Request for Information for Six Chemicals To Develop Immediately Dangerous to Life or Health (IDLH) Values., 61057-61058 [2019-24465]

Download as PDF Federal Register / Vol. 84, No. 218 / Tuesday, November 12, 2019 / Notices mitigation measures. These proposed interim registration review decisions are supported by the rationales included in those documents. Following public comment, the Agency will issue interim or final registration review decisions for the pesticides listed in Table 1 in Unit IV. The registration review final rule at 40 CFR 155.58(a) provides for a minimum 60-day public comment period on all proposed interim registration review decisions. This comment period is intended to provide an opportunity for public input and a mechanism for initiating any necessary amendments to the proposed interim decision. All comments should be submitted using the methods in ADDRESSES and must be received by EPA on or before the closing date. These comments will become part of the docket for the pesticides included in the Tables in Unit IV. Comments received after the close of the comment period will be marked ‘‘late.’’ EPA is not required to consider these late comments. The Agency will carefully consider all comments received by the closing date and may provide a ‘‘Response to Comments Memorandum’’ in the docket. The interim registration review decision will explain the effect that any comments had on the interim decision and provide the Agency’s response to significant comments. Background on the registration review program is provided at: https:// www.epa.gov/pesticide-reevaluation. Authority: 7 U.S.C. 136 et seq. Dated: October 29, 2019. Mary Reaves, Acting Director, Pesticide Re-Evaluation Division, Office of Pesticide Programs. [FR Doc. 2019–24514 Filed 11–8–19; 8:45 am] BILLING CODE 6560–50–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [CDC–2019–0093; NIOSH–156–E] Request for Information for Six Chemicals To Develop Immediately Dangerous to Life or Health (IDLH) Values. National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS). ACTION: Request for information. AGENCY: VerDate Sep<11>2014 17:47 Nov 08, 2019 Jkt 250001 The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to evaluate the scientific data for 6 chemicals—allyl alcohol, bromine chloride, hydrogen bromide, hydrogen iodide, lewisite (a chemical warfare agent), and propylene imine—to develop new or updated Immediately Dangerous to Life or Health (IDLH) values. DATES: Electronic or written comments must be received by January 13, 2020. ADDRESSES: You may submit comments, identified by CDC–2019–0093 and Docket Number NIOSH–156–E, by either of the two following methods: • Federal eRulemaking Portal: https:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: NIOSH Docket Office, Robert A. Taft Laboratories, MS–C34, 1090 Tusculum Avenue, Cincinnati, OH 45226. Instructions: All information received in response to this notice must include the agency name and docket number (CDC–2019–0093; NIOSH–156–E). All relevant comments received will be posted without change to https:// www.regulations.gov, including any personal information provided. All electronic comments should be formatted in Microsoft Word. Please make reference to CDC–2019–0093 and Docket Number NIOSH–156–E. FOR FURTHER INFORMATION CONTACT: R. Todd Niemeier, MS, NIOSH, MS–C32, 1090 Tusculum Avenue, Cincinnati, OH 45226, telephone (513) 533–8166. SUPPLEMENTARY INFORMATION: In 2013, NIOSH published Current Intelligence Bulletin (CIB) 66—Derivation of Immediately Dangerous to Life or Health (IDLH) Values [https://www.cdc.gov/ niosh/docs/2014-100/pdfs/2014100.pdf] [NIOSH 2013]. The information presented in this CIB represents the most recent update of the scientific rationale and the methodology (hereby referred to as the IDLH methodology) used to derive IDLH values. Since the establishment of the IDLH values in the 1970s, NIOSH has continued to review available scientific data to improve the protocol used to derive acute exposure guidelines, in addition to the chemicalspecific IDLH values. IDLH values are based on health effects considerations determined through a critical assessment of the toxicology and human health effects data. This approach ensures that the IDLH values reflect an airborne concentration of a substance that represents a high-risk situation that may endanger workers’ lives or health. SUMMARY: PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 61057 The primary steps applied in the establishment of an IDLH value include the following: 1. Critical review of human and animal toxicity data to identify potentially relevant studies and characterize the various lines of evidence that can support the derivation of the IDLH value; 2. Determination of a chemical’s mode of action (MOA) or description of how a chemical exerts its toxic effects; 3. Application of duration adjustments (time scaling) to determine 30-minute-equivalent exposure concentrations and the conduct of other dosimetry adjustments, as needed; 4. Experimental or other data to establish a point of departure (POD) such as lethal concentrations (e.g., LC50), lowest observed adverse effect level (LOAEL), or no observed adverse effect level (NOAEL); 5. Selection and application of an uncertainty factor (UF) for POD or critical adverse effect concentration, identified from the available studies to account for issues associated with interspecies and intraspecies differences, severity of the observed effects, data quality, or data insufficiencies; and 6. Development of the final recommendation for the IDLH value from the various alternative lines of evidence, with use of a weight-ofevidence approach to all of the data. NIOSH seeks to obtain materials, including published and unpublished reports and research findings, to evaluate the possible acute health risks of occupational exposure to the following six chemicals: 1. Allyl Alcohol (CAS# 107–18–6) 2. Bromine Chloride (CAS# 13863–41– 7) 3. Hydrogen Bromide (CAS# 10035–10– 6) 4. Hydrogen Iodide (CAS# 10034–85–2) 5. Lewisite (a chemical warfare agent) (CAS#s 541–25–3, 40334–69–8, 40334–70–1) 6. Propylene Imine (CAS# 75–55–8) Materials also include reports of acute animal toxicity studies, acute human toxicology studies, mode of action studies, and other information about a chemical’s toxic effects such as studies on sensory or respiratory irritation, nervous system effects (e.g., dizziness, central nervous system excitability, autonomic effects, muscle tone/ equilibrium effects, sensorimotor reactivity, nervous system histopathology), metabolic toxicants, target organ toxicants, gastrointestinal effects, cardiovascular changes, and asphyxiants. E:\FR\FM\12NON1.SGM 12NON1 61058 Federal Register / Vol. 84, No. 218 / Tuesday, November 12, 2019 / Notices In a subsequent notice, Draft IDLH Value profiles for these chemicals will be made available for public comment. Reference NIOSH [2013]. Current intelligence bulletin 66: derivation of immediately dangerous to life or health (IDLH) values. Cincinnati, OH: US Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication 2014–100. John J. Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 2019–24465 Filed 11–8–19; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–6089–N] Medicare, Medicaid, and Children’s Health Insurance Programs; Provider Enrollment Application Fee Amount for Calendar Year 2020 Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. AGENCY: This notice announces a $595.00 calendar year (CY) 2020 application fee for institutional providers that are initially enrolling in the Medicare or Medicaid program or the Children’s Health Insurance Program (CHIP); revalidating their Medicare, Medicaid, or CHIP enrollment; or adding a new Medicare practice location. This fee is required with any enrollment application submitted on or after January 1, 2020 and on or before December 31, 2020. DATES: The application fee announced in this notice is effective on January 1, 2020. FOR FURTHER INFORMATION CONTACT: Melissa Singer, (410) 786–0365. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background In the February 2, 2011 Federal Register (76 FR 5862), we published a final rule with comment period titled ‘‘Medicare, Medicaid, and Children’s Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers.’’ This VerDate Sep<11>2014 17:47 Nov 08, 2019 Jkt 250001 rule finalized, among other things, provisions related to the submission of application fees as part of the Medicare, Medicaid, and CHIP provider enrollment processes. As provided in section 1866(j)(2)(C)(i) of the Social Security Act (the Act) and in 42 CFR 424.514, ‘‘institutional providers’’ that are initially enrolling in the Medicare or Medicaid programs or CHIP, revalidating their enrollment, or adding a new Medicare practice location are required to submit a fee with their enrollment application. An ‘‘institutional provider’’ for purposes of Medicare is defined at § 424.502 as (a)ny provider or supplier that submits a paper Medicare enrollment application using the CMS–855A, CMS–855B (not including physician and non-physician practitioner organizations), CMS–855S, CMS–20134, or associated internetbased PECOS enrollment application. As we explained in the February 2, 2011 final rule (76 FR 5914), in addition to the providers and suppliers subject to the application fee under Medicare, Medicaid-only and CHIP-only institutional providers would include nursing facilities, intermediate care facilities for persons with intellectual disabilities (ICF/IID), psychiatric residential treatment facilities, and may include other institutional provider types designated by a state in accordance with their approved state plan. As indicated in §§ 424.514 and 455.460, the application fee is not required for either of the following: • A Medicare physician or nonphysician practitioner submitting a CMS–855I. • A prospective or revalidating Medicaid or CHIP provider— ++ Who is an individual physician or non-physician practitioner; or ++ That is enrolled in Title XVIII of the Act or another state’s Title XIX or XXI plan and has paid the application fee to a Medicare contractor or another state. II. Provisions of the Notice Section 1866(j)(2)(C)(i)(I) of the Act established a $500 application fee for institutional providers in calendar year (CY) 2010. Consistent with section 1866(j)(2)(C)(i)(II) of the Act, § 424.514(d)(2) states that for CY 2011 and subsequent years, the preceding year’s fee will be adjusted by the percentage change in the consumer price index (CPI) for all urban consumers (all items; United States city average, CPI U) for the 12 month period ending on June 30 of the previous year. Each year since 2011, accordingly, we have published in the Federal Register PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 an announcement of the application fee amount for the forthcoming CY based on the above formula. Most recently, in the November 19, 2018 Federal Register (83 FR 58255), we published a notice announcing a fee amount for the period of January 1, 2019 through December 31, 2019 of $586.00. The $586.00 fee amount for CY 2019 was used to calculate the fee amount for CY 2020 as specified in § 424.514(d)(2). According to Bureau of Labor Statistics (BLS) data, the CPU–U increase for the period of July 1, 2018 through June 30, 2019 was 1.6 percent. As required by § 424.514(d)(2), the preceding year’s fee of $586 will be adjusted by the CPI–U of 1.6 percent. This results in a CY 2020 application fee amount of $595.376 ($586 × 1.016). As we must round this to the nearest whole dollar amount, the resultant application fee amount for CY 2020 is $595.00. III. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping, or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995. However, it does reference previously approved information collections. The Forms CMS–855A, CMS–855B, and CMS–855I are approved under OMB control number 0938–0685; the Form CMS–855S is approved under OMB control number 0938–1056. IV. Regulatory Impact Statement A. Background We have examined the impact of this notice as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96– 354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104–4), Executive Order 13132 on Federalism (August 4, 1999), the Congressional Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing Regulation and Controlling Regulatory Costs (January 30, 2017). 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, E:\FR\FM\12NON1.SGM 12NON1

