
A list of completed studies that your organization has sponsored for this topic. In the list, please
Description of whether the above studies constitute
Your contribution is very beneficial to the Program. Materials submitted must be publicly available or able to be made public. Materials that are considered confidential; marketing materials; study types not included in the review; or information on topics not included in the review cannot be used by the EPC Program. This is a voluntary request for information, and all costs for complying with this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program website and available for public comment for a period of 4 weeks. If you would like to be notified when the draft is posted, please sign up for the email list at:
(1) What metrics of documentation burden that have been developed or used (including metrics broadly—quantitative and qualitative)?
(a) For which settings, populations, and intended uses were the metrics developed?
(b) How have these metrics been applied?
(c) Is there published information available on validity of the metrics?
(d) What are the key strengths and weaknesses of different metrics that have been used?
(2) What are the different perspectives on the appropriateness of different metrics of documentation burden that have been applied/proposed (
(3) What are the perceptions of documentation burden from the perspective of people in different clinical roles (
(4) What is the role of patients in documentation burden?
(5) What is the role of setting (
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, we, or us) 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.
Submit written comments (including recommendations) on the collection of information by November 13, 2023.
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted 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.
Section 402 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 342) deems a food to be adulterated, in part, if the food bears or contains any poisonous or deleterious substance that may render it injurious to health. Section 301(a) of the FD&C Act (21 U.S.C. 331(a)) prohibits the introduction or delivery for introduction into interstate commerce of adulterated food. Under section 404 of the FD&C Act (21 U.S.C. 344), our regulations require registration of food processing establishments, filing of process or other data, and maintenance of processing and production records for acidified foods and thermally processed low-acid foods in hermetically sealed containers. These requirements are intended to ensure safe manufacturing, processing, and packing procedures and to permit us to verify that these procedures are being followed. Improperly processed low-acid foods present life-threatening hazards if contaminated with foodborne microorganisms, especially
To protect the public health, our regulations require that each firm that manufactures, processes, or packs acidified foods or thermally processed low-acid foods in hermetically sealed containers for introduction into interstate commerce register the establishment with us using Form FDA 2541 (§§ 108.25(c)(1) and 108.35(c)(1) (21 CFR 108.25(c)(1) and 108.35(c)(1)). In addition to registering the plant, each firm is required to provide data on the processes used to produce these foods, using Forms FDA 2541d, FDA 2541e, and FDA 2541f for all methods except aseptic processing, or Form FDA 2541g for aseptic processing of low-acid foods in hermetically sealed containers (§§ 108.25(c)(2) and 108.35(c)(2)). Plant registration and process filing may be accomplished simultaneously. Process data must be filed prior to packing any new product, and operating processes and procedures must be posted near the processing equipment or made available to the operator (21 CFR 113.87(a)).
Regulations in parts 108, 113, and 114 (21 CFR parts 108, 113, and 114) require firms to maintain records showing adherence to the substantive requirements of the regulations. These records must be made available to FDA on request. Firms also must document corrective actions when process controls and procedures do not fall within specified limits (§§ 113.89, 114.89, and 114.100(c)); to report any instance of potential health-endangering spoilage, process deviation, or contamination with microorganisms where any lot of the food has entered distribution in commerce (§§ 108.25(d) and 108.35(d) and (e)); and to develop and keep on file plans for recalling products that may endanger the public health (§§ 108.25(e) and 108.35(f)). To permit lots to be traced after distribution, acidified foods and thermally processed low-acid foods in hermetically sealed containers must be marked with an identifying code (§ 113.60(c) (thermally processed low-acid foods) and § 114.80(b) (acidified foods)).
The records of processing information are periodically reviewed during factory inspections by FDA to verify fulfillment of the requirements in parts 113 or 114. Scheduled thermal processes are examined and reviewed to determine their adequacy to protect public health. In the event of a public health emergency, records are used to pinpoint potentially hazardous foods rapidly and thus limit recall activity to affected lots.
As described in FDA regulations, processors may obtain the paper version of Forms FDA 2541, FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g at
Although we encourage commercial processors to use the electronic submission system for plant registration and process filing, we will continue to make paper-based forms available. To standardize the burden associated with process filing, regardless of whether the process filing is submitted electronically or using a paper form, we are offering the public the opportunity to use four forms, each of which pertains to a specific type of commercial processing and is available both on the electronic submission system and as a paper-based form. The electronic submission system
• Form FDA 2541d (Food Process Filing for Low-Acid Retorted Method);
• Form FDA 2541e (Food Process Filing for Acidified Method);
• Form FDA 2541f (Food Process Filing for Water Activity/Formulation Control Method); and
• Form FDA 2541g (Food Process Filing for Low-Acid Aseptic Systems).
In the
FDA estimates the burden of this collection of information as follows:
We base our estimates in table 1 on registrations, process filings, and reports received. The estimates for hours per response are based on our experience with similar programs and information received from industry.
Our regulations require that processors mark thermally processed low-acid foods in hermetically sealed containers (§ 113.60(c)) and acidified foods (§ 114.80(b)) with an identifying code to permit lots to be traced after distribution. No burden has been estimated for the third-party disclosure requirements in §§ 113.60(c) and 114.80(b) because the coding process is done as a usual and customary part of normal business activities. Coding is a business practice in foods for liability purposes, inventory control, and process control in the event of a problem. Under 5 CFR 1320.3(b)(2), the time, effort, and financial resources necessary to comply with a collection of information are excluded from the burden estimate if the reporting, recordkeeping, or disclosure activities needed to comply are usual and customary because they would occur in the normal course of activities.
Since the publication of the 60-day notice we have adjusted our burden estimate. Our estimated burden for the information collection reflects an increase of 3,606 total burden hours and a corresponding increase of 10,141 total annual responses. This increase corresponds with data obtained from past submissions.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined that the sterile dry powder excipient-free formulation of CYTOXAN (cyclophosphamide) for Injection, 500 milligrams (mg)/vial, 1 gram (g)/vial, and 2 g/vial, and the sterile dry powder with sodium chloride formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to the sterile dry powder excipient-free formulation or the sterile dry powder with sodium chloride formulation of these drug products, and it will allow FDA to continue to approve ANDAs that refer to these formulations of CYTOXAN as long as they meet relevant legal and regulatory requirements.
Tereza Hess, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6221, Silver Spring, MD 20993-0002, 202-768-5659,
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made: (1) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that referred to the listed drug have been approved and (2) prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
CYTOXAN (cyclophosphamide) for Injection (sterile dry powder with sodium chloride formulation), with the 500 mg/vial, initially approved on May 4, 1964, the 1 g/vial, initially approved on August 30, 1982, and the 2 g/vial, initially approved on August 30, 1982, are the subjects of NDA 012142, held by Baxter Pharmaceuticals. Subsequently, CYTOXAN (cyclophosphamide) for Injection (lyophilized powder with mannitol) was also approved under NDA 012142, with the 500 mg/vial approved on January 4, 1984; the 1 g/vial approved on September 24, 1985; and the 2 g/vial approved on December 10, 1985. On November 7, 2003, the lyophilized powder with mannitol formulation in 500 mg/vial, 1 g/vial, and 2 g/vial strengths was reformulated and approved as a sterile dry powder excipient-free formulation under Supplement 107 to NDA 012142. On March 31, 2012, the CYTOXAN (cyclophosphamide) for Injection, sterile dry powder with sodium chloride formulation in 500 mg/vial, 1 g/vial, and 2 g/vial strengths was reformulated and approved as a lyophilized powder with mannitol formulation under Supplement 113. CYTOXAN is indicated for treatment of malignant lymphomas: Hodgkin's disease, lymphocytic lymphoma, mixed-cell type lymphoma, histiocytic lymphoma, Burkitt's lymphoma, multiple myeloma, leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of the ovary, retinoblastoma, breast carcinoma, and minimal change nephrotic syndrome in pediatric patients.
FDA previously determined that certain CYTOXAN (cyclophosphamide) for Injection formulations and strengths were not discontinued from sale for reasons of safety or effectiveness, but these determinations did not address all previously approved formulations and strengths. In the
The sterile dry powder excipient-free formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial, and the sterile dry powder with sodium chloride formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial, are discontinued.
Lachman Consultant Services, Inc., submitted a citizen petition dated May 5, 2020 (Docket No. FDA-2020-P-1344), under 21 CFR 10.30, requesting that the Agency determine whether discontinued formulations of all strengths of CYTOXAN (cyclophosphamide) for Injection approved under NDA 012142, including the sterile dry powder excipient-free formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial, were withdrawn from sale for reasons of safety or effectiveness. Epic Pharma,
After considering the citizen petitions and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that CYTOXAN (cyclophosphamide) for Injection (sterile dry powder excipient-free formulation), 500 mg/vial, 1 g/vial, and 2 g/vial, and CYTOXAN (cyclophosphamide) for Injection (sterile dry powder with sodium chloride formulation), 500 mg/vial, 1 g/vial, and 2 g/vial, were not withdrawn for reasons of safety or effectiveness. The petitioners have identified no data or other information suggesting that the sterile dry powder excipient-free formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial, or the sterile dry powder with sodium chloride formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of the sterile dry powder excipient-free formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial, and the sterile dry powder with sodium chloride formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that these drug products were withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency has determined that the sterile dry powder excipient-free formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial, and the sterile dry powder with sodium chloride formulation of CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial, drug products have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of approved ANDAs that have the sterile dry powder excipient-free formulation or the sterile dry powder with sodium chloride formulation. ANDAs that refer to CYTOXAN (cyclophosphamide) for Injection, 500 mg/vial, 1 g/vial, and 2 g/vial may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or we) 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.
Submit written comments (including recommendations) on the collection of information by November 13, 2023.
To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
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 the voluntary submission of allegations of regulatory misconduct to FDA's Center for Devices and Radiological Health (CDRH). An allegation of regulatory misconduct is a claim that a medical device manufacturer or individuals marketing medical devices or electronic products regulated by CDRH may be doing so in a manner that violates the law. Reporting these allegations can help make FDA aware of regulatory concerns it may not learn of otherwise. This information can help FDA identify the potential risks to patients and determine whether further investigation is warranted, as well as any steps needed to address or correct a potential violation. Anyone may file a complaint reporting an allegation of regulatory misconduct. FDA encourages people submitting allegations to include supporting information and contact information in case additional information is needed for FDA to understand the allegation and act on the report; however, you can choose to submit a report anonymously. FDA will not share your identity or contact information with anyone outside FDA unless required to do so by law, regulation, or court order.
Allegations of regulatory misconduct may include failure to register and list a medical device, marketing uncleared or unapproved products, failure to follow quality system requirements, or misleading promotion.
You can submit an allegation through the Allegations of Regulatory Misconduct Form (
FDA published a 60-day notice for public comment in the
We also received suggestions on how our submission form might be improved. In response to this comment, we are revising the submission form using asterisks to more clearly indicate which fields are required for submission versus non-required fields. The form also has been updated to allow submission of the company's website.
Similarly, one comment noted that current procedures do not allow for complete anonymity when submitting allegations of regulatory misconduct to FDA. The comment suggests changing the submission process to allow submission of attachments to the form, rather than via separate email. While we have not made changes regarding the submission process at this time, we appreciate these suggestions and continue to consider enhancements and updates to our systems as our limited resources permit. We recognize that confidentiality is an important concern. Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), the public has broad access to government documents. However, FOIA provides certain exemptions from mandatory public disclosure of government records (5 U.S.C. 552(b)(1-9)). FDA will make the fullest possible disclosure of records to the public, consistent with the rights of individuals to privacy, the property rights of persons in trade and confidential commercial or financial information.
Finally, one comment expressed concern regarding verification by FDA of the accuracy and validity of the information (allegations) submitted. Allegations of regulatory misconduct related to medical devices are reviewed by CDRH. CDRH prioritizes the review of allegations based on the level of potential risks, within the context of an overall benefit-risk profile, to patients, and takes responsive action accordingly. We note, however, that subsequent questions or inquiry intended to clarify information submitted is not considered a collection of information under the PRA (see 5 CFR 1320.3(h)(9)) subject to OMB review and approval. To learn more about CDRH's process for handling allegations, please visit:
We estimate the burden of this collection of information as follows:
We recently consolidated the intake of allegations across CDRH Offices. This has improved our estimate and we have adjusted the number of responses accordingly. The number of responses is based on the voluntary allegations received by CDRH in 2022. The adjusted estimated burden for the information collection reflects an increase of 900 responses and a corresponding increase of 225 hours.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by December 11, 2023.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before December 11, 2023. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the
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
Domini Bean, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-5733,
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (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, when appropriate, and other forms of information technology.
This information collection supports our regulations in part 315 (21 CFR part 315) that require manufacturers of diagnostic radiopharmaceuticals to submit information that demonstrates the safety and effectiveness of: (1) a new diagnostic radiopharmaceutical or (2) a new indication for use of an approved diagnostic radiopharmaceutical. Information about the safety or effectiveness of a diagnostic radiopharmaceutical enables us to properly evaluate the safety and effectiveness profiles of such radiopharmaceuticals.
The information, which is usually submitted as part of a new drug application (NDA) or biologics license application or as a supplement to an approved application typically includes, but is not limited to: (1) nonclinical and clinical data on the pharmacology; (2) toxicology; (3) adverse events; (4) radiation safety assessments; and (5) chemistry, manufacturing, and controls. The content and format of an application for approval of a new drug are set forth in § 314.50 (21 CFR 314.50) and have been approved under OMB control number 0910-0001.
In table 1, row 1, we estimate the annual reporting burden for preparing the safety and effectiveness sections of an application. This estimate does not include the time needed to conduct studies and clinical trials or other research from which the reported information is obtained.
Based on past submissions of human drug applications, new indication supplements for diagnostic radiopharmaceuticals, or both, we estimate that three submissions will be received annually from three applicants and that 2,000 hours would be spent preparing the portions of the application that would be affected by this information collection. We further estimate the total time needed to prepare complete applications for diagnostic radiopharmaceuticals as approximately 6,000 hours. This information collection does not impose any additional reporting burden for safety and effectiveness information on diagnostic radiopharmaceuticals beyond the estimated burden of 2,000 hours, because safety and effectiveness information is already required in § 314.50 and has been approved under OMB control number 0910-0001. In fact, clarification of our criteria for the
In table 1, row 2, we estimate the annual reporting burden for preparing the safety and effectiveness sections of a supplement to an approved application. This estimate does not include the time needed to conduct studies and clinical trials or other research from which the reported information is obtained.
Based on past submissions of human drug applications, new indication supplements for diagnostic radiopharmaceuticals, or both, we estimate that one submission will be received annually. We estimate the total time needed to prepare complete applications for supplements to new applications for diagnostic radiopharmaceuticals as approximately between 500 and 1,000 hours. We calculated the median of this estimate to arrive at approximately 750 hours. We further estimate that the total time needed to prepare the portions of the application that would be affected by this information collection as 750 hours. As previously stated, this information collection does not impose any additional reporting burden for safety and effectiveness information on diagnostic radiopharmaceuticals beyond the estimated burden of 750 hours, because safety and effectiveness information is already required in § 314.50 and has been approved under OMB control number 0910-0001.
We estimate the burden of this collection of information as follows:
Since our last OMB approval, our estimated burden for the information collection reflects an overall decrease of 11 responses with a corresponding decrease of 12,000 burden hours. We attribute this adjustment to a decrease in the number of submissions for NDAs for diagnostic radiopharmaceuticals and new indication supplements for diagnostic radiopharmaceuticals we received over the past few years.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Either electronic or written comments on the collection of information must be submitted by December 11, 2023.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as
• 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
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,
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (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, when appropriate, and other forms of information technology.
Section 1701(a)(4) of the Public Health Service 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 promotion is truthful, balanced, and accurately communicated so that patients and healthcare providers can make informed decisions about treatment options. OPDP's research program provides 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 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 the characteristics of the disease and product 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. 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 will inform the first topic area, advertising features.
Because we recognize that the strength of data and the confidence in the robust nature of the findings are improved through the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our home page at
This study builds on OPDP's portfolio of research on market claims and disclosures to explore the influence of statements around patient adherence and preference in prescription drug promotion. Previous FDA-funded research has shown that market claims that advertise drug characteristics unrelated to medicinal properties, such as “#1 Prescribed,” influence consumer and provider perceptions about a drug's efficacy (Ref. 1). In the same study, results of a tradeoff analysis suggested that patients prefer a drug over a
It is not known how claims that appeal to the possibility for greater adherence or to social norms around what other patients or healthcare providers prefer influence perceptions of a drug. A related question is whether including a disclosure stating the uncertainty around such claims (
The present research is designed to complement previous research by experimentally examining the role of adherence and patient preference claims in prescription drug promotion. We have the following specific questions:
1. Does the presence or absence of an implied-adherence claim affect consumers' behavioral intentions or risk, benefit, and adherence perceptions?
2. Does the presence or absence of an adherence-related patient preference claim affect consumers' behavioral intentions or risk, benefit, and adherence perceptions?
3. Does the presence of both types of claims (adherence and preference) have a cumulative impact on consumers' behavioral intentions or risk, benefit, and adherence perceptions?
4. Does a disclosure of information to the effect that there is no conclusive research on whether the drug results in better adherence mitigate consumers' behavioral intentions or risk, benefit, and adherence perceptions?
To complete this research, we will show participants a website for a fictitious prescription drug product for type 2 diabetes. We propose the design in table 1, which varies based on whether the fictitious prescription drug promotional communication includes a claim about:
• implied adherence;
• patient preference; and
• a disclosure that there is no conclusive research on adherence.
Recruitment will occur by email through an internet panel, and participant eligibility will be determined with a screener at the beginning of the online survey. For the pretest, we expect to screen 253 consumers and 294 primary care physicians (PCPs) to reach our desired number of completed surveys. We will conduct complete pretest surveys with 160 consumers who self-identify as having been diagnosed with diabetes and 160 PCPs who treat diabetes (both obtained from a web-based research vendor) to ensure that the questionnaire programming works as expected. For the main study, we expect to screen 566 consumers and 660 PCPs to reach our desired number of completed surveys. Thus, for the main study final sample, we will recruit 360 adult voluntary participants aged 18 years or older who self-identify as having been diagnosed with diabetes and 360 voluntary participants who are employed as PCPs who treat diabetes. We will exclude individuals who work in healthcare settings, employees of the Department of Health and Human Services, and individuals who work in the marketing, advertising, or pharmaceutical industries.
The total annual estimated burden imposed by this collection of information is 520 hours (table 2). These estimates account for over-recruitment of 10 percent to account for survey incompletes. As with most online and mail surveys, it is always possible that some participants are in the process of completing the survey when the target number is reached and that those surveys will be completed and received before the survey is closed out. To account for this, we have estimated approximately 10 percent overage.
Each participant will see one of eight versions of a consumer web page for a fictitious prescription diabetes treatment, as reflected in table 1. They will answer a questionnaire designed to take no more than 20 minutes regarding benefit and risk perceptions, adherence perceptions, behavioral intentions, adherence claim retention, and patient preference claim retention. The survey is available upon request at
The following references are on display with the Dockets Management Staff (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is requesting nominations for voting members, excluding consumer and industry representatives, to serve on the Digital Health Advisory Committee (the Committee) in the Center for Devices and Radiological Health. Nominations will be accepted for current vacancies effective with this notice. FDA seeks to include the views of members of all gender groups, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore, encourages nominations of appropriately qualified candidates from these groups.
Nominations received on or before December 11, 2023 will be given first consideration for membership on the Committee. Nominations received after December 11, 2023 will be considered for nomination to the committee as later vacancies occur.
All nominations for membership should be sent electronically by logging into the FDA Advisory Committee Membership Nomination Portal (
James Swink, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993-0002, 301-796-6313,
FDA is requesting nominations for voting members to fill current vacancies on the Digital Health Advisory Committee. This notice does not include consumer and industry representative nominations. The Agency will publish two separate notices announcing the vacancy of a representative of consumer interests and a vacancy of representatives of interests of the device manufacturing industry.
The Committee provides advice on complex scientific and technical issues related to Digital Health Technologies (DHTs). This also may include advice on the regulation of DHTs, and/or their use, including use of DHTs in clinical trials or postmarket studies subject to FDA regulation. Topics relating to DHTs, such as artificial intelligence/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring,
The Committee consists of a core of nine voting members, including the Chair. Members and the Chair are selected by the Commissioner or designee from among authorities who are knowledgeable in the fields of digital health, such as artificial intelligence/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, software development, user experience, real-world data, real-world evidence, patient-generated health data, interoperability, personalized medicine/genetics, decentralized clinical trials, cybersecurity, and implementation in clinical practice of and patient experience with digital health, as well as other relevant areas. Members will be invited to serve for overlapping terms of up to 4 years. Non-Federal members of this Committee will serve either as Special Government Employees or nonvoting representatives. Federal members will serve as Regular Government Employees. The core of voting members may include one technically qualified member, selected by the Commissioner or designee, who serves as an individual, but who is identified with consumer interests and is recommended by either a consortium of consumer-oriented organizations or other interested persons. The Commissioner or designee shall also have the authority to select from a group of individuals nominated by industry to serve temporarily as nonvoting members who are identified with and represent industry interests.
Any interested person may nominate one or more qualified individuals for membership on the Committee with the exception of the following: Individuals who are not U.S. citizens or nationals cannot be appointed as Advisory Committee Members (42 U.S.C. 217(a)) in the FDA. Self-nominations are also accepted. Nominations must include a cover letter; a current, complete résumé or curriculum vitae for each nominee, including current business and/or home address, telephone number, and email address if available, and a signed copy of the Acknowledgement and Consent form available at the FDA Advisory Nomination Portal (see
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or the Agency) has determined that MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 milligram (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for trametinib dimethyl sulfoxide tablets, 1 mg, if all other legal and regulatory requirements are met.
Nikki Mueller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-796-3601,
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of an ANDA to market a generic version of a previously approved drug product. To obtain approval, the ANDA applicant must show, among other things, that the generic drug product: (1) has the same active ingredient(s), dosage form, route of administration, strength, conditions of use, and (with certain exceptions) labeling as the listed drug, which is a version of the drug that was previously approved, and (2) is bioequivalent to the listed drug. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
Section 505(j)(7) of the FD&C Act requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (§ 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug.
MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 mg, is the subject of NDA 204114, held by Novartis Pharmaceuticals Corp., and initially approved on May 29, 2013. MEKINIST is a kinase inhibitor indicated as a single agent for the treatment of BRAF-inhibitor treatment-naïve patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 mg, is currently listed in the “Discontinued Drug Product List” section of the Orange Book. Apotex Inc., submitted a citizen petition dated May 4, 2023 (Docket No. FDA-2023-P-1795), under 21 CFR 10.30, requesting that the Agency determine whether MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 mg, was withdrawn from sale for reasons of safety or effectiveness.
After considering the citizen petition and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 mg, was not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 mg, was withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to MEKINIST (trametinib dimethyl sulfoxide) tablets, 1 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is requesting nominations for a voting consumer representative to serve on the Digital Health Advisory Committee. FDA is also requesting that any consumer organizations interested in participating in the selection of a voting consumer representative to serve on the Digital Health Advisory Committee notify FDA in writing. Nominees recommended to serve as a voting consumer representative may either be self-nominated or may be nominated by a consumer organization. Nominations will be accepted for the current vacancy effective with this notice. FDA seeks to include the views of members of all gender groups, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.
Any consumer organization interested in participating in the selection of an appropriate voting member to represent consumer interests on the Digital Health Advisory Committee may send a letter or email stating that interest to FDA (see
All statements of interest from consumer organizations interested in participating in the selection process should be submitted electronically to
Consumer representative nominations should be submitted electronically by logging into the FDA Advisory Committee Membership Nomination Portal:
FDA is requesting nominations for a voting consumer representative on the Digital Health Advisory Committee. Elsewhere in this
The Committee provides advice on complex scientific and technical issues related to Digital Health Technologies (DHTs). This also may include advice on the regulation of DHTs, and/or their use, including use of DHTs in clinical trials or postmarket studies subject to FDA regulation. Topics relating to DHTs, such as artificial intelligence/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software, may be considered by the Committee. The Committee advises the Commissioner on issues related to DHTs, including, for example, real-world data, real-world evidence, patient-generated health data,
Persons nominated for membership as a consumer representative on this committee should meet the following criteria: (1) demonstrate an affiliation with and/or active participation in in consumer or community-based organizations, (2) be able to analyze technical data, (3) understand research design, (4) discuss benefits and risks, and (5) evaluate the safety and efficacy of products under review. The consumer representative should be able to represent the consumer perspective on issues and actions before the advisory committee; serve as a liaison between the committee and interested consumers, associations, coalitions, and consumer organizations; and facilitate dialogue with the advisory committees on scientific issues that affect consumers.
Selection of members representing consumer interests is conducted through procedures that include the use of organizations representing the public interest and public advocacy groups. These organizations recommend nominees for the Agency's selection. Representatives from the consumer health branches of Federal, State, and local governments also may participate in the selection process. Any consumer organization interested in participating in the selection of an appropriate voting member to represent consumer interests should send a letter stating that interest to FDA (see
Within the subsequent 45 days, FDA will compile a list of consumer organizations that will participate in the selection process and will forward to each such organization a ballot listing at least two qualified nominees selected by the Agency based on the nominations received, together with each nominee's current curriculum vitae or résumé. Ballots are to be filled out and returned to FDA within 30 days. The nominee receiving the highest number of votes ordinarily will be selected to serve as the member representing consumer interests for that particular advisory committee.
Any interested person or organization may nominate one or more qualified persons to represent consumer interests on the Digital Health Advisory Committee with the exception of the following: individuals who are not U.S. citizens or nationals cannot be appointed as Advisory Committee Members (42 U.S.C. 217(a)) in FDA. Self-nominations are also accepted. Nominations must include a current, complete résumé or curriculum vitae for each nominee, including current business and/or home address, telephone number, and email address if available; a signed copy of the Acknowledgment and Consent form available at the FDA Advisory Nomination Portal (see
Nominations should also specify the advisory committee for which the nominee is recommended. In addition, nominations must also acknowledge that the nominee is aware of the nomination, unless self-nominated. FDA will ask potential candidates to provide detailed information concerning such matters related to financial holdings, employment, and research grants and/or contracts to permit evaluation of possible sources of conflicts of interest. Members will be invited to serve for terms up to 4 years.
FDA will review all nominations received within the specified timeframes and prepare a ballot containing the names of qualified nominees. Names not selected will remain on a list of eligible nominees and be reviewed periodically by FDA to determine continued interest. After selecting qualified nominees for the ballot, FDA will provide those consumer organizations that are participating in the selection process with the opportunity to vote on the listed nominees. Only organizations vote in the selection process. Persons who nominate themselves to serve as voting consumer representatives will not participate in the selection process.
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is requesting nominations for temporary nonvoting industry representatives to be included in a pool of individuals to serve on the Digital Health Advisory Committee. FDA is also requesting that industry organizations interested in participating in the selection of a pool of nonvoting industry representatives to serve as temporary nonvoting members on the Digital Health Advisory Committee (the Committee) in the Center for Devices and Radiological Health notify FDA in writing. Nominees recommended to serve as a temporary nonvoting industry representative may either be self-nominated or nominated by an industry organization. This position may be filled by representatives of different medical device areas based on areas of expertise relevant to the topics being considered by the Committee. Nominations will be accepted for current vacancies effective with this notice. FDA seeks to include the views of members of all gender groups, members of all racial and ethnic groups, and individuals with and without disabilities on its advisory committees and, therefore encourages nominations of appropriately qualified candidates from these groups.
Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interest, must send a letter stating that interest to the FDA by
All statements of interest from interested industry organizations interested in participating in the selection process of a pool of nonvoting industry representatives should be sent electronically to Margaret Ames (see
Information about becoming a member on an FDA advisory committee can also be obtained by visiting FDA's website at
Margaret Ames, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5213, Silver Spring, MD 20993-0002, 301-796-5960, email:
For questions relating to the Digital Health Advisory Committee, contact James Swink, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Room 5211, Silver Spring, MD 20993-0002, 301-796-6313,
FDA is requesting nominations for a pool of nonvoting industry representatives for the Digital Health Advisory Committee (this position may be filled by representatives of different medical device areas based on areas of expertise relevant to the topics being considered by the Advisory Committee).
Elsewhere in this
The Committee provides advice on complex scientific and technical issues related to Digital Health Technologies (DHTs). This also may include advice on the regulation of DHTs, and/or their use, including use of DHTs in clinical trials or postmarket studies subject to FDA regulation. Topics relating to DHTs, such as artificial intelligence/machine learning, augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software, may be considered by the Committee. The Committee advises the Commissioner on issues related to DHTs, including, for example, real-world data, real-world evidence, patient-generated health data, interoperability, personalized medicine/genetics, decentralized clinical trials, use of DHTs in clinical trials for medical products, cybersecurity, DHT user experience, and Agency policies and regulations regarding these technologies. The Committee provides relevant expertise and perspective to improve Agency understanding of the benefits, risks, and clinical outcomes associated with use of DHTs. The Committee performs its duties by providing advice and recommendations on new approaches to develop and evaluate DHTs and to promote innovation of DHTs, as well as identifying risks, barriers, or unintended consequences that could result from proposed or established Agency policy or regulation for topics related to DHTs.
Persons nominated for the Digital Health Advisory Committee should be full-time employees of firms that manufacture medical device products, or consulting firms that represent manufacturers or have similar appropriate ties to industry.
Any industry organization interested in participating in the selection of an appropriate nonvoting member to represent industry interest must send a letter stating that interest to the FDA contact (see
Individuals may self-nominate and/or an organization may nominate one or more individuals to serve as a temporary nonvoting industry representative. Nominations must include a cover letter and a current, complete résumé or
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the
Either electronic or written comments on the collection of information must be submitted by December 11, 2023.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Rachel Showalter, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
Under the PRA (44 U.S.C. 3501-3521), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (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, when appropriate, and other forms of information technology.
This information collection supports implementation of Agency statutory and regulatory requirements regarding substances prohibited from use in animal food or feed. Bovine spongiform encephalopathy (BSE) is a progressive and fatal neurological disorder of cattle that results from an unconventional transmissible agent. Our regulation at § 589.2001 (21 CFR 589.2001) is designed to safeguard against the establishment and amplification of BSE in the United States through animal feed. The regulation prohibits the use of certain cattle origin materials in the food or feed of all animals. These
Under our regulations, we may designate a country from which cattle materials are not considered CMPAF. A country seeking to be so designated must send a written request to the Director of the Center for Veterinary Medicine, including certain required information. We use the information provided to determine whether to grant a request for designation and to impose conditions if a request is granted. Additionally, designated countries will be subject to our future review to determine whether their designations remain appropriate. As part of this process, we may ask designated countries at any time to confirm that their BSE situation and the information submitted by them in support of their original application remains unchanged. We may revoke a country's designation if we determine that it is no longer appropriate. Therefore, designated countries may respond to our periodic requests by submitting information to confirm their designations remain appropriate. We use the information to ensure their designations remain appropriate.
Renderers that receive, manufacture, process, blend, or distribute CMPAF, or products that contain or may contain CMPAF, must take measures to ensure that the materials are not introduced into animal feed, including maintaining adequate written procedures specifying how such processes are to be carried out.
FDA estimates the burden of this collection of information as follows:
The information the country is required to submit includes information about that country's BSE case history, risk factors, measures to prevent the introduction and transmission of BSE, and any other information relevant to determining whether the cattle materials from the requesting country do or do not meet the definitions set forth in § 589.2001(b)(1).
Since the last renewal, we have reduced the request for designation burden from 80 hours to 40 hours. This reduction is because respondents are required to provide this information to other entities in order to comply with international standards and therefore will have already compiled the necessary information.
Our estimate of the reporting burden for designation under § 589.2001(f) is based on estimates found in our final rule. Since the rule's effective date in 2009, only two requests for designation have been received; however, we retain our current estimate of one to permit such requests for designation by respondents and to permit related responses to FDA.
The burden we attribute to recordkeeping activities is assumed to be distributed among the individual elements and averaged among respondents. The total number of recordkeepers contains a subset of 50 recordkeepers who maintain written procedures and records specifically required by 21 CFR 589.2001(c).
We have adjusted our recordkeeping burden estimate in Table 2, which results in a decrease of 2,525 hours. This is based primarily on consolidation within the industry and a decrease in the estimated number of respondents subject to recordkeeping requirements.
Based on our review since the last OMB approval, there is an overall adjustment decrease of 2,565 burden hours. The adjustment is attributable to decreases in the average reporting burden time and in respondent subject to recordkeeping requirements.
Food and Drug Administration, HHS.
Notice of establishment.
Under the Federal Advisory Committee Act, the Food and Drug Administration (FDA or Agency) is announcing the establishment of the Digital Health Advisory Committee. The Commissioner of Food and Drugs (Commissioner) has determined that it is in the public interest to establish such a committee. Duration of this committee is 2 years from the date the Charter is filed, unless the Commissioner formally determines that renewal is in the public interest.
Either electronic or written comments on the notice must be submitted by December 11, 2023. FDA is establishing a docket for public comment on this document. The docket number is FDA-2023-N-3941. The docket will close on December 11, 2023.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” FDA 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
James Swink, Office of Management, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5211, Silver Spring, MD 20993, 301-796-6313,
The Digital Health Advisory Committee (Committee) provides advice to the Commissioner or designee, on complex scientific and technical issues related to digital health technologies (DHTs). This also may include advice on the regulation of DHTs, and/or their use, including use of DHTs in clinical trials or postmarket studies subject to FDA regulation. Topics relating to DHTs, such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring, and software, may be considered by the Committee. The Committee advises the Commissioner on issues related to DHTs, including, for example, real-world data, real-world evidence, patient-generated health data, interoperability, personalized medicine/genetics, decentralized clinical trials, use of DHTs in clinical trials for medical products, cybersecurity, DHT user experience, and Agency policies and regulations regarding these technologies. The Committee provides relevant expertise and perspective to improve Agency understanding of the benefits, risks, and clinical outcomes associated with use of DHTs. The Committee performs its duties by providing advice and recommendations on new approaches to develop and evaluate DHTs and to promote innovation of DHTs, as well as identifying risks, barriers, or unintended consequences that could result from proposed or established Agency policy or regulation for topics related to DHTs.
The Committee shall consist of a core of nine voting members including the Chair. Members and the Chair are
The Commissioner or designee shall also have the authority to select from a group of individuals nominated by industry to serve temporarily as non-voting members who are identified with and represent industry interests. The number of temporary members selected for a particular meeting will depend on the meeting topic.
In announcing the establishment of this Advisory Committee under the Federal Advisory Committee Act (5 U.S.C. 1001
Elsewhere in this issue of the
FDA intends to publish in the
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Notice.
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Commission on Childhood Vaccines (ACCV) will hold public meetings for the 2024 calendar year (CY). Information about ACCV, agendas, and materials for these meetings can be found on the ACCV website at
ACCV meetings will be held on March 7, 2024, 10:00 a.m.-4:00 p.m. Eastern Time (ET); March 8, 2024, 10:00 a.m.-4:00 p.m. ET; September 5, 2024, 10:00 a.m.-4:00 p.m. ET; September 6, 2024, 10:00 a.m.-4:00 p.m. ET.
Meetings may be held in-person or by Zoom webinar. For updates on how the meeting will be held, visit the ACCV website meeting page included below 30 business days before the date of the meeting, where instructions for joining meetings either in-person or remotely will be posted. In-person ACCV meetings will be held at 5600 Fishers Lane, Rockville, MD 20857. For meeting information updates, go to the ACCV website meeting page at
Pita Gomez, Principal Staff Liaison, Division of Injury Compensation Programs, HRSA, 5600 Fishers Lane, 8W-25A, Rockville, MD 20857; 800-338-2382; or
ACCV provides advice and recommendations to the Secretary of HHS (Secretary) on policy, program development, and other issues related to implementation of the National Vaccine Injury Compensation Program and concerning other matters as described under section 2119 of the Public Health Service Act (42 U.S.C. 300aa-19).
Since priorities dictate meeting times, be advised that start times, end times, and agenda items are subject to change. For CY 2024 meetings, agenda items may include, but are not limited to: updates from the Division of Injury Compensation Programs, Department of Justice, Office of Infectious Disease and HIV/AIDS Policy (HHS), Immunization Safety Office (Centers for Disease Control and Prevention), National Institute of Allergy and Infectious Diseases (National Institutes of Health) and Center for Biologics Evaluation and Research (Food and Drug Administration). Refer to the ACCV website listed above for all current and updated information concerning the CY 2024 ACCV meetings, including draft agendas and meeting materials that will be posted 5 calendar days before the meeting.
These meetings are open to the public. Meetings held by Zoom webinar will require registration. Registration details will be provided on our ACCV website at
Members of the public will have the opportunity to provide comments. Public participants may submit written statements in advance of the scheduled meeting(s). Oral comments will be honored in the order they are requested and may be limited as time allows. Requests to submit a written statement or make oral comments to ACCV should
Individuals who need special assistance or another reasonable accommodation should notify Pita Gomez using the contact information listed above at least 10 business days before the meeting(s) they wish to attend. Since all in-person meetings will occur in a federal government building, attendees must go through a security check to enter the building. Non-U.S. Citizen attendees must notify HRSA of their planned attendance at least 20 business days prior to the meeting to facilitate their entry into the building. All attendees are required to present government-issued identification prior to entry.
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory Committee on Heritable Disorders in Newborns and Children (ACHDNC or Committee) has scheduled a public meeting to be held on Thursday, November 2, 2023, and Friday, November 3, 2023. Information about the ACHDNC and the agenda for this meeting can be found on the ACHDNC website at
Thursday, November 2, 2023, from 10:00 a.m. to 4:00 p.m. Eastern Time (ET) and Friday, November 3, 2023, from 10:00 a.m. to 2:00 p.m. ET.
This meeting will be held via webinar. While this meeting is open to the public, advance registration is required.
Please visit the ACHDNC website for information on registration:
Alaina Harris, Maternal and Child Health Bureau, HRSA, 5600 Fishers Lane, Room 18W66, Rockville, Maryland 20857; 301-443-0721; or
ACHDNC provides advice and recommendations to the Secretary of Health and Human Services (Secretary) on the development of newborn screening activities, technologies, policies, guidelines, and programs for effectively reducing morbidity and mortality in newborns and children having, or at risk for, heritable disorders. ACHDNC reviews and reports regularly on newborn and childhood screening practices, recommends improvements in the national newborn and childhood screening programs, and fulfills requirements stated in the authorizing legislation. In addition, ACHDNC's recommendations regarding inclusion of additional conditions for screening on the Recommended Uniform Screening Panel, following adoption by the Secretary, are evidence-informed preventive health services provided for in the comprehensive guidelines supported by HRSA pursuant to section 2713 of the Public Health Service Act (42 U.S.C. 300gg-13). Under this provision, non-grandfathered group health plans and health insurance issuers offering non-grandfathered group or individual health insurance are required to provide insurance coverage without cost-sharing (a co-payment, co-insurance, or deductible) for preventive services for plan years (
During the November 2-3, 2023, meeting, ACHDNC will hear from experts in the fields of public health, medicine, heritable disorders, rare disorders, and newborn screening. Agenda items include the following:
(1) An update on the Krabbe disease expedited evidence review update;
(2) An update on the Duchenne Muscular Dystrophy evidence review update;
(3) An update by the ACHDNC Decision Matrix ad hoc topic group and potential vote on revisions to the ACHDNC Decision Matrix;
(4) A presentation and discussion on the ACHDNC's conflict of interest procedures;
(5) Ad hoc topic group updates; and
(6) A possible presentation on the National Academies of Sciences, Engineering, and Medicine Workshop on Next Generation Screening.
ACHDNC will not vote on recommending conditions for inclusion in the Recommended Uniform Screening Panel during this meeting; however, Krabbe disease and Duchenne Muscular Dystrophy evidence review updates along with a discussion and a potential vote on revisions to the ACHDNC Decision Matrix may inform such potential future recommendations. Agenda items are subject to change as priorities dictate. Information about ACHDNC, including a roster of members and past meeting summaries, is available on the ACHDNC website.
Members of the public will have the opportunity to provide comments on any or all of the above agenda items. Public participants may request to provide general oral comments and may submit written statements in advance of the scheduled meeting. Oral comments will be honored in the order they are requested and may be limited as time allows. Members of the public registered to provide oral public comments on all other newborn screening related topics are tentatively scheduled to provide their statements on Thursday, November 2, 2023. Requests to provide a written statement or make oral comments to ACHDNC must be submitted via the registration website by 12:00 p.m. ET on Friday, October 20, 2023. Written comments will be shared with the Committee, so that they have an opportunity to consider them prior to the meeting.
Individuals who need special assistance or another reasonable accommodation should notify Alaina Harris at the address and phone number listed above at least 10 business days prior to the meeting.
Health Resources and Services Administration (HRSA), Department of Health and Human Services.
Notice.
In accordance with the Federal Advisory Committee Act, this notice announces that the Advisory
December 5, 2023, 10 a.m. to 5 p.m. Eastern Time and December 6, 2023, 9:30 a.m. to 2 p.m. Eastern Time.
This meeting will be held in person at HRSA Headquarters (5600 Fishers Lane, Room 5W07, Rockville, MD, 20857) and virtually via webinar.
Vanessa Lee, MPH, Designated Federal Official, Maternal and Child Health Bureau, HRSA, 5600 Fishers Lane, Room 18N84, Rockville, MD 20857; 301-443-0543; or
ACIMM is authorized by section 222 of the Public Health Service Act (42 U.S.C. 217a), as amended. The Committee is governed by provisions of the Federal Advisory Committee Act (5 U.S.C. Chapter 10), as amended.
ACIMM advises the Secretary of Health and Human Services (Secretary) on department activities, partnerships, policies, and programs directed at reducing infant mortality, maternal mortality, and severe maternal morbidity, and improving the health status of infants and women before, during, and after pregnancy. The Committee provides advice on how to coordinate federal, state, local, tribal, and territorial governmental efforts designed to improve infant mortality, related adverse birth outcomes, maternal health, as well as influence similar efforts in the private and voluntary sectors. The Committee provides guidance and recommendations on the policies, programs, and resources required to address the disparities and inequities in infant mortality, related adverse birth outcomes and maternal health outcomes, including maternal mortality and severe maternal morbidity. With its focus on underlying causes of the disparities and inequities seen in birth outcomes for women and infants, the Committee advises the Secretary on the health, social, economic, and environmental factors contributing to the inequities and proposes structural, policy, and/or systems level changes.
The agenda for the December 5-6, 2023, meeting is being finalized and may include the following topics: an update on the recommendations submitted to the Secretary on improving birth outcomes among American Indian/Alaska Native mothers and infants; updates on the federal Healthy Start program; Committee workgroup discussions on rural health/systems issues, social determinants of health, and preconception/interconception care and reproductive health; federal updates; and Committee operations. Agenda items are subject to change as priorities dictate. Refer to the ACIMM website listed above for any updated information concerning the meeting.
Members of the public will have the opportunity to provide written or oral comments. Requests to submit a written statement or make oral comments to ACIMM should be sent to Vanessa Lee, using the email address above at least 3 business days prior to the meeting. Public participants may submit written statements in advance of the scheduled meeting by emailing
Individuals who plan to attend and need special assistance or a reasonable accommodation should notify Vanessa Lee at the contact information listed above at least 10 business days prior to the meeting.
Federal Emergency Management Agency, Department of Homeland Security.
Notice.
This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Federal Regulations. The currently effective community number is shown in the table below and must be used for all new policies and renewals.
These flood hazard determinations will be finalized on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities.
From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Insurance and Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period.
The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below.
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided.
Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer
The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
These flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. The flood hazard determinations are in accordance with 44 CFR 65.4.
The affected communities are listed in the following table. Flood hazard determination information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Federal Emergency Management Agency, Department of Homeland Security.
Notice.
New or modified Base (1-percent annual chance) Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, and/or regulatory floodways (hereinafter referred to as flood hazard determinations) as shown on the indicated Letter of Map Revision (LOMR) for each of the communities listed in the table below are finalized. Each LOMR revises the Flood Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance Study (FIS) reports,
Each LOMR was finalized as in the table below.
Each LOMR is available for inspection at both the respective Community Map Repository address listed in the table below and online through the FEMA Map Service Center at
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
The Federal Emergency Management Agency (FEMA) makes the final flood hazard determinations as shown in the LOMRs for each community listed in the table below. Notice of these modified flood hazard determinations has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Insurance and Mitigation has resolved any appeals resulting from this notification.
The modified flood hazard determinations are made pursuant to section 206 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001
The currently effective community number is shown and must be used for all new policies and renewals.
The new or modified flood hazard information is the basis for the floodplain management measures that the community is required either to adopt or to show evidence of being already in effect in order to remain qualified for participation in the National Flood Insurance Program (NFIP).
This new or modified flood hazard information, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities.
This new or modified flood hazard determinations are used to meet the floodplain management requirements of the NFIP. The changes in flood hazard determinations are in accordance with 44 CFR 65.4.
Interested lessees and owners of real property are encouraged to review the final flood hazard information available at the address cited below for each community or online through the FEMA Map Service Center at
Federal Emergency Management Agency, Department of Homeland Security.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP).
Comments are to be submitted on or before January 10, 2024.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location
You may submit comments, identified by Docket No. FEMA-B-2374, to Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472, (202) 646-7659, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location
U.S. Immigration and Customs Enforcement, Department of Homeland Security.
30-Day notice.
In accordance with the Paperwork Reduction Act (PRA) of 1995 the Department of Homeland Security (DHS), U.S. Immigration and Customs Enforcement (ICE) will submit the following Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and clearance. This information collection was previously published in the
Comments are encouraged and will be accepted until November 13, 2023.
Written comments and recommendations for the proposed information collection should be sent within 30 days of the publication of this notice to
If you have questions related to this collection please contact: Chelsea Dennis, ICE/OIPE, (202) 423-7456,
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the
(2) Evaluate the accuracy of the agencies 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,
(1)
(2)
(3)
(4)
(5)
Notice.
The Department of Labor's (DOL) Employment and Training Administration (ETA) is soliciting comments concerning a proposed extension for the authority to conduct the information collection request (ICR) titled, “Quarterly Narrative Progress Report, Employment and Training Supplemental Budget Request Activities.” This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA).
Consideration will be given to all written comments received by December 11, 2023.
A copy of this ICR with applicable supporting documentation, including a description of the likely respondents, proposed frequency of response, and estimated total burden, may be obtained free by contacting Jennifer Garrett by telephone at (415) 910-2585, TTY 1-877-889-5627 (these are not toll-free numbers), or by email at
Submit written comments about, or requests for a copy of, this ICR by mail or courier to the U.S. Department of Labor, Employment and Training Administration, Office of Unemployment Insurance, 200 Constitution Avenue NW, Room S-4524, Washington, DC 20210; by email:
Jennifer Garrett by telephone at 415-910-2585 (this is not a toll-free number) or by email at
DOL, as part of continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to the Office of Management and Budget (OMB) for final approval. This program helps to ensure 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 can be properly assessed.
The ETA National and Regional Offices use the Quarterly Narrative Progress Report, Employment and Training Supplemental Budget Request Activities, to monitor the progress of State Workforce Agencies (SWAs) in implementing supplemental grant projects. ETA provides supplemental grants for SWAs to prevent and detect improper benefit payments, improve state performance, and address outdated information technology (IT) system infrastructures. ETA implements these projects through Unemployment Insurance (UI) Supplemental Budget Request (SBR) grants, Reemployment Services and Eligibility Assessments (RESEA) grants, and Dislocated Worker Grants (DWGs) to states for demonstration and special projects such as Reemployment and Systems Integration (RSI). This information collection includes the funded project/activity, the targeted start and completion dates for the project/activity, and the quarterly implementation status. These data are needed for budget preparation and control; program planning and evaluation; program monitoring, oversight, and performance accountability; actuarial and program research; and for accounting to Congress and the public. Title III, Section 303(a)(6) of the Social Security Act authorizes this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to provide comments to the contact shown in the
Submitted comments will also be a matter of public record for this ICR and
DOL is 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, (
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 350l
The Investment Company Act of 1940 (the “Act”)
If the board's counsel has represented the fund's investment adviser, principal underwriter, administrator (collectively, “management organizations”) or their “control persons”
Any fund that relies on one of the exemptive rules must comply with the requirements in the definition of “independent legal counsel” under rule 0-1. We assume that approximately 2,909 funds rely on at least one of the exemptive rules annually.
The estimates of average burden hours are made solely for the purposes of the Paperwork Reduction Act. These estimates are not derived from a comprehensive or even a representative survey or study of the costs of Commission rules.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Form N-17f-1 (17 CFR 274.219) is entitled “Certificate of Accounting of Securities and Similar Investments of a Management Investment Company in the Custody of Members of National Securities Exchanges.” The form serves as a cover sheet to the accountant's certificate that is required to be filed periodically with the Commission pursuant to rule 17f-1 (17 CFR 270.17f-1) under the Act, entitled “Custody of Securities with Members of National Securities Exchanges,” which sets forth the conditions under which a fund may place its assets in the custody of a member of a national securities exchange. Rule 17f-1 requires, among other things, that an independent public accountant verify the fund's assets at the end of every annual and semi-annual fiscal period, and at least one other time during the fiscal year as chosen by the independent accountant. Requiring an independent accountant to examine the fund's assets in the custody of a member of a national securities exchange assists Commission staff in its inspection program and helps to ensure that the fund assets are subject to proper auditing procedures. The accountant's certificate stating that it has made an examination, and describing the nature and the extent of the examination, must be attached to Form N-17f-1 and filed with the Commission promptly after each examination. The form facilitates the filing of the accountant's certificates, and increases the accessibility of the certificates to both Commission staff and interested investors.
The estimate of average burden hours is made solely for the purposes of the Paperwork Reduction Act, and is not derived from a comprehensive or even a representative survey or study of the costs of Commission rules. Compliance with the collections of information required by Form N-17f-1 is mandatory for funds that place their assets in the custody of a national securities exchange member. Responses will not be kept confidential. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid control number.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold an Open Meeting on Friday, October 13, 2023 at 9:30 a.m. (ET).
The meeting will be webcast on the Commission's website at
This meeting will begin at 9:30 a.m. (ET) and will be open to the public via webcast on the Commission's website at
1. The Commission will consider whether to adopt a rule under the Securities Exchange Act of 1934 (“Exchange Act”) to increase the transparency and efficiency of the securities lending market.
2. The Commission will consider whether to adopt a rule under the Exchange Act that is designed to provide greater transparency to investors and other market participants by increasing the public availability of short sale-related data and whether to approve a proposed amendment to the national market system plan governing the consolidated audit trail (“CAT”) created pursuant to the Exchange Act to require a CAT reporting firm that is reporting short sales to indicate whether such firm is asserting use of the bona fide market making exception under Rule 203(b) of Regulation SHO.
For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact Vanessa A. Countryman from the Office of the Secretary at (202) 551-5400.
Notice is hereby given that, pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Rule 6e-2 (17 CFR 270.6e-2) under the Investment Company Act of 1940 (“Act”) (15 U.S.C. 80a) is an exemptive rule that provides separate accounts formed by life insurance companies to fund certain variable life insurance products, exemptions from certain provisions of the Act, subject to conditions set forth in the rule.
Rule 6e-2 provides a separate account with an exemption from the registration provisions of section 8(a) of the Act if the account files with the Commission Form N-6EI-1 (17 CFR 274.301), a notification of claim of exemption.
The rule also exempts a separate account from a number of other sections of the Act, provided that the separate account makes certain disclosure in its registration statements (in the case of those separate accounts that elect to register), reports to contractholders, proxy solicitations, and submissions to state regulatory authorities, as prescribed by the rule.
Since 2008, there have been no filings of Form N-6EI-1 by separate accounts. Therefore, there has been no cost or burden to the industry since that time. The Commission requests authorization to maintain an inventory of one burden hour for administrative purposes.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Notice is hereby given of the following determinations: I hereby determine that certain objects being imported from abroad pursuant to an agreement with their foreign owner or custodian for temporary display in the exhibition “Monet and his Modern Legacy” at the Nelson-Atkins Museum of Art, Kansas City, Missouri; the Cleveland Museum of Art, Cleveland, Ohio; and at possible additional exhibitions or venues yet to be determined, are of cultural significance, and, further, that their temporary exhibition or display within the United States as aforementioned is in the national interest. I have ordered that Public Notice of these determinations be published in the
Reed Liriano, Program Coordinator, Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The foregoing determinations were made pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order
Tennessee Valley Authority.
Notice of Intent.
The Tennessee Valley Authority (TVA) intends to prepare an environmental assessment (EA) or environmental impact statement (EIS) to address the potential environmental impacts associated with the proposed installation and operation of six new aeroderivative combustion turbine (CT) units at the Allen Combustion Turbine (ACT) site, located in Shelby County, Tennessee, southwest of the City of Memphis. The new aeroderivative units would generate approximately 200 Megawatts (MW) of power to help meet the growing system demand. The units would provide flexible and dispatchable transmission grid support and facilitate the integration of renewable generation onto the TVA bulk transmission system, consistent with TVA's 2019 Integrated Resource Plan (IRP). TVA is inviting public comment concerning the scope of the review, alternatives being considered, and environmental issues that should be addressed.
The public scoping period begins with the publication of this Notice of Intent in the
Written comments should be submitted by email to
Matthew Higdon by email to
This notice is provided in accordance with the Council on Environmental Quality's Regulations (40 CFR parts 1500 to 1508) and TVA's procedures for implementing the National Environmental Policy Act (NEPA). TVA is an agency and instrumentality of the United States, established by an act of Congress in 1933, to foster the social and economic welfare of the people of the Tennessee Valley region and to promote the proper use and conservation of the region's natural resources. One component of this mission is the generation, transmission, and sale of reliable and affordable electric energy.
TVA anticipates that the scope of the EA or EIS will evaluate an Action Alternative and a No Action Alternative. Under the Action Alternative, TVA would install and operate six new aeroderivative combustion turbine units generating approximately 200 MW of power at ACT. TVA would also continue to operate two existing CT units which would provide an additional 120 MW of power. The new units would support fast-start dispatching and have synchronous condensing capabilities to improve grid stability. Four of the units would have black-start capabilities. Under the proposal, TVA would implement the best available control technologies to mitigate air emissions. Construction would occur over a one-year timeframe (approximately) beginning in 2025 or 2026, with construction activities taking place within previously disturbed areas at ACT and adjacent properties. Commercial operations would begin in 2025 or 2026.
Under the No Action Alternative, TVA would not install new aeroderivative CT units at the ACT, and TVA would retire all existing units. The No Action alternative provides a baseline for comparing against the Action Alternative.
In the 2019 IRP, TVA evaluated six scenarios (plausible futures) and five strategies (potential TVA responses to those plausible futures) and identified a range of potential resource additions and retirements throughout the TVA power service area, which encompasses approximately 80,000 square miles. The target supply mix adopted by the TVA Board through the 2019 IRP included the addition of up to 5,200 MW of simple cycle capacity by 2028 to facilitate the integration of solar onto the TVA bulk power system.
Investments in adding aeroderivative CTs to the peaking fleet aligns with the direction in the IRP, which recommended enhancing system flexibility to integrate renewables and distributed resources, with substantial solar additions over the next two decades. As the amount of solar generation on the TVA generation portfolio continues to increase, flexibility of the remainder of the fleet becomes even more important. For instance, cloud patterns that temporarily block the sun and reduce solar generation require other generating units to respond to continue to reliably supply power to customers. Aeroderivative CTs are inherently well-suited to provide flexibility, enabling the remainder of the system to better integrate renewables.
Since the completion of the IRP, TVA has seen a strong increase in electric demand. Population has increased in the TVA service region by 1.5 percent since 2019. TVA expects continued strong growth in annual electric demand through the middle of this decade. Forecasted electric demand is expected to grow more than one percent per year on average between 2023-2026. Current system modeling shows that with increased residential migration and commercial development, TVA must add capacity to the system to maintain adequate operating reserves.
In 2019, TVA also completed a CT Modernization Study to evaluate the condition of its existing CT units and form recommendations for investments to ensure a reliable and flexible peaking fleet into the future. The results of the study identified the ACT units as the “most challenged” based on their age and material condition and recommended that they be replaced. The CT Modernization Study also recommended adding new aeroderivative CTs to enhance system flexibility, integrate increasing renewable capacity, and provide dispatchable capacity. The proposed action would also be consistent with the findings and recommendations of this study.
In June 2021, TVA issued an environmental assessment (EA) addressing the retirement of the CT units at Allen. At that time, TVA issued the Paradise and Colbert Combustion Turbine EA and an associated finding of no significant impact, in which TVA
In December 2022, during Winter Storm Elliott, 16 of the units at ACT failed to start, impacting the TVA system position by 240 MWs. Since this event, these 16 units at Allen have ceased operations. Only two units at ACT (Units 19 and 20) are operable.
The purpose of the proposed action is to increase the flexibility and reliability of TVA power system by improving TVA's transmission system stability in western Tennessee and providing new, dispatchable generation to support the continued system load growth experienced in the TVA power service area over the past few years. These improvements would help TVA to expand and integrate renewable energy resources onto its transmission grid, which would allow TVA to advance its decarbonization goals.
TVA has identified the need to improve the stability of its transmission system in the western portion of Tennessee. In this area, additional resources are needed to ensure that adequate transmission voltages are maintained within the desired limits. In addition, as identified in the 2019 IRP, TVA needs flexible, dispatchable power that can successfully integrate increasing amounts of renewable energy sources while ensuring it can meet required year-round generation and maximum capacity system demands and planning reserve margin targets.
The EA or EIS will include an evaluation of the environmental, social, and economic impacts associated with implementing the proposed action. Because all ground disturbing activities associated with the proposal would occur within previously disturbed areas of TVA's Allen facility, TVA anticipates that the primary issues to be addressed in the EA or EIS will be impacts to air quality, climate change, environmental justice, and transportation. Other resource issues, including socioeconomics and surface water quality, will be addressed. Measures to avoid, minimize, and mitigate adverse effects will be identified and evaluated in the EA or EIS. TVA seeks input from the public during the scoping period on other relevant issues that should be considered and potential mitigation measures.
TVA anticipates seeking required permits or authorizations, as appropriate. TVA's proposed action may require issuance of an air permit under the Clean Air Act; an Individual or Nationwide Permit under Section 404 of the Clean Water Act; Section 401 Water Quality Certification; conformance with Executive Orders on Environmental Justice (12898), Wetlands (11990), Floodplain Management (11988), Migratory Birds (13186), and Invasive Species (13112); and compliance with Section 106 of the National Historic Preservation Act, Section 7 of the Endangered Species Act, and other applicable Local, Federal, and State regulations.
Scoping, which is integral to the process for implementing NEPA, provides an early and open process to ensure that issues are identified early and properly studied; issues of little significance do not consume substantial time and effort; the draft EA or EIS is thorough and balanced; and delays caused by an inadequate EA or EIS are avoided. TVA seeks comment and participation from all interested parties for identification of potential alternatives, information, and analyses relevant to the proposed action in this EA or EIS. Public comments received during the scoping period will assist TVA in determining the appropriate level of NEPA review.
Information about this project is available at
TVA will consider comments received during the scoping period and develop a scoping report which will be published online. The scoping report will summarize public and agency comments that were received and identify the projected schedule for completing the environmental review process. TVA will post a draft EA or EIS for public review and comment on the project web page. TVA anticipates holding a public open house after releasing the draft EA or EIS. TVA expects to release the draft EA or EIS in Spring or Summer 2024 and a final EA or EIS in late 2024. If an EIS is prepared, TVA would publish a Record of Decision at least 30 days after the release of the final EIS.
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before November 1, 2023.
Send comments identified by docket number FAA-2023-0754 using any of the following methods:
•
•
•
•
Deana Stedman, AIR-646, Federal Aviation Administration, phone (206) 231-3187, email
The petitioner also requests relief from § 23.811(b) and (c), which are commuter category airplane safety requirements for emergency exit marking, that require exits and doors to be internally marked with the word “exit” by a sign that meets a specific size, color, and illumination as stated in those regulations.
The petitioner also requests relief from § 23.812, which contains the safety requirements for commuter category airplanes for emergency lighting.
The requested relief is for the Textron Model 390 airplane, Type Certificate A00010WI, which was certified as normal category. The petitioner's project would increase the gross weight of the airplane which would necessitate compliance with the requirements for commuter category airplanes.
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before November 1, 2023.
Send comments identified by docket number FAA-2023-0741 using any of the following methods:
•
•
•
•
Deana Stedman, AIR-646, Federal Aviation Administration, phone (206) 231-3187, email
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice of petition for exemption received.
This notice contains a summary of a petition seeking relief from specified requirements of Federal Aviation Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before November 1, 2023.
Send comments identified by docket number FAA-2023-0753 using any of the following methods:
•
•
•
•
Deana Stedman, AIR-646, Federal Aviation Administration, phone (206) 231-3187, email
This notice is published pursuant to 14 CFR 11.85.
Federal Motor Carrier Safety Administration (FMCSA), Department of Transportation (DOT).
Notice of public meeting.
This notice announces a meeting of the WOTAB.
The meeting will be held on Thursday, October 26, 2023, from 10 a.m. to 4:30 p.m. ET. Requests for accommodations for a disability must be received by Friday, October 21. Requests to submit written materials for consideration during the meeting must be received no later than Friday, October 21.
The meeting will be held virtually for its entirety. Please register in advance of the meeting at
Ms. Shannon L. Watson, Designated Federal Officer, WOTAB, FMCSA, 1200 New Jersey Avenue SE, Washington, DC 20590, (202) 360-2925,
WOTAB was created under the Federal Advisory Committee Act (FACA) in accordance with section 23007(d)(1) of the Bipartisan Infrastructure Law (BIL) (Pub. L. 117-58), which requires the Federal Motor Carrier Safety Administration (FMCSA) to establish WOTAB. WOTAB will review and report on policies that provide education, training, mentorship, and outreach to women in the trucking industry and identify barriers and industry trends that directly or indirectly discourage women from pursuing and retaining careers in trucking.
WOTAB operates in accordance with FACA under the terms of the WOTAB charter, filed February 11, 2022.
WOTAB will begin consideration of Task 23-4: Examining ways in which trucking companies, nonprofit organizations, training, and education providers, and trucking associations may coordinate functions to facilitate support for women pursuing careers in trucking. For this and all topics considered by the committee, FMCSA will include presentations by Agency experts and those in the field under discussion.
The meeting will be open to the public via virtual platform. Advance
DOT is committed to providing equal access to this meeting for all participants. If you need alternative formats or services due to a disability, such as sign language interpretation or other ancillary aids, please contact the person listed in the
Oral comments from the public will be heard during designated comment periods at the discretion of the WOTAB chair and Designated Federal Officer. To accommodate as many speakers as possible, the time for each commenter may be limited. Speakers are requested to submit a written copy of their remarks for inclusion in the meeting records and for circulation to WOTAB members. All prepared remarks submitted on time will be accepted and considered as part of the record. Any member of the public may present a written statement to the committee at any time.
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 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. Currently, the IRS is soliciting comments concerning the burden associated with the information collection requirements related to the sale of residence from qualified personal residence trust.
Written comments should be received on or before December 11, 2023 to be assured of consideration.
Direct all written comments to Andrés Garcia, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or by email to
Requests for additional information or copies of the form and instructions should be directed to Ronald J. Durbala, at (202) 317-5746, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW, Washington, DC 20224, or through the internet at
The following paragraph applies to all 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 if 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.
• 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 using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments submitted in response to this notice will be summarized and/or included in the ICR for OMB approval of the extension of the information collection; they will also become a matter of public record.
Department of Veterans Affairs.
Notice of solicitation for nominations.
The Department of Veteran Affairs (VA) Office of Research and Development (ORD) is committed to having a diverse and inclusive membership on its National Research Advisory Council (NRAC or the Council). The NRAC is seeking nominations for its 2024 membership cycle of qualified candidates who promote racial and ethnic diversity, as well as sex, geographic, religious, disability/mobility, and prior military service diversity in membership.
Nominations for membership on NRAC must be received by November 15, 2023 no later than 4 p.m., Eastern Standard Time. Submission of an application does not guarantee selection.
All nomination packages should be emailed to Rashelle Robinson:
Allison Williams ND Ph.D. RN at
The Council provides advice to the Secretary of Veterans Affairs (Secretary) and the Under Secretary for Health (USH) and makes recommendations on the nature and scope of research and development sponsored and/or conducted by the Veterans Health Administration (VHA) to include:
(1) the policies and projects of the Office of Research and Development (ORD);
(2) the focus of research on the high priority health care needs of Veterans;
(3) the balance of basic, applied, and outcomes research;
(4) the scientific merit review process;
(5) the appropriate mechanisms by which ORD can leverage its resources to enhance the research financial base;
(6) the rapid response to changing health care needs, while maintaining the stability of the research infrastructure; and
(7) the protection of human subjects of research.
a. basic biomedical research;
b. rehabilitation research and development;
c. health services research and development;
d. clinical research;
e. geriatric care;
f. primary care;
g. special Veterans population health issues;
h. occupational and environmental health research;
i. mental health and behavioral research; and
j. surgery.
In addition, the NRAC will have at least one Veteran as a member to ensure an important perspective on the health problems of Veterans.
To the extent possible, the Secretary seeks members who have diverse professional and personal qualifications including but not limited to subject matter experts in the areas described above. We ask that nominations include any relevant experience information so that VA can ensure diverse Council membership.
(1) A cover letter that clearly states the name and affiliation of the nominee, the basis for the nomination (
(2) The nominee's contact information, including name, mailing address, telephone numbers, and email address;
(3) The nominee's curriculum vitae that shows all relevant professional, publications, Veterans service involvement and/or work experience;
(4) A summary of the nominee's experience and qualifications relative to the membership consideration described above; and
(5) A statement confirming that the nominee is not a federally-registered lobbyist.
Packages will be reviewed by ORD Leadership staff and individuals selected for appointment to the Council will be notified via email.
The Department makes every effort to ensure that the membership of VA Federal advisory committees is diverse in terms of points of view represented and the committee's capabilities. Appointments to this Council shall be made without discrimination because of a person's race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability or genetic information. Nominations must state that the nominee is willing to serve as a member of the Council and appears to have no conflict of interest that would preclude membership. An ethics review is conducted for each selected nominee.
September 28, 2023.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change consists of modifications to the DTC Operational Arrangements (Necessary for Securities to Become and Remain Eligible for DTC Services) (“OA”)
In its filing with the Commission, the clearing agency 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 clearing agency has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The OA is designed to maximize the number of issues of securities that may be made eligible for DTC services, providing for the orderly processing of such securities and timely payments to Participants. DTC's experience demonstrates that when Participants, Issuers, Underwriters, Agents (as such terms are defined in the Rules
Section 17A(b)(3)(F) of the Act
The proposed rule changes are also designed to be consistent with Rule 17Ad-22(e)(23) of the Act,
DTC does not believe that the proposed rule change would have any impact on competition because the proposed changes merely relate to updates and clarifications of the OA which would not significantly affect the rights and obligations of users of DTC's services and would not disproportionally impact any users.
DTC has not received or solicited any written comments relating to this proposal. If any written comments are received, they would be publicly filed as an Exhibit 2 to this filing, as required by Form 19b-4 and the General Instructions thereto.
Persons submitting comments are cautioned that, according to Section IV (Solicitation of Comments) of the Exhibit 1A in the General Instructions to Form 19b-4, the Commission does not edit personal identifying information from comment submissions. Commenters should submit only information that they wish to make available publicly, including their name, email address, and any other identifying information.
All prospective commenters should follow the Commission's instructions on how to submit comments,
DTC reserves the right to not respond to any comments received.
The foregoing rule change has become effective 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.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Final rule.
FRA is requiring the installation of inward- and outward-facing locomotive image recording devices on all lead locomotives in passenger trains, as required by the Fixing America's Surface Transportation Act (FAST Act). In general, the final rule requires that these devices record while a lead locomotive is in motion and retain the data in a crashworthy memory module. The rule also treats locomotive-mounted recording devices on passenger locomotives as “safety devices” under existing Federal railroad safety regulations to prohibit tampering with or disabling them. Further, this rule governs the use of passenger locomotive recordings to conduct operational tests to determine passenger railroad operating employees' compliance with applicable railroad rules and Federal regulations. Finally, this rule requires Texas Central Railroad (TCRR) to install and maintain trainset image recording systems appropriate to TCRR's operation.
This final rule is effective November 13, 2023.
Brian Roberts, Attorney Adviser, Office of the Chief Counsel, at email:
The following abbreviations are used in this document's preamble:
FRA is publishing this final rule as mandated by section 11411 of the FAST Act, codified at 49 U.S.C. 20168 (the Statute), and under the agency's general railroad safety rulemaking authority at 49 U.S.C. 20103.
In light of the Statute's mandate, relevant NTSB recommendations, the RSAC Working Group's discussions, accident history, and railroad safety violations that FRA had investigated,
Having carefully considered the public comments in response to the NPRM, FRA issues this final rule amending the regulatory requirements of Railroad Operating Rules (49 CFR part 217), Railroad Operating Practices (49 CFR part 218), Railroad Locomotive Safety Standards (49 CFR part 229), and Texas Central High-Speed Rail Safety Standards (49 CFR part 299). This final rule requires intercity passenger and commuter railroads
FRA notes that the image recording device requirements for passenger train locomotives in this final rule supplement FRA's existing locomotive event recorder regulation in part 229. Locomotive event recorders are required on the lead locomotives of trains traveling over 30 mph and already record numerous operational parameters that assist in accident/incident investigation and prevention (
FRA used a cost-benefit analysis to evaluate the impact of the final rule on passenger railroads required to install and maintain locomotive image recording devices. FRA estimated the low and high costs of this final rule over a 10-year period, using discount rates of 3 and 7 percent, with the results shown in the tables below.
The primary source of expected benefits is the potential reduction in safety risk. FRA conducted a literature review to determine the effectiveness rate of inward- and outward-facing recording devices, but was unable to determine an appropriate rate. The benefits for the final rule are qualitatively discussed. The reduction in safety risk is expected to come primarily from the change in crew behavior. Railroads can deter unsafe behavior if crewmembers realize their actions may be observed on a frequent, but random, basis by railroad supervisors. Locomotive image recorders cannot directly prevent an accident from occurring, but rather can provide investigators with information after an accident occurs that can help to prevent future accidents of that type from occurring.
In the NPRM, FRA specifically requested information from the public as well as comments on its proposals. Commenters provided valuable information and comments on issues where FRA asked for comments as well as on various other issues. In total, FRA received comments from fifteen different individuals or organizations in response to the NPRM.
An FRA employee also received an email from New York's Metropolitan Transportation Authority providing information about the economic cost of the requirements proposed in the NPRM. FRA is treating that email as a comment and it is addressed in the Regulatory Impact Analysis (RIA) of this final rule. The full email has also been placed into the rulemaking docket along with a memorandum from FRA explaining the context for the email. Further, in its submitted comments, the International Association of Sheet Metal, Air, Rail and Transportation Workers (SMART) disagreed with FRA's characterization in the NPRM that a public hearing would be provided only if a party was unable to adequately present his or her position by written statement; however, neither SMART, nor any other party, requested a public hearing on this rulemaking. Accordingly, a public hearing was not provided.
Most of the comments in response to the NPRM are discussed below or in the Regulatory Impact and Notices portion of this final rule. The order in which the comments are discussed in this final rule, whether by issue or by commenter, is not intended to reflect the significance of the comment raised or the standing of the commenter.
