83 FR 26685 - Request for the Technical Review of 3 Draft Immediately Dangerous to Life or Health (IDLH) Value Profiles
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 111 (June 8, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 111 (June 8, 2018)
| Page Range | 26685-26686 | |
| FR Document | 2018-12364 |
[Federal Register Volume 83, Number 111 (Friday, June 8, 2018)] [Notices] [Pages 26685-26686] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-12364] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [Docket Number CDC-2018-0055, NIOSH 156-D] Request for the Technical Review of 3 Draft Immediately Dangerous to Life or Health (IDLH) Value Profiles AGENCY: National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), [[Page 26686]] Department of Health and Human Services (HHS). ACTION: Request for comments. ----------------------------------------------------------------------- SUMMARY: The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of three (3) draft Immediately Dangerous to Life or Health (IDLH) Value Profiles now available for public comment for the chemicals bromine trifluoride, chlorine trifluoride, and ethylene dibromide. To view the notice and related materials, visit www.regulations.gov and enter CDC-2018-0055 in the search field and click ``Search.'' Table of ContentsDates Addresses For Further Information Contact Supplementary Information Background Reference DATES: Electronic or written comments must be received by August 7, 2018. ADDRESSES: You may submit comments, identified by CDC-2018-0055 and docket number NIOSH 156-D, by any of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Mail: National Institute for Occupational Safety and Health, NIOSH Docket Office, 1090 Tusculum Avenue, MS C-34, Cincinnati, Ohio 45226-1998. Instructions: All information received in response to this notice must include the agency name and docket number [CDC-2018-0055; NIOSH 156-D]. All relevant comments received will be posted without change to www.regulations.gov, including any personal information provided. For access to the docket to read background documents or comments received, go to www.regulations.gov. All information received in response to this notice will also be available for public examination and copying at the NIOSH Docket Office, 1150 Tusculum Avenue, Room 155, Cincinnati, OH 45226-1998. FOR FURTHER INFORMATION CONTACT: R. Todd Niemeier, NIOSH, Robert A. Taft Laboratories, MS-C32, 1090 Tusculum, Cincinnati, OH 45226, telephone (513) 533-8166 (not a toll free number). SUPPLEMENTARY INFORMATION: NIOSH is requesting technical reviews of the three (3) draft IDLH Value Profiles. To facilitate the review of these documents, NIOSH requests that the following questions be taken into consideration: 1. Does this document clearly outline the health hazards associated with acute (or short-term) exposures to the chemical? If not, what specific information is missing from the document? 2. Are the rationale and logic behind the derivation of an IDLH value for a specific chemical clearly explained? If not, what specific information is needed to clarify the basis of the IDLH value? 3. Are the conclusions supported by the data? 4. Are the tables clear and appropriate? 5. Is the document organized appropriately? If not, what improvements are needed? 6. Are you aware of any scientific data reported in governmental publications, databases, peer-reviewed journals, or other sources that should be included within this document? NIOSH seeks comments on 3 draft IDLH values and IDLH Value Profiles. The draft IDLH Value Profiles were developed to provide the scientific rationale behind derivation of IDLH values for the following chemicals: ------------------------------------------------------------------------ Document No. Chemical CAS No. ------------------------------------------------------------------------ C-01.......................... Bromine Trifluoride.. (7787-71-5) C-02.......................... Chlorine Trifluoride. (7790-91-2) C-03.......................... Ethylene Dibromide... (106-93-4) ------------------------------------------------------------------------ Each IDLH Value Profile provides a detailed summary of the health hazards of acute exposures to high airborne concentrations and the rationale for the proposed IDLH value with the chemical(s) of interest. Background: In 2013, NIOSH published Current Intelligence Bulletin (CIB) 66--Derivation of Immediately Dangerous to Life or Health (IDLH) Values [NIOSH 2013]. 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. 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. The primary objectives of this document are to: 1. Provide a brief history of the development of IDLH values. 