Agencies

[Federal Register Volume 84, Number 218 (Tuesday, November 12, 2019)]
[Notices]
[Pages 61057-61058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24465]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[CDC-2019-0093; NIOSH-156-E]


Request for Information for Six Chemicals To Develop Immediately 
Dangerous to Life or Health (IDLH) Values.

AGENCY: National Institute for Occupational Safety and Health (NIOSH) 
of the Centers for Disease Control and Prevention (CDC), Department of 
Health and Human Services (HHS).

ACTION: Request for information.

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

SUMMARY: The National Institute for Occupational Safety and Health 
(NIOSH) of the Centers for Disease Control and Prevention (CDC) intends 
to evaluate the scientific data for 6 chemicals--allyl alcohol, bromine 
chloride, hydrogen bromide, hydrogen iodide, lewisite (a chemical 
warfare agent), and propylene imine--to develop new or updated 
Immediately Dangerous to Life or Health (IDLH) values.

DATES: Electronic or written comments must be received by January 13, 
2020.

ADDRESSES: You may submit comments, identified by CDC-2019-0093 and 
Docket Number NIOSH-156-E, by either of the two following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: NIOSH Docket Office, Robert A. Taft Laboratories, 
MS-C34, 1090 Tusculum Avenue, Cincinnati, OH 45226.
    Instructions: All information received in response to this notice 
must include the agency name and docket number (CDC-2019-0093; NIOSH-
156-E). All relevant comments received will be posted without change to 
https://www.regulations.gov, including any personal information 
provided. All electronic comments should be formatted in Microsoft 
Word. Please make reference to CDC-2019-0093 and Docket Number NIOSH-
156-E.