In the NPRM, FRA did not propose to require the installation and use of inward- and outward-facing recording devices in freight locomotives, nor did FRA propose that any of the NPRM's requirements apply to inward- and outward-facing locomotive recording devices that have been voluntarily installed by freight railroads. While FRA discussed the issue of inward- and outward-facing recording devices on freight locomotives at various points in the NPRM, FRA specifically addressed the issue under the heading “Mandatory Installment of Inward- and Outward-Facing Recording Devices on Freight Locomotives.” In that section, FRA discussed its decision not to propose such a requirement because: (1) the Statute did not require recording devices be installed on freight locomotives; (2) the cost of installing such devices could outweigh the safety benefits; and (3) many freight railroads, including all Class I railroads, had already installed or were in the process of installing such recording devices.
In addition, FRA specifically asked for public comment on whether some or all freight railroads should be required to equip their locomotives with recording devices and, if FRA did not require freight railroads to install these devices on their locomotives, the extent to which the requirements proposed in the NPRM should apply to inward- and outward-facing locomotive recording devices on freight railroads that have already installed such devices or install such devices in the future.
As proposed in the NPRM, FRA is declining to adopt any requirements that freight locomotives install or use inward- or outward-facing recording devices in freight locomotives, nor will any requirements of this rule apply to inward- or outward-facing locomotive recording devices that have been voluntarily installed by freight railroads. The Statute requires inward- and outward-facing image recording devices in controlling passenger locomotives as well as gives the Secretary discretion to require in-cab audio recording devices. 49 U.S.C. 20168(a), (e)(1)(A). There is no statutory requirement to create standards for, or apply any of the requirements of this final rule to, freight locomotive image or audio recordings.
FRA did not receive comments showing that benefits would outweigh costs for freight railroads. Accordingly, FRA declines to require freight railroads to install recording devices at this time. However, freight locomotives that are used in commuter or intercity passenger service, other than for rescue purposes, are passenger locomotives and are subject to all the final rule's requirements. In other words, freight locomotives that do not perform any passenger railroad related service, or are used only for rescue purposes, are not subject to the requirements of this final rule. Additional discussion on this topic is provided below.
The Association of American Railroads (AAR) commented that requiring freight railroads to install locomotive recording devices was not necessary, as many freight railroads had already installed, or were in the process of installing, recording devices voluntarily. AAR stated that a survey of AAR's Class I member railroads showed that these railroads “will have installed approximately 20,500 inward-facing cameras and 22,000 outward-facing cameras in the near future.”
The Brotherhood of Locomotive Engineers and Trainmen (BLET), the Transportation Trades Department, AFL-CIO (TTD), and SMART also expressed opposition to FRA requiring freight railroads to install inward- and outward-facing locomotive recording devices. SMART agreed with FRA's statement in the NPRM that the cost for freight railroads to implement similar procedures as those proposed in the NPRM for passenger trains may outweigh the potential safety benefits.
The NTSB and Wi-Tronix, LLC (Wi-Tronix), a company that provides connected solutions for locomotive fleets, commented that FRA should require inward- and outward-facing locomotive recording devices in freight locomotives. The NTSB contended that inward- and outward-facing audio and image recorders are needed in freight railroad operations, referencing NTSB Safety Recommendations R-10-01 and R-10-02, which were issued following four separate NTSB accident investigations involving freight rail operations. The NTSB asserted that the need for recording devices in freight railroad investigations is exactly the same as in passenger railroad investigations given that: (1) freight and passenger trains operate on the same tracks and both pose risks of accidents that have the potential to significantly affect the public; and (2) recorded information about safety issues identified in freight railroad accidents and incidents could inform, mitigate, or prevent similar safety issues in passenger railroad operations. Therefore, the NTSB believed it would be “shortsighted” for FRA to limit the rule to apply only to lead passenger locomotives.
Like the NTSB, Wi-Tronix also commented that the rail network is integrated and that commuter and intercity passenger trains often share the same track and dispatch system, among other things, with freight trains. Acknowledging the increase in video system use for safety and operating rule compliance, Wi-Tronix stated that there “are roughly 20 times the number of freight locomotives compared with passenger locomotives,” and the full safety benefits of the technology would not be realized without the requirement covering all locomotive types.
FRA recognizes the potential safety benefits of locomotive recording devices in freight locomotives as noted in the NTSB's and Wi-Tronix's comments. However, FRA disagrees that the full safety benefits of this technology can only be achieved with a specific regulatory requirement that freight railroads install inward- and outward-facing image and/or audio recorders.
As stated in the NPRM, many freight railroads, including all Class I railroads, have either already installed or are in the process of installing recording devices in their locomotives. As noted by AAR in its comment, “approximately 20,500 inward-facing cameras and 22,000 outward-facing cameras” will be installed on AAR Class I member railroads “in the near future.” In addition, AAR points out in its comments that recordings from these voluntarily installed systems are already subject to the accident data preservation requirements in 49 CFR 229.135(e).
Furthermore, requiring freight railroads to comply with the final rule's requirements would be expensive with questionable benefit. FRA has investigated few, if any, freight railroad accidents where freight locomotive image data should have been present but was not because it was destroyed in the accident. Furthermore, while the vast majority of Class I railroads have or are installing inward- and outward-facing cameras, very few short line railroads (Class II or Class III railroad) have either inward- or outward-facing cameras installed on their locomotives. In fact, for these much smaller railroads, FRA estimates that only 1% have inward-facing locomotive cameras and 25% have outward-facing cameras installed on their locomotives. This is not necessarily surprising as Class II and Class III railroads are less likely to need locomotive cameras given the lower speeds, shorter distances, and the less regular nature of the services that these railroads operate. These definitionally smaller operations would be significantly affected economically if FRA imposed the requirements of this final rule to freight railroads and would have difficulty absorbing the cost without much safety benefit.
Therefore, for the reasons explained above, FRA is declining to require freight railroads to install recording devices at this time. FRA will continue to monitor the freight industry's voluntary installation of the devices and the effectiveness of those devices in freight rail operations. Based on this continued monitoring, FRA may take additional action in a separate proceeding to address the use of locomotive recording devices on freight railroads.
In addition to its opposition to FRA requiring inward- and outward-facing recording devices on freight locomotives, AAR also suggested that FRA add language to part 229 mirroring the preemptive effect language in §§ 217.2 (preemptive effect of railroad operating rules) and 218.4 (preemptive effect of railroad operating practices). AAR asserted that both these provisions clarify FRA's intent to create a national standard and this final rule should include this preemption language for national uniformity. AAR added that, to preclude the creation of a patchwork of conflicting state and local requirements applying to freight railroads, FRA should state that its decision to not propose a locomotive recording device requirement for freight railroads reflects the agency's position that it is unnecessary to issue such a regulation.
In issuing this final rule, FRA has sought to stay within the Statute's mandate, 49 U.S.C. 20168, and not undertake a broader revision of part 229. Accordingly, FRA declines to add
In addition to FRA inviting comments on whether the agency should require the installation of inward- and outward-facing recording devices on freight locomotives, FRA also sought comment on whether the proposed requirements should apply to recording devices that have already been installed on freight locomotives. Except for AAR, which supported FRA's proposal to exclude freight trains from this proposed rule, all the commenters generally favored applying the requirements of this final rule to freight locomotives that have voluntarily installed inward- or outward-facing recording devices.
Based on the same reasoning provided above, the NTSB commented that FRA should ensure the same level of safety for both passenger and freight railroads and that any recording device that either a passenger or freight railroad has voluntarily installed should be required to meet the minimum standards in this final rule. While BLET, SMART, and TTD all opposed requiring freight railroads to equip their locomotives with recording devices, they all agreed that freight railroads that voluntarily install such devices should nonetheless have to comply with the final rule's railroad employee protections and adhere to a uniform national standard created by FRA and applicable to both freight and passenger locomotive recording devices, regardless of whether they were installed before or after the rule's issuance. TTD specifically urged FRA to apply the final rule's requirements to protect against employee retaliation under part 217 operational testing, regardless of whether FRA requires the installation of the locomotive recording device(s).
After considering the comments, FRA is declining to impose any of the requirements in this final rule on freight railroads that have voluntarily installed recording devices on their locomotives. However, it is FRA's expectation that all railroads that voluntarily install recording devices on their locomotives, including freight railroads, will adhere to practices that are consistent with those in this final rule, such as those provided under new part 217 requirements that serve to protect employees from targeted testing as a form of retaliation when railroads conduct operational testing using recording devices or their recordings.
FRA has independent authority to disapprove a freight railroad's operating rules testing program, required under Part 217.
Finally, the American Public Transportation Association (APTA) submitted a comment asking FRA whether freight locomotives that do not have inward-facing locomotive cameras compliant with this final rule would be allowed to “rescue” passenger trains that fail en route. In such situations, a freight locomotive “rescues” the failed passenger train by operating as the lead locomotive of the passenger train and hauling the train to its destination or repair point. Having considered APTA's comment, this final rule includes a new provision, § 229.139(l), that excludes freight locomotives from compliance with the requirements of new § 229.136 when they are performing rescue operations for intercity or commuter passenger trains. However, this exception applies only for the limited purposes of rescuing an intercity or commuter passenger train; a freight locomotive used in regular passenger service will not be covered by the exception. The exclusion is based on identical language in the definition of “locomotive” for purposes of FRA's Passenger Equipment Safety Standards in § 238.5 of this chapter.
While the Statute gives FRA discretion to require the installation of audio-recording devices on passenger train lead locomotives and to establish corresponding technical details for such devices, FRA did not propose specific rule text in the NPRM that would require audio recording devices. Rather, FRA requested comment on numerous specific issues related to audio recorders, to evaluate whether to require audio recorders in passenger or freight locomotives in this final rule. Specifically, FRA asked about: (1) the usefulness of audio recordings in certain accident investigations; (2) what benefits they provide in addition to the benefits of image recordings; and (3) whether any benefits outweigh the installation cost for these devices, the cost of crashworthy memory for these devices, the loss of personal privacy for occupants inside the locomotive cab, or the potential that recordings from these devices could be abused by railroad supervisors.
FRA also asked for comments on whether FRA should require audio recorders to stop recording after the locomotive has stopped, if FRA were to adopt a requirement for the installation of locomotive audio recorders in the final rule. In addition, FRA asked whether FRA should require exterior recording devices that would be capable of recording sounds such as the locomotive horn/bell, audible grade crossing warning devices, engine noises, and other sounds relevant during post-accident investigations, and what the utility of these recordings would be when weighed against the potential cost. In responding to these questions, FRA asked commenters to provide specific information on the costs of installing audio recorders.
In response to these requests for comments, most parties agreed with FRA's proposal not to require the installation of locomotive audio recording devices in either passenger or freight locomotives. Commenters who advocated for the installation of such devices pointed to their usefulness in post-accident investigations. Although FRA did not receive responses to all its requests for comments related to audio recording devices, commenters did
As for the question whether FRA should require locomotive audio recordings at all, BLET, TTD, and SMART asserted that audio recorders should not be required. Moreover, BLET and SMART specifically asked FRA to prohibit audio recordings within the locomotive cab. BLET stated that, although audio and image recordings could be used to aid in accident investigations, the recording devices would also add another level of distraction and discomfort for train crews (
In response to FRA's request for comments on whether to require exterior recording devices, BLET stated that all key locomotive operations, including throttle, braking, locomotive horn/bell, are already captured on the locomotive's event recorder. Further, BLET noted that because grade crossing warning devices are intended to warn motorists, not the train crew, it would be more helpful instead to mount audio recorders at highway-grade crossing signal control boxes. Accordingly, BLET saw no value in requiring exterior locomotive recording devices; however, if FRA were to consider requiring such devices anyway, BLET commented that FRA should consider exterior audio devices that could be engaged or disengaged by selecting from the locomotive's software preferences for the camera. BLET stated the cost to do so would be nominal as it is already an included feature on some locomotives. BLET further indicated that this feature was discussed at RSAC Working Group meetings.
TTD asserted that audio recording devices would have a negative impact on train crews' morale and the labor-management relationship, and could possibly record and lead to the release of private conversations unrelated to safety-sensitive tasks. TTD noted that a substantial amount of information is already recorded or transmitted, or both, via on-board equipment and radio communications, and eventually will be through image recorders. Thus, TTD did not see how audio recording devices would improve safety and asserted that FRA should not mandate audio recorders in the final rule.
SMART commented that during RSAC Working Group meetings, both railroads and labor organizations expressed unanimous opposition to a locomotive audio recorder requirement. SMART believed employees deserve some privacy protections and concurred with FRA's reasoning in the NPRM that audio recorders should not be required.
In addition to labor organizations, APTA commented that it also opposed requiring locomotive audio recorders. APTA stated that the railroad industry supports most of FRA's NPRM analysis regarding audio recordings, and that the industry believes that locomotive audio recordings are redundant and secondary to both locomotive image recorders and pre-existing communication systems, such as radio. APTA also stated that audio recordings, like video recordings, are not monitored by the railroads in real time, and therefore, have minimal value in preventing accidents.
Notwithstanding APTA's assertion that the industry opposed a locomotive audio recorder requirement, the National Railroad Passenger Corporation (Amtrak) commented that FRA should create an exterior recording device requirement to aid in post-accident investigations because these devices are extremely beneficial in private litigation. Amtrak provided figures on the cost of installing image recording devices for their fleet to be $10,080 as well as the cost per locomotive of new audio equipment to be $23,349, as FRA requested. Additionally, in the RIA, FRA estimates a range that starts at $6,000 for each audio recording device up to a cost of $23,349. This lower estimate was based on discussions with FRA's subject matter experts and online research.
Amtrak also commented that the benefits provided by locomotive audio recordings would outweigh concerns about the potential loss of personal privacy for locomotive cab occupants, because while operating a locomotive, the use of audio-visual recordings would be a condition of employment applicable under the railroad's enforcement of rules. In addition, Amtrak asserted that the benefits of locomotive audio devices would outweigh the potential for abuse by railroad management because Amtrak has an established company program and process in place providing that the use of audio and visual recordings is for compliance means only.
The NTSB also urged FRA to require both internal and external locomotive audio recorders as part of this final rule. As noted in the NPRM, the NTSB has conveyed to FRA that to satisfy NTSB Recommendations R-10-01 & -02, FRA would need to include both audio and image recording provisions in this rulemaking.
The NTSB cited how important both inward-facing locomotive image and audio recordings were in its investigation of the December 18. 2017, derailment of Amtrak passenger train 501 in DuPont, Washington. According to the NTSB, these internal locomotive audio and visual recordings helped the agency determine that neither personal electronic device use nor brief conversations between the engineer and conductor were causes of the derailment.
While internal locomotive audio recordings were useful in the NTSB's investigation of the Amtrak passenger train 501 accident, NTSB's comment states that it was audio recording devices inside the locomotive along with inward-facing locomotive video recording devices that helped the NTSB make determinations as to what could be excluded as the cause of the 2017 Amtrak accident in Dupont, Washington. Furthermore, the NTSB investigation into this accident is just one specific investigation into one specific railroad accident. FRA did not
Wi-Tronix also commented on FRA's decision to not include an audio recorder proposal in the NPRM and agreed with the NTSB that, based upon its incident investigation experience over the years, the availability of audio locomotive recordings has played a critical role in determining the chain of events during an accident investigation and the implementation of the technology is essential in getting the “step-change improvement” in human factor safety that FRA desires. Wi-Tronix also commented on the potential for privacy concerns with audio recordings that were raised by TTD and SMART. Wi-Tronix believes that with current technology, recorded audio information could be sequestered and be made available only to regulators and other officials on a limited basis after an emergency incident. Further, Wi-Tronix stated that artificial intelligence and machine learning could use the audio information for analytics anonymously without personal information included. Wi-Tronix said that the implementation of audio recordings, in conjunction with video recordings, is not a major cost driver for system implementation.
Finally, an anonymous commenter stated that installing inward and outward-facing recording devices could be beneficial when investigating railroad accidents. The commenter expressed hope that these recording devices will decrease the number of railroad related accidents.
After considering all the comments received on whether audio recording devices should be required on lead passenger locomotives, FRA has determined that a requirement for such devices on lead passenger locomotives is not justified. Accordingly, in this final rule, FRA is not adopting a requirement for the installation of audio recording devices on passenger or freight locomotives. FRA does not believe that the potential added utility of audio recordings, in addition to image recordings as well as the data provided by a locomotive's event recorder, outweighs the cost that would result. Indeed, while audio recording devices may provide some additional useful information in certain accident investigation scenarios, the overall usefulness of locomotive audio recordings is diminished by the statutorily mandated requirement of inward- and outward-facing locomotive cameras as well as existing requirements for event recorders on all lead passenger locomotives. Further, as previously stated, there is no requirement in the FAST Act that passenger or freight locomotives be equipped with either internal or external audio recording devices. Therefore, FRA is allowing railroads to decide whether to equip their locomotives with external and/or internal audio devices.
Passenger locomotive cabs, unlike freight locomotive cabs or even commercial airliner cockpits, are typically occupied by only one crewmember, while additional crewmembers are located in the passenger train consist assisting passengers. As there is usually only one crewmember in the locomotive cab while a passenger train is in motion, it is unclear what information internal locomotive audio recorders would provide that inward-facing locomotive cameras could not. For example, as cited in the NPRM, in both the 2008 Chatsworth Southern California Regional Rail Authority (Metrolink) accident,
External locomotive audio recorders are unlikely to provide much additional information in post-accident investigations. As stated by BLET, all key locomotive operations, including throttle, braking, and locomotive horn/bell, are already required to be captured on the locomotive's event recorder. If an accident occurs, this data can be retrieved from the event recorder. Combining the event recorder data with information gained from external locomotive cameras diminishes the need for external audio recording devices. Accordingly, given the information already available to FRA and other investigators from event recorders and locomotive cameras, FRA cannot justify mandating the installation of an external audio recording device at this time.
Moreover, locomotive audio recorders will not greatly increase a passenger railroad's ability to deter railroad safety violations, such as the use of prohibited personal electronic devices, beyond the deterrence already provided by inward-facing image recorders. Because the locomotive engineer is typically alone in the locomotive cab, it is unlikely that audio recordings will pick up audio information useful to prove that a rail safety violation occurred that could not be determined from video footage. In fact, audio recordings might not pick up anything at all.
Further, FRA shares SMART's and TTD's concern that because train crews might be more likely to congregate in the locomotive cab when not performing their safety-related duties (
Finally, based on information provided by the railroad industry, FRA subject matter experts, and online research, FRA estimates that the inclusion of audio recording devices would cost passenger railroads between $25.2 and $98.1 million dollars within the first four years of implementation to install on over 4,200 passenger locomotives. Although FRA recognizes that Wi-Tronix commented that the cost of locomotive audio recorders in conjunction with image recording device would be nominal, there may be only a small number of accidents where audio recordings might be beneficial and Wi-Tronix did not provide any data to support its cost assertion.
FRA understands from RSAC Working Group discussions and its own research that the audio recording devices and microphones contained within a locomotive's image recorders have some costs, but railroads indicate a crash-hardened memory module for audio recordings might increase costs of compliance. FRA is also concerned about the background noise levels inside the cabs of certain locomotives and has previously conveyed that concern to the NTSB. Because of the noise, additional equipment may be
However, FRA also disagrees with BLET and SMART, and nothing in this final rule precludes passenger or freight railroads from voluntarily installing and using either internal or external locomotive audio recording devices as part of their operation, if they so choose. The FAST Act provided FRA with discretion whether to include a regulatory requirement for inside-locomotive audio recording devices,
FRA also received a comment from APTA suggesting that FRA remove any reference to audible sounds from the definition of “recording device” as proposed in the NPRM. For the reasons discussed in Section II.T below, FRA disagrees and intends that audio recordings be subject to the preservation requirements and other relevant requirements of § 229.136.
In the NPRM, FRA requested comments on a number of questions regarding whether FRA should set a specific run-time or shutoff requirement for locomotive recording devices. Specifically, FRA requested comment on its proposal to provide passenger railroads the discretion to decide whether locomotive recording devices would continue to record when a locomotive is not in motion, if the railroad retains a recording of the last 12 hours of operation of the locomotive on a memory module compliant with the requirements proposed in § 229.136. FRA also asked for comments on: what safety benefits would result from recordings made when a locomotive is occupied, but not moving; whether a specific run-time or shutoff requirement would present any technical hurdles for the railroads, and if so, the cost of those hurdles (in dollars); the privacy implications of recordings being made during down times when the crew is not performing safety-related duties; the potential risk of data being overwritten if an accident occurs in a remote location and the device continues to record; and finally, whether passenger railroads should be exempt from any requirement to stop locomotive recording devices from recording when the locomotive is stopped.
FRA received numerous responses to these requests for comments. Most of the comments focused on what the run-time/shutoff standard should be, if any. Both Amtrak and APTA expressed views consistent with FRA's proposed standard that passenger railroads have the discretion to determine their own run-time/shutoff standard for locomotive recording devices. APTA noted that locomotive cabs are workplaces, whether occupied or not, and therefore they should be able to run their locomotive cameras continually. APTA asserted that allowing cameras to run continually would serve as a deterrent against locomotive safety device tampering, assist with potential criminal investigations (such as vandalism), and provide a valuable tool for railroad security. However, APTA stated while its members support the position that railroads should be able to record using their locomotive image recorders when the locomotive is stopped, the decision whether to record while the locomotive is stopped should be left to the individual railroad.
Amtrak's comments were similar to APTA's. Amtrak opposed FRA adopting a stricter standard than that proposed in the NPRM. Amtrak also contended that railroads should be allowed to record after the train has stopped moving (
The NTSB commented that FRA should require inward-facing cameras to record whenever a locomotive is powered on, regardless if the locomotive is moving or stationary, and that railroads should not have the discretion to decide to stop recording when a locomotive is not moving. The NTSB stated that safety-sensitive duties frequently occur when locomotives are stationary, and there is no way to limit recordings to only capture safety-related activities. According to the NTSB, by recording anytime the locomotive is powered on, key pre-accident events would be recorded, such as pre-job briefings, and critical post-accident events, such as calling emergency services, would be recorded and available in post-accident analysis. The NTSB also asserted that requiring continuous recording while a locomotive is powered on would help identify those occasions when an employee tampers with or disables a safety device.
In contrast, BLET, SMART, and TTD disagreed with the aforementioned comments as well as FRA's proposal in the NPRM to provide passenger railroads maximum flexibility in determining the run-time/shutoff time for their recording devices. BLET commented that, regardless of whether the recorders are image or audio recorders, they should be shut off and no longer recording when the train's motion has stopped and the brakes are applied. According to BLET, it would be unacceptable if the cameras can still run when a locomotive is stopped and everything over the course of a crew's duty tour would be under analysis by the railroad.
Further, BLET stated that the time when a train has stopped moving is the only time that a crew has available to eat, use the bathroom facilities, or just relax, noting some railroads permit and even encourage napping to mitigate employee fatigue. BLET claimed there are numerous studies that prove if an individual is recorded on camera continually it will increase the individual's stress level, which thereby increases the individual's fatigue. BLET also pointed out that on many occasions, a train crew may have expired under the hours of service laws and simply be waiting to be relieved. BLET asserted that no safety benefits would result from filming and recording these types of non-operational activities.
BLET also expressed concern for train crewmembers' privacy if inward-facing cameras record when no safety-related duties are being performed. BLET commented that cameras could record employees changing their clothing or needing to express breast milk, which BLET believed cannot be safely and perhaps lawfully done in the sanitary compartment.
Finally, BLET asserted that FRA should not only consider a regulatory restriction on the run-time/shutoff for locomotive recording devices but should also address use of the cameras for monitoring employees. Specifically, BLET commented that some railroads have claimed the technological capacity to view the inside of a locomotive cab regardless of whether the camera's output is being recorded. Therefore, according to BLET, not only should railroads be prohibited from recording when a locomotive is stopped, but railroads should also be prohibited from surveilling their employees when a locomotive is stopped and the cameras
SMART and TTD suggested a slightly different standard than that proposed by BLET in that FRA should require railroads to shut off their inward-facing cameras five minutes after a train has stopped. TTD asserted that a five-minute window of additional recording after the train has stopped moving would allow FRA the necessary time to gather post-accident or -incident investigation information, without infringing on the crew's privacy. TTD stated that, in contrast, the standard proposed in the NPRM would allow the railroads to record at all times, even when the train is stopped and the crew is not performing any safety-sensitive duties. TTD asserted that there is no value to recording when trains are stopped, such as at sidings, which occurs with some frequency. Further, TTD agreed with BLET that operating a train is a fatiguing job and that constant filming of train crews will increase tension, and according to SMART, likely also result in “unsafe practices.”
SMART echoed TTD's position that inward-facing cameras should not record when trains are stopped and crews are not performing safety-sensitive activities. Like TTD, SMART pointed out that crews often sit in a siding or at a signal for hours with no safety-related duties being performed. SMART also stated that requiring inward-facing locomotive cameras to stop recording five minutes after a train stops would protect against any personal harassment from the unnecessary recording of personal, but not safety-sensitive information.
However, while both TTD and SMART believed a strict five-minute shutoff standard after a train has stopped moving is necessary for inward-facing image recorders, both organizations specifically stated they did not object to a less prescriptive run-off/shutdown requirement for outward-facing cameras. In fact, they stated that the outward-facing cameras would provide the security benefits cited by APTA and Amtrak, and protect the railroad by helping deter vandalism, theft, and other criminal activities.
After consideration of all comments received on this issue, in this final rule, FRA is adopting the standard it proposed in the NPRM. FRA will not prescribe a mandated run-time/shutoff requirement for passenger locomotive recording devices. As will be discussed in greater detail below in Section II.C, as long as the locomotive's required inward- and outward-facing cameras are recording anytime the locomotive is in motion and the passenger railroad is complying with all other requirements of the final rule described below (
As discussed in the NPRM, the railroad industry is highly regulated, and there are already a large number of Federal statutes and regulations governing railroad employees' performance of safety-related duties when they occupy the cab of a lead locomotive.
FRA also requested and received comments on the potential risk of overwriting valuable recorded data if an accident occurs in a remote location and a locomotive's recording device(s) continue to record after the accident has occurred and the recordings before and during the accident are recorded over. Both the NTSB and APTA submitted comments on this issue.
The NTSB indicated it has found that, in most major accidents, the locomotive loses power, which stops all recording devices and negates the risk of overwriting accident data. However, the NTSB commented that railroads should put procedures in place to preserve recordings in the event of a less severe accident in a remote location where the locomotive does not lose power and the footage could be overwritten.
APTA commented that concerns about passenger trains might be misplaced and pointed out that instead of passenger trains, freight trains are more likely to pass through or stop in remote areas or areas that are potentially harder to access, and have longer one-direction trip-duty times than commuter and, in some cases, intercity passenger trains. APTA stated that commuter trains trip lengths are shorter, and it is not uncommon for a train to travel in one direction leading with a conventional locomotive and then do a reverse trip in the other direction leading with the train's cab car. APTA also maintained that crew on-duty times for commuter and intercity passenger routes are generally shorter and scheduled to minimize any jobs approaching 12 hours on duty so that crews have additional rest before their next trip, and that crews may even change train consists. APTA believed these elements contribute towards reducing the potential for critical video being overwritten in an accident.
In addition, the NTSB commented that FRA should address the issue of buffering in this final rule to ensure that all critical events occurring before an accident occurs are recorded. The NTSB stated that frequently saving data to permanent storage from temporary memory—that is, buffering—will help prevent the loss of audio and images due to accidents and power disruptions, as it has experienced varied success with recording devices capturing the time period before an accident. The NTSB noted that, in the February 8, 2018, CSX Transportation accident in Cayce, South Carolina, the outward-facing image and audio recorder did not record critical events before the accident; instead, the audio stopped
After carefully considering both NTSB's and APTA's comments, FRA has determined it would be premature to create a regulatory requirement for passenger railroads addressing the potential for data being overwritten if an accident occurs in a remote location where there is no loss of power to the recording device, but the memory module is not immediately available. Although FRA agrees that passenger railroads should consider the possibility that commuter or intercity passenger trains could have an accident in a location where the locomotive does not lose power, the footage in the memory module may not be readily retrieved, and the footage could be overwritten, FRA has found no evidence of such a passenger train accident occurring. FRA also agrees with APTA's comment that, overall, passenger trains are far less likely to pass through or stop in remote areas when compared to freight trains. Therefore, lacking evidence of such a passenger train accident or incident occurring, and considering the limited likelihood of such a situation occurring in the future, FRA declines to adopt a regulatory provision specific to the risk of data being overwritten in such a scenario.
FRA received numerous comments stating that locomotive image recording devices previously installed or ordered before the publication date of the final rule should be excluded from complying with the final rule's requirements. For reasons discussed below, FRA disagrees with the comments and will not allow previously installed or ordered locomotive image recording devices or voluntarily installed audio recording devices to be excluded from this final rule's coverage. Instead, as proposed in the NPRM, this final rule provides passenger railroads with a four-year implementation period within which all of their lead locomotives must be brought into compliance with the rule's requirements.
APTA commented that FRA should allow exclusions for recording devices that have been installed or are in the process of being installed prior to the issuance of the final rule. APTA asserted that if FRA does not exclude these devices, there is a strong possibility that railroads that were early adopters of locomotive recording device technology will be financially penalized because the proposed requirements for image recorders would be too prescriptive and older locomotive recording devices could not comply. APTA also maintained that the cost to retrofit existing lead locomotives would be significant and could delay the availability of data for use by the passenger railroads as well as FRA and the NTSB for post-accident investigations. APTA stated that 76 percent of passenger locomotives already have image recording devices installed and that 93 percent of passenger railroads have installed image recording devices in all of their vehicles, or are in the process of doing so, and that “a few large railroads” equipped, or partially equipped, their fleets with recording devices within the last year. Given APTA's assumption that locomotive image recording systems have a life span of eight years, APTA believed that these railroads will lose most of the full life-cycle of the recording devices if FRA does not include an exclusion clause in this final rule.
AAR also agreed that FRA should include an exclusion provision to protect early adopters of this technology. According to AAR, during the 2014 RSAC Working Group meetings FRA proposed that recording systems installed on locomotives prior to the rule's effective date would be considered compliant for ten years from the final rule's publication date, with the exception that memory modules would be required to meet the crashworthiness requirements within three years of publication. AAR therefore suggested that recording systems installed prior to the final rule's publication date be considered compliant until ten years from that date, whether or not all of the functional requirements of the rule were met by the already-installed system.
The North Country Transit District (NCTD), which operates the COASTER commuter rail service in Northern San Diego County, California, suggested that the final rule should exclude locomotive recording devices that were installed prior to the effective date of the final rule and do not meet the crashworthy memory module requirements. NCTD stated it began installing inward- and outward-facing cameras with audio recorders in 2012 and had just completed a global replacement of cameras and recording devices on its entire locomotive and cab car fleet.
Finally, the Commuter Rail Division of the Illinois Regional Transportation Authority (Metra) also agreed with many of the same comments that passenger railroads have already begun to utilize recording equipment and, therefore, FRA should allow existing equipment to continue to be used to avoid punishing early adopters of the technology.
Although FRA appreciates the concerns raised by the commenters, FRA does not believe it in the public's interest or the interest of rail safety to provide an exception from the final rule's requirements for locomotive image recorders installed prior to the rule's publication date. Older cameras that do not meet the final rule's requirements would likely not provide the benefits (deterrence and accident investigation) that the rule seeks to provide. As discussed above, the Cayce accident is a prime example of how accident investigations could be adversely affected by use of older camera systems, because external locomotive image (and audio) data was lost in the accident. Under the requirements of this final rule, locomotive recordings must now be stored on a certified crashworthy memory module as required by the FAST Act, or an alternative remote storage system approved by FRA. If FRA were to exempt older image recording systems from the requirements of this final rule, it would increase the likelihood of more vital accident data being lost by use of non-compliant systems. Four years is an adequate time for passenger railroads with installed or currently ordered locomotive recording systems to get remaining value out of the recording systems without unduly putting value maximization of current locomotive recording systems above passenger rail safety. In addition, the NTSB has supported FRA's four-year implementation period as encouraging prompt implementation of the final rule's requirements. As stated above and in the NTSB's comment, the NTSB's report from the DuPont accident showed there is a clear investigative benefit to the information obtained from locomotive recording devices. According to the NTSB, “any further delays beyond the proposed 4-year deadline would be unacceptable,” given NTSB issued Safety Recommendation R-10-01 in 2010.
Passenger locomotive image recorders that do not meet the final rule's requirements might not be sufficient to identify railroad safety violations as well as provide adequate data for post-
FRA received numerous comments about the proposed requirement to store locomotive recorder data on a certified crashworthy event recorder memory module and potential alternatives to meet an appropriate crashworthiness level to protect stored locomotive image recording system data. APTA stated that a crashworthy memory module is unnecessary due to the installation of positive train control (PTC) on passenger railroads, which will eliminate most of the accidents that FRA cited in the NPRM, and that passenger railroads believe crashworthy memory retention could be achieved by simply positioning the recording devices in an area to minimize impact forces. However, APTA supported FRA's suggestion to provide waivers for the memory module's crashworthiness when the recording is transmitted to a remote location, stating the technology surrounding image recordings is advancing more quickly than the rulemaking process, and encouraged FRA to consider waivers for remote storage options in lieu of crashworthiness standards.
Wi-Tronix raised concerns that some of the proposed requirements for inward- and outward-facing cameras, such as the 12 hours of required storage together with the crashworthy memory module requirement, added unnecessary costs to railroads without a justification. Understanding the final rule's need for data preservation, Wi-Tronix asserted there are other technical approaches that could accomplish the same goals on a more cost-effective basis, stating that cloud solutions accomplish the same data retention and have the potential to be more economical while creating other value in the process.
Conversely, both the NTSB and SMART supported the proposed crashworthy memory module requirement. In addition, BLET commented that the paramount consideration and goal of the final rule should be a uniformity of standards throughout the whole railroad industry, whether locomotive recording devices be required by the Statute or voluntarily installed. Therefore, BLET believed it makes logical and economic sense to store all forms of recorder operational data (
FRA also received comments about exempting from the crashworthy memory module requirement those systems that can store locomotive recorder data safely and remotely. As previously stated, APTA commented that FRA should avoid mandating onboard locomotive storage of data in favor of more flexible storage options for passenger railroads, including cloud or remote storage. Hitachi, Ltd. (Hitachi) agreed with APTA that remote storage should be allowed and recommended that the rule avoid mandating onboard crashworthy memory storage for locomotive recording data. Hitachi stated that image processing and data communications technology has matured in transmitting real-time images to be stored and analyzed remotely at centralized locations, and thus the final rule should avoid mandating onboard locomotive storage in favor of remote storage options that make more economic sense for the railroad.
The NTSB, however, disagreed with exempting locomotive recorders from crashworthiness requirements even when the recording system is designed to immediately transmit and store data at a remote location. The NTSB asserted the exemption would risk the loss of data when an accident occurs in an area where data cannot be reliably transmitted, such as in tunnels or remote regions. BLET also commented that wireless transmission and storage of locomotive audio or image data should be prohibited to prevent private, personal data from being hacked.
In response to these comments, FRA emphasizes that the requirements for crash and fire protection of in-cab recordings—
For FRA to approve use of a locomotive recording device system that only uses remote storage for its recorded data, the passenger railroad must show conclusively how the remote storage system provides at least equivalent data protections to those provided by use of a certified crashworthy memory module under appendix D to part 229. Specifically, the railroad must describe how all of the data will be reliably and securely transferred to the cloud or other remote storage location and how that data will be reliably and securely stored and retrievable. The railroad must also show how the reliable and secure transfer of all locomotive image recording device data to a remote storage location will occur under a variety of situations, including situations involving accidents and/or incidents (especially in outlying or remote areas), system failures, or other similar contingencies. FRA will not approve the use of any locomotive
Freight railroads that have voluntarily installed or are planning to voluntarily install inward- or outward-facing recording devices on their locomotives are not required to store the data on a certified crashworthy event recorder memory module. However, FRA recommends that if a freight railroad chooses to use a memory module, it should mount and position the module in such a way as to provide the module with maximum protection.
FRA understands the NTSB's preference for stricter recorder survivability standards. The NTSB has recommended FRA require event recorder data to be also recorded in another location remote from the lead locomotive(s) to minimize the likelihood of data destruction in an accident, as has occurred in certain accidents (NTSB Safety Recommendation R-13-22).
As discussed in the NPRM, the railroad accidents that led NTSB to issue recommendations related to locomotive image and audio recording devices were caused by human factors—and nearly all were PTC-preventable. Thus, given the full implementation of PTC systems on intercity passenger and commuter railroad main lines, the likelihood of similar accidents occurring should be greatly reduced, if not eliminated. In turn, the need should diminish for more stringent crashworthy memory module requirements to preserve image and audio recordings for use to investigate accidents resulting from human factor causes on main track.
Memory modules are acceptable that meet the specified performance criteria in either Table 1 or Table 2 of section C, appendix D to part 229. As FRA discussed in the rulemaking promulgating the crashworthy memory module standards, each set of criteria in Tables 1 and 2 is a performance standard, and FRA has not included any specific test procedures to achieve the required level of performance. FRA did not believe it necessary to include specific testing criteria in the regulation, as the rail industry and equipment manufacturers are in the best position to determine the exact way they will test for the specified performance parameters.
APTA commented that it was opposed to requiring recordings from voluntarily installed recording devices to be stored on a certified crashworthy memory module under part 229, appendix D. FRA does not agree. Although this final rule does not require passenger railroads to install locomotive audio recorders, because installing such devices is not required by the FAST Act, if passenger railroads voluntarily install audio recording devices, the data recorded must be maintained on a crashworthy memory module to ensure the data is available for use by FRA as well as other Federal agencies (and railroads themselves) to conduct effective post-accident/incident investigations and more accurately determine the causes of accidents/incidents. Accordingly, § 229.136(a)(5) requires any passenger locomotive recording device data, whether image or audio data, to be recorded on a certified crashworthy memory module as described in part 229, appendix D, or on an alternative, remote storage system, as approved by FRA. For further discussion on this final rule's accident/incident preservation requirements for locomotive recording devices, please see the discussion under § 229.136(f) in this rule's Section-by-Section Analysis.
APTA expressed concern about the proposal to require aligning an outward-facing locomotive image recording device to point parallel to the centerline of tangent track on which the lead locomotive is traveling. APTA believed the proposal would require mounting the camera within the gauge of the track and stated that, because many locomotive designs have center collision posts or center doors, the cameras may need to be mounted on the side of the locomotive and be aimed towards the center of the track. APTA therefore requested the rule be clarified accordingly to permit such camera placement.
However, the rule text needs no such clarification because this rule does not require outward-facing image recording devices to be mounted on the centerline of a passenger locomotive. FRA recognizes that cab car and multiple-unit (MU) passenger locomotives have features that may inhibit the placement of cameras on the centerline, and FRA never intended to require cameras to be mounted on the centerline. The rule requires cameras to be aimed “parallel” to the centerline of tangent track, wherever the cameras may be placed on the leading end of the locomotive, and FRA is adopting the proposed rule text without change.
APTA commented that requiring outward-facing locomotive image recorders to be able to distinguish the signal aspects displayed by wayside signals, as proposed in the NPRM, would be too prescriptive and overcomplicate the outward-facing camera system. APTA preferred a more performance-based standard, and added there are multiple environmental factors that affect the image quality of outward-facing camera footage that are not within the railroad's control. APTA also stated that the proposed standard to record at 15 frames per second (fps) and the proposed resolution requirement are vague and would make design compliance subject to many factors that would increase costs. APTA therefore offered alternative language allowing the railroads to determine the frame rate and resolution for their locomotives' outward-facing cameras. Similarly, Wi-Tronix asserted that basing the resolution requirement for outward-facing cameras upon whether a system
TTD commented that it did not object to less prescriptive requirements on outward-facing cameras for the purposes of preventing vandalism, theft, or other criminal activity. However, BLET supported more prescriptive requirements for outward-facing locomotive image recording devices, commenting that it favored requiring locomotive recordings to have an accurate date/time stamp calibrated to coincide with the date/time stamp on the lead locomotive's event recorder. BLET stated that investigative efforts would be hampered, instead of facilitated, if such a requirement were not adopted.
Finally, Metra commented that FRA should permit flexibility in the selection and implementing of railroads' locomotive image and audio recording systems. Specifically, Metra stated that if the systems meet the technical requirements, railroads should have leeway to determine the type and model of recording system used and what sound audio recording systems will capture (
After consideration of all comments received, FRA is adopting the requirements for outward-facing locomotive image recording devices in § 229.136(b)(1) as proposed in the NPRM. FRA understands concerns that certain requirements for outward-facing cameras are prescriptive; however, this was FRA's intention. As compared to the defined space inside a locomotive cab, the area outside and ahead of a locomotive is vast and unbounded. Consequently, establishing certain, more prescriptive, uniform performance parameters helps ensure that image recordings conform to minimum standards necessary for reliable, post-accident/incident investigation. A more performance-based approach risks potential variances and omission of necessary data. However, FRA makes clear that these standards are minimum standards, and passenger railroads do have considerable discretion as to how they want their outward-facing locomotive cameras to operate and record data.
In the NPRM, FRA discussed the possibility of inward-facing image recorders being a tool to identify fatigue, prevent fatigue-related accidents/incidents, and identify when fatigue has been a relevant factor in an accident/incident. However, APTA commented that relying on image data as a fatigue-mitigation tool has limited application, stating it is unclear what criteria the industry would use to determine when an employee is fatigued and that such analysis on the part of the railroad could be subjective.
This final rule requires the inward-facing image recording systems to have sufficient resolution only “to record crewmember actions”; FRA has not adopted the proposed text specifically addressing crewmember incapacitation. FRA is still hopeful that inward-facing locomotive cameras can be helpful devices to determine whether fatigue may have caused or contributed to an accident or incident. However, FRA agrees that requiring passenger railroad to make a determination that their inward-facing locomotive image recording systems have sufficient resolution to identify whether a crewmember is physically incapacitated is too subjective a standard.
APTA sought clarification whether the proposal implied that passenger railroads must conduct real-time monitoring of their locomotive cabs. According to APTA, the passenger railroad industry does not support real-time monitoring and, if remote monitoring is added as a requirement, FRA would need to significantly adjust its cost burden estimates to account for staffing and other increased costs of such monitoring. As discussed in the Section-by-Section analysis below, FRA has not adopted the proposed language that APTA believed may imply a requirement to engage in real-time monitoring of the train crew. FRA intended no such requirement.
APTA suggested changes to the proposal in § 229.136(c)(1) that the inward-facing recording system be positioned to provide “complete coverage of all areas of the controlling locomotive cab where a crewmember typically may be positioned.” APTA commented that the proposal was too prescriptive, stating that multiple designs of locomotives would require various solutions and therefore the devices should be positioned to provide coverage of areas of the controlling locomotive cab as defined by the operating railroad.
Similarly, SMART disagreed with requiring the inward-facing image recorders to provide “complete” coverage of the locomotive cab, and instead suggested that the standard should provide for “overall” coverage. SMART acknowledged that an inward-facing locomotive image recording device must be positioned to provide coverage of the controlling locomotive, but believed requiring “complete” coverage might be overly broad and imply coverage to include every minute area of the locomotive.
In general, the requirement to provide “complete” coverage is intended to ensure that the recording system not omit footage of crewmember actions in any part of the locomotive cab that might be vital in post-accident/incident investigations.
APTA opposed including the language in proposed paragraph § 229.136(c)(1)(ii) (now in (c)(1)(iii)) requiring recording systems to automatically switch to infrared or another operating mode that enables the recording to have sufficient clarity when ambient light levels drop too low for
FRA disagrees that the proposed requirement for a recording system to switch to another operating mode to enable effective recording when ambient light levels are too low for normal operation is overly prescriptive. As proposed, the camera system may use any operating mode that enables the passenger railroad to record with sufficient clarity all areas of the lead locomotive cab where a crewmember typically may be positioned. Infrared technology is one way of meeting this requirement, but the use of infrared technology is not required. This is a key requirement, however, to ensure that regardless of the technology used to record inside the locomotive cab at nighttime or in other periods of low ambient light (
In addition, BLET commented that locomotive technologies are already excessively distracting to crewmembers, there is no need for additional distractions, and cameras or independent light sources should never emit any light that distracts the crew from safely performing their duties or interferes with the crew's vision outside the locomotive window. APTA also stated that a crew should always be able to use the locomotive's sun visor to block direct sunlight that could affect the crew's sight and the identification of signals or other objects outside of the locomotive cab windows.
Existing FRA regulations provide that any illumination in low-light conditions cannot interfere with a crew's vision (49 CFR 229.127(a)), and the placement of image recording devices cannot obstruct a crew's view of the right-of-way from its normal positions in the cab (49 CFR 229.119(b)). The use of infrared technology itself is not a distraction to crewmembers and should be installed on a locomotive so it does not interfere with the ability of crewmembers to safely perform their duties. In addition, although FRA does agree that train crews should be able to use the locomotive's sun visor to block direct sunlight that could affect the crews' vision, FRA cautions railroads to not place the inward-facing cameras in such a way that they can be blocked by the train crew's use of the locomotive visor.
APTA commented that it supported the proposed standard to require inward-facing recording devices to record at a frame rate of at least 5 fps. In contrast, BLET commented that 5 fps could be too low a frame rate for use during accident reconstruction if the pictures are not fluid enough to capture action as it happens at the speed it happens. Although BLET understood that allowing inward-facing image recorders to record at a lower frame rate enabled passenger railroads to store more image data at a lower expense, BLET was concerned that the frame rate could create synchronization inaccuracies when the video and audio are captured or played back at different rates. Therefore, BLET stressed that the final rule should specify a frame rate that will prevent these types of inaccuracies.
The NTSB agreed with BLET that a recording rate of 5 fps was not sufficient for inward-facing image recorders. According to the NTSB, because locomotive operating compartments contain numerous indicator lights and displays, cameras recording at 5 fps may not adequately capture possible intermittent warnings or indicator lights. The NTSB stated that it was not aware of any memory limitations that would necessitate such a low frame rate and, instead, recommended at least a 10-fps recording rate for inward-facing image recorders.
FRA understands the concerns raised by BLET and the NTSB. However, FRA is adopting 5 fps as the minimum standard to provide passenger railroads maximum flexibility to comply with the requirements of this final rule. As previously discussed in the NPRM as well as below, a rate of 5 fps is APTA's recommended practice for the selection of recording systems for use in transit-related closed circuit television recording systems and in low-traffic areas or areas where only walking-pace motion is likely (such as passenger areas). Moreover, this frame rate is only a minimum standard. For instance, FRA expects that some passenger railroads may install inward-facing recording systems with a higher frame rate to enhance the use of the devices for operational testing. In addition, under paragraph § 229.136(g), discussed below in the Section-by-Section Analysis, passenger railroads must provide a written description of the technical aspects of any locomotive image recording system installed to comply with this section. Under § 229.136(c)(1)(i), FRA will not approve an image recording system that does not have “sufficient resolution to record crewmember actions,” even if the system records at a minimum frame rate of 5 fps. As a result, recording systems that cannot accurately provide information or sufficiently record what is occurring within the locomotive cab will not be approved prior to installation.
BLET and SMART both supported the proposed requirement that inward-facing locomotive cameras may not record any activity within a locomotive's sanitation compartment as defined in § 229.5, and that no image recording device be installed in a location where the device could record activities within the locomotive's sanitation compartment. Although the Supreme Court has ruled that a locomotive is a workplace and therefore employees have no expectation of privacy,
FRA received several comments in response to what, if any, notice passenger railroad crewmembers should receive that locomotive recording devices are present in the locomotive cab. APTA commented that its member passenger railroads have already addressed this issue by providing information using operational notices to affected employees. APTA also added, as discussed above, that courts, including the Supreme Court, have ruled that a locomotive is a workplace and employees have no expectation of privacy within it. In contrast to APTA's comment, Amtrak stated that providing notice by Form FRA F 6180-49A alone, as proposed in the NPRM, was inadequate because it could in practice limit who sees the information. Instead, Amtrak recommended that FRA require signage alerting the crew that audio-visual recording devices are present. SMART agreed with Amtrak's comment
Because as noted above, crewmembers have no expectation of privacy in a locomotive cab, excluding the sanitation compartment, FRA has concluded that although it proposed to provide notice of recording devices to crewmembers via a notation on Form F 6180-49A (Locomotive Inspection and Repair Record), such notice is not required as a matter of privacy concerns. Therefore, FRA will not require railroads to post signage alerting crewmembers that audio-visual recording devices are present.
However, the value of requiring the presence of a locomotive recording device to be noted on a locomotive inspection and repair record, similar to § 229.135(a)'s requirement for locomotive event recorders, is to ensure that the device is inspected and in proper operating condition as this rule requires. In this regard, as discussed below in Section II.I.3, when a railroad removes a locomotive image recording device from service, a qualified person must record the date the device was removed from service on Form FRA F 6180-49AP (Passenger Locomotive Inspection and Repair Record). This requirement varies slightly from the requirement proposed in the NPRM, where FRA proposed that the notation indicating a locomotive image recording device has been removed from service be made under the REMARKS section of Form F 6180-49A. This is no longer the case. Instead, FRA has created a new form, Form F 6180-49AP, specifically for passenger locomotives.
As discussed below in the section-by-section analysis for new § 229.22, Passenger locomotive inspection and repair record, Form F 6180-49AP will serve as the new counterpart to Form F 6180-49A, and will include a designated row for entering information about annual testing of locomotive image recording devices required under § 229.136, consistent with the designated row on Form F 6180-49A (as well as new Form F 6180-49AP) for entering information about required locomotive event recorder testing. FRA makes clear that this new form will in no way affect use of the F 6180-49A form by locomotives in freight or switching service, which are not subject to the requirements of this rule, nor will it affect use of the F 6180-49A form by passenger locomotives that are not used as the lead locomotives in commuter or intercity passenger train service.
Further, FRA understands and does not dispute the legal precedent raised by APTA that locomotives are highly regulated workplaces, and employees have no expectation of privacy while performing, or ready to perform, operating duties within a locomotive. The only area where train crews do have an expectation of privacy is within a locomotive's sanitation compartment, treatment of which is discussed above in Section II.G.
FRA received several comments on the appropriateness of the standard in proposed § 229.136(i) that would require inward- and outward-facing locomotive image recording devices to be repaired or replaced at the next calendar day inspection or be removed from service. Many commenters claimed the standard was too burdensome and should be revised. APTA asserted that requiring these systems to be repaired or replaced by the next calendar day inspection is impractical, stating that locomotive image recording systems can fail for many different reasons, and repairs can sometimes take several days. According to APTA, the passenger railroad industry has limited fleet availability and restricting locomotives or trainsets due to locomotive image recording system failures alone could have a substantial impact on dispatching trains, potentially taking an entire trainset out of service when the cars are semi-permanently coupled. APTA contended that the proposed standard was financially unrealistic and, if adopted, would require the industry to obtain additional locomotives or trainsets, driving up the cost of the final rule and significantly affecting the rule's cost-benefit analysis. APTA stated that the Statute prevents FRA from adopting a standard that “requir[es] a railroad carrier to cease or restrict operations upon a technical failure of an inward- or outward-facing image recording device or in-cab audio device,”
Metra agreed with APTA's assertion that FRA's proposed standard conflicted with the Statute. Metra suggested that FRA should interpret “as soon as practicable” under the Statute to mean 48 hours at a minimum. Metra stated that, because the locomotive recording systems it uses require substantial investment in both money and workforce any requirement to repair or replace non-functioning equipment that provides for less than 48 hours is not practicable. In its comments, AAR agreed with Metra that “as soon as practicable” should be at least 48 hours from the discovery that the device has failed, citing the cost of image recording devices, the multitude of components that could cause the device to fail, and the inevitability of tampering.
Amtrak also commented on the appropriateness of FRA's proposal and suggested basing the standard on the “next capable facility” rather than on a specific unit of time. According to Amtrak, long-distance passenger trains may operate for multiple days until a suitable repair facility is available to replace equipment and often calendar day inspections are performed at outlying locations where minimal workforces do not have the suitable means to replace equipment. Amtrak believed a requirement to repair the equipment at the next capable facility would address this concern, and that this standard should apply to both inward- and outward-facing locomotive cameras.
A private citizen also commented that, in some situations, passenger trains are parked overnight far from comprehensive repair facilities. The commenter therefore believed there should be an allowance for locomotive recording devices to make it back to an appropriate repair facility without cancellation or delays to passenger trains. The commenter stated that ultimately the use and repair of the devices should not force passengers into less safe situations by requiring them to drive instead of taking the train, given that rail is a safer mode of travel.
However, not all commenters objected to FRA's proposed standard. BLET stated that locomotive cameras should be treated the same as any device mounted on or in a locomotive cab, asserting that locomotive cameras are appurtenances under § 229.7 and should be treated in a similar fashion to event
FRA agrees with BLET's reasoning and is largely adopting the standard proposed in the NPRM that all inward- and outward-facing image recording devices either need to be repaired or replaced within the next calendar day inspection or be removed from service. However, after consideration and review of the comments received, FRA reexamined how this requirement would affect long-distance intercity passenger trains and is creating a new exception to the requirement for these trains. Instead of taking a lead locomotive on a long-distance intercity passenger train out of service if it cannot be repaired or replaced by the next calendar-day inspection, the locomotive may continue in service until arrival at its destination terminal or its nearest forward point of repair, whichever occurs first. At that point, the locomotive must be taken out of service until the device is repaired or replaced.
FRA determined an exception for long-distance intercity passenger trains was necessary, taking into further account the implications of the difference between the application of this final rule and the locomotive event recorder rule in § 229.135. Section 229.135 requires locomotive event recorders to be installed on both freight and passenger locomotives, yet this final rule requires locomotive image recording devices to be installed only on passenger train lead locomotives. Because a much smaller number of locomotives will be required to have compliant image recording devices than event recorders, FRA expects there will be a correspondingly smaller number of locations throughout the nation where properly equipped replacement locomotives and image recording devices are available, as well as where appropriate parts and equipment for repair are available. Accordingly, long-distance intercity passenger trains may need to travel beyond the location of their next calendar day inspection until a suitable repair facility is available to repair or replace the equipment, especially because calendar day inspections for long-distance intercity passenger trains are sometimes performed at outlying locations, as Amtrak commented.
This exception is limited to long-distance intercity passenger trains. The majority of passenger locomotives in this Nation operate in commuter service or short-distance intercity passenger service
Hitachi commented that allowing a passenger train to continue in operation without the proper image recording capabilities until the next calendar day inspection conflicts with FRA's defining locomotive recording devices as a safety device under part 218. FRA disagrees that there is a contradiction. Taking a locomotive out of service immediately because a safety device (
APTA commented that when a railroad removes a locomotive image recording device from service, the final rule should not require a qualified person to record the removal date on Form FRA F 6180-49A, under the REMARKS section. As discussed above in Section II.H, APTA repeated its objection to the NPRM's proposed requirement that the railroad note the presence of any image or audio recording system on Form FRA F 6180-49A. APTA stated that passenger railroads already address the issue by providing information to affected employees through operational notices. In addition, APTA believed adding this paperwork burden is not beneficial to safety, and claimed that FRA has not considered this cost in its cost-benefit analysis.
Although FRA agrees with established legal precedent that train crews have no expectation of privacy in a locomotive cab, excluding the sanitation compartment, FRA disagrees that this form notation requirement is a paperwork burden without a safety benefit. As discussed above in Section II.H, passenger railroads will be required to note in the REMARKS section of new Form FRA F 6180-49AP, specifically for passenger locomotives, when an image recording device has been removed from service. This notation will serve as a quick reference to inform crewmembers and other passenger railroad employees (
In its comments, Amtrak asserted that a notation on form FRA F 6180-49A is not sufficient notice that a locomotive's inward- or outward-facing camera is out-of-service. Instead, Amtrak recommended making a record in an electronic maintenance system and opening a work order for repair, along with applying a non-compliant tag on the equipment. Amtrak stated such a process would be similar to that for the failure of dynamic brakes under § 232.109 of this chapter.
FRA maintains that the requirement as proposed is adequate to provide notice that either the locomotive's inward- or outward-facing camera system is malfunctioning. Moreover, the reporting of any defect on a locomotive is subject to the calendar day inspection requirements in § 229.21. However, part 229 does not require a non-compliant tag to be placed on a locomotive with a defective event recorder under § 229.135, and no such tag is required under this final rule.
In response to FRA's proposal, APTA questioned why an approval process
FRA has not adopted APTA's comment. The Statute requires FRA, as the Secretary's delegate, to establish a review and approval process for inward- and outward-facing locomotive image recorders.
In commenting on proposed § 229.136(g), Wi-Tronix stated that the approval process for locomotive recording devices needed clarification. According to Wi-Tronix, the proposed requirements would lead to confusion and delays in the marketplace because railroads often look for a certified product or service and have little desire to go through an additional certification process. Wi-Tronix requested FRA clarify whether suppliers can self-submit a system for approval, and believed the timelines and process (including each railroad needing separate certification) to be commercially impractical and lead to increased costs and slow the rule's implementation.
Separately, Amtrak requested changing the approval process submission timeframes, citing constraints due to clerical limitations and the logistics of acquiring equipment. Amtrak stated that a more realistic and achievable timeframe would be 90 days for existing systems and 180 days for proposed systems.
FRA disagrees that the approval process is unclear. Section 229.136(g)(1) explains what a passenger railroad must include in its description of the technical aspects of the locomotive image recording system. Although the paragraph does not provide extensive technical detail, FRA does not consider this to be a limitation but rather to provide the passenger railroads flexibility in preparing their submissions.
FRA also believes 60 days from the effective date of this final rule provides railroads sufficient time to prepare and submit descriptions of the technical aspects of their existing locomotive image recording systems. (Please note that the 60-day period after the final rule's effective date reflects an earlier effective date than indicated in the NPRM, so that the overall length of the submission period is the same.) This final rule takes effect on November 13, 2023, which is 30 days after publication of this final rule. Accordingly, railroads have a total of 90 days from this final rule's publication to prepare and submit descriptions of the technical aspects of their existing locomotive image recording systems. Such description of the technical aspects may be submitted to FRA in electronic form.
In this final rule, FRA is also correcting an error in proposed § 229.136(g)(2) in which FRA stated that the submissions for existing systems must be made “not less than” 30 (now 60) days after the effective date of the final rule. However, the explanation of this proposed paragraph in the NPRM's Section-by-Section Analysis did correctly state that the submissions must be made “not more than” 30 (now 60) days after the effective date of a final rule. FRA is correcting the erroneous language in the text of paragraph (g)(2) accordingly, as railroads are not required to wait until the end of the period to make their submissions. FRA is also revising the approval process in this final rule to make clear affirmative approval from FRA will be required before a passenger railroad's inward- or outward-facing locomotive image recording system can be installed or placed into service. This is a change from the proposal in the NPRM that, in the absence of written disapproval from FRA within 90 days of FRA's receipt of the submission, the railroad's locomotive image recording system would be considered approved. FRA has concluded that a transparent and conclusive approval process is required, and it would not be in the public's interest to allow for the possibility that a non-compliant system could be approved through unexpected events or inadvertence. At the same time, FRA plans to publish a list of any previously approved systems on its website for railroads' convenience, as FRA noted in the NPRM.
Because this final rule requires FRA's affirmative approval before a locomotive image recording system can be installed or placed into service on a locomotive, if a railroad chooses to submit the required information 180 days before installation of these systems, consistent with Amtrak's comment, FRA would not object. In fact, as a practical matter, FRA encourages railroads to make their submissions well in advance of the submission deadline, so that if the submission were incomplete or requires clarification, or if FRA were to disapprove any or all of a railroad's submission, the railroad could timely respond to minimize, if not avoid altogether, any impact on the railroad's proposed installation schedule or the use of railroad resources.
Finally, in response to Wi-Tronix's comment, the submission must come from the applying passenger railroad, as opposed to a supplier or other party, though it may of course be prepared in consultation with a supplier or other party. This is necessary as each railroad may use potentially different types of locomotives with different internal and external characteristics. How each passenger railroad complies with the requirements of § 229.136, such as (but not limited to) how the inward- and outward-facing locomotive cameras are installed or placed, is for the passenger railroad to describe and demonstrate.
Finally, similar to other comments BLET made on the NPRM, BLET stated that the requirements of § 229.136(g) should apply whether a system is installed on a voluntary basis or mandated by law. FRA disagrees. As discussed previously, the requirements of this rulemaking do not apply to freight locomotives that have or will have installed locomotive image recorders. However, FRA expects that all railroads that voluntarily install recording devices on their locomotives will adhere to practices that are consistent with those in this final rule, and FRA invites parties with questions about the voluntary installation of recording devices on locomotives to contact FRA for such technical assistance.
FRA received several comments about the proposed four-year implementation period within which all lead passenger train locomotives in commuter or intercity passenger service would be required to be equipped with compliant inward- and outward-facing image recording devices. Commenters provided different suggestions on how FRA should set the implementation date for the final rule. APTA stated that if FRA would not exclude from the final rule existing locomotives already equipped with recording devices, the rule should take effect 10 years from its publication date. APTA believed the 10-year period would allow passenger railroads to obtain the full, life-cycle value of locomotive image recording systems installed or soon to be installed,
Metra suggested that FRA phase-in the requirements with an 8-year implementation period in which passenger railroads have 70 percent of their locomotive fleets compliant within the first 5 years. Metra stated that it was generally supportive of FRA's implementation requirement, but found the proposed 4-year timeframe to be insufficient for an entity the size of Metra, which has over 529 pieces of equipment requiring installation.
Other commenters supported the proposed 4-year implementation period. The NTSB stated that the deadline would encourage prompt implementation of the final rule's requirements. As the NTSB discussed in its report on the DuPont accident, and as discussed earlier in this final rule, there is a clear investigative benefit to the information provided by locomotive recording devices. The NTSB also noted that it had issued NTSB Safety Recommendation R-10-01 in 2010, on the need for locomotive recorder devices, and that any further delay beyond the proposed deadline in the NPRM would be unacceptable. SMART also commented that the final rule should allow 4 years for passenger railroads to install compliant recording devices, but sought to require that as compliant devices are installed on locomotives, railroads should comply with the other requirements of the final rule.
FRA maintains that 4 years is an adequate time-period for passenger railroads to comply with the final rule's requirements. Granting passenger railroads a full 10 years or a phased-in 8 years to comply with the minimum requirements would be both excessive and not in the best interests of the public or rail safety. As the NTSB commented, recent accidents involving passenger trains have proven how valuable locomotive image recordings can be as part of post-accident/incident analysis to identify rail safety hazards. The 4-year period allows passenger railroads sufficient time to get significant remaining value out of their equipment while taking into account the increased post-accident investigation benefit and other benefits that result from compliance with the final rule's requirements.
FRA invited comment on the appropriateness of the proposal that image recording systems installed after one year from the final rule's publication date on new, remanufactured, or existing locomotives used in commuter or intercity passenger service meet the requirements of this final rule. Based on concerns about the length of the public procurement process, number of locomotives already equipped with image recording devices, and the lifespan of these devices, APTA and Hitachi asked that FRA extend the time to comply until after two years from the final rule's publication date.
FRA has decided against extending the time from one to two years because the one-year period is intended to provide an appropriate margin of time for passenger railroads to obtain image recording systems compliant with the requirements of this final rule for installation on new, remanufactured, and existing locomotives. These requirements are minimum standards and are achievable. In this regard, AAR commented that FRA should compare the standards in this rulemaking with the May 29, 2019, standards proposed by Transport Canada to prevent conflicting requirements between Canada and the United States.
In the NPRM, FRA discussed the potential benefits to railroads that use locomotive recording devices as part of their operational (efficiency) testing programs and proposed requirements for railroads choosing to use locomotive recording devices to conduct operational testing under part 217, to protect employees from targeted testing as a form of retaliation. FRA received various comments regarding FRA's proposed amendments to part 217, and the agency's existing operational testing requirements.
AAR commented that because existing part 217 applies to both passenger and freight railroads, FRA's proposed revisions to § 217.9 (proposed new paragraphs (b)(3) and (4) governing operational testing using locomotive recording devices) would apply to both types of railroads. AAR noted that FRA's stated intent in the NPRM's preamble was that these provisions would apply to passenger railroads only. Accordingly, AAR suggested that FRA modify proposed paragraphs (b)(3) and (4) to specify that the paragraphs apply to passenger railroads only.
AAR is correct. FRA did not intend proposed new paragraphs (b)(3) and (4) to apply to freight railroads. Therefore, in this final rule, FRA is clarifying its intent to exclude freight railroads from these requirements by using the word “passenger railroad,” instead of “railroad,” in new paragraphs (b)(3) and (4) of §§ 217.9. However, as discussed above in Section II.A.2, it is FRA's expectation that all railroads that voluntarily install recording devices on their locomotives will adhere to practices that are consistent with those in this final rule, notably the new part 217 requirements that serve to protect employees from targeted testing as a form of retaliation when railroads
APTA commented that FRA should not adopt in this final rule any of the requirements FRA proposed to add to § 217.9 because the regular monitoring of image recordings does not need to be under or part of a railroad's operational testing program. Instead, APTA asserted that passenger railroads should be allowed to establish their own practices to monitor employees' compliance with rules and deter them from unsafe actions. APTA also contended that the additional burdens from the requirements FRA proposed may incentivize railroads not to use recording devices in operational testing and therefore reduce one of the benefits of this rulemaking.
In addition, APTA claimed that requiring test subjects for operational testing using locomotive recorders to be selected at random would create an unnecessary cost and burden for passenger railroads, because the ability to use cameras in the railroads' current operational testing plans already exists and this cost was not considered in the NPRM's cost estimate. Finally, APTA objected to FRA's proposed condition that operational testing be completed within 72 hours of the completion of the tested employee's tour of duty, calling it impractical and indicating that such is allowed when testing for radio rules compliance.
FRA disagrees with APTA's comment that the regular monitoring of locomotive recordings does not need to be under a railroad's operational testing program or that passenger railroads should be allowed to establish their own plans and practices to monitor employees using these recordings. Section 20168(i) of the Statute prevents in-cab audio or image recordings from being used to retaliate against an employee. New § 217.9(b)(3) requires passenger railroads to describe how they will randomly select testing subjects, better enabling FRA to oversee that passenger railroads are fulfilling the requirements and railroad supervisors are not unfairly selecting specific employees for operational testing as a form of retaliation. FRA is including in-cab audio recorders and their recordings under paragraph (b)(3), as previously discussed. It does not make sense to require passenger railroads to select their operational testing subjects randomly when using image recorders or their recordings without applying the same protections to the use of audio recorders and their recordings.
FRA disagrees that the limitations on operational testing will cause passenger railroads to abandon using these devices for operational testing purposes altogether. APTA's assertion that any costs associated with these limitations are unnecessary is flawed, in part because the Statute itself prohibits the use of locomotive recording devices as a medium to retaliate against employees. Further, the RIA accompanying this final rule addresses in more detail APTA's claim that FRA has not sufficiently accounted for the cost of implementing a random selection program for locomotive recordings. Finally, while APTA compares testing for radio rules compliance with using locomotive recording devices for operational testing, listening to radio recordings provides a far more limited window into the crew's activities and has far less potential for abuse than locomotive recording devices.
BLET also objected to FRA's proposed revisions to § 217.9 allowing railroads to utilize locomotive recordings for operational testing purposes. BLET asserted that railroads have historically used operational testing as an indirect way to discipline their employees. According to BLET, although locomotive engineers are accustomed to how operational testing is currently done (
In contrast to BLET's comment, FRA received comments from TTD, Metra, and SMART, in support of FRA's proposed additions to § 217.9. TTD called FRA's proposed requirement for operational testing subjects to be selected at random a “meaningful step towards fair usage of recorded images.” Metra agreed with TTD and specifically asked FRA to make clear in the final rule that passenger railroads could not use subjective factors in the utilization of locomotive recordings to conduct operational tests. SMART and BLET also “applauded” FRA on its proposed random testing requirement and SMART stated that the provision would prevent a vindictive supervisor from tracking an employee the supervisor personally dislikes for punishment, such as a union representative. While still opposed to locomotive recordings being used for operational testing purposes at all, BLET also commented that how the random testing requirement was actually practiced by rail carriers in the field would be the determining factor on carrying out the intent of the regulation.
TTD also expressed its support for the proposed requirement that any operational test or inspection must be performed within 72 hours after the employee's tour of duty. TTD called this a critical tenet to ensure that data received by the railroads is not misused and believed FRA should not weaken any of the proposed protections in a final rule.
FRA agrees with TTD, Metra, and SMART and is adopting the proposed requirements in paragraphs (b)(3) and (4). FRA notes that APTA and BLET objected to the proposed requirements for opposing reasons. As stated above, APTA commented that FRA should not adopt any of the proposed requirements, not because APTA is opposed to using locomotive recording devices in operational testing, but because APTA believed the regulations would place constraints on the use of the devices that many passenger railroads already use as part of operational testing and cause these railroads to change their existing testing programs. APTA preferred FRA instead let railroads make their own decisions on how to use their locomotive recording devices. Conversely, BLET objected to the proposed requirements on the basis that railroads should not be allowed to use locomotive recording devices for operational testing in any circumstance, because they could be used to unfairly target their employees. As explained below, the conditions FRA is adopting in this final rule address the targeting of employees when passenger railroads use locomotive recording devices for part 217 testing purposes.
Without addressing BLET's allegation that operational testing has historically been used to target and discipline employees, FRA acknowledges that the amendments to § 217.9 in this final rule are intended to ensure passenger railroad supervisors do not use inward-facing locomotive cameras or in-cab audio recording devices to target specific employees. Hence, FRA's insistence that subjects for operational testing be selected at random, that there must be a testing plan that FRA can
Further, as stated previously, locomotive engineers and other railroad employees who work in a locomotive have no expectation of privacy, with the exception of the locomotive's sanitation compartment. Railroad employees can be observed in the locomotive at various times by railroad management, FRA inspectors, or even members of the public. Although BLET maintained that the constant surveillance of railroad employees would negatively impact the employees' behavior, passenger railroads have been using locomotive cameras long before this rulemaking without any such observable impact on passenger train safety.
APTA commented that FRA should not adopt in § 217.9 any reference to audio recordings or related language as it would provide FRA with regulatory authority for something not within the scope of the NPRM or under current FRA regulations. FRA disagrees. FRA widely discussed and asked numerous questions about audio recording devices in the NPRM, in addition to raising the requirement in the NPRM. FRA specifically proposed that inward-facing locomotive image and in-cab audio recordings, if used for operational testing, would be subject to the proposed requirements in § 217.9. Additionally, FRA has for some time regulated railroads' operational testing programs, and specifically what railroads can and cannot do as part of these programs.
BLET commented that allowing locomotive recording devices as an operational testing tool would have a negative effect on FRA's C3RS program. C3RS is a confidential reporting system that allows railroad employees in the field to report incidents where a potential accident was averted, or a risk was mitigated. The report is generated by the railroad employee without fear of reprisal from railroad management. BLET stated that confidentiality is the key to the success of the C3RS program but, with the constant surveillance of locomotive cameras, railroads may not feel there is an advantage to C3RS if they can simply watch accumulated video to identify trends. According to BLET, when a railroad has observed sufficient footage it could modify its operational testing to increase the number of exceptions and consequent cases of employee discipline, and thereby ignore the underlying safety problem or rule violation because the person committing the violation would be removed.
FRA does not believe that inward-facing cameras used for operational testing will negatively affect FRA's C3RS program. Passenger and freight railroads began installing inward-facing cameras in locomotives many years ago and FRA is not aware of any evidence, nor has BLET provided any, that these cameras have negatively impacted the C3RS program.
BLET commented that in the event recorder regulation all actions required to be captured are enumerated in the regulation. However, BLET asserted that for image or audio data captured by a camera or other recording devices, the NPRM lacked specificity as to which rules or regulations the data could be used to determine compliance. FRA did not provide in the NPRM, and declines to do so in this final rule, specific guidance on how the locomotive cameras should be used for evaluating compliance with specific rules or regulations, other than such use must comport with the stated protections for employees. FRA expects that railroads will use the locomotive image recording devices as a tool for purposes of carrying out their operational testing program requirements, evaluating compliance with the rules and regulations they already take into consideration as part of their operational testing programs.
