Health Effects of Occupational Exposure to Silver Nanomaterials

The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention held public reviews in 2016 and 2018, including public meetings, concerning public review and discussion of draft document entitled Draft Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials. The purpose of these meetings was to provide a forum for discussion about each draft document, to request feedback and comments, and to allow the public and stakeholders to make presentations and ask clarifying questions of NIOSH.

The public meetings were held on March 23, 2016, and October 30, 2018. NIOSH considered the public, stakeholder, and peer review comments received on the 2016 draft document in developing the 2018 draft document. Further information about the two draft documents and public comment periods including public meetings was published in the Federal Register on September 18, 2018 [83 FR 181]. The public, stakeholder, and peer review comments received on the 2018 draft document were considered in developing the final 2021 publication.

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To view the notice and related materials, visit http://www.regulations.gov and enter CDC-2016-0001 in the search field and click “Search.”

Second peer review

Title: Draft NIOSH Current Intelligence Bulletin: Health Effects of Occupational Exposure to Silver Nanomaterials

Subject: Occupational exposure to silver and silver nanomaterials.

Purpose: NIOSH has developed a draft technical report that provides a critical review of available scientific literature and data relating to occupational exposures to silver and silver nanomaterials. The technical report provides recommendations for the safe handling of these materials including a recommended exposure limit (REL).

Timing of Second Review: September – November 2018

Primary Disciplines or Expertise Needed for Review: Industrial hygiene; toxicology; occupational health; risk assessment; epidemiology.

Type of Review: Individual

Number of Reviewers: 4-6

Reviewers Selected by: NIOSH

Public Nominations Requested for Reviewers: No

Opportunities for the Public to Comment: Yes

Peer Reviewers Provided with Public Comments Before Their Review: No

Charge to Peer Reviewers:

1. Does the document accurately identify and characterize the health hazards of exposures to silver and silver nanomaterials based on available scientific literature?
2. Are the risk assessment and dosimetry modeling methods presented in the draft document consistent with current scientific knowledge and practice?
3. Is the relationship between exposure to silver nanomaterials and biological activity (toxicity) accurately portrayed in the draft document?
4. Is the available scientific evidence fully described regarding the human health relevance of the adverse health endpoints observed in rats associated with exposure to silver nanomaterials?
5. Are the sampling and analytical methods for silver and silver nanomaterials adequate to measure worker exposure?
6. Are the recommended strategies for controlling exposure to silver and silver nanomaterials (e.g. engineering controls, work practices, personal protective equipment) reasonable?
7. Is the proposed recommended exposure limit (REL) well-supported by the science presented in the document?
8. Are the important data gaps and future research needs complete and clearly described?

First peer review

Timing of First Review: January – April 2016

Primary Disciplines or Expertise Needed for Review: Industrial hygiene; toxicology; occupational health; risk assessment; epidemiology.

Type of Review: Individual

Number of Reviewers: 4

Reviewers Selected by: NIOSH

Public Nominations Requested for Reviewers: No

Opportunities for the Public to Comment: Yes

Peer Reviewers Provided with Public Comments Before Their Review: No

Peer Reviewers

1. Karin Aschberger, MS, MAS, PhD
   Scientific Officer, European Commission, Joint Research Centre
   Institute for Health and Consumer Protection, Systems Toxicology Unit
   Expertise: health risk assessment, nanomaterials, biochemistry, toxicology
2. Terry Gordon, MS, PhD
   Professor, Dept Environmental Medicine
   New York University School of Medicine
   Expertise: inhalation toxicology, nanotechnology
3. Thomas Peters, MS, PhD
   Professor, Occupational and Environmental Health
   University of Iowa College of Public Health
   Expertise: aerosol physics, engineered nanomaterials exposure assessment
4. Jay Zhao, MPH, PhD, DABT
   Senior Toxicologist, US EPA
   National Center for Environmental Assessment
   Expertise: toxicology, health risk assessment

Charge to Peer Reviewers

1. Does the document accurately identify and characterize the health hazards of exposures to silver and silver nanomaterials based on available scientific literature?
2. Does the risk assessment and dosimetry modeling represent a reasonable methodology for estimating worker risks from exposure to silver nanomaterials?
3. Is the relationship between exposure to silver nanomaterials and biological activity (toxicity) accurately portrayed in the draft document?
4. Are the recommended strategies for controlling exposure to silver and silver nanomaterials (e.g., engineering controls, work practices, personal protective equipment) reasonable?
5. Are the sampling and analytical methods for silver and silver nanomaterials adequate to measure worker exposure?