82 FR 13809 - Draft Current Intelligence Bulletin: The Occupational Exposure Banding Process: Guidance for the Evaluation of Chemical Hazards; Notice of Public Meeting; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 82, Issue 49 (March 15, 2017)
Centers for Disease Control and Prevention
Federal Register Volume 82, Issue 49 (March 15, 2017)
| Page Range | 13809-13811 | |
| FR Document | 2017-05115 |
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)] [Notices] [Pages 13809-13811] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-05115] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention [CDC-2017-0028, Docket Number NIOSH-290] Draft Current Intelligence Bulletin: The Occupational Exposure Banding Process: Guidance for the Evaluation of Chemical Hazards; Notice of Public Meeting; Request for Comments 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: Notice of public meeting and availability of draft document for public comment. ----------------------------------------------------------------------- SUMMARY: The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the availability of a draft Current Intelligence Bulletin entitled The Occupational Exposure Banding Process: Guidance for the Evaluation of Chemical Hazards for public comment. NIOSH is seeking comments on the draft document and plans to have a public meeting to discuss the document. The draft document can be found at www.regulations.gov by entering CDC-2017-0028 in the search field and clicking ``Search.'' Table of ContentsDates Addresses For Further Information Contact Supplementary Information Background DATES: A public meeting will be held on Tuesday, May 23, 2016, from 9:00 a.m. to 3:00 p.m. Eastern Time, or until the last public presenter has spoken, whichever occurs first. Please note that public comments may end before the time indicated following the last call for comments. Members of the public who wish to provide public comments should plan to attend the meeting at the start time listed. Electronic or written comments must be received by June 13, 2017. ADDRESSES: The public meeting will be held at the Robert A. Taft Laboratories, Auditorium, 1150 Tusculum Avenue, Cincinnati, Ohio 45226. The meeting will also be available through a conference call phone number and Webcast live on the Internet for a limited number of participants. Written Comments: You may submit written comments, identified by CDC-2017-0028 and Docket Number NIOSH-290, by either of the following two methods: Federal eRulemaking Portal: 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. All information received in response to this notice must include the agency name and docket number [CDC-2017-0028; NIOSH-290]. All relevant comments received, including any personal information provided, will be posted without change to www.regulations.gov. To access the docket, read background documents or read comments, go to www.regulations.gov and enter CDC-2017-0028 in the search field and clicking ``Search.'' All information received in response to this notice will be available for public examination and [[Page 13810]] copying at the NIOSH Docket Office, 1150 Tusculum Avenue, Room 155, Cincinnati, Ohio 45226-1998. FOR FURTHER INFORMATION CONTACT: Melissa Seaton, NIOSH, Education and Information Division, 1090 Tusculum Avenue, MS C-32, Cincinnati, OH 45226, telephone (513) 533-8248, Fax (513) 533-8230 (not toll free numbers), email [email protected]. SUPPLEMENTARY INFORMATION: Registration: Notification of intent to attend the meeting, for both in-person and remote participation, or to provide oral comments must be made to the NIOSH Docket Office, at [email protected], (513) 533-8611 (not a toll free number), no later than April 21, 2017 for U.S. citizens, and no later than April 7, 2017 for non-U.S. citizens, to allow sufficient time for mandatory facility security clearance procedures to be completed. Priority for attendance will be given to those providing oral comments. Other requests to attend the meeting will then be accommodated on a first-come, first-served basis. All requests to present should contain the name, address, telephone number, and relevant business affiliations of the presenter, topic of the presentation, whether you will be presenting in person or by phone, and the approximate time requested for the presentation. Oral presentations will be limited to 15 minutes per presenter. If additional time becomes available, presenters will be notified. After reviewing the requests for presentations, NIOSH will notify the presenter when his/her presentation is scheduled. If a participant is not in attendance when his/her presentation is scheduled to begin, the remaining participants will be heard in order. After the last scheduled speaker is heard, participants who missed their assigned times may be allowed to speak, limited by time available. Oral comments given at the meeting will be recorded and included in the docket. Attendees who wish to speak but did not submit a request for the opportunity to make a presentation may be given this opportunity after the scheduled speakers are heard, at the discretion of the presiding officer and limited by time available. Status: The meeting is open to