FRA received comments from APTA, BLET, and the NTSB on FRA's proposal to include image and audio recording equipment installed on a passenger train locomotive as a “safety device” under § 218.53(c). APTA objected to the proposed changes and did not believe including an image recording device as a safety device under part 218 was necessary. APTA claimed that although tampering has not been a known issue for passenger railroads, the railroads already have internal rules and policies that prevent tampering with locomotive image recording devices. In addition, APTA stated that locomotive cameras do not need protection from the public, as they are not readily publicly accessible, and that the presence or operability of locomotive image recording devices does not affect the safe operation of a passenger locomotive or the train it is powering because these devices are strictly forensic in nature and cannot prevent any accident or incident.
In contrast to APTA's position, both BLET and the NTSB supported including locomotive recording devices as safety devices under part 218. The NTSB agreed with FRA that treating a locomotive-mounted image or audio recording device as a “safety device” will deter employees from tampering with or disabling one of these devices. BLET also agreed, but added that the technical requirements and standards for locomotive recording devices should be no less stringent that the requirements for event recorders.
FRA agrees with the NTSB that including locomotive recording devices under the definition of “safety device” in § 218.53(c) will deter railroad employees from tampering with such devices. However, because a locomotive recording device is not currently defined as a “safety device,” FRA is not aware of the extent to which there may be tampering with these devices. FRA expects locomotive recording devices to be at least as, if not more, susceptible to tampering as event recorders, which are safety devices under part 218. For example, as stated in the NPRM, in one incident of tampering with an inward-facing locomotive camera system, FRA viewed a recording in which an engineer covered the inward-facing cameras on his locomotive, apparently unaware of another camera mounted on the ceiling near the back wall of the cab. That camera recorded him appearing to play a game on a personal electronic device while operating a moving freight train. Accordingly, the changes to part 218 will serve not only to discourage passenger railroad employees from tampering with these important safety devices, but to hold individuals who do engage in such tampering accountable under FRA's rail safety regulations.
Even if train crew tampering with locomotive image recorders would continue to be handled under passenger railroads' rules and policies, as APTA suggested, this does not confer the same significance as a safety device subject to part 218. By including passenger
FRA also disagrees with APTA that the presence or operability of image recording devices does not affect the safe operation of a passenger locomotive or the train it is powering. Although locomotive recording devices can provide information about the actions of train crewmembers following the occurrence of an accident or incident, properly function recording devices can serve additional safety purposes. In its comments to FRA, NCTD stated that its COASTER commuter rail service can currently observe through its inward-facing cameras in real time when the equipment is in range of the railroad's wireless mesh network along NCTD's right-of-way. FRA notes the ability to observe a train crew in real time could provide the railroad an opportunity to intervene if, for example, it observed unauthorized persons in or around the locomotive cab, including closely monitoring interactions with passengers, in addition to curbing violations of railroad rules that could lead to a potentially catastrophic incident or accident. In this regard, Wi-Tronix commented that the benefits of being able to livestream video and data during emergency situations would be a great benefit to the public, as well as when the train crew experiences a health issue or there is hostile activity in the locomotive cab.
Regardless of whether locomotive recording devices are monitored in real time, the train crews' awareness of the devices will deter behavior that can negatively affect railroad safety, such as crewmember cell phone use while performing safety-sensitive functions, and the presence of cameras may also deter unauthorized occupancy of the locomotive or curb actions of other persons who may interact with the crew. Although the information currently provided by locomotive recording devices is mostly forensic in nature, the information can be critical in post-accident analysis and cannot be obtained from other sources such as locomotive event recorders. For instance, while locomotive event recorders provide information on data elements including locomotive speed and the amount and time of the locomotive's brake application, information from recording devices may be particularly useful in accidents arising from human factor causes, as image data can show investigators what the train crew was doing in the locomotive from a perspective that event recorders cannot provide. The railroads can then use this information to change railroad rules or revise their training programs to help prevent these types of accidents from reoccurring. This post-accident/incident data will be a vital source of information for FRA, the NTSB, and railroads to determine the cause of accidents/incidents as well as whether any action is necessary to prevent similar incidents from occurring in the future.
FRA also received a comment from Metra about the addition of § 218.53(d), which clarifies that the requirements of §§ 218.59 and 218.61 do not apply to recording devices voluntarily installed on freight locomotives. Metra noted that because these devices are voluntarily installed by freight railroads, the railroads can operate lead freight locomotives without such functioning recording devices. Metra is correct that freight railroads can operate freight locomotives without recording devices in compliance with this rule. However, as previously discussed, unless used as a rescue locomotive, a freight locomotive used in commuter or intercity passenger service must comply with all the requirements of this final rule.
APTA commented that although it understood FRA arrived at the 12-hour retention period for locomotive image recording data by reference to NTSB recommendations and the Statute's requirements, the requirement was excessive and unnecessary compared to the requirements of other federal agencies. APTA stated that the Federal Aviation Administration requires only 30 minutes of recording, claimed that the NTSB cited limited data supporting its recommendation for the 12-hour timeframe, and asserted that, unlike some freight trains, commuter train trip lengths are much shorter and “turn backs,” where the locomotive is in the lead in one direction and a cab car is in the lead in the other direction, are common after completing a run or directional trip. According to APTA, crew on-duty time for commuter and intercity passenger routes are scheduled to minimize jobs close to 12 hours on duty, some crews have a respite before their next trip, and some crews may also change train consists during their duty tour. APTA believed these elements contribute towards reducing the overwrite potential of critical image recordings available to investigate an incident and therefore asked that passenger railroads be allowed to determine their own time for storing their locomotives' image recording data. APTA added that passenger railroads already have image recording devices in other vehicles in a train consist for security purposes and noted they are generally recorded onto the same storage system as locomotive recording systems; consequently, APTA asserted that a shorter storage duration for locomotive recorders is necessary from a capacity perspective.
Hitachi also asserted that 12 hours of required recording time is excessive, commenting that accidents happen due to actions or inactions that span just minutes. Hitachi suggested a two-hour recording window would be more appropriate instead.
However, the Statute specifically mandates that locomotive image recording devices be capable of a minimum of 12 hours of continuous recording.
Responding to FRA's questions in the NPRM as to whether requiring passenger railroads to maintain a total of 24 hours of continuous recording capability would be feasible, Amtrak stated that the potential cost to double the recording timeframe from 12 to 24 hours would be “astronomical,” with only minimal additional benefits. According to Amtrak, the current marketplace does not have solutions that can capture recording time beyond approximately 14 hours and, under the hours of service laws, crews are only permitted 12 hours of continuous time on duty.
FRA agrees with Amtrak that the cost of a 24-hour recording timeframe would
FRA received several comments highlighting privacy concerns with FRA potentially taking possession of locomotive recordings as part of an accident investigation. The NPRM contains a detailed discussion of these privacy issues, and FRA specifically stated that it would “rarely take possession of recordings.” In its comments, APTA asserted that FRA should state that it will “never” take possession of recordings. According to APTA, the NTSB has protections in place that would protect the release of such recordings (49 U.S.C. 1114(c) and (d)), while FRA does not. APTA stated that FRA inspectors should be able to view any video or listen to any audio recordings, but to prevent the release of sensitive data, FRA should not take possession of the recordings. APTA asserted that FRA should not be allowed to take possession of recordings unless FRA has the same statutory prohibition as the NTSB protecting against the release of information.
The NTSB stated that it has longstanding legal restrictions and procedures in place that protect crew privacy and prevent the public release of sensitive onboard audio and video recovered in the accidents it investigates. The NTSB noted that 49 U.S.C. 1114(c) and (d) prohibit the agency from publicly disclosing voice and video recording from inside locomotive cabs involved in accidents or incidents. The law also specifies the circumstances under which the NTSB may make public an audio transcript or written depiction of visual information relevant to an accident or incident. Thus, the NTSB believes that current Federal law protecting against the public release of locomotive image or audio recordings during NTSB investigations is sufficient.
AAR also commented that the Statute stipulates that DOT may not disclose to the public “any part of an in-cab audio or image recording . . . related to an accident or incident investigated by the Secretary.”
Finally, SMART commented that it supports the nondisclosure of audio and image recordings or transcripts of oral communications related to an accident investigated by FRA.
As raised in the comments, valid privacy concerns exist on the appropriate protection and dissemination of locomotive recordings that are made, particularly where an accident has occurred and the recordings may be graphic and violent. It is not desirable for railroad employees or their families to have such images released publicly. Congress has previously provided statutory protections for a train's audio and image recordings that the NTSB takes possession of during the course of its accident investigations (49 U.S.C. 1114(d) and 1154(a)). Therefore, when the NTSB takes possession of such locomotive recordings, it is prohibited from releasing the contents of the recordings (except that transcripts may be released as part of its accident investigation proceedings).
Similarly, the Statute (49 U.S.C. 20168(h)) prohibits FRA from publicly disclosing recordings that FRA takes possession of after a railroad accident has occurred. Subsection (h) of the Statute, which is similar to the FOIA exemption for locomotive recordings applicable to the NTSB at 49 U.S.C. 1114(d), prohibits FRA from disclosing publicly locomotive audio and image recordings, or transcripts of communications by and among train employees or other operating employees, or between such operating employees and communication center employees, related to an accident investigated by FRA.
The Statute's prohibition on FRA disclosing publicly locomotive audio and image recordings or transcripts of oral communications among certain railroad employees addresses the concerns expressed by commenters. Therefore, FRA declines to adopt APTA's suggestion to “never” take possession of a locomotive recording. As stated in the NPRM, for the most serious of rail accidents, FRA anticipates that the NTSB will take possession of locomotive recordings, as they currently do, and that FRA will have the opportunity to view or listen to the recordings as a party to the investigation and in conducting its own parallel investigation under its separate statutory authority (49 U.S.C. 20107(a)(1)). However, in the vast majority of rail related accidents, the NTSB does not launch an investigation, and FRA is the sole Federal accident investigator. In these accidents or incidents, FRA normally attempts to view the recordings while they are still within the railroad's possession. However, if necessary, FRA has the statutory authority and obligation, as the Secretary's delegate to investigate railroad accidents, to take possession of locomotive image and audio recordings as part of an FRA accident investigation or investigation of a violation of a railroad safety law, regulation or order.
FRA received several comments expressing concerns that locomotive recording systems would be used as a form of retaliation against railroad employees, even though using passenger locomotive recording devices to retaliate against employees is prohibited by the Statute.
Hitachi also expressed concerns with how locomotive recording devices would be used and commented that there is significant room for abuse if the proposed analytic tools are used for purposes outside of the narrow scope defined by the proposed rule. Hitachi therefore recommended that FRA bar railroad operators or owners from utilizing recordings for purposes other than training or accident investigations.
SMART commented that FRA misinterpreted Congress' intent to prevent the use of locomotive recording devices for retaliation by concluding that the anti-retaliation provision of the Statute did not apply to railroad rules violations discovered via locomotive image or audio devices.
FRA disagrees with SMART's contention that the investigation of a railroad safety violation violates the Statute's anti-retaliation requirements. One of the purposes of this rulemaking is to use locomotive recording devices as a tool to identify and address safety violations that endanger public safety, such as personal electronic device usage while performing safety-critical duties. This purpose is not inconsistent with the Statute, which addresses retaliation implicated by other existing statutes (
Amtrak commented that it already has an established company program and process in place governing the use of audio and visual recordings for compliance means only.
FRA disagrees with Amtrak's suggestion that a railroad's company policy is sufficient to prevent retaliation incidents. FRA proposed in the NPRM, and is now adopting in this final rule, several requirements to prevent railroad retaliation against trains crews and other railroad employees. This final rule, in compliance with the Statute,
BLET commented that monitoring the day-to-day performance of workers can have damaging effects outside any of the claimed benefits of the final rule. According to BLET, visual or audio surveillance will build resentment and a climate of distrust between the railroad and its workers. BLET asserted that no matter the privacy protections and respect of use adopted in passenger railroad policies, railroad employees will resent the presence of the locomotive recording devices and find their presence offensive, and there will be a multitude of unforeseeable consequences that neither FRA, nor the passenger railroads have considered.
It is likely that Congress took these concerns into account when mandating the installation of inward- and outward-facing image recording devices in all regularly scheduled intercity or commuter rail passenger locomotives in the Statute. Locomotive recording devices are not a novel technology. Locomotive cameras and recording devices have become common within locomotives over the past two decades. FRA does not believe this final rule will introduce a major change to the working conditions of a large segment of passenger train crews, as suggested by BLET.
FRA received several comments about the download and security feature requirements for locomotive image recording systems proposed in the NPRM (paragraph (d) of proposed § 229.136). Amtrak commented that this final rule should not regulate the download and security features of these systems, believing an industry-adopted standard is better suited to fit the technological capabilities of locomotive image recording systems. APTA agreed with Amtrak, and commented that passenger railroads should be allowed to develop their own best practices for conducting inspections and downloading data without prescriptive standards, stating that passenger railroads have been handling these downloads for quite some time.
In contrast, BLET commented that there should be uniform standards and requirements in this final rule for all locomotive-mounted recording systems, electronic downloads, and security features, such as encryption functions, etc. BLET stated that if this type of data is not encrypted and a strict chain of custody is not maintained, any credibility or value of using the data for post-accident investigation could be called into question. According to BLET, wireless transmission of audio or image recording data should also be prohibited to prevent such private, personal data from being hacked.
The standard FRA adopts in this final rule balances the concerns of the commenters. The standard adopted is broader than that proposed in the NPRM, which addressed electronic security measures only to prevent unauthorized downloads of recordings. As adopted in this final rule, § 229.136(d) requires passenger railroads to develop a system that allows only authorized downloads and has electronic security measures to prevent unauthorized access to, and download, deletion, or alteration of, the recording system or its recordings. FRA therefore expects that passenger rail will safeguard the recordings using encryption technology or equivalent data protection measures. However, this paragraph does not prescribe how such a system must be specifically created or structured, and recognizes that recordings must be accessible for review during an accident or incident investigation, as provided in 49 U.S.C. 20168(b)(3), and may be put to other lawful purposes,
Hitachi commented that, as proposed, the requirements for download and security features of locomotive recording systems would seem to require both a standard and a crashworthy memory module. Hitachi stated that, if a crashworthy module meets all the requirements, then standard memory modules are unnecessary and could potentially create confusion.
FRA has not adopted the reference to standard memory modules in this final rule, as its inclusion in the NPRM was in error. Locomotive recording device data, whether it be audio or image recording data, must be stored on a crashworthy memory module. Because locomotive image or audio recordings cannot be stored on standard memory modules, the download and security features required of locomotive recording systems in § 229.136(d) refer only to certified crashworthy memory modules in this final rule.
Wi-Tronix commented that locomotive image recording systems should be required to be self-monitoring and self-reporting, stating that the technology exists for these systems to monitor their own operational health and report their status. FRA agrees that a self-monitoring system is necessary to alert train crews and railroad maintenance crews conducting inspections whether the recording system is even working. Without a self-monitoring system, a locomotive could operate for an extended period of time without a functioning locomotive camera system.
APTA commented that the self-monitoring capabilities in the proposal did not appear to be a part of FRA's cost estimate for installation or ongoing operation and maintenance costs, and requested that FRA justify the requirement using a cost-benefit analysis. Although FRA did include the cost for self-monitoring capabilities in the NPRM's RIA, as FRA assumed that any locomotive image recording device would have a self-monitoring capability built into the initial design, FRA has updated the cost based on the comments that were received and provided a range of costs to better account for any variance that might occur in the cost of such devices.
In addition, APTA questioned the requirement that railroads take a sample download during a periodic inspection to ensure that the image recording system is functioning properly. APTA stated that passenger railroads need to limit those with the ability to download and access audio/image recordings, asserting that many railroads do not allow their maintenance personnel to do this. According to APTA, there could be a need to verify proper functioning during the periodic inspection, but taking a download should not be required and there are other ways to ensure proper functionality.
In the NPRM, FRA asked for comment on the types of restrictions that should be placed on sample recording device downloads from passenger train lead locomotives under proposed § 229.136(e)(2), as FRA anticipated that sample downloads for inspection or maintenance purpose might often be taken by non-managerial or operating employees, such as mechanical department employees in a locomotive repair facility. BLET responded by stating it is reasonable to conclude that railroads will need to check images and recordings from time to time to ensure the proper functioning of the system. However, BLET added that the individual checking the system should not also be conducting operational testing, unless that individual is qualified to do so and is authorized to perform operational tests, and requested that FRA require all recordings used for inspection or testing purposes to be deleted once system functioning is confirmed.
Based on the comments received, FRA is modifying the proposed requirement. Passenger railroads must still conduct a sample download from the image recording system's crashworthy memory module; however, FRA is changing the frequency of the download test from a periodic to an annual requirement. This change will reduce the need for railroad employees to download and observe image recordings. Of course, passenger railroads may ensure the proper functioning of a recording system at any time. The authority under § 229.136(f)(3)(vii) to perform inspection, testing, maintenance, or repair activities to ensure the proper installation and functioning of an inward-facing image recorder is not limited to fulfilling the minimum requirements of § 229.136(e)(2) to take a sample download from the image recording system's crashworthy memory module to confirm proper operation of the system.
FRA makes clear that the final rule requires the sample download for the annual test be taken directly from the image recording system's crashworthy memory module, or its equivalent in the case of remote storage approved under § 229.136(g). Taking the download from this memory module is necessary to ensure not only that the locomotive cameras are unobstructed and pointing in the correct position to capture crew activity, but to ensure that the camera system is properly recording to the memory module. For example, an inward-facing camera could be technically recording, but the camera could be out of focus. Further, this clarification is also intended to prevent any misunderstanding that passenger railroads could comply with this paragraph's testing requirements by simply streaming a recording from an image recording system without downloading the recording from the system's memory module. An actual download from the system's crashworthy memory module is required to ensure the integrity and proper functioning of the image recording system.
Although this final rule creates a specific annual test for locomotive image recording systems, passenger railroads must inspect the locomotive's image recording devices as part of other locomotive inspections required under part 229 (
In commenting on the preservation and handling requirement for passenger locomotive recording devices as proposed in the NPRM, APTA asserted that FRA did not account for the cost of the proposed chain-of-custody requirements as part of FRA's cost estimate for ongoing operation and maintenance costs added. APTA therefore requested that FRA justify these costs versus the established benefits. FRA acknowledges it inadvertently omitted these costs from the NPRM's RIA. FRA has revised the RIA accompanying this final rule accordingly to include these costs.
FRA also received comments on whether FRA should create a specific provision that prohibits the public release of an image or audio recording by any person or railroad. BLET commented that there should be a restriction on public release, stating that without legal limitations upon disclosure, a regulatory scheme for governing the use of in-cab cameras presents a significant problem of public and personal privacy. According to BLET, FRA has not yet stated an intention to curb usage by the railroad carrier or shield employees from improper disclosure of sensitive footage, asserting that information from locomotive recorders should be strictly controlled to prevent posting on social media websites under the guises of promoting education and safety. BLET also asserted that FRA should prohibit a railroad from disclosing locomotive recording data of its employees to another railroad that is not the employing railroad. BLET added that if audio is recorded, it should be recorded on its own separate channel so it can be isolated for sound quality.
APTA commented that many agencies providing passenger rail service have significant protections in place to prevent the release of image or audio recordings, but stated that a specific provision, even limited in scope, prohibiting public release would supplement these agencies' existing policies and offer protections where other agencies have no such restrictions in place. The NTSB also commented that it supports FRA ensuring railroads have appropriate limitations established for the public release of in-cab audio and image recordings.
Under 49 U.S.C. 20168, which governs the installation of audio and image recording devices in passenger train service, Congress has limited the uses to which passenger railroads (49 U.S.C. 20168(d)) and the Secretary of Transportation (49 U.S.C. 20168(h)) can put locomotive image or audio recording device data, including those uses the Secretary deems appropriate under 49 U.S.C. 20168(d)(4). This final rule delineates those allowable uses of both image and audio recording device data in § 229.136(f)(3), and mere public disclosure is not an authorized use.
Further, as provided in § 229.136(f)(2), image or audio recording system data from a locomotive in commuter or intercity passenger service that has been involved in an accident/incident that must be reported to FRA under part 225 of this chapter, can only be extracted and analyzed by the railroad for the purposes described in § 229.136(f)(3). The data cannot be used for any other purpose except by direction of FRA or another Federal agency. Likewise, FRA may not disclose publicly any part of an in-cab audio or image recording or transcript of oral communications by or among train employees or other operating employees responsible for the movement and direction of the train, or between such operating employees and company communication centers, related to an accident or incident investigated by FRA. However, FRA may make public any part of a transcript or any written depiction of visual information that FRA determines is relevant to the accident at the time a majority of the other factual reports on the accident or incident are released to the public.
APTA separately commented that the requirements of § 229.136(f) pertaining to handling of recordings should not apply to audio recording devices or their recordings, stating that audio requirements were not part of the NPRM, and therefore should not be a part of the final rule. FRA disagrees. Although FRA did not propose in the NPRM and does not require in this final rule the installation of devices to record audio either inside or outside the locomotive cab, passenger railroads that have installed these devices or install these devices in the future must preserve resulting recordings according to the preservation and handling requirements of § 229.136(f)(2), if the locomotive is involved in a reportable accident or incident under 49 CFR part 225. Such information will be relevant to an accident investigation conducted by FRA, the NTSB, or other investigator.
APTA asked how the rule would address a situation where an accident occurs and one public agency owns the rolling stock, but another agency operates the rolling stock. APTA sought clarification as to which entity would be required to preserve the locomotive recording data.
The rule provides that the operating railroad at the time of the accident is responsible for maintaining the data. However, like many issues where there is shared usage of equipment between entities involved in providing passenger rail service, as a practical matter, FRA expects the entities to work such issues out by agreement. Such coordination among the entities involved in providing passenger rail service is also consistent with that expected under the System Safety Program rulemaking, 49 CFR part 270. The entities may mutually agree on fulfilling responsibilities under this final rule on each other's behalf, as tailored to their individual circumstances.
APTA next asked how railroads could provide FRA or the NTSB image or audio data in a usable format when the software required for playback of such data downloaded from a locomotive is contractually controlled by a usage agreement involving the system's original equipment manufacturer (OEM), and the OEM requires each user of the software to sign the user
This question is a good example of why FRA is requiring railroads to either provide the image and/or audio data in a readable format, or make available any platform, software, media device,
As noted above, entities providing passenger rail service may contract with other parties to fulfill the requirements of this rule and may therefore enter into agreements with manufacturers to develop their locomotive recording systems. FRA will not provide specific guidance on how the procurement and bidding process for such technology should be managed other than to reiterate FRA's concern as to the accessibility of the locomotive recording device data. Unless the recordings are in a readily available format for investigators to use, the post-accident value of the recordings and the accident investigations themselves may be impaired.
APTA opposed FRA specifying in the NPRM permissible uses for locomotive recording device technology, asserting that the final rule should only set minimum safety requirements. APTA stated FRA should either not adopt such a proposal or instead take a broader approach that allows passenger railroads to develop their own uses for safety and security purposes. APTA cited to the experience railroads have using such data for several purposes, including investigating accidents. APTA added that allowing passenger railroads to use their locomotive image and audio recording devices to monitor locomotive cabs for unauthorized occupancy should be deleted as it could be interpreted as a requirement to use remote monitoring, which is not practical for the passenger railroad industry which operates thousands of trains a day.
FRA is adopting the permissible uses for locomotive recording devices as proposed. The Statute enumerates certain purposes for which passenger railroads may use locomotive recording device data and authorizes FRA, as the Secretary's delegate, to provide for other appropriate purposes.
The final rule does not require passenger railroads to remotely monitor their locomotives for unauthorized occupancy, though it allows passenger railroads to use their recording device data to do so. For further discussion on remote monitoring, please see Section II.G.
In its comments, BLET stated that the permissible uses for locomotive recording device technology should apply to both passenger and freight railroads that voluntarily install locomotive recording devices. BLET further suggested that such a uniform set of standards and requirements provide for the encryption of image and voice recordings and access only by authorized personnel, to safeguard the identities of the recorded individuals. Moreover, in the event that surveillance data is used in disciplinary and/or certification revocation proceedings, BLET asserted that the identities of those who decrypt the data should be made known to the labor organizations representing the charged employees, and that such persons be made to testify as a witness at any discipline or revocation hearing, if requested by the labor organizations.
In addition, BLET commented that, in the NPRM, FRA repeated a misperception of what cameras can do to promote safety by asking whether there are other safety-appropriate uses for locomotive recordings. According to BLET, cameras provide no protection against accidents that would happen within an operational envelope, and do not prevent electronic device usage. BLET questioned what safety goal is achieved when a personal electronic device is found through locomotive recording data, when the recording itself could not prevent it. BLET also questioned the extent to which locomotive recording data in post-accident analysis can actually help in day-to-day operations. Overall, BLET believed locomotive recorders will serve only to document a problem someone already knew existed and negligence over time, but that safety will not improve as a result if the underlying issue is not addressed.
As previously noted, FRA lacks the justification to apply the requirements for permissible uses of locomotive recording device technology in this final rule to freight railroads, in accordance with FRA's implementation of the Statute. However, it is FRA's expectation that all railroads that voluntarily install recording devices on their locomotive will adhere to practices that are consistent with those in this final rule. In addition, BLET's suggestion to encrypt all locomotive recording data would unnecessarily increase the cost of this rulemaking, although FRA expects that encryption technology or equivalent data protection measures will be used, given the requirements in this final rule that such data may only be accessed by authorized personnel and its integrity be safeguarded against unauthorized download, deletion, or alteration. Finally, although FRA agrees that most of the benefits of this rulemaking will come from enhancing post-accident analysis through the information contained in locomotive recordings, FRA strongly disagrees that locomotive recording devices will provide no deterrence against personal electronic device use or other safety violations occurring during railroad operations. FRA also notes that, as identified by Congress, the recordings may serve to document a criminal act or monitor unauthorized occupancy of a locomotive.
APTA commented that the NPRM did not address a situation where data from
FRA discussed extensively in the NPRM how concerns about preventing accidents caused by distraction involving the use of personal electronic devices was one of the bases for this rulemaking, as well as the focus of NTSB recommendations and RSAC Working Group discussion. As a result, FRA received several comments about locomotive recording devices and how they would deter crewmembers from using personal electronic devices while performing safety sensitive service.
BLET commented that locomotive cameras will not deter negative behavior involving crewmembers or personal cell phone usage. BLET asserted that evidence shows individuals continued to use their personal phones when locomotive cameras were present, and that locomotive cameras will just show the behavior, which is already known to exist.
BLET also commented that FRA did not include a discussion in the NPRM on technology that can disrupt cell phone connectivity. BLET stated it partnered with Amtrak on a project that demonstrated the utility of technology that would both intercept cell phone connectivity outside of the locomotive and alert designated supervisors in real time of any attempt to use a cell phone. BLET found this to be a significant safety enhancement at relatively low cost, one that operates far less intrusively than inward-facing locomotive cameras, and noted that this technology was not mentioned in the NPRM as a potential “alternative technology.”
Wi-Tronix commented that major passenger train incidents over the past decade proved that distracted driver operation is a critical problem and that technology also exists to monitor such activity in locomotive cabs. Wi-Tronix stated that the integration of image and audio recording data and the detection of such data in cellular logs, when integrated and synchronized with event recorder data, make an extremely powerful tool for accident/incident investigation and to influence behavior.
While BLET is correct that the presence of inward-facing locomotive recording devices will not entirely prevent the usage of personal electronic devices when performing safety-sensitive service, the presence of these devices will nonetheless provide a deterrent effect. FRA found a study by the Virginia Tech Transportation Institute that examined the change in commercial truck driver behavior when an image recording device was within the cab of the vehicle.
Moreover, aside from the deterrent effect locomotive recording devices have in preventing personal electronic device usage, the recording devices provide other important safety functions unrelated to personal electronic device usage. For example, one of the primary functions of locomotive recording devices is to provide information as to the causes(s) of a railroad accident or incident. Therefore, although FRA encourages the use and development of technology to promote safety, the technology described by the commenters to detect or prevent personal electronic device usage cannot be considered an “alternative technology” for purposes of the statutory requirement to install inward- and outward-facing locomotive image recorders.
Railroad carriers providing “intercity rail passenger transportation” and “commuter rail passenger transportation” subject to this final rule are covered by 49 U.S.C. 24102 (passenger railroads required to install PTC systems under 49 U.S.C. 20157(a)). Although FRA did not specifically request comments on PTC, FRA received several comments relating to PTC technology, the nature of the overlap between passenger railroads required to install PTC and locomotive image recording devices, and the interaction between locomotive recording devices and PTC systems. Specifically, commenters asserted that passenger railroads should not be required to divert resources from installing, maintaining, and operating PTC systems to address the recording device requirements in this rulemaking.
APTA cited the accidents and associated NTSB recommendations discussed in the NPRM and stated that almost every one of the accidents would have been prevented by a functioning PTC system. In addition, APTA stated that most were accidents involving freight trains, not passenger trains.
Hitachi agreed with APTA that all the accidents discussed in the NPRM were arguably PTC-preventable accidents. Hitachi believed that, although image recording devices could prove useful as accident investigation tools in the future, accident prevention should currently be the primary focus and, as a result, railroads should not divert valuable resources from operating and maintaining PTC equipment “to meet well-intentioned, but misguided FRA mandates.”
BLET also took issue with the accidents FRA discussed in the NPRM. BLET pointed out that two of the accidents, the 2008 accident in Chatsworth, California, and the 1999 accident in Bryan, Ohio, led to the NTSB recommending both the installation of PTC and the installation of locomotive image recording devices. According to BLET, the NTSB stated that PTC could have prevented these accidents from occurring. Therefore, BLET questioned why locomotive image recording systems would be appropriate where PTC is installed and operating, except perhaps to use outward-facing cameras to document signal visibility due to dense fog, which was at issue in the Bryan, Ohio, accident.
Additionally, FRA received a comment from a private citizen who stated that outward-facing locomotive recording devices offer no preventative qualities. The commenter believed that resources dedicated to outward-facing recording systems detract from finite resources available for safety, installing a form of PTC technology would be a
FRA understands the concerns raised by commenters and does not dispute the commenters' assertion that many, if not all, of the accidents cited in the NPRM could have been prevented by the implementation of PTC systems, nor does FRA dispute the safety benefits of PTC systems. However, PTC is not an adequate “alternative technology” under the Statute, as PTC and locomotive recording devices serve different safety functions. PTC is designed to prevent certain accidents, and, although locomotive recording devices do have the potential to help prevent accidents, one of the main purposes of locomotive recording devices is to record information to provide to investigators after an accident or incident has occurred.
All PTC systems must be designed to prevent train-to train collisions, over-speed derailments, incursions into established work zones, and movement of trains through switches left in the wrong position, in accordance with the requirements of 49 CFR part 236, subpart I. As touched on above, one of the primary uses of locomotive recording devices is for investigating railroad accidents or incidents caused by human factors where standard event recorders can provide little or incomplete information about what occurred in the locomotive cab prior to the accident or incident.
As previously stated, the Statute requires the promulgation of regulations requiring passenger railroads to install recording devices in all controlling (or “lead”) locomotives. When the locomotive recording devices statutory mandate was enacted, the statutory mandate to implement PTC on passenger railroads had long been in place.
Wi-Tronix commented that data created by locomotive image recorders will need to be accessed for artificial intelligence and image analytics purposes, stating that artificial intelligence and image analytics are key elements to improving industry safety, as seen in the automotive industry. As a result, Wi-Tronix asserted there needs to be a mechanism to allow for sharing anonymous data for use in improving safety and operations.
FRA declines to develop a mechanism in this rule for sharing anonymous data from locomotive image recording devices. The Statute did not mandate the establishment of such a mechanism, and FRA expects that passenger railroads would be reluctant to share the data due to the need to address proprietary, liability, privacy and other potential issues and concerns. Although FRA strongly supports the use of data to promote safety purposes, this final rule is not the appropriate forum for imposing such a requirement, consideration of which would require the involvement of all stakeholders. See also the discussion under Section II.L.5 above, noting that this final rule will not affect the adoption of C3RS programs, which allow railroad employees to raise safety incidents confidentially and generate reports based on such incidents without identifying data.
Hitachi commented that FRA should investigate and suggest updates for procurements, to favor transit agencies, considering the best technology or exploring the most advanced technological applications. FRA declines to adopt this suggestion, as it is beyond the scope of this rulemaking. FRA's purpose in this final rule is to implement the statutory mandate to establish minimum standards for inward- and outward-facing locomotive image recording systems for passenger railroads. Railroads may, of course, exceed these minimum standards and work together in procuring and applying the technology, including the development of industry specifications and best practices consistent with this rule.
APTA provided a comment specific to commuter railroads that utilize some general purpose (GP)-style locomotives with one cab only on the short-hood end, and a narrow car body on the long-hood end. These locomotives can operate in the lead with the long- or short-hood forward while in revenue service. APTA sought clarification whether the long-hood of these locomotives must comply with the final rule, even if operated only occasionally long-hood forward, and believed that such use should be excluded by the final rule.
FRA disagrees with APTA's comment that these locomotives should be excluded from the final rule's requirements. If a railroad operates such locomotives long-hood forward in regularly scheduled passenger service, however occasionally the locomotive configuration may be used, the long-hood must be equipped with an outward-facing image recording device in the direction that the locomotive is traveling. FRA disagrees with APTA, in part, because an exclusion could incentivize use of locomotives in this configuration. FRA addresses the costs associated with long-hood forward use of locomotives in this final rule's RIA by increasing the number of impacted locomotives affected by the final rule.
Wi-Tronix, believing that passenger railroad cab cars may not be locomotives, commented that it would be critical that cab cars be covered by this final rule's requirements applicable to locomotives. FRA makes clear that cab cars are indeed locomotives subject to this final rule. Cab cars are formally recognized by the existing definition of “control cab locomotive” in § 229.5 to mean a “locomotive.”
FRA did not request or receive any comments regarding the potential civil penalties FRA could issue for violations of new or amended requirements in this final rule. FRA will modify the schedule of civil penalties on its website
FRA is authorized to assess a civil penalty of at least $976 and not more than $31,928 per any violation of the requirements established in this final rule.
Texas Central Railroad (TCRR) intends to implement a high-speed passenger rail system by using the Tokaido Shinkansen system's service-proven technology and by replicating Central Japan Railway Company's (JRC) operational and maintenance practices and procedures. The contemplated system will run between Dallas and Houston, Texas, with an intermediate stop in Grimes County, Texas, approximately 240 miles, at a speed not to exceed 205 mph. TCRR plans to implement the latest, service-proven derivative of the N700 trainset and other core systems currently in use on the Tokaido Shinkansen line, which have been refined for high-speed operations over the last 50-plus years.
On November 3, 2020, FRA published a final rule establishing regulatory requirements applicable only to TCRR—a rule of particular applicability (RPA).
On March 10, 2020, FRA published an NPRM proposing a set of safety requirements for TCRR (the TCRR NPRM). FRA proposed to make FRA's regulation implementing section 11411 of the FAST Act applicable to TCRR's high-speed trainsets used in revenue service.
During the 77-day comment period on the TCRR NPRM, FRA received comments from TCRR on the topic of locomotive image recorders. TCRR requested that FRA exercise its statutorily granted discretion under 49 U.S.C. 20168(e)(2) and exempt TCRR from the requirement to install inward- and outward-facing image recording devices, asserting that TCRR will implement an alternative technology or practice that provides an equivalent or greater level of safety or is better suited to the risks of the operation. In support of its request, TCRR stated that such alternative technologies or practices to be employed include: a signaling system that will comply with the requirements for PTC under 49 U.S.C. 20157 and be installed throughout the TCRR system (including trainset maintenance facilities) and used at all speeds; a dedicated, fully fenced (except for elevated structures), grade-separated right-of-way; an intrusion detection system; a right-of-way barrier plan to protect against unauthorized incursions into the right-of-way and from adjacent highway and freight rail operations; and wind, rain, and flood hazard detectors located at specific sites along the right-of-way.
FRA recognizes and appreciates the mitigations that TCRR will have in place under part 299 and that those mitigations are modeled on the very successful Tokaido Shinkansen system. However, even with all the mitigations TCRR is putting in place to avoid any form of accident/incident, it is in the interest of railroad safety to require TCRR to install image recording systems in its high-speed trainsets. Notably, should an event occur despite the mitigations put in place by the railroad, it will be even more crucial to have imagery from the recording system to determine how the event occurred and/or what was occurring in the controlling cab of the trainset in the time before and during the event. See also the discussion under Section II.W of this final rule, noting that FRA cannot consider PTC an adequate “alternative technology” to installation of inward- and outward-facing image recording devices for purposes of the statutory exemption. Accordingly, TCRR is not exempt from the requirement to install inward- and outward-facing image recording devices.
Contrary to the discussion in the TCRR NPRM, in which FRA stated it would make appropriate conforming changes to the requirements outlined in the NPRM, essentially making the requirements of § 229.136 applicable to TCRR, FRA is adding § 299.449 to part 299 to contain the specific requirements for the image recording system applicable only to TCRR.
Section 299.449, as adopted in this final rule, reflects FRA's efforts to tailor the locomotive image recorder requirement to TCRR's equipment and operation and to address TCRR's comments. Section V, Section-by-Section Analysis, below, contains a discussion of the changes made and codified under §§ 299.5 and 299.449, and under appendix A to part 299, Criteria for Certification of Crashworthy Event Recorder Memory Module. FRA has made both editorial and substantive changes in applying the rule text in § 229.136 and appendix D to part 229 to TCRR's rule of particular applicability, part 299. The changes ease understanding of the various requirements, as applied to TCRR, including clarifying whether a requirement pertains to a component of the image recording system (such as an
This section responds to public comments and identifies any changes made from the provisions as proposed in the NPRM. Provisions that received no comment, and are otherwise being finalized as proposed, are not discussed again here.
In this final rule, FRA is clarifying its intent to exclude freight railroads from these requirements by using the term “passenger railroad,” instead of “railroad,” throughout paragraphs (b)(3) and (4).
FRA is also adding audio recordings to paragraph (b)(3)(iii). Although proposed paragraph (b)(3)(iii) did not expressly mention audio recordings as subject to the 72-hour limitation on operational tests or inspections after completion of the employee's tour of duty, the omission of audio recordings was inadvertent and not consistent with proposed paragraph (b)(3) as a whole. For instance, proposed paragraph (b)(3)'s introductory text made clear that operational tests and inspections involving inward-facing image or in-cab audio recordings must comply with the conditions in paragraphs (b)(3)(i), (ii), and (iii). Further, it would not make sense for FRA to require passenger railroads to select testing subjects at random for operational testing involving inward-facing locomotive image recordings, but allow the potential for specific employees to be targeted for operational testing with audio recording devices. Therefore, FRA is correcting the inadvertent omission in this final rule. Accordingly, while the final rule does not require passenger railroads to install audio recording devices of any kind, if passenger railroads choose to install such devices and then use them for operational testing, the same protections for operational testing and use of image recorders also apply for operational testing and use of audio recorders.
FRA is revising paragraph (d) of this section to make clear that the provisions in §§ 218.59 and 218.61 do not apply to locomotive-mounted image or audio recording equipment on freight locomotives. FRA's use of “or,” instead of “and” as proposed in the NPRM, is to avoid the potential ambiguity that both image and audio recording equipment on a freight locomotive must be present for the exclusion to apply. It is FRA's intention that §§ 218.59 and 218.61 will not apply to either type of recording device on a freight locomotive, whether alone or in combination.
FRA is also revising subsection (c) of this section to read that the requirements of this section do not apply to inward- or outward-facing image recording devices that are installed on freight locomotives, instead of inward- and outward-facing image recording devices on freight locomotives. Like its revision in § 218.53, FRA is substituting the word “and” with “or” to avoid the potential ambiguity that both an inward- and outward-facing image recording device must be present on a freight locomotive to avoid the application of this section, when the presence of either an inward- or outward-facing image recording device is sufficient to avoid the section's requirements.
Although proposed in the NPRM, FRA is not amending this section to add a definition for “NTSB” as the acronym for the National Transportation Safety Board, an independent U.S. government investigative agency responsible for civil transportation accident investigation. The term is not used in any of the amended or new language being added to part 229 by this final rule.
FRA is making conforming changes to § 229.21 to reflect the allowance for movement beyond a calendar day inspection point of a lead locomotive in long-distance intercity passenger train service with a locomotive image recorder system or device defect. See the discussion in the Section-by-Section analysis of § 229.136, below, as well as Section II.I (Repairing, Replacing, or Removing Locomotive Image Recording Devices From Service) within the Discussion of Specific Comments and Conclusions, above. Although not expressly proposed in the NPRM, these changes are limited only to such long-distance intercity passenger trains led by locomotives subject to this final rule's locomotive image recorder requirements—and only to the handling of such locomotive image recording systems or devices. FRA intends no other changes to this section's application or effect.
FRA has added this section in preparing the final rule to establish use of new Form FRA F 6180-49AP (Passenger Locomotive Inspection and Repair Record) to collect Federally required locomotive inspection, testing, and repair information for lead locomotives in commuter or intercity passenger train service, including information for locomotive recording devices. This new form is based on existing Form FRA F 6180-49A (Locomotive Inspection and Repair Record), which has been used for many years as the centralized record of Federally required inspection, testing, and repair information for all locomotives, as defined broadly in § 229.5. Form FRA F 6180-49AP, as the new counterpart to Form FRA F 6180-49A, will include a designated row for entering information about annual testing of locomotive image recording devices required under § 229.136, consistent with the designated row on Form FRA F 6180-49A (as well as new Form FRA F 6180-49AP) for entering information about required locomotive event recorder testing. Form FRA F 6180-49AP will also continue to be organized to fit on one double-sided page, for ease of use and printing and copying.
Establishing use of the new F 6180-49AP form for lead locomotives in commuter or intercity passenger train service will help avoid any potential confusion for freight railroad operators as to the application of locomotive recording device requirements under this rule, and also conserve valuable space on the existing F 6180-49A form. Freight railroads operate the vast majority of locomotives, and the locomotive recording device requirements in this rule do not apply to locomotives in freight service, or to locomotives used in switching service. Nor will the rule affect use of the F 6180-49A form by non-lead locomotives in commuter or intercity passenger train service.
To phase-in use of new Form FRA F 6180-49AP for lead locomotives in commuter or intercity passenger train service, § 229.22 expressly permits continued use and maintenance of Form FRA F 6180-49A until October 12,
FRA is making changes in this section's regulatory text from the NPRM. In various paragraphs, the changes remove redundant words or phrases from the proposed language to streamline the final rule. Where these and other purely stylistic textual changes do not modify the meaning or requirements of the paragraphs or this section, they will not be addressed in the analysis below.
FRA is modifying the headings for paragraphs (b), (c), (d), and (e) by inserting the word “lead” into each paragraph heading, to clarify that only passenger locomotives in the lead position must comply with these paragraphs' requirements. FRA is also adding clarifying text to avoid any confusion as to the applicability of this section's requirements to recording devices or systems voluntarily installed in locomotives. FRA has therefore inserted “as required under paragraph (a)(1) or (2) of this section” to make clear that the corresponding text applies only to locomotives required to be equipped with recording devices or systems under paragraph (a)(1) or (2) of this section.
In paragraph (a)(3), FRA has changed the name of the form referenced in this paragraph from “Form FRA F 6180-49A” to “Form FRA F 6180-49AP,” as FRA has created this new form specifically for passenger locomotives subject to the requirements in this final rule. Passenger railroads must still note the presence of any image or audio recording system in the REMARKS section; however, passenger railroads must use new Form FRA F 6180-49AP for their lead locomotives used in commuter or intercity passenger train service.
In paragraph (a)(5), FRA is adding language making clear that locomotive recording device data can be stored on a certified crashworthy event recorder memory module or an alternative, remote storage system that provides equivalent data protections if approved by FRA. See Section II.E.2 (Potential Exemptions From the Crashworthy Memory Module Requirements) for a detailed discussion of FRA's considerations in approving a remote storage system as part of the locomotive recording system approval process. FRA has added paragraphs (a)(5)(i) and (ii) to clarify when required image recording and voluntarily installed audio recording devices on lead locomotives must comply with the paragraph's requirements. Paragraph (a)(5)(i) references paragraphs (a)(1) and (2) for when image recording devices on lead locomotives must comply with this paragraph's requirements, while paragraph (a)(5)(ii) specifies when voluntarily installed audio recording devices on lead locomotives must comply with the same requirements. FRA added these paragraphs because the NPRM was unclear when voluntarily installed audio recording devices on lead locomotives in commuter or intercity passenger service would be required to record their data to a certified crashworthy event recorder memory module or FRA-approved remote storage system.
FRA is not adopting the language proposed in paragraph (c)(1)(i) specifying that the locomotive inward-facing camera system have sufficient resolution to record whether a crewmember is physically incapacitated and whether a crewmember is complying with the indicators of a signal system or other operational control system. Instead, FRA is simply retaining the requirement that the inward-facing camera system have sufficient resolution to record crewmember actions, without the more prescriptive language. FRA reiterates that this paragraph does not require the real-time monitoring of passenger train crews. Please see the above discussion in Section II.G (Inward-Facing Locomotive Image Recording Systems and Devices).
FRA is also renumbering paragraph (c) for clarity. The proposed regulatory language in paragraph (c)(1)(ii) is now contained in paragraphs (c)(1)(ii) and (iii) in this final rule. Similarly, the regulatory language in proposed paragraphs (c)(2), (3), and (4) is now found in paragraphs (c)(1)(iv), (2), and (3), respectively. In addition, FRA is adding the phrase “on image recordings” in paragraph (c)(1)(iv) for clarity.
FRA is modifying and broadening paragraph (d) from the proposal in the NPRM to make clear that, in addition to unauthorized downloads, passenger railroads must also take necessary protective measures against unauthorized access to the recording system and its recordings that could lead to the deletion or alteration of data. Likewise, paragraph (d)'s heading now refers to “protection requirements,” rather than “download protection requirements,” to make clear this paragraph's requirements address measures to protect the integrity of the recording system more than just protecting against unauthorized downloads. In addition, as stated above in Section II.R (Download and Security Features of Locomotive Recording Systems), the reference to standard memory modules in this paragraph was proposed in error and has not been retained.
FRA is also adding paragraphs (d)(1) and (2) to clarify when required image recording and voluntarily installed audio recording devices on lead locomotives must comply with paragraph (d)'s requirements. Paragraph (d)(1) includes requirements for image recording devices on lead locomotives, while paragraph (d)(2) addresses requirements for voluntarily installed audio recording devices on the same locomotives. The language FRA is adopting in paragraphs (d)(1) and (2) is nearly identical to that which FRA is adopting in paragraphs (a)(5)(i) and (ii). Similar to those new paragraphs, which are discussed above, FRA is adding these paragraphs to paragraph (d) because the NPRM was unclear when voluntarily installed audio recording devices on lead locomotives in commuter or intercity passenger service would have to meet the paragraph's requirements.
In paragraph (e), FRA is modifying paragraph (e)(1) so that it directly references the requirements in paragraph (i) for the removal from service and handling for repair of inward- and outward-facing image recording systems. FRA had initially proposed referencing the daily inspection requirements in § 229.21 (Daily inspection). However, as discussed in Section II.I (Repairing, Replacing, or Removing Locomotive Image Recording Devices From Service), FRA has modified the requirements for the removal from service and handling for repair of inward- and outward-facing image recording systems on long-distance intercity passenger trains, as specified in paragraph (i) of this section.
FRA is also modifying paragraph (e)(2)'s requirements based on comments it received, which are discussed above in Section II.S (Self-Monitoring and Self-Reporting Systems or Devices on Locomotive Image Recording Systems). Specifically, paragraph (e)(2) makes clear that the required sample download(s) must be taken directly from the image recording system's crashworthy memory module, or FRA-approved remote storage system, to confirm proper operation of the system. Paragraph (e)(2) also now provides for taking the required sample
Information concerning the results of this annual test must be entered on new Form FRA F 6180-49AP in a row specifically dedicated for this purpose. The added row on the new form parallels, and is directly below, the row for entering information concerning the results of event recorder tests required by §§ 229.25(d) and 229.27(c), and provides for entering the same information as for other required tests.
In paragraph (f), the exception to a railroad's use of image or audio recording device data in paragraph (f)(2)(ii) applies by direction of FRA or “another Federal agency,” including but not limited to the NTSB. This change is consistent with the use of similar forms of “another Federal agency” throughout paragraph (f)(2) and clarifies that another Federal agency is not limited to the NTSB. FRA is also modifying the language in paragraph (f)(3)(vii) to make clear that a railroad may perform inspection, testing, maintenance, or repair activities on an “image or audio recorder,” and not only an “inward-facing image recorder” as stated in the NPRM, to ensure proper installation and functioning. Passenger railroads may of course perform such activities on inward- or outward locomotive image or audio recording devices at any time.
In paragraph (g), FRA is requiring a “description” of the technical aspects of any locomotive image recording system intended to comply with this section, rather than a “written description” as proposed in the NPRM. In addition, paragraph (g) specifies an email address rather than a mailing address for submitting the description to FRA. FRA has made these changes to encourage and promote the electronic submission of the information to FRA. This final rule also clarifies that railroads should submit to FRA a description of the technical aspects of any locomotive image recording system “intended” to comply with the section, rather than after a recording system has been “installed,” as stated in the NPRM. FRA revised this language as it is rational that railroads would seek FRA's approval of their locomotive image recording systems before spending money to install a potentially non-approved system on their locomotives.
Further, FRA is correcting paragraph (g)(2)'s submission date requirements, to address an inadvertent error in the proposed rule, and also modifying paragraph (g)(3) to make clear that FRA must review a railroad's submission and approve any locomotive image recording system before the system can be installed or put into service in compliance with this section. Please see Section II.J (FRA Approval Process for Locomotive Image Recording Systems and Devices) above, for more detailed discussion of these revisions.
In paragraph (i), FRA is inserting the word “alone” into the regulatory text to clarify that a locomotive with only an out-of-service image recording device is not considered to be in an improper condition, unsafe to operate, or a non-complying locomotive under §§ 229.7 and 229.9. However, as unchanged from the NPRM, paragraph (i) also makes clear that a railroad must remove the device from service if the railroad knows the device is not properly recording. Further, when a railroad removes a locomotive image recording device from service, a qualified person must record the date the device was removed from service under the REMARKS section of Form FRA F 6180-49AP—not Form FRA F 6180-49A. For a more extensive discussion of this requirement, please see Sections II.H (Notice Provided When Locomotive Recording Devices Are Present) and II.I.3 (Documenting When a Locomotive Image Recording Device Has Been Removed From Service), above.
In addition, except for long-distance intercity passenger trains, a locomotive with a defective image recording device may remain as the lead locomotive only until the next calendar-day inspection required under § 229.21. This includes a lead locomotive in a commuter train with an image recording device found defective at an outlying inspection point, which may remain as the train's lead locomotive only until the next calendar-day inspection required under § 229.21. As discussed above in Section II.I (Repairing, Replacing, or Removing Locomotive Image Recording Devices From Service), FRA has expanded the movement-for-repair allowance for a long-distance intercity passenger train's lead locomotive with a defective image recording device so that it may remain as the lead locomotive until arrival at its destination terminal or its nearest forward point of repair, whichever occurs first.
FRA notes that the rule does not specify how a railroad shall indicate on the F 6180-49AP form when a locomotive image recording device is returned to service. This is intended to provide railroads the flexibility to denote this information in the REMARKS or the REPAIRS section of the F 6180-49AP form, or in an equivalent location.
FRA is adding paragraph (l) to exclude from compliance with the requirements of this section freight locomotives acting as passenger locomotives when they are performing rescue operations for intercity or commuter passenger trains. Please see the above discussion in Section II.A.3 (Application of Requirements to Freight Locomotives Performing Rescue Operations).
Finally, FRA is revising the introductory paragraph of appendix D to part 229 to clarify that data from image and voluntarily-installed audio recording systems must be recorded on a certified crashworthy memory module or on an alternative, remote storage system that provides equivalent data protections and is approved by FRA.
Consistent with the revisions made to part 229 in this final rule, FRA is adding three new definitions to part 299: “Event recorder memory module”, “Image recording system”, and “Recording device”. These define key components of what comprises the image recording system and are substantively similar to the definitions of the same terms in § 229.5. The definitions in part 299 differ only slightly from those in part 229 to reflect editorial revisions to harmonize the definitions with the rest of part 299.
Section 299.449 is based on § 229.136. Similar to § 229.136, FRA is requiring all TCRR high-speed passenger trainsets used in revenue service to be equipped with an image recording system as described under § 299.449 prior to commencing revenue operations. However, because TCRR is not yet operating, it does not need to avail itself of an implementation period for this requirement, as in § 229.136(a), and FRA has not included one.
As provided in § 229.136(a)(3), if a locomotive is equipped with an image or audio recording system, that fact must be annotated on the locomotive's Form FRA F 6180-49AP. FRA is not including this annotation requirement in § 299.449, however, as TCRR is not required to use Form FRA F 6180-49AP.
FRA has also revised the language in § 299.449(a)(4) to clarify that TCRR's locomotive image recording device data must recorded on either a certified crashworthy memory module or an alternative, remote storage system that provides at least equivalent data protections and has been approved by FRA under § 299.449(g).
In commenting on the TCRR NPRM, TCRR stated that the resolution
FRA notes that TCRR raises issues that were not fully considered for an exclusive, high-speed passenger rail system. Accordingly, and consistent with FRA's approach to regulating TCRR as a system, FRA is requiring the railroad to develop and define certain image recording system requirements for inclusion in its inspection, testing, and maintenance program. Specifically, § 299.449(b)(4) requires TCRR to define the resolution requirements for outward-facing image recording devices in its inspection, testing, and maintenance program. TCRR must ensure such requirements provide sufficient resolution to determine the position of switch points 50 feet in advance of the trainset (wherever the outward-facing image recording device may be located) while operating at speeds of 170 km/h (106 mph) or below (TCRR track class H4 and below), and to capture images in daylight or with normal nighttime illumination from the trainset's headlight, required by § 299.433. As the resolution requirements adopted under § 229.136(b)(1)(iii) are not specifically attuned to exclusively higher speed passenger rail operations as contemplated by TCRR, FRA has taken into account the conditions under which the outward-facing image recording devices are expected to operate. FRA notes that, with respect to switches, facing-point diverging moves present an increased risk of derailment, or other accident/incident, compared to other types of moves through a switch, and TCRR's outward-facing image recording devices must therefore be able to capture the position of the switch points. However, FRA is also sensitive to TCRR's concern that at the proposed maximum operating speeds of 330 km/h (205 mph), it may be difficult for an image recording device to capture useful images so close to the leading edge of the trainset. Further, under TCRR's proposed system, facing-point (switch) diverging moves would occur most commonly when entering a station location, at lower speeds. Thus, FRA believes it has harmonized the requirements for outward-facing image recording devices so that they are suitable for TCRR while still capturing images of the more crucial movements along TCRR's right-of-way.
Additionally, § 299.449(c)(1)(i) provides that TCRR will define the resolution requirements for its inward-facing image recording devices in its inspection, testing, and maintenance program, ensuring sufficient resolution to record crewmember actions, including under the lighting conditions specified in § 299.449(c)(1)(iii).
TCRR commented on the periodic inspection and download requirements in proposed paragraph § 229.136(e)(2) to take sample downloads of the image recording system to confirm operation of the system. TCRR agreed with APTA's comment on the part 229 proposal,
Finally, § 299.449(i) addresses the removal of an image recording system or device from service and handling for repair. In commenting on proposed § 229.136(i), the part 229 counterpart to this section, TCRR essentially echoed APTA's comments on the proposal.
Initially, FRA notes that a requirement to repair or replace a defective image recording device or system by the next pre-service inspection would mirror the requirement for event recorders under § 299.439(d). Additionally, FRA is treating the image recording system as a safety device under part 218 and, accordingly, expects that the railroad will make preparations to be able to repair or replace a non-functioning image recording device or system within the timeframe permitted under the regulation. FRA is also treating TCRR trainsets similar to Amtrak's semi-permanently coupled, high-speed trainsets operated exclusively in a designated rail corridor, which are not subject to § 229.136(i)'s exception for long-distance intercity passenger trains.
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The distinction between the above examples is that in Example 2, there is no cab end that can serve as the leading end for trainset A while operating in revenue service.
Finally, FRA has added paragraphs (k)(1) and (2) to provide the same employee protections as described under § 217.9(b)(3) and (4). As the rationale for the requirements is the same as discussed under § 217.9(b)(3) and (4), FRA will rely on that discussion without repeating here. FRA's omission of paragraph (k) in the NPRM to provide these protections expressly was inadvertent, and notes that there are some minor differences between paragraph (k) and § 217.9(b)(3) and (4) only to harmonize the language with that used in part 299 for TCRR.
FRA is revising the introductory paragraph of appendix A to part 299 to harmonize the language of the appendix with the introductory paragraph of appendix D to part 229, reflecting the changes made in this final rule.
This final rule was designated as significant by the Office of Information and Regulatory Affairs. The final rule follows the direction of Executive Order 13563, which emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. However, FRA was unable to determine how effective locomotive image recording devices will be at reducing accidents. Thus, instead of presenting the quantifiable benefits, FRA presents the benefits qualitatively, as discussed further below. Details on the estimated costs of this final rule can be found in the rule's economic analysis.
This final rule directly responds to the Congressional mandate in section 11411 of the FAST Act that FRA, by delegation from the Secretary, require each railroad that provides intercity rail passenger or commuter rail passenger transportation to install image recording devices on the controlling locomotives of its passenger trains. The requirements of this final rule, as applied to passenger trains, are directly or implicitly required by the Statute and will promote railroad safety.
FRA has prepared and placed an RIA addressing the economic impact of this final rule in the rulemaking docket (Docket no. FRA-2016-0036). The RIA provides estimates of the costs of this final rule that are likely to be incurred over a ten-year period. FRA estimates the low- and high-range costs of this final rule using discount rates of 3 and 7 percent in the tables below.
As discussed in the preamble above, FRA may consider crashworthiness protection requirements unnecessary (or met) in the future for passenger locomotive image recording device memory modules if recorded data is stored at a remote location away from a locomotive consist, safe from accident destruction. FRA did not require this option because the agency does not believe current technology would reliably allow for such remote transmission and storage in all instances, and such a system would likely be much costlier to develop in order to transfer the recorded data to a centralized location.
In the 2015 Amtrak accident in Philadelphia, Pennsylvania, image recording devices could have helped provide additional causal information during the post-accident investigation. Causal data is especially critical for the prevention of future accidents when no apparent accident cause can be determined through other means. Further, images can become key to identifying new safety concerns that otherwise would be difficult to research or identify, which could lead FRA and the railroad industry to better understand areas in which safety could be improved. Other safety benefits will also primarily accrue from the deterrence of unsafe behaviors that cause railroad accidents. For instance, the presence of locomotive image recording devices could have deterred the engineer from text messaging while operating the Metrolink train involved in the 2008 accident at Chatsworth, California. In the RIA, FRA discusses and provides examples of how the deterrent effect of locomotive image recording devices could reduce negative behavior because train crews know their actions are being recorded.
The primary source of expected benefits is the potential reduction in safety risk. FRA conducted a literature review to determine the effectiveness rate of inward- and outward-facing recording devices, but was unable to determine an appropriate rate. The benefits for the final rule are qualitatively discussed. The reduction in safety risk is expected to come primarily from the change in crew behavior. Railroads can deter unsafe behavior if crewmembers realize their actions may be observed on a frequent, but random, basis by railroad supervisors. Locomotive image recorders cannot directly prevent an accident from occurring, but rather can provide investigators with information after an accident occurs that can help to prevent future accidents of that type from occurring.
Although FRA is declining to require locomotive recording devices in freight locomotives, many freight railroads have informed FRA the above reasons are why railroads install camera systems even without an FRA regulation. FRA's analysis shows there are many factors that are difficult to quantify that combine to warrant the final rule.
The Regulatory Flexibility Act of 1980 (5 U.S.C. 601
Under section 312 of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121, FRA has issued a final policy statement that formally establishes “small entities” as railroads that meet the line-haulage revenue requirements of a Class III railroad, which is $20 million or less in inflation-adjusted annual revenues, and commuter railroads or small governmental jurisdictions that serve populations of 50,000 or less.
This final rule will apply to railroad carriers that provide regularly scheduled intercity rail or commuter rail passenger transportation to the public. FRA notes that one passenger railroad is considered a small entity: the Hawkeye Express (operated by the Iowa Northern Railway Company). All other passenger railroad operations in the United States are part of larger governmental entities whose service jurisdictions exceed 50,000 in population, and, based on the definition, are not considered small entities. Hawkeye Express is a short-haul passenger railroad that does not provide commuter or intercity passenger service, and therefore will not be affected by the final rule. Additionally, the Hawkeye Express has not been in operation for at least the past two years. FRA does not believe that the provisions of the final rule will significantly impact a substantial number of small entities.
FRA invited all interested parties to submit comments, data, and information demonstrating the potential economic impact on any small entity that would result from the adoption of the final rule. During the NPRM comment period, FRA did not receive any comments from the public or stakeholders regarding the impact that the final rule would have on small entities.
Accordingly, the FRA Administrator hereby certifies this rule will not have a significant economic impact on a substantial number of small entities.
The information collection requirements in this final rule are being submitted to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
All estimates
For information or a copy of the paperwork package submitted to OMB, contact Ms. Arlette Mussington, Information Collection Clearance Officer, at email:
Organizations and individuals desiring to submit comments on the collection of information requirements should direct them to Ms. Arlette Mussington, Information Collection Clearance Officer, at email:
OMB must make a decision concerning the collection of information requirements contained in this rule between 30 and 60 days after publication of this document in the
FRA is not authorized to impose a penalty on persons for violating information collection requirements that do not display a current OMB control number, if required. The current OMB control number for this rule is 2130-0035.
Executive Order 13132, “Federalism” (64 FR 43255, Aug. 10, 1999), requires FRA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” are defined in the Executive Order to include regulations that have “substantial direct effects on the States,
FRA has analyzed this final rule under the principles and criteria contained in Executive Order 13132. This final rule could affect State and local governments to the extent that they sponsor, or exercise oversight of, passenger railroads. Because this final rule is required by Federal statute for passenger railroads under 49 U.S.C. 20168, the consultation and funding requirements of Executive Order 13132 do not apply. However, this final rule could have preemptive effect by operation of law under certain provisions of the Federal railroad safety statutes, specifically the former Locomotive Inspection Act and the former Federal Railroad Safety Act of 1970, repealed and recodified at 49 U.S.C. 20701
In sum, FRA has analyzed this final rule under the principles and criteria in Executive Order 13132. As explained above, FRA has determined this final rule has no federalism implications, other than the possible preemption of State laws under Federal railroad safety statutes, specifically 49 U.S.C. 20701
Consistent with the National Environmental Policy Act (NEPA; 42 U.S.C. 4321
The purpose of this rulemaking is to require commuter and intercity passenger railroads to install recording devices on locomotives in compliance with this rule and use those devices to help investigate and prevent railroad accidents. This rule does not directly or indirectly impact any environmental resources and will not result in significantly increased emissions of air or water pollutants or noise. In analyzing the applicability of a CE, FRA must also consider whether unusual circumstances are present that would warrant a more detailed environmental review.
Pursuant to Section 106 of the National Historic Preservation Act and its implementing regulations, FRA has determined this undertaking has no potential to affect historic properties.
Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, and DOT Order 5610.2C (require DOT agencies to achieve environmental justice as part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects, including interrelated social and economic effects, of their programs, policies, and activities on minority populations and low-income populations. The DOT Order instructs DOT agencies to address compliance with Executive Order 12898 and requirements within the DOT Order in rulemaking activities, as appropriate. FRA has evaluated this final rule under Executive Order 12898 and the DOT Order and has determined it will not cause disproportionately high and adverse human health and environmental effects on minority populations or low-income populations.
FRA has evaluated this final rule under the principles and criteria in Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, dated November 6, 2000. The final rule will not have a substantial direct effect on one or more Indian tribes, will not impose substantial direct compliance costs on Indian Tribal Governments, and will not preempt tribal laws. Therefore, the funding and consultation requirements of Executive Order 13175 do not apply, and a tribal summary impact statement is not required.
Under Section 201 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 2 U.S.C. 1531), each Federal agency “shall, unless otherwise prohibited by law, assess the effects of Federal regulatory actions on State, local, and tribal governments, and the private sector (other than to the extent that such regulations incorporate requirements specifically set forth in
Executive Order 13211 requires Federal agencies to prepare a Statement of Energy Effects for any “significant energy action.”
The Trade Agreements Act of 1979 (Pub. L. 96-39, 19 U.S.C. 2501
Pursuant to the Congressional Review Act (5 U.S.C. 801
Occupational safety and health, Penalties, Railroad employees, Railroad safety, Reporting and recordkeeping requirements.
Locomotives, Occupational safety and health, Penalties, Railroad employees, Railroad safety, and Tampering.
Locomotives, Penalties, Railroad employees, Railroad safety, Reporting and recordkeeping requirements.
High-speed rail, Railroad safety, Reporting and recording requirements, Tokaido Shinkansen.
For the reasons discussed in the preamble, FRA is amending chapter II, subtitle B of title 49, Code of Federal Regulations, as follows:
The authority citation for part 217 is revised to read as follows:
(b) * * *
(3) A passenger railroad that utilizes inward-facing locomotive image or in-cab audio recordings to conduct operational tests and inspections shall adopt and comply with a procedure in its operational tests and inspections program that ensures employees are randomly subject to such operational tests and inspections involving image or audio recordings. The procedure adopted by a passenger railroad must:
(i) Establish objective, neutral criteria to ensure every employee subject to such operational tests and inspections is selected randomly for such operational tests and inspections within a specified time frame;
(ii) Not permit subjective factors to play a role in selection,
(iii) Require that any operational test or inspection using locomotive image or audio recordings be performed within 72 hours of the completion of the employee's tour of duty that is the subject of the operational test. Any operational test performed more than 72 hours after the completion of the tour of duty that is the subject of the test is a violation of this section. The 72-hour limitation does not apply to investigations of railroad accidents/incidents or to violations of Federal railroad safety laws, regulations, or orders, or any criminal laws.
(4) FRA may review a passenger railroad's procedure implementing paragraph (b)(3) of this section, and, for cause stated, may disapprove such procedure under paragraph (h) of this section.
49 U.S.C. 20103, 20107, 20131, 20138, 20144, 20168; 28 U.S.C. 2461 note; and 49 CFR 1.89.
(c)
(d) The provisions in §§ 218.59 and 218.61 do not apply to locomotive-mounted image or audio recording equipment on freight locomotives.
(c) If a locomotive in commuter or intercity passenger service is equipped with a device to record data concerning the operation of that locomotive or the train it is powering, that device may be deactivated only under the provisions of § 229.135 of this chapter. Inward- and outward-facing image recording devices on commuter or intercity passenger
* * * This regulation applies to a variety of devices including equipment known as “event recorders,” “alerters,” “deadman controls,” “automatic cab signal,” “cab signal whistles,” “automatic train stop equipment,” “automatic train control equipment,” “positive train control equipment,” and “passenger locomotive-mounted image and audio recording equipment.” * * *
49 U.S.C. 20103, 20107, 20133, 20137-38, 20143, 20168, 20701-03, 21301-02, 21304, 28 U.S.C. 2461, note; and 49 CFR 1.89.
(a) Except for MU locomotives, each locomotive in use shall be inspected at least once during each calendar day. A written report of the inspection shall be made. This report shall contain the name of the carrier; the initials and number of the locomotive; the place, date and time of the inspection; a description of the non-complying conditions disclosed by the inspection; and the signature of the employee making the inspection. Except as provided in §§ 229.9, 229.136, 229.137, and 229.139, any conditions that constitute non-compliance with any requirement of this part shall be repaired before the locomotive is used. Except with respect to conditions that do not comply with §§ 229.136, 229.137, or 229.139, a notation shall be made on the report indicating the nature of the repairs that have been made. Repairs made for conditions that do not comply with §§ 229.136, 229.137, or 229.139 may be noted on the report, or in electronic form. The person making the repairs shall sign the report. The report shall be filed and retained for at least 92 days in the office of the carrier at the terminal at which the locomotive is cared for. A record shall be maintained on each locomotive showing the place, date and time of the previous inspection.
(b) Each MU locomotive in use shall be inspected at least once during each calendar day and a written report of the inspection shall be made. This report may be part of a single master report covering an entire group of MU locomotives. If any non-complying conditions are found, a separate, individual report shall be made containing the name of the carrier; the initials and number of the locomotive; the place, date, and time of the inspection; the non-complying conditions found; and the signature of the inspector. Except as provided in §§ 229.9, 229.136, 229.137, and 229.139, any conditions that constitute non-compliance with any requirement of this part shall be repaired before the locomotive is used. Except with respect to conditions that do not comply with §§ 229.136, 229.137, or 229.139, a notation shall be made on the report indicating the nature of the repairs that have been made. Repairs made for conditions that do not comply with §§ 229.136, 229.137, or 229.139 may be noted on the report, or in electronic form. A notation shall be made on the report indicating the nature of the repairs that have been made. The person making the repairs shall sign the report. The report shall be filed in the office of the carrier at the place where the inspection is made or at one central location and retained for at least 92 days.
(a)
(b)
(2) For purposes of complying with the inspection, testing, and repair recordkeeping requirements in §§ 229.23, 229.27, 229.29, 229.31, 229.33, 229.55, 229.103, 229.105, 229.114, 229.123, and 229.135 with respect to Form FRA F 6180-49A, each locomotive subject to the requirements of § 229.136 shall instead use and maintain Form FRA F 6180-49AP no later than October 12, 2027.
(c)
(d)
(a)
(i) If the lead locomotive is equipped with an image recording system, the system must be turned on and recording whenever a train is in motion, at all train speeds.
(ii) If operating circumstances cause the controlling locomotive to be other than the lead locomotive, railroads must
(iii) Both cabs of a dual-cab locomotive shall be equipped with inward- and outward-facing image recording systems. Image recordings for only a dual-cab locomotive's active cab and the leading end of the locomotive's movement are required to be made and retained.
(2) Image recording systems installed after October 12, 2024, on new, remanufactured, or existing lead locomotives used in commuter or intercity passenger service shall meet the requirements of this section. Lead locomotives used in commuter or intercity passenger service must be equipped with an image recording system meeting the requirements of this section no later than October 12, 2027.
(3) For lead locomotives in commuter or intercity passenger service, railroads must note the presence of any image or audio recording systems in the REMARKS section of Form FRA F 6180-49AP in the locomotive cab.
(4) As required under paragraph (a)(1) or (2) of this section, the image recording system shall record at least the most recent 12 hours of operation of a lead locomotive in commuter or intercity passenger service.
(5) Locomotive recording device data for each lead locomotive used in commuter or intercity passenger service shall be recorded on a memory module meeting the requirements for a certified crashworthy event recorder memory module described in appendix D to this part, or on an alternative, remote storage system that provides at least equivalent data protections and is approved by FRA under paragraph (g) of this section.
(i) Paragraph (a)(5) of this section applies to locomotive image recording systems as required under paragraph (a)(1) or (2) of this section.
(ii) Audio recording systems installed after October 12, 2024, on new, remanufactured, or existing lead locomotives used in commuter or intercity passenger service shall meet the requirements of paragraph (a)(5) of this section. Audio recording systems installed on lead locomotives in commuter or intercity passenger service must meet the requirements of paragraph (a)(5) of this section no later than October 12, 2027.