2. Update the scientific bases and risk assessment methodology used to derive IDLH values from quality data. 3. Provide transparency behind the rationale and derivation process for IDLH values. 4. Demonstrate how scientifically credible IDLH values can be derived from available data resources. The IDLH methodology is based on a weight-of-evidence approach that applies scientific judgment for critical evaluation of the quality and consistency of scientific data and in extrapolation from the available data to the IDLH value. The weight-of-evidence approach refers to critical examination of all available data from diverse lines of evidence and the derivation of a scientific interpretation on the basis of the collective body of data, including its relevance, quality, and reported results. Conceptually, the derivation process for IDLH values is similar to that used in other risk-assessment applications, including these steps: 1. Hazard characterization. 2. Identification of critical adverse effects. 3. Identification of a POD. 4. Application of appropriate UFs, based on the study and POD. 5. Determination of the final risk value. Reference NIOSH [2013]. Current Intelligence Bulletin 66: Derivation of immediately dangerous to life or health (IDLH) values. Cincinnati, OH: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication 2014-100. Dated: June 5, 2018. John J. Howard, Director, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 2018-12364 Filed 6-7-18; 8:45 am] BILLING CODE 4163-19-P
![Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices 26685
DEPARTMENT OF HEALTH AND accessible, equitable, and affordable, The Council meets in the Washington,
HUMAN SERVICES and to work within the U.S. Department DC, metropolitan area, generally in
of Health and Human Services and with Rockville, Maryland, approximately
Agency for Healthcare Research and other partners to make sure that the three times a year to provide broad
Quality evidence is understood and used. guidance to the Secretary and AHRQ’s
DATES: Nominations should be received Director on the direction of and
Agency Information Collection programs undertaken by AHRQ.
Activities: Proposed Collection; on or before 60 days after date of
publication. Seven individuals will be selected by
Comment Request; Correction the Secretary to serve on the Council
ADDRESSES: Nominations should be sent beginning with the meeting in the
AGENCY: Agency for Healthcare Research
to Jaime Zimmerman AHRQ, 5600 spring of 2019. Members generally serve
and Quality (AHRQ), Department of
Fishers Lane, 06E37A, Rockville, 3-year terms. Appointments are
Health and Human Services.
Maryland 20857. Nominations may also staggered to permit an orderly rotation
ACTION: Notice, correction. be emailed to of membership.
SUMMARY: The Agency for Healthcare NationalAdvisoryCouncil@ahrq.hhs.gov. Interested persons may nominate one
Research and Quality published a FOR FURTHER INFORMATION CONTACT: or more qualified persons for
correction document in the Federal Jaime Zimmerman, AHRQ, at (301) 427– membership on the Council. Self-
Register of May 29, 2018 regarding 1456. nominations are accepted. Nominations
AHRQ Seeking Input on Library of SUPPLEMENTARY INFORMATION: 42 U.S.C. shall include: (1) A copy of the
Patient-Centered Outcomes Research 299c establishes a National Advisory nominee’s resume or curriculum vitae;
Resources. This document contained an Council for Healthcare Research and and (2) a statement that the nominee is
error in the email address where Quality (the Council). Seven current willing to serve as a member of the
comments should be submitted. members’ terms will expire in Council. Selected candidates will be
FOR FURTHER INFORMATION CONTACT: November 2018. To fill these positions, asked to provide detailed information
Carla Ladner at 301–427–1205 or we are seeking individuals who are concerning their financial interests,
AHRQ_Fed_Register@ahrq.hhs.gov. distinguished in: (1) The conduct of consultant positions and research grants
research, demonstration projects, and and contracts, to permit evaluation of
Correction possible sources of conflict of interest.
evaluations with respect to health care;
In the correction to the Federal (2) the fields of health care quality Please note that once a candidate is
Register of May 29, 2018, in FR Doc research or health care improvement; (3) nominated, AHRQ may consider that
2018–11472, on page 1, line 29, correct the practice of medicine; (4) other nomination for future positions on the
the caption under ADDRESSES to read: health professions; (5) representing the Council.