the public, limited only by the space available. The meeting space accommodates approximately 100 people. In addition, there will be an audio conference for those who cannot attend in person. There is no registration fee to attend this public meeting. However, those wishing to attend are encouraged to sign up by April 21, 2017 with the contact person in this notice. Security Considerations: Due to mandatory security clearance procedures at the Robert A Taft Laboratories, in-person attendees must present valid government-issued picture identification to security personnel upon entering the building and go through an airport-type security check. Non-U.S. citizens: are encouraged to participate in the audio conferencing due to the extra clearance involved with in-person attendance. To attend in person, a non-U.S. citizen will have to call or send an email before April 7, 2017 to the contact person in this notice, and provide passport information. If clearance is received, you will be notified; otherwise, you will not be able to attend the meeting in person. Non-U.S. Citizens must provide the following information in writing to the NIOSH Docket Office at the address above no later than April 7, 2017: Name; gender; date of birth; place of birth (city, province, state, country); citizenship; passport number; date of passport issue; date of passport expiration; type of visa; U.S. naturalization number (if a naturalized citizen); U.S. naturalization date (if a naturalized citizen); visitor's organization; organization address; organization telephone number; visitor's position/title within the organization. This information will be transmitted to the CDC Security Office for approval. Visitors will be notified as soon as approval has been obtained. If access approval is not granted to a non-U.S. Citizen, the individual may participate through a conference call phone number and Webcast live on the Internet. Background Occupational exposure banding is a process of quickly assigning chemicals into specific categories or bands. These bands are assigned based on a chemical's potency and the negative health outcomes associated with exposure to the chemical. The output of this process is an occupational exposure band (OEB), which corresponds to a range of exposure concentrations that is expected to be protective to worker health. Recently NIOSH has developed a process to apply the occupational exposure banding process to a broad spectrum of occupational settings. The NIOSH occupational exposure banding process uses available, but often limited, toxicological data to determine a potential range of chemical exposure levels that can be used as targets for exposure controls to reduce risk among workers. The purpose of the public meeting and public comment period is to obtain comments on the draft document. Comments are being sought from individuals including scientists and representatives from various government agencies, industry, labor, and other stakeholders, and also the public. If there are errors of fact, unsubstantiated claims, evidence of careless experimental work, inclusion of too much information already in the literature, or statements that are inaccurate, please note such in your review comments. I. Technical Review and Charge Questions. The authors ask that special emphasis be placed on technical review of the following issues: 1. If a chemical can cause an immediate effect (necrosis, sensitization, pulmonary edema, central nervous system (CNS) effects), should there be special guidelines for assigning a short term OEB or emphasizing the importance of keeping even short duration exposures below the OEB for those types of toxicants? 2. If a skin toxicant is a corrosive, irritant, or sensitizer, should there be any special designation assigned along with the occupational exposure band (OEB)? Additionally, please comment on the utility of using skin and eye effects to create inhalation based bands. 3. The comparison of Tier 1 and Tier 2 results for a set of chemicals showed that Tier 1 and Tier 2 produce the same band for 65% of the chemicals tested. Tier 1 is more protective for 17.5% of the chemicals, while Tier 2 is more protective for 17.5% of the chemicals. NIOSH currently recommends that both the tier 1 and tier 2 process be completed for a particular chemical. Do you agree with this recommendation? If not, what approach should NIOSH take? 4. NIOSH has proposed a number of sources of information for the different human health and toxicological endpoints under consideration. Are there other sources of information that should be recommended? Are there some sources that should be omitted? 5. In tier 1, the NIOSH method does not currently assign chemicals to an OEB based on H335 or H336 (drowsiness and dizziness). Should NIOSH include H335/H336 in the tier 1 methodology? If so, what criteria should be used for banding and why? 6. In Section 3.2 the process for assessing whether enough information is available to conduct occupational exposure banding is presented. Please comment on the use of a numerical scale (determinant scores) to document endpoint-specific data availability. Further, is the minimum value of 30 out [[Page 13811]] of a possible total of 125 (for the total determinant score) a suitable choice for the data sufficiency threshold? Is the relative weight for each score appropriate? 