(b)
(i) Include an image recording device aimed parallel to the centerline of tangent track within the gauge on the front end of the locomotive;
(ii) Be able to distinguish the signal aspects displayed by wayside signals;
(iii) Record at a minimum frame rate of 15 frames per second (or its equivalent) and have sufficient resolution to record the position of switch points 50 feet in front of the locomotive;
(iv) Be able to capture images in daylight or with normal nighttime illumination from the headlight of the locomotive; and
(v) Include an accurate time and date stamp on image recordings.
(2) If a lead locomotive in commuter or intercity passenger service experiences a technical failure of its outward-facing image recording system, then the system shall be removed from service and handled in accordance with paragraph (i) of this section.
(c)
(i) Have sufficient resolution to record crewmember actions;
(ii) Record at a minimum frame rate of 5 frames per second;
(iii) Be capable of using ambient light in the cab, and when ambient light levels drop too low for normal operation, automatically switch to infrared or another operating mode that enables the recording sufficient clarity to comply with the requirements of this paragraph (c)(1); and
(iv) Include an accurate time and date stamp on image recordings.
(2) No image recordings may be made of any activities within a locomotive's sanitation compartment as defined in § 229.5, and no image recording device shall be installed in a location where the device can record activities within a sanitation compartment.
(3) If a lead locomotive in commuter or intercity passenger service experiences a technical failure of its inward-facing image recording system, the system shall be removed from service and handled in accordance with paragraph (i) of this section.
(d)
(1) Paragraph (d) of this section applies to locomotive image recording systems as required under paragraph (a)(1) or (2) of this section.
(2) Audio recording systems installed after October 12, 2024, on new, remanufactured, or existing lead locomotives used in commuter or intercity passenger service shall meet the requirements of paragraph (d) of this section. Audio recording devices installed on lead locomotives in commuter or intercity passenger service must meet the requirements of paragraph (d) of this section no later than October 12, 2027.
(e)
(1) If a fault with the image recording system is detected, the locomotive may be used in the lead position only in accordance with paragraph (i) of this section.
(2) As required under paragraph (a)(1) or (2) of this section, at each annual test required under § 229.27, the railroad conducting the inspection shall take sample download(s) from the image recording system's crashworthy event recorder memory module, or an FRA-approved equivalent under paragraph (g) of this section, to confirm proper operation of the system, and, if necessary, repair the system to full operation.
(f)
(2)
(i) The original downloaded data file, or an unanalyzed exact copy of it, is retained in secure custody under the railroad's procedure adopted under paragraph (f)(1) of this section; and
(ii) The original downloaded data file, or an unanalyzed exact copy of it, is not utilized for any other purpose, except by direction of FRA or another Federal agency.
(3)
(i) Investigate an accident/incident that is required to be reported to FRA under part 225 of this chapter;
(ii) Investigate a violation of a Federal railroad safety law, regulation, or order, or a railroad's operating rules and procedures;
(iii) Conduct an operational test under § 217.9 of this chapter;
(iv) Monitor for unauthorized occupancy of a locomotive's cab or a control cab locomotive's operating compartment;
(v) Investigate a violation of a criminal law;
(vi) Assist Federal agencies in the investigation of a suspected or confirmed act of terrorism; or
(vii) Perform inspection, testing, maintenance, or repair activities to ensure the proper installation and functioning of an image or audio recorder.
(g)
(1) The description must include information specifically addressing the image recording system's:
(i) Minimum 12-hour continuous recording capability;
(ii) Crashworthiness; and
(iii) Post-accident accessibility of the system's recordings.
(2) The railroad must submit the statement not less than 90 days before the installation of such image recording system, or, for existing systems, not more than 60 days after November 13, 2023.
(3) The FRA Associate Administrator for Railroad Safety and Chief Safety Officer will review a railroad's submission and must approve any locomotive image recording system intended to comply with this section before the system can be installed or put into service. FRA may disapprove any locomotive image recording systems that do not meet the requirements of this section.
(h)
(i)
(j)
(k)
(2) Multiple locomotives coupled together; or
(3) One or more locomotives coupled with one or more cars.
(l)
Section 229.135(b) requires railroads to equip certain locomotives with an event recorder that includes a certified crashworthy event recorder memory module. Section 229.136(a)(1) requires passenger railroads to install locomotive-mounted image recording systems in every lead locomotive used in commuter or intercity passenger service. As required by § 229.136(a)(5), data from these image and voluntarily installed audio recording systems must be recorded on a certified crashworthy memory module or on an alternative, remote storage system that provides at least equivalent data protections and is approved by FRA under § 229.136(g). This appendix prescribes the requirements for certifying an event recorder memory module (ERMM) or a locomotive-mounted audio and/or image recording device memory module as crashworthy. For purposes of this
49 U.S.C. 20103, 20107, 20133, 20141, 20302-20303, 20306, 20701-20702, 21301-21302, 21304; 28 U.S.C. 2461, note; and 49 CFR 1.89.
(a)
(i) Outward-facing image recording devices capable of recording images of the right-of-way ahead of the trainset in the direction of travel as further described in paragraph (b) of this section; and,
(ii) Inward-facing image recording devices capable of recording images of crewmember activities inside the leading trainset cab as further described in paragraph (c) of this section.
(2) The image recording system must be turned on and recording whenever a trainset is in motion, at all speeds. If operating circumstances cause the controlling cab to be other than the cab of the leading end of the trainset, the railroad must also record images of activities inside the controlling cab.
(3) The trainset image recording system shall record at a minimum the most recent 12 hours of operation of a leading trainset cab used in revenue service.
(4) Image recording device data for each leading trainset cab used in revenue service shall be recorded on a memory module meeting the requirements for a certified crashworthy event recorder memory module described in appendix A to this part or on an alternative, remote storage system that provides at least equivalent data protections and is approved by FRA under paragraph (g) of this section.
(b)
(1) Include an image recording device aimed parallel to the centerline of tangent track within the gauge on the leading end of the trainset;
(2) Be able to distinguish the signal aspects displayed by go/no-go signals;
(3) Record at a minimum frame rate of 15 frames per second (or its equivalent);
(4) Have sufficient resolution, as defined by the railroad in the railroad's inspection, testing, and maintenance program under § 299.445, to record the position of switch points in advance of the trainset at speeds of 170 km/h (106 mph) and below, and to capture images in daylight or with normal nighttime illumination from the headlight of the trainset; and
(5) Include an accurate time and date stamp on image recordings.
(c)
(i) Have sufficient resolution, as defined in the railroad's inspection, testing, and maintenance program under § 299.445, to record crewmember actions;
(ii) Record at a minimum frame rate of 5 frames per second;
(iii) Be capable of using ambient light in the cab, and when ambient light levels drop too low for normal operation, automatically switch to infrared or another operating mode that enables the recording sufficient clarity to comply with the requirements of this paragraph (c)(1); and
(iv) Include an accurate time and date stamp on image recordings.
(2) Inward-facing image recording devices shall not be installed in a location where the device can record activities within a trainset cab's sanitation compartment, as defined in § 229.5 of this chapter, and shall not be used to make recordings of any activities within a trainset cab's sanitation compartment.
(3) If a leading trainset cab used in revenue service experiences a technical failure of its inward-facing image recording system, then the system shall be removed from service and handled in accordance with paragraph (i) of this section.
(d)
(e)
(2) Periodic inspection requirements for the trainset image recording system shall be defined in the railroad's inspection, testing, and maintenance program required under § 299.445. As part of the periodic inspection, the railroad shall take sample download(s) from the image recording system's crashworthy memory module to confirm proper operation of the system, and, if necessary, repair the system to full operation.
(f)
(2)
(i) The original downloaded data file, or an unanalyzed exact copy of it, is retained in secure custody under the railroad's procedure adopted under paragraph (f)(1) of this section; and
(ii) It is not utilized for analysis or any other purpose, except by direction of FRA or another Federal agency.
(3)
(i) Investigate an accident/incident that is required to be reported to FRA under part 225 of this chapter;
(ii) Investigate a violation of a Federal railroad safety law, regulation, or order, or the railroad's operating rules and procedures;
(iii) Conduct an operational test under § 299.505;
(iv) Monitor for unauthorized occupancy of a trainset's cab or operating compartment;
(v) Investigate a violation of a criminal law;
(vi) Assist Federal agencies in the investigation of a suspected or confirmed act of terrorism; or
(vii) Perform inspection, testing, maintenance, or repair activities to ensure the proper installation and functioning of an image or audio recorder as required under paragraph (e)(2) of this section.
(g)
(1) The description must specifically address the image recording system's—
(i) Minimum 12-hour continuous recording capability;
(ii) Crashworthiness; and
(iii) Post-accident accessibility of the system's recordings.
(2) The railroad must submit the written statement not less than 90 days before the installation of such image recording system.
(3) The Associate Administrator will review the railroad's description and may approve, or disapprove, the image recording system if it does not meet the requirements of this section. FRA may disapprove any recording systems that do not meet the requirements of this section.
(h)
(i)
(i) May remove from service the entire image recording system or an image recording device in a leading trainset cab used in revenue service for any reason.
(ii) Must remove from service the entire image recording system or an image recording device in a leading trainset cab used in revenue service if the railroad knows the system or device is not properly recording.
(2) When a railroad removes the entire image recording system or an image recording device in a leading trainset cab used in revenue service from service, a qualified person shall record the date the system or device was removed from service in the trainset's maintenance records.
(3) A trainset on which the entire image recording system, or an image recording device in a leading trainset cab used in revenue service, has been taken out of service as provided in paragraphs (i)(1)(i) or (ii) of this section may be used as a leading trainset cab in revenue service only until the next pre-service inspection required under the railroad's inspection, testing, and maintenance program.
(4) A trainset with an image recording device that has been taken out of service on only one cab end may be used in revenue service beyond the next pre-service inspection without repair provided the other cab end is the leading end of the trainset and the image recording system is otherwise operative for that cab end.
(5) A trainset with an inoperative image recording device alone is not deemed to be in an improper condition, unsafe to operate, or non-complying under § 299.447. However, a trainset with an entire image record system taken out of service or image recording devices taken out service in both cab ends, may not be used in revenue service beyond the next pre-service inspection required under the railroad's inspection, testing, and maintenance program without repair or replacement of the non-operative system or devices.
(j)
(k)
(i) Establish objective, neutral criteria to ensure every employee subject to such operational tests and inspections is selected randomly for such operational tests and inspections within a specified time frame;
(ii) Not permit subjective factors to play a role in selection,
(iii) Require that any operational test or inspection using trainset image or audio recordings be performed within 72 hours of the completion of the
(2) FRA may review the railroad's procedure implementing paragraph (k)(1) of this section, and, for cause stated, may disapprove such procedure under § 299.505(h).
Section 299.439(c) requires that trainsets be equipped with an event recorder that includes a certified crashworthy event recorder memory module. Section 299.449(a)(1) requires the railroad to install an image recording system in its trainsets used in revenue service. As required by § 299.449(a)(4), data from these image recording systems must be recorded on a certified crashworthy memory module or an alternative, remote storage system that provides at least equivalent data protections and is approved by FRA under § 299.15. This appendix prescribes the requirements for certifying an event recorder memory module (ERMM) or a trainset-mounted audio and/or image recording device memory module as crashworthy. For purposes of this appendix, a trainset-mounted audio or image recording system memory module is also considered an ERMM. This appendix includes the performance criteria and test sequence for establishing the crashworthiness of the ERMM as well as the marking of the event recorder containing the crashworthy ERMM.
Issued in Washington, DC.
Substance Abuse and Mental Health Services Administration (SAMHSA), Department of Health and Human Services (HHS).
Issuance of mandatory guidelines.
The Department of Health and Human Services (“HHS” or “Department”) has revised the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG), which published in the
The mandatory guidelines are effective February 1, 2024.
Eugene D. Hayes, Ph.D., MBA, SAMHSA, CSAP, DWP; 5600 Fishers Lane, Room 16N02, Rockville, MD 20857, by telephone (240) 276-1459 or by email at
These revised Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG) establish a process whereby the Department annually publishes the authorized drug testing panel (
The Department is publishing a separate Federal Register Notification (FRN) elsewhere in this issue of the
Pursuant to its authority under section 503 of Public Law 100-71, 5 U.S.C. 7301, and Executive Order 12564, HHS establishes the scientific and technical guidelines for Federal workplace drug testing programs and establishes standards for certification of laboratories engaged in drug testing for Federal agencies.
Using data obtained from the Federal Workplace Drug Testing Programs and HHS-certified laboratories, the Department estimates that 275,000 urine specimens are tested annually by Federal agencies. No Federal agencies are testing hair or oral fluid specimens at this time.
HHS originally published the Mandatory Guidelines for Federal Workplace Drug Testing Programs (hereinafter referred to as Guidelines or Mandatory Guidelines) in the
There was a 60-day public comment period following publication of the proposed UrMG, during which 22 commenters submitted 93 comments on the UrMG. These commenters were comprised of individuals, organizations, and private sector companies. The comments are available for public view at
The following comments were directed to the information and questions in the preamble.
The Department requested comments on its proposal to publish the drug testing panel separately from the UrMG in a
Eight commenters disagreed with publishing a revised drug testing panel without a public comment period, expressing concerns that stakeholders including individuals subject to federally regulated drug testing would not be given the opportunity to provide comment and that the Department would miss valuable input including information on costs and burden. Some of these commenters suggested alternate ways to permit public comment while enabling a quicker response to testing panel changes (
Consistent with current procedures, prior to making a change to the drug or biomarker testing panel, the Department will conduct a thorough review of the scientific and medical literature, and will solicit review and input from subject matter experts such as Responsible Persons (RPs) of HHS-certified laboratories, Medical Review Officers (MROs), research scientists, manufacturers of collection devices and/or immunoassay kits, as well as Federal partners such as the Department of Transportation (DOT), the Food and Drug Administration (FDA), and the Drug Enforcement Administration (DEA). Further, the Department plans to provide notice and opportunity for public comment regarding any proposed changes to the drug and biomarker testing panels as part of Drug Testing Advisory Board (DTAB) meetings and procedures.
Information regarding any proposed changes to the drug analyte and biomarker testing panels and a request for public comment will be included in an advance notice of the DTAB meeting published in the
The Department will make the final decision on any panel changes and include the effective date(s) in the annual Notification, to allow time for drug testing service providers (
Four commenters disagreed that HHS is exempt from the Administrative Procedure Act (APA) requirements. Two of these specifically stated that the Guidelines are subject to APA requirements because DOT is required to use the Guidelines for their transportation industry drug testing programs. The Department explained why the APA does not apply under the
Ten commenters were concerned that the Department will not allow sufficient time for stakeholders to implement changes (
In regard to the use of FDA-cleared immunoassay initial tests, two commenters suggested that federally regulated drug testing could fall under what they referred to as the FDA's Employment and Insurance exemption. The Department notes that, while some drugs of abuse test systems intended for employment and insurance testing are, under certain circumstances, exempt from the premarket notification procedures in 21 CFR part 807, subpart E, such exemptions do not apply to test systems intended for Federal drug testing programs. See 21 CFR part 862, subpart D. Applicant and HHS-certified test facilities must verify that test systems subject to FDA regulations are approved or otherwise cleared by FDA and, in addition, must validate test systems prior to use in accordance with requirements specified in the National Laboratory Certification Program (NLCP) Manuals for Urine Laboratories and Initial Instrumented Test Facilities (IITFs).
One commenter appeared to misinterpret the Department's testing panel proposal, objecting to the Department making changes to the testing panels each year. The Department plans to issue an annual Notification with the current testing panels and required nomenclature, but will make changes only when needed to ensure the continued effectiveness of Federal workplace drug testing programs, which may not be every year.
Four commenters specifically agreed with the need to streamline and improve processes for making changes to the testing panels. Three of these commenters expressed concern over the process for testing panel review and who would be involved, and suggested involving other stakeholders (
The other commenter suggested that the Department include additional prescriptive language in each annual Notification (
One commenter stated that testing panel changes would lead to an increase in incorrect information on the Federal CCF. The Department disagrees, noting that the Federal CCF does not include preprinted analyte names.
One of the commenters agreed with posting a Notification without a public comment period for added drugs, but disagreed with removing drugs from the testing panel without public comment. The commenter noted that entities (
See additional comments under Section 3.4 below.
The Department requested comments on its proposal to publish the biomarker testing panel separately from the UrMG in the
Two commenters disagreed with publishing a biomarker testing panel without a public comment period, expressing concerns that stakeholders would not be given the opportunity to provide comment and that the Department would miss valuable input including information on costs and burden.
Two other commenters specifically agreed with the need to streamline and improve processes for making changes to the testing panels, but suggested involving other stakeholders (
One commenter disagreed that HHS is exempt from the APA requirements. The Department has reviewed the comment and determined that no change is needed to the proposed Guidelines. The Department explained why the APA does not apply under the
Two commenters were concerned that the Department will not allow sufficient time for stakeholders to implement changes (
Two commenters suggested that the Department require all HHS-certified laboratories to perform standardized specimen validity and biomarker tests on all federally regulated specimens, and allow laboratories to choose whether to offer additional specialized tests upon MRO request on a case-by-case basis. This is consistent with current UrMG requirements for specimen validity testing. The Department is not requiring all certified laboratories to conduct biomarker testing at this time. However, if the drug testing industry identifies a need for such tests and an HHS-certified laboratory chooses to offer a biomarker test to their regulated clients, the Department will ensure that the tests provide scientifically valid and forensically defensible results and will revisit the need for requiring the test on all specimens.
The Department removed the additional decision point for codeine and morphine, adjusted the confirmatory test cutoff for morphine from 2,000 to 4,000 ng/mL, and removed the additional requirement for clinical evidence of illegal opioid use. The Department received one comment agreeing with these changes to the UrMG.
In Section 13.11, the Department added requirements for each MRO performing medical review services for Federal agencies to submit semiannual reports, in January and July of each year, of Federal agency specimens that were reported as positive for a drug or drug metabolite by the laboratory and verified as negative by the MRO, along with the reason for the negative verification (
Four commenters disagreed, stating that HHS had not clearly described the reason and the process for such reports. One commenter noted that the Department had not presented data documenting that MROs were incorrectly reporting specimens, and it was unclear how the reports could be matched to laboratory report information submitted to the National Laboratory Certification Program (NLCP). Another commenter was concerned that donors would be identifiable, and that “a database of legal drug use” would violate donor privacy. One of the commenters expressed concern over “unintended consequences” for DOT and state workplace drug testing programs, without further explanation.
One commenter disagreed on the basis of added costs and burden to MROs (
One commenter agreed that such reports could be beneficial, but suggested that MROs provide the same information as provided by laboratories to the NLCP. The commenter incorrectly stated that laboratories do not provide specimen identification numbers to the NLCP.
The Department has reviewed the comments and determined that no change is needed to the proposed Guidelines. To clarify, this reporting policy is only for Federal agency specimens, not DOT-regulated specimens. Further, the reports are not for all positive specimens, only for those specimens that were reported as positive by the laboratory and verified as negative by the MRO. The requested MRO information is sufficient to enable matching to HHS-certified laboratory information provided to the NLCP without identifying the donor. At this time, there is no system-wide mechanism for identifying MRO verification practices for Federal agency specimens that are inconsistent with the Mandatory Guidelines, so data on incorrect reporting is not available. The Department is not planning to share MRO-specific information, but may share statistical information and deidentified examples of incorrect reporting by various means (
The Department did not propose any changes to the UrMG in regard to marijuana testing, but received three comments from three commenters disagreeing with the current requirements. Two commenters supported medical use of marijuana. One commenter supported legalization of marijuana in general.
Current Federal law requires Federal agencies to test for marijuana under E.O. 12564 in their workplace drug testing programs. The Department also edited Section 13.5(c) to clarify that only prescription medications can be offered as a legitimate medical explanation for a positive drug test (as described under Section 13.5 below). No further edits are required at this time.
The Department has not included a discussion in the preamble of any sections for which public comments were not submitted or for minor wording changes (
Two commenters agreed and one disagreed with the Department's proposed revision to the Substituted Specimen definition in Section 1.5 to include specimens tested for a biomarker. The commenter who disagreed stated that there are situations in which a legitimate specimen may be reported as outside the standards for human specimens, and these should be reported as invalid. The Department has reviewed the comment and determined that no change is needed to the proposed Guidelines. The Department will follow the procedures summarized under
In Section 1.7(a), the Department proposed to remove two exceptions for reporting a refusal to test for a pre-employment test: a donor who fails to appear in a reasonable time and a donor who leaves the collection site before the collection process begins. Seven
Five commenters disagreed with the changes, noting that an applicant may fail to appear because they have taken a different job offer. The commenters noted that a refusal to test in the individual's record could prevent individuals from taking other job offers and/or require them to undergo unnecessary return-to-duty testing. The Department has reviewed the comments and determined that no change is needed. As stated in this section, the Federal agency determines a reasonable time for the donor to take the test, consistent with applicable agency regulations, and directs the individual accordingly. At the time an applicant is scheduled for a pre-employment drug test, or before, Federal agencies should provide the applicant with instructions on how to notify the agency in the event that they decide to withdraw their application or to not accept a job offer. Such instructions will allow the agency to cancel the drug test and help applicants avoid a refusal to test result.
One commenter noted that the Guidelines should state that the designated employer representative (DER) makes the determination of a refusal to test. The Department has reviewed the comment and determined that no change is needed. As stated in this section, the Federal agency takes action consistent with applicable agency regulations.
The Department revised Section 3.4 to describe the annual publication of the drug testing and biomarker testing panels and the nomenclature required for laboratory and MRO reports. Three commenters submitted four comments on the required nomenclature required for laboratory and MRO reports, which are addressed below. Comments on the testing panels are addressed under
In regard to the required nomenclature specified in the annual
The Department will establish required terminology based on correct scientific nomenclature for added analytes. As described under
One commenter stated that the Department should specify what constitutes an incorrect form, how a collector's signed memorandum must be submitted to correct submission of an incorrect CCF, and what actions an HHS-certified laboratory must take in response to an incorrect CCF. The Department has determined that no changes to the Guidelines are needed. The Department issues Guidance for Using the Federal CCF as part of the OMB-approved package and provides information and guidance specific to the current and expired versions of the Federal CCF, rather than including them in these Guidelines.
There were no comments on this section; however, the Department added a sentence in item h stating that a donor is not required to remove any items worn for faith-based reasons. This requirement will be specified for all authorized specimen types.
The Department did not propose any changes to this section. One commenter submitted a comment specifically agreeing with the existing UrMG requirement for laboratories to maintain substituted urine specimens for a period of one year after reporting. The comment appeared to be in response to DOT's February 28, 2022 notice of proposed rulemaking (NPRM) for transportation industry drug testing programs.
The Department did not propose any changes to this section; however, one commenter indicated that this section is unclear and needs substantial clarification regarding additional MRO training (
The Department has reviewed these comments and edited item b of this section to clarify that MROs must be trained on any revisions to the drug and biomarker testing panels. In regard to training, SAMHSA relies on the approved MRO certification entities to ensure that MROs certified by their organizations meet Guidelines requirements. Current documents on the SAMHSA website
The Department revised Section 13.5(d)(2) to clarify that passive exposure to any drug (not just marijuana smoke) and ingestion of food products containing a drug (not just those containing marijuana) are not acceptable medical explanations for a positive drug test. The Department also added Section 13.5(d)(2)(iii) to clarify that only prescription medications can be offered as a legitimate medical explanation for
In addition to the changes described above, the Department reordered UrMG Sections 13.8 and 13.9 to reflect the procedural order (
The potential impact that these Guidelines have on the Department of Transportation (DOT) and/or Nuclear Regulatory Commission (NRC) regulated industries depends on the extent to which these agencies incorporate the UrMG revisions into their regulatory programs. Therefore, analysis of the potential impact of these Guidelines on such programs falls under the regulatory purview of DOT and NRC.
Executive Order 14094 of April 6, 2023 (Modernizing Regulatory Review) reaffirms the statement set forth in 13563 of January 18, 2011 (Improving Regulation and Regulatory Review) that “Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation.” Consistent with this mandate, Executive Order 13563 requires agencies to tailor “regulations to impose the least burden on society, consistent with obtaining regulatory objectives.” Executive Order 13563 also requires agencies to “identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice” while selecting “those approaches that maximize net benefits.” The regulatory approach in this document will reduce burdens to providers and to consumers while continuing to provide adequate protections for public health and welfare.
The Secretary has examined the impact of the Guidelines under Executive Order 12866, as amended by Executive Order 14094, which directs Federal agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity).
According to Executive Order 12866, as amended by Executive Order 14094, defines a “significant regulatory action” as one that is likely to result in a rule that may meet any one of a number of specified conditions, including: (1) have an annual effect on the economy of $200 million or more in any one year (adjusted every 3 years by the Administrator of the Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in the Executive order, as specifically authorized in a timely manner by the Administrator of OIRA in each case. The Administrative Procedure Act (APA) delineates an exception to its rulemaking procedures for “a matter relating to agency management or personnel” 5 U.S.C. 553(a)(2). Because the Guidelines issued by the Secretary govern Federal workplace drug testing programs, HHS has taken the position that the Guidelines are a “matter relating to agency management or personnel” and, thus, are not subject to the APA's requirements for notice and comment rulemaking. This position is consistent with Executive Order 12564 regarding Drug-Free Workplaces, which directs the Secretary to promulgate scientific and technical guidelines for executive agency drug testing programs.
The Department included a Regulatory Impact and Notices section with cost and benefits analysis and burden estimates in the April 7, 2022
One commenter noted that the Department did not consider the application of the Guidelines to DOT testing, and recommended reanalysis of the costs and burden of the proposed changes with consideration of the impact on testing by the transportation industry. Please see the first paragraph of the Regulatory Impact and Notices section above.
The other commenter disagreed with the Department's statement in the preamble to the proposed UrMG that “implementation costs would be lower for laboratories that already offer the drug test” compared to those laboratories that do not test for the added drug. The commenter indicated that the list of cost impacts for any change should include the laboratory's assay validation, materials management, and updates to IT systems (
The information collection requirements (
In support of the Government Paperwork Reduction Act (PRA), the Department revised the Federal CCF to enable its use as an electronic form (78 FR 42091, July 15, 2013) and developed requirements and oversight procedures to ensure that HHS-certified test facilities and other service providers (
Since 2013, SAMHSA has encouraged the use of Federal ECCFs and other electronic processes in HHS-certified test facilities, when practicable, for federally regulated testing operations. In accordance with section 8108(a) of the SUPPORT for Patients and Communities Act, SAMHSA originally set a deadline of August 31, 2023 for all HHS-certified laboratories to submit a request for approval of a digital (paperless) electronic Federal CCF. The Department subsequently extended the deadline to August 31, 2026, to enable sufficient time for all HHS-certified laboratories to identify and contract with an ECCF supplier or to develop an ECCF.
The title and description of the information collected and respondent description are shown in the following paragraphs with an estimate of the annual reporting, disclosure, and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
The following reporting requirements are also in the Guidelines, but have not been addressed in the above reporting burden table: collector must report any unusual donor behavior or refusal to participate in the collection process on the Federal CCF (Sections 1.8, 8.9); collector annotates the Federal CCF when a sample is a blind sample (Section 10.3(a)); MRO notifies the Federal agency and HHS when an error occurs on a blind sample (Section 10.4(d)); and Sections 13.6 and 13.7 describe the actions an MRO takes for the medical evaluation of a donor who cannot provide a urine specimen. SAMHSA has not calculated a separate reporting burden for these requirements because they are included in the burden hours estimated for collectors to complete Federal CCFs and for MROs to report results to Federal agencies.
The following disclosure requirements are also included in the Guidelines, but have not been addressed in the above disclosure burden table: the collector must explain the basic collection procedure to the donor and answer any questions (Section 8.3(e) and (g)). SAMHSA believes having the collector explain the collection procedure to the donor and answer any questions is a standard business practice and not a disclosure burden.
The Guidelines contain several recordkeeping requirements that SAMHSA considers not to be an additional recordkeeping burden. In subpart D, a trainer is required to document the training of an individual
As required by section 3507(d) of the PRA, the Secretary submitted a copy of the proposed Guidelines to OMB for its review. Comments on the information collection requirements were specifically solicited in order to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of HHS's functions, including whether the information will have practical utility; (2) evaluate the accuracy of HHS'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.
(a) These Guidelines apply to:
(1) Executive agencies as defined in 5 U.S.C. 105;
(2) The Uniformed Services, as defined in 5 U.S.C. 2101(3), but excluding the Armed Forces as defined in 5 U.S.C. 2101(2);
(3) Any other employing unit or authority of the Federal Government except the United States Postal Service, the Postal Rate Commission, and employing units or authorities in the Judicial and Legislative Branches; and
(4) The Intelligence Community, as defined by Executive Order 12333, is subject to these Guidelines only to the extent agreed to by the head of the affected agency;
(5) Laboratories and instrumented initial test facilities (IITFs) that provide drug testing services to the Federal agencies;
(6) Collectors who provide specimen collection services to the Federal agencies; and
(7) Medical Review Officers (MROs) who provide drug testing review and interpretation of results services to the Federal agencies.
(b) These Guidelines do not apply to drug testing under authority other than Executive Order 12564, including testing of persons in the criminal justice system, such as arrestees, detainees, probationers, incarcerated persons, or parolees.
(a) Executive Order 12564 and Public Law 100-71 require the Department of Health and Human Services (HHS) to establish scientific and technical guidelines for Federal workplace drug testing programs.
(b) The Secretary has the responsibility to implement these Guidelines.
(a) Each Federal agency must ensure that its workplace drug testing program complies with the provisions of these Guidelines unless a waiver has been obtained from the Secretary.
(b) To obtain a waiver, a Federal agency must submit a written request to the Secretary that describes the specific change for which a waiver is sought and a detailed justification for the change.
(a) To ensure the full reliability and accuracy of specimen tests, the accurate reporting of test results, and the integrity and efficacy of Federal drug testing programs, the Secretary may make changes to these Guidelines to reflect improvements in the available science and technology.
(b) Revisions to these Guidelines will be published in final as a notification in the
The following definitions are adopted:
Consistent with 5 U.S.C. 552a and 48 CFR 24.101 through 24.104, all agency contracts with laboratories, IITFs, collectors, and MROs must require that they comply with the Privacy Act, 5 U.S.C. 552a. In addition, the contracts must require compliance with employee access and confidentiality provisions of section 503 of Public Law 100-71. Each Federal agency must establish a Privacy Act System of Records or modify an existing system or use any applicable Government-wide system of records to cover the records of employee drug test results. All contracts and the Privacy Act System of Records must specifically require that employee records be maintained and used with the highest regard for employee privacy.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule (Rule), 45 CFR parts 160 and 164, subparts A and E, may be applicable to certain health care providers with whom a Federal agency may contract. If a health care provider is a HIPAA covered entity, the provider must protect the individually identifiable health information it maintains in accordance with the requirements of the Rule, which includes not using or disclosing the information except as permitted by the Rule and ensuring there are reasonable safeguards in place to protect the privacy of the information. For more information regarding the HIPAA Privacy Rule, please visit
(a) As a donor for a federally regulated drug test, you have refused to take a federally regulated drug test if you:
(1) Fail to appear for any test within a reasonable time, as determined by the Federal agency, consistent with applicable agency regulations, after being directed to do so by the Federal agency;
(2) Fail to remain at the collection site until the collection process is complete;
(3) Fail to provide a specimen (
(4) In the case of a direct observed or monitored collection, fail to permit the observation or monitoring of your provision of a specimen when required as described in Sections 8.9 and 8.10;
(5) Fail to provide a sufficient amount of urine when directed, and it has been determined, through a required medical evaluation, that there was no legitimate medical explanation for the failure as determined by the process described in Section 13.6;
(6) Fail or decline to participate in an alternate specimen collection (
(7) Fail to undergo a medical examination or evaluation, as directed by the MRO as part of the verification process (
(8) Fail to cooperate with any part of the testing process (
(9) For an observed collection, fail to follow the observer's instructions related to the collection process;
(10) Bring materials to the collection site for the purpose of adulterating, substituting, or diluting the specimen;
(11) Attempt to adulterate, substitute, or dilute the specimen;
(12) Possess or wear a prosthetic or other device that could be used to interfere with the collection process; or
(13) Admit to the collector or MRO that you have adulterated or substituted the specimen.
(a) A refusal to take a test may result in the initiation of disciplinary or adverse action for a Federal employee, up to and including removal from Federal employment. An applicant's refusal to take a pre-employment test may result in non-selection for Federal employment.
(b) When a donor has refused to participate in a part of the collection process, including failing to appear in a reasonable time for any test, the collector must terminate the collection process and take action as described in Section 8.13. Required action includes immediately notifying the Federal agency's designated representative by any means (
(c) When documenting a refusal to test during the verification process as described in Sections 13.4, 13.5, and 13.6, the MRO must complete the MRO copy of the Federal CCF to include:
(1) Checking the refusal to test box;
(2) Providing a reason for the refusal in the remarks line; and
(3) Signing and dating the MRO copy of the Federal CCF.
A Federal agency may collect urine and/or an alternate specimen type for its workplace drug testing program. Only specimen types authorized by Mandatory Guidelines for Federal Workplace Drug Testing Programs may be collected. An agency using urine must follow these Guidelines.
A Federal agency may collect a urine specimen for the following reasons:
(a) Federal agency applicant/Pre-employment test;
(b) Random test;
(c) Reasonable suspicion/cause test;
(d) Post accident test;
(e) Return to duty test; or
(f) Follow-up test.
Each urine specimen is collected as a split specimen as described in Section 2.5.
A donor is expected to provide at least 45 mL of urine for a specimen.
The collector pours at least 30 mL into a specimen bottle that is designated as A (primary) and then pours at least 15 mL into a specimen bottle that is designated as B (split).
Entities and individuals subject to these Guidelines under Section 1.1 may not release specimens collected pursuant to Executive Order 12564, Public Law 100-71, and these Guidelines to donors or their designees. Specimens also may not be released to any other entity or individual unless expressly authorized by these Guidelines or by applicable Federal law. This section does not prohibit a donor's request to have a split (B) specimen tested in accordance with Section 13.9.
A Federal agency:
(a) Must ensure that each specimen is tested for marijuana and cocaine metabolites as provided in the drug testing panel described under Section 3.4;
(b) Is authorized to test each specimen for other Schedule I or II drugs as provided in the drug testing panel;
(c) Must ensure that the following specimen validity tests are conducted on each urine specimen:
(1) Determine the creatinine concentration on every specimen;
(2) Determine the specific gravity on every specimen for which the creatinine concentration is less than 20 mg/dL;
(3) Determine the pH on every specimen; and
(4) Perform one or more specimen validity tests for oxidizing adulterants on every specimen.
(d) Is authorized to test each specimen for one or more biomarkers as provided in the biomarker testing panel; and
(e) May perform additional testing if a specimen exhibits abnormal characteristics (
(a) On a case-by-case basis, a specimen may be tested for additional drugs, if a Federal agency is conducting the collection for reasonable suspicion or post accident testing. A specimen collected from a Federal agency employee may be tested by the Federal agency for any drugs listed in Schedule I or II of the Controlled Substances Act. The Federal agency must request the HHS-certified laboratory to test for the additional drug, include a justification to test a specific specimen for the drug, and ensure that the HHS-certified laboratory has the capability to test for the drug and has established properly validated initial and confirmatory analytical methods. If an initial test procedure is not available upon request for a suspected Schedule I or Schedule II drug, the Federal agency can request an HHS-certified laboratory to test for the drug by analyzing two separate aliquots of the specimen in two separate testing batches using the confirmatory analytical method. Additionally, the split (B) specimen will be available for testing if the donor requests a retest at another HHS-certified laboratory.
(b) A Federal agency covered by these Guidelines must petition the Secretary in writing for approval to routinely test for any drug class not listed in the drug testing panel described under Section 3.4. Such approval must be limited to the use of the appropriate science and technology and must not otherwise limit agency discretion to test for any drug tested under Section 3.2(a).
(a) Specimens collected pursuant to Executive Order 12564, Public Law 100-71, and these Guidelines must only be tested for drugs and to determine their validity in accordance with subpart C of these Guidelines. Use of specimens by donors, their designees, or any other entity, for other purposes (
(b) These Guidelines are not intended to prohibit Federal agencies specifically authorized by law to test a specimen for additional classes of drugs in its workplace drug testing program.
The Secretary will publish the drug and biomarker test analytes and cutoffs (
This drug testing panel will remain in effect until the effective date of a new drug testing panel published in the
(a) The drug testing panel will include drugs authorized for testing in Federal workplace drug testing programs, with the required test analytes and cutoffs;
(b) The biomarker testing panel will include biomarkers authorized for testing in Federal workplace drug testing programs, with the required test analytes and cutoffs; and
(c) HHS-certified IITFs, HHS-certified laboratories, and Medical Review Officers must use the nomenclature (
An HHS-certified laboratory is authorized to perform additional drug and/or specimen validity tests on a case-by-case basis as necessary to provide information that the MRO would use to report a verified drug test result (
An HHS-certified laboratory reports a primary (A) specimen as adulterated when:
(a) The pH is less than 4 or equal to or greater than 11 using either a pH meter or a colorimetric pH test for the initial test on the first aliquot and a pH meter for the confirmatory test on the second aliquot;
(b) The nitrite concentration is equal to or greater than 500 mcg/mL using either a nitrite colorimetric test or a general oxidant colorimetric test for the initial test on the first aliquot and a different confirmatory test (
(c) The presence of chromium (VI) is verified using either a general oxidant colorimetric test (with an equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL) for the initial test on the first aliquot and a different confirmatory test (
(d) The presence of a halogen (
(e) The presence of glutaraldehyde is verified using either an aldehyde test (aldehyde present) or the characteristic immunoassay response on one or more drug immunoassay tests for the initial test on the first aliquot and a different confirmatory test (
(f) The presence of pyridine (pyridinium chlorochromate) is verified using either a general oxidant colorimetric test (with an equal to or greater than 200 mcg/mL nitrite-equivalent cutoff or an equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL) for the initial test on the first aliquot and a different confirmatory test (
(g) The presence of a surfactant is verified by using a surfactant colorimetric test with an equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for the initial test on the first aliquot and a different confirmatory test (
(h) The presence of any other adulterant not specified in paragraphs (b) through (g) of this section is verified using an initial test on the first aliquot and a different confirmatory test on the second aliquot.
An HHS-certified laboratory reports a primary (A) specimen as substituted when:
(a) The creatinine concentration is less than 2 mg/dL on both the initial and confirmatory creatinine tests on two separate aliquots (
(b) A biomarker is not detected or is present at a concentration inconsistent with that established for human urine for both the initial (first) test and the confirmatory (second) test on two separate aliquots (
A dilute result may be reported only in conjunction with the positive or negative drug test results for a specimen.
(a) An HHS-certified laboratory or an HHS-certified IITF reports a primary (A) specimen as dilute when the creatinine concentration is greater than 5 mg/dL but less than 20 mg/dL and the specific gravity is equal to or greater than 1.002 but less than 1.003 on a single aliquot.
(b) In addition, an HHS-certified laboratory reports a primary (A) specimen as dilute when the creatinine concentration is equal to or greater than 2 mg/dL but less than 20 mg/dL and the specific gravity is greater than 1.0010 but less than 1.0030.
An HHS-certified laboratory reports a primary (A) specimen as an invalid result when:
(a) Inconsistent creatinine concentration and specific gravity results are obtained (
(b) The pH is equal to or greater than 4 and less than 4.5 or equal to or greater than 9 and less than 11 using either a colorimetric pH test or pH meter for the initial test and a pH meter for the confirmatory test on two separate aliquots;
(c) The nitrite concentration is equal to or greater than 200 mcg/mL using a nitrite colorimetric test or equal to or greater than the equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric test for both the initial (first) test and the second test or using either initial test and the nitrite concentration is equal to or greater than 200 mcg/mL but less than 500 mcg/mL for a different confirmatory test (
(d) The possible presence of chromium (VI) is determined using the same chromium (VI) colorimetric test with a cutoff equal to or greater than 50 mcg/mL chromium (VI) for both the initial (first) test and the second test on two separate aliquots;
(e) The possible presence of a halogen (
(f) The possible presence of glutaraldehyde is determined by using the same aldehyde test (aldehyde present) or characteristic immunoassay response on one or more drug immunoassay tests for both the initial (first) test and the second test on two separate aliquots;
(g) The possible presence of an oxidizing adulterant is determined by using the same general oxidant colorimetric test (with an equal to or greater than 200 mcg/mL nitrite-equivalent cutoff, an equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff, or a halogen concentration is equal to or greater than the LOQ) for both the initial (first) test and the second test on two separate aliquots;
(h) The possible presence of a surfactant is determined by using the same surfactant colorimetric test with an equal to greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for both the initial (first) test and the second test on two separate aliquots or a foam/shake test for the initial test;
(i) Interference occurs on the initial drug tests on two separate aliquots (
(j) Interference with the confirmatory drug test occurs on two separate aliquots of the specimen and the laboratory is unable to identify the interfering substance;
(k) The physical appearance of the specimen (
(l) The specimen has been tested and the appearances of the primary (A) and the split (B) specimens (
(m) A specimen validity test (
(a) A collector who has been trained to collect urine specimens in accordance with these Guidelines.
(b) The immediate supervisor of a Federal employee donor may only collect that donor's specimen when no other collector is available. The supervisor must be a trained collector.
(c) The hiring official of a Federal agency applicant may only collect that Federal agency applicant's specimen when no other collector is available. The hiring official must be a trained collector.
(a) A Federal agency employee who is in a testing designated position and subject to the Federal agency drug testing rules must not be a collector for co-workers in the same testing pool or
(b) A Federal agency applicant or employee must not collect their own drug testing specimen.
(c) An employee working for an HHS-certified laboratory or IITF must not act as a collector if the employee could link the identity of the donor to the donor's drug test result.
(d) To avoid a potential conflict of interest, a collector must not be related to the employee (
(a) An individual may serve as a collector if they fulfill the following conditions:
(1) Is knowledgeable about the collection procedure described in these Guidelines;
(2) Is knowledgeable about any guidance provided by the Federal agency's Drug-Free Workplace Program and additional information provided by the Secretary relating to the collection procedure described in these Guidelines;
(3) Is trained and qualified to collect a urine specimen. Training must include the following:
(i) All steps necessary to complete a urine collection;
(ii) Completion and distribution of the Federal CCF;
(iii) Problem collections;
(iv) Fatal flaws, correctable flaws, and how to correct problems in collections; and
(v) The collector's responsibility for maintaining the integrity of the collection process, ensuring the privacy of the donor, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate.
(4) Has demonstrated proficiency in collections by completing five consecutive error-free mock collections.
(i) The five mock collections must include one uneventful collection scenario, one insufficient specimen quantity scenario, one temperature out of range scenario, one scenario in which the donor refuses to sign the Federal CCF, and one scenario in which the donor refuses to initial the specimen bottle tamper-evident seal.
(ii) A qualified trainer for collectors must monitor and evaluate the individual being trained, in person or by a means that provides real-time observation and interaction between the trainer and the trainee, and the trainer must attest in writing that the mock collections are error-free.
(b) A trained collector must complete refresher training at least every five years that includes the requirements in Section 4.3(a).
(c) The collector must maintain the documentation of their training and provide that documentation to a Federal agency when requested.
(d) An individual may not collect specimens for a Federal agency until the individual's training as a collector has been properly documented.
(a) An individual may serve as an observer for a direct observed collection when the individual has satisfied the requirements:
(1) Is knowledgeable about the direct observed collection procedure described in Section 8.9;
(2) Is knowledgeable about any guidance provided by the Federal agency's Drug-Free Workplace Program or additional information provided by the Secretary relating to the direct observed collection procedure described in these Guidelines;
(3) Has received training on the following subjects:
(i) All steps necessary to perform a direct observed collection; and
(ii) The observer's responsibility for maintaining the integrity of the collection process, ensuring the privacy of individuals being tested, ensuring that the observation is done in a professional manner that minimizes the discomfort to the employee so observed, ensuring the security of the specimen by maintaining visual contact with the collection container until it is delivered to the collector, and avoiding conduct or statements that could be viewed as offensive or inappropriate.
(b) The gender of the observer must be the same as the donor's gender, which is determined by the donor's gender identity. The observer selection process is described in Section 8.10(b).
(c) The observer is not required to be a trained collector.
(a) Individuals are considered qualified trainers for collectors and may train others to collect urine specimens when they have completed the following:
(1) Qualified as a trained collector and regularly conducted urine drug test collections for a period of at least one year; or
(2) Completed a “train the trainer” course given by an organization (
(b) A qualified trainer for collectors must complete refresher training at least every five years in accordance with the collector requirements in Section 4.3(a).
(c) A qualified trainer for collectors must maintain the documentation of the trainer's training and provide that documentation to a Federal agency when requested.
A Federal agency must ensure the following:
(a) The collector has satisfied the requirements described in Section 4.3;
(b) The collector, who may be self-employed, or an organization (
(c) The collector has been provided the name and telephone number of the Federal agency representative.
(a) A collection site may be a permanent or temporary facility located either at the work site or at a remote site.
(b) In the event that an agency-designated collection site is not accessible and there is an immediate requirement to collect a urine specimen (
The facility used as a collection site must have the following:
(a) Provisions to ensure donor privacy during the collection (as described in Section 8.1);
(b) A suitable and clean surface area that is not accessible to the donor for handling the specimens and completing the required paperwork;
(c) A secure temporary storage area to maintain specimens until the specimen is transferred to an HHS-certified laboratory or IITF;
(d) A restricted access area where only authorized personnel may be present during the collection;
(e) A restricted access area for the storage of collection supplies;
(f) A restricted access area for the secure storage of records; and
(g) The ability to restrict the donor access to potential diluents in accordance with Section 8.2.
Collection site records must be stored at a secure site designated by the collector or the collector's employer.
Collection site records (
(a) A collector must do the following to maintain the security and integrity of a specimen:
(1) Not allow unauthorized personnel to enter the collection area during the collection procedure;
(2) Perform only one donor collection at a time;
(3) Restrict access to collection supplies before, during, and after collection;
(4) Ensure that only the collector and the donor are allowed to handle the unsealed specimen;
(5) Ensure the chain of custody process is maintained and documented throughout the entire collection, storage, and transport procedures;
(6) Ensure that the Federal CCF is completed and distributed as required; and
(7) Ensure that specimens transported to an HHS-certified laboratory or IITF are sealed and placed in transport containers designed to minimize the possibility of damage during shipment (
(b) Couriers, express carriers, and postal service personnel are not required to document chain of custody since specimens are sealed in packages that would indicate tampering during transit to the HHS-certified laboratory or IITF.
Collections must be performed at a site that provides reasonable privacy (as described in Section 8.1).
The OMB-approved Federal CCF must be used to document custody and control of each specimen at the collection site.
(a) The use of a non-Federal CCF or an expired Federal CCF is not, by itself, a reason for the HHS-certified laboratory or IITF to automatically reject the specimen for testing or for the MRO to cancel the test.
(b) If the collector does not use the correct OMB-approved Federal CCF, the collector must document that it is a Federal agency specimen collection and provide the reason that the incorrect form was used. Based on the information provided by the collector, the HHS-certified laboratory or IITF must handle and test the specimen as a Federal agency specimen.
(c) If the HHS-certified laboratory, HHS-certified IITF, or MRO discovers that the collector used an incorrect form, the laboratory, IITF, or MRO must obtain a memorandum for the record from the collector describing the reason the incorrect form was used. If a memorandum for the record cannot be obtained, the laboratory or IITF reports a rejected for testing result to the MRO and the MRO cancels the test. The HHS-certified laboratory or IITF must wait at least 5 business days while attempting to obtain the memorandum before reporting a rejected for testing result to the MRO.
A single-use collection container with a means (
(a) The collection container, the thermometer, and the specimen bottles must not substantially affect the composition of drugs and/or metabolites in the urine specimen.
(b) The two specimen bottles must be sealable and non-leaking, and must maintain the integrity of the specimen during storage and transport so that the specimen contained therein can be tested in an HHS-certified laboratory or IITF for the presence of drugs or their metabolites.
(c) The two specimen bottles must be sufficiently transparent (
Section 7.3 What are the minimum performance requirements for a urine collection container and specimen bottles?
(a) The collection container must be capable of holding at least 55 mL and have a volume marking clearly noting a level of 45 mL.
(b) One of the two specimen bottles must be capable of holding at least 35 mL and the other at least 20 mL, and each must have a volume marking clearly noting the appropriate level (30 mL for the primary specimen and 15 mL for the split specimen).
(c) The thermometer may be affixed to or built into the collection container and must provide graduated temperature readings from 32-38 °C/90-100 °F. Alternatively, the collector may use another technology to measure specimen temperature (
The following privacy requirements apply when a donor is providing a urine specimen:
(a) Only authorized personnel and the donor may be present in the restricted access area where the collection takes place.
(b) The collector is not required to be the same gender as the donor. The gender of the observer for purposes of a direct observed collection (
(c) The collector must give the donor visual privacy while providing the specimen. The donor is allowed to provide a urine specimen in an enclosed
The collector must deter the dilution or substitution of a specimen at the collection site by:
(a) Placing a toilet bluing agent in a toilet bowl or toilet tank, so the reservoir of water in the toilet bowl always remains blue. If no bluing agent is available or if the toilet has an automatic flushing system, the collector shall turn the water supply off to the toilet and flush the toilet to remove the water in the toilet when possible.
(b) Secure other sources of water (
The collector must take the following steps before beginning a urine specimen collection:
(a) If a donor fails to arrive at the collection site at the assigned time, the collector must follow the Federal agency policy or contact the Federal agency representative to obtain guidance on action to be taken.
(b) When the donor arrives at the collection site, the collector should begin the collection procedure without undue delay. For example, the collection should not be delayed because the donor states that they are unable to urinate or an authorized employer or employer representative is late in arriving.
(c) The collector requests the donor to present photo identification (
(d) The collector must provide identification (
(e) The collector explains the basic collection procedure to the donor.
(f) The collector provides the instructions for completing the Federal CCF for the donor's review, and informs the donor that the instructions are available upon request.
(g) The collector answers any reasonable and appropriate questions the donor may have regarding the collection procedure.
(h) The collector asks the donor to remove any unnecessary outer garments (
(i) The collector asks the donor to empty the donor's pockets and display the contents to ensure no items are present that could be used to adulterate or substitute the specimen.
(1) If no items are present that can be used to adulterate, substitute, or dilute the specimen, the collector instructs the donor to return the items to their pockets and continues the collection procedure.
(2) If an item is present whose purpose is to adulterate, substitute, or dilute the specimen (
(3) If an item that could be used to adulterate, substitute, or dilute the specimen (
(4) If the donor refuses to show the collector the items in their pockets, this is considered a refusal to test. The collector must stop the collection and report the refusal to test as described in Section 8.13.
(j) The collector shall instruct the donor to wash and dry the donor's hands prior to urination. After washing the donor's hands, the donor must remain in the presence of the collector and must not have access to any water fountain, faucet, soap dispenser, cleaning agent, or any other materials which could be used to adulterate or substitute the specimen.
(k) If the donor refuses to wash their hands when instructed by the collector, this is considered a “refusal to test.” The collector must stop the collection and report the refusal to test as described in Section 8.13.
(a) The collector will provide or the donor may select a specimen collection container that is clean, unused, wrapped/sealed in original packaging and compliant with subpart G of these Guidelines. The specimen collection container package will be opened in view of the donor.
(b)The collector instructs the donor to provide the specimen in the privacy of a stall or otherwise partitioned area that allows for individual privacy. The collector directs the donor to provide a specimen of at least 45 mL, to not flush the toilet, and to return with the specimen as soon as the donor has completed the void.
(1) Except in the case of a direct observed collection (
(2) The collector may set a reasonable time limit for specimen collection.
(c) The collector notes any unusual behavior or appearance of the donor on the Federal CCF. If the collector detects any conduct that clearly indicates an attempt to tamper with a specimen (
Integrity and Identity of the Specimen. The collector must take the following steps during and after the donor provides the urine specimen:
(a) The collector must inform the donor that, once the collection procedure has begun, the donor must remain at the collection site (
(b) After providing the specimen, the donor gives the specimen collection container to the collector. Both the donor and the collector must keep the specimen container in view at all times until the collector seals the specimen bottles as described in Section 8.8.
(c) After the donor has given the specimen to the collector, whenever practical, the donor shall be allowed to wash the donor's hands and the donor may flush the toilet.
(d) The collector must measure the temperature of the specimen within 4 minutes of receiving the specimen from the donor. The collector records on the Federal CCF whether or not the temperature is in the acceptable range of 32°-38°C/90°-100 °F.
(1) The temperature measuring device must accurately reflect the temperature of the specimen and not contaminate the specimen.
(2) If the temperature of the specimen is outside the range of 32°-38°C/90°-100 °F, that is a reason to believe that the donor may have adulterated or substituted the specimen. Another specimen must be collected under direct observation in accordance with Section 8.9. The collector must forward both specimens (
(e) The collector must inspect the specimen to determine if there is any sign indicating that the specimen may not be a valid urine specimen (
(1) The collector notes any unusual finding on the Federal CCF. A specimen suspected of not being a valid urine specimen must be forwarded to an HHS-certified laboratory for testing.
(2) When there is any reason to believe that a donor may have adulterated or substituted the specimen, another specimen must be obtained as soon as possible under direct observation in accordance with Section 8.10. The collector must forward both specimens (
(f) The collector must determine the volume of urine in the specimen container. The collector must never combine urine collected from separate voids to create a specimen.
(1) If the volume is at least 45 mL, the collector will proceed with steps described in Section 8.8.
(2) If the volume is less than 45 mL, the collector discards the specimen and immediately collects a second specimen using the same procedures as for the first specimen (including steps in Section 8.5(c) and (d)).
(i) The collector may give the donor a reasonable amount of liquid to drink for this purpose (
(ii) If the donor provides a sufficient urine specimen (
(iii) If the employee has not provided a sufficient specimen (
(g) If the donor fails to remain present through the completion of the collection, declines to have a direct observed collection as required in Section 8.5(d)(2) or (e)(2), refuses to provide a second specimen as required in Section 8.5(f)(2), or refuses to provide an alternate specimen as authorized in Section 8.5(f)(2)(iii), the collector stops the collection and reports the refusal to test in accordance with Section 8.13.
(a) If the donor states that they are unable to provide a urine specimen during the collection process, the collector requests that the donor enter the restroom (stall) and attempt to provide a urine specimen.
(b) The donor demonstrates their inability to provide a specimen when he or she comes out of the stall with an empty collection container.
(1) If the donor states that they could provide a specimen after drinking some fluids, the collector gives the donor a reasonable amount of liquid to drink for this purpose (
(2) If the donor states that they are unable to provide a urine specimen, the collector records the reason for not collecting a urine specimen on the Federal CCF, notifies the Federal agency's designated representative for authorization to collect an alternate specimen, and sends the appropriate copies of the Federal CCF to the MRO and to the Federal agency's designated representative. The Federal agency may choose to provide the collection site with a standard protocol to follow in lieu of requiring the collector to notify the agency's designated representative for authorization in each case. If an alternate specimen is authorized, the collector may begin the collection procedure for the alternate specimen (see Section 8.7) in accordance with the Mandatory Guidelines for Federal Workplace Drug Testing Programs using the alternate specimen.
Yes, if the alternate specimen type is authorized by Mandatory Guidelines for Federal Workplace Drug Testing Programs and specifically authorized by the Federal agency.
(a) All Federal agency collections are to be split specimen collections.
(b) The collector, in the presence of the donor, pours the urine from the collection container into two specimen bottles to be labeled “A” and “B”. The collector pours at least 30 mL of urine into Bottle A and at least 15 mL into Bottle B, and caps each bottle.
(c) In the presence of the donor, the collector places a tamper-evident label/seal from the Federal CCF over each specimen bottle cap. The collector records the date of the collection on the tamper-evident labels/seals.
(d) The collector instructs the donor to initial the tamper-evident labels/seals on each specimen bottle. If the donor refuses to initial the labels/seals, the collector notes the refusal on the Federal CCF and continues with the collection process.
(e) The collector must ensure that all required information is included on the Federal CCF.
(f) The collector asks the donor to read and sign a statement on the Federal
(g) The collector signs and prints their name on the Federal CCF, completes the Federal CCF, and distributes the copies of the Federal CCF as required.
(h) The collector seals the specimens (Bottle A and Bottle B) in a package and, within 24 hours or during the next business day, sends them to the HHS-certified laboratory or IITF that will be testing the Bottle A urine specimen.
(i) If the specimen and Federal CCF are not immediately transported to an HHS-certified laboratory or IITF, they must remain under direct control of the collector or be appropriately secured under proper specimen storage conditions until transported.
(j) The collector must discard any urine left over in the collection container after both specimen bottles have been appropriately filled and sealed. There is one exception to this requirement: the collector may use excess urine to conduct clinical tests (
A direct observed collection procedure must be conducted when:
(a) The agency has authorized a direct observed collection because:
(1) The donor's previous drug test result was reported by an MRO as positive, adulterated, or substituted; or
(2) The HHS-certified laboratory reports to the MRO that a specimen is invalid, and the MRO reported to the agency that there was not a legitimate medical explanation for the result; or
(3) The MRO reported to the agency that the primary (A) specimen was positive, adulterated, or substituted but the test was cancelled because the split (B) specimen could not be tested or the split specimen failed to reconfirm the primary specimen result; or
(b) At the collection site, an immediate collection of a second urine specimen is required because:
(1) The temperature of the specimen collected during a routine collection is outside the acceptable temperature range; or
(2) The collector suspects that the donor has tampered with the specimen during a routine collection (
(c) The collector must contact a collection site supervisor to review and concur in advance with any decision by the collector to obtain a specimen under direct observation.
(d) If the donor declines to have a direct observed collection, the collector reports a refusal to test (
(a) A direct observed collection procedure is the same as that for a routine collection, except an observer watches the donor urinate into the collection container. The observer's gender must be the same as the donor's gender, which is determined by the donor's gender identity, with no exception to this requirement.
(b) Before an observer is selected, the collector informs the donor that the gender of the observer will match the donor's gender, which is determined by the donor's gender identity (as defined in Section 1.5). The collector then selects the observer to conduct the observation:
(i) The collector asks the donor to identify the donor's gender on the Federal CCF and initial it.
(ii) The donor will then be provided an observer whose gender matches the donor's gender.
(iii) The collector documents the observer's name and gender on the Federal CCF.
(c) If there is no collector available of the same gender as the donor's gender, the collector or collection site supervisor shall select an observer trained in direct observed specimen collection as described in Section 4.4. The observer may be an individual that is not a trained collector.
(d) At the point in a routine collection where the donor enters the restroom with the collection container, a direct observed collection includes the following additional steps:
(1) The observer enters the restroom with the donor;
(2) The observer must directly watch the urine go from the donor's body into the collection container (the use of mirrors or video cameras is not permitted);
(3) The observer must not touch or handle the collection container unless the observer is also serving as the collector;
(4) After the donor has completed urinating into the collection container:
(i) If the same person serves as the observer and collector, that person may receive the collection container from the donor while they are both in the restroom;
(ii) If the observer is not serving as the collector, the donor and observer leave the restroom and the donor hands the collection container directly to the collector. The observer must maintain visual contact of the collection container until the donor hands the container to the collector.
(5) The collector checks the box for an observed collection on the Federal CCF and writes the name of the observer and the reason for an observed collection on the Federal CCF; and
(6) The collector then continues with the routine collection procedure in Section 8.3.
Section 8.11 When is a monitored collection conducted?
(a) In the event that an agency-designated collection site is not available and there is an immediate requirement to collect a specimen (
(b) If the enclosure used by the donor to provide a specimen has a source of water that cannot be disabled or secured, a monitored collection must be conducted.
(c) If the donor declines to permit a collection to be monitored when required, the collector reports a refusal to test (
A monitored collection is the same as that for a routine collection, except that a monitor accompanies the donor into the restroom to check for signs that the donor may be tampering with the specimen. The monitor remains in the restroom, but outside the stall, while the donor is providing the specimen. A person of the same gender as the donor shall serve as the monitor, unless the monitor is a medical professional (
(a) The collector secures the restroom being used for the monitored collection so that no one except the employee and
(b) The monitor enters the restroom with the donor.
(c) The monitor must not watch the employee urinate into the collection container. If the monitor hears sounds or makes other observations indicating an attempt by the donor to tamper with a specimen, there must be an additional collection under direct observation in accordance with Section 8.9.
(d) The monitor must not touch or handle the collection container unless the monitor is also the collector.
(e) After the donor has completed urinating into the collection container:
(1) If the same person serves as the monitor and collector, that person may receive the collection container from the donor while they are both in the restroom;
(2) If the monitor is not serving as the collector, the donor and monitor leave the restroom and the donor hands the collection container directly to the collector. The monitor must ensure that the employee takes the collection container directly to the collector as soon as the employee has exited the enclosure.
(f) If the monitor is not serving as the collector, the collector writes the name of the monitor on the Federal CCF.
(g) The collector then continues with the routine collection procedure in Section 8.3.
If there is a refusal to test as defined in Section 1.7, the collector stops the collection, discards any urine collected and reports the refusal to test by:
(a) Notifying the Federal agency by means (
(b) Documenting the refusal to test including the reason on the Federal CCF, and
(c) Sending all copies of the Federal CCF to the Federal agency's designated representative.
(a) A Federal agency must ensure that collectors and collection sites satisfy all requirements in subparts D, E, F, G, and H of these Guidelines.
(b) A Federal agency (or only one Federal agency when several agencies are using the same collection site) must inspect 5 percent or up to a maximum of 50 collection sites each year, selected randomly from those sites used to collect agency specimens (
(c) A Federal agency must investigate reported collection site deficiencies (
(a) The Secretary has broad discretion to take appropriate action to ensure the full reliability and accuracy of drug testing and reporting, to resolve problems related to drug testing, and to enforce all standards set forth in these Guidelines. The Secretary has the authority to issue directives to any HHS-certified laboratory or IITF including suspending the use of certain analytical procedures when necessary to protect the integrity of the testing process; ordering any HHS-certified laboratory or IITF to undertake corrective actions to respond to material deficiencies identified by an inspection or through performance testing; ordering any HHS-certified laboratory or IITF to send specimens or specimen aliquots to another HHS-certified laboratory for retesting when necessary to ensure the accuracy of testing under these Guidelines; ordering the review of results for specimens tested under the Guidelines for private sector clients to the extent necessary to ensure the full reliability of drug testing for Federal agencies; and ordering any other action necessary to address deficiencies in drug testing, analysis, specimen collection, chain of custody, reporting of results, or any other aspect of the certification program.
(b) A laboratory or IITF is prohibited from stating or implying that it is certified by HHS under these Guidelines to test urine specimens for Federal agencies unless it holds such certification.
(a) A laboratory or IITF seeking HHS certification must:
(1) Submit a completed OMB-approved application form (
(2) Have its application reviewed as complete and accepted by HHS;
(3) Successfully complete the PT challenges in 3 consecutive sets of initial PT samples;
(4) Satisfy all the requirements for an initial inspection; and
(5) Receive notification of certification from the Secretary before testing specimens for Federal agencies.
(a) To maintain HHS certification, a laboratory or IITF must:
(1) Successfully participate in both the maintenance PT and inspection programs (
(2) Respond in an appropriate, timely, and complete manner to required corrective action requests if deficiencies are identified in the maintenance PT performance, during the inspections, operations, or reporting; and
(3) Satisfactorily complete corrective remedial actions, and undergo special inspection and special PT sets to maintain or restore certification when material deficiencies occur in either the PT program, inspection program, or in operations and reporting.
(a) A laboratory or IITF that does not maintain its HHS certification must:
(1) Stop testing federally regulated specimens;
(2) Ensure the security of federally regulated specimens and records throughout the required storage period described in Sections 11.20, 11.21, 12.18, and 14.8;
(3) Ensure access to federally regulated specimens and records in accordance with Sections 11.23, 11.24, 12.20, and 12.21 and subpart P of these Guidelines; and
(4) Follow the HHS suspension and revocation procedures when imposed by the Secretary, follow the HHS procedures in subpart P of these Guidelines that will be used for all actions associated with the suspension and/or revocation of HHS-certification.
(a) PT samples used to evaluate drug tests will be prepared using the following specifications:
(1) PT samples may contain one or more of the drugs and drug metabolites in the drug classes listed in the drug testing panel and must satisfy one of the following parameters:
(i) The concentration of a drug or metabolite will be at least 20 percent above the initial test cutoff for the drug or drug metabolite;
(ii) The concentration of a drug or metabolite may be as low as 40 percent of the confirmatory test cutoff when the PT sample is designated as a retest sample; or
(iii) The concentration of drug or metabolite may differ from Section 9.5(a)(1)(i) and (ii) for a special purpose.
(2) A PT sample may contain an interfering substance, an adulterant, or other substances for special purposes, or may satisfy the criteria for a substituted specimen, dilute specimen, or invalid result.
(3) A negative PT sample will not contain a measurable amount of a target analyte.
(b) PT samples used to evaluate specimen validity tests shall satisfy, but are not limited to, one of the following criteria:
(1) The nitrite concentration will be at least 20 percent above the cutoff;
(2) The pH will be between 1.5 and 5.0 or between 8.5 and 12.5;
(3) The concentration of an oxidant will be at a level sufficient to challenge a laboratory's ability to identify and confirm the oxidant;
(4) The creatinine concentration will be between 0 and 20 mg/dL; or
(5) The specific gravity will be less than or equal to 1.0050 or between 1.0170 and 1.0230.
(c) For each PT cycle, the set of PT samples going to each HHS-certified laboratory or IITF will vary but, within each calendar year, each HHS-certified laboratory or IITF will analyze essentially the same total set of samples.
(d) The laboratory or IITF must (to the greatest extent possible) handle, test, and report a PT sample in a manner identical to that used for a donor specimen, unless otherwise specified.
(a) An applicant laboratory that seeks certification under these Guidelines to perform urine testing must satisfy the following criteria on three consecutive sets of PT samples:
(1) Have no false positive results;
(2) Correctly identify, confirm, and report at least 90 percent of the total drug challenges over the three sets of PT samples;
(3) Correctly identify at least 80 percent of the drug challenges for each initial drug test over the three sets of PT samples;
(4) For the confirmatory drug tests, correctly determine the concentrations (
(5) For the confirmatory drug tests, do not obtain any drug concentration that differs by more than ±50 percent from the appropriate reference or peer group mean;
(6) For each confirmatory drug test, correctly identify and determine the concentrations (
(7) Correctly identify at least 80 percent of the total specimen validity testing challenges over the three sets of PT samples;
(8) Correctly identify at least 80 percent of the challenges for each individual specimen validity test over the three sets of PT samples;
(9) For quantitative specimen validity tests, obtain quantitative values for at least 80 percent of the total challenges over the three sets of PT samples that satisfy the following criteria:
(i) Nitrite and creatinine concentrations are no more than ±20 percent or ±2 standard deviations from the appropriate reference or peer group mean; and
(ii) pH values are no more than ±0.3 pH units from the appropriate reference or peer group mean using a pH meter; and
(iii) Specific gravity values are no more than ±0.0003 specific gravity units from the appropriate reference or peer group mean when the mean is less than 1.0100 and specific gravity values are no more than ±0.0004 specific gravity units from the appropriate reference or peer group mean when the mean is equal to or greater than 1.0100;
(10) Do not obtain any quantitative value on a specimen validity test PT sample that differs from the appropriate reference or peer group mean by more than ±50 percent for nitrite and creatinine concentrations, ±0.8 pH units using a pH meter, ±0.0006 specific gravity units when the mean is less than 1.0100, or ±0.0007 specific gravity units when the mean is equal to or greater than 1.0100; and
(11) Do not report any sample as adulterated with a compound that is not present in the sample, adulterated based on pH when the appropriate reference or peer group mean is within the acceptable pH range, substituted when the appropriate reference or peer group means for both creatinine and specific gravity are within the acceptable range, or substituted when the appropriate reference or peer group mean for a biomarker is within the acceptable range.
(b) Failure to satisfy these requirements will result in the denial of the laboratory's application for HHS certification to perform urine testing.
(a) A laboratory certified under these Guidelines to perform urine testing must satisfy the following criteria on the maintenance PT samples:
(1) Have no false positive results;
(2) Correctly identify, confirm, and report at least 90 percent of the total drug challenges over two consecutive PT cycles;
(3) Correctly identify at least 80 percent of the drug challenges for each initial drug test over two consecutive PT cycles;
(4) For the confirmatory drug tests, correctly determine that the concentrations for at least 80 percent of the total drug challenges are no more than ±20 percent or ±2 standard deviations (whichever is larger) from the appropriate reference or peer group means over two consecutive PT cycles;
(5) For the confirmatory drug tests, do not obtain any drug concentration that differs by more than ±50 percent from the appropriate reference or peer group means;
(6) For each confirmatory drug test, correctly identify and determine that the concentrations for at least 50 percent of the drug challenges for an individual drug are no more than ±20 percent or ±2 standard deviations (whichever is larger) from the appropriate reference or peer group means over two consecutive PT cycles;
(7) Correctly identify at least 80 percent of the total specimen validity testing challenges over two consecutive PT cycles;
(8) Correctly identify at least 80 percent of the challenges for each
(9) For quantitative specimen validity tests, obtain quantitative values for at least 80 percent of the total challenges over two consecutive PT cycles that satisfy the following criteria:
(i) Nitrite and creatinine concentrations are no more than ±20 percent or ±2 standard deviations from the appropriate reference or peer group mean;
(ii) pH values are no more than ±0.3 pH units from the appropriate reference or peer group mean using a pH meter; and
(iii) Specific gravity values are no more than ±0.0003 specific gravity units from the appropriate reference or peer group mean when the mean is less than 1.0100 and specific gravity values are no more than ±0.0004 specific gravity units from the appropriate reference or peer group mean when the mean is equal to or greater than 1.0100;
(10) Do not obtain any quantitative value on a specimen validity test PT sample that differs from the appropriate reference or peer group mean by more than ±50 percent for nitrite and creatinine concentrations, ±0.8 pH units using a pH meter, ±0.0006 specific gravity units when the mean is less than 1.0100, or ±0.0007 specific gravity units when the mean is equal to or greater than 1.0100; and
(11) Do not report any PT sample as adulterated with a compound that is not present in the sample, adulterated based on pH when the appropriate reference or peer group mean is within the acceptable pH range, substituted when the appropriate reference or peer group means for both creatinine and specific gravity are within the acceptable range, or substituted when the appropriate reference or peer group mean for a biomarker is within the acceptable range.
(b) Failure to participate in all PT cycles or to satisfy these requirements may result in suspension or revocation of an HHS-certified laboratory's certification.
(a) An applicant IITF that seeks certification under these Guidelines must satisfy the following criteria on three consecutive sets of PT samples:
(1) Correctly identify at least 90 percent of the total drug challenges over the three sets of PT samples;
(2) Correctly identify at least 80 percent of the drug challenges for each individual drug test over the three sets of PT samples;
(3) Correctly identify at least 80 percent of the total specimen validity test challenges over the three sets of PT samples;
(4) Correctly identify at least 80 percent of the challenges for each individual specimen validity test over the three sets of PT samples;
(5) For quantitative specimen validity tests, obtain quantitative values for at least 80 percent of the total specimen validity test challenges over the three sets of PT samples that satisfy the following criteria:
(i) Creatinine concentrations are no more than ±20 percent or ±2 standard deviations (whichever is larger) from the appropriate reference or peer group mean; and
(ii) Specific gravity values are no more than ±0.001 specific gravity units from the appropriate reference or peer group mean; and
(6) Must not obtain any quantitative value on a specimen validity test PT sample that differs from the appropriate reference or peer group mean by more than ±50 percent for creatinine concentration or ±0.002 specific gravity units for specific gravity.