Electronic responses are preferred and private health care sector (including The Department seeks a broad
should be sent to: PCORResources@ health plans, providers, and purchasers) geographic representation. In addition,
ahrq.hhs.gov. or administrators of health care delivery AHRQ conducts and supports research
Dated: June 4, 2018. systems; (6) the fields of health care concerning priority populations, which
Carla M. Ladner, economics, information systems, law, include: Low-income groups; minority
Correspondence Analyst/Federal Register ethics, business, or public policy; and, groups; women; children; the elderly;
Liaison—AHRQ. (7) representing the interests of patients and individuals with special health care
[FR Doc. 2018–12312 Filed 6–7–18; 8:45 am] and consumers of health care. 42 U.S.C. needs, including individuals with
299c(c)(2). disabilities and individuals who need
BILLING CODE 4160–90–P
Individuals are particularly sought chronic care or end-of-life health care.
with experience and success in See 42 U.S.C. 299(c). Nominations of
DEPARTMENT OF HEALTH AND activities specified in the summary persons with expertise in health care for
HUMAN SERVICES above. 42 U.S.C. 299c provides that the these priority populations are
Secretary shall appoint to the National encouraged.
Agency for Healthcare Research and Advisory Council for Healthcare Francis D. Chesley, Jr.,
Quality Research and Quality twenty one Acting Deputy Director.
appropriately qualified individuals. At
Agency Information Collection [FR Doc. 2018–12361 Filed 6–7–18; 8:45 am]
least seventeen members shall be
Activities: Proposed Collection; representatives of the public and at least BILLING CODE 4160–90–P
National Advisory Council for one member shall be a specialist in the
Healthcare Research and Quality: rural aspects of one or more of the
Request for Nominations for Public DEPARTMENT OF HEALTH AND
professions or fields listed in the above HUMAN SERVICES
Members summary. In addition, the Secretary
AGENCY: Agency for Healthcare Research designates, as ex officio members, Centers for Disease Control and
and Quality (AHRQ), HHS. representatives from other Federal Prevention
ACTION: Notice of request for agencies, principally agencies that
conduct or support health care research, [Docket Number CDC–2018–0055, NIOSH
nominations for public members. 156–D]
as well as Federal officials the Secretary
SUMMARY: The Council is to advise the may consider appropriate. 42 U.S.C.
amozie on DSK3GDR082PROD with NOTICES1
Request for the Technical Review of 3
Secretary of HHS (Secretary) and the 299c(c)(3). Consistent with revised Draft Immediately Dangerous to Life or
Director of the Agency for Healthcare guidance regarding the ban on lobbyists Health (IDLH) Value Profiles
Research and Quality (AHRQ) on serving as members of advisory boards
matters related to activities of the and commissions, AHRQ will accept AGENCY: National Institute for
Agency to carry out its mission. AHRQ’s nominations for Federally-registered Occupational Safety and Health
mission is to produce evidence to make lobbyists to serve on the Council in a (NIOSH) of the Centers for Disease
health care safer, higher quality, more representative capacity. Control and Prevention (CDC),
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![26686 Federal Register / Vol. 83, No. 111 / Friday, June 8, 2018 / Notices
Department of Health and Human • Federal eRulemaking Portal: http:// facilitate the review of these documents,
Services (HHS). www.regulations.gov. Follow the NIOSH requests that the following
ACTION: Request for comments. instructions for submitting comments. questions be taken into consideration:
• Mail: National Institute for 1. Does this document clearly outline
SUMMARY: The National Institute for Occupational Safety and Health, NIOSH the health hazards associated with acute
Occupational Safety and Health of the Docket Office, 1090 Tusculum Avenue, (or short-term) exposures to the
Centers for Disease Control and MS C–34, Cincinnati, Ohio 45226–1998. chemical? If not, what specific
Prevention announces the availability of Instructions: All information received information is missing from the
three (3) draft Immediately Dangerous to in response to this notice must include document?
Life or Health (IDLH) Value Profiles the agency name and docket number 2. Are the rationale and logic behind
now available for public comment for [CDC–2018–0055; NIOSH 156–D]. All the derivation of an IDLH value for a
the chemicals bromine trifluoride, relevant comments received will be specific chemical clearly explained? If
chlorine trifluoride, and ethylene posted without change to not, what specific information is needed
dibromide. To view the notice and www.regulations.gov, including any to clarify the basis of the IDLH value?
related materials, visit personal information provided. For 3. Are the conclusions supported by
www.regulations.gov and enter CDC– access to the docket to read background the data?
2018–0055 in the search field and click documents or comments received, go to 4. Are the tables clear and
‘‘Search.’’ www.regulations.gov. All information appropriate?
received in response to this notice will 5. Is the document organized
Table of Contents also be available for public examination appropriately? If not, what
• Dates and copying at the NIOSH Docket improvements are needed?