7. How should NIOSH consider data collected on structural analogs or related chemicals in the banding scheme? 8. Qualitative and quantitative technical criteria have been adopted for some endpoints. Is this approach adequately justified and suitably explained in the document? If not, how should the explanations be refined? 9. If a chemical has two forms (vapor or particulate) in the workplace, we have recommended that the most protective OEB take precedence. Please comment on the utility and adequacy of that recommendation. 10. Acute toxicity information may be presented in an array of different units. We have attempted to address those possibilities in the banding criteria for the acute toxicity endpoint, especially for inhalation exposures. Is this information sufficiently clear? Are suitable rubrics for unit conversions provided? 11. Does this draft document adequately describe the occupational exposure banding process in a way that supports its use in assigning ranges of exposure concentrations to protect worker health in the occupational setting? Public Review The external review of the draft document has been (1) developed in accordance with Office of Management and Budget (OMB) guidelines, (2) is consistent with NIOSH peer review practice, and (3) is meant to ensure that credible and appropriate science is reflected within the draft document. Dated: March 10, 2017. Frank Hearl, Chief of Staff, National Institute for Occupational Safety and Health, Centers for Disease Control and Prevention. [FR Doc. 2017-05115 Filed 3-14-17; 8:45 am] BILLING CODE 4163-19-P
![Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices 13809
Patient Safety and Quality Improvement and Patient Safety Rule, when a PSO Control and Prevention (CDC)
Final Rule, 42 CFR part 3 (Patient Safety chooses to voluntarily relinquish its announces the availability of a draft
Rule), published in the Federal Register status as a PSO for any reason, or when Current Intelligence Bulletin entitled
on November 21, 2008, establish a a PSO’s listing expires. Section 3.108(d) The Occupational Exposure Banding
framework by which hospitals, doctors, of the Patient Safety Rule requires Process: Guidance for the Evaluation of
and other health care providers may AHRQ to provide public notice when it Chemical Hazards for public comment.
voluntarily report information to Patient removes an organization from the list of NIOSH is seeking comments on the draft
Safety Organizations (PSOs), on a federally approved PSOs. document and plans to have a public
privileged and confidential basis, for the AHRQ has accepted a notification meeting to discuss the document. The
aggregation and analysis of patient from the MagMutual Patient Safety draft document can be found at
safety events. The Patient Safety Rule Institute, LLC, a component entity of www.regulations.gov by entering CDC–
authorizes AHRQ, on behalf of the MAG Mutual Insurance Company, PSO 2017–0028 in the search field and
Secretary of HHS, to list as a PSO an number P0159, to voluntarily relinquish clicking ‘‘Search.’’
entity that attests that it meets the its status as a PSO. Accordingly, the
Table of Contents
statutory and regulatory requirements MagMutual Patient Safety Institute, LLC
for listing. A PSO can be ‘‘delisted’’ by was delisted effective at 12:00 Midnight • Dates
the Secretary if it is found to no longer ET (2400) on February 21, 2017. • Addresses
meet the requirements of the Patient The MagMutual Patient Safety • For Further Information Contact
Safety Act and Patient Safety Rule, Institute, LLC has patient safety work • Supplementary Information
• Background
when a PSO chooses to voluntarily product (PSWP) in its possession. The
relinquish its status as a PSO for any PSO will meet the requirements of DATES: A public meeting will be held on
reason, or when a PSO’s listing expires. section 3.108(c)(2)(i) of the Patient Tuesday, May 23, 2016, from 9:00 a.m.
AHRQ has accepted a notification of Safety Rule regarding notification to to 3:00 p.m. Eastern Time, or until the
voluntary relinquishment from the providers that have reported to the PSO. last public presenter has spoken,
MagMutual Patient Safety Institute, LLC In addition, according to sections whichever occurs first. Please note that
of its status as a PSO, and has delisted 3.108(c)(2)(ii) and 3.108(b)(3) of the public comments may end before the
the PSO accordingly. Patient Safety Rule regarding time indicated following the last call for
DATES: The directories for both listed disposition of PSWP, the PSO has 90 comments. Members of the public who
and delisted PSOs are ongoing and days from the effective date of delisting wish to provide public comments
reviewed weekly by AHRQ. The and revocation to complete the should plan to attend the meeting at the
delisting was effective at 12:00 Midnight disposition of PSWP that is currently in start time listed. Electronic or written
ET (2400) on February 21, 2017. the PSO’s possession. comments must be received by June 13,
ADDRESSES: Both directories can be More information on PSOs can be 2017.