FOR FURTHER INFORMATION CONTACT: R. Todd Niemeier, MS, NIOSH, MS-C32, 
1090 Tusculum Avenue, Cincinnati, OH 45226, telephone (513) 533-8166.

SUPPLEMENTARY INFORMATION: In 2013, NIOSH published Current 
Intelligence Bulletin (CIB) 66--Derivation of Immediately Dangerous to 
Life or Health (IDLH) Values [https://www.cdc.gov/niosh/docs/2014-100/pdfs/2014-100.pdf] [NIOSH 2013]. The information presented in this CIB 
represents the most recent update of the scientific rationale and the 
methodology (hereby referred to as the IDLH methodology) used to derive 
IDLH values. Since the establishment of the IDLH values in the 1970s, 
NIOSH has continued to review available scientific data to improve the 
protocol used to derive acute exposure guidelines, in addition to the 
chemical-specific IDLH values.
    IDLH values are based on health effects considerations determined 
through a critical assessment of the toxicology and human health 
effects data. This approach ensures that the IDLH values reflect an 
airborne concentration of a substance that represents a high-risk 
situation that may endanger workers' lives or health.
    The primary steps applied in the establishment of an IDLH value 
include the following:
    1. Critical review of human and animal toxicity data to identify 
potentially relevant studies and characterize the various lines of 
evidence that can support the derivation of the IDLH value;
    2. Determination of a chemical's mode of action (MOA) or 
description of how a chemical exerts its toxic effects;
    3. Application of duration adjustments (time scaling) to determine 
30-minute-equivalent exposure concentrations and the conduct of other 
dosimetry adjustments, as needed;
    4. Experimental or other data to establish a point of departure 
(POD) such as lethal concentrations (e.g., LC50), lowest observed 
adverse effect level (LOAEL), or no observed adverse effect level 
(NOAEL);
    5. Selection and application of an uncertainty factor (UF) for POD 
or critical adverse effect concentration, identified from the available 
studies to account for issues associated with interspecies and 
intraspecies differences, severity of the observed effects, data 
quality, or data insufficiencies; and
    6. Development of the final recommendation for the IDLH value from 
the various alternative lines of evidence, with use of a weight-of-
evidence approach to all of the data.
    NIOSH seeks to obtain materials, including published and 
unpublished reports and research findings, to evaluate the possible 
acute health risks of occupational exposure to the following six 
chemicals:

1. Allyl Alcohol (CAS# 107-18-6)
2. Bromine Chloride (CAS# 13863-41-7)
3. Hydrogen Bromide (CAS# 10035-10-6)
4. Hydrogen Iodide (CAS# 10034-85-2)
5. Lewisite (a chemical warfare agent) (CAS#s 541-25-3, 40334-69-8, 
40334-70-1)
6. Propylene Imine (CAS# 75-55-8)

    Materials also include reports of acute animal toxicity studies, 
acute human toxicology studies, mode of action studies, and other 
information about a chemical's toxic effects such as studies on sensory 
or respiratory irritation, nervous system effects (e.g., dizziness, 
central nervous system excitability, autonomic effects, muscle tone/
equilibrium effects, sensorimotor reactivity, nervous system 
histopathology), metabolic toxicants, target organ toxicants, 
gastrointestinal effects, cardiovascular changes, and asphyxiants.

[[Page 61058]]

    In a subsequent notice, Draft IDLH Value profiles for these 
chemicals will be made available for public comment.

Reference

    NIOSH [2013]. Current intelligence bulletin 66: derivation of 
immediately dangerous to life or health (IDLH) values. Cincinnati, OH: 
US Department of Health and Human Services, Centers for Disease Control 
and Prevention, National Institute for Occupational Safety and Health, 
DHHS (NIOSH) Publication 2014-100.

John J. Howard,
Director, National Institute for Occupational Safety and Health, 
Centers for Disease Control and Prevention.
[FR Doc. 2019-24465 Filed 11-8-19; 8:45 am]
 BILLING CODE 4163-18-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.