• Addresses Office, 1150 Tusculum Avenue, Room 6. Are you aware of any scientific data
• For Further Information Contact 155, Cincinnati, OH 45226–1998. reported in governmental publications,
• Supplementary Information FOR FURTHER INFORMATION CONTACT:
• Background
databases, peer-reviewed journals, or
R. Todd Niemeier, NIOSH, Robert A. other sources that should be included
• Reference
Taft Laboratories, MS–C32, 1090 within this document?
DATES:Electronic or written comments Tusculum, Cincinnati, OH 45226, NIOSH seeks comments on 3 draft
must be received by August 7, 2018. telephone (513) 533–8166 (not a toll free IDLH values and IDLH Value Profiles.
ADDRESSES: You may submit comments, number). The draft IDLH Value Profiles were
identified by CDC–2018–0055 and SUPPLEMENTARY INFORMATION: NIOSH is developed to provide the scientific
docket number NIOSH 156–D, by any of requesting technical reviews of the three rationale behind derivation of IDLH
the following methods: (3) draft IDLH Value Profiles. To values for the following chemicals:
Document No. Chemical CAS No.
C–01 ........................................................................................ Bromine Trifluoride .................................................................. (7787–71–5)
C–02 ........................................................................................ Chlorine Trifluoride .................................................................. (7790–91–2)
C–03 ........................................................................................ Ethylene Dibromide ................................................................. (106–93–4)
Each IDLH Value Profile provides a 2. Update the scientific bases and risk 2. Identification of critical adverse
detailed summary of the health hazards assessment methodology used to derive effects.
of acute exposures to high airborne IDLH values from quality data. 3. Identification of a POD.
concentrations and the rationale for the 3. Provide transparency behind the
proposed IDLH value with the rationale and derivation process for 4. Application of appropriate UFs,
chemical(s) of interest. IDLH values. based on the study and POD.
Background: In 2013, NIOSH 4. Demonstrate how scientifically 5. Determination of the final risk
published Current Intelligence Bulletin credible IDLH values can be derived value.
(CIB) 66—Derivation of Immediately from available data resources.
The IDLH methodology is based on a Reference
Dangerous to Life or Health (IDLH)
Values [NIOSH 2013]. Since the weight-of-evidence approach that NIOSH [2013]. Current Intelligence Bulletin
establishment of the IDLH values in the applies scientific judgment for critical 66: Derivation of immediately dangerous
evaluation of the quality and to life or health (IDLH) values.
1970s, NIOSH has continued to review
consistency of scientific data and in Cincinnati, OH: U.S. Department of
available scientific data to improve the
extrapolation from the available data to Health and Human Services, Centers for
protocol used to derive acute exposure
the IDLH value. The weight-of-evidence Disease Control and Prevention, National
guidelines, in addition to the chemical-
approach refers to critical examination Institute for Occupational Safety and
specific IDLH values. The information
of all available data from diverse lines Health, DHHS (NIOSH) Publication
presented in this CIB represents the
of evidence and the derivation of a 2014–100.
most recent update of the scientific scientific interpretation on the basis of
amozie on DSK3GDR082PROD with NOTICES1
rationale and the methodology (hereby Dated: June 5, 2018.
the collective body of data, including its
referred to as the IDLH methodology) relevance, quality, and reported results. John J. Howard,
used to derive IDLH values. The Conceptually, the derivation process for Director, National Institute for Occupational
primary objectives of this document are IDLH values is similar to that used in Safety and Health, Centers for Disease Control
to: other risk-assessment applications, and Prevention.
1. Provide a brief history of the including these steps: [FR Doc. 2018–12364 Filed 6–7–18; 8:45 am]
development of IDLH values. 1. Hazard characterization. BILLING CODE 4163–19–P
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Document Created: 2018-06-08 01:21:57
Document Modified: 2018-06-08 01:21:57
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Request for comments. | |
| Dates | Electronic or written comments must be received by August 7, 2018. | |
| Contact | R. Todd Niemeier, NIOSH, Robert A. Taft Laboratories, MS-C32, 1090 Tusculum, Cincinnati, OH 45226, telephone (513) 533-8166 (not a toll free number). | |
| FR Citation | 83 FR 26685 |
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