(b) Failure to satisfy these requirements will result in disqualification.
(a) An IITF certified under these Guidelines must satisfy the following criteria on the maintenance PT samples to maintain its certification:
(1) Correctly identify at least 90 percent of the total drug challenges over two consecutive PT cycles;
(2) Correctly identify at least 80 percent of the drug challenges for each individual drug test over two consecutive PT cycles;
(3) Correctly identify at least 80 percent of the total specimen validity test challenges over two consecutive PT cycles;
(4) Correctly identify at least 80 percent of the challenges for each individual specimen validity test over two consecutive PT cycles;
(5) For quantitative specimen validity tests, obtain quantitative values for at least 80 percent of the total specimen validity test challenges over two consecutive PT cycles that satisfy the following criteria:
(i) Creatinine concentrations are no more than ±20 percent or ±2 standard deviations (whichever is larger) from the appropriate reference or peer group mean; and
(ii) Specific gravity values are no more than ±0.001 specific gravity units from the appropriate reference or peer group mean; and
(6) Must not obtain any quantitative value on a specimen validity test PT sample that differs from the appropriate reference or peer group mean by more than ±50 percent for creatinine concentration, or ±0.002 specific gravity units for specific gravity.
(b) Failure to participate in all PT cycles or to satisfy these requirements may result in suspension or revocation of an HHS-certified IITF's certification.
(a) An applicant laboratory or IITF is inspected by a team of two inspectors.
(b) Each inspector conducts an independent review and evaluation of all aspects of the laboratory's or IITF's testing procedures and facilities using an inspection checklist.
(a) An HHS-certified laboratory or IITF must undergo an inspection 3 months after becoming certified and at least every 6 months thereafter.
(b) An HHS-certified laboratory or IITF is inspected by two or more inspectors. The number of inspectors is determined according to the number of specimens reviewed. Additional information regarding inspections is available from SAMHSA.
(c) Each inspector conducts an independent evaluation and review of the HHS-certified laboratory's or IITF's procedures, records, and facilities using guidance provided by the Secretary.
(d) To remain certified, an HHS-certified laboratory or IITF must continue to satisfy the minimum requirements as stated in these Guidelines.
(a) An individual may be selected as an inspector for the Secretary if they satisfy the following criteria:
(1) Has experience and an educational background similar to that required for either a responsible person or a certifying scientist for an HHS-certified laboratory as described in subpart K of these Guidelines or as a responsible technician for an HHS-certified IITF as described in subpart L of these Guidelines;
(2) Has read and thoroughly understands the policies and requirements contained in these Guidelines and in other guidance
(3) Submits a resume and documentation of qualifications to HHS;
(4) Attends approved training; and
(5) Performs acceptably as an inspector on an inspection of an HHS-certified laboratory or IITF.
(b) The Secretary or a Federal agency may conduct an inspection at any time.
If an applicant laboratory or IITF fails to satisfy the requirements established for the initial certification process, the laboratory or IITF must start the certification process from the beginning.
(a) If an HHS-certified laboratory or IITF fails to satisfy the minimum requirements for certification, the laboratory or IITF is given a period of time (
(b) A laboratory's or IITF's HHS certification may be revoked, suspended, or no further action taken depending on the seriousness of the deficiencies and whether there is evidence that the deficiencies have been corrected and that current performance meets the requirements for certification.
(c) An HHS-certified laboratory or IITF may be required to undergo a special inspection or to test additional PT samples to address deficiencies.
(d) If an HHS-certified laboratory's or IITF's certification is revoked or suspended in accordance with the process described in subpart P of these Guidelines, the laboratory or IITF is not permitted to test federally regulated specimens until the suspension is lifted or the laboratory or IITF has successfully completed the certification requirements as a new applicant laboratory or IITF.
(a) The Secretary shall revoke certification of an HHS-certified laboratory or IITF in accordance with these Guidelines if the Secretary determines that revocation is necessary to ensure fully reliable and accurate drug and specimen validity test results and reports.
(b) The Secretary shall consider the following factors in determining whether revocation is necessary:
(1) Unsatisfactory performance in analyzing and reporting the results of drug and specimen validity tests (
(2) Unsatisfactory participation in performance testing or inspections;
(3) A material violation of a certification standard, contract term, or other condition imposed on the HHS-certified laboratory or IITF by a Federal agency using the laboratory's or IITF's services;
(4) Conviction for any criminal offense committed as an incident to operation of the HHS-certified laboratory or IITF; or
(5) Any other cause that materially affects the ability of the HHS-certified laboratory or IITF to ensure fully reliable and accurate drug test results and reports.
(c) The period and terms of revocation shall be determined by the Secretary and shall depend upon the facts and circumstances of the revocation and the need to ensure accurate and reliable drug testing.
(a) The Secretary may immediately suspend (either partially or fully) a laboratory's or IITF's HHS certification to conduct drug testing for Federal agencies if the Secretary has reason to believe that revocation may be required and that immediate action is necessary to protect the interests of the United States and its employees.
(b) The Secretary shall determine the period and terms of suspension based upon the facts and circumstances of the suspension and the need to ensure accurate and reliable drug testing.
(a) When laboratory's or IITF's HHS certification is suspended or the Secretary seeks to revoke HHS certification, the Secretary shall immediately serve the HHS-certified laboratory or IITF with written notice of the suspension or proposed revocation by fax, mail, personal service, or registered or certified mail, return receipt requested. This notice shall state the following:
(1) The reasons for the suspension or proposed revocation;
(2) The terms of the suspension or proposed revocation; and
(3) The period of suspension or proposed revocation.
(b) The written notice shall state that the laboratory or IITF will be afforded an opportunity for an informal review of the suspension or proposed revocation if it so requests in writing within 30 days of the date the laboratory or IITF received the notice, or if expedited review is requested, within 3 days of the date the laboratory or IITF received the notice. Subpart P of these Guidelines contains detailed procedures to be followed for an informal review of the suspension or proposed revocation.
(c) A suspension must be effective immediately. A proposed revocation must be effective 30 days after written notice is given or, if review is requested, upon the reviewing official's decision to uphold the proposed revocation. If the reviewing official decides not to uphold the suspension or proposed revocation, the suspension must terminate immediately and any proposed revocation shall not take effect.
(d) The Secretary will publish in the
Following revocation, a laboratory or IITF may apply for recertification. Unless otherwise provided by the Secretary in the notice of revocation under Section 9.17 or the reviewing official's decision under Section 16.9(e) or 16.14(a), a laboratory or IITF which has had its certification revoked may reapply for HHS certification as an applicant laboratory or IITF.
(a) The list of HHS-certified laboratories and IITFs is published monthly in the
(b) An applicant laboratory or IITF is not included on the list.
(a) Each Federal agency is required to submit blind samples for its workplace drug testing program. The collector must send the blind samples to the HHS-certified laboratory or IITF that the collector sends employee specimens.
(b) Each Federal agency must submit at least 3 percent blind samples along with its donor specimens based on the projected total number of donor specimens collected per year (up to a maximum of 400 blind samples). Every effort should be made to ensure that blind samples are submitted quarterly.
(c) Approximately 75 percent of the blind samples submitted each year by an agency must be negative, 15 percent must be positive for one or more drugs, and 10 percent must either be adulterated or substituted.
(a) Drug positive blind samples must be validated by the supplier as to their content using appropriate initial and confirmatory tests.
(1) Drug positive blind samples must contain one or more of the drugs or metabolites listed in the drug testing panel.
(2) Drug positive blind samples must contain concentrations of drugs between 1.5 and 2 times the initial drug test cutoff.
(b) Drug negative blind samples (
(c) A blind sample that is adulterated must be validated using appropriate initial and confirmatory specimen validity tests, and have the characteristics to clearly show that it is an adulterated sample at the time of validation.
(d) A blind sample that is substituted must be validated using appropriate initial and confirmatory specimen validity tests, and have the characteristics to clearly show that it is a substituted sample at the time of validation.
(e) The supplier must provide information on the blind samples' content, validation, expected results, and stability to the collection site/collector sending the blind samples to the laboratory or IITF, and must provide the information upon request to the MRO, the Federal agency for which the blind sample was submitted, or the Secretary.
(a) A blind sample must be submitted as a split specimen (specimens A and B) with the current Federal CCF that the HHS-certified laboratory or IITF uses for donor specimens. The collector provides the required information to ensure that the Federal CCF has been properly completed and provides fictitious initials on the specimen label/seal. The collector must indicate that the specimen is a blind sample on the MRO copy where a donor would normally provide a signature.
(b) A collector should attempt to distribute the required number of blind samples randomly with donor specimens rather than submitting the full complement of blind samples as a single group.
If an HHS-certified laboratory or IITF reports a result for a blind sample that is inconsistent with the expected result (
(a) The MRO must contact the laboratory or IITF and attempt to determine if the laboratory or IITF made an error during the testing or reporting of the sample;
(b) The MRO must contact the blind sample supplier and attempt to determine if the supplier made an error during the preparation or transfer of the sample;
(c) The MRO must contact the collector and determine if the collector made an error when preparing the blind sample for transfer to the HHS-certified laboratory or IITF;
(d) If there is no obvious reason for the inconsistent result, the MRO must notify both the Federal agency for which the blind sample was submitted and the Secretary; and
(e) The Secretary shall investigate the blind sample error. A report of the Secretary's investigative findings and the corrective action taken in response to identified deficiencies must be sent to the Federal agency. The Secretary shall ensure notification of the finding as appropriate to other Federal agencies and coordinate any necessary actions to prevent the recurrence of the error.
(a) An HHS-certified laboratory must have a standard operating procedure (SOP) manual that describes, in detail, all HHS-certified laboratory operations. When followed, the SOP manual ensures that all specimens are tested using the same procedures.
(b) The SOP manual must include at a minimum, but is not limited to, a detailed description of the following:
(1) Chain of custody procedures;
(2) Accessioning;
(3) Security;
(4) Quality control/quality assurance programs;
(5) Analytical methods and procedures;
(6) Equipment and maintenance programs;
(7) Personnel training;
(8) Reporting procedures; and
(9) Computers, software, and laboratory information management systems.
(c) All procedures in the SOP manual must be compliant with these Guidelines and all guidance provided by the Secretary.
(d) A copy of all procedures that have been replaced or revised and the dates on which the procedures were in effect must be maintained for at least 2 years.
(a) Manage the day-to-day operations of the HHS-certified laboratory even if another individual has overall responsibility for alternate areas of a multi-specialty laboratory.
(b) Ensure that there are sufficient personnel with adequate training and experience to supervise and conduct the work of the HHS-certified laboratory. The RP must ensure the continued competency of laboratory staff by documenting their in-service training, reviewing their work performance, and verifying their skills.
(c) Maintain a complete and current SOP manual that is available to all personnel of the HHS-certified
(d) Maintain a quality assurance program that ensures the proper performance and reporting of all test results; verify and monitor acceptable analytical performance for all controls and calibrators; monitor quality control testing; and document the validity, reliability, accuracy, precision, and performance characteristics of each test and test system.
(e) Initiate and implement all remedial actions necessary to maintain satisfactory operation and performance of the HHS-certified laboratory in response to the following: quality control systems not within performance specifications; errors in result reporting or in analysis of performance testing samples; and inspection deficiencies. The RP must ensure that specimen results are not reported until all corrective actions have been taken and that the results provided are accurate and reliable.
The RP must have documented scientific qualifications in analytical toxicology.
Minimum qualifications are:
(a) Certification or licensure as a laboratory director by the state in forensic or clinical laboratory toxicology, a Ph.D. in one of the natural sciences, or training and experience comparable to a Ph.D. in one of the natural sciences with training and laboratory/research experience in biology, chemistry, and pharmacology or toxicology;
(b) Experience in forensic toxicology with emphasis on the collection and analysis of biological specimens for drugs of abuse;
(c) Experience in forensic applications of analytical toxicology (
(d) Fulfillment of the RP responsibilities and qualifications, as demonstrated by the HHS-certified laboratory's performance and verified upon interview by HHS-trained inspectors during each on-site inspection; and
(e) Qualify as a certifying scientist.
(a) HHS-certified laboratories must have multiple RPs or one RP and an alternate RP. If the RP(s) are concurrently absent, an alternate RP must be present and qualified to fulfill the responsibilities of the RP.
(1) If an HHS-certified laboratory is without the RP and alternate RP for 14 calendar days or less (
(2) The Secretary, in accordance with these Guidelines, will suspend a laboratory's HHS certification for all specimens if the laboratory does not have an RP or alternate RP for a period of more than 14 calendar days. The suspension will be lifted upon the Secretary's approval of a new permanent RP or alternate RP.
(b) If the RP leaves an HHS-certified laboratory:
(1) The HHS-certified laboratory may maintain certification and continue testing federally regulated specimens under the direction of an alternate RP for a period of up to 180 days while seeking to hire and receive the Secretary's approval of the RP's replacement.
(2) The Secretary, in accordance with these Guidelines, will suspend a laboratory's HHS certification for all federally regulated specimens if the laboratory does not have a permanent RP within 180 days. The suspension will be lifted upon the Secretary's approval of the new permanent RP.
(c) To nominate an individual as an RP or alternate RP, the HHS-certified laboratory must submit the following documents to the Secretary: the candidate's current resume or curriculum vitae, copies of diplomas and licensures, a training plan (not to exceed 90 days) to transition the candidate into the position, an itemized comparison of the candidate's qualifications to the minimum RP qualifications described in the Guidelines, and have official academic transcript(s) submitted from the candidate's institution(s) of higher learning. The candidate must be found qualified during an on-site inspection of the HHS-certified laboratory.
(d) The HHS-certified laboratory must fulfill additional inspection and PT criteria as required prior to conducting federally regulated testing under a new RP.
(a) A certifying scientist must have:
(1) At least a bachelor's degree in the chemical or biological sciences or medical technology, or equivalent;
(2) Training and experience in the analytical methods and forensic procedures used by the HHS-certified laboratory relevant to the results that the individual certifies; and
(3) Training and experience in reviewing and reporting forensic test results and maintaining chain of custody, and an understanding of appropriate remedial actions in response to problems that may arise.
(b) A certifying technician must have:
(1) Training and experience in the analytical methods and forensic procedures used by the HHS-certified laboratory relevant to the results that the individual certifies; and
(2) Training and experience in reviewing and reporting forensic test results and maintaining chain of custody, and an understanding of appropriate remedial actions in response to problems that may arise.
(a) All HHS-certified laboratory staff (
(b) Each individual working in an HHS-certified laboratory must be properly trained (
(a) An HHS-certified laboratory must control access to the drug testing facility, specimens, aliquots, and records.
(b) Authorized visitors must be escorted at all times, except for individuals conducting inspections (
(c) An HHS-certified laboratory must maintain records documenting the identity of the visitor and escort, date, time of entry and exit, and purpose for access to the secured area.
(a) HHS-certified laboratories must use chain of custody procedures (internal and external) to maintain control and accountability of specimens from the time of receipt at the laboratory through completion of testing, reporting of results, during storage, and continuing until final disposition of the specimens.
(b) HHS-certified laboratories must use chain of custody procedures to document the handling and transfer of aliquots throughout the testing process until final disposal.
(c) The chain of custody must be documented using either paper copy or electronic procedures.
(d) Each individual who handles a specimen or aliquot must sign and complete the appropriate entries on the chain of custody form when the specimen or aliquot is handled or transferred, and every individual in the chain must be identified.
(e) The date and purpose must be recorded on an appropriate chain of custody form each time a specimen or aliquot is handled or transferred.
An HHS-certified laboratory must test the specimen in the same manner as a specimen that had not been previously tested.
(a) An initial drug test may be:
(1) An immunoassay; or
(2) An alternate technology (
(b) An HHS-certified laboratory must validate an initial drug test before testing specimens.
(c) Initial drug tests must be accurate and reliable for the testing of specimens when identifying drugs or their metabolites.
(d) An HHS-certified laboratory may conduct a second initial drug test using a method with different specificity, to rule out cross-reacting compounds. This second initial drug test must satisfy the batch quality control requirements specified in Section 11.12.
(a) An HHS-certified laboratory must demonstrate and document the following for each initial drug test:
(1) The ability to differentiate negative specimens from those requiring further testing;
(2) The performance of the test around the cutoff, using samples at several concentrations between 0 and 150 percent of the cutoff;
(3) The effective concentration range of the test (linearity);
(4) The potential for carryover;
(5) The potential for interfering substances; and
(6) The potential matrix effects if using an alternate technology.
(b) Each new lot of reagent must be verified prior to being placed into service.
(c) Each initial drug test using an alternate technology must be re-verified periodically or at least annually.
(a) Each batch of specimens must contain the following controls:
(1) At least one control certified to contain no drug or drug metabolite;
(2) At least one positive control with the drug or drug metabolite targeted at a concentration 25 percent above the cutoff;
(3) At least one control with the drug or drug metabolite targeted at a concentration 75 percent of the cutoff; and
(4) At least one control that appears as a donor specimen to the analysts.
(b) Calibrators and controls must total at least 10 percent of the aliquots analyzed in each batch.
(a) The analytical method must use mass spectrometric identification (
(b) A confirmatory drug test must be validated before it can be used to test federally regulated specimens.
(c) Confirmatory drug tests must be accurate and reliable for the testing of a urine specimen when identifying and quantifying drugs or their metabolites.
(a) An HHS-certified laboratory must demonstrate and document the following for each confirmatory drug test:
(1) The linear range of the analysis;
(2) The limit of detection;
(3) The limit of quantification;
(4) The accuracy and precision at the cutoff;
(5) The accuracy (bias) and precision at 40 percent of the cutoff;
(6) The potential for interfering substances;
(7) The potential for carryover; and
(8) The potential matrix effects if using liquid chromatography coupled with mass spectrometry.
(b) Each new lot of reagent must be verified prior to being placed into service.
(c) HHS-certified laboratories must re-verify each confirmatory drug test method periodically or at least annually.
(a) At a minimum, each batch of specimens must contain the following calibrators and controls:
(1) A calibrator at the cutoff;
(2) At least one control certified to contain no drug or drug metabolite;
(3) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff; and
(4) At least one control targeted at or less than 40 percent of the cutoff.
(b) Calibrators and controls must total at least 10 percent of the aliquots analyzed in each batch.
(a) Each invalid, adulterated, or substituted specimen validity test result must be based on an initial specimen validity test on one aliquot and a confirmatory specimen validity test on a second aliquot;
(b) The HHS-certified laboratory must establish acceptance criteria and analyze calibrators and controls as appropriate to verify and document the validity of the test results (required specimen validity tests are addressed in Section 11.18); and
(c) Controls must be analyzed concurrently with specimens.
An HHS-certified laboratory must demonstrate and document for each specimen validity test the appropriate performance characteristics of the test, and must re-verify the test periodically, or at least annually. Each new lot of reagent must be verified prior to being placed into service.
(a) The requirements for measuring creatinine concentration are as follows:
(1) The creatinine concentration must be measured to one decimal place on both the initial creatinine test and the confirmatory creatinine test;
(2) The initial creatinine test must have the following calibrators and controls:
(i) A calibrator at 2 mg/dL;
(ii) A control in the range of 1.0 mg/dL to 1.5 mg/dL;
(iii) A control in the range of 3 mg/dL to 20 mg/dL; and
(iv) A control in the range of 21 mg/dL to 25 mg/dL.
(3) The confirmatory creatinine test (performed on those specimens with a creatinine concentration less than 2 mg/dL on the initial test) must have the following calibrators and controls:
(i) A calibrator at 2 mg/dL;
(ii) A control in the range of 1.0 mg/dL to 1.5 mg/dL; and
(iii) A control in the range of 3 mg/dL to 4 mg/dL.
(b) The requirements for measuring specific gravity are as follows:
(1) For specimens with initial creatinine test results greater than 5 mg/dL and less than 20 mg/dL, laboratories may perform a screening test using a refractometer that measures urine specific gravity to at least three decimal places to identify specific gravity values that are acceptable (equal to or greater than 1.003) or dilute (equal to or greater than 1.002 and less than 1.003). Specimens must be subjected to an initial specific gravity test using a four decimal place refractometer when the initial creatinine test result is less than or equal to 5 mg/dL or when the screening specific gravity test result using a three decimal place refractometer is less than 1.002.
(2) The screening specific gravity test must have the following calibrators and controls:
(i) A calibrator or control at 1.000;
(ii) One control targeted at 1.002;
(iii) One control in the range of 1.004 to 1.018.
(3) For the initial and confirmatory specific gravity tests, the refractometer must report and display specific gravity to four decimal places. The refractometer must be interfaced with a laboratory information management system (LIMS), computer, and/or generate a paper copy of the digital electronic display to document the numerical values of the specific gravity test results;
(4) The initial and confirmatory specific gravity tests must have the following calibrators and controls:
(i) A calibrator or control at 1.0000;
(ii) One control targeted at 1.0020;
(iii) One control in the range of 1.0040 to 1.0180; and
(iv) One control equal to or greater than 1.0200 but not greater than 1.0250.
(c) Requirements for measuring pH are as follows:
(1) Colorimetric pH tests that have the dynamic range of 3 to 12 to support the 4 and 11 pH cutoffs and pH meters must be capable of measuring pH to one decimal place. Colorimetric pH tests, dipsticks, and pH paper (
(2) For the initial and confirmatory pH tests, the pH meter must report and display pH to at least one decimal place. The pH meter must be interfaced with a LIMS, computer, and/or generate a paper copy of the digital electronic display to document the numerical values of the pH test results;
(3) pH screening tests must have, at a minimum, the following controls:
(i) One control below the lower decision point in use;
(ii) One control between the decision points in use; and
(iii) One control above the upper decision point in use;
(4) An initial colorimetric pH test must have the following calibrators and controls:
(i) One calibrator at 4;
(ii) One calibrator at 11;
(iii) One control in the range of 3 to 3.8;
(iv) One control in the range 4.2 to 5;
(v) One control in the range of 5 to 9;
(vi) One control in the range of 10 to 10.8; and
(vii) One control in the range of 11.2 to 12;
(5) An initial pH meter test, if a pH screening test is not used, must have the following calibrators and controls:
(i) One calibrator at 3;
(ii) One calibrator at 7;
(iii) One calibrator at 10;
(iv) One control in the range of 3 to 3.8;
(v) One control in the range 4.2 to 5;
(vi) One control in the range of 10 to 10.8; and
(vii) One control in the range of 11.2 to 12;
(6) An initial pH meter test (if a pH screening test is used) or confirmatory pH meter test must have the following calibrators and controls when the result of the preceding pH test indicates that the pH is below the lower decision point in use:
(i) One calibrator at 4;
(ii) One calibrator at 7;
(iii) One control in the range of 3 to 3.8; and
(iv) One control in the range 4.2 to 5; and
(7) An initial pH meter test (if a pH screening test is used) or confirmatory pH meter test must have the following calibrators and controls when the result of the preceding pH test indicates that the pH is above the upper decision point in use:
(i) One calibrator at 7;
(ii) One calibrator at 10;
(iii) One control in the range of 10 to 10.8; and
(iv) One control in the range of 11.2 to 12.
(d) Requirements for performing oxidizing adulterant tests are as follows:
(1) The initial test must include an appropriate calibrator at the cutoff specified in Section 11.19(d)(2), (3), or (4) for the compound of interest, a control without the compound of interest (
(2) A confirmatory test for a specific oxidizing adulterant must use a different analytical method than that used for the initial test. Each confirmatory test batch must include an appropriate calibrator, a control without the compound of interest (
(e) The requirements for measuring the nitrite concentration are that the initial and confirmatory nitrite tests must have a calibrator at the cutoff, a control without nitrite (
(a) Laboratories must report a test result to the agency's MRO within an average of 5 working days after receipt of the specimen. Reports must use the Federal CCF and/or an electronic report, as described in items p and q below. Before any test result can be reported, it must be certified by a certifying scientist or a certifying technician (as appropriate).
(b) A primary (A) specimen is reported negative when each initial drug test is negative or if the specimen is negative upon confirmatory drug
(c) A primary (A) specimen is reported positive for a specific drug or drug metabolite when both the initial drug test is positive and the confirmatory drug test is positive in accordance with the cutoffs listed in the drug testing panel.
(d) A primary (A) urine specimen is reported adulterated when:
(1) The pH is less than 4 or equal to or greater than 11 using either a pH meter or a colorimetric pH test for the initial test on the first aliquot and a pH meter for the confirmatory test on the second aliquot;
(2) The nitrite concentration is equal to or greater than 500 mcg/mL using either a nitrite colorimetric test or a general oxidant colorimetric test for the initial test on the first aliquot and a different confirmatory test (
(3) The presence of chromium (VI) is verified using either a general oxidant colorimetric test (with an equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL) for the initial test on the first aliquot and a different confirmatory test (
(4) The presence of halogen (
(5) The presence of glutaraldehyde is verified using either an aldehyde test (aldehyde present) or the characteristic immunoassay response on one or more drug immunoassay tests for the initial test on the first aliquot and a different confirmatory method (
(6) The presence of pyridine (pyridinium chlorochromate) is verified using either a general oxidant colorimetric test (with an equal to or greater than 200 mcg/mL nitrite-equivalent cutoff or an equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff) or a chromium (VI) colorimetric test (chromium (VI) concentration equal to or greater than 50 mcg/mL) for the initial test on the first aliquot and a different confirmatory method (
(7) The presence of a surfactant is verified by using a surfactant colorimetric test with an equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for the initial test on the first aliquot and a different confirmatory test (
(8) The presence of any other adulterant not specified in Section 11.19(d)(2) through (7) is verified using an initial test on the first aliquot and a different confirmatory test on the second aliquot.
(e) A primary (A) urine specimen is reported substituted when:
(1) The creatinine concentration is less than 2 mg/dL and the specific gravity is less than or equal to 1.0010 or equal to or greater than 1.0200 on both the initial and confirmatory creatinine tests (
(2) A biomarker is not present or is present at a concentration inconsistent with that established for human urine.
(f) A primary (A) urine specimen is reported dilute when the creatinine concentration is equal to or greater than 2 mg/dL but less than 20 mg/dL and the specific gravity is greater than 1.0010 but less than 1.0030 on a single aliquot.
(g) For a specimen that has an invalid result for one of the reasons stated in Section 11.19(h)(4) through (13), the HHS-certified laboratory shall contact the MRO and both will decide if testing by another HHS-certified laboratory would be useful in being able to report a positive, adulterated, or substituted result. If no further testing is necessary, the HHS-certified laboratory then reports the invalid result to the MRO.
(h) A primary (A) urine specimen is reported as an invalid result when:
(1) Inconsistent creatinine concentration and specific gravity results are obtained (
(2) The pH is equal to or greater than 4 and less than 4.5 or equal to or greater than 9 and less than 11 using either a colorimetric pH test or pH meter for the initial test and a pH meter for the confirmatory test on two separate aliquots;
(3) The nitrite concentration is equal to or greater than 200 mcg/mL using a nitrite colorimetric test or equal to or greater than the equivalent of 200 mcg/mL nitrite using a general oxidant colorimetric test for both the initial (first) test and the second test or using either initial test and the nitrite concentration is equal to or greater than 200 mcg/mL but less than 500 mcg/mL for a different confirmatory test (
(4) The possible presence of chromium (VI) is determined using the same chromium (VI) colorimetric test with a cutoff equal to or greater than 50 mcg/mL chromium (VI) for both the initial (first) test and the second test on two separate aliquots;
(5) The possible presence of a halogen (
(6) The possible presence of glutaraldehyde is determined by using the same aldehyde test (aldehyde present) or characteristic immunoassay response on one or more drug immunoassay tests for both the initial (first) test and the second test on two separate aliquots;
(7) The possible presence of an oxidizing adulterant is determined by using the same general oxidant colorimetric test (with an equal to or greater than 200 mcg/mL nitrite-equivalent cutoff, an equal to or greater than 50 mcg/mL chromium (VI)-equivalent cutoff, or a halogen concentration is equal to or greater than the LOQ) for both the initial (first) test and the second test on two separate aliquots;
(8) The possible presence of a surfactant is determined by using the same surfactant colorimetric test with an equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff for both the initial (first) test and the second test on two separate aliquots or a foam/shake test for the initial test;
(9) Interference occurs on the initial drug tests on two separate aliquots (
(10) Interference with the confirmatory drug test occurs on at least two separate aliquots of the specimen and the HHS-certified laboratory is unable to identify the interfering substance;
(11) The physical appearance of the specimen is such that testing the specimen may damage the laboratory's instruments;
(12) The physical appearances of the A and B specimens are clearly different (note: A is tested); or
(13) A specimen validity test (
(i) An HHS-certified laboratory shall reject a primary (A) specimen for testing when a fatal flaw occurs as described in Section 15.1 or when a correctable flaw as described in Section 15.2 is not recovered. The HHS-certified laboratory will indicate on the Federal CCF that the specimen was rejected for testing and provide the reason for reporting the rejected for testing result.
(j) An HHS-certified laboratory must report all positive, adulterated, substituted, and invalid test results for a urine specimen. For example, a specimen can be positive for a drug and adulterated.
(k) An HHS-certified laboratory must report the confirmatory concentration of each drug or drug metabolite reported for a positive result.
(l) An HHS-certified laboratory must report numerical values of the specimen validity test results that support an adulterated, substituted, or invalid result (as appropriate).
(m) An HHS-certified laboratory must report results using the HHS-specified nomenclature published with the drug and biomarker testing panels.
(n) When the concentration of a drug or drug metabolite exceeds the validated linear range of the confirmatory test, HHS-certified laboratories may report to the MRO that the quantitative value exceeds the linear range of the test or that the quantitative value is greater than “insert the actual value for the upper limit of the linear range,” or laboratories may report a quantitative value above the upper limit of the linear range that was obtained by diluting an aliquot of the specimen to achieve a result within the method's linear range and multiplying the result by the appropriate dilution factor.
(o) HHS-certified laboratories may transmit test results to the MRO by various electronic means (
(p) HHS-certified laboratories must fax, courier, mail, or electronically transmit a legible image or copy of the completed Federal CCF and/or forward a computer-generated electronic report. The computer-generated report must contain sufficient information to ensure that the test results can accurately represent the content of the custody and control form that the MRO received from the collector.
(q) For positive, adulterated, substituted, invalid, and rejected specimens, laboratories must fax, courier, mail, or electronically transmit a legible image or copy of the completed Federal CCF.
(a) An HHS-certified laboratory must retain specimens that were reported as positive, adulterated, substituted, or as an invalid result for a minimum of 1 year.
(b) Retained urine specimens must be kept in secured frozen storage (-20°C or less) to ensure their availability for retesting during an administrative or judicial proceeding.
(c) Federal agencies may request that the HHS-certified laboratory retain a specimen for an additional specified period of time and must make that request within the 1-year period following the laboratory's reporting of the specimen.
(a) An HHS-certified laboratory must retain all records generated to support test results for at least 2 years. The laboratory may convert hardcopy records to electronic records for storage and then discard the hardcopy records after 6 months.
(b) A Federal agency may request the HHS-certified laboratory to maintain a documentation package (as described in Section 11.23) that supports the chain of custody, testing, and reporting of a donor's specimen that is under legal challenge by a donor. The Federal agency's request to the laboratory must be in writing and must specify the period of time to maintain the documentation package.
(c) An HHS-certified laboratory may retain records other than those included in the documentation package beyond the normal 2-year period of time.
(a) HHS-certified laboratories must provide to each Federal agency for which they perform testing a semiannual statistical summary report that must be submitted by mail, fax, or email within 14 working days after the end of the semiannual period. The summary report must not include any personally identifiable information. A copy of the semiannual statistical summary report will also be sent to the Secretary or designated HHS representative. The semiannual statistical report contains the following information:
(1) Reporting period (inclusive dates);
(2) HHS-certified laboratory name and address;
(3) Federal agency name;
(4) Number of specimen results reported;
(5) Number of specimens collected by reason for test;
(6) Number of specimens reported negative and the number reported negative/dilute;
(7) Number of specimens rejected for testing because of a fatal flaw;
(8) Number of specimens rejected for testing because of an uncorrected flaw;
(9) Number of specimens tested positive by each initial drug test;
(10) Number of specimens reported positive;
(11) Number of specimens reported positive for each drug and drug metabolite;
(12) Number of specimens reported adulterated;
(13) Number of specimens reported substituted; and
(14) Number of specimens reported as invalid result.
(b) An HHS-certified laboratory must make copies of an agency's test results available when requested to do so by the Secretary or by the Federal agency for which the laboratory is performing drug-testing services.
(c) An HHS-certified laboratory must ensure that a qualified individual is available to testify in a proceeding against a Federal employee when the proceeding is based on a test result reported by the laboratory.
(a) Following a Federal agency's receipt of a positive, adulterated, or substituted drug test report, the Federal agency may submit a written request for copies of the records relating to the drug test results or a documentation package or any relevant certification, review, or revocation of certification records.
(b) Standard documentation packages provided by an HHS-certified laboratory must contain the following items:
(1) A cover sheet providing a brief description of the procedures and tests performed on the donor's specimen;
(2) A table of contents that lists all documents and materials in the package by page number;
(3) A copy of the Federal CCF with any attachments, internal chain of custody records for the specimen, memoranda (if any) generated by the HHS-certified laboratory, and a copy of the electronic report (if any) generated by the HHS-certified laboratory;
(4) A brief description of the HHS-certified laboratory's initial drug and specimen validity testing procedures, instrumentation, and batch quality control requirements;
(5) Copies of the initial test data for the donor's specimen with all calibrators and controls and copies of all internal chain of custody documents related to the initial tests;
(6) A brief description of the HHS-certified laboratory's confirmatory drug (and specimen validity, if applicable) testing procedures, instrumentation, and batch quality control requirements;
(7) Copies of the confirmatory test data for the donor's specimen with all calibrators and controls and copies of all internal chain of custody documents related to the confirmatory tests; and
(8) Copies of the résumé or curriculum vitae for the RP(s) and the certifying technician or certifying scientist of record.
Federal applicants or employees who are subject to a workplace drug test may submit a written request through the MRO and/or the Federal agency requesting copies of any records relating to their drug test results or a documentation package as described in Section 11.23(b) and any relevant certification, review, or revocation of certification records. Federal applicants or employees, or their designees, are not permitted access to their specimens collected pursuant to Executive Order 12564, Public Law 100-71, and these Guidelines.
An HHS-certified laboratory must not enter into any relationship with a Federal agency's MRO that may be construed as a potential conflict of interest or derive any financial benefit by having a Federal agency use a specific MRO.
This means an MRO may be an employee of the agency or a contractor for the agency; however, an MRO shall not be an employee or agent of or have any financial interest in the HHS-certified laboratory for which the MRO is reviewing drug testing results. Additionally, an MRO shall not derive any financial benefit by having an agency use a specific HHS-certified laboratory or have any agreement with an HHS-certified laboratory that may be construed as a potential conflict of interest.
An HHS-certified laboratory can enter into any relationship with an HHS-certified IITF.
(a) An HHS-certified IITF must have a standard operating procedure (SOP) manual that describes, in detail, all HHS-certified IITF operations. When followed, the SOP manual ensures that all specimens are tested consistently using the same procedures.
(b) The SOP manual must include at a minimum, but is not limited to, a detailed description of the following:
(1) Chain of custody procedures;
(2) Accessioning;
(3) Security;
(4) Quality control/quality assurance programs;
(5) Analytical methods and procedures;
(6) Equipment and maintenance programs;
(7) Personnel training;
(8) Reporting procedures; and
(9) Computers, software, and laboratory information management systems.
(c) All procedures in the SOP manual must be compliant with these Guidelines and all guidance provided by the Secretary.
(d) A copy of all procedures that have been replaced or revised and the dates on which the procedures were in effect must be maintained for two years.
(a) Manage the day-to-day operations of the HHS-certified IITF even if another individual has overall responsibility for alternate areas of a multi-specialty facility.
(b) Ensure that there are sufficient personnel with adequate training and experience to supervise and conduct the work of the HHS-certified IITF. The RT must ensure the continued competency of IITF personnel by documenting their in-service training, reviewing their work performance, and verifying their skills.
(c) Maintain a complete and current SOP manual that is available to all personnel of the HHS-certified IITF, and ensure that it is followed. The SOP manual must be reviewed, signed, and dated by the RT when procedures are first placed into use or changed or when a new individual assumes responsibility for the management of the HHS-certified IITF. The SOP must be reviewed and documented by the RT annually.
(d) Maintain a quality assurance program that ensures the proper performance and reporting of all test results; verify and monitor acceptable analytical performance for all controls and calibrators; monitor quality control testing; and document the validity, reliability, accuracy, precision, and performance characteristics of each test and test system.
(e) Initiate and implement all remedial actions necessary to maintain satisfactory operation and performance of the HHS-certified IITF in response to the following: quality control systems not within performance specifications, errors in result reporting or in analysis of performance testing samples, and inspection deficiencies. The RT must ensure that specimen results are not
An RT must:
(a) Have at least a bachelor's degree in the chemical or biological sciences or medical technology, or equivalent;
(b) Have training and experience in the analytical methods and forensic procedures used by the HHS-certified IITF;
(c) Have training and experience in reviewing and reporting forensic test results and maintaining chain of custody, and an understanding of appropriate remedial actions in response to problems that may arise;
(d) Be found to fulfill RT responsibilities and qualifications, as demonstrated by the HHS-certified IITF's performance and verified upon interview by HHS-trained inspectors during each on-site inspection; and
(e) Qualify as a certifying technician.
(a) HHS-certified IITFs must have an RT and an alternate RT. When an RT is absent, an alternate RT must be present and qualified to fulfill the responsibilities of the RT.
(1) If an HHS-certified IITF is without the RT and alternate RT for 14 calendar days or less (
(2) The Secretary, in accordance with these Guidelines, will suspend an IITF's HHS certification for all specimens if the IITF does not have an RT or alternate RT for a period of more than 14 calendar days. The suspension will be lifted upon the Secretary's approval of a new permanent RT or alternate RT.
(b) If the RT leaves an HHS-certified IITF:
(1) The HHS-certified IITF may maintain certification and continue testing federally regulated specimens under the direction of an alternate RT for a period of up to 180 days while seeking to hire and receive the Secretary's approval of the RT's replacement.
(2) The Secretary, in accordance with these Guidelines, will suspend an IITF's HHS certification for all federally regulated specimens if the IITF does not have a permanent RT within 180 days. The suspension will be lifted upon the Secretary's approval of the new permanent RT.
(c) To nominate an individual as the RT or alternate RT, the HHS-certified IITF must submit the following documents to the Secretary: the candidate's current resume or curriculum vitae, copies of diplomas and licensures, a training plan (not to exceed 90 days) to transition the candidate into the position, an itemized comparison of the candidate's qualifications to the minimum RT qualifications described in the Guidelines, and have official academic transcript(s) submitted from the candidate's institution(s) of higher learning. The candidate must be found qualified during an on-site inspection of the HHS-certified IITF.
(d) The HHS-certified IITF must fulfill additional inspection and PT criteria as required prior to conducting federally regulated testing under a new RT.
A certifying technician must have:
(a) Training and experience in the analytical methods and forensic procedures used by the HHS-certified IITF relevant to the results that the individual certifies; and
(b) Training and experience in reviewing and reporting forensic test results and maintaining chain of custody, and an understanding of appropriate remedial actions in response to problems that may arise.
(a) All HHS-certified IITF staff (
(b) Each individual working in an HHS-certified IITF must be properly trained (
(a) An HHS-certified IITF must control access to the drug testing facility, specimens, aliquots, and records.
(b) Authorized visitors must be escorted at all times except for individuals conducting inspections (
(c) An HHS-certified IITF must maintain records documenting the identity of the visitor and escort, date, time of entry and exit, and purpose for the access to the secured area.
(a) HHS-certified IITFs must use chain of custody procedures (internal and external) to maintain control and accountability of specimens from the time of receipt at the IITF through completion of testing, reporting of results, during storage, and continuing until final disposition of the specimens.
(b) HHS-certified IITFs must use chain of custody procedures to document the handling and transfer of aliquots throughout the testing process until final disposal.
(c) The chain of custody must be documented using either paper copy or electronic procedures.
(d) Each individual who handles a specimen or aliquot must sign and complete the appropriate entries on the chain of custody form when the specimen or aliquot is handled or transferred, and every individual in the chain must be identified.
(e) The date and purpose must be recorded on an appropriate chain of custody form each time a specimen or aliquot is handled or transferred.
(a) An initial drug test may be:
(1) An immunoassay; or
(2) An alternate technology (
(b) An HHS-certified IITF must validate an initial drug test before testing specimens;
(c) Initial drug tests must be accurate and reliable for the testing of urine specimens when identifying drugs or their metabolites.
(d) An HHS-certified IITF may conduct a second initial drug test using a method with different specificity, to rule out cross-reacting compounds. This second initial drug test must satisfy the batch quality control requirements specified in Section 12.11.
(a) An HHS-certified IITF must demonstrate and document the following for each initial drug test:
(1) The ability to differentiate negative specimens from those requiring further testing;
(2) The performance of the test around the cutoff, using samples at several concentrations between 0 and 150 percent of the cutoff;
(3) The effective concentration range of the test (linearity);
(4) The potential for carryover;
(5) The potential for interfering substances; and
(6) The potential matrix effects if using an alternate technology.
(b) Each new lot of reagent must be verified prior to being placed into service.
(c) Each initial drug test using an alternate technology must be re-verified periodically or at least annually.
(a) Each batch of specimens must contain the following calibrators and controls:
(1) At least one control certified to contain no drug or drug metabolite;
(2) At least one positive control with the drug or drug metabolite targeted at a concentration 25 percent above the cutoff;
(3) At least one control with the drug or drug metabolite targeted at a concentration 75 percent of the cutoff; and
(4) At least one control that appears as a donor specimen to the analysts.
(b) Calibrators and controls must total at least 10 percent of the aliquots analyzed in each batch.
(a) Each specimen validity test result must be based on performing a single test on one aliquot;
(b) The HHS-certified IITF must establish acceptance criteria and analyze calibrators and controls as appropriate to verify and document the validity of the test results in accordance with Section 12.14; and
(c) Controls must be analyzed concurrently with specimens.
An HHS-certified IITF must demonstrate and document for each specimen validity test the appropriate performance characteristics of the test, and must re-verify the test periodically, or at least annually. Each new lot of reagent must be verified prior to being placed into service.
(a) The requirements for measuring creatinine concentration are as follows:
(1) The creatinine concentration must be measured to one decimal place on the test;
(2) The creatinine test must have the following calibrators and controls:
(i) A calibrator at 2 mg/dL;
(ii) A control in the range of 1.0 mg/dL to 1.5 mg/dL;
(iii) A control in the range of 3 mg/dL to 20 mg/dL; and
(iv) A control in the range of 21 mg/dL to 25 mg/dL.
(b) The requirements for measuring specific gravity are as follows:
(1) For specimens with creatinine test results greater than 5 mg/dL and less than 20 mg/dL, an IITF must perform a screening test using a refractometer to identify specific gravity values that are acceptable (equal to or greater than1.003) or dilute (equal to or greater than1.002 and less than1.003). Specimens must be forwarded to an HHS-certified laboratory when the creatinine test result is less than or equal to 5 mg/dL or when the screening specific gravity test result is less than 1.002.
(2) The screening specific gravity test must have the following calibrators and controls:
(i) A calibrator or control at 1.000;
(ii) One control targeted at 1.002; and
(iii) One control in the range of 1.004 to 1.018.
(c) The requirements for measuring pH are as follows:
(1) The IITF may perform the pH test using a pH meter, colorimetric pH test, dipsticks, or pH paper. Specimens must be forwarded to an HHS-certified laboratory when the pH is less than 4.5 or equal to or greater than 9.0.
(2) The pH test must have, at a minimum, the following calibrators and controls:
(i) One control below 4.5;
(ii) One control between 4.5 and 9.0;
(iii) One control above 9.0; and
(iv) One or more calibrators as appropriate for the test. For a pH meter: calibrators at 4, 7, and 10.
(d) The requirements for measuring the nitrite concentration are that the nitrite test must have a calibrator at 200 mcg/mL nitrite, a control without nitrite (
(e) Requirements for performing oxidizing adulterant tests are that the test must include an appropriate calibrator at the cutoff specified in Section 11.19(d)(3), (4), or (6) for the compound of interest, a control without the compound of interest (
(a) An HHS-certified IITF must report a test result to the agency's MRO within an average of 3 working days after receipt of the specimen. Reports must use the Federal CCF and/or an electronic report. Before any test result can be reported, it must be certified by a certifying technician.
(b) A primary (A) specimen is reported negative when each drug test is negative and each specimen validity test result indicates that the specimen is a valid urine specimen.
(c) A primary (A) urine specimen is reported dilute when the creatinine concentration is greater than 5 mg/dL but less than 20 mg/dL and the specific gravity is equal to or greater than 1.002 but less than 1.003.
(d) An HHS-certified IITF shall reject a urine specimen for testing when a fatal flaw occurs as described in Section 15.1 or when a correctable flaw as described in Section 15.2 is not recovered. The HHS-certified IITF will indicate on the Federal CCF that the specimen was rejected for testing and provide the reason for reporting the rejected for testing result.
(e) An HHS-certified IITF must report results using the HHS-specified nomenclature published with the drug and biomarker testing panels.
(f) HHS-certified IITFs may transmit test results to the MRO by various electronic means (
(g) HHS-certified IITFs must fax, courier, mail, or electronically transmit a legible image or copy of the completed Federal CCF and/or forward a computer-generated electronic report. The
(h) For rejected specimens, IITFs must fax, courier, mail, or electronically transmit a legible image or copy of the completed Federal CCF.
(a) The remaining specimen is resealed using a tamper-evident label/seal;
(b) The individual resealing the remaining specimen initials and dates the tamper-evident label/seal; and
(c) The resealed specimen and split specimen and the Federal CCF are sealed in a leak-proof plastic bag, and are sent to an HHS-certified laboratory under chain of custody within one day after completing the drug and specimen validity tests.
A specimen that is negative, negative/dilute, or rejected for testing is discarded.
(a) An HHS-certified IITF must retain all records generated to support test results for at least 2 years. The IITF may convert hardcopy records to electronic records for storage and then discard the hardcopy records after six months.
(b) A Federal agency may request the HHS-certified IITF to maintain a documentation package (as described in Section 12.20) that supports the chain of custody, testing, and reporting of a donor's specimen that is under legal challenge by a donor. The Federal agency's request to the IITF must be in writing and must specify the period of time to maintain the documentation package.
(c) An HHS-certified IITF may retain records other than those included in the documentation package beyond the normal two-year period of time.
(a) HHS-certified IITFs must provide to each Federal agency for which they perform testing a semiannual statistical summary report that must be submitted by mail, fax, or email within 14 working days after the end of the semiannual period. The summary report must not include any personally identifiable information. A copy of the semiannual statistical summary report will also be sent to the Secretary or designated HHS representative. The semiannual statistical report contains the following information:
(1) Reporting period (inclusive dates);
(2) HHS-certified IITF name and address;
(3) Federal agency name;
(4) Total number of specimens tested;
(5) Number of specimens collected by reason for test;
(6) Number of specimens reported negative and the number reported negative/dilute;
(7) Number of specimens rejected for testing because of a fatal flaw;
(8) Number of specimens rejected for testing because of an uncorrected flaw;
(9) Number of specimens tested positive by each initial drug test; and
(10) Number of specimens forwarded to an HHS-certified laboratory for testing.
(b) An HHS-certified IITF must make copies of an agency's test results available when requested to do so by the Secretary or by the Federal agency for which the IITF is performing drug-testing services.
(c) An HHS-certified IITF must ensure that a qualified individual is available to testify in a proceeding against a Federal employee when the proceeding is based on a test result reported by the IITF.
(a) Following a Federal agency's receipt of a positive, adulterated, or substituted drug test report from a laboratory, the Federal agency may submit a written request for copies of the IITF records relating to the drug test results or a documentation package or any relevant certification, review, or revocation of certification records.
(b) Standard documentation packages provided by an HHS-certified IITF must contain the following items:
(1) A cover sheet providing a brief description of the procedures and tests performed on the donor's specimen;
(2) A table of contents that lists all documents and materials in the package by page number;
(3) A copy of the Federal CCF with any attachments, internal chain of custody records for the specimen, memoranda (if any) generated by the HHS-certified IITF, and a copy of the electronic report (if any) generated by the HHS-certified IITF;
(4) A brief description of the HHS-certified IITF's drug and specimen validity testing procedures, instrumentation, and batch quality control requirements;
(5) Copies of all test data for the donor's specimen with all calibrators and controls and copies of all internal chain of custody documents related to the tests; and
(6) Copies of the résumé or curriculum vitae for the RT and for the certifying technician of record.
A Federal employee who is the subject of a drug test may provide a written request through the MRO and/or the Federal agency requesting access to any records relating to the employee's drug test results or a documentation package (as described in Section 12.20) and any relevant certification, review, or revocation of certification records.
An HHS-certified IITF must not enter into any relationship with a Federal agency's MRO that may be construed as a potential conflict of interest or derive any financial benefit by having a Federal agency use a specific MRO.
This means an MRO may be an employee of the agency or a contractor for the agency; however, an MRO shall not be an employee or agent of or have any financial interest in the HHS-certified IITF for which the MRO is reviewing drug testing results. Additionally, an MRO shall not derive any financial benefit by having an agency use a specific HHS-certified IITF or have any agreement with an HHS-certified IITF that may be construed as a potential conflict of interest.
An HHS-certified IITF can enter into any relationship with an HHS-certified laboratory.
(a) A currently licensed physician who has:
(1) A Doctor of Medicine (M.D.) or Doctor of Osteopathy (D.O.) degree;
(2) Knowledge regarding the pharmacology and toxicology of illicit drugs;
(3) The training necessary to serve as an MRO as set out in Section 13.3;
(4) Satisfactorily passed an initial examination administered by a nationally recognized entity or a subspecialty board that has been approved by the Secretary to certify MROs; and
(5) At least every five years from initial certification, completed requalification training on the topics in Section 13.3 and satisfactorily passed a requalification examination administered by a nationally recognized entity or a subspecialty board that has been approved by the Secretary to certify MROs.
All nationally recognized entities or subspecialty boards which seek approval by the Secretary to certify physicians as MROs for Federal workplace drug testing programs must submit their qualifications, a sample examination, and other necessary supporting examination materials (
(a) A physician must receive training that includes a thorough review of the following:
(1) The collection procedures used to collect Federal agency specimens;
(2) How to interpret test results reported by HHS-certified IITFs and laboratories (
(3) Chain of custody, reporting, and recordkeeping requirements for Federal agency specimens;
(4) The HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs for all authorized specimen types; and
(5) Procedures for interpretation, review (
(b) Certified MROs must complete training on any revisions to these Guidelines including any changes to the drug and biomarker testing panels prior to their effective date, to continue serving as an MRO for Federal agency specimens.
(a) The MRO must review all positive, adulterated, rejected for testing, invalid, and substituted test results.
(b) Staff under the direct, personal supervision of the MRO may review and report negative and (for urine) negative/dilute test results to the agency's designated representative. The MRO must review at least 5 percent of all negative results reported by the MRO staff to ensure that the MRO staff are properly performing the review process.
(c) The MRO must discuss potential invalid results with the HHS-certified laboratory, as addressed in Section 11.19(g) to determine whether testing at another HHS-certified laboratory may be warranted.
(d) After receiving a report from an HHS-certified laboratory or (for urine) HHS-certified IITF, the MRO must:
(1) Review the information on the MRO copy of the Federal CCF that was received from the collector and the report received from the HHS-certified laboratory or HHS-certified IITF;
(2) Interview the donor when required;
(3) Make a determination regarding the test result; and
(4) Report the verified result to the Federal agency.
(e) The MRO must maintain records for a minimum of two years while maintaining the confidentiality of the information. The MRO may convert hardcopy records to electronic records for storage and discard the hardcopy records after six months.
(f) The MRO must conduct a medical examination or a review of the examining physician's findings and make a determination of refusal to test or cancelled test when a collector reports that the donor was unable to provide a specimen and an alternate specimen was not collected, as addressed in Sections 8.6 and 13.6.
(a) When the HHS-certified laboratory or HHS-certified IITF reports a negative result for the primary (A) specimen, the MRO reports a negative result to the agency.
(b) When the HHS-certified laboratory or HHS-certified IITF reports a negative/dilute result for the primary (A) urine specimen, the MRO reports a negative/dilute result to the agency and directs the agency to immediately collect another specimen from the donor.
(1) If the recollected specimen provides a negative or negative/dilute result, the MRO reports a negative result to the agency, with no further action required.
(2) If the recollected specimen provides a result other than negative or negative/dilute, the MRO follows the procedures in Section 13.5(c) through (f) for the recollected specimen.
(c) When the HHS-certified laboratory reports multiple results for the primary (A) urine specimen, the MRO must follow the verification procedures described in Section 13.5(d) through (f) and:
(1) The MRO reports all verified positive and/or refusal to test results to the Federal agency.
(2) If an invalid result was reported in conjunction with a positive, adulterated, or substituted result, the MRO does not report the verified invalid result to the Federal agency at this time. The MRO takes action for the verified invalid result(s) for the primary (A) specimen as described in Section 13.5(f) only when:
(i) The MRO verifies the positive, adulterated, or substituted result as negative based on a legitimate medical explanation as described in Section 13.5(d)(2) and (e)(1); or
(ii) The split (B) specimen is tested and reported as a failure to reconfirm the positive, adulterated, or substituted result as described in Section 14.6(m).
(d) When the HHS-certified laboratory reports a positive result for the primary (A) specimen, the MRO must contact the donor to determine if there is any legitimate medical explanation for the positive result.
(1) If the donor admits unauthorized use of the drug(s) that caused the positive result, the MRO reports the test result as positive to the agency. The MRO must document the donor's admission of unauthorized drug use in the MRO records and in the MRO's report to the Federal agency.
(2) If the donor provides documentation (
(i) Passive exposure to a drug (
(ii) Ingestion of food products containing a drug (
(iii) A physician's authorization or medical recommendation for a Schedule 1 controlled substance is not a legitimate medical explanation for a positive drug test result.
(3) If the donor is unable to provide a legitimate medical explanation for the positive result, the MRO reports the positive result to the agency. If the laboratory also reports that the urine specimen is dilute, the MRO may choose not to report the dilute result.
(e) When the HHS-certified laboratory reports an adulterated or substituted result for the primary (A) urine specimen, the MRO contacts the donor to determine if the donor has a legitimate medical explanation for the adulterated or substituted result.
(1) If the donor provides a legitimate medical explanation, the MRO reports a negative result to the Federal agency.
(2) If the donor is unable to provide a legitimate medical explanation, the MRO reports a refusal to test to the Federal agency because the urine specimen was adulterated or substituted.
(f) When the HHS-certified laboratory reports an invalid result for the primary (A) urine specimen, the MRO must contact the donor to determine if there is a legitimate explanation for the invalid result. In the case of an invalid result based on pH of 9.0 to 9.5, when an employee has no other medical explanation for the pH in this range, the MRO must consider whether there is evidence of elapsed time and high temperature that could account for the pH value. The MRO may contact the collection site, HHS-certified IITF, and/or HHS-certified laboratory to discuss time and temperature issues (
(1) If the donor provides a legitimate explanation (
(2) If the donor is unable to provide a legitimate explanation or if the MRO determines that time and temperature fail to account for the pH in the 9.0-9.5 range, the MRO reports a test cancelled result with the reason for the invalid result and directs the Federal agency to immediately collect another urine specimen from the donor using a direct observed collection.
(i) If the specimen collected under direct observation provides a valid result, the MRO follows the procedures in Section 13.5(a) through (e).
(ii) If the specimen collected under direct observation provides an invalid result, the MRO reports this specimen as test cancelled and recommends that the agency collect another authorized specimen type (
(g) When two separate specimens collected during the same testing event were sent to the HHS-certified laboratory for testing (
(1) If both specimens were verified negative, report the result as negative.
(2) If one specimen was verified negative and the other was not (
(3) If both specimens were verified as positive, adulterated, and/or substituted, report all results. For example, if you verified one specimen as positive and the other as a refusal to test because the specimen was adulterated, report the positive and the refusal results to the Federal agency.
(4) If one specimen has been verified and the HHS-certified laboratory has not reported the result(s) of the other specimen,
(i) Report verified result(s) of positive, adulterated, or substituted immediately and do not wait to receive the result(s) of the other specimen.
(ii) Do not report a verified result of negative, negative/dilute, or invalid for the first specimen to the Federal agency. Hold the report until results of both specimens have been received and verified.
(5) When the HHS-certified laboratory reports an invalid result for one or both specimens, follow the procedures in Section 13.5(c).
(h) When the HHS-certified laboratory or HHS-certified IITF reports a rejected for testing result for the primary (A) specimen, the MRO reports a test cancelled result to the agency and recommends that the agency collect another specimen from the donor. The recollected specimen must be the same type (
(a) When another specimen type (
(b) When the Federal agency did not authorize the collection of an alternate specimen, the MRO consults with the Federal agency. The Federal agency immediately directs the donor to obtain, within five days, an evaluation from a licensed physician, acceptable to the MRO, who has expertise in the medical issues raised by the donor's failure to provide a specimen. The MRO may perform this evaluation if the MRO has appropriate expertise.
(1) For purposes of this section, a medical condition includes an ascertainable physiological condition (
(2) As the MRO, if another physician will perform the evaluation, you must provide the other physician with the following information and instructions:
(i) That the donor was required to take a federally regulated drug test, but was unable to provide a sufficient amount of urine to complete the test;
(ii) The consequences of the appropriate Federal agency regulation for refusing to take the required drug test;
(iii) That, after completing the evaluation, the referral physician must agree to provide a written statement to the MRO with a recommendation for one of the determinations described in Section 13.6(b)(3) and the basis for the recommendation. The statement must not include detailed information on the employee's medical condition beyond what is necessary to explain the referral physician's conclusion.
(3) As the MRO, if another physician performed the evaluation, you must consider and assess the referral physician's recommendations in making your determination. You must make one of the following determinations and report it to the Federal agency in writing:
(i) A medical condition as defined in Section 13.6(b)(1) has, or with a high degree of probability could have, precluded the employee from providing a sufficient amount of urine, but is not a permanent or long-term disability. As the MRO, you must report a test cancelled result to the Federal agency.
(ii) A permanent or long-term medical condition as defined in Section 13.6(b)(1) has, or with a high degree of probability could have, precluded the employee from providing a sufficient amount of urine and is highly likely to prevent the employee from providing a sufficient amount of urine for a very long or indefinite period of time. As the MRO, you must follow the requirements of Section 13.7, as appropriate. If Section 13.7 is not applicable, you report a test cancelled result to the Federal agency and recommend that the agency authorize collection of an alternate specimen type (
(iii) There is not an adequate basis for determining that a medical condition has, or with a high degree of probability could have, precluded the employee from providing a sufficient amount of urine. As the MRO, you must report a refusal to test to the Federal agency.
(4) When a Federal agency receives a report from the MRO indicating that a test is cancelled as provided in Section 13.6(b)(3)(i), the agency takes no further action with respect to the donor. When a test is canceled as provided in Section 13.6(b)(3)(ii), the agency takes no further action with respect to the donor other than designating collection of an alternate specimen type (
(a) This section concerns a situation in which the donor has a medical condition that precludes the donor from providing a sufficient specimen for a Federal agency applicant/pre-employment test, a follow-up test, or a return-to-duty test and the condition involves a permanent or long-term disability and the Federal agency does not authorize collection of an alternate specimen. As the MRO in this situation, you must do the following:
(1) You must determine if there is clinical evidence that the individual is an illicit drug user. You must make this determination by personally conducting, or causing to be conducted, a medical evaluation and through consultation with the donor's physician and/or the physician who conducted the evaluation under Section 13.6.
(2) If you do not personally conduct the medical evaluation, you must ensure that one is conducted by a licensed physician acceptable to you.
(b) If the medical evaluation reveals no clinical evidence of illicit drug use, as the MRO, you must report the result to the Federal agency as a negative test with written notations regarding results of both the evaluation conducted under Section 13.6 and any further medical examination. This report must state the basis for the determination that a permanent or long-term medical condition exists, making provision of a sufficient urine specimen impossible, and for the determination that no signs and symptoms of drug use exist. The MRO recommends that the agency authorize collection of an alternate specimen type (
(c) If the medical evaluation reveals clinical evidence of drug use, as the MRO, you must report the result to the Federal agency as a cancelled test with written notations regarding results of both the evaluation conducted under Section 13.6 and any further medical examination. This report must state that a permanent or long-term medical condition [as defined in Section 13.6(b)(1)] exists, making provision of a sufficient urine specimen impossible, and state the reason for the determination that signs and symptoms of drug use exist. Because this is a cancelled test, it does not serve the purposes of a negative test (
(a) The MRO must report all verified results to an agency using the completed MRO copy of the Federal CCF or a separate report using a letter/memorandum format. The MRO may use various electronic means for reporting (
(b) A verified result may not be reported to the agency until the MRO has completed the review process.
(c) The MRO must send a copy of either the completed MRO copy of the Federal CCF or the separate letter/memorandum report for all positive, adulterated, and substituted results.
(d) The MRO must not disclose numerical values of drug test results to the agency.
(e) The MRO must report drug test results using the HHS-specified nomenclature published with the drug and biomarker testing panels.
(a) For a positive, adulterated, or substituted result reported on a primary (A) specimen, a donor may request through the MRO that the split (B)
(b) The donor has 72 hours (from the time the MRO notified the donor that the donor's specimen was reported positive, adulterated, or substituted to request a test of the split (B) specimen. The MRO must inform the donor that the donor has the opportunity to request a test of the split (B) specimen when the MRO informs the donor that a positive, adulterated, or substituted result is being reported to the Federal agency on the primary (A) specimen.
An MRO must not be an employee, agent of, or have any financial interest in an HHS-certified laboratory or an HHS-certified IITF for which the MRO is reviewing drug test results.
This means an MRO must not derive any financial benefit by having an agency use a specific HHS-certified laboratory or HHS-certified IITF, or have any agreement with the HHS-certified laboratory or the HHS-certified IITF that may be construed as a potential conflict of interest.
(a) An MRO must send to the Secretary or designated HHS representative a semiannual report of Federal agency specimens that were reported as positive for a drug or drug metabolite by a laboratory and verified as negative by the MRO. The report must not include any personally identifiable information for the donor and must be submitted by mail, fax, or other secure electronic transmission method within 14 working days after the end of the semiannual period (
(1) Reporting period (inclusive dates);
(2) MRO name, company name, and address;
(3) Federal agency name; and
(4) For each laboratory-reported positive drug test result that was verified as negative by the MRO:
(i) Specimen identification number;
(ii) Laboratory name and address;
(iii) Positive drug(s) or drug metabolite(s) verified as negative;
(iv) MRO reason for verifying the positive drug(s) or drug metabolite(s) as negative (
(v) All results reported to the Federal agency by the MRO for the specimen; and
(vi) Date of the MRO report to the Federal agency.
(b) An MRO must provide copies of the drug test reports that the MRO has sent to a Federal agency when requested to do so by the Secretary.
(c) If an MRO did not verify any positive laboratory results as negative during the reporting period, the MRO should file a report that states that the MRO has no reportable results during the applicable reporting period.
(a) Before allowing an individual to serve as an MRO for the agency, a Federal agency must verify and document the following:
(1) that the individual satisfies all requirements in Section 13.1, including certification by an MRO certification organization that has been approved by the Secretary, as described in Section 13.2; and
(2) that the individual is not an employee, agent of, or have any financial interest in an HHS-certified laboratory or an HHS-certified IITF that tests the agency's specimens, as described in Section 13.10.
(b) The Federal agency must verify and document that each MRO reviewing and reporting results for the agency:
(1) completes training on any revisions to these Guidelines, including any changes to the drug and biomarker testing panels, prior to their effective date;
(2) at least every five years, maintains their certification by completing requalification training and passing a requalification examination; and
(3) provides biannual reports to the Secretary or designated HHS representative as required in Section 13.11;
(c) The Federal agency must ensure that each MRO reports drug test results to the agency in accordance with Sections 13.8 and 14.7.
(1) Before allowing an MRO to report results electronically, the agency must obtain documentation from the MRO to confirm that the MRO and any external service providers ensure the confidentiality, integrity, and availability of the data and limit access to any data transmission, storage, and retrieval system.
(a) The donor may request, verbally or in writing, through the MRO that the split (B) urine specimen be tested at a different (
(b) A donor has 72 hours to initiate the request after being informed of the result by the MRO. The MRO must document in the MRO's records the verbal request from the donor to have the split (B) specimen tested.
(c) If a split (B) urine specimen cannot be tested by a second HHS-certified laboratory (
(d) If a donor chooses not to have the split (B) specimen tested by a second HHS-certified laboratory, a Federal agency may have a split (B) specimen retested as part of a legal or administrative proceeding to defend an original positive, adulterated, or substituted result.
(a) The testing of a split (B) specimen for a drug or metabolite is not subject to the testing cutoffs established.
(b) The HHS-certified laboratory is only required to confirm the presence of the drug or metabolite that was reported positive in the primary (A) specimen.
(c) For a split (B) urine specimen, if the second HHS-certified laboratory fails to reconfirm the presence of the drug or drug metabolite that was reported by the first HHS-certified laboratory, the second laboratory must conduct specimen validity tests in an attempt to determine the reason for being unable to reconfirm the presence of the drug or drug metabolite. The second laboratory should conduct the same specimen validity tests as it would conduct on a primary (A) urine specimen and reports those results to the MRO.
(a) An HHS-certified laboratory must use one of the following criteria to reconfirm an adulterated result when testing a split (B) urine specimen:
(1) pH must be measured using the laboratory's confirmatory pH test with the appropriate cutoff (
(2) Nitrite must be measured using the laboratory's confirmatory nitrite test with a cutoff of equal to or greater than 500 mcg/mL;
(3) Surfactant must be measured using the laboratory's confirmatory surfactant test with a cutoff of equal to or greater than 100 mcg/mL dodecylbenzene sulfonate-equivalent cutoff; or
(4) For adulterants without a specified cutoff (
(b) The second HHS-certified laboratory may only conduct the confirmatory specimen validity test(s) needed to reconfirm the adulterated result reported by the first HHS-certified laboratory.
(a) An HHS-certified laboratory must use the following criteria to reconfirm a substituted result when testing a split (B) urine specimen:
(1)
(2)
(b) The second HHS-certified laboratory may only conduct the confirmatory specimen validity test(s) needed to reconfirm the substituted result reported by the first HHS-certified laboratory.
The second HHS-certified laboratory must report the result to the MRO using the HHS-specified nomenclature published with the drug and biomarker testing panels.
The MRO takes the following actions when the second HHS-certified laboratory reports the result for the split (B) urine specimen as:
(a)
(b)
(c)
(1)
(2)
(i) If the primary (A) specimen's test results confirm that the specimen was substituted, the MRO reports a refusal to test (substituted) to the agency.
(ii) If the primary (A) specimen's results fail to confirm that the specimen was substituted, the MRO cancels both tests and directs the agency to immediately collect another specimen using a direct observed collection procedure. The MRO shall notify the HHS office responsible for coordination of the drug-free workplace program about the failed to reconfirm and cancelled test.
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n)
(o)
(p)
(q)
(r)
(a) The MRO must report all verified results to an agency using the completed MRO copy of the Federal CCF or a separate report using a letter/memorandum format. The MRO may use various electronic means for reporting (
(b) A verified result may not be reported to the agency until the MRO has completed the review process.
(c) The MRO must send a copy of either the completed MRO copy of the Federal CCF or the separate letter/memorandum report for all split specimen results.
(d) The MRO must not disclose the numerical values of the drug test results to the agency.
(e) The MRO must report drug test results using the HHS-specified nomenclature published with the drug and biomarker testing panels.
A split (B) specimen is retained for the same period of time that a primary (A) specimen is retained and under the same storage conditions, in accordance with Section 11.20. This applies even for those cases when the split (B) specimen is tested by a second HHS-certified laboratory and the second HHS-certified laboratory does not confirm the original result reported by the first HHS-certified laboratory for the primary (A) specimen.
The following discrepancies are considered to be fatal flaws. The HHS-certified laboratory or IITF must stop the testing process, reject the specimen for testing, and indicate the reason for rejecting the specimen on the Federal CCF when:
(a) The specimen ID number on the primary (A) or split (B) specimen label/seal does not match the ID number on the Federal CCF, or the ID number is missing either on the Federal CCF or on either specimen label/seal;
(b) The primary (A) specimen label/seal is missing, misapplied, broken, or shows evidence of tampering and the split (B) specimen cannot be re-designated as the primary (A) specimen;
(c) The collector's printed name and signature are omitted on the Federal CCF;
(d) There is an insufficient amount of specimen for analysis in the primary (A) specimen and the split (B) specimen cannot be re-designated as the primary (A) specimen;
(e) The accessioner failed to document the primary (A) specimen seal condition on the Federal CCF at the time of accessioning, and the split (B) specimen cannot be re-designated as the primary (A) specimen;
(f) The specimen was received at the HHS-certified laboratory or IITF without a CCF;
(g) The CCF was received at the HHS-certified laboratory or IITF without a specimen;
(h) The collector performed two separate collections using one CCF; or
(i) The HHS-certified laboratory or IITF identifies a flaw (other than those specified above) that prevents testing or affects the forensic defensibility of the drug test and cannot be corrected.
The following discrepancies are considered to be correctable:
(a) If a collector failed to sign the Federal CCF, the HHS-certified laboratory or IITF must hold the specimen and attempt to obtain a memorandum for record to recover the collector's signature. If, after holding the specimen for at least 5 business days, the HHS-certified laboratory or IITF cannot recover the collector's signature, the laboratory or IITF must report a rejected for testing result and indicate the reason for the rejected for testing result on the Federal CCF.
(b) If a specimen is submitted using a non-Federal form or an expired Federal CCF, the HHS-certified laboratory or IITF must test the specimen and also attempt to obtain a memorandum for record explaining why a non-Federal form or an expired Federal CCF was used and ensure that the form used contains all the required information. If, after holding the report for at least 5 business days, the HHS-certified laboratory or IITF cannot obtain a memorandum for record from the collector, the laboratory or IITF must report a rejected for testing result and indicate the reason for the rejected for testing result on the report to the MRO.
(a) The following omissions and discrepancies on the Federal CCF that are received by the HHS-certified laboratory or IITF should not cause an HHS-certified laboratory or IITF to reject a urine specimen or cause an MRO to cancel a test:
(1) An incorrect laboratory name and address appearing at the top of the form;
(2) Incomplete/incorrect/unreadable employer name or address;
(3) MRO name is missing;
(4) Incomplete/incorrect MRO address;
(5) A transposition of numbers in the donor's Social Security Number or employee identification number;
(6) A telephone number is missing/incorrect;
(7) A fax number is missing/incorrect;
(8) A “reason for test” box is not marked;
(9) A “drug tests to be performed” box is not marked;
(10) A “collection” box is not marked;
(11) The “observed” box is not marked (if applicable);
(12) The collection site address is missing;
(13) The collector's printed name is missing but the collector's signature is properly recorded;
(14) The time of collection is not indicated;
(15) The date of collection is not indicated;
(16) Incorrect name of delivery service;
(17) The collector has changed or corrected information by crossing out the original information on either the Federal CCF or specimen label/seal without dating and initialing the change; or
(18) The donor's name inadvertently appears on the HHS-certified laboratory or IITF copy of the Federal CCF or on the tamper-evident labels used to seal the specimens.