accessed electronically at the following obtained through AHRQ’s PSO Web site ADDRESSES: The public meeting will be
HHS Web site: http:// at http://www.pso.ahrq.gov. held at the Robert A. Taft Laboratories,
www.pso.ahrq.gov/listed. Sharon B. Arnold, Auditorium, 1150 Tusculum Avenue,
FOR FURTHER INFORMATION CONTACT: Acting Director. Cincinnati, Ohio 45226. The meeting
Eileen Hogan, Center for Quality [FR Doc. 2017–05073 Filed 3–14–17; 8:45 am]
will also be available through a
Improvement and Patient Safety, AHRQ, conference call phone number and
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5600 Fishers Lane, Room 06N94B, Webcast live on the Internet for a
Rockville, MD 20857; Telephone (toll limited number of participants.
free): (866) 403–3697; Telephone (local): DEPARTMENT OF HEALTH AND Written Comments: You may submit
(301) 427–1111; TTY (toll free): (866) HUMAN SERVICES written comments, identified by CDC–
438–7231; TTY (local): (301) 427–1130; 2017–0028 and Docket Number NIOSH–
Email: pso@ahrq.hhs.gov. Centers for Disease Control and 290, by either of the following two
SUPPLEMENTARY INFORMATION: Prevention methods:
• Federal eRulemaking Portal:
Background [CDC–2017–0028, Docket Number NIOSH– www.regulations.gov. Follow the
290] instructions for submitting comments.
The Patient Safety Act, 42 U.S.C.
299b–21 to b–26, authorizes the listing • Mail: National Institute for
Draft Current Intelligence Bulletin: The
of PSOs, which are entities or Occupational Safety and Health, NIOSH
Occupational Exposure Banding
component organizations whose Docket Office, 1090 Tusculum Avenue,
Process: Guidance for the Evaluation
mission and primary activity are to MS C–34, Cincinnati, Ohio 45226–1998.
of Chemical Hazards; Notice of Public
conduct activities to improve patient All information received in response
Meeting; Request for Comments
safety and the quality of health care to this notice must include the agency
delivery. AGENCY: National Institute for name and docket number [CDC–2017–
HHS issued the Patient Safety Rule to Occupational Safety and Health 0028; NIOSH–290]. All relevant
implement the Patient Safety Act. (NIOSH) of the Centers for Disease comments received, including any
AHRQ administers the provisions of the Control and Prevention (CDC), personal information provided, will be
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
Patient Safety Act and Patient Safety Department of Health and Human posted without change to
Rule relating to the listing and operation Services (HHS). www.regulations.gov. To access the
of PSOs. The Patient Safety Rule ACTION: Notice of public meeting and docket, read background documents or
authorizes AHRQ to list as a PSO an availability of draft document for public read comments, go to
entity that attests that it meets the comment. www.regulations.gov and enter CDC–
statutory and regulatory requirements 2017–0028 in the search field and
for listing. A PSO can be ‘‘delisted’’ if SUMMARY: The National Institute for clicking ‘‘Search.’’ All information
it is found to no longer meet the Occupational Safety and Health received in response to this notice will
requirements of the Patient Safety Act (NIOSH) of the Centers for Disease be available for public examination and
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![Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices 13811
of a possible total of 125 (for the total DEPARTMENT OF HEALTH AND Hazard Analysis and Critical Control
determinant score) a suitable choice for HUMAN SERVICES Point (HACCP) Procedures for the Safe
the data sufficiency threshold? Is the and Sanitary Processing and Importing
relative weight for each score Food and Drug Administration of Juice—21 CFR Part 120
appropriate? OMB Control Number 0910–0466—
7. How should NIOSH consider data [Docket No. FDA–2013–N–1427] Extension
collected on structural analogs or FDA’s regulations in part 120 (21 CFR
related chemicals in the banding Agency Information Collection
Activities; Submission for Office of part 120) mandate the application of
scheme? HACCP procedures to the processing of
Management and Budget Review;
8. Qualitative and quantitative Comment Request; Hazard Analysis fruit and vegetable juices. HACCP is a
technical criteria have been adopted for and Critical Control Point Procedures preventative system of hazard control
some endpoints. Is this approach for the Safe and Sanitary Processing designed to help ensure the safety of
adequately justified and suitably foods. The regulations were issued
and Importing of Juice
explained in the document? If not, how under FDA’s statutory authority to
should the explanations be refined? AGENCY: Food and Drug Administration, regulate food safety under section
HHS. 402(a)(4) of the Federal Food, Drug, and
9. If a chemical has two forms (vapor
Cosmetic Act (the FD&C Act) (21 U.S.C.