(19) The collector failed to check the specimen temperature box and the “Remarks” line did not have a comment regarding the temperature being out of range. If, after at least 5 business days, the collector cannot provide a memorandum for record to attest to the fact that the collector did measure the specimen temperature, the HHS-certified laboratory or IITF may report the test result for the specimen but indicates that the collector could not provide a memorandum to recover the omission.
(b) The following omissions and discrepancies on the Federal CCF that are made at the HHS-certified laboratory or IITF should not cause an MRO to cancel a test:
(1) The testing laboratory or IITF fails to indicate the correct name and address in the results section when a different laboratory or IITF name and address is printed at the top of the Federal CCF;
(2) The accessioner fails to print their name;
(3) The certifying scientist or certifying technician fails to print their name;
(4) The certifying scientist or certifying technician accidentally initials the Federal CCF rather than signing for a specimen reported as rejected for testing;
(c) The above omissions and discrepancies should occur no more than once a month. The expectation is that each trained collector and HHS-certified laboratory or IITF will make every effort to ensure that the Federal CCF is properly completed and that all the information is correct. When an error occurs more than once a month, the MRO must direct the collector, HHS-certified laboratory, or HHS-certified IITF (whichever is responsible for the error) to immediately take corrective action to prevent the recurrence of the error.
(a) An MRO must attempt to correct the following errors:
(1) The donor's signature is missing on the MRO copy of the Federal CCF and the collector failed to provide a comment that the donor refused to sign the form;
(2) The certifying scientist failed to sign the Federal CCF for a specimen being reported drug positive, adulterated, invalid, or substituted; or
(3) The electronic report provided by the HHS-certified laboratory or HHS-certified IITF does not contain all the data elements required for the HHS standard laboratory or IITF electronic report for a specimen being reported drug positive, adulterated, invalid result, or substituted.
(b) If the error in Section 15.4(a)(1) occurs, the MRO must contact the collector to obtain a statement to verify that the donor refused to sign the MRO copy. If, after at least 5 business days, the collector cannot provide such a statement, the MRO must cancel the test.
(c) If the error in Section 15.4(a)(2) occurs, the MRO must obtain a
(d) If the error in Section 15.4(a)(3) occurs, the MRO must contact the HHS-certified laboratory or HHS-certified IITF. If, after at least 5 business days, the laboratory or IITF does not retransmit a corrected electronic report, the MRO must cancel the test.
These procedures apply when:
(a) The Secretary has notified an HHS-certified laboratory or IITF in writing that its certification to perform drug testing under these Guidelines has been suspended or that the Secretary proposes to revoke such certification.
(b) The HHS-certified laboratory or IITF has, within 30 days of the date of such notification or within 3 days of the date of such notification when seeking an expedited review of a suspension, requested in writing an opportunity for an informal review of the suspension or proposed revocation.
The scope of review shall be limited to the facts relevant to any suspension or proposed revocation, the necessary interpretations of those facts, the relevant Mandatory Guidelines for Federal Workplace Drug Testing Programs, and other relevant law. The legal validity of these Guidelines shall not be subject to review under these procedures.
The appellant's request for review shall specify the name, address, and telephone number of the appellant's representative. In its first written submission to the reviewing official, the respondent shall specify the name, address, and telephone number of the respondent's representative.
(a) Within 30 days of the date of the notice of the suspension or proposed revocation, the appellant must submit a written request to the reviewing official seeking review, unless some other time period is agreed to by the parties. A copy must also be sent to the respondent. The request for review must include a copy of the notice of suspension or proposed revocation, a brief statement of why the decision to suspend or propose revocation is wrong, and the appellant's request for an oral presentation, if desired.
(b) Within 5 days after receiving the request for review, the reviewing official will send an acknowledgment and advise the appellant of the next steps. The reviewing official will also send a copy of the acknowledgment to the respondent.
Upon mutual agreement of the parties to hold these procedures in abeyance, the reviewing official will stay these procedures for a reasonable time while the laboratory or IITF attempts to regain compliance with the Guidelines or the parties otherwise attempt to settle the dispute. As part of an abeyance agreement, the parties can agree to extend the time period for requesting review of the suspension or proposed revocation. If abeyance begins after a request for review has been filed, the appellant shall notify the reviewing official at the end of the abeyance period, advising whether the dispute has been resolved. If the dispute has been resolved, the request for review will be dismissed. If the dispute has not been resolved, the review procedures will begin at the point at which they were interrupted by the abeyance agreement with such modifications to the procedures as the reviewing official deems appropriate.
The appellant and the respondent each participate in developing the file for the reviewing official and in submitting written arguments. The procedures for development of the review file and submission of written argument are:
(a)
(1) A review file containing the documents supporting appellant's argument, tabbed and organized chronologically, and accompanied by an index identifying each document. Only essential documents should be submitted to the reviewing official.
(2) A written statement, not to exceed 20 double-spaced pages, explaining why respondent's decision to suspend or propose revocation of appellant's certification is wrong (appellant's brief).
(b)
(1) A review file containing documents supporting respondent's decision to suspend or revoke appellant's certification to perform drug testing, which is tabbed and organized chronologically, and accompanied by an index identifying each document. Only essential documents should be submitted to the reviewing official.
(2) A written statement, not exceeding 20 double-spaced pages in length, explaining the basis for suspension or proposed revocation (respondent's brief).
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(e)
(1)
(2)
(3)
(4)
(5)
(f)
(g)
(a)
(b)
(c)
(1) A review file containing essential documents relevant to the review, which is tabbed, indexed, and organized chronologically; and
(2) A written statement, not to exceed 20 double-spaced pages, explaining the party's position concerning the suspension and any proposed revocation. No reply brief is permitted.
(d)
(e)
(f)
Except for routine administrative and procedural matters, a party shall not communicate with the reviewing or presiding official without notice to the other party.
(a) Because of the importance of a timely review, the reviewing official should normally transmit written communications to either party by fax, secured electronic transmissions, or overnight mail in which case the date of transmission or day following mailing will be considered the date of receipt. In the case of communications sent by regular mail, the date of receipt will be considered 3 days after the date of mailing.
(b) In counting days, include Saturdays, Sundays, and Federal holidays. However, if a due date falls on a Saturday, Sunday, or Federal holiday, then the due date is the next Federal working day.
In addition to any other authority specified in these procedures, the reviewing official and the presiding official, with respect to those authorities involving the oral presentation, shall have the authority to issue orders; examine witnesses; take all steps necessary for the conduct of an orderly hearing; rule on requests and motions; grant extensions of time for good reasons; dismiss for failure to meet deadlines or other requirements; order the parties to submit relevant information or witnesses; remand a case for further action by the respondent; waive or modify these procedures in a specific case, usually with notice to the parties; reconsider a decision of the reviewing official where a party promptly alleges a clear error of fact or law; and to take any other action necessary to resolve disputes in accordance with the objectives of these procedures.
The administrative record of review consists of the review file; other submissions by the parties; transcripts or other records of any meetings, conference calls, or oral presentation; evidence submitted at the oral presentation; and orders and other documents issued by the reviewing and presiding officials.
(a)
(b)
(c)
Before any legal action is filed in court challenging the suspension or proposed revocation, respondent shall exhaust administrative remedies provided under this subpart, unless otherwise provided by Federal Law. The reviewing official's decision, under Section 16.9(e) or 16.14(a) constitutes final agency action and is ripe for judicial review as of the date of the decision.
Substance Abuse and Mental Health Services Administration (SAMHSA), Department of Health and Human Services (HHS).
Issuance of mandatory guidelines.
The Department of Health and Human Services (“HHS” or “Department”) has revised the Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) which published in the
The mandatory guidelines are effective October 10, 2023.
Eugene D. Hayes, Ph.D., MBA, SAMHSA, CSAP, DWP; 5600 Fishers Lane, Room 16N02, Rockville, MD 20857, by telephone (240) 276-1459 or by email at
These revised Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid (OFMG) establish a process whereby the Department annually publishes the authorized drug testing panel (
The Department is publishing a separate Federal Register Notification (FRN) elsewhere in this issue of the
Pursuant to its authority under section 503 of Public Law 100-71, 5 U.S.C. 7301, and Executive Order 12564, HHS establishes the scientific and technical guidelines for Federal workplace drug testing programs and establishes standards for certification of laboratories engaged in drug testing for Federal agencies.
Using data obtained from the Federal Workplace Drug Testing Programs and HHS-certified laboratories, the Department estimates that 275,000 urine specimens are tested annually by Federal agencies. No Federal agencies are testing hair or oral fluid specimens at this time.
HHS originally published the Mandatory Guidelines for Federal Workplace Drug Testing Programs (hereinafter referred to as Guidelines or Mandatory Guidelines) in the
There was a 60-day public comment period following publication of the proposed OFMG, during which 53 commenters submitted 204 comments on the OFMG. These commenters were comprised of individuals, organizations, and private sector companies. The comments are available for public view at
The following comments were directed to the information and questions in the preamble.
Some submitted comments were specific to transportation industry drug testing which is regulated by the Department of Transportation (DOT). The Department has noted these comments below, but responded only to comments that are relevant to these Guidelines. DOT issued a notice of proposed rulemaking (NPRM) on February 28, 2022 (87 FR 11156). Subsequently, DOT extended the comment period to April 29, 2022 (87 FR 16160), and published the final rule on May 2, 2023 (88 FR 27596).
The Department requested comments on its proposal to publish the drug testing panel separately from the OFMG in a Federal Register\[[[[p Notification (FRN) each year. Fifteen commenters submitted a total of 40 comments on this topic for the OFMG.
Nine commenters disagreed with publishing a revised drug testing panel without a public comment period, expressing concerns that stakeholders including individuals subject to federally regulated drug testing would not be given the opportunity to provide comment and that the Department would miss valuable input including information on costs and burden. Some of these commenters suggested alternate ways to permit public comment while enabling a quicker response to testing panel changes (
Consistent with current procedures, prior to making a change to the drug or biomarker testing panel, the Department will conduct a thorough review of the scientific and medical literature, and will solicit review and input from subject matter experts such as Responsible Persons (RPs) of HHS-certified laboratories, Medical Review Officers (MROs), research scientists,
Information regarding any proposed changes to the drug and biomarker testing panels and a request for public comment will be included in an advance notice of the DTAB meeting published in the
The Department will make the final decision on any panel changes and include the effective date(s) in the annual Notice, to allow time for drug testing service providers (
Three commenters specifically agreed with the need to streamline and improve processes for making changes to the testing panels, but expressed concern over the process for testing panel review and who would be involved. These commenters suggested involving other stakeholders (
Four commenters disagreed that HHS is exempt from the Administrative Procedure Act (APA) requirements. Two of these specifically stated that the Guidelines are subject to APA requirements because DOT is required to use the Guidelines for their transportation industry drug testing programs. The Department has reviewed these comments and determined that no change is needed to the proposed Guidelines. The Department explained why the APA does not apply under the
Two commenters suggested that the Department limit changes to every few years (
Eight commenters were concerned that the Department will not allow sufficient time for stakeholders to implement changes (
In regard to the use of FDA-cleared collection devices and immunoassay initial tests, four commenters suggested that federally regulated drug testing could fall under what they referred to as the FDA's Employment and Insurance exemption. The Department notes that, while some drugs of abuse test systems intended for employment and insurance testing are, under certain circumstances, exempt from the premarket notification procedures in 21 CFR part 807, subpart E, such exemptions do not apply to test systems intended for Federal drug testing programs. See 21 CFR part 862, subpart D. Because the Department does not address FDA clearance requirements for test systems in the Mandatory Guidelines, the reference to FDA clearance for oral fluid collection devices has been removed from Section 7.1. Applicant and HHS-certified laboratories must verify that oral fluid collection devices and test systems subject to FDA regulations are approved or otherwise cleared by FDA and, in addition, must validate the oral fluid collection devices and test systems prior to use in accordance with requirements specified in the National Laboratory Certification Program (NLCP) Manual for Oral Fluid Laboratories.
Two commenters appeared to misinterpret the Department's testing panel proposal, objecting to the Department making changes to the testing panels each year. The Department plans to issue an annual Notice with the current testing panels and required nomenclature, but will make changes only when needed to ensure the continued effectiveness of Federal workplace drug testing programs, which may not be every year.
See additional comments under Section 3.4 below.
The Department requested comments on its proposal to publish the biomarker testing panel separately from the OFMG in a
One commenter disagreed with specimen validity or biomarker testing for oral fluid specimens, because all collections are observed and collection devices are required to have volume indicators. The commenter stated these tests would be unnecessary and increase costs. The commenter also noted that the observed collections and required inspection of the oral fluid reduced the risk of adulteration or substitution. Four commenters suggested that the Department require all HHS-certified laboratories to perform standardized specimen validity and biomarker tests on all federally regulated specimens, and allow laboratories to choose whether to offer additional specialized tests upon MRO request on a case-by-case basis. The Department agrees that there are no known effective subversion products for oral fluid specimens at this time; however, such products may be available in the future. The Department has also included examples in the HHS Oral Fluid Specimen Handbook (posted on SAMHSA's website,
Two commenters disagreed with publishing a biomarker testing panel without a public comment period, expressing concerns that stakeholders would not be given the opportunity to provide comment and that the Department would miss valuable input including information on costs and burden. The Department has reviewed these comments and determined that no changes to the proposed Guidelines are needed. The Department has developed procedures which will allow review and comment before testing panel changes are published, as described under
Three commenters specifically agreed with the need to streamline and improve processes for making changes to the testing panels. One of these commenters noted that since there are no currently agreed-upon analytes to assess OF validity and there may be differences in buffered collection devices, determining a biomarker panel may be complex. The other two commenters suggested involving other stakeholders (
One commenter disagreed that HHS is exempt from the APA requirements. The Department has reviewed the comment and determined that no change is needed to the proposed Guidelines. The Department explained why the APA does not apply under the
In Section 13.5, the Department removed the requirement for the MRO to report specimens with morphine and/or codeine between the cutoff and 150 ng/mL as positive based on clinical evidence of illicit drug use and, instead, directed the MRO to verify such specimens as negative unless the donor admits to illegal opioid use that could have caused the positive result. Four commenters agreed with this change.
In Section 13.11, the Department added requirements for each MRO performing medical review services for Federal agencies to submit semiannual reports, in January and July of each year, of Federal agency specimens that were reported as positive for a drug or drug metabolite by the laboratory and verified as negative by the MRO, along with the reason for the negative verification (
Three commenters disagreed, stating that HHS had not clearly described the reason and the process for such reports. One commenter noted that the Department had not presented data documenting that MROs were incorrectly reporting specimens, and it was unclear how the reports could be matched to laboratory report information submitted to the National Laboratory Certification Program (NLCP). Another commenter stated that it was unclear what actions would be taken if the Department disagreed with the MRO report. The third commenter was concerned that donors would be identifiable, and that “a database of legal drug use” would violate donor privacy. One of the commenters expressed concern over “unintended consequences” for DOT and state workplace drug testing programs, without further explanation.
Two commenters disagreed on the basis of added costs and burden to MROs. One claimed that this would result in MROs tracking and reporting all results sent by the laboratory, as they are already required to report positive results to the Federal Motor Carrier Safety Administration (FMCSA) Clearinghouse. The other claimed that this would require documentation and report generation for each non-negative result, and expressed concern that smaller MRO practices could find the process too time-consuming and costly to continue in the program.
One commenter agreed that such reports could be beneficial, but suggested that MROs provide the same information as provided by laboratories to the NLCP. The commenter incorrectly stated that laboratories do not provide specimen identification numbers to the NLCP.
The Department has reviewed the comments and determined that no change is needed to the proposed Guidelines. To clarify, this reporting policy is only for Federal agency specimens, not DOT-regulated specimens. Further, the reports are not for all positive specimens, only for those specimens that were reported as positive by the laboratory and verified as negative by the MRO. The requested MRO information is sufficient to enable matching to HHS-certified laboratory information provided to the NLCP without identifying the donor. At this time, there is no system-wide mechanism for identifying MRO verification practices for Federal agency specimens that are inconsistent with the Guidelines, so data on incorrect reporting is not available. The Department is not planning to share MRO-specific information, but may share statistical information and deidentified examples by various means (
The Department did not propose any changes to the OFMG in regard to marijuana testing, but received comments from 21 commenters: 20 disagreed and one agreed with the current requirements. Seventeen commenters supported medical use of marijuana. Some of these noted that many doctors and medical professionals support the use of medical marijuana and that many States have legalized marijuana for medical use. Commenters expressed concern that Federal employees using marijuana for health reasons could lose their jobs or benefits or that Federal employees without access to medical marijuana may use other drugs such as opioids. Three commenters supported legalization of marijuana in general. One commenter stated that marijuana testing should be removed from the Guidelines until research can establish reliable levels to distinguish marijuana use from use of a legal hemp product (
One commenter agreed with continuing to recognize marijuana as a Schedule I drug, with zero tolerance for safety-sensitive positions. The commenter stated that the liability and risk are not worth allowing employees in safety-sensitive positions to use medical marijuana.
Current Federal law requires Federal agencies to test for marijuana under E.O. 12564 in their workplace drug testing
Five commenters submitted general comments concerning the OFMG. Three agreed with the use of oral fluid testing, citing benefits of oral fluid as a testing matrix compared to urine (
The Department has not included a discussion in the preamble of any sections for which public comments were not submitted or for minor wording changes (
Two commenters agreed and two disagreed with the Department's proposed revision to the Substituted Specimen definition in Section 1.5 to include specimens tested for a biomarker.
Of the two commenters who disagreed, one stated that there are situations in which a legitimate specimen may be reported as outside the standards for human specimens, and these should be reported as invalid. The other commenter stated that there should be clear notice and the opportunity to comment on specific biomarkers and criteria for substitution and that HHS should continue to require laboratories to report specimens as invalid based on normally occurring endogenous substances that appear unusual but do not violate standards for identified validity tests. The Department has reviewed the comments and determined that no change is needed to the proposed Guidelines. The Department will follow the procedures summarized under
In Section 1.7(a), the Department proposed to remove two exceptions for reporting a refusal to test for a pre-employment test: a donor who fails to appear in a reasonable time and a donor who leaves the collection site before the collection process begins. Nine commenters submitted a total of 16 comments on this proposal. Many of the commenters referenced DOT drug testing requirements and/or transportation industry issues that are not relevant to these Guidelines.
Eight commenters disagreed with the changes, noting that an applicant may fail to appear because they have taken a different job offer. The commenters noted that a refusal to test in the individual's record could prevent individuals from taking other job offers and/or require them to undergo unnecessary return-to-duty testing. The Department has reviewed the comments and determined that no change is needed. As stated in this section, the Federal agency determines a reasonable time for the donor to take the test, specifies the time consistent with agency regulations, and directs the individual accordingly. At the time an applicant is scheduled for a pre-employment drug test, or before, Federal agencies should provide the applicant with instructions on how to notify the agency in the event that they decide to withdraw their application or to not accept a job offer. Such instructions will allow the agency to cancel the drug test and help applicants avoid a refusal to test result.
Three commenters noted that the Guidelines should state that the designated employer representative (DER) makes the determination of a refusal to test. A fourth commenter noted that the employer, not the collector, should determine whether a failure to appear for a pre-employment test should be considered a refusal, as the collection site may not know that a donor is coming or how much time the employer allows the donor to complete a test. The Department has reviewed the comments and determined that no change is needed. As stated in this section, the Federal agency takes action consistent with applicable agency regulations. Corresponding wording in Section 8.3 specifies that the collector follows the Federal agency policy or contacts the Federal agency representative to obtain guidance on action to be taken before reporting a refusal to test because a donor does not arrive at an assigned time.
One commenter suggested that the Department add procedures to follow when the collection site cannot collect a specimen (
In Section 2.2, the Department allows oral fluid to be used for any type of testing conducted in Federal agency drug testing programs, and had not proposed any changes. Six commenters submitted comments in response to DOT's February 28, 2022 NPRM, regarding whether oral fluid should be allowed for all or only some testing reasons.
The Department did not propose any changes to the requirements for split oral fluid collections in Sections 2.5 and 8.8 (
Three of the commenters requested a clear definition of “single device” and the fourth commenter recommended that both HHS and DOT specifically allow a device that collects a specimen that is then split or divided into the primary (A) and split (B) specimens. HHS and DOT have discussed oral fluid collection requirements. The Department will retain the split specimen collection requirements in the current OFMG which are based on current devices used in non-regulated drug testing and also allow for development of additional device types validated to meet program requirements. HHS-certified laboratories must ensure compliance with DOT regulations for specimens collected and tested under their regulations.
The Department revised Section 3.4 to describe the annual publication of the drug testing and biomarker testing panels and the nomenclature required for laboratory and MRO reports. Seven commenters submitted 10 comments on the required nomenclature required for laboratory and MRO reports, which are addressed below. Comments on the testing panels are addressed under
In regard to the required nomenclature specified in the annual
One commenter disagreed with requiring both cocaine and benzoylecgonine as confirmatory test analytes, and recommended testing oral fluid specimens for benzoylecgonine only. The commentor cited their experience in testing for cocaine and metabolites in oral fluid; however, the commentor did not provide a scientific literature citation for their recommendation. SAMHSA has reviewed the literature and disagrees that testing for benzoylecgonine alone yields the same results as testing for both analytes. A 2010 dosing study showed that testing for both cocaine and benzoylecgonine increases detection rates in the periods 0.08-0.25 hours and 24-48 hours post-dosing as compared to testing for cocaine or benzoylecgonine alone.
The annual
One commenter submitted suggested rewording Section 4.1(a) to require the collector to be trained on “each manufacturer's procedures for the collection device.” The Department disagrees with the suggested edit, which may be misconstrued as requiring a collector to be trained on all devices. The current OFMG wording (
Five commenters submitted comments in response to DOT's February 28, 2022 NPRM, regarding who may collect an oral fluid specimen.
The Department did not propose any changes to this section. One commenter submitted a comment in response to DOT's February 28, 2022 NPRM, regarding maintaining a fax number on the Federal Custody and Control Form (CCF).
One commenter stated that the Department should specify what constitutes an incorrect form, how a collector's signed memorandum must be submitted to correct submission of an incorrect CCF, and what actions an HHS-certified laboratory must take in response to an incorrect CCF. The Department has determined that no changes to the Guidelines are needed. The Department issues Guidance for Using the Federal CCF as part of the OMB-approved package and provides information and guidance specific to the current and expired versions of the Federal CCF, rather than including them in these Guidelines.
In Section 7.2(b)(2), the Department added a requirement for oral fluid specimen tubes to be sufficiently transparent to enable a visual assessment of the contents without opening the tube. See also Section 8.5(a)(3). Two commenters disagreed with the term “sufficiently transparent,” noting that opaque tubes would enable visual assessment. The Department did not intend that all tubes must be entirely clear (thus, the term “sufficiently transparent”). An opaque tube would not allow visual assessment of the contents. For clarity, the Department has added “(
In Section 7.2(b)(3), the Department added a requirement for the collection device manufacturer to include the device lot expiration date on each specimen tube, to enable the collector to verify that each tube is within its expiration date prior to use. This is consistent with the current Federal CCF and associated documents (
One commenter agreed that the manufacturer should include the lot number and expiration date on each collection tube. The Department has provided additional guidance to laboratories noting that if the expiration date is not visible on the tube upon receipt and the device lot number is visible, the laboratory may use that information to recover the expiration date.
One of the commenters noted that the expiration date could be a required field on an ECCF, preventing the collector from continuing the collection without entering an expiration date. The Department agrees that ECCF system providers could implement this safeguard, but this does not obviate the need for the laboratory to verify the expiration date on each tube, just as the laboratory must verify the specimen identification number on each tube and the CCF.
The Department proposed revisions to Section 8.3 consistent with removal of refusal to test exceptions for pre-employment collections (see Section 1.7), reordered collection steps (
In regard to determining a refusal to test, one commenter suggested that the Department establish the beginning of the collection by specifying that the collection begins when the collector has checked the donor's identification. Another commenter who suggested the Department retain exceptions for pre-employment drug test collections (see Section 1.7) also suggested that this step be specified as the beginning of a pre-employment collection. The Department has determined that no revision is needed. The Guidelines clearly describe the preliminary collection steps and specify that the collector reports a refusal to test when a donor leaves the collection site before the collection is complete.
To deter donor attempts to adulterate or substitute the specimen, the Department proposed that the collector inspect the contents of the donor's pockets only when the collector does not keep the donor under direct observation until the end of the collection, including the 10-minute wait period described in Section 8.3(h). If the donor refuses to display the contents of their pockets, the collector will continue with the oral fluid collection, but will keep the donor under their direct observation and will not report this as a refusal to test. Five commenters disagreed, stating that a donor's refusal to empty their pockets should be reported as a refusal to test, for consistency with requirements for a urine collection. The Department has considered these comments and decided that no change is needed. The proposed procedures facilitate the collection process and prevent specimen tampering while maintaining donor privacy. There were no comments on this topic; however, the Department added a sentence in item e stating that a donor is not required to remove any items worn for faith-based reasons. This requirement will be specified for all authorized specimen types.
One commenter expressed concern over the requirement in Section 8.3(h)(4) for the collector to direct the donor to remain at the collection site until the end of the collection, stating that the refusal to test could be cancelled if the donor claimed that the collector did not mention this. The Department has determined that no revision is needed. It is incumbent upon the collector to instruct the donor throughout the collection process, including the instruction to remain through the end of the collection, and to inform the donor of the consequences for leaving early.
The Department added steps in Section 8.4 to deter donor attempts to tamper with the specimen. Added item a requires the donor to wash their hands under the collector's observation and to keep their hands within view and avoid touching items or surfaces after handwashing. Added Section 8.4(b)(1) specifies that the collector opens the package containing the collection device in the presence of the donor. Five commenters submitted comments on this section.
Two commenters stated that requiring the donor to wash their hands was unnecessary and could cause a problem when the oral fluid collection site has no sink or water. The commenters suggested allowing the donor to wear gloves or use hand wipes as an alternative. The Department has reviewed these comments and determined that no changes are needed to the Guidelines. The instruction does not preclude the use of other means of handwashing. The Department has included examples of alternate means (
The same two commenters suggested that the donor be instructed not to touch the collection pad. The Department does not agree that this added instruction is needed. The OFMG require the collector to be present and maintain visual contact with the donor throughout the collection, and specifically require the collector to go over the manufacturer's instructions for use of the device with the donor, observe the donor washing their hands before handling the device, and observe the donor positioning the device in their mouth. If the collector detects any conduct that clearly indicates an attempt to tamper with the specimen, the collector reports a refusal to test.
One commenter stated that requiring the donor to avoid touching items or surfaces was unnecessary and unreasonable. Two others agreed that the donor should not touch items that they brought with them after washing their hands, but stated that it may be difficult for the donor to avoid touching surfaces at the collection site. The Department has reviewed the comments and determined that no changes are needed to the Guidelines. The instruction to not touch items or surfaces at the collection site is a reasonable precaution, and compliance should not be difficult for the donor.
Another commenter specifically agreed with added Section 8.4(a)(1), noting this would eliminate errors and attempts to subvert the test.
In regard to added Section 8.4(b)(1), three commenters disagreed with the collector opening the package containing the collection device. Two recommended that the donor open the package, because some devices that are
Another commenter suggested adding the instruction for the collector to verify and record the device expiration date in Section 8.4(b)(1). The Department agrees with the commenter in part, and has edited Section 8.4(b) to state that each device used must be within the manufacturer's expiration date and inserted a new Section 8.4(c) requiring the collector to verify that each device is within its expiration date prior to use and to document the action on the Federal CCF. As discussed under Section 7.2 above, the Department disagrees with requiring the collector and not the laboratory to record the expiration date.
One commenter suggested that the Department clarify how many collection attempts should be allowed when a donor is unable to provide a sufficient specimen and recommended that only one additional attempt be allowed to limit costs. The Department reviewed the comment and determined that no change is needed to the proposed Guidelines. As noted in the preamble to the current OFMG, the Department set the time limit but did not set a limit for the number of attempts because there may be different reasons for failing to collect the specimen from the donor.
Comments relating to Section 8.8 are addressed under Section 2.5 above.
One commenter disagreed with the requirement for the collector to send all copies of the Federal CCF to the Federal agency's designated representative, and stated that the collector should keep the Collector Copy and give the Donor Copy to the donor. The Department has reviewed the comment and determined that no change is needed. The current wording reflects HHS requirements.
Two commenters submitted comments on this section. One commenter stated that the requirements for additional MRO training in the section are unclear and should be revised to clarify requirements (
The Department has reviewed these comments and edited item b of this section to clarify that MROs must be trained on any revisions to the drug and biomarker testing panels. In regard to training, SAMHSA relies on the approved MRO certification entities to ensure that MROs certified by their organizations meet Guidelines requirements. Current documents on the SAMHSA website
The Department received three comments on its proposed revisions to Section 13.5.
One commenter agreed with the Department's proposed revision to item 13.5(b)(2) clarifying that the MRO acts on an invalid result only when the MRO has verified the other results for the specimen as negative or when the split specimen was reported as a failure to reconfirm.
The Department revised Section 13.5(c)(2) to clarify that passive exposure to any drug (not just marijuana smoke) and ingestion of food products containing a drug (not just those containing marijuana) are not acceptable medical explanations for a positive drug test. The Department clarified existing item ii regarding ingestion of food products containing a drug and added a new item iii. Although an increased number of States have authorized marijuana use for medical purposes, marijuana remains a Schedule 1 controlled substance and cannot be prescribed under Federal law. For purposes of the Federal drug free workplace program, Federal law pertaining to marijuana control supersedes State marijuana laws, so a physician's recommendation for marijuana use is not a legitimate medical explanation for a positive marijuana test. Also see comments under
In addition to the changes described above, the Department reordered OFMG Sections 13.8 and 13.9 to reflect the procedural order (
As noted in Section 7.2(b), an oral fluid collection device must have an indicator that demonstrates the adequacy of the volume of oral fluid specimen collected. Because the oral fluid specimen volume is critical for determining the specimen concentration, the collector must document that they observed the volume indicator(s) at the time of collection. The Department has revised Section 15.1 (
The potential impact that these Guidelines have on the Department of Transportation (DOT) and/or Nuclear Regulatory Commission (NRC) regulated industries depend on the extent to which these agencies incorporate the OFMG revisions into their regulatory programs. Therefore, analysis of the potential impact of these Guidelines on such programs falls under the regulatory purview of DOT and NRC.
Executive Order 14094 of April 6, 2023 (Modernizing Regulatory Review) reaffirms the statement set forth in 13563 of January 18, 2011 (Improving Regulation and Regulatory Review) that “Our regulatory system must protect public health, welfare, safety, and our environment while promoting economic growth, innovation, competitiveness, and job creation.” Consistent with this mandate, Executive Order 13563 requires agencies to tailor “regulations to impose the least burden on society, consistent with obtaining regulatory objectives.” Executive Order 13563 also requires agencies to “identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice” while selecting “those approaches that maximize net benefits.” The regulatory approach in this document will reduce burdens to providers and to consumers while continuing to provide adequate protections for public health and welfare.
The Secretary has examined the impact of the Guidelines under Executive Order 12866, as amended by Executive Order 14094, which directs Federal agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity).
According to Executive Order 12866, as amended by Executive Order 14094, a “significant regulatory action” is one that is likely to result in a rule that may meet any one of a number of specified conditions, including: (1) have an annual effect on the economy of $200 million or more in any one year (adjusted every 3 years by the Administrator of the Office of Information and Regulatory Affairs (OIRA) for changes in gross domestic product); or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, territorial, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise legal or policy issues for which centralized review would meaningfully further the President's priorities or the principles set forth in the Executive order, as specifically authorized in a timely manner by the Administrator of OIRA in each case. The Administrative Procedure Act (APA) delineates an exception to its rulemaking procedures for “a matter relating to agency management or personnel” 5 U.S.C. 553(a)(2). Because the Guidelines issued by the Secretary govern Federal workplace drug testing programs, HHS has taken the position that the Guidelines are a “matter relating to agency management or personnel” and, thus, are not subject to the APA's requirements for notice and comment rulemaking. This position is consistent with Executive Order 12564 regarding Drug-Free Workplaces, which directs the Secretary to promulgate scientific and technical guidelines for executive agency drug testing programs.
The Department included a Regulatory Impact and Notices section with cost and benefits analysis and burden estimates in the April 7, 2022
One commenter noted that the Department did not consider the application of the Guidelines to DOT testing, and recommended reanalysis of the costs and burden of the proposed changes with consideration of the impact on testing by the transportation industry. Please see the first paragraph of the Regulatory Impact and Notices section above.
One commenter stated that the Department did not consider costs to MROs for training and education to bring MROs and MRO staff up to date on new drug panels and reporting methods. This commenter requested that the MRO community be allowed input to testing panel and nomenclature changes to enable adequate staffing and preparation. Another commenter disagreed with the Department's statement in the preamble to the proposed OFMG that “implementation costs would be lower for laboratories that already offer the drug test” compared to those laboratories that do not test for the added drug. The commenter indicated that the list of cost impacts for any change should include the laboratory's assay validation, materials management, and updates to IT systems (
The information collection requirements (
In support of the Government Paperwork Reduction Act (PRA), the
Since 2013, SAMHSA has encouraged the use of Federal ECCFs and other electronic processes in HHS-certified test facilities, when practicable, for federally regulated testing operations. In accordance with section 8108(a) of the SUPPORT for Patients and Communities Act, SAMHSA originally set a deadline of August 31, 2023 for all HHS-certified laboratories to submit a request for approval of a digital (paperless) electronic Federal CCF. The Department subsequently extended the deadline to August 31, 2026, to enable sufficient time for all HHS-certified laboratories to identify and contract with an ECCF supplier or to develop an ECCF.
The title and description of the information collected and respondent description are shown in the following paragraphs with an estimate of the annual reporting, disclosure, and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
The following reporting requirements are also in the Guidelines, but have not been addressed in the above reporting burden table: collector must report any unusual donor behavior or refusal to participate in the collection process on the Federal CCF (Sections 1.8, 8.9); collector annotates the Federal CCF when a sample is a blind sample (Section 10.3(a)); MRO notifies the Federal agency and HHS when an error occurs on a blind sample (Section 10.4(d)); and Sections 13.6 and 13.7 describe the actions an MRO takes for the medical evaluation of a donor who cannot provide an oral fluid specimen. SAMHSA has not calculated a separate reporting burden for these requirements because they are included in the burden hours estimated for collectors to complete Federal CCFs and for MROs to report results to Federal agencies.
The following disclosure requirements are also included in the Guidelines, but have not been addressed in the above disclosure burden table: the collector must explain the basic collection procedure to the donor and answer any questions (Section 8.3(h)). SAMHSA believes having the collector explain the collection procedure to the donor and answer any questions is a standard business practice and not a disclosure burden.
The Guidelines contain several recordkeeping requirements that SAMHSA considers not to be an additional recordkeeping burden. In subpart D, a trainer is required to document the training of an individual to be a collector (Section 4.3(a)(3)) and the documentation must be maintained in the collector's training file (Section 4.3(c)). SAMHSA believes this training documentation is common practice and is not considered an additional burden. In subpart F, if a collector uses an incorrect form to collect a Federal agency specimen, the collector is required to provide a statement (Section 6.2(b)) explaining why an incorrect form was used to document collecting the specimen. SAMHSA believes this is an extremely infrequent occurrence and does not create a significant additional recordkeeping burden. Subpart H (Section 8.4(e)) requires collectors to enter any information on the Federal CCF of any unusual findings during the oral fluid specimen collection procedure. These recordkeeping requirements are an integral part of the collection procedure and are essential to documenting the chain of custody for the specimens collected. The burden for these entries is included in the recordkeeping burden estimated to complete the Federal CCF and is, therefore, not considered an additional recordkeeping burden. Subpart K describes a number of recordkeeping requirements for laboratories associated with their testing procedures, maintaining chain of custody, and keeping records (
Thus, the total annual response burden associated with the testing of oral fluid specimens by the laboratories is estimated to be 13,221 hours (that is, the sum of the total hours from the above tables). Because of the expected transition from urine to oral fluid testing, this number will replace some of the 1,788,809 hours currently approved by OMB under control number 0930-0158 for urine testing under the current Guidelines.
As required by section 3507(d) of the PRA, the Secretary submitted a copy of the proposed Guidelines to OMB for its review. Comments on the information collection requirements were specifically solicited in order to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of HHS's functions, including whether the information will have practical utility; (2) evaluate the accuracy of HHS'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.
(a) These Guidelines apply to:
(1) Executive agencies as defined in 5 U.S.C. 105;
(2) The Uniformed Services, as defined in 5 U.S.C. 2101(3), but excluding the Armed Forces as defined in 5 U.S.C. 2101(2);
(3) Any other employing unit or authority of the Federal Government except the United States Postal Service, the Postal Rate Commission, and employing units or authorities in the Judicial and Legislative Branches; and
(4) The Intelligence Community, as defined by Executive Order 12333, is subject to these Guidelines only to the extent agreed to by the head of the affected agency;
(5) Laboratories that provide drug testing services to the Federal agencies;
(6) Collectors who provide specimen collection services to the Federal agencies; and
(7) Medical Review Officers (MROs) who provide drug testing review and interpretation of results services to the Federal agencies.
(b) These Guidelines do not apply to drug testing under authority other than Executive Order 12564, including testing of persons in the criminal justice system, such as arrestees, detainees, probationers, incarcerated persons, or parolees.
(a) Executive Order 12564 and Public Law 100-71 require the Department of Health and Human Services (HHS) to establish scientific and technical guidelines for Federal workplace drug testing programs.
(b) The Secretary has the responsibility to implement these Guidelines.
(a) Each Federal agency must ensure that its workplace drug testing program complies with the provisions of these Guidelines unless a waiver has been obtained from the Secretary.
(b) To obtain a waiver, a Federal agency must submit a written request to the Secretary that describes the specific change for which a waiver is sought and a detailed justification for the change.
(a) To ensure the full reliability and accuracy of specimen tests, the accurate reporting of test results, and the integrity and efficacy of Federal drug testing programs, the Secretary may make changes to these Guidelines to reflect improvements in the available science and technology.
(b) Revisions to these Guidelines will be published in final as a notification in the
The following definitions are adopted:
Consistent with 5 U.S.C. 552a and 48 CFR 24.101 through 24.104, all agency contracts with laboratories, collectors, and MROs must require that they comply with the Privacy Act, 5 U.S.C. 552a. In addition, the contracts must require compliance with employee access and confidentiality provisions of section 503 of Public Law 100-71. Each Federal agency must establish a Privacy Act System of Records or modify an existing system or use any applicable Government-wide system of records to cover the records of employee drug test results. All contracts and the Privacy Act System of Records must specifically require that employee records be maintained and used with the highest regard for employee privacy.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule (Rule), 45 CFR parts 160 and 164, subparts A and E, may be applicable to certain health care providers with whom a Federal agency may contract. If a health care provider is a HIPAA covered entity, the provider must protect the individually identifiable health information it maintains in accordance with the requirements of the Rule, which includes not using or disclosing the information except as permitted by the Rule and ensuring there are reasonable safeguards in place to protect the privacy of the information. For more information regarding the HIPAA Privacy Rule, please visit
(a) As a donor for a federally regulated drug test, you have refused to take a federally regulated drug test if you:
(1) Fail to appear for any test within a reasonable time, as determined by the Federal agency, consistent with applicable agency regulations, after being directed to do so by the Federal agency;
(2) Fail to remain at the collection site until the collection process is complete;
(3) Fail to provide a specimen (
(4) Fail to provide a sufficient amount of oral fluid when directed, and it has been determined, through a required medical evaluation, that there was no legitimate medical explanation for the failure as determined by the process described in Section 13.6;
(5) Fail or decline to participate in an alternate specimen collection (
(6) Fail to undergo a medical examination or evaluation, as directed by the MRO as part of the verification process (
(7) Fail to cooperate with any part of the testing process (
(8) Bring materials to the collection site for the purpose of adulterating, substituting, or diluting the specimen;
(9) Attempt to adulterate, substitute, or dilute the specimen; or
(10) Admit to the collector or MRO that you have adulterated or substituted the specimen.
(a) A refusal to take a test may result in the initiation of disciplinary or adverse action for a Federal employee, up to and including removal from Federal employment. An applicant's refusal to take a pre-employment test may result in non-selection for Federal employment.
(b) When a donor has refused to participate in a part of the collection process, including failing to appear in a reasonable time for any test, the collector must terminate the collection process and take action as described in Section 8.9. Required action includes immediately notifying the Federal agency's designated representative by any means (
(c) When documenting a refusal to test during the verification process as described in Sections 13.4, 13.5, and 13.6, the MRO must complete the MRO copy of the Federal CCF to include:
(1) Checking the refusal to test box;
(2) Providing a reason for the refusal in the remarks line; and
(3) Signing and dating the MRO copy of the Federal CCF.
A Federal agency may collect oral fluid and/or an alternate specimen type for its workplace drug testing program. Only specimen types authorized by Mandatory Guidelines for Federal Workplace Drug Testing Programs may be collected. An agency using oral fluid must follow these Guidelines.
A Federal agency may collect an oral fluid specimen for the following reasons:
(a) Federal agency applicant/Pre-employment test;
(b) Random test;
(c) Reasonable suspicion/cause test;
(d) Post accident test;
(e) Return to duty test; or
(f) Follow-up test.
Each oral fluid specimen is collected as a split specimen (
A volume of at least 1 mL of undiluted (neat) oral fluid for each oral fluid specimen (designated “Tube A” and “Tube B”) is collected using a collection device. If the device does not include a diluent (or other component, process, or method that modifies the volume of the testable specimen), the A and B tubes must have a volume marking clearly noting a level of 1 mL.
The collector collects at least 1 mL of undiluted (neat) oral fluid in a collection device designated as “A” (primary) and at least 1 mL of undiluted (neat) oral fluid in a collection device designated as “B” (split) either simultaneously or serially (
Entities and individuals subject to these Guidelines under Section 1.1 may not release specimens collected pursuant to Executive Order 12564, Public Law 100-71, and these Guidelines to donors or their designees. Specimens also may not be released to any other entity or individual unless expressly authorized by these Guidelines or by applicable Federal law. This section does not prohibit a donor's request to have a split (B) specimen tested in accordance with Section 13.9.
A Federal agency:
(a) Must ensure that each specimen is tested for marijuana and cocaine as provided in the drug testing panel described under Section 3.4;
(b) Is authorized to test each specimen for other Schedule I or II drugs as provided in the drug testing panel;
(c) Is authorized upon a Medical Review Officer's request to test an oral fluid specimen to determine specimen validity using, for example, a test for a specific adulterant;
(d) Is authorized to test each specimen for one or more biomarkers as provided in the biomarker testing panel; and
(e) May perform additional testing if a specimen exhibits abnormal characteristics (
(a) On a case-by-case basis, a specimen may be tested for additional
(b) A Federal agency covered by these Guidelines must petition the Secretary in writing for approval to routinely test for any drug class not listed in the drug testing panel described under Section 3.4. Such approval must be limited to the use of the appropriate science and technology and must not otherwise limit agency discretion to test for any drug tested under Section 3.2(a).
(a) Specimens collected pursuant to Executive Order 12564, Public Law 100-71, and these Guidelines must only be tested for drugs and to determine their validity in accordance with subpart C of these Guidelines. Use of specimens by donors, their designees, or any other entity, for other purposes (
(b) These Guidelines are not intended to prohibit Federal agencies specifically authorized by law to test a specimen for additional classes of drugs in its workplace drug testing program.
The Secretary will publish the drug and biomarker test analytes and cutoffs (
This drug testing panel will remain in effect until the effective date of a new drug testing panel published in the
(a) The drug testing panel will include drugs authorized for testing in Federal workplace drug testing programs, with the required test analytes and cutoffs;
(b) The biomarker testing panel will include biomarkers authorized for testing in Federal workplace drug testing programs, with the required test analytes and cutoffs; and
(c) HHS-certified laboratories and Medical Review Officers must use the nomenclature (
An HHS-certified laboratory is authorized to perform additional drug and/or specimen validity tests on a case-by-case basis as necessary to provide information that the MRO would use to report a verified drug test result (
An HHS-certified laboratory reports a primary (A) specimen as adulterated when the presence of an adulterant is verified using an initial test on the first aliquot and a different confirmatory test on the second aliquot.
An HHS-certified laboratory reports a primary (A) specimen as substituted when a biomarker is not detected or is present at a concentration inconsistent with that established for human oral fluid for both the initial (first) test and the confirmatory (second) test on two separate aliquots (
An HHS-certified laboratory reports a primary (A) oral fluid specimen as an invalid result when:
(a) Interference occurs on the initial drug tests on two separate aliquots (
(b) Interference with the confirmatory drug test occurs on two separate aliquots of the specimen and the laboratory is unable to identify the interfering substance;
(c) The physical appearance of the specimen (
(d) The specimen has been tested and the appearances of the primary (A) and the split (B) specimens (
(e) A specimen validity test on two separate aliquots of the specimen indicates that the specimen is not valid for testing.
(a) A collector who has been trained to collect oral fluid specimens in accordance with these Guidelines and the manufacturer's procedures for the collection device.
(b) The immediate supervisor of a Federal employee donor may only collect that donor's specimen when no other collector is available. The supervisor must be a trained collector.
(c) The hiring official of a Federal agency applicant may only collect that Federal agency applicant's specimen when no other collector is available. The hiring official must be a trained collector.
(a) A Federal agency employee who is in a testing designated position and subject to the Federal agency drug testing rules must not be a collector for co-workers in the same testing pool or who work with that employee on a daily basis.
(b) A Federal agency applicant or employee must not collect their own drug testing specimen.
(c) An employee working for an HHS-certified laboratory must not act as a collector if the employee could link the identity of the donor to the donor's drug test result.
(d) To avoid a potential conflict of interest, a collector must not be related to the employee (
(a) An individual may serve as a collector if they fulfill the following conditions:
(1) Is knowledgeable about the collection procedure described in these Guidelines;
(2) Is knowledgeable about any guidance provided by the Federal agency's Drug-Free Workplace Program and additional information provided by the Secretary relating to the collection procedure described in these Guidelines;
(3) Is trained and qualified to use the specific oral fluid collection device. Training must include the following:
(i) All steps necessary to complete an oral fluid collection;
(ii) Completion and distribution of the Federal CCF;
(iii) Problem collections;
(iv) Fatal flaws, correctable flaws, and how to correct problems in collections; and
(v) The collector's responsibility for maintaining the integrity of the collection process, ensuring the privacy of the donor, ensuring the security of the specimen, and avoiding conduct or statements that could be viewed as offensive or inappropriate.
(4) Has demonstrated proficiency in collections by completing five consecutive error-free mock collections.
(i) The five mock collections must include two uneventful collection scenarios, one insufficient specimen quantity scenario, one scenario in which the donor refuses to sign the Federal CCF, and one scenario in which the donor refuses to initial the specimen tube tamper-evident seal.
(ii) A qualified trainer for collectors must monitor and evaluate the individual being trained, in person or by a means that provides real-time observation and interaction between the trainer and the trainee, and the trainer must attest in writing that the mock collections are error-free.
(b) A trained collector must complete refresher training at least every five years that includes the requirements in
(c) The collector must maintain the documentation of their training and provide that documentation to a Federal agency when requested.
(d) An individual may not collect specimens for a Federal agency until the individual's training as a collector has been properly documented.
(a) Individuals are considered qualified trainers for collectors for a specific oral fluid collection device and may train others to collect oral fluid specimens using that collection device when they have completed the following:
(1) Qualified as a trained collector and regularly conducted oral fluid drug test collections using that collection device for a period of at least one year or
(2) Completed a “train the trainer” course given by an organization (
(b) A qualified trainer for collectors must complete refresher training at least every five years in accordance with the collector requirements in Section 4.3(a).
(c) A qualified trainer for collectors must maintain the documentation of the trainer's training and provide that documentation to a Federal agency when requested.
A Federal agency must ensure the following:
(a) The collector has satisfied the requirements described in Section 4.3;
(b) The collector, who may be self-employed, or an organization (
(c) The collector has been provided the name and telephone number of the Federal agency representative.
(a) A collection site may be a permanent or temporary facility located either at the work site or at a remote site.
(b) In the event that an agency-designated collection site is not accessible and there is an immediate requirement to collect an oral fluid specimen (
The facility used as a collection site must have the following:
(a) Provisions to ensure donor privacy during the collection (as described in Section 8.1);
(b) A suitable and clean surface area that is not accessible to the donor for handling the specimens and completing the required paperwork;
(c) A secure temporary storage area to maintain specimens until the specimen is transferred to an HHS-certified laboratory;
(d) A restricted access area where only authorized personnel may be present during the collection;
(e) A restricted access area for the storage of collection supplies; and
(f) A restricted access area for the secure storage of records.
Collection site records must be stored at a secure site designated by the collector or the collector's employer.
Collection site records (
(a) A collector must do the following to maintain the security and integrity of a specimen:
(1) Not allow unauthorized personnel to enter the collection area during the collection procedure;
(2) Perform only one donor collection at a time;
(3) Restrict access to collection supplies before, during, and after collection;
(4) Ensure that only the collector and the donor are allowed to handle the unsealed specimen;
(5) Ensure the chain of custody process is maintained and documented throughout the entire collection, storage, and transport procedures;
(6) Ensure that the Federal CCF is completed and distributed as required; and
(7) Ensure that specimens transported to an HHS-certified laboratory are sealed and placed in transport containers designed to minimize the possibility of damage during shipment (
(b) Couriers, express carriers, and postal service personnel are not required to document chain of custody since specimens are sealed in packages that would indicate tampering during transit to the HHS-certified laboratory.
Collections must be performed at a site that provides reasonable privacy (as described in Section 8.1).
The OMB-approved Federal CCF must be used to document custody and control of each specimen at the collection site.
(a) The use of a non-Federal CCF or an expired Federal CCF is not, by itself, a reason for the HHS-certified laboratory to automatically reject the specimen for testing or for the MRO to cancel the test.
(b) If the collector does not use the correct OMB-approved Federal CCF, the collector must document that it is a Federal agency specimen collection and provide the reason that the incorrect form was used. Based on the information provided by the collector, the HHS-certified laboratory must handle and test the specimen as a Federal agency specimen.
(c) If the HHS-certified laboratory or MRO discovers that the collector used an incorrect form, the laboratory or MRO must obtain a memorandum for the record from the collector describing the reason the incorrect form was used. If a memorandum for the record cannot be obtained, the laboratory reports a rejected for testing result to the MRO and the MRO cancels the test. The HHS-certified laboratory must wait at least 5 business days while attempting to obtain the memorandum before reporting a rejected for testing result to the MRO.
A single-use collection device intended to collect an oral fluid specimen must be used. This collection device must maintain the integrity of such specimens during storage and transport so that the specimen contained therein can be tested in an HHS-certified laboratory for the presence of drugs or their metabolites.
An oral fluid specimen collection device must provide:
(a) An indicator that demonstrates the adequacy of the volume of oral fluid specimen collected;
(b) One or two sealable, non-leaking tubes [depending on the device type, as described in Section 8.8(a)] that:
(1) maintain the integrity of the specimen during storage and transport so that the specimen contained therein can be tested in an HHS-certified laboratory for the presence of drugs or their metabolites,
(2) are sufficiently transparent (
(3) include the device lot expiration date on each specimen tube (
(c) Components that ensure pre-analytical drug and drug metabolite stability; and
(d) Components that do not substantially affect the composition of drugs and/or drug metabolites in the oral fluid specimen.
An oral fluid collection device must meet the following minimum performance requirements.
(a) Reliable collection of a minimum of 1 mL of undiluted (neat) oral fluid;
(b) If the collection device contains a diluent (or other component, process, or method that modifies the volume of the testable specimen):
(1) The volume of oral fluid collected should be at least 1.0 mL ±10 percent, and
(2) The volume of diluent in the device should be within ±2.5 percent of the diluent target volume;
(c) Stability (recoverable concentrations ≥80 percent of the concentration at the time of collection) of the drugs and/or drug metabolites for five days at room temperature (64-77 °F/18-25 °C) and under the manufacturer's intended shipping and storage conditions; and
(d) Recover ≥80 percent (but no more than 120 percent) of drug and/or drug metabolite in the undiluted (neat) oral fluid at (or near) the initial test cutoff listed in the drug testing panel.
The following privacy requirements apply when a donor is providing an oral fluid specimen:
(a) Only authorized personnel and the donor may be present in the restricted access area where the collection takes place.
(b) The collector is not required to be the same gender as the donor.
The collector must take all reasonable steps to prevent the adulteration or substitution of an oral fluid specimen at the collection site.
The collector must take the following steps before beginning an oral fluid specimen collection:
(a) If a donor fails to arrive at the collection site at the assigned time, the collector must follow the Federal agency policy or contact the Federal agency representative to obtain guidance on action to be taken.
(b) When the donor arrives at the collection site, the collector should begin the collection procedure without undue delay. For example, the collection should not be delayed because an authorized employer or employer representative is late in arriving.
(c) The collector requests the donor to present photo identification (
(d) The collector must provide identification (
(e) The collector asks the donor to remove any unnecessary outer garments (
(f) If the donor will remain under the collector's direct observation until the end of the collection, including the 10-minute wait period described in Section 8.3(h), the collector proceeds to Section 8.3(g). If the collector will not keep the donor under direct observation from this point until the end of the collection, the collector asks the donor to empty the donor's pockets and display the contents to ensure no items are present that could be used to adulterate or substitute the specimen.
(1) If no items are present that can be used to adulterate or substitute the specimen, the collector instructs the donor to return the items to their pockets and continues the collection procedure.
(2) If an item is present whose purpose is to adulterate or substitute the specimen (
(3) If an item that could be used to adulterate or substitute the specimen (
(4) If the donor refuses to show the collector the items in their pockets, the collector must keep the donor under direct observation until the end of the oral fluid collection.
(g) The collector requests that the donor open the donor's mouth, and the collector inspects the oral cavity to ensure that it is free of any items (
(1) If an item is present that whose purpose is to adulterate or substitute the specimen (
(2) If an item is present that could impede or interfere with the collection of an oral fluid specimen (including abnormally colored saliva), or the donor claims to have “dry mouth,” the collector gives the donor water (
(3) If the donor claims that they have a medical condition that prevents opening their mouth for inspection, the collector follows the procedure in Section 8.6(b)(2).
(h) The collector must initiate a 10-minute wait period prior to collecting the specimen. During these 10 minutes, the collector must:
(1) Explain the basic collection procedure to the donor;
(2) Provide the instructions for completing the Federal CCF for the donor's review, and informs the donor that these instructions and the collection device-specific instructions are available upon request.
(3) Answer any reasonable and appropriate questions the donor may have regarding the collection procedure; and
(4) Inform the donor that they must remain at the collection site (
(a) The collector shall instruct the donor to wash and dry the donor's hands under the collector's observation, and to keep their hands within view and avoid touching items or surfaces after handwashing. If the donor refuses to wash their hands when instructed by the collector, this is a refusal to test.
(b) The collector will provide or the donor may select the specimen collection device(s) to be used for the collection. The device(s) must be clean, unused, and wrapped/sealed in original packaging and must be within the manufacturer's expiration date printed on the specimen tube. See Section 8.8(a) for types of specimen collection devices used for oral fluid split specimen collections.
(1) The collector will open the package in view of the donor.
(2) Both the collector and the donor must keep the unwrapped collection devices in view at all times until each collection device containing the donor's oral fluid specimen has been sealed and labeled.
(c) The collector verifies that each device is within the manufacturer's expiration date, and documents this action on the Federal CCF.
(d) The collector reviews with the donor the procedures required for a successful oral fluid specimen collection as stated in the manufacturer's instructions for the specimen collection device.
(e) The collector notes any unusual behavior or appearance of the donor on the Federal CCF. If the collector detects any conduct that clearly indicates an attempt to tamper with a specimen (
Integrity and Identity of the Specimen. The collector must take the following steps during and after the donor provides the oral fluid specimen:
(a) The collector shall be present and maintain visual contact with the donor during the procedures outlined in this section.
(1) Under the observation of the collector, the donor is responsible for positioning the specimen collection device for collection. The collector must ensure the collection is performed correctly and that the collection device is working properly. If there is a failure to collect the specimen, the collector must begin the process again, beginning with Step 8.4(b), using a new specimen collection device (for both A and B specimens) and notes the failed collection attempt on the Federal CCF. If the donor states that they are unable to provide an oral fluid specimen during the collection process or after multiple failures to collect the specimen, the collector follows the procedure in Section 8.6.
(2) The donor and the collector must complete the collection in accordance with the manufacturer instructions for the collection device.
(3) The collector must inspect the specimen to determine if there is any sign indicating that the specimen may not be a valid oral fluid specimen (
(b) If the donor fails to remain present through the completion of the collection, fails to follow the instructions for the collection device, refuses to begin the collection process after a failure to collect the specimen as required in Section 8.5(a)(1), refuses to provide a split specimen as instructed by the collector, or refuses to provide an alternate specimen when directed to do so, the collector stops the collection and reports the refusal to test in accordance with Section 8.9.
(a) If the donor states that they are unable to provide an oral fluid specimen during the collection process, the collector requests that the donor follow the collector instructions and attempt to provide an oral fluid specimen.
(b) The donor demonstrates their inability to provide a specimen when, after 15 minutes of using the collection device, there is insufficient volume or no oral fluid collected using the device.
(1) If the donor states that they could provide a specimen after drinking some fluids, the collector gives the donor a drink (up to 8 ounces) and waits an additional 10 minutes before beginning the specimen collection (a period of 1 hour must be provided or until the donor has provided a sufficient oral fluid specimen). If the donor simply needs more time before attempting to provide an oral fluid specimen, the donor may choose not to drink any fluids during the 1 hour wait time. The collector must inform the donor that the donor must remain at the collection site (
(2) If the donor states that they are unable to provide an oral fluid specimen, the collector records the reason for not collecting an oral fluid specimen on the Federal CCF, notifies the Federal agency's designated representative for authorization to collect an alternate specimen, and sends the appropriate copies of the Federal CCF to the MRO and to the Federal agency's designated representative. The Federal agency may choose to provide the collection site with a standard protocol to follow in lieu of requiring the collector to notify the agency's designated representative for authorization in each case. If an alternate specimen is authorized, the collector may begin the collection procedure for the alternate specimen (see Section 8.7) in accordance with the Mandatory Guidelines for Federal Workplace Drug Testing Programs using the alternate specimen.
Yes, if the alternate specimen type is authorized by Mandatory Guidelines for Federal Workplace Drug Testing Programs and specifically authorized by the Federal agency.
(a) All Federal agency collections are to be split specimen collections. An oral fluid split specimen collection may be:
(1) Two specimens collected simultaneously with two separate collection devices;
(2) Two specimens collected serially with two separate collection devices. The donor is not allowed to drink or rinse their mouth between the two collections. Collection of the second specimen must begin within two minutes after the completion of the first collection and recorded on the Federal CCF;
(3) Two specimens collected simultaneously using a single collection device that directs the oral fluid into two separate collection tubes; or
(4) A single specimen collected using a single collection device, that is subsequently subdivided into two specimens.
(b) A volume of at least 1 mL of undiluted (neat) oral fluid is collected for the specimen designated as “Tube
(c) In the presence of the donor, the collector places a tamper-evident label/seal from the Federal CCF over the cap of each specimen tube. The collector records the date of the collection on the tamper-evident labels/seals.
(d) The collector instructs the donor to initial the tamper-evident labels/seals on each specimen tube. If the donor refuses to initial the labels/seals, the collector notes the refusal on the Federal CCF and continues with the collection process.
(e) The collector must ensure that all required information is included on the Federal CCF.
(f) The collector asks the donor to read and sign a statement on the Federal CCF certifying that the specimens identified were collected from the donor. If the donor refuses to sign the certification statement, the collector notes the refusal on the Federal CCF and continues with the collection process.
(g) The collector signs and prints their name on the Federal CCF, completes the Federal CCF, and distributes the copies of the Federal CCF as required.
(h) The collector seals the specimens (Tube A and Tube B) in a package and, within 24 hours or during the next business day, sends them to the HHS-certified laboratory that will be testing the Tube A oral fluid specimen.
(i) If the specimen and Federal CCF are not immediately transported to an HHS-certified laboratory, they must remain under direct control of the collector or be appropriately secured under proper specimen storage conditions until transported.
If there is a refusal to test as defined in Section 1.7, the collector stops the collection, discards any oral fluid specimen collected and reports the refusal to test by:
(a) Notifying the Federal agency by means (
(b) Documenting the refusal to test including the reason on the Federal CCF, and
(c) Sending all copies of the Federal CCF to the Federal agency's designated representative.
(a) A Federal agency must ensure that collectors and collection sites satisfy all requirements in subparts D, E, F, G, and H of these Guidelines.
(b) A Federal agency (or only one Federal agency when several agencies are using the same collection site) must inspect 5 percent or up to a maximum of 50 collection sites each year, selected randomly from those sites used to collect agency specimens (
(c) A Federal agency must investigate reported collection site deficiencies (
(a) The Secretary has broad discretion to take appropriate action to ensure the full reliability and accuracy of drug testing and reporting, to resolve problems related to drug testing, and to enforce all standards set forth in these Guidelines. The Secretary has the authority to issue directives to any HHS-certified laboratory, including suspending the use of certain analytical procedures when necessary to protect the integrity of the testing process; ordering any HHS-certified laboratory to undertake corrective actions to respond to material deficiencies identified by an inspection or through performance testing; ordering any HHS-certified laboratory to send specimens or specimen aliquots to another HHS-certified laboratory for retesting when necessary to ensure the accuracy of testing under these Guidelines; ordering the review of results for specimens tested under the Guidelines for private sector clients to the extent necessary to ensure the full reliability of drug testing for Federal agencies; and ordering any other action necessary to address deficiencies in drug testing, analysis, specimen collection, chain of custody, reporting of results, or any other aspect of the certification program.
(b) A laboratory is prohibited from stating or implying that it is certified by HHS under these Guidelines to test oral fluid specimens for Federal agencies unless it holds such certification.
(a) A laboratory seeking HHS certification must:
(1) Submit a completed OMB-approved application form (
(2) Have its application reviewed as complete and accepted by HHS;
(3) Successfully complete the PT challenges in 3 consecutive sets of initial PT samples;
(4) Satisfy all the requirements for an initial inspection; and
(5) Receive notification of certification from the Secretary before testing specimens for Federal agencies.
(a) To maintain HHS certification, a laboratory must:
(1) Successfully participate in both the maintenance PT and inspection programs (
(2) Respond in an appropriate, timely, and complete manner to required corrective action requests if deficiencies are identified in the maintenance PT performance, during the inspections, operations, or reporting; and
(3) Satisfactorily complete corrective remedial actions, and undergo special inspection and special PT sets to maintain or restore certification when material deficiencies occur in either the PT program, inspection program, or in operations and reporting.
(a) A laboratory that does not maintain its HHS certification must:
(1) Stop testing federally regulated specimens;
(2) Ensure the security of federally regulated specimens and records throughout the required storage period described in Sections 11.18, 11.19, and 14.8;
(3) Ensure access to federally regulated specimens and records in accordance with Sections 11.21 and 11.22 and subpart P of these Guidelines; and
(4) Follow the HHS suspension and revocation procedures when imposed by the Secretary, follow the HHS
(a) PT samples used to evaluate drug tests will be prepared using the following specifications:
(1) PT samples may contain one or more of the drugs and drug metabolites in the drug classes listed in the drug testing panel and may be sent to the laboratory as undiluted (neat) oral fluid. The PT samples must satisfy one of the following parameters:
(i) The concentration of a drug or metabolite will be at least 20 percent above the initial test cutoff for the drug or drug metabolite;
(ii) The concentration of a drug or metabolite may be as low as 40 percent of the confirmatory test cutoff when the PT sample is designated as a retest sample; or
(iii) The concentration of drug or metabolite may differ from Section 9.5(a)(1)(i) and (ii) for a special purpose.
(2) A PT sample may contain an interfering substance, an adulterant, or other substances for special purposes, or may satisfy the criteria for a substituted specimen or invalid result.
(3) A negative PT sample will not contain a measurable amount of a target analyte.
(b) The laboratory must (to the greatest extent possible) handle, test, and report a PT sample in a manner identical to that used for a donor specimen, unless otherwise specified.
(a) An applicant laboratory that seeks certification under these Guidelines to perform oral fluid testing must satisfy the following criteria on three consecutive sets of PT samples:
(1) Have no false positive results;
(2) Correctly identify, confirm, and report at least 90 percent of the total drug challenges over the three sets of PT samples;
(3) Correctly identify at least 80 percent of the drug challenges for each initial drug test over the three sets of PT samples;
(4) For the confirmatory drug tests, correctly determine the concentrations (
(5) For the confirmatory drug tests, do not obtain any drug concentration that differs by more than ±50 percent from the appropriate reference or peer group mean;
(6) For each confirmatory drug test, correctly identify and determine the concentrations (
(7) Correctly identify at least 80 percent of the total specimen validity testing challenges over the three sets of PT samples;
(8) Correctly identify at least 80 percent of the challenges for each individual specimen validity test over the three sets of PT samples;
(9) For quantitative specimen validity tests, obtain quantitative values for at least 80 percent of the total challenges over the three sets of PT samples that satisfy the specified criteria; and
(10) Do not report any PT sample as adulterated with a compound that is not present in the sample or substituted when the appropriate reference or peer group mean for a biomarker is within the acceptable range.
(b) Failure to satisfy these requirements will result in the denial of the laboratory's application for HHS certification to perform oral fluid testing.
(a) A laboratory certified under these Guidelines to perform oral fluid testing must satisfy the following criteria on the maintenance PT samples:
(1) Have no false positive results;
(2) Correctly identify, confirm, and report at least 90 percent of the total drug challenges over two consecutive PT cycles;
(3) Correctly identify at least 80 percent of the drug challenges for each initial drug test over two consecutive PT cycles;
(4) For the confirmatory drug tests, correctly determine that the concentrations for at least 80 percent of the total drug challenges are no more than ±20 percent or ±2 standard deviations (whichever is larger) from the appropriate reference or peer group means over two consecutive PT cycles;
(5) For the confirmatory drug tests, do not obtain any drug concentration that differs by more than ±50 percent from the appropriate reference or peer group means;
(6) For each confirmatory drug test, correctly identify and determine that the concentrations for at least 50 percent of the drug challenges for an individual drug are no more than ±20 percent or ±2 standard deviations (whichever is larger) from the appropriate reference or peer group means over two consecutive PT cycles;
(7) Correctly identify at least 80 percent of the total specimen validity testing challenges over two consecutive PT cycles;
(8) Correctly identify at least 80 percent of the challenges for each individual specimen validity test over two consecutive PT cycles;
(9) For quantitative specimen validity tests, obtain quantitative values for at least 80 percent of the total challenges over two consecutive PT cycles that satisfy the specified criteria; and
(10) Do not report any PT sample as adulterated with a compound that is not present in the sample or substituted when the appropriate reference or peer group mean for a biomarker is within the acceptable range.
(b) Failure to participate in all PT cycles or to satisfy these requirements may result in suspension or revocation of an HHS-certified laboratory's certification.
(a) An applicant laboratory is inspected by a team of two inspectors.
(b) Each inspector conducts an independent review and evaluation of all aspects of the laboratory's testing procedures and facilities using an inspection checklist.
(a) An HHS-certified laboratory must undergo an inspection 3 months after becoming certified and at least every 6 months thereafter.
(b) An HHS-certified laboratory is inspected by two or more inspectors. The number of inspectors is determined according to the number of specimens to be reviewed. Additional information regarding inspections is available from SAMHSA.
(c) Each inspector conducts an independent evaluation and review of the HHS-certified laboratory's procedures, records, and facilities using guidance provided by the Secretary.
(d) To remain certified, an HHS-certified laboratory must continue to satisfy the minimum requirements as stated in these Guidelines.
(a) An individual may be selected as an inspector for the Secretary if they satisfy the following criteria:
(1) Has experience and an educational background similar to that required for either a responsible person or a certifying scientist for an HHS-certified laboratory as described in subpart K of these Guidelines;
(2) Has read and thoroughly understands the policies and requirements contained in these Guidelines and in other guidance consistent with these Guidelines provided by the Secretary;
(3) Submits a resume and documentation of qualifications to HHS;
(4) Attends approved training; and
(5) Performs acceptably as an inspector on an inspection of an HHS-certified laboratory.
(b) The Secretary or a Federal agency may conduct an inspection at any time.
If an applicant laboratory fails to satisfy the requirements established for the initial certification process, the laboratory must start the certification process from the beginning.
(a) If an HHS-certified laboratory fails to satisfy the minimum requirements for certification, the laboratory is given a period of time (
(b) A laboratory's HHS certification may be revoked, suspended, or no further action taken depending on the seriousness of the deficiencies and whether there is evidence that the deficiencies have been corrected and that current performance meets the requirements for certification.
(c) An HHS-certified laboratory may be required to undergo a special inspection or to test additional PT samples to address deficiencies.
(d) If an HHS-certified laboratory's certification is revoked or suspended in accordance with the process described in subpart P of these Guidelines, the laboratory is not permitted to test federally regulated specimens until the suspension is lifted or the laboratory has successfully completed the certification requirements as a new applicant laboratory.
(a) The Secretary shall revoke certification of an HHS-certified laboratory in accordance with these Guidelines if the Secretary determines that revocation is necessary to ensure fully reliable and accurate drug test results and reports.
(b) The Secretary shall consider the following factors in determining whether revocation is necessary:
(1) Unsatisfactory performance in analyzing and reporting the results of drug tests (
(2) Unsatisfactory participation in performance testing or inspections;
(3) A material violation of a certification standard, contract term, or other condition imposed on the HHS-certified laboratory by a Federal agency using the laboratory's services;
(4) Conviction for any criminal offense committed as an incident to operation of the HHS-certified laboratory; or
(5) Any other cause that materially affects the ability of the HHS-certified laboratory to ensure fully reliable and accurate drug test results and reports.
(c) The period and terms of revocation shall be determined by the Secretary and shall depend upon the facts and circumstances of the revocation and the need to ensure accurate and reliable drug testing.
(a) The Secretary may immediately suspend (either partially or fully) a laboratory's HHS certification to conduct drug testing for Federal agencies if the Secretary has reason to believe that revocation may be required and that immediate action is necessary to protect the interests of the United States and its employees.
(b) The Secretary shall determine the period and terms of suspension based upon the facts and circumstances of the suspension and the need to ensure accurate and reliable drug testing.
(a) When a laboratory's HHS certification is suspended or the Secretary seeks to revoke HHS certification, the Secretary shall immediately serve the HHS-certified laboratory with written notice of the suspension or proposed revocation by fax, mail, personal service, or registered or certified mail, return receipt requested. This notice shall state the following:
(1) The reasons for the suspension or proposed revocation;
(2) The terms of the suspension or proposed revocation; and
(3) The period of suspension or proposed revocation.
(b) The written notice shall state that the laboratory will be afforded an opportunity for an informal review of the suspension or proposed revocation if it so requests in writing within 30 days of the date the laboratory received the notice, or if expedited review is requested, within 3 days of the date the laboratory received the notice. Subpart P of these Guidelines contains detailed procedures to be followed for an informal review of the suspension or proposed revocation.
(c) A suspension must be effective immediately. A proposed revocation must be effective 30 days after written notice is given or, if review is requested, upon the reviewing official's decision to uphold the proposed revocation. If the reviewing official decides not to uphold the suspension or proposed revocation, the suspension must terminate immediately and any proposed revocation shall not take effect.
(d) The Secretary will publish in the
Following revocation, a laboratory may apply for recertification. Unless
(a) The list of HHS-certified laboratories is published monthly in the
(b) An applicant laboratory is not included on the list.
(a) Each Federal agency is required to submit blind samples for its workplace drug testing program. The collector must send the blind samples to the HHS-certified laboratory that the collector sends employee specimens.
(b) Each Federal agency must submit at least 3 percent blind samples along with its donor specimens based on the projected total number of donor specimens collected per year (up to a maximum of 400 blind samples). Every effort should be made to ensure that blind samples are submitted quarterly.
(c) Approximately 75 percent of the blind samples submitted each year by an agency must be negative and 25 percent must be positive for one or more drugs.
(a) Drug positive blind samples must be validated by the supplier in the selected manufacturer's collection device as to their content using appropriate initial and confirmatory tests.
(1) Drug positive blind samples must contain one or more of the drugs or metabolites listed in the drug testing panel.
(2) Drug positive blind samples must contain concentrations of drugs between 1.5 and 2 times the initial drug test cutoff.
(b) Drug negative blind samples (
(c) The supplier must provide information on the blind samples' content, validation, expected results, and stability to the collection site/collector sending the blind samples to the laboratory, and must provide the information upon request to the MRO, the Federal agency for which the blind sample was submitted, or the Secretary.
(a) A blind sample must be submitted as a split specimen (specimens A and B) with the current Federal CCF that the HHS-certified laboratory uses for donor specimens. The collector provides the required information to ensure that the Federal CCF has been properly completed and provides fictitious initials on the specimen label/seal. The collector must indicate that the specimen is a blind sample on the MRO copy where a donor would normally provide a signature.
(b) A collector should attempt to distribute the required number of blind samples randomly with donor specimens rather than submitting the full complement of blind samples as a single group.
If an HHS-certified laboratory reports a result for a blind sample that is inconsistent with the expected result (e.g., a laboratory reports a negative result for a blind sample that was supposed to be positive, a laboratory reports a positive result for a blind sample that was supposed to be negative):
(a) The MRO must contact the laboratory and attempt to determine if the laboratory made an error during the testing or reporting of the sample;
(b) The MRO must contact the blind sample supplier and attempt to determine if the supplier made an error during the preparation or transfer of the sample;
(c) The MRO must contact the collector and determine if the collector made an error when preparing the blind sample for transfer to the HHS-certified laboratory;
(d) If there is no obvious reason for the inconsistent result, the MRO must notify both the Federal agency for which the blind sample was submitted and the Secretary; and
(e) The Secretary shall investigate the blind sample error. A report of the Secretary's investigative findings and the corrective action taken in response to identified deficiencies must be sent to the Federal agency. The Secretary shall ensure notification of the finding as appropriate to other Federal agencies and coordinate any necessary actions to prevent the recurrence of the error.
(a) An HHS-certified laboratory must have a standard operating procedure (SOP) manual that describes, in detail, all HHS-certified laboratory operations. When followed, the SOP manual ensures that all specimens are tested using the same procedures.
(b) The SOP manual must include at a minimum, but is not limited to, a detailed description of the following:
(1) Chain of custody procedures;
(2) Accessioning;
(3) Security;
(4) Quality control/quality assurance programs;
(5) Analytical methods and procedures;
(6) Equipment and maintenance programs;
(7) Personnel training;
(8) Reporting procedures; and
(9) Computers, software, and laboratory information management systems.
(c) All procedures in the SOP manual must be compliant with these Guidelines and all guidance provided by the Secretary.
(d) A copy of all procedures that have been replaced or revised and the dates on which the procedures were in effect must be maintained for at least 2 years.
(a) Manage the day-to-day operations of the HHS-certified laboratory even if another individual has overall responsibility for alternate areas of a multi-specialty laboratory.
(b) Ensure that there are sufficient personnel with adequate training and experience to supervise and conduct the work of the HHS-certified laboratory. The RP must ensure the continued competency of laboratory staff by documenting their in-service training, reviewing their work performance, and verifying their skills.
(c) Maintain a complete and current SOP manual that is available to all personnel of the HHS-certified laboratory and ensure that it is followed. The SOP manual must be reviewed, signed, and dated by the RP(s) when procedures are first placed into use and when changed or when a new individual assumes responsibility for the management of the HHS-certified
(d) Maintain a quality assurance program that ensures the proper performance and reporting of all test results; verify and monitor acceptable analytical performance for all controls and calibrators; monitor quality control testing; and document the validity, reliability, accuracy, precision, and performance characteristics of each test and test system.
(e) Initiate and implement all remedial actions necessary to maintain satisfactory operation and performance of the HHS-certified laboratory in response to the following: quality control systems not within performance specifications; errors in result reporting or in analysis of performance testing samples; and inspection deficiencies. The RP must ensure that specimen results are not reported until all corrective actions have been taken and that the results provided are accurate and reliable.
The RP must have documented scientific qualifications in analytical toxicology.
Minimum qualifications are:
(a) Certification or licensure as a laboratory director by the state in forensic or clinical laboratory toxicology, a Ph.D. in one of the natural sciences, or training and experience comparable to a Ph.D. in one of the natural sciences with training and laboratory/research experience in biology, chemistry, and pharmacology or toxicology;
(b) Experience in forensic toxicology with emphasis on the collection and analysis of biological specimens for drugs of abuse;
(c) Experience in forensic applications of analytical toxicology (
(d) Fulfillment of the RP responsibilities and qualifications, as demonstrated by the HHS-certified laboratory's performance and verified upon interview by HHS-trained inspectors during each on-site inspection; and
(e) Qualify as a certifying scientist.
(a) HHS-certified laboratories must have multiple RPs or one RP and an alternate RP. If the RP(s) are concurrently absent, an alternate RP must be present and qualified to fulfill the responsibilities of the RP.
(1) If an HHS-certified laboratory is without the RP and alternate RP for 14 calendar days or less (
(2) The Secretary, in accordance with these Guidelines, will suspend a laboratory's HHS certification for all specimens if the laboratory does not have an RP or alternate RP for a period of more than 14 calendar days. The suspension will be lifted upon the Secretary's approval of a new permanent RP or alternate RP.
(b) If the RP leaves an HHS-certified laboratory:
(1) The HHS-certified laboratory may maintain certification and continue testing federally regulated specimens under the direction of an alternate RP for a period of up to 180 days while seeking to hire and receive the Secretary's approval of the RP's replacement.
(2) The Secretary, in accordance with these Guidelines, will suspend a laboratory's HHS certification for all federally regulated specimens if the laboratory does not have a permanent RP within 180 days. The suspension will be lifted upon the Secretary's approval of the new permanent RP.
(c) To nominate an individual as an RP or alternate RP, the HHS-certified laboratory must submit the following documents to the Secretary: the candidate's current resume or curriculum vitae, copies of diplomas and licensures, a training plan (not to exceed 90 days) to transition the candidate into the position, an itemized comparison of the candidate's qualifications to the minimum RP qualifications described in the Guidelines, and have official academic transcript(s) submitted from the candidate's institution(s) of higher learning. The candidate must be found qualified during an on-site inspection of the HHS-certified laboratory.
(d) The HHS-certified laboratory must fulfill additional inspection and PT criteria as required prior to conducting federally regulated testing under a new RP.
(a) A certifying scientist must have:
(1) At least a bachelor's degree in the chemical or biological sciences or medical technology, or equivalent;
(2) Training and experience in the analytical methods and forensic procedures used by the HHS-certified laboratory relevant to the results that the individual certifies; and
(3) Training and experience in reviewing and reporting forensic test results and maintaining chain of custody, and an understanding of appropriate remedial actions in response to problems that may arise.
(b) A certifying technician must have:
(1) Training and experience in the analytical methods and forensic procedures used by the HHS-certified laboratory relevant to the results that the individual certifies; and
(2) Training and experience in reviewing and reporting forensic test results and maintaining chain of custody, and an understanding of appropriate remedial actions in response to problems that may arise.
(a) All HHS-certified laboratory staff (
(b) Each individual working in an HHS-certified laboratory must be properly trained (
(a) An HHS-certified laboratory must control access to the drug testing facility, specimens, aliquots, and records.
(b) Authorized visitors must be escorted at all times, except for individuals conducting inspections (
(c) An HHS-certified laboratory must maintain records documenting the identity of the visitor and escort, date, time of entry and exit, and purpose for access to the secured area.
(a) HHS-certified laboratories must use chain of custody procedures (internal and external) to maintain control and accountability of specimens from the time of receipt at the laboratory through completion of testing, reporting of results, during storage, and continuing until final disposition of the specimens.
(b) HHS-certified laboratories must use chain of custody procedures to document the handling and transfer of aliquots throughout the testing process until final disposal.
(c) The chain of custody must be documented using either paper copy or electronic procedures.
(d) Each individual who handles a specimen or aliquot must sign and complete the appropriate entries on the chain of custody form when the specimen or aliquot is handled or transferred, and every individual in the chain must be identified.
(e) The date and purpose must be recorded on an appropriate chain of custody form each time a specimen or aliquot is handled or transferred.
(a) An initial drug test may be:
(1) An immunoassay or
(2) An alternate technology (
(b) An HHS-certified laboratory must validate an initial drug test before testing specimens.
(c) Initial drug tests must be accurate and reliable for the testing of specimens when identifying drugs or their metabolites.
(d) An HHS-certified laboratory may conduct a second initial drug test using a method with different specificity, to rule out cross-reacting compounds. This second initial drug test must satisfy the batch quality control requirements specified in Section 11.11.
(a) An HHS-certified laboratory must demonstrate and document the following for each initial drug test:
(1) The ability to differentiate negative specimens from those requiring further testing;
(2) The performance of the test around the cutoff, using samples at several concentrations between 0 and 150 percent of the cutoff;
(3) The effective concentration range of the test (linearity);
(4) The potential for carryover;
(5) The potential for interfering substances; and
(6) The potential matrix effects if using an alternate technology.
(b) Each new lot of reagent must be verified prior to being placed into service.
(c) Each initial drug test using an alternate technology must be re-verified periodically or at least annually.
(a) Each batch of specimens must contain the following controls:
(1) At least one control certified to contain no drug or drug metabolite;
(2) At least one positive control with the drug or drug metabolite targeted at a concentration 25 percent above the cutoff;
(3) At least one control with the drug or drug metabolite targeted at a concentration 75 percent of the cutoff; and
(4) At least one control that appears as a donor specimen to the analysts.
(b) Calibrators and controls must total at least 10 percent of the aliquots analyzed in each batch.
(a) The analytical method must use mass spectrometric identification (
(b) A confirmatory drug test must be validated before it can be used to test federally regulated specimens.
(c) Confirmatory drug tests must be accurate and reliable for the testing of an oral fluid specimen when identifying and quantifying drugs or their metabolites.
(a) An HHS-certified laboratory must demonstrate and document the following for each confirmatory drug test:
(1) The linear range of the analysis;
(2) The limit of detection;
(3) The limit of quantification;
(4) The accuracy and precision at the cutoff;
(5) The accuracy (bias) and precision at 40 percent of the cutoff;
(6) The potential for interfering substances;
(7) The potential for carryover; and
(8) The potential matrix effects if using liquid chromatography coupled with mass spectrometry.
(b) Each new lot of reagent must be verified prior to being placed into service.
(c) HHS-certified laboratories must re-verify each confirmatory drug test method periodically or at least annually.
(a) At a minimum, each batch of specimens must contain the following calibrators and controls:
(1) A calibrator at the cutoff;
(2) At least one control certified to contain no drug or drug metabolite;
(3) At least one positive control with the drug or drug metabolite targeted at 25 percent above the cutoff; and
(4) At least one control targeted at or less than 40 percent of the cutoff.
(b) Calibrators and controls must total at least 10 percent of the aliquots analyzed in each batch.
An HHS-certified laboratory may perform specimen validity tests in accordance with Sections 3.1 and 3.5.
(a) Each invalid, adulterated, or substituted specimen validity test result must be based on an initial specimen validity test on one aliquot and a confirmatory specimen validity test on a second aliquot;
(b) The HHS-certified laboratory must establish acceptance criteria and analyze calibrators and controls as appropriate to verify and document the validity of the test results; and
(c) Controls must be analyzed concurrently with specimens.
An HHS-certified laboratory must demonstrate and document for each specimen validity test the appropriate performance characteristics of the test, and must re-verify the test periodically, or at least annually. Each new lot of reagent must be verified prior to being placed into service.
(a) Laboratories must report a test result to the agency's MRO within an average of 5 working days after receipt of the specimen. Reports must use the Federal CCF and/or an electronic report, as described in items o and p below.
(b) A primary (A) specimen is reported negative when each initial drug test is negative or if the specimen is negative upon confirmatory drug testing, and the specimen does not meet invalid criteria as described in Section 11.17(g)(1) through (5).
(c) A primary (A) specimen is reported positive for a specific drug or drug metabolite when both the initial drug test is positive and the confirmatory drug test is positive in accordance with the cutoffs listed in the drug testing panel.
(d) A primary (A) oral fluid specimen is reported adulterated when the presence of an adulterant is verified using an initial test on the first aliquot and a different confirmatory test on the second aliquot.
(e) A primary (A) oral fluid specimen is reported substituted when a biomarker is not present or is present at a concentration inconsistent with that established for human oral fluid.
(f) For a specimen that has an invalid result for one of the reasons stated in Section 11/17(g)(1) through (5), the HHS-certified laboratory shall contact the MRO and both will decide if testing by another HHS-certified laboratory would be useful in being able to report a positive, adulterated, or substituted result. If no further testing is necessary, the HHS-certified laboratory then reports the invalid result to the MRO.
(g) A primary (A) oral fluid specimen is reported as an invalid result when:
(1) Interference occurs on the initial drug tests on two separate aliquots (
(2) Interference with the confirmatory drug test occurs on at least two separate aliquots of the specimen and the HHS-certified laboratory is unable to identify the interfering substance;
(3) The physical appearance of the specimen is such that testing the specimen may damage the laboratory's instruments;
(4) The physical appearances of the A and B specimens are clearly different (note: A is tested); or
(5) A specimen validity test on two separate aliquots of the specimen indicates that the specimen is not valid for testing.
(h) An HHS-certified laboratory shall reject a primary (A) specimen for testing when a fatal flaw occurs as described in Section 15.1 or when a correctable flaw as described in Section 15.2 is not recovered. The HHS-certified laboratory will indicate on the Federal CCF that the specimen was rejected for testing and provide the reason for reporting the rejected for testing result.
(i) An HHS-certified laboratory must report all positive, adulterated, substituted, and invalid test results for an oral fluid specimen. For example, a specimen can be positive for a drug and adulterated.
(j) An HHS-certified laboratory must report the confirmatory concentration of each drug or drug metabolite reported for a positive result.
(k) An HHS-certified laboratory must report numerical values of the specimen validity test results that support an adulterated, substituted, or invalid result (as appropriate).
(l) An HHS-certified laboratory must report results using the HHS-specified nomenclature published with the drug and biomarker testing panels.
(m) When the concentration of a drug or drug metabolite exceeds the validated linear range of the confirmatory test, HHS-certified laboratories may report to the MRO that the quantitative value exceeds the linear range of the test or that the quantitative value is greater than “insert the actual value for the upper limit of the linear range,” or laboratories may report a quantitative value above the upper limit of the linear range that was obtained by diluting an aliquot of the specimen to achieve a result within the method's linear range and multiplying the result by the appropriate dilution factor.
(n) HHS-certified laboratories may transmit test results to the MRO by various electronic means (
(o) HHS-certified laboratories must fax, courier, mail, or electronically transmit a legible image or copy of the completed Federal CCF and/or forward a computer-generated electronic report. The computer-generated report must contain sufficient information to ensure that the test results can accurately represent the content of the custody and control form that the MRO received from the collector.
(p) For positive, adulterated, substituted, invalid, and rejected specimens, laboratories must fax, courier, mail, or electronically transmit a legible image or copy of the completed Federal CCF.
(a) An HHS-certified laboratory must retain specimens that were reported as positive, adulterated, substituted, or as an invalid result for a minimum of 1 year.
(b) Retained oral fluid specimens must be kept in secured storage in accordance with the collection device manufacturer's specifications (
(c) Federal agencies may request that the HHS-certified laboratory retain a specimen for an additional specified period of time and must make that request within the 1-year period following the laboratory's reporting of the specimen.
(a) An HHS-certified laboratory must retain all records generated to support test results for at least 2 years. The laboratory may convert hardcopy records to electronic records for storage and then discard the hardcopy records after 6 months.
(b) A Federal agency may request the HHS-certified laboratory to maintain a documentation package (as described in Section 11.21) that supports the chain of custody, testing, and reporting of a donor's specimen that is under legal challenge by a donor. The Federal agency's request to the laboratory must be in writing and must specify the period of time to maintain the documentation package.
(c) An HHS-certified laboratory may retain records other than those included in the documentation package beyond the normal 2-year period of time.
(a) HHS-certified laboratories must provide to each Federal agency for which they perform testing a semiannual statistical summary report that must be submitted by mail, fax, or email within 14 working days after the end of the semiannual period. The summary report must not include any personally identifiable information. A copy of the semiannual statistical summary report will also be sent to the Secretary or designated HHS representative. The semiannual statistical report contains the following information:
(1) Reporting period (inclusive dates);
(2) HHS-certified laboratory name and address;
(3) Federal agency name;
(4) Number of specimen results reported;
(5) Number of specimens collected by reason for test;
(6) Number of specimens reported negative;
(7) Number of specimens rejected for testing because of a fatal flaw;
(8) Number of specimens rejected for testing because of an uncorrected flaw;
(9) Number of specimens tested positive by each initial drug test;
(10) Number of specimens reported positive;
(11) Number of specimens reported positive for each drug and drug metabolite;
(12) Number of specimens reported adulterated;
(13) Number of specimens reported substituted; and
(14) Number of specimens reported as invalid result.
(b) An HHS-certified laboratory must make copies of an agency's test results available when requested to do so by the Secretary or by the Federal agency for which the laboratory is performing drug-testing services.
(c) An HHS-certified laboratory must ensure that a qualified individual is available to testify in a proceeding against a Federal employee when the proceeding is based on a test result reported by the laboratory.
(a) Following a Federal agency's receipt of a positive, adulterated, or substituted drug test report, the Federal agency may submit a written request for copies of the records relating to the drug test results or a documentation package or any relevant certification, review, or revocation of certification records.
(b) Standard documentation packages provided by an HHS-certified laboratory must contain the following items:
(1) A cover sheet providing a brief description of the procedures and tests performed on the donor's specimen;
(2) A table of contents that lists all documents and materials in the package by page number;
(3) A copy of the Federal CCF with any attachments, internal chain of custody records for the specimen, memoranda (if any) generated by the HHS-certified laboratory, and a copy of the electronic report (if any) generated by the HHS-certified laboratory;
(4) A brief description of the HHS-certified laboratory's initial drug (and specimen validity, if applicable) testing procedures, instrumentation, and batch quality control requirements;
(5) Copies of the initial test data for the donor's specimen with all calibrators and controls and copies of all internal chain of custody documents related to the initial tests;
(6) A brief description of the HHS-certified laboratory's confirmatory drug (and specimen validity, if applicable) testing procedures, instrumentation, and batch quality control requirements;
(7) Copies of the confirmatory test data for the donor's specimen with all calibrators and controls and copies of all internal chain of custody documents related to the confirmatory tests; and
(8) Copies of the résumé or curriculum vitae for the RP(s) and the certifying technician or certifying scientist of record.
Federal applicants or employees who are subject to a workplace drug test may submit a written request through the MRO and/or the Federal agency requesting copies of any records relating to their drug test results or a documentation package as described in Section 11.21(b) and any relevant certification, review, or revocation of certification records. Federal applicants or employees, or their designees, are not permitted access to their specimens collected pursuant to Executive Order 12564, Public Law 100-71, and these Guidelines.
An HHS-certified laboratory must not enter into any relationship with a Federal agency's MRO that may be construed as a potential conflict of interest or derive any financial benefit by having a Federal agency use a specific MRO.
This means an MRO may be an employee of the agency or a contractor for the agency; however, an MRO shall not be an employee or agent of or have any financial interest in the HHS-certified laboratory for which the MRO is reviewing drug testing results. Additionally, an MRO shall not derive any financial benefit by having an agency use a specific HHS-certified laboratory or have any agreement with an HHS-certified laboratory that may be construed as a potential conflict of interest.
No, only HHS-certified laboratories are authorized to test oral fluid specimens for Federal agency workplace drug testing programs in accordance with these Guidelines.
(a) A currently licensed physician who has:
(1) A Doctor of Medicine (M.D.) or Doctor of Osteopathy (D.O.) degree;
(2) Knowledge regarding the pharmacology and toxicology of illicit drugs;
(3) The training necessary to serve as an MRO as set out in Section 13.3;
(4) Satisfactorily passed an initial examination administered by a nationally recognized entity or a subspecialty board that has been approved by the Secretary to certify MROs; and
(5) At least every five years from initial certification, completed requalification training on the topics in Section 13.3 and satisfactorily passed a requalification examination administered by a nationally recognized entity or a subspecialty board that has been approved by the Secretary to certify MROs.
All nationally recognized entities or subspecialty boards which seek approval by the Secretary to certify physicians as MROs for Federal workplace drug testing programs must submit their qualifications, a sample examination, and other necessary supporting examination materials (
(a) A physician must receive training that includes a thorough review of the following:
(1) The collection procedures used to collect Federal agency specimens;
(2) How to interpret test results reported by HHS-certified IITFs and laboratories (
(3) Chain of custody, reporting, and recordkeeping requirements for Federal agency specimens;
(4) The HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs for all authorized specimen types; and
(5) Procedures for interpretation, review (
(b) Certified MROs must complete training on any revisions to these Guidelines including any changes to the drug and biomarker testing panels prior to their effective date, to continue serving as an MRO for Federal agency specimens.
(a) The MRO must review all positive, adulterated, rejected for testing, invalid, and substituted test results.
(b) Staff under the direct, personal supervision of the MRO may review and report negative and (for urine) negative/dilute test results to the agency's designated representative. The MRO must review at least 5 percent of all negative results reported by the MRO staff to ensure that the MRO staff are properly performing the review process.
(c) The MRO must discuss potential invalid results with the HHS-certified laboratory, as addressed in Section 11.17(f) to determine whether testing at another HHS-certified laboratory may be warranted.
(d) After receiving a report from an HHS-certified laboratory or (for urine) HHS-certified IITF, the MRO must:
(1) Review the information on the MRO copy of the Federal CCF that was received from the collector and the report received from the HHS-certified laboratory or HHS-certified IITF;
(2) Interview the donor when required;
(3) Make a determination regarding the test result; and
(4) Report the verified result to the Federal agency.
(e) The MRO must maintain records for a minimum of two years while maintaining the confidentiality of the information. The MRO may convert hardcopy records to electronic records for storage and discard the hardcopy records after six months.
(f) The MRO must conduct a medical examination or a review of the examining physician's findings and make a determination of refusal to test or cancelled test when a collector reports that the donor was unable to provide a specimen and an alternate specimen was not collected, as addressed in Sections 8.6 and 13.6.
(a) When the HHS-certified laboratory reports a negative result for the primary (A) specimen, the MRO reports a negative result to the agency.
(b) When the HHS-certified laboratory reports multiple results for the primary (A) specimen, the MRO must follow the verification procedures described in Section 13.5(c) through (f) and:
(1) The MRO reports all verified positive and/or refusal to test results to the Federal agency.
(2) If an invalid result was reported in conjunction with a positive, adulterated, or substituted result, the MRO does not report the verified invalid result to the Federal agency at this time. The MRO takes action for the verified invalid result(s) for the primary (A) specimen as described in Section 13.5(e) only when:
(i) The MRO verifies the positive, adulterated, or substituted result as negative based on a legitimate medical explanation as described in Section 13.5(c)(2) and (d)(1), or based on codeine and/or morphine concentrations less than 150 ng/mL as described in Section 13.5(c)(3)(i); or
(ii) The split (B) specimen is tested and reported as a failure to reconfirm the positive, adulterated or substituted result reported for the primary (A) specimen as described in Section 14.6(m).
(c) When the HHS-certified laboratory reports a positive result for the primary (A) specimen, the MRO must contact the donor to determine if there is any legitimate medical explanation for the positive result.
(1) If the donor admits unauthorized use of the drug(s) that caused the positive result, the MRO reports the test result as positive to the agency. The MRO must document the donor's admission of unauthorized drug use in the MRO records and in the MRO's report to the Federal agency.
(2) If the donor provides documentation (
(i) Passive exposure to a drug (
(ii) Ingestion of food products containing a drug (
(iii) A physician's authorization or medical recommendation for a Schedule 1 controlled substance is not a legitimate medical explanation for a positive drug test result.
(3) If the donor is unable to provide a legitimate medical explanation for the positive result, the MRO reports the positive result to the agency, for all drugs except codeine and/or morphine as follows:
(i) For codeine and/or morphine less than 150 ng/mL, the MRO must report the result as negative to the agency, unless the donor admits unauthorized use of the drug(s) that caused the positive result as described in Section 13.5(c)(1).
(ii) For codeine and/or morphine equal to or greater than 150 ng/mL and no legitimate medical explanation, the MRO shall report a positive result to the agency. Consumption of food products must not be considered a legitimate medical explanation for the donor having morphine or codeine at or above this concentration.
(d) When the HHS-certified laboratory reports an adulterated or substituted result for the primary (A) oral fluid specimen, the MRO contacts the donor to determine if the donor has a legitimate medical explanation for the adulterated or substituted result.
(1) If the donor provides a legitimate medical explanation, the MRO reports a negative result to the Federal agency.
(2) If the donor is unable to provide a legitimate medical explanation, the MRO reports a refusal to test to the Federal agency because the oral fluid specimen was adulterated or substituted.
(e) When the HHS-certified laboratory reports an invalid result for the primary (A) oral fluid specimen, the MRO must contact the donor to determine if there is a legitimate explanation for the invalid result.
(1) If the donor provides a legitimate explanation (
(2) If the donor is unable to provide a legitimate explanation, the MRO reports a test cancelled result with the reason for the invalid result and directs the Federal agency to immediately collect another specimen from the donor.
(i) If the second specimen collected provides a valid result, the MRO follows the procedures in Section 13.5(a) through (d).
(ii) If the second specimen collected provides an invalid result, the MRO reports this specimen as test cancelled and recommends that the agency collect another authorized specimen type (
(f) When the HHS-certified laboratory reports a rejected for testing result for the primary (A) specimen, the MRO reports a test cancelled result to the agency and recommends that the agency collect another specimen from the donor.
(a) When another specimen type (
(b) When the Federal agency did not authorize the collection of an alternate specimen, the MRO consults with the Federal agency. The Federal agency immediately directs the donor to obtain, within five days, an evaluation from a licensed physician, acceptable to the MRO, who has expertise in the medical issues raised by the donor's failure to provide a specimen. The MRO may perform this evaluation if the MRO has appropriate expertise.
(1) For purposes of this section, a medical condition includes an ascertainable physiological condition. Permanent or long-term medical conditions are those physiological, anatomic, or psychological abnormalities documented as being present prior to the attempted collection, and considered not amenable to correction or cure for an extended period of time.
(2) As the MRO, if another physician will perform the evaluation, you must provide the other physician with the following information and instructions:
(i) That the donor was required to take a federally regulated drug test, but was unable to provide a sufficient amount of oral fluid to complete the test;
(ii) The consequences of the appropriate Federal agency regulation for refusing to take the required drug test;
(iii) That, after completing the evaluation, the referral physician must agree to provide a written statement to the MRO with a recommendation for one of the determinations described in Section 13.6(b)(3) and the basis for the recommendation. The statement must not include detailed information on the employee's medical condition beyond what is necessary to explain the referral physician's conclusion.
(3) As the MRO, if another physician performed the evaluation, you must consider and assess the referral physician's recommendations in making your determination. You must make one of the following determinations and report it to the Federal agency in writing:
(i) A medical condition as defined in Section 13.6(b)(1) has, or with a high degree of probability could have, precluded the employee from providing a sufficient amount of oral fluid, but is not a permanent or long-term disability. As the MRO, you must report a test cancelled result to the Federal agency.
(ii) A permanent or long-term medical condition as defined in Section 13.6(b)(1) has, or with a high degree of probability could have, precluded the employee from providing a sufficient amount of oral fluid and is highly likely to prevent the employee from providing a sufficient amount of oral fluid for a very long or indefinite period of time. As the MRO, you must follow the requirements of Section 13.7, as appropriate. If Section 13.7 is not applicable, you report a test cancelled result to the Federal agency and recommend that the agency authorize collection of an alternate specimen type (
(iii) There is not an adequate basis for determining that a medical condition has or, with a high degree of probability, could have precluded the employee from providing a sufficient amount of oral fluid. As the MRO, you must report a refusal to test to the Federal agency.
(4) When a Federal agency receives a report from the MRO indicating that a test is cancelled as provided in Section 13.6(b)(3)(i), the agency takes no further action with respect to the donor. When a test is canceled as provided in Section 13.6(b)(3)(ii), the agency takes no further action with respect to the donor other than designating collection of an alternate specimen type (
(a) This section concerns a situation in which the donor has a medical condition that precludes the donor from providing a sufficient specimen for a Federal agency applicant/pre-employment test, a follow-up test, or a return-to-duty test and the condition involves a permanent or long-term disability and the Federal agency does not authorize collection of an alternate specimen. As the MRO in this situation, you must do the following:
(1) You must determine if there is clinical evidence that the individual is an illicit drug user. You must make this determination by personally conducting, or causing to be conducted, a medical evaluation and through consultation with the donor's physician and/or the physician who conducted the evaluation under Section 13.6.
(2) If you do not personally conduct the medical evaluation, you must ensure that one is conducted by a licensed physician acceptable to you.
(b) If the medical evaluation reveals no clinical evidence of drug use, as the MRO, you must report the result to the Federal agency as a negative test with written notations regarding results of both the evaluation conducted under Section 13.6 and any further medical examination. This report must state the basis for the determination that a permanent or long-term medical condition exists, making provision of a sufficient oral fluid specimen
(c) If the medical evaluation reveals clinical evidence of drug use, as the MRO, you must report the result to the Federal agency as a cancelled test with written notations regarding results of both the evaluation conducted under Section 13.6 and any further medical examination. This report must state that a permanent or long-term medical condition [as defined in Section 13.6(b)(1)] exists, making provision of a sufficient oral fluid specimen impossible, and state the reason for the determination that signs and symptoms of drug use exist. Because this is a cancelled test, it does not serve the purposes of a negative test (
(a) The MRO must report all verified results to an agency using the completed MRO copy of the Federal CCF or a separate report using a letter/memorandum format. The MRO may use various electronic means for reporting (
(b) A verified result may not be reported to the agency until the MRO has completed the review process.
(c) The MRO must send a copy of either the completed MRO copy of the Federal CCF or the separate letter/memorandum report for all positive, adulterated, and substituted results.
(d) The MRO must not disclose numerical values of drug test results to the agency.
(e) The MRO must report drug test results using the HHS-specified nomenclature published with the drug and biomarker testing panels.
(a) For a positive, adulterated, or substituted result reported on a primary (A) specimen, a donor may request through the MRO that the split (B) specimen be tested by a second HHS-certified laboratory to verify the result reported by the first HHS-certified laboratory.
(b) The donor has 72 hours from the time the MRO notified the donor that the donor's specimen was reported positive, adulterated, or substituted to request a test of the split (B) specimen. The MRO must inform the donor that the donor has the opportunity to request a test of the split (B) specimen when the MRO informs the donor that a positive, adulterated, or substituted result is being reported to the Federal agency on the primary (A) specimen.
An MRO must not be an employee, agent of, or have any financial interest in an HHS-certified laboratory for which the MRO is reviewing drug test results.
This means an MRO must not derive any financial benefit by having an agency use a specific HHS-certified laboratory, or have any agreement with the HHS-certified laboratory that may be construed as a potential conflict of interest.
(a) An MRO must send to the Secretary or designated HHS representative a semiannual report of Federal agency specimens that were reported as positive for a drug or drug metabolite by a laboratory and verified as negative by the MRO. The report must not include any personally identifiable information for the donor and must be submitted by mail, fax, or other secure electronic transmission method within 14 working days after the end of the semiannual period (
(1) Reporting period (inclusive dates);
(2) MRO name, company name, and address;
(3) Federal agency name; and
(4) For each laboratory-reported positive drug test result that was verified as negative by the MRO:
(i) Specimen identification number;
(ii) Laboratory name and address;
(iii) Positive drug(s) or drug metabolite(s) verified as negative;
(iv) MRO reason for verifying the positive drug(s) or drug metabolite(s) as negative (
(v) All results reported to the Federal agency by the MRO for the specimen; and
(vi) Date of the MRO report to the Federal agency.
(b) An MRO must provide copies of the drug test reports that the MRO has sent to a Federal agency when requested to do so by the Secretary.
(c) If an MRO did not verify any positive laboratory results as negative during the reporting period, the MRO should file a report that states that the MRO has no reportable results during the applicable reporting period.
(a) Before allowing an individual to serve as an MRO for the agency, a Federal agency must verify and document the following:
(1) that the individual satisfies all requirements in Section 13.1, including certification by an MRO certification organization that has been approved by the Secretary, as described in Section 13.2; and
(2) that the individual is not an employee, agent of, or have any financial interest in an HHS-certified laboratory that tests the agency's specimens, as described in Section 13.10.
(b) The Federal agency must verify and document that each MRO reviewing and reporting results for the agency:
(1) completes training on any revisions to these Guidelines, including any changes to the drug and biomarker testing panels, prior to their effective date;
(2) at least every five years, maintains their certification by completing requalification training and passing a requalification examination; and
(3) provides biannual reports to the Secretary or designated HHS representative as required in Section 13.11;
(c) The Federal agency must ensure that each MRO reports drug test results to the agency in accordance with Sections 13.8 and 14.7.
(1) Before allowing an MRO to report results electronically, the agency must obtain documentation from the MRO to confirm that the MRO and any external service providers ensure the confidentiality, integrity, and availability of the data and limit access to any data transmission, storage, and retrieval system.
(a) The donor may request, verbally or in writing, through the MRO that the split (B) oral fluid specimen be tested at a different (
(b) A donor has 72 hours to initiate the request after being informed of the result by the MRO. The MRO must document in the MRO's records the verbal request from the donor to have the split (B) specimen tested.
(c) If a split (B) oral fluid specimen cannot be tested by a second HHS-certified laboratory (
(d) If a donor chooses not to have the split (B) specimen tested by a second HHS-certified oral fluid laboratory, a Federal agency may have a split (B) specimen retested as part of a legal or administrative proceeding to defend an original positive, adulterated, or substituted result.
(a) The testing of a split (B) specimen for a drug or metabolite is not subject to the testing cutoffs established.
(b) The HHS-certified laboratory is only required to confirm the presence of the drug or metabolite that was reported positive in the primary (A) specimen.
(a) The HHS-certified laboratory must use its confirmatory specimen validity test at an established LOQ to reconfirm the presence of the adulterant.
(b) The second HHS-certified laboratory may only conduct the confirmatory specimen validity test(s) needed to reconfirm the adulterated result reported by the first HHS-certified laboratory.
The second HHS-certified laboratory may only conduct the confirmatory biomarker test(s) needed to reconfirm the substituted result reported by the first HHS-certified laboratory.
The second HHS-certified laboratory must report the result to the MRO using the HHS-specified nomenclature published with the drug and biomarker testing panels.
The MRO takes the following actions when the second HHS-certified laboratory reports the result for the split (B) oral fluid specimen as:
(a)
(b)
(c)
(1) If the primary (A) specimen's test results confirm that the specimen was substituted, the MRO reports a refusal to test (substituted) to the agency.
(2) If the primary (A) specimen's results fail to confirm that the specimen was substituted, the MRO cancels both tests and directs the agency to immediately collect another specimen using a direct observed collection procedure. The MRO shall notify the HHS office responsible for coordination of the drug-free workplace program about the failed to reconfirm and cancelled test.
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(m)
(n)
(o)
(p)
(q)
(r)
(a) The MRO must report all verified results to an agency using the completed MRO copy of the Federal CCF or a separate report using a letter/memorandum format. The MRO may use various electronic means for reporting (
(b) A verified result may not be reported to the agency until the MRO has completed the review process.
(c) The MRO must send a copy of either the completed MRO copy of the Federal CCF or the separate letter/memorandum report for all split specimen results.
(d) The MRO must not disclose the numerical values of the drug test results to the agency.
(e) The MRO must report drug test results using the HHS-specified nomenclature published with the drug and biomarker testing panels.
A split (B) specimen is retained for the same period of time that a primary (A) specimen is retained and under the same storage conditions, in accordance with Section 11.18. This applies even for those cases when the split (B) specimen is tested by a second HHS-certified laboratory and the second HHS-certified laboratory does not confirm the original result reported by the first HHS-certified laboratory for the primary (A) specimen.
The following discrepancies are considered to be fatal flaws. The HHS-certified laboratory must stop the testing process, reject the specimen for testing, and indicate the reason for rejecting the specimen on the Federal CCF when:
(a) The specimen ID number on the primary (A) or split (B) specimen label/seal does not match the ID number on the Federal CCF, or the ID number is missing either on the Federal CCF or on either specimen label/seal;
(b) The primary (A) specimen label/seal is missing, misapplied, broken, or shows evidence of tampering and the split (B) specimen cannot be re-designated as the primary (A) specimen;
(c) The primary (A) specimen was collected using an expired device (
(d) The collector's printed name and signature are omitted on the Federal CCF;
(e) The collector failed to document observation of the volume indicator(s) at the time of collection for a collection device containing a diluent.
(f) There is an insufficient amount of specimen for analysis in the primary (A) specimen and the split (B) specimen cannot be re-designated as the primary (A) specimen;
(g) The accessioner failed to document the primary (A) specimen seal condition on the Federal CCF at the time of accessioning, and the split (B) specimen cannot be re-designated as the primary (A) specimen;
(h) The specimen was received at the HHS-certified laboratory without a CCF;
(i) The CCF was received at the HHS-certified laboratory without a specimen;
(j) The collector performed two separate collections using one CCF; or
(k) The HHS-certified laboratory identifies a flaw (other than those specified above) that prevents testing or affects the forensic defensibility of the drug test and cannot be corrected.
The following discrepancies are considered to be correctable:
(a) If a collector failed to sign the Federal CCF, the HHS-certified laboratory must hold the specimen and attempt to obtain a memorandum for record to recover the collector's signature. If, after holding the specimen for at least 5 business days, the HHS-certified laboratory cannot recover the collector's signature, the laboratory must report a rejected for testing result and indicate the reason for the rejected for testing result on the Federal CCF.
(b) If a specimen is submitted using a non-Federal form or an expired Federal CCF, the HHS-certified laboratory must test the specimen and also attempt to obtain a memorandum for record explaining why a non-Federal form or an expired Federal CCF was used and ensure that the form used contains all the required information. If, after holding the report for at least 5 business days, the HHS-certified laboratory cannot obtain a memorandum for record from the collector, the laboratory must report a rejected for testing result and indicate the reason for the rejected for testing result on the report to the MRO.
(a) The following omissions and discrepancies on the Federal CCF that are received by the HHS-certified laboratory should not cause an HHS-certified laboratory to reject an oral fluid specimen or cause an MRO to cancel a test:
(1) An incorrect laboratory name and address appearing at the top of the form;
(2) Incomplete/incorrect/unreadable employer name or address;
(3) MRO name is missing;
(4) Incomplete/incorrect MRO address;
(5) A transposition of numbers in the donor's Social Security Number or employee identification number;
(6) A telephone number is missing/incorrect;
(7) A fax number is missing/incorrect;
(8) A “reason for test” box is not marked;
(9) A “drug tests to be performed” box is not marked;
(10) The specimen type box (Oral Fluid) is not marked (
(11) A “collection” box is not marked;
(12) The “each device within expiration date” box is not marked;
(13) The collection site address is missing;
(14) The collector's printed name is missing but the collector's signature is properly recorded;
(15) The time of collection is not indicated;
(16) The date of collection is not indicated;
(17) Incorrect name of delivery service;
(18) The collector has changed or corrected information by crossing out the original information on either the Federal CCF or specimen label/seal without dating and initialing the change; or
(19) The donor's name inadvertently appears on the HHS-certified laboratory copy of the Federal CCF or on the tamper-evident labels used to seal the specimens.
(b) The following omissions and discrepancies on the Federal CCF that are made at the HHS-certified laboratory should not cause an MRO to cancel a test:
(1) The testing laboratory fails to indicate the correct name and address in the results section when a different laboratory name and address is printed at the top of the Federal CCF;
(2) The accessioner fails to print their name;
(3) The certifying scientist or certifying technician fails to print their name;
(4) The certifying scientist or certifying technician accidentally initials the Federal CCF rather than signing for a specimen reported as rejected for testing;
(c) The above omissions and discrepancies should occur no more than once a month. The expectation is that each trained collector and HHS-certified laboratory will make every effort to ensure that the Federal CCF is properly completed and that all the information is correct. When an error occurs more than once a month, the MRO must direct the collector or HHS-certified laboratory (whichever is responsible for the error) to immediately take corrective action to prevent the recurrence of the error.
(a) An MRO must attempt to correct the following errors:
(1) The donor's signature is missing on the MRO copy of the Federal CCF and the collector failed to provide a comment that the donor refused to sign the form;
(2) The certifying scientist failed to sign the Federal CCF for a specimen being reported drug positive, adulterated, invalid, or substituted; or
(3) The electronic report provided by the HHS-certified laboratory does not contain all the data elements required for the HHS standard laboratory electronic report for a specimen being reported drug positive, adulterated, invalid result, or substituted.
(b) If the error in Section 15.4(a)(1) occurs, the MRO must contact the collector to obtain a statement to verify that the donor refused to sign the MRO copy. If, after at least 5 business days, the collector cannot provide such a statement, the MRO must cancel the test.
(c) If the error in Section 15.4(a)(2) occurs, the MRO must obtain a statement from the certifying scientist that they forgot to sign the Federal CCF, but did, in fact, properly conduct the certification review. If, after at least 5 business days, the MRO cannot get a statement from the certifying scientist, the MRO must cancel the test.
(d) If the error in Section 15.4(a)(3) occurs, the MRO must contact the HHS-certified laboratory. If, after at least 5 business days, the laboratory does not retransmit a corrected electronic report, the MRO must cancel the test.
These procedures apply when:
(a) The Secretary has notified an HHS-certified laboratory in writing that its certification to perform drug testing
(b) The HHS-certified laboratory has, within 30 days of the date of such notification or within 3 days of the date of such notification when seeking an expedited review of a suspension, requested in writing an opportunity for an informal review of the suspension or proposed revocation.
The scope of review shall be limited to the facts relevant to any suspension or proposed revocation, the necessary interpretations of those facts, the relevant Mandatory Guidelines for Federal Workplace Drug Testing Programs, and other relevant law. The legal validity of these Guidelines shall not be subject to review under these procedures.
The appellant's request for review shall specify the name, address, and telephone number of the appellant's representative. In its first written submission to the reviewing official, the respondent shall specify the name, address, and telephone number of the respondent's representative.
(a) Within 30 days of the date of the notice of the suspension or proposed revocation, the appellant must submit a written request to the reviewing official seeking review, unless some other time period is agreed to by the parties. A copy must also be sent to the respondent. The request for review must include a copy of the notice of suspension or proposed revocation, a brief statement of why the decision to suspend or propose revocation is wrong, and the appellant's request for an oral presentation, if desired.
(b) Within 5 days after receiving the request for review, the reviewing official will send an acknowledgment and advise the appellant of the next steps. The reviewing official will also send a copy of the acknowledgment to the respondent.
Upon mutual agreement of the parties to hold these procedures in abeyance, the reviewing official will stay these procedures for a reasonable time while the laboratory attempts to regain compliance with the Guidelines or the parties otherwise attempt to settle the dispute. As part of an abeyance agreement, the parties can agree to extend the time period for requesting review of the suspension or proposed revocation. If abeyance begins after a request for review has been filed, the appellant shall notify the reviewing official at the end of the abeyance period, advising whether the dispute has been resolved. If the dispute has been resolved, the request for review will be dismissed. If the dispute has not been resolved, the review procedures will begin at the point at which they were interrupted by the abeyance agreement with such modifications to the procedures as the reviewing official deems appropriate.
The appellant and the respondent each participate in developing the file for the reviewing official and in submitting written arguments. The procedures for development of the review file and submission of written argument are:
(a)
(1) A review file containing the documents supporting appellant's argument, tabbed and organized chronologically, and accompanied by an index identifying each document. Only essential documents should be submitted to the reviewing official.
(2) A written statement, not to exceed 20 double-spaced pages, explaining why respondent's decision to suspend or propose revocation of appellant's certification is wrong (appellant's brief).
(b)
(1) A review file containing documents supporting respondent's decision to suspend or revoke appellant's certification to perform drug testing, which is tabbed and organized chronologically, and accompanied by an index identifying each document. Only essential documents should be submitted to the reviewing official.
(2) A written statement, not exceeding 20 double-spaced pages in length, explaining the basis for suspension or proposed revocation (respondent's brief).
(c)
(d)
(e)
(a)
(b)
(c)
(d)
(e)
(1)
(2)
(3)
(4)
(5)
(f)
(g)
(a)
(b)
(c)
(1) A review file containing essential documents relevant to the review, which is tabbed, indexed, and organized chronologically; and
(2) A written statement, not to exceed 20 double-spaced pages, explaining the party's position concerning the suspension and any proposed revocation. No reply brief is permitted.
(d)
(e)
(f)
Except for routine administrative and procedural matters, a party shall not communicate with the reviewing or presiding official without notice to the other party.
(a) Because of the importance of a timely review, the reviewing official should normally transmit written communications to either party by fax, secured electronic transmissions, or overnight mail in which case the date of transmission or day following mailing will be considered the date of receipt. In the case of communications sent by regular mail, the date of receipt will be considered 3 days after the date of mailing.
(b) In counting days, include Saturdays, Sundays, and Federal holidays. However, if a due date falls on
In addition to any other authority specified in these procedures, the reviewing official and the presiding official, with respect to those authorities involving the oral presentation, shall have the authority to issue orders; examine witnesses; take all steps necessary for the conduct of an orderly hearing; rule on requests and motions; grant extensions of time for good reasons; dismiss for failure to meet deadlines or other requirements; order the parties to submit relevant information or witnesses; remand a case for further action by the respondent; waive or modify these procedures in a specific case, usually with notice to the parties; reconsider a decision of the reviewing official where a party promptly alleges a clear error of fact or law; and to take any other action necessary to resolve disputes in accordance with the objectives of these procedures.
The administrative record of review consists of the review file; other submissions by the parties; transcripts or other records of any meetings, conference calls, or oral presentation; evidence submitted at the oral presentation; and orders and other documents issued by the reviewing and presiding officials.
(a)
(b)
(c)
Before any legal action is filed in court challenging the suspension or proposed revocation, respondent shall exhaust administrative remedies provided under this subpart, unless otherwise provided by Federal Law. The reviewing official's decision, under Section 16.9(e) or 16.14(a) constitutes final agency action and is ripe for judicial review as of the date of the decision.
Commodity Futures Trading Commission.
Notice of proposed rulemaking.
The Commodity Futures Trading Commission (Commission or CFTC) is proposing amendments to certain provisions of its regulations that would: update the Portfolio Requirement thresholds within the “Qualified Eligible Person” definition; require commodity pool operators (CPOs) and commodity trading advisors (CTAs) operating pools and trading programs under the applicable Commission regulations to provide certain minimum disclosures to their prospective pool participants and advisory clients; include revisions that are consistent with long-standing Commission exemptive letters addressing the timing of certain pools' periodic financial reporting; and several technical amendments related to the structure of the regulations that are the subject of this proposal.
Comments must be received by December 11, 2023.
You may submit comments, which must be in writing and identified by RIN 3038-AF25, by any of the following methods:
•
•
•
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
Amanda L. Olear, Director, 202-418-5283 or
As amended by the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act),
Generally, CEA section 4m(1) requires each person whose intermediary activities satisfy either the CPO or CTA definition to register as such with the CFTC.
Part 4 of the Commission's regulations specifically governs the operations and activities of CPOs and CTAs.
Regulation 4.7 provides exemptions from certain part 4 compliance requirements regarding disclosure, periodic reporting, and recordkeeping for registered CPOs and CTAs, whose prospective and actual pool participants and/or advisory services are restricted to individuals and entities considered “Qualified Eligible Persons,” and who claim the desired exemptions, pursuant to paragraph (d) of that section.
After a careful review of the existing language and structure of Regulation 4.7, and considering the clear public and regulatory interest of maintaining and modernizing older, but still widely utilized provisions, the Commission is issuing this Notice of Proposed Rulemaking (NPRM or Proposal) comprised of targeted amendments to update the regulation in several ways. In particular, the Commission is proposing amendments that would: (1) increase the financial thresholds in the Portfolio Requirement of the “Qualified Eligible Person” (QEP) definition in Regulation 4.7(a) to reflect inflation; (2) require certain minimum disclosures for 4.7 pools and trading programs operated and offered by CPOs and CTAs; (3) add a process under Regulation 4.7(b)(3) permitting CPOs to elect an alternative account statement schedule for certain 4.7 pools consistent with long-standing exemptive letters issued by the Commission;
As discussed above, Regulation 4.7 provides exemptions to CPOs and CTAs for their 4.7 pools and trading programs from various compliance, disclosure, and recordkeeping requirements within part 4 of the Commission's regulations, provided that their prospective and actual pool participants and advisory clients are restricted to QEPs. Regulation 4.7(a) bifurcates the definition of QEP into paragraphs (a)(2) and (a)(3) representing two different QEP categories: (1) those persons
Currently, the Portfolio Requirement contains two thresholds; if either (or some combination of the two) is satisfied by a person listed under Regulation 4.7(a)(3), then a CPO or CTA may consider them a QEP eligible to invest in the offered 4.7 pool or trading program. More specifically, a person can satisfy the Portfolio Requirement by: (1) owning securities (including pool participations) of issuers not affiliated with such person and other investments
The Portfolio Requirement has remained unchanged since its original adoption by the Commission in 1992.
The 1992 Proposed and Final Rules provide insight into the level of sophistication the Commission then considered necessary for natural persons (and other persons listed within Regulation 4.7(a)(3)) to qualify as QEPs. For example, in response to comments suggesting that the Commission not adopt any Portfolio Requirement, and instead rely solely on the parameters of the SEC's “accredited investor” definition, the Commission explicitly declined to do so.
In determining an appropriate increase for each threshold, the Commission preliminarily believes two inflation indexes published by the United States Bureau of Labor Statistics (BLS) are appropriate to consider. Specifically, the Commission consulted the Consumer Price Index for All Urban Consumers (CPI-U) and the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W).
Given these results, the Commission is proposing to update the Portfolio Requirement's thresholds by doubling the Securities Portfolio Test in Regulation 4.7(a)(1)(v)(A) to $4,000,000, and the Initial Margin and Premium Test in Regulation 4.7(a)(1)(v)(B) to $400,000. Although these figures do not match the results provided by the CPI-U and CPI-W indexes exactly, being slightly lower than the February 2023 buying power stated above, the Commission preliminarily believes that Portfolio Requirement thresholds rounded down to the nearest million and hundred thousand would be simpler for CPOs and CTAs relying on Regulation 4.7 to apply in determining if a prospective pool participant or advisory client is a QEP. Additionally, the Commission would continue to permit persons to meet the Portfolio Requirement through a combination of the two Portfolio Requirement thresholds as currently allowed under Regulation 4.7(a)(1)(v)(C), which would largely remain unchanged by this NPRM, except to update the example provided therein of how the two tests could be combined to reflect the higher proposed thresholds.
The Commission recognizes that these increases to the Portfolio Requirement will likely result in a certain portion of currently-qualifying QEPs no longer
The Commission solicits comment on these proposed increases to the Portfolio Requirement in the QEP definition. In addition, the Commission also seeks comment on the following:
1. Are the CPI-U and the CPI-W indexes the most appropriate for considering the impact of inflation on the thresholds within the Portfolio Requirement, and if they are not, what other suggested indexes or methods should the Commission consider using to assess inflationary effects?
2. The Commission is also seeking any data or information, from CPOs and CTAs that utilize Regulation 4.7, on the estimated number of advisory clients and pool participants that currently qualify as QEPs via the existing Portfolio Requirement, but would not so qualify if the increased monetary thresholds in the Portfolio Requirement described above are adopted.
3. How much time would CPOs and CTAs need to determine that their existing QEP pool participants and clients would continue to satisfy the increased Securities Portfolio or Initial Margin and Premium Tests, if adopted as proposed?
As stated above, Regulation 4.7 provides exemptions from the broader part 4 compliance requirements, including those regulations requiring disclosures of general and performance information about a pool or trading program, for CPOs with respect to pools offered solely to QEPs, and for CTAs advising or managing the accounts of QEPs. More specifically, Regulation 4.7(b)(2) provides an exemption for CPOs with respect to their pools offered solely to QEPs regarding: (1) the requirement to deliver a disclosure document in Regulation 4.21; (2) the general disclosures required by Regulation 4.24; (3) the performance disclosures required by Regulation 4.25; and (4) the use and amendment requirements in Regulation 4.26; so long as the CPO provides a form statement on the cover page of any offering memorandum it chooses to distribute to its prospective pool participants (or near the signature line of the pool's subscription agreement, if its CPO chooses not to distribute an offering memorandum).
At the time of Regulation 4.7's adoption in 1992, the Commission's rationale for providing these broad disclosure exemptions was, in part, based on the belief that QEPs are able to identify and obtain the information they deem necessary to evaluate the investment offered and thus that prescriptive rules imposing specific disclosure requirements are not essential.
In proposing Regulation 4.7, the Commission explained that, with respect to its oversight of CPOs and CTAs, it had endeavored to construct a regulatory framework that avoids unnecessary burdens without reducing investor protection and refined that framework as appropriate to respond to changing market conditions and to simplify and streamline the regulatory structure without creating regulatory
In 2014, staff in the Commission's Division of Swap Dealer and Intermediary Oversight (DSIO) convened a roundtable on the risk management practices of CPOs.
Moreover, particularly once their relationship with a CPO or CTA is established, QEPs of all types may have diminished power over time to demand the same level of information about their investments as they had received at the outset, due to the presence of lock-up periods or infrequently permitted redemptions that may require extended notice periods following initial investment.
In addition to the aforementioned concerns about the unequal bargaining power of QEPs, in the 30 years since that provision was adopted, the Commission has, as described above, witnessed a significant expansion and growth in the complexity and diversity of commodity interest products offered to QEPs via 4.7 pools and trading programs, as well as an expansion in the asset classes subject to the Commission's jurisdiction and oversight. Broadly speaking, since the CFTC's authority over swaps and the swap markets was expanded under the Dodd-Frank Act, there has been a considerable change in the way that swaps trade. For example, when Regulation 4.7 was adopted in 1992, swaps trading occurred over-the-counter and the total estimated size of the market was approximately $9T in today's dollars;
Although the Commission in 1992 considered the commodity interest products then available in developing existing customer protections for QEPs in Regulation 4.7, product innovation in the commodity interest markets has continued at a rapid and unrelenting pace
In addition to developments regarding products, market structure has also evolved in the years following the initial adoption of Regulation 4.7. Commodity pools and CTA advisory clients can access the futures markets either directly
Thus, given these developments in the commodity interest markets, among others, and similar to the circumstances underlying the 1992 Final Rule, with respect to Regulation 4.7, the Commission continues seeking to construct a regulatory framework that avoids unnecessary burdens without reducing investor protection and to respond to changing market conditions without creating regulatory gaps.
Importantly, the Commission does not intend this NPRM to dissuade registered CPOs and CTAs from structuring their pools and trading programs to qualify for and utilize the exemptions in Regulation 4.7. Rather, the Commission preliminarily believes that, as a result of the changing market conditions described above, an evolved approach to QEP Disclosures under Regulation 4.7 is necessary to ensure that QEPs consistently receive specific, baseline information with respect to their investments in the commodity interest markets, and further, that such proposed regulatory adjustments would not greatly reduce the benefits intermediaries currently derive from relying upon the relief in Regulation 4.7.
With this Proposal, the Commission is not proposing to rescind the disclosure exemptions in Regulations 4.7(b)(2) and (c)(1) in their entirety. Rather, the Commission aims to make targeted updates to these provisions that are designed to enhance customer protection, transparency, and fairness within the market of 4.7 pools and trading programs. The proposed amendments are intended to: (1) recognize the increasingly complex and diverse commodity interest investment products offered to QEPs today, and reflect the resulting evolution in view by the Commission that requiring basic disclosures to encourage informed investment decisions is the necessary and preferred approach for 4.7 pools and trading programs; (2) create a formalized Commission regulatory regime for promotional, advertising, and disclosure practices for CPOs and CTAs relying on Regulation 4.7 with respect to their QEP offerings, allowing for prospective and current participants and clients to better compare strategies, fees, and other characteristics of 4.7 pools and trading programs through consistent QEP Disclosures; and (3) strengthen intermediary oversight by incorporating the review of QEP Disclosures into existing examination processes used by the Commission and NFA, which, in turn, would increase their accuracy and quality over time.
By creating a formalized regulatory regime in part 4 for the promotional, advertising, and disclosure practices of CPOs and CTAs with respect to their 4.7 pools and trading programs, the Commission preliminarily believes that this would strengthen its oversight of CPOs and CTAs relying on Regulation 4.7 and that QEPs and the commodity interest markets overall would benefit as a result. The promotional, advertising, and disclosure practices of CPOs and CTAs utilizing Regulation 4.7 have changed a great deal since the original adoption of these exemptions. The Commission has observed that, despite there being no such requirements in Regulation 4.7, many CPOs and CTAs currently provide and distribute some disclosures and information regarding their 4.7 pools and trading programs to prospective QEP pool participants and advisory clients. These QEP Disclosures are commonly delivered in the form of private placement memoranda or trading program brochures, and typically include much of the information the Commission is proposing to require in this rule proposal. This practice results both from investor demand seeking to understand the 4.7 pools and trading programs offered in the current marketplace, as described above, as well as the requirements of other applicable regulatory regimes, like the Federal securities laws.
The Commission preliminarily believes that establishing minimum content requirements would ensure that existing QEP Disclosures are consistent in structure, accurate, kept up-to-date, and contain materially complete information regarding 4.7 pools and trading programs. As a result, current and prospective QEP participants and clients would be able to better compare investment programs, trading strategies, fees, and other characteristics of 4.7 pools and trading programs. Additionally, even if the QEP Disclosures provided by CPOs and CTAs relying upon Regulation 4.7 differ in form and detail, the minimum required disclosures proposed in this NPRM would result in all QEPs receiving the same level of basic information prior to making an investment decision. The Commission preliminarily concludes that replacing the existing broad exemptions with a targeted minimum disclosure regime under Regulation 4.7 will ultimately bring discipline to the current
Finally, the Commission believes that amending Regulation 4.7 to require CPOs and CTAs to disclose certain information about their 4.7 pools and trading programs, as well as to keep such QEP Disclosures as business records, would facilitate more effective oversight of registered CPOs and CTAs and their offerings by the Commission and NFA. The Commission expects that creating a formalized, affirmative regulatory requirement that materially accurate QEP Disclosures be delivered and kept current, would likely enhance investor confidence in commodity interest products generally by providing an increased level of transparency for the Commission and NFA into these registrants' activities for examination and enforcement purposes, thereby improving oversight.
The amendments proposed in this NPRM strike an appropriate balance, in the Commission's opinion, by establishing minimum content requirements for QEP Disclosures regarding 4.7 pools and trading programs, and mandating that they be kept as business records of the intermediary, while still retaining exemptions from the provisions of part 4 that require filing and pre-approval of non-4.7 Disclosure Documents by the Commission and NFA.
Among the existing disclosures outlined in part 4 for registered CPOs and CTAs not claiming Regulation 4.7, the Commission believes that both the general disclosures, as described in Regulations 4.24 and 4.34, and performance disclosures, as described in Regulations 4.25 and 4.35, form the foundational level of information about a pool's or advisory program's trading strategies, material risks, fees, and conflicts associated therewith; furthermore, the Commission preliminarily believes that disclosure by a CPO or CTA is the primary source of information a prospective or actual participant or client would rely upon to make an appropriately informed investment decision, even for those financially sophisticated persons who are QEPs. Specifically, the subset of general disclosures listed in Regulations 4.24 and 4.34 that the Commission is proposing to now be required for 4.7 pools and trading programs would provide prospective QEP pool participants and clients with important information on principal risk factors, investment programs, use of proceeds, custodians, fees and expenses, and conflicts of interest. The subset of performance disclosures from Regulations 4.25 and 4.35 that the Commission is proposing to require would further involve the presentation of vital current and past performance metrics in a format consistent with that already developed for non-QEP pool participants and advisory clients. Combined, the Commission intends the proposed addition of these disclosures to Regulation 4.7 to both provide appropriate customer protection safeguards and to support its intermediary oversight through methods that have been assessed and further developed since their adoption, nearly thirty years ago.
The Commission requests comment on all aspects of the proposed amendments outlined below that would require certain information be disclosed to prospective QEP pool participants and advisory clients under Regulation 4.7, that QEP Disclosures are regularly updated and materially complete, and that they be included in the business records of CPOs and CTAs claiming Regulation 4.7 exemptions. In addition, the Commission seeks comment on the following questions:
1. Should the Commission increase or decrease the types of information included in Proposed Regulations 4.7(b)(2) and (c)(1)? In particular, should additional disclosure requirements listed in Regulations 4.24 and 4.34 be included for CPOs and CTAs, respectively? If so, what disclosures?
2. The Commission is seeking specific data or information regarding: (i) the current number of CPOs and CTAs utilizing Regulation 4.7 that provide the proposed minimum disclosures to their QEP participants and clients; (ii) the level of disclosure currently provided by CPOs and CTAs to their QEP participants and clients; (iii) if disclosures are provided, the general format, tenor, and manner used in both structuring and delivering the disclosures; and (iv) the context and timing of when any such disclosures are provided (
3. What specific challenges would CPOs and CTAs face in complying with the disclosure requirements in Proposed Regulations 4.7(b)(2) and (c)(1)? Should the Commission consider an implementation period for the proposed amendments, and if so, how much time should the Commission allow for CPOs and CTAs to develop and prepare QEP Disclosures that would comply with the proposed amendments?
The following sections explain the proposed amendments in more detail.
The Commission is proposing to amend the disclosure relief outlined in Regulations 4.7(b)(2)(i) and (ii) to require CPOs to deliver to their 4.7 pools' prospective participants QEP Disclosures that enumerate certain specific disclosures, including descriptions of the 4.7 pool's principal risk factors, its investment program, use of proceeds, custodians, fees and expenses, conflicts of interest, and certain performance disclosures, including basic past performance information. As a consequence of requiring these minimum disclosures for 4.7 pools, the Commission is also proposing a corresponding amendment to remove the exemption from disclosing the past performance of 4.7 pools in the Disclosure Documents of non-4.7 pools. That provision had been proposed and adopted “in connection with” the previous policy position that 4.7 pools had no minimum or mandatory disclosure requirements,
As proposed, Regulation 4.7(b)(2)(i) would no longer provide an exemption from Regulation 4.21, and instead of requiring compliance with Regulations
Furthermore, it is crucial that QEP Disclosures used and distributed by CPOs be kept current and that they be maintained as business records to ensure compliance with the proposed general and performance disclosure requirements and to facilitate Commission and NFA oversight of these intermediaries. The Commission is therefore proposing to amend Regulation 4.7(b)(5) to require that QEP Disclosures be maintained among a CPO's other books and records for a 4.7 pool and made available to any representative of the Commission, NFA, or the U.S. Department of Justice in accordance with Regulation 1.31. This amendment would allow the Commission and NFA to review QEP Disclosures as part of routine examinations and civil enforcement actions. Finally, Proposed Regulation 4.7(b)(2)(i) no longer provides an exemption from Regulation 4.26 in its entirety; the Commission is proposing to restrict this exemption to Regulation 4.26(d) only, such that compliance with Regulations 4.26(a) through (c), provisions that generally govern the use and amendment of this information, would otherwise be required. Because the Commission is not proposing to require that QEP Disclosures for 4.7 pools be filed and approved by NFA prior to their first use, Proposed Regulation 4.7(b)(2)(i) retains an exemption from Regulation 4.26(d).
The Commission is proposing to add Proposed Regulation 4.7(b)(2)(i)(A) that would require QEP Disclosures distributed in connection with soliciting prospective participants in a 4.7 pool to include a description of the principal risk factors as required by Regulation 4.24(g). Specifically, Regulation 4.24(g) requires CPOs to describe, in their Disclosure Documents, the principal risk factors of a pool investment including, without limitation, risks relating to volatility, leverage, liquidity, counterparty creditworthiness, as applicable to the types of trading programs to be followed, trading structures to be employed and investment activity (including retail forex and swap transactions) expected to be engaged in by the offered pool.
The Commission is also proposing to require that QEP Disclosures include the information mandated by Regulation 4.24(h),
The Commission is also proposing to require that CPOs disclose information regarding their fees and expenses for their 4.7 pools in a manner consistent with Regulation 4.24(i). Regulation 4.24(i) requires CPOs to provide a complete description of each fee, commission, and other expense, which the CPO knows or should know has been incurred by the pool for its preceding fiscal year and is expected to be incurred by the pool in its current fiscal year, including fees and other expenses incurred in connection with the pool's participation in investee pools and funds.
The Commission is proposing to amend Regulation 4.7(b)(2)(i) to require the disclosure of conflicts of interest in QEP Disclosures for 4.7 pools, as required by Regulation 4.24(j). Regulation 4.24(j) requires CPOs to provide a full description of any actual or potential conflicts of interest
The Commission is further proposing to require CPOs to disclose certain performance information as required by Regulation 4.25 in the QEP Disclosures for their 4.7 pools. Specifically, the Commission is proposing to partially remove the existing complete exemption from Regulation 4.25 by requiring CPOs to disclose all performance information listed under Regulation 4.25 with respect to their 4.7 pools, with the exception of performance information for pools other than the 4.7 pool. Regulation 4.25 requires CPOs to include capsule performance information for both pools and accounts, subject to certain presentation and content requirements outlined in paragraph (a) of that section.
Consistent with the proposed amendments regarding additional disclosures for 4.7 pools discussed above, the Commission is also proposing to specifically enumerate additional disclosure requirements for 4.7 trading programs in Regulation 4.7(c)(1). Specifically, Proposed Regulation 4.7(c)(1)(i) would no longer provide an exemption from Regulation 4.31, and, in lieu of requiring compliance with Regulations 4.34 and 4.35 in their entirety, the Commission is proposing to enumerate specific disclosure requirements it wishes to prioritize for 4.7 trading programs. Proposed Regulation 4.7(c)(1)(i) would also include new paragraphs (c)(1)(i)(A) through (F) that list the specific disclosures the Commission is proposing to require for CTAs and their 4.7 trading programs, including descriptions of certain persons to be identified, the principal risk factors of the investment, the CTA's trading program, fees, conflicts of interest, and performance disclosures. The Commission also proposes to relocate the existing disclosure requirements in current Regulation 4.7(c)(2)(i) into Proposed Regulations 4.7(c)(2)(i)(G) and 4.7(c)(2)(i)(H). Proposed Regulation 4.7(c)(2)(i)(G) continues to require that QEP Disclosures provide all additional disclosures necessary to make the information contained therein, in the context in which it is furnished, not misleading, and Proposed Regulation 4.7(c)(2)(i)(H) continues to require a form statement like that currently required by Regulation 4.7(c)(1)(i).
Additionally, the Commission is proposing to remove the exemption from disclosing past performance of 4.7 trading programs in the Disclosure Documents of non-4.7 trading programs. That provision had been proposed and adopted in connection with the previous policy position that 4.7 trading programs offered by CTAs had no minimum or mandatory disclosure requirements for their prospective QEP advisory clients, which the Commission is proposing to change through this NPRM. Moreover, the Commission preliminarily believes such information would be valuable to all prospective CTA clients, regardless of their sophistication or experience, and therefore, proposes to require more complete disclosure of a CTA's programs, whether 4.7 or not, in Disclosure Documents provided to non-QEP advisory clients.
Further, as discussed in relation to 4.7 pools above, the Commission preliminarily believes that it is crucial that QEP Disclosures used by CTAs be maintained as business records of the CTA to ensure compliance with the general and performance disclosure requirements proposed in this NPRM and to facilitate Commission and NFA oversight of these intermediaries. Therefore, the Commission is also proposing to amend Regulation 4.7(c)(2), such that CTAs would be required to maintain the QEP Disclosures among the other books and records for their 4.7 trading programs, making them available to the Commission, NFA, and the U.S. Department of Justice, in accordance with Regulation 1.31. Finally, Proposed Regulation 4.7(c)(1)(i) would also no longer provide an exemption from Regulation 4.36 in its entirety; the Commission is proposing to restrict this exemption to Regulation 4.36(d) only, such that compliance with Regulations 4.36(a) through (c), provisions that generally govern the use and amendment of this information, would be required. Because the Commission is not proposing to require that QEP
The Commission is proposing to require that CTAs provide their prospective QEP clients with information on certain persons to be identified, as mandated by Regulation 4.34(e). Specifically, Regulation 4.34(e) requires CTAs to identify by name each principal of the CTA, the FCM and/or RFED with which the CTA will require its client to maintain an account, and the introducing broker through which the CTA will require the client to introduce its account (or, if the client is free to choose which FCM, RFED, or introducing broker it uses, then a statement to that effect).
The Commission is proposing to require that QEP Disclosures contain a discussion of the 4.7 trading program's principal risk factors, identical to that required by Regulation 4.34(g). Regulation 4.34(g) requires CTAs to discuss in their Disclosure Documents the principal risk factors of their trading programs, including, without limitation, risks due to volatility, leverage, liquidity, and counterparty creditworthiness, as applicable to the offered trading program and the types of transactions and investment activity expected to be engaged in pursuant to such program (including retail forex and swap transactions, if any).
The Commission is also proposing to require CTAs to provide in their QEP Disclosures a description of the 4.7 trading program as required by Regulation 4.34(h). Regulation 4.34(h) requires CTAs to include a description of their trading programs in their Disclosure Documents; such description must include: (1) the method chosen by the CTA concerning how FCMs and/or RFEDs carrying accounts it manages treat offsetting positions pursuant to Regulation 1.46, if the method is other than to close out all offsetting positions or to close out offsetting positions on other than a first-in, first-out basis; and (2) the types of commodity interests and other interests the CTA intends to trade, with a description of any restrictions or limitations on such trading established by the CTA or otherwise.
The Commission is further proposing to require CTAs to provide in the QEP Disclosures a description of each fee they will charge QEP advisory clients, as required by Regulation 4.34(i). Regulation 4.34(i) requires CTAs to include within their Disclosure Documents a complete description of fees they will charge their clients. Pursuant to this requirement, the description must specify the dollar amount of each fee, wherever possible, and must provide additional detail and explanation of certain fees, where the fees are dependent on specifically listed base amounts, or on any increase in a client's commodity interest account.
With respect to conflicts of interest, the Commission is proposing to require CTAs offering 4.7 trading programs to disclose their conflicts of interest as required by Regulation 4.34(j) in their QEP Disclosures. Regulation 4.34(j) requires CTAs to include a full description of any actual or potential conflicts of interest regarding any aspect of their trading programs on the part of: (1) the CTA; (2) any FCM and/or RFED with which the client will be required to maintain its commodity interest account; (3) any introducing broker through which the client will be required to introduce its account to an FCM and/or RFED; and (4) any principal of the foregoing, within their Disclosure Documents.
Finally, the Commission is also proposing to require CTAs offering 4.7 trading programs to include past performance information in their QEP Disclosures as required by Regulation 4.35. Currently, CTAs are exempt from disclosing performance information for their 4.7 trading programs. Because the Commission preliminarily believes such performance information regarding 4.7 trading programs would be valuable and provide necessary detail to prospective QEP advisory clients, the Commission is proposing to require CTAs include all performance information required under Regulation 4.35 with respect to the offered 4.7 trading program in their QEP Disclosures.