or particulate) in the workplace, we ACTION: Notice. 342(a)(4)). Under section 402(a)(4) of the
have recommended that the most FD&C Act, a food is adulterated if it is
protective OEB take precedence. Please SUMMARY: The Food and Drug prepared, packed, or held under
comment on the utility and adequacy of Administration (FDA) is announcing insanitary conditions whereby it may
that recommendation. that a proposed collection of have been contaminated with filth or
10. Acute toxicity information may be information has been submitted to the rendered injurious to health. The
presented in an array of different units. Office of Management and Budget Agency also has authority under section
We have attempted to address those (OMB) for review and clearance under 361 of the Public Health Service Act (42
possibilities in the banding criteria for the Paperwork Reduction Act of 1995. U.S.C. 264) to issue and enforce
the acute toxicity endpoint, especially regulations to prevent the introduction,
for inhalation exposures. Is this DATES: Fax written comments on the transmission, or spread of
information sufficiently clear? Are collection of information by April 14, communicable diseases from one State,
suitable rubrics for unit conversions 2017. territory, or possession to another, or
provided? from outside the United States into this
ADDRESSES: To ensure that comments on country. Under section 701(a) of the
11. Does this draft document the information collection are received, FD&C Act (21 U.S.C. 371(a)), FDA is
adequately describe the occupational OMB recommends that written authorized to issue regulations for the
exposure banding process in a way that comments be faxed to the Office of efficient enforcement of that act.
supports its use in assigning ranges of Information and Regulatory Affairs, Under HACCP, processors of fruit and
exposure concentrations to protect OMB, Attn: FDA Desk Officer, FAX: vegetable juices establish and follow a
worker health in the occupational 202–395–7285, or emailed to oira_ preplanned sequence of operations and
setting? submission@omb.eop.gov. All observations (the HACCP plan) designed
comments should be identified with the to avoid or eliminate one or more
Public Review
OMB control number 0910–0466. Also specific food hazards, and thereby
The external review of the draft include the FDA docket number found ensure that their products are safe,
document has been (1) developed in in brackets in the heading of this wholesome, and not adulterated; in
accordance with Office of Management document. compliance with section 402 of the
and Budget (OMB) guidelines, (2) is FD&C Act. Information development
FOR FURTHER INFORMATION CONTACT: FDA and recordkeeping are essential parts of
consistent with NIOSH peer review
PRA Staff, Office of Operations, Food any HACCP system. The information
practice, and (3) is meant to ensure that
and Drug Administration, Three White collection requirements are narrowly
credible and appropriate science is
Flint North, 10A63, 11601 Landsdown tailored to focus on the development of
reflected within the draft document.
St., North Bethesda, MD 20852, appropriate controls and document
Dated: March 10, 2017. PRAStaff@fda.hhs.gov. those aspects of processing that are
Frank Hearl, critical to food safety.
SUPPLEMENTARY INFORMATION: In
Chief of Staff, National Institute for In the Federal Register of August 30,
compliance with 44 U.S.C. 3507, FDA 2016 (81 FR 59636), FDA published a
Occupational Safety and Health, Centers for
has submitted the following proposed 60-day notice requesting public
Disease Control and Prevention.
collection of information to OMB for comment on the proposed collection of
[FR Doc. 2017–05115 Filed 3–14–17; 8:45 am]
review and clearance. information. No comments were
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received.
FDA estimates the burden of this
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
collection of information as follows:
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Document Created: 2017-03-15 06:04:54
Document Modified: 2017-03-15 06:04:54
| 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 | Notice of public meeting and availability of draft document for public comment. | |
| Dates | A public meeting will be held on Tuesday, May 23, 2016, from 9:00 a.m. to 3:00 p.m. Eastern Time, or until the last public presenter has spoken, whichever occurs first. Please note that public comments may end before the time indicated following the last call for comments. Members of the public who wish to provide public comments should plan to attend the meeting at the start time listed. Electronic or written comments must be received by June 13, 2017. | |
| Contact | Melissa Seaton, NIOSH, Education and Information Division, 1090 Tusculum Avenue, MS C-32, Cincinnati, OH 45226, telephone (513) 533-8248, Fax (513) 533-8230 (not toll free numbers), email [email protected] | |
| FR Citation | 82 FR 13809 |
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