Regulation 4.35 requires CTAs to include in their Disclosure Documents capsule performance information for past performance of an account or trading program, subject to certain presentation and content requirements as outlined paragraph (a) of that section.
Regulation 4.7(b)(3) currently provides an exemption from the requirement in Regulations 4.22(a) and (b) that CPOs provide monthly account statements containing specific information to participants in their commodity pools.
Consistent with past Commission efforts to memorialize routinely granted Commission letter relief via regulatory amendments that streamline availability, provide consistency, and eliminate the need to process and respond to requests individually, the Commission proposes to amend Regulation 4.7 in a manner that would allow the CPOs of 4.7 pools that are Funds of Funds to distribute monthly account statements within 45 days of the month-end, provided that a CPO notifies its QEP pool participants, so they are aware of the schedule for the distribution of account statements. The Commission solicits comment generally on Proposed Regulation 4.7(b)(3)(iv); in particular, the Commission requests comment on whether the proposed amendment effectively creates a mechanism in Regulation 4.7(b)(3) that is equivalent to the exemptive letters currently issued by the Commission, and whether the alternate account statement distribution schedule and notice requirements are clear.
Finally, the Proposal also includes a number of technical amendments to Regulation 4.7 that are designed to improve its efficiency and usefulness for intermediaries and their prospective and actual QEP pool participants and advisory clients, as well as the general public. For example, the Commission is proposing to delete the introductory paragraph to Regulation 4.7 and to generally restructure the definitions section in Regulation 4.7(a), eliminating what it preliminarily views as unnecessary subparagraph levels in the QEP definition and alphabetizing the definitions. The Commission has also proposed amendments to ensure that cross-references within Regulation 4.7 and other part 4 regulations are accurate. The Commission is seeking comment on these and any other technical amendments that it should consider for ease of use, as well as whether there are any other cross-references within Regulation 4.7 not addressed by the Proposal that should also be corrected. The Commission intends to include additional conforming amendments correcting cross-references to Regulation 4.7 provisions found in other parts of the Commission's regulations as technical amendments in a future final rule. The Commission requests comment and public input on this approach as well.
The Regulatory Flexibility Act (RFA) requires that Federal agencies, in promulgating regulations, consider whether the regulations they propose will have a significant economic impact on a substantial number of small entities, and if so, to provide a regulatory flexibility analysis regarding the economic impact on those entities.
The Commission has previously established certain definitions of “small entities” to be used by the Commission in evaluating the impact of its rules on such entities in accordance with the requirements of the RFA.
Regarding CTAs, the Commission has previously considered whether such registrants would be deemed small entities for purposes of the RFA on a case-by-case basis, in the context of the particular Commission regulation at
The portions of this NPRM directly impacting CTAs would affect only CTAs registered or required to register with the Commission that offer and operate trading programs designed for QEPs. These proposed amendments would, in particular: (1) require CTAs claiming the Regulation 4.7 exemption to provide certain general and performance disclosures enumerated in other part 4 regulations regarding their 4.7 trading programs to their prospective and current QEP advisory clients; (2) require such CTAs to include past performance information for their 4.7 trading programs in any Disclosure Documents they use and distribute for their non-4.7 trading programs' advisory clients; and (3) require such registered CTAs to retain the proposed limited QEP Disclosures regarding their 4.7 trading programs as business records of the intermediary. As stated above, these proposed requirements primarily impact registered CTAs offering 4.7 trading programs to QEP advisory clients and claiming the compliance exemptions currently offered by Regulation 4.7. Although data on the specific size of registered CTAs offering 4.7 trading programs is limited, it is the Commission's anecdotal experience that such CTAs claiming compliance exemptions in Regulation 4.7 for the purposes of soliciting and serving QEP advisory clients are frequently large financial institutions with substantial financial assets and advisory experience, or affiliates thereof. Given that registered CTAs do not have a capital requirement applicable to them, it is not possible for the Commission to readily determine the typical or average size of registered CTAs, or even of registered CTAs who solely offer 4.7 trading programs; moreover, registered CTAs frequently offer a mix of 4.7 trading programs and trading programs or strategies subject to the full application of the Commission's part 4 regulations. Therefore, although the Commission has previously determined whether CTAs are small entities for RFA purposes on a case-by-case basis, the Commission is not currently in a position to determine whether registered CTAs affected by this NPRM would include a substantial number of small entities, on which the NPRM would have a significant economic impact. Therefore, pursuant to 5 U.S.C. 603, the Commission offers for public comment this initial regulatory flexibility analysis addressing the impact of the Proposal on small entities:
As discussed in detail above in this Preamble, since the 1992 Final Rule adopting Regulation 4.7, the Commission has witnessed substantial increases in the intermediary population utilizing those exemptions for 4.7 pools and trading programs offered and available to QEPs. This development also coincides with current commodity interest market conditions, in which the Commission has also seen significant expansion and growth in the complexity and diversity of commodity interest products offered via 4.7 pools and trading programs, which may be more challenging to fully understand. Given further that QEPs, for a variety of reasons, may have varying levels of resources and leverage to demand and monitor the information necessary for them to make informed investment decisions, the Commission believes it is no longer appropriate to rely solely on QEPs' individual ability to obtain such information, absent formal regulatory requirements that such information be provided.
The objective of these proposed amendments is to establish minimum disclosure requirements applicable to all CTAs offering 4.7 trading programs, replacing the current
As mentioned above, CTAs are generally not subject to any minimum capital requirements, nor does the Commission collect data on the “size” of registered CTAs via Commission registration applications or other required Commission filings or reports. Therefore, the Commission has no data to analyze that would enable it to estimate how many registered CTAs
The proposed amendments would require CTAs registered and claiming the exemption in Regulation 4.7(c)(1) to provide certain general and performance disclosures regarding their 4.7 trading programs to prospective and current QEP advisory clients, to ensure that the information provided is materially complete and accurate, and to periodically update such information as needed. As noted above, the proposed amendments would, in particular: (1) require CTAs relying on the Regulation 4.7 exemption to provide certain general and performance disclosures enumerated in other part 4 regulations regarding their 4.7 trading programs to their prospective and current QEP advisory clients; (2) require such CTAs to include past performance information for their 4.7 trading programs in the Disclosure Documents they use and distribute for their non-4.7 trading programs; and (3) require such
The Commission anticipates that the proposed amendments would affect registered CTAs claiming Regulation 4.7 and offering 4.7 trading programs, which, as stated above, may include some small entities for RFA purposes. Nonetheless, regardless of whether a CTA is considered a small entity, the Commission believes that all registered CTAs offering and managing 4.7 trading programs generally possess the professional skills necessary to generate and distribute the subset of disclosures proposed to be required and to appropriately retain such QEP Disclosures as business records of their registered intermediary,
The Commission is generally unaware of any Federal rules or regulations which may conflict with the proposed amendments. Federal securities laws and regulations do govern investment disclosures by registered investment advisers, which may result in those entities that are dually registered with the SEC and CFTC being subject to more than one regulatory regime. The Commission does not expect the proposed amendments to conflict with those laws and regulations, based on its understanding of those disclosure requirements. Moreover, some 4.7 CTAs are registered only with the Commission and thus, are not currently subject to any other regulations mandating disclosures to their QEP advisory clients.
Potential alternatives to the proposed amendments would be: (1) to not amend Regulation 4.7 to add disclosure requirements for 4.7 trading programs; or (2) to amend Regulation 4.7(c)(1) to require compliance with the entirety of the disclosure regulations generally applicable to registered CTAs offering trading programs to non-QEP advisory clients. Additionally, the Commission could also consider limiting the application of the proposed amendments to registered CTAs claiming Regulation 4.7 and offering 4.7 trading programs to those CTAs who are not small entities for RFA purposes.
The Commission believes that there have been significant developments in the commodity interest markets since Regulation 4.7 was adopted in 1992. Based on current market conditions and the increasing complexity of commodity interest products, among other factors, the Commission preliminarily believes it necessary to establish minimum disclosures for CTAs offering 4.7 trading programs at this time. Although declining to require any disclosures would certainly minimize the economic impact on registered CTAs that are also small entities, the Commission believes that, due to the circumstances explained above, including the varying resources available to QEPs to independently demand and assess the accuracy of such disclosures, certain information should be required to be disclosed to all QEP advisory clients, in furtherance of the Commission's regulatory goals and the purposes of the CEA. Additionally, the Commission believes it would be overly burdensome if registered CTAs offering 4.7 trading programs were required to comply with the entirety of Regulations 4.34 and 4.35, and to comply with the review and filing requirements in Regulation 4.36, given the characteristics of their advisory clients. Through these proposed amendments, the Commission is seeking to balance its customer protection and regulatory concerns for QEP advisory clients and 4.7 trading programs with the existing compliance burdens of registered CTAs. Thus, the proposed amendments prioritize and require certain disclosures, while providing relief from others, and permit CTAs to use and distribute QEP Disclosures containing that information without filing or advance review by the Commission or NFA, provided that they are complete, accurate, and kept as business records of the CTA. In the Commission's opinion, the proposed amendments offer a more tailored approach to QEP Disclosure requirements applicable to CTAs' 4.7 trading programs and would have less of an economic impact on CTAs claiming Regulation 4.7 than requiring compliance with the entirety of the part 4 disclosure requirements.
Finally, as stated above, CTAs are generally not subject to capital requirements under the Commission's regulatory regime, and CTAs manage the assets of their advisory clients, whether QEPs or not, without receiving or taking custody of those assets, due to the statutory and regulatory provisions defining the permitted activities of CTAs. The Commission also does not collect data on the size of CTAs registered or required to register with it, beyond their assets under management, and it would be difficult to determine or estimate the number of registered CTAs that may be considered small entities for RFA purposes. Therefore, the Commission is unable to limit the application of the proposed amendments to CTAs offering 4.7 trading programs who are not small entities for RFA purposes, though anecdotally the Commission believes that the majority of CTAs utilizing Regulation 4.7 would not be considered small entities. As noted earlier, regardless of whether a CTA is considered a small entity, the Commission believes that all registered CTAs offering and managing 4.7 trading programs generally possess the resources and know-how necessary to generate and distribute the subset of disclosures proposed to be required and to appropriately retain such QEP Disclosures as business records of their registered intermediary.
To the extent the proposed amendments may apply to an unknown number of small entities who are registered CTAs offering 4.7 trading programs, the Commission believes that its customer protection and oversight concerns under the CEA in ensuring that QEP advisory clients are adequately and consistently informed regarding 4.7 trading programs, and that the Commission can effectively oversee the activities of all CTAs claiming exemptions under Regulation 4.7, nevertheless outweigh that concern. The Commission understands that the direct effect of these proposed amendments would be an increase in the operating costs of CTAs utilizing Regulation 4.7, due to the addition of minimum content, dissemination, and recordkeeping requirements for QEP
Therefore, in comparing the aforementioned alternatives of (1) not amending Regulation 4.7 to impose disclosure requirements for 4.7 trading programs, and (2) amending Regulation 4.7(c)(1) to require compliance with the entirety of the disclosure regulations generally applicable to registered CTAs offering trading programs to non-QEP advisory clients, the Commission believes that the proposed minimum disclosure requirements strike an appropriate balance that achieves the Commission's regulatory objectives without burdening the small entity population of CTAs offering 4.7 trading programs with the compliance costs and burdens that would be associated with the full disclosure regime required under part 4.
The Paperwork Reduction Act of 1995 (PRA)
This NPRM, if adopted, would result in a collection of information within the meaning of the PRA, as discussed below. The Proposal affects a collection of information for which the Commission has previously received a control number from OMB. The title for this collection is, “Rules Relating to the Operations and Activities of Commodity Pool Operators and Commodity Trading Advisors and to Monthly Reporting by Futures Commission Merchants” (Collection 3038-0005).
The Commission is therefore submitting this NPRM to OMB for review.
Collection 3038-0005 governs responses made pursuant to part 4 of the Commission's regulations, pertaining to the operations of CPOs and CTAs, including the itemization of compliance burdens remaining after CPOs and CTAs elect certain exemptions from broader compliance obligations in the part 4 regulations. The Commission is proposing to amend Collection 3038-0005 to account for the amendments proposed in this NPRM, as follows: (a) adding reporting burdens for the proposed required general and performance disclosures to prospective or actual QEP pool participants and advisory clients by CPOs and CTAs, pursuant to the proposed amendments to Regulations 4.7(b)(2) and (c)(1); (b) increasing the existing recordkeeping requirements of Regulations 4.7(b)(5) and (c)(2) to include the proposed maintenance of QEP Disclosures as business records by CPOs and CTAs utilizing Regulation 4.7; and (c) adding monthly account statements as a permissible reporting schedule by CPOs of 4.7 pools that are Funds of Funds through Proposed Regulation 4.7(b)(3)(iv). In addition, and more generally, the Commission is proposing to update its estimates of the number of respondents subject to the information collection requirements under Regulation 4.7, such that they are better aligned with more recent NFA data provided to the Commission on the number of CPOs (and pools) and CTAs subject to those requirements. Accordingly, the Commission proposes to revise Collection 3038-0005 to address the reporting and recordkeeping burdens associated with these proposed amendments as described in further detail below.
As stated above, Regulation 4.7 currently provides exemptions from the broader part 4 compliance requirements, and Regulation 4.7(b)(2), in particular, provides exemptions for CPOs with respect to 4.7 pools offered solely to QEPs from the requirements of Regulations 4.21, 4.24, 4.25, and 4.26, under certain additional conditions further specified in the regulation.
Additionally, this NPRM proposes to amend Regulation 4.7(b)(5) to require that CPOs retain the QEP Disclosures they use and distribute to their prospective and actual QEP pool participants as business records of the CPO. Collection 3038-0005 currently contains a recordkeeping burden associated with Regulation 4.7(b)(5) which estimates that each CPO expends approximately 2 hours maintaining business records related to its 4.7 pool(s), as that provision requires. The Commission recommends an increase of 0.5 hours to this existing burden, to account for the additional burden of retaining the QEP Disclosures as CPO business records, and estimates that the respondents include 1,000 CPOs each operating up to five 4.7 pools. Accordingly, the aggregate annual estimate for the recordkeeping burden associated with Proposed Regulation 4.7(b)(5) would be as follows:
Finally, the Commission is also proposing amendments to Regulation 4.7(b)(3) that would, consistent with routinely issued Commission exemptive letters, permit CPOs of 4.7 pools that are Funds of Funds to distribute monthly account statements within 45 days of the month-end.
Similar to Regulation 4.7(b)(2), Regulation 4.7(c)(1) provides exemptions for CTAs with respect to their 4.7 trading programs offered to QEPs from Regulations 4.31, 4.34, 4.35, and 4.36, subject to additional conditions specified in that regulation.
Additionally, this NPRM proposes to amend Regulation 4.7(c)(2) to require that CTAs retain the QEP Disclosures they use and distribute to their
The Commission invites the public and other Federal agencies to comment on any aspect of the proposed information collection requirements discussed above. Pursuant to 44 U.S.C. 3506(c)(2)(B), the Commission solicits comment in order to (1) evaluate whether the proposed collections of information are necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) evaluate the accuracy of the estimated burden of the proposed information collection requirements, including the degree to which the methodology and assumptions the Commission employed were valid; (3) determine whether there are ways to enhance the quality, utility, and clarity of the information proposed to be collected; and (4) minimize the burden of the proposed collections of information on those who are required to respond,
The public and other Federal agencies may submit comments directly to the Office of Information and Regulatory Affairs, Office of Management and Budget, Room 10235, New Executive Office Building, Washington, DC 20503, Attn: Desk Officer of the Commodity Futures Trading Commission, by fax at (202) 395-6566, or by email at
Section 15(a)
The Commission recognizes that the proposed amendments to Regulation 4.7 in this NPRM will result in additional costs for CPOs and CTAs operating 4.7 pools and trading programs. However, the Commission lacks the data necessary to reasonably quantify all of the costs and benefits considered below. Additionally, any initial and recurring compliance costs for any particular CPO or CTA will depend on its size, existing infrastructure, practices, and cost structures. The Commission welcomes comments on such costs, particularly from existing CPOs and CTAs utilizing Regulation 4.7 exemptions, who may be better able to provide quantitative cost data or estimates, based on their respective experiences. Commenters may also suggest other alternative(s) to the proposed approach that would be expected to further the Commission's stated policy and regulatory goals as described in this NPRM.
The Commission is also including a number of questions herein for the purpose of eliciting direct cost estimates from public commenters wherever possible. Quantifying other costs and benefits, such as the effects of potential induced changes in the behavior of CPOs, CTAs, and their QEPs resulting from the proposed amendments are inherently harder to measure
As described in more detail above, the QEP definition in Regulation 4.7 outlines two categories, those that do not have to satisfy the Portfolio Requirement, listed in Regulation 4.7(a)(2), and those that do, listed in Regulation 4.7(a)(3). Persons listed in Regulation 4.7(a)(3), including natural persons who must also be considered “accredited investors,” must meet the Portfolio Requirement by either: (1) owning securities and other assets worth at least $2,000,000; (2) having on deposit with an FCM for their own account at least $200,000 in initial margin, option premiums, or minimum security deposits; or (3) owning a portfolio of funds and assets that, when expressed as percentages of the first two thresholds, have a combined value of at least 100%.
The Commission is proposing in this NPRM to increase the Portfolio Requirement in Regulation 4.7 such that persons listed in Regulation 4.7(a)(3) could satisfy the QEP definition by either: (1) owning securities and other assets worth at least $4,000,000; (2) having on deposit with an FCM for their own account at least $400,000 in initial margin, option premiums, or minimum security deposits; or (3) owning a portfolio of funds and assets that, when expressed as percentages of the prior two thresholds, have a combined value
The Portfolio Requirement was adopted to identify those prospective participants in the commodity interest markets that are of a size sufficient to indicate that the participant has substantial investment experience and thus a high degree of sophistication with regard to investments as well as financial resources to withstand the risk of their investments.
The Commission understands that raising the Portfolio Requirement thresholds may cause some QEPs to no longer be so qualified, turning them into non-QEP participants in the commodity interest markets. The Commission nonetheless believes preliminarily that this proposed amendment would benefit the commodity interest markets and the general public by realigning financial thresholds in its most commonly used regulations to account for the impacts of inflation since its original adoption and to more accurately reflect the current economic reality, such that the scope of Regulation 4.7 would be more closely aligned with the Commission's original intent in the 1992 Final Rule. Additionally, to the extent that former QEPs choose to continue investing in commodity pools or allocate their funds to be managed by CTAs, such persons may then purchase participations in pools or utilize the services of CTAs not operating pursuant to Regulation 4.7. This, in turn, could result in the creation and offering of additional pools and trading programs by registered CPOs and CTAs outside of the Regulation 4.7 regime, given the potential additional demand by non-QEPs. Because more capital may, as a result, likely be deployed to such pools and trading programs subject to the full panoply of the Commission's part 4 compliance requirements, this could indirectly lead to greater transparency in the offerings of registered CPOs and CTAs, as well as improved customer protection for persons engaging with CPOs and CTAs. Moreover, if additional pools and trading programs are created for the non-QEP investing public, this would be expected to enhance the variety and vibrancy of the non-QEP pool and trading program marketplace. As a result, more options for non-QEP individuals and entities to gain access to the commodity interest markets in a manner consistent with their individual risk appetites and exposure needs would become available.
If the proposed amendments are adopted, CPOs that currently offer pools operated under Regulation 4.7 may no longer accept additional investment from pool participants that fall in the gap between the old and new Portfolio Requirement thresholds. Such registered CPOs and CTAs may decide to offer pools and trading programs not exempt under Regulation 4.7 that would necessarily have higher operating and compliance costs, due to the unavailability of Regulation 4.7 compliance exemptions for those investment products.
The Commission poses the following questions to better assess the costs and benefits of the proposed increases to the QEP definition's Portfolio Requirement in Regulation 4.7(a)(1)(v). The Commission requests further that, to the extent possible, commenters please provide quantitative bases for your responses.
1. How many QEPs would intermediaries expect to no longer be considered QEPs, if the Portfolio Requirement threshold increases are adopted?
2. How many CPOs and CTAs that currently offer pools and trading programs exclusively to QEPs have participants and clients that would no longer be QEPs under the new thresholds?
3. If the increased thresholds are adopted, will registered CPOs and CTAs form and begin offering new pools and trading programs designed for non-QEPs?
Section 15(a) of the CEA requires the Commission to consider the costs and benefits of the proposed amendments to Regulation 4.7 with respect to the following factors: protection of market participants and the public; efficiency, competitiveness, and financial integrity of markets; price discovery; sound risk management practices; and other public interest considerations. As discussed above, the proposed revision of Regulation 4.7(a)(1)(v) would increase the financial thresholds for the Portfolio Requirement in the definition of QEPs. These proposed updates to the thresholds would, in the Commission's preliminary opinion, more closely align the QEP definition with the intent of the regulation, which is to assure that offerings operated pursuant to Regulation 4.7 compliance exemptions are only made to persons with sufficient expertise and assets.
As stated above, the Commission believes preliminarily that this proposed amendment would benefit the commodity interest markets and the general public by realigning financial thresholds in its most commonly used regulations in a manner that accounts for the impacts of inflation since their original adoption and more accurately reflects current economic circumstances; the Commission expects that this would result in persons investing in commodity interest products offered by registered CPOs and CTAs being more accurately categorized as QEPs, and thus, more appropriately limited in their investment choices. Moreover, raising the Portfolio Requirement thresholds, as a practical matter, would likely limit the prospective investor population for 4.7 pools and trading programs to a smaller number of persons. To the extent persons who meet the higher Portfolio Requirement thresholds are (on average) more financially sophisticated or resilient than those who no longer qualify, this proposed amendment should result in individuals and entities, both QEPs and non-QEPs, being offered pools and trading programs that are regulated in a manner commensurate with their respective needs for customer protection. If the increased thresholds further lead to the creation of more commodity pools and trading programs subject to the full part 4 compliance requirements by registered CPOs and CTAs, this too would potentially lead to greater transparency in their activities, which also protects persons investing in commodity interest investment products. Additionally, greater variety in the commodity pools and trading programs available to non-QEPs would provide more options for this population to consider, which may further enable them to make more appropriate investment decisions by choosing the offerings best suited to
The proposed amendments to the Portfolio Requirement may also affect the size, composition, or number of commodity pools and trading programs in the commodity interest markets, especially those offered solely to QEPs. This may, in turn, affect the flow of investing in commodity interests. Financial economics literature suggests that, to the extent changing the QEP definition reduces the flow of non-commercial funds into commodity interest markets, the cost to commercial traders using futures markets to hedge their risks may increase.
The increased Portfolio Requirement thresholds are likely to result in fewer persons being considered QEPs, which may further result in fewer participants and clients in offered pools and trading programs operated under Regulation 4.7. An additional indirect effect of the proposed rule change could be a change in the flow of investment in commodity interests by non-commercial traders. The financial economics literature has found ambiguous results regarding the relationship between increased investment by non-commercial traders in commodity interest markets and price discovery.
Increasing the Portfolio Requirement thresholds may result in registered CPOs and CTAs that previously only offered pools and trading programs to QEPs creating and offering pools and trading programs designed for persons that are not QEPs. Consequently, these non-QEP pools and trading programs operated by registered CPOs and CTAs would then be subject to the full complement of part 4 compliance requirements, which could result in more diligent risk management practices by the CPOs and CTAs.
The original Portfolio Requirement thresholds in the QEP definition were intended to ensure that only persons possessing an appropriate and high level of trading experience, acumen, and financial resources would be eligible to invest in complex commodity interest investments offered and operated under Regulation 4.7. The Commission determined it appropriate to lessen the compliance burdens for registered CPOs and CTAs limiting their prospective participants and clients to financially sophisticated QEPs through the exemptions provided by Regulation 4.7 for their 4.7 pools and trading programs. The 1992 Portfolio Requirement thresholds were adopted to provide a metric by which CPOs and CTAs could approximately assess the experience and financial wherewithal of potential pool participants or advisory clients, ensuring that they truly possessed the sophistication and resilience of other QEPs not subject to such thresholds. Updating these thresholds to account for inflation would realign the Portfolio Requirement with the original intent of the QEP definition and modernize its provisions consistent with today's economic circumstances.
In general, registered CPOs and CTAs are required by several part 4 regulations (
The Proposal would narrow the existing exemptions in Regulation 4.7 by proposing to require compliance with portions of the broader disclosure requirements in part 4, thereby establishing minimum content, use, and recordkeeping requirements applicable to QEP Disclosures, and bringing the disclosure requirements for 4.7 pools and trading programs closer to those applicable to pools and trading programs offered to non-QEPs by registered CPOs and CTAs. Specifically, CPOs and CTAs utilizing Regulation 4.7 would be required by the proposed amendments to provide QEP Disclosures containing, at a minimum, the information outlined above through offering memoranda or trading program brochures delivered to their prospective QEP pool participants or advisory clients. Although the extent of information proposed to be required under Regulation 4.7 is less than that required by the part 4 regulations for non-QEP pools and trading programs, these proposed amendments represent a significant policy change from the current status quo, where Regulation 4.7 currently provides broad exemptions from the entirety of the CPO and CTA disclosure regulations. Under the Proposal, CPOs and CTAs offering and operating 4.7 pools and trading programs would be required to provide information to their prospective QEP participants and clients regarding principal risk factors, investment programs, use of proceeds, custodians, fees and expenses, conflicts of interest, and certain performance information. Importantly, the Proposal also includes amendments to Regulation 4.7 that would require that the QEP Disclosures be materially complete and accurate, be kept up-to-date through routine reviews and updated as needed to reflect any changes to a 4.7 pool or trading program, and be maintained among an intermediary's other books and records for the pool or trading program and made available to any representative of the Commission, NFA, or the U.S. Department of Justice, in accordance with Regulation 1.31.
The direct effects of these proposed amendments would include greater availability and increased accuracy and reliability of the information QEPs receive prior to making their investment decisions. Mandating the provision of certain foundational information to all QEPs, which the proposed amendments would require to be kept up-to-date and accurate, is expected to result in more
Several aspects of the Proposal may also indirectly enhance Commission and NFA oversight of CPOs and CTAs utilizing Regulation 4.7. First, the improved ability of QEPs to more easily compare and understand critical information about 4.7 pools and trading programs offered to them may provide incentives for better governance of those commodity interest investment products by CPOs and CTAs.
Disclosure of information about an offered 4.7 pool or trading program may also result in additional benefits inuring to QEP pool participants and advisory clients. One such benefit would be the expectation that CPOs and CTAs may seek to compete with one another to offer lower or more cost-efficient fees and expenses, or to minimize potential conflicts of interest, for the purposes of presenting more attractive and competitive investment products to prospective QEP participants and clients. This may result in CPOs and CTAs attempting to eliminate any fees and expenses extraneous to their 4.7 pools and trading programs, and/or to mitigate or resolve their conflicts of interest, each of which would benefit QEPs investing in these offerings. Additionally, by requiring the provision of standard disclosures to QEP pool participants and advisory clients, and the maintenance of such disclosures by the CPO or CTA in its books and records (which are subject to routine review by the Commission and NFA as part of their examination functions), the Commission preliminarily believes that these proposed amendments would result in higher quality disclosures on an on-going basis, even after a QEP participant or client receives information initially, due to the consistent and regular review of such QEP Disclosures by subject matter expert regulators,
The direct effect of these proposed amendments would be an increase in the operating costs of CPOs and CTAs utilizing Regulation 4.7, due to the addition of minimum content requirements for QEP Disclosures and requirements that such information be produced, disseminated to prospective pool participants and advisory clients, updated regularly, and kept as business records of the CPO or CTA. Regarding information production, CPOs and CTAs claiming Regulation 4.7 would be required to disclose information on several important features of their 4.7 pools and trading programs relevant to expected future performance and activities of the CPO or CTA, including past performance, fees and expenses, principal risk factors, and potential conflicts of interest.
The Commission understands that some of the information proposed to be required is similar in content to information that many CPOs and CTAs are already providing based on the demands of such QEPs, or because they are otherwise required to produce such information for compliance requirements in other regulatory regimes, like that of the SEC. Additionally, though, the QEP Disclosures would also require the provision of information that CPOs and CTAs already produce to comply with other CFTC regulations. For example, CPOs are already required by Regulations 4.7(b)(3) and 4.22(a) and (b) to calculate the net asset value of 4.7 pool(s), accounting for fees, expenses, commissions, and other financial information, no less frequently than on a quarterly basis, for the purposes of producing account statements for QEP pool participants. The Proposal would also require CPOs and CTAs to provide past performance information prospectively to QEP pool participants. The Commission expects that the information required to produce a 4.7 pool's or trading program's performance
In addition to this direct effect, the proposed disclosure requirements may affect how CPOs and CTAs operate more generally. For example, providing descriptions of 4.7 pools' and trading programs' investment program information, principal risk factors and past returns routinely may likely make such information more publicly available,
The Commission poses the following questions to better assess the costs and benefits of the proposed disclosure requirements that would be added to Regulations 4.7(b) and (c). The Commission requests further that, to the extent possible, commenters please provide quantitative bases for your responses.
1. To what extent is the information necessary to provide past performance and fees already gathered in order to provide account information under Regulations 4.7 and 4.22? What additional steps would be required to process and disseminate that information in QEP Disclosures, as required under the Proposal?
2. What are the costs of gathering and disseminating the other types of information required to be included in QEP Disclosures?
3. How will the fees and expenses charged by CPOs and CTAs for pools and trading programs operated under Regulation 4.7 be affected by the proposed disclosure requirements?
4. To what extent would CPOs' and CTAs' trading strategies be revealed in QEP Disclosures? How would such proposed disclosure requirements impact the development of such trading strategies and/or directly affect the behaviors of CPOs and CTAs utilizing Regulation 4.7?
Section 15(a) of the CEA requires the Commission to consider the costs and benefits of the proposed amendments to Regulations 4.7(b)(2), (b)(5), (c)(1), and (c)(2), with respect to the following factors: protection of market participants and the public; efficiency, competitiveness, and financial integrity of markets; price discovery; sound risk management practices; and other public interest considerations.
As discussed above, for CPOs and CTAs operating pools and trading programs under Regulations 4.7, the NPRM would narrow the existing exemptions from the part 4 disclosure regulations available under Regulations 4.7(b)(2) and (c)(1). Under the Proposal, such CPOs and CTAs would be required to provide QEP Disclosures containing information regarding past performance, fees and expenses, principal risk factors, potential conflicts of interest, and other aspects of their investments to prospective QEP pool participants and advisory clients.
These proposed amendments to Regulation 4.7 would mandate a minimum amount of transparency into pools and trading programs trading commodity interests and restricting their offerings to QEPs. This could help such QEPs protect themselves against excessive fees and self-dealing, and generally help insure that the products offered by such CPOs and CTAs are performing and being operated, as anticipated. In addition, mandating QEP Disclosures and requiring that they be materially accurate and complete, rather than just optional and not materially misleading, will benefit market participants and the public by ensuring that prospective investors would receive QEP Disclosures containing, at a minimum, certain important general and performance information that they can reliably assume is kept current and materially complete with respect to the items proposed to be required. Finally, requiring that such QEP Disclosures be maintained among CPOs' and CTAs' other books and records, and thus made available to the Commission and NFA, would allow for improved oversight of the regulated activities of CPOs and CTAs.
The proposed amendments regarding QEP Disclosures may also indirectly affect the functioning of commodity interest markets. To the extent that the proposed changes would increase transparency and affect the number or composition of pools and trading programs operated under Regulation 4.7, the NPRM might also affect the flow of investing in commodity interests. Financial economics literature suggests that, to the extent greater transparency into pools and trading programs increases the flow of non-commercial funds into commodity interest markets, that may also tend to reduce the costs to commercial traders using the futures market to hedge.
This increase in transparency resulting from the Proposal may also lead to QEPs having better information about fees and expenses, performance, and potential returns on their investments in 4.7 pools and trading programs, which may lead further to enhanced competition amongst CPOs and CTAs relying on Regulation 4.7. There is considerable evidence that eliminating prohibitions on price advertising, or mandating transparency of prices can lead to more “competitive markets,” in the sense that service providers and vendors compete to offer lower prices to consumers of their products.
As noted above, an indirect effect of the Proposal could be a change in the flow of investment into commodity interests by non-commercial traders. Financial economics literature has found ambiguous results regarding the relationship between increased investment by non-commercial traders in commodity interest markets and price discovery.
The NPRM may also help some QEPs better manage their business risks. For example, some QEPs are insurance companies and pensions funds that have specific operational risks that may be mitigated through appropriate financial investment. The availability and provision of more accurate and complete information about 4.7 pools and trading programs, including their fees and principal risk factors, may assist such QEPs in making more appropriate and targeted investment decisions that support their operations.
As discussed above, the Proposal may also promote sound risk management by CPOs and CTAs. Specifically, requiring QEP Disclosures be maintained among CPOs' and CTAs' other books and records would allow for greater regulatory oversight of such intermediaries by the Commission and NFA. This requirement would help identify those intermediaries that lack suitable risk management practices, or that are engaging in practices that do not match their QEP Disclosures and other regulatory filings, potentially encouraging the adoption of better risk management practices. Finally, the anticipation of greater regulatory oversight and transparency in their operations might also provide an incentive for CPOs and CTAs to adopt and follow sound risk management practices.
The proposed requirement for CPOs and CTAs to include past performance information in their QEP Disclosures may enable regulators and the general public to gain a better understanding of the trading behavior of CPOs and CTAs utilizing Regulation 4.7, and consequently, the impact they have on commodity interest markets through their 4.7 pools and trading programs.
CPOs operating pools under Regulation 4.7 are required to provide account statements to investors “no less frequently than quarterly within 30 days after the end of the reporting period.”
Consistent with longstanding exemptive letter relief described herein, the Proposal would add a provision to Regulation 4.7(b)(3) allowing CPOs of 4.7 pools that are Funds of Funds to distribute account statements on a monthly basis, within 45 days of the end of the month-end, provided that such CPOs notify their pool participants, so they know when to expect to receive their account statements.
Relative to the baseline, the primary benefit of this proposed amendment is to make it more feasible for 4.7 pools to invest in other pools or collective investment vehicles without potentially violating the periodic reporting requirements in Regulation 4.7. This proposed amendment may also allow CPOs of 4.7 pools to seek higher returns and/or better diversification for their participants by investing in other pools or other collective investment vehicles, without having to seek an exemptive letter to ensure they can meet their periodic reporting requirements, or without risking chronic compliance violations. Consequently, this proposed amendment may encourage more CPOs to operate their 4.7 pools as Funds of Funds, and that may further result in higher returns and/or more effective diversification for their QEP pool participants. Additionally, offering this alternative account statement schedule would allow CPOs of 4.7 Fund of Funds pools to provide more accurate and complete account statements to their QEP participants more frequently, rather than generating quarterly account statements containing estimates of such information, if they have not yet received it. The Commission further predicts that an overall benefit of this proposed amendment would be more frequent, accurate, and complete periodic reporting to QEP participants in 4.7 Fund of Funds pools.
Finally, as noted above, exemptive letters providing relief from this reporting requirement have been commonly issued by the Commission for many years. Hence, as a practical matter, a primary benefit from this proposed amendment is CPOs of 4.7 Fund of Funds pools being able to adopt an alternative account statement schedule at their convenience or immediately when necessary, rather than being required to seek an exemptive letter individually from the
Relative to the baseline, the primary cost of the proposed amendment would be the offering of a monthly account statement schedule, provided such monthly statements are provided within 45 days of the end of the month, as an alternative to the current at least quarterly statement schedule provided within 30 days of the end of the quarter. Although the addition of 15 days may slightly delay the arrival of account information to QEP pool participants each month, such participants would also be receiving account statements containing more complete and accurate information more often, as a monthly schedule is more frequent than that required by Regulation 4.7(b)(3) currently, and the 15 days is designed to allow CPOs to compile more information about the 4.7 pool's underlying investments in such statements. CPOs of 4.7 Fund of Funds pools may also incur costs to effectively notify QEP participants of their adoption of this alternative account statement schedule. To the extent this alternative account statement schedule encourages CPOs to operate more of their 4.7 pools as Funds of Funds, QEP participants therein may experience slightly higher costs, as the fees and expenses from underlying pools or other collective investment vehicles could possibly be passed along to them by their 4.7 Fund of Funds pool's CPO.
The Commission poses the following questions to better assess the costs and benefits of the proposed amendment permitting an alternative monthly account statement schedule for Fund of Funds pools operated by CPOs utilizing Regulation 4.7. The Commission requests further that, to the extent possible, commenters please provide quantitative bases for your responses.
1. How many CPOs operate their 4.7 pools as Funds of Funds, meaning such pools invest in other 4.7 pools, other commodity pools, or other collective investment vehicles?
2. How many CPOs operating 4.7 pools provide sufficiently timely account statements to their participants that are other 4.7 commodity pools, so as to allow their CPOs to also produce their own account statements within 30 days of the quarter-end?
3. How many 4.7 Fund of Funds pools are currently able to provide quarterly account statements within 30 days of the end of the quarter, without the alternative monthly schedule currently provided exemptive relief?
Section 15(a) of the CEA requires the Commission to consider the costs and benefits of the proposed amendments to Regulation 4.7(b)(3) with respect to the following factors: protection of market participants and the public; efficiency, competitiveness, and financial integrity of markets; price discovery; sound risk management practices; and other public interest considerations. As discussed above, the addition to Regulation 4.7(b)(3) of a permissible monthly account statement schedule would facilitate compliance with periodic reporting deadlines for CPOs of 4.7 Fund of Funds pools. Absent this change (and assuming such 4.7 pool has received no exemptive letter from the Commission), it may otherwise be impractical for such 4.7 pools to operate as Funds of Funds.
The baseline requirement in Regulation 4.7(b)(3) for at least quarterly account statements distributed within 30 days of the quarter-end helps ensure that QEP pool participants have access to timely information about the 4.7 pool's performance, and serves to protect such participants from malfeasance and other sources of poor pool performance. As discussed above, relative to the baseline, the proposed amendment would permit CPOs of 4.7 Fund of Funds pools to adopt an alternative monthly account statement schedule, provided such statements are provided within 45 days of the end of each month, and provided that they notify their QEP pool participants of such reporting schedule. To the extent the proposed amendment may encourage QEPs to participate in 4.7 Fund of Funds pools, rather than other 4.7 pools, it may require them to adjust to a different account statement schedule, but would likely ultimately provide them with more complete and accurate account statements on a more frequent basis. Additionally, the proposed amendment may facilitate the formation of 4.7 Fund of Funds pools by making it easier for their CPOs to comply with the applicable periodic reporting requirements under Regulation 4.7; this trend may also serve to benefit QEP participants, in that the CPOs of 4.7 Fund of Funds pools may be able to operate them in a manner that achieves exposure to a wider variety of underlying investment strategies through their investee pools, while continuing to remain compliant with their regulatory obligations. Finally, such CPOs would also have greater incentive and may possess more resources to monitor the behavior of their 4.7 Fund of Funds pools' underlying investments in other pools or funds, than QEPs directly investing therein.
The proposed amendment to Regulation 4.7(b)(3) may indirectly affect the functioning of commodity interest markets. To the extent that the proposed amendment affects the behavior of CPOs or the size and composition of their 4.7 Fund of Funds pools, it might also affect the flow of investing in commodity interests. The financial economics literature suggests that increased investment by non-commercial traders in commodity interest markets will generally reduce the difference between futures prices and expected future spot prices.
To the extent that the proposed amendment to Regulation 4.7(b)(3) affects the size or composition of 4.7 pools, it might also affect the flow of investing in commodity interests. The financial economics literature has found ambiguous results regarding the relationship between increased investment by non-commercial traders
Periodic reporting requirements in the form of regular account statements provided to pool participants serve as an effective means for participants as well as CPOs to monitor pools' risk management. Because the amount of funds a CPO manages through its operated pools is likely responsive to its past performance,
A key practical consideration is that, absent exemptive letters issued by the Commission, the existing Regulation 4.7(b)(3) appears to make it very difficult for CPOs to operate their 4.7 pools as Funds of Funds, while complying with applicable periodic reporting requirements. To the extent that facilitating the operation of such 4.7 pools as Funds of Funds is a legitimate policy goal of the Commission (as suggested by its routine granting of exemptive letters on this topic), changing the regulations to explicitly permit this alternative account statement schedule would be a more effective and direct means of accomplishing that objective that further ensures more consistent treatment of similarly situated registrants.
Section 15(b) of the CEA requires the Commission to take into consideration the public interest to be protected by the antitrust laws and endeavor to take the least anticompetitive means of achieving the purposes of the CEA in issuing any order or adopting any Commission rule or regulation.
The Commission has considered the proposed amendments in this NPRM to determine whether they are anticompetitive and has preliminarily identified no anticompetitive effects. The Commission requests comment on whether the NPRM is anticompetitive and, if it is, what the anticompetitive effects are.
Because the Commission has preliminarily determined that the Proposal is not anticompetitive and has no anticompetitive effects, the Commission has not identified any less anticompetitive means of achieving the purposes of the CEA. The Commission requests comment on whether there are less anticompetitive means of achieving the relevant purposes of the CEA that would otherwise be served by adopting the amendments proposed in this NPRM.
Advertising, Brokers, Commodity futures, Commodity pool operators, Commodity trading advisors, Consumer protection, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, the Commodity Futures Trading Commission proposes to amend 17 CFR part 4 as follows:
7 U.S.C. 1a, 2, 6(c), 6b, 6c, 6l, 6m, 6n, 6o, 12a, and 23.
The revisions and additions read as follows:
(a)
(2)
(3)
(4)
(i) A natural person who is not a resident of the United States;
(ii) A partnership, corporation or other entity, other than an entity organized principally for passive investment, organized under the laws of a foreign jurisdiction and which has its principal place of business in a foreign jurisdiction;
(iii) An estate or trust, the income of which is not subject to United States income tax regardless of source;
(iv) An entity organized principally for passive investment such as a pool, investment company or other similar entity;
(v) A pension plan for the employees, officers or principals of an entity organized and with its principal place of business outside the United States.
(5)
(i) Owns securities (including pool participations) of issuers not affiliated
(ii) Has had on deposit with a futures commission merchant, for its own account at any time during the six-month period preceding either the date of sale to that person of a pool participation in the exempt pool or the date that the person opens an exempt account with the commodity trading advisor, at least $400,000 in exchange-specified initial margin and option premiums, together with any required minimum security deposits for retail forex transactions (defined in § 5.1(m) of this chapter), for commodity interest transactions; or
(iii) Owns a portfolio comprised of a combination of the funds or property specified in paragraphs (a)(5)(i) and (ii) of this section, in which the sum of the funds or property includable under paragraph (a)(5)(i) of this section, expressed as a percentage of the minimum amount required thereunder, and the amount of initial margin, option premiums, and minimum security deposits includable under paragraph (a)(5)(ii) of this section, expressed as a percentage of the minimum amount required thereunder, equals at least one hundred percent. An example of a composite portfolio acceptable under this paragraph (a)(5)(iii) would consist of $2,000,000 in securities and other property (50% of paragraph (a)(5)(i) of this section) and $200,000 in initial margin, option premiums, and minimum security deposits (50% of paragraph (a)(5)(ii) of this section).
(6)
(i)
(B) A retail foreign exchange dealer registered pursuant to section 2(c)(2)(B)(i)(II)(gg) of the Act, or a principal thereof;
(C) A swap dealer registered pursuant to section 4s(a)(1) of the Act, or a principal thereof;
(D) A broker or dealer registered pursuant to section 15 of the Securities Exchange Act of 1934, or a principal thereof;
(E) A commodity pool operator registered pursuant to section 4m of the Act, or a principal thereof;
(
(
(F) A commodity trading advisor registered pursuant to section 4m of the Act, or a principal thereof;
(
(
(G) An investment adviser registered pursuant to section 203 of the Investment Advisers Act of 1940 (“Investment Advisers Act”) or pursuant to the laws of any state, or a principal thereof;
(
(
(H) A “qualified purchaser” as defined in section 2(a)(51)(A) of the Investment Company Act of 1940 (“Investment Company Act”);
(I) A “knowledgeable employee” as defined in § 270.3c-5 of this title;
(J) With respect to an exempt pool:
(
(
(
(
(
(
(
(
(
(
(
(
(K) With respect to an exempt account:
(
(
(
(
(
(
(
(
(
(
(
(
(L) A trust;
(
(
(M) An organization described in section 501(c)(3) of the Internal Revenue Code (the “IRC”);
(N) A Non-United States person;
(O) An entity in which all of the unit owners or participants, other than the commodity trading advisor claiming relief under this section, are qualified eligible persons;
(P) An exempt pool; or
(Q) Notwithstanding paragraph (a)(6)(ii) of this section, an entity as to which a notice of eligibility has been filed pursuant to § 4.5 which is operated in accordance with such rule and in which all unit owners or participants, other than the commodity trading advisor claiming relief under this section, are qualified eligible persons.
(ii)
(A) An investment company registered under the Investment Company Act or a business development company as defined in section 2(a)(48) of such Act not formed for the specific purpose of either investing in the exempt pool or opening an exempt account;
(B) A bank as defined in section 3(a)(2) of the Securities Act of 1933 (the “Securities Act”) or any savings and loan association or other institution as defined in section 3(a)(5)(A) of the Securities Act acting for its own account or for the account of a qualified eligible person;
(C) An insurance company as defined in section 2(13) of the Securities Act acting for its own account or for the account of a qualified eligible person;
(D) A plan established and maintained by a state, its political subdivisions, or any agency or instrumentality of a state or its political subdivisions, for the benefit of its employees, if such plan has total assets in excess of $5,000,000;
(E) An employee benefit plan within the meaning of the Employee Retirement Income Security Act of 1974;
(F) A private business development company as defined in section 202(a)(22) of the Investment Advisers Act;
(G) An organization described in section 501(c)(3) of the IRC, with total assets in excess of $5,000,000;
(H) A corporation, Massachusetts or similar business trust, or partnership, limited liability company or similar business venture, other than a pool, which has total assets in excess of $5,000,000, and is not formed for the specific purpose of either participating in the exempt pool or opening an exempt account;
(I) A natural person whose individual net worth, or joint net worth with that person's spouse, at the time of either his purchase in the exempt pool or his opening of an exempt account would qualify him as an accredited investor as defined in § 230.501(a)(5) of this title;
(J) A natural person who would qualify as an accredited investor as defined in § 230.501(a)(6) of this title;
(K) A pool, trust, insurance company separate account or bank collective trust, with total assets in excess of $5,000,000, not formed for the specific purpose of either participating in the exempt pool or opening an exempt
(L) Except as provided for the governmental entities referenced in paragraph (a)(6)(ii)(D) of this section, if otherwise authorized by law to engage in such transactions, a governmental entity (including the United States, a state, or a foreign government) or political subdivision thereof, or a multinational or supranational entity or an instrumentality, agency, or department of any of the foregoing.
(7)
(b) * * *
(2) * * *
(i) Exemption from the specific requirements in §§ 4.24 and 4.26(d) with respect to each pool;
(A) A description of principal risk factors for the exempt pool, as required by § 4.24(g);
(B) A description of the exempt pool's investment program and use of proceeds, as required by § 4.24(h);
(C) A description of fees and expenses, as required by § 4.24(i);
(D) A description of conflicts of interest, as required by § 4.24(j);
(E) Performance disclosures, as required by § 4.25, with the exception of information required by paragraphs (a)(3) and (c)(2) of § 4.25;
(F) All other disclosures necessary to make the information contained therein, in the context in which it is furnished, not misleading; and
(G) The following statement, prominently disclosed on the cover page of the offering memorandum:
“PURSUANT TO AN EXEMPTION FROM THE COMMODITY FUTURES TRADING COMMISSION IN CONNECTION WITH POOLS WHOSE PARTICIPANTS ARE LIMITED TO QUALIFIED ELIGIBLE PERSONS, AN OFFERING MEMORANDUM FOR THIS POOL IS NOT REQUIRED TO BE, AND HAS NOT BEEN, FILED WITH THE COMMISSION. THE COMMODITY FUTURES TRADING COMMISSION DOES NOT PASS UPON THE MERITS OF PARTICIPATING IN A POOL OR UPON THE ADEQUACY OR ACCURACY OF AN OFFERING MEMORANDUM. CONSEQUENTLY, THE COMMODITY FUTURES TRADING COMMISSION HAS NOT REVIEWED OR APPROVED THIS OFFERING OR ANY OFFERING MEMORANDUM FOR THIS POOL PRIOR TO FIRST USE.”
(3) * * *
(iv) Where the exempt pool is invested in one or more other pools or funds operated by third parties, the commodity pool operator may choose instead to prepare and distribute to its pool participants statements signed and affirmed in accordance with § 4.22(h) on a monthly basis within 45 days of the month-end;
(5)
(c) * * *
(1) * * *
(i) Exemption from the specific requirements of §§ 4.34 and 4.36(d);
(A) A description of persons to be identified, as required by § 4.34(e);
(B) A description of principal risk factors, as required by § 4.34(g);
(C) A description of the exempt commodity trading advisor's trading program, as required by § 4.34(h);
(D) A description of fees, as required by § 4.34(i);
(E) A description of conflicts of interest, as required by § 4.34(j);
(F) Performance disclosures, as required by § 4.35;
(G) All additional disclosures necessary to make the information contained therein, in the context in which it is furnished, not misleading; and
(H) The following statement, prominently displayed on the cover page of the brochure or other disclosure statement:
“PURSUANT TO AN EXEMPTION FROM THE COMMODITY FUTURES TRADING COMMISSION IN CONNECTION WITH ACCOUNTS OF QUALIFIED ELIGIBLE PERSONS, THIS BROCHURE OR ACCOUNT DOCUMENT IS NOT REQUIRED TO BE, AND HAS NOT BEEN, FILED WITH THE COMMISSION. THE COMMODITY FUTURES TRADING COMMISSION DOES NOT PASS UPON THE MERITS OF PARTICIPATING IN A TRADING PROGRAM OR UPON THE ADEQUACY OR ACCURACY OF COMMODITY TRADING ADVISOR DISCLOSURE. CONSEQUENTLY, THE COMMODITY FUTURES TRADING COMMISSION HAS NOT REVIEWED OR APPROVED THIS TRADING PROGRAM OR THIS BROCHURE OR ACCOUNT DOCUMENT PRIOR TO FIRST USE.”
(2)
(d) * * *
(4)(i) Any exemption from the requirements of §§ 4.22, 4.23, 4.24, 4.25, and 4.26 claimed hereunder with respect to a pool shall not affect the obligation of the commodity pool
(ii) Any exemption from the requirements of §§ 4.33, 4.34, and 4.36 claimed hereunder shall not affect the obligation of the commodity trading advisor to comply with all other applicable provisions of this part, the Act and the Commission's rules and regulations, with respect to any qualified eligible person and any other client to which the commodity trading advisor provides or intends to provide commodity interest trading advice.
(a) * * *
(8) * * *
(i) * * *
(C) * * *
(
(a) * * *
(2) For the purpose of the Disclosure Document delivery requirement, including any offering memorandum delivered pursuant to § 4.7(b)(2)(i) or § 4.12(b)(2)(i), the term “prospective pool participant” does not include a commodity pool operated by a pool operator that is the same as, or that controls, is controlled by, or is under common control with, the pool operator of the offered pool.
The revisions read as follows:
(a) * * *
(4) For the purpose of the Account Statement delivery requirement, including any Account Statement distributed pursuant to § 4.7(b)(3) or § 4.12(b)(2)(ii), the term “participant” does not include a commodity pool operated by a pool operator that is the same as, or that controls, is controlled by, or is under common control with, the pool operator of a pool in which the commodity pool has invested.
(c) * * *
(7) For a pool that has ceased operation prior to, or as of, the end of the fiscal year, the commodity pool operator may provide the following, within 90 days of the permanent cessation of trading, in lieu of the annual report that would otherwise be required by § 4.22(c) or § 4.7(b)(4):
(8) For the purpose of the Annual Report distribution requirement, including any annual report distributed pursuant to § 4.7(b)(4) or § 4.12(b)(2)(iii), the term “participant” does not include a commodity pool operated by a pool operator that is the same as, or that controls, is controlled by, or is under common control with, the pool operator of a pool in which the commodity pool has invested;
(d)(1) Subject to the provisions of paragraphs (d)(2) and (g)(2) of this section, the financial statements in the Annual Report required by this section or by § 4.7(b)(4) must be presented and computed in accordance with United States generally accepted accounting principles consistently applied and must be audited by an independent public accountant;
(2)(i) Where a pool is organized in a jurisdiction other than the United States, the financial statements in the Annual Report required by this section or by § 4.7(b)(4) may be presented and computed in accordance with the generally accepted accounting principles, standards or practices followed in such other jurisdiction;
(f) * * *
(2) In the event a commodity pool operator finds that it cannot obtain information necessary to prepare annual financial statements for a pool that it operates within the time specified in paragraph (c) of this section or § 4.7(b)(4)(i), as a result of the pool investing in another collective investment vehicle, it may claim an extension of time under the following conditions:
(iv) * * *
(B) For all reports prepared under paragraph (c) of this section and for reports prepared under § 4.7(b)(4)(i) that are audited by an independent public accountant, the commodity pool operator has been informed by the independent public accountant engaged to audit the commodity pool's financial statements that specified information required to complete the pool's Annual Report is necessary in order for the accountant to render an opinion on the commodity pool's financial statements. The notice must include the name, main business address, main telephone number, and contact person of the accountant; and
(C) The information specified by the accountant cannot be obtained in sufficient time for the Annual Report to be prepared, audited, and distributed before the Extended Date.
The following appendices will not appear in the Code of Federal Regulations.
On this matter, Chairman Behnam and Commissioners Johnson and Goldsmith Romero voted in the affirmative. Commissioner Pham concurred. Commissioner Mersinger voted in the negative.
Federal regulation expressly establishes that customer protection is a core principle of and central to the oversight mission of the Commodity Futures Trading Commission (CFTC or Commission). For almost a century, mandatory disclosure has played a critical role in market regulation, directly shaping the development of the U.S. capital and derivatives markets.
The Commission allocates resources among registration and supervision responsibilities and enforcement actions to foster effective oversight of market participants and transactions. This approach not only enhances the integrity of markets, but effectively protects customers from material misrepresentations and fraud.
Congress has judiciously introduced Federal markets legislation, often in response to nationwide or global market-wide crises, and has carefully balanced Federal regulation with the role and significance of state regulatory oversight.
One hundred years ago, Congress passed the Grain Futures Act—the statute that was superseded by the Commodity Exchange Act (CEA) and that established the Grain Futures Administration (GFA, the predecessor of the CFTC)—authorizing the GFA to regulate certain commodity futures. A decade later, in the wake of the stock market crash of 1929 and the conclusion of the roaring '20s—a period characterized by a surging economy and intense market speculation accompanied by pervasive fraud in retail securities markets
Consistent with an adage made popular by U.S. Supreme Court Justice Louis Brandeis—“[s]unlight is said to be the best of disinfectants; electric light the most efficient policeman”
Disclosure increases transparency, reduces asymmetries of information, and mitigates fraud and manipulation as well as other misconduct in our financial markets. In the absence of mandatory disclosures, investors may have limited access to the material information needed to make a reasonable investment decision. Mandatory disclosure neutralizes incentives to misrepresent material information.
It is incumbent upon the Commission to continue to carry out this mandate reflected in the principles of Federal markets regulation and firmly established in the CEA.
Novel financial products, such as digital assets and innovative technologies like distributed digital ledger or blockchain technology and generative artificial intelligence, increasingly dominate regulatory discourse and popular discussions. The derivatives markets offer futures on digital assets, which are priced on a volatile spot market, employ technology that is highly complex and rapidly changing, and offer novel market structures including market structures designed to permit retail customers direct access to trading and clearing platforms. In some contexts, trading structures eliminate intermediaries such as a futures commission merchants (FCM), raising important questions regarding the best approach for preserving important customer protections such as segregation of customer assets.
As our markets are evolving, more and more vulnerable customers increasingly engage in complex derivatives activities. It is important that these customers have an opportunity to consider critical, material information when making an investment decision. Disclosure serves a valuable role in protecting customers.
Consequently, regulators must continuously revisit regulation to ensure that it remains fit for purpose. Our regulations must keep pace with innovation in our evolving markets. In particular, we must refresh our understanding of which customers may benefit from disclosure when investing, directly or indirectly, in derivatives markets.
I support the notice of proposed rulemaking (NPRM) regarding commodity pool operators (CPOs), commodity trading advisors (CTAs), and commodity pools operated under CFTC Regulation 4.7. The NPRM addresses regulatory gaps that have arisen due to, at least in part, the changing dynamics in the derivatives markets. The proposed amendments adapt the CFTC's existing regulations to reinforce, preserve, and promote customer protection safeguards. CFTC Regulation 4.7 dictates the disclosure obligations of CPOs and CTAs by establishing the test for classifying a natural person as a retail investor to whom extensive disclosures and financial reports must be delivered or a financially sophisticated investor with respect to whom a more streamlined process may be warranted.
Adopted in 1979, part 4 of the CFTC's regulations requires CPOs and CTAs to deliver disclosures and regular financial reports to pool participants or advisory clients.
CFTC Regulation 4.7, adopted in 1992, creates an exemption from certain part 4 requirements for CPOs and CTAs that privately offer or sell pool participations solely to qualified eligible persons (QEPs) pursuant to an exemption under the Securities Act or direct or guide the commodity trading accounts of QEPs. As a result, QEPs or wealthy individuals do not
A natural person, investing capital in a commodity pool or whose trading account invests in derivatives, would be a QEP if the individual is an “accredited investor,” as defined by the SEC in Regulation D under the Securities Act, and also meets the CFTC's portfolio requirement.
Recognizing that classifying individuals as QEPs may result in reduced regulatory protections, it is therefore critical that the Commission is careful in setting out the standard for determining that an individual is a QEP.
An individual customer may experience substantial losses if the market moves against the customer's positions. This concern is heightened by the fact that the participation interests acquired in an exempt pool offering are not registered offerings subject to the SEC's robust public offering disclosure regime outlined in public offering registration obligation.
Commodity pools are commonly hedge funds that may use leverage to magnify returns, engage in speculation, and take directional positions. These types of structured investment strategies may result in amplified losses for customers.
While our markets are undergoing unprecedented changes, robust customer protections must remain consistent and effective. Natural persons who currently meet the outdated thresholds in the portfolio requirement test introduced in 1992 are not necessarily sophisticated investors in today's markets. What's worse, under the existing regulation, individuals that meet the QEP test may not be receiving disclosures to be fully apprised of the risks associated with investing in novel derivatives instruments, whether directly or through a commodity pool, and our evolving markets.
This NPRM has two important objectives.
First, it doubles the financial thresholds of the portfolio requirement test to account for inflation since the exemption was adopted in 1992, thereby recalibrating the standard for determining which pool investors or advisory clients are QEPs.
Second, the NPRM sets a new minimum standard of disclosure regarding pools and trading programs that must be provided to all QEPs or wealthy investors, while retaining the more robust disclosure and reporting requirements applicable to non-QEPs or retail investors.
I appreciate the staff's efforts in heightening disclosure and enhancing customer protections and their cooperation in implementing my comments to refine the preamble and regulatory text concerning the specific disclosures that will be required under the proposed rule.
I am looking forward to thoughtful comments and responses from market participants. In particular, I welcome perspectives on the potential impact of the proposed rule changes on natural persons who are investing in exempt pools operated by a CPO, or are advisory clients of a CTA, that is relying on the exemptions under CFTC Regulation 4.7 and navigating our complex and evolving derivatives markets.
I regrettably dissent from the Commission's
First, I agree that it is time for the Commission to consider increasing the monetary thresholds in the “Portfolio Requirement” in the definition of a QEP in Rule 4.7(a) to account for inflation. As I previously have stated, “I believe that it is incumbent upon the CFTC, like any regulatory agency, to continually review its rule set to evaluate whether rules . . . need to be updated because they have simply failed to keep up with the times.”
Second, I support proposing a process in our rules that would permit CPOs relying on Rule 4.7 to elect an alternate account statement schedule that is consistent with exemptive letters issued regularly by the Commission. This schedule would address the fact that our current rule is not workable in the context of funds-of-funds, and also would generate more frequent reporting. As I previously have stated, “when one of our rules needs to be fixed because it is unworkable, ambiguous, or inefficient, corrective action by notice-and-comment rulemaking is the gold standard because it allows the Commission to hear from stakeholders and develop regulatory solutions that provide certainty.”
However, I cannot support the proposal to narrow the scope of the historical exemptions in Rule 4.7 by imposing universal disclosure requirements to QEPs. It represents a “mandate first, evaluate later” approach based on assumptions, speculation, and poor
Rule 4.7 provides exemptions for registered CPOs and CTAs operating commodity pools and trading programs restricted to QEPs (“4.7 CPOs and CTAs”) from, among other things, disclosure, recordkeeping, and use-and-filing requirements that otherwise would apply pursuant to the CFTC's rules. The rationale for the exemptions is that QEPs are sufficiently financially sophisticated, and have sufficient leverage and resources, to protect their own interests when participating in such pools and trading programs.
As explained in the Proposing Release, the definition of a QEP is bifurcated into two categories: (1) those pool participants or advisory clients that need to satisfy a “Portfolio Requirement” to be considered a QEP; and (2) those that do not. The Portfolio Requirement, in turn, can be met by satisfying either a Securities Portfolio Test of $2 million or an Initial Margin and Premium Test of $200,000, or a combination of the two.
The Commission is proposing to double the monetary thresholds of the Portfolio Requirement in the QEP definition to $4 million for the Securities Portfolio Test and $400,000 for the Initial Margin and Premium Test. This proposal is intended to account for inflation since Rule 4.7 was adopted in 1992.
At the same time, the Commission also is proposing to narrow the scope of Rule 4.7 by eliminating a significant portion of the current disclosure exemptions available to 4.7 CPOs and CTAs, thereby imposing universal disclosure requirements to QEPs. This is a “mandate first, evaluate later” approach to regulation that I strongly oppose.
The Proposing Release begins by observing that the number of 4.7 CPOs and CTAs, and the number of commodity pools and trading programs relying on Rule 4.7, have ballooned over the years.
The definition of QEP in Regulation 4.7 encompasses a broad spectrum of market participants from large fund complexes and other institutional investors with significant assets under management to individuals with varying backgrounds and experience, each of which has vastly different resources available to insist upon the disclosure of information regarding the offered 4.7 pool or trading program and then to analyze whatever information is provided.
Yet, this justification fails to consider that the increasing numbers of pools and trading programs relying on Rule 4.7, and of QEPs that may not have the wherewithal to protect their interests, may result from the erosion in the Portfolio Requirement's monetary thresholds due to inflation—which the Commission is now proposing to address. If the Commission appropriately adjusts the Portfolio Requirement thresholds for becoming a QEP to return them to levels comparable to when the Commission adopted the disclosure exemptions in Rule 4.7, then there is no logical reason why it should also eliminate those disclosure exemptions with respect to QEPs that still satisfy the new (higher) thresholds and are entirely capable of protecting their interests.
Another rationale the Proposing Release offers for imposing universal disclosure requirements to QEPs is that “the Commission has . . . witnessed a significant expansion and growth in the complexity and diversity of commodity interest products offered to QEPs via 4.7 pools and trading programs,” and “product innovation in the commodity interest markets has continued at a rapid and unrelenting pace.”
Yet, the Proposing Release offers no evidence to support its paternalistic conjecture that QEPs may not appreciate the nature of the risk associated with trading swaps in commodity pools and trading programs that rely on the exemptions in Rule 4.7. And there is no logical reason why such swap trading should now require a significant narrowing of the exemptions in Rule 4.7 more than a decade after Congress enacted a full regulatory regime for swaps in the Dodd-Frank Act
As for digital assets and technological innovation, the Proposing Release recognizes that it is relying on mere speculation. It candidly acknowledges that: (1) “Given the relatively recent development of digital assets,
Throughout the 30 years since Rule 4.7 was adopted, there has been a steady expansion of the number, complexity, and diversity of available derivatives products, and derivatives markets have undergone transformational changes resulting from technological innovation (none greater than the migration from open-outcry pit trading to all-electronic trading). Yet, through it all, there has never been any suggestion that the exemptions under Rule 4.7 needed to be significantly narrowed as a result.
We should not act based on what we don't know. More specifically, we should not impose universal disclosure requirements to QEPs based on speculation about hypothetical future developments. As markets continue to evolve and innovate as they always have done, we as regulators should evaluate first and then adopt regulations only as appropriate based on the results of that evaluation. Once again, this proposal has it exactly backwards.
Certainly, regulators must often act quickly when confronted with urgent circumstances. But that is hardly the case here.
The Proposing Release contains no indication that QEPs are clamoring for the Commission to require disclosures by 4.7 CPOs and CTAs. Indeed, one of the principal sources cited in support of the assertion that there is a problem that needs to be addressed is a roundtable—on CPO risk management practices—convened by CFTC staff way back in 2014.
Other support for the claim that the Commission needs to act consists of footnote citations to individual cases of alleged wrongdoing by 4.7 CPOs and CTAs. These footnotes cite news clippings reporting on allegations in deposition testimony, statements of litigation counsel, and litigation documents—with no indication whether these allegations were proved to be true.
Overall, the sourcing in the Proposing Release is woefully insufficient to support a proposal to impose universal disclosure requirements to QEPs on 4.7 CPOs and CTAs. There is no reason the Commission cannot undertake a proper evaluation of whether there really is a problem that needs to be addressed and, if so, the appropriate means to address it.
The Commission has a variety of tools at its disposal to undertake such an evaluation. For starters, our staff could convene a roundtable specifically devoted to this issue, so that the Commission would not have to look to comments at a roundtable in another context that occurred nine years ago. The Commission or staff also could issue a Request for Comment or an Advance Notice of Proposed Rulemaking—both tools that have been utilized recently
A sound notice of proposed rulemaking is characterized by, among other things: (1) transparency as to the agency's plans; and (2) requests for comment on key issues. This Proposing Release is deficient on both counts.
The Proposing Release is not fully transparent about the Commission's plans on two key issues.
Would these “former QEPs” be permitted to make additional investments in commodity pools and trading programs that are exempt under Rule 4.7 and in which they currently are investing? The Proposing Release explains that it would continue the requirement of existing Rule 4.7(a)(3)
I appreciate the rationale of existing Rule 4.7(a)(3) with respect to a participant in an exempt commodity pool whose financial resources drop below QEP thresholds. But I am not sure that same rationale should apply where a participant drops below QEP thresholds because the Commission is “moving the goalposts” by increasing those thresholds. I imagine there may be QEPs that are comfortable with their 4.7 CPOs, pleased by the performance of the 4.7 exempt pools in which they are participating, and satisfied with the information disclosures they have received—and that would like to be able to contribute additional funds to those investments.
The Commission should be forthright that the proposal would deny them this opportunity if they fall on the wrong side of the increased thresholds being proposed, and seek comment from potentially affected QEPs specifically on that issue. To shroud the issue in mystery in the Proposing Release is inconsistent with sound notice-and-comment rulemaking.
Second, the Proposing Release does transparently reveal that the CFTC would use universal disclosure requirements to QEPs imposed on 4.7 CPOs and CTAs as “an additional level of oversight” by “incorporating the review of [the new mandatory disclosures] into existing examination processes used by the Commission . . .”
What Commission programs or functions will have to be cut or curtailed in order for it to perform this new task? The public is entitled to know whether the CFTC's review of required disclosures to QEPs that are capable of protecting their own interests may come at the expense of, say, reductions in enforcement resources to prosecute those who defraud retail customers, or the Commission's oversight of derivatives exchanges and clearinghouses for which we are responsible by statute. But once again, the Proposing Release is silent.
It is somewhat startling how few questions the Proposing Release asks regarding its proposed amendments to Rule 4.7. Most notably, it does not even request comment on the foundational question of whether universal disclosure requirements to QEPs are needed. As discussed above, the Commission's justifications for the proposed requirements are poorly sourced and based largely on assumptions and allegations—but the Proposing Release does not ask the public if those assumptions and allegations are accurate.
Accordingly, since the Commission declines to ask these questions, I will. I invite comment—especially, but not exclusively, from QEPs—on the following questions regarding the amendments that the Commission is proposing to Rule 4.7:
1. Do QEPs agree that the Commission should impose universal disclosure requirements on 4.7 CPOs and CTAs? Why or why not?
2. Is the Commission correct in its preliminary belief that universal disclosure requirements to QEPs are necessary to address unequal bargaining power of QEPs? Would they be necessary if the Commission's proposed increases to the Portfolio Requirement monetary thresholds in the QEP definition are adopted?
3. Is the Commission correct in its preliminary belief that universal disclosure requirements to QEPs are necessary in light
4. Is the Commission correct in its preliminary belief that the development of markets for swaps and digital assets necessitates universal disclosure requirements to QEPs?
5. Are there alternative, more tailored, means by which the Commission could achieve its policy objectives than the universal disclosure requirements to QEPs that it is proposing? If so, please describe.
6. Should QEPs under existing Rule 4.7 that would no longer qualify as QEPs under the proposed amendments to the Portfolio Requirement thresholds in Rule 4.7 be permitted to contribute additional funds to exempt commodity pools operated by 4.7 CPOs in which they currently are participating? Why or why not?
7. Should the Commission impose universal disclosure requirements to QEPs that are capable of protecting their own interests in order to incorporate the review of such disclosures into its existing examination processes if such review comes at the expense of other Commission responsibilities? Why or why not?
8. To what extent will the proposed universal disclosure requirements to QEPs impact the benefits that 4.7 CPOs and CTAs derive from relying on the exemptions in Rule 4.7? Is it likely that 4.7 CPOs and CTAs will decide to no longer rely on the remaining exemptions afforded by Rule 4.7 if the proposed universal disclosure requirements to QEPs are adopted?
9. If a 4.7 CPO or CTA is registered as an investment adviser with the SEC and not subject to an exemption regarding disclosures required by the SEC, should the CFTC accept compliance with disclosures required by the SEC as sufficient to satisfy the proposed universal disclosure requirements to QEPs under Rule 4.7, too?
10. Is the Commission's PRA estimate of 1.5 annual burden hours per response for the disclosures proposed to be required of 4.7 CPOs and CTAs appropriate? If not, what would be an appropriate estimate?
Given my support for certain aspects of this proposal, and given my support for obtaining public input on initiatives to improve our rulebook generally, I wish that I could support the issuance of the Proposing Release. Unfortunately, because of its “mandate first, evaluate later” approach to the issue of disclosures to QEPs by 4.7 CPOs and CTAs, and its serious omissions in transparency and requests for comment, I cannot do so. Accordingly, I respectfully dissent.
I respectfully concur on the Notice of Proposed Rulemaking Regarding Commodity Pool Operators, Commodity Trading Advisors, and Commodity Pools Operated under Regulation 4.7: Updating the “Qualified Eligible Person” Definition; Adding Minimum Disclosure Requirements for Pools and Trading Programs; Permitting Monthly Account Statements for Funds of Funds; Technical Amendments (CPO/CTA NPRM), because I am concerned that the proposed changes for commodity pool operators (CPOs) and commodity trading advisors (CTAs) offering to or advising sophisticated clients, or “qualified eligible persons” (QEPs), are burdensome and unnecessary for entities that are already subject to extensive CFTC regulation or banking, securities, insurance, or other financial services regulation.
I reiterate the concerns in my prior dissent on the CFTC's proposed amendments to Form PF.
In a time of economic challenges, including rising inflation, we must be careful when considering proposals that could inhibit positive economic activity that supports American businesses and jobs. I look forward to hearing from commenters as to the proposed amendments, including practical implementation issues and the relative costs and benefits of the proposal.