Procedures for Commenting on TLVs and BEIs

Procedures for Commenting on TLVs and BEIs

The ACGIH encourages interested parties to submit comments and data relevant to the TLV and BEI committee work. The public may offer input to any TLV or BEI Committee by e-mail to science@acgih.org. Adherence to the TLV and BEI development process is paramount and therefore requires considerations when submitting comments to the ACGIH. Below you will find the appropriate procedures for submitting comments at different stages of the TLV and BEI development process.

The Under Study lists serve as notification and invitation to interested parties to submit substantive data and comments to assist the committees in their deliberations. Each committee considers only those comments and data that address issues of health and exposure, but not economic or technical feasibility. Comments must be accompanied by copies of substantiating data, preferably in the form of peer-reviewed literature. Should the data be from unpublished studies, ACGIH requires written authorization from the owner of the studies granting ACGIH permission to (1) use, (2) cite within the Documentation, and (3) upon request from a third party, release the information. All three permissions must be stated/covered in the written authorization. (See endnote for a sample permission statement.) Electronic submission of all information to the ACGIH Science Group at science@acgih.org is preferred and greatly increases the ease and efficiency with which the committee can consider the comments or data.

Under Study

The draft Documentation is not available to the public during this stage of the development process and is not released until it is at the Notice of Intended Changes (NIC) stage. Authorship of the Documentation is not disclosed.

Notice of Intended Change

Following the NIC ratification by the ACGIH Board of Directors, interested parties, including ACGIH members, are invited to provide data and substantive comments, preferably in the form of peer-reviewed literature, on the proposed TLVs or BEIs contained in the NIC. Should the data be from unpublished studies, ACGIH requires written authorization from the owner of the studies granting ACGIH permission to (1) use, (2) cite within the Documentation, and (3) upon request from a third party, release the information. All three permissions must be stated/covered in the written authorization. See endnote for a sample permission statement. The most effective and helpful comments are those that address specific points within the draft Documentation. Changes or updates are made to the draft Documentation as necessary. If the committee finds or receives substantive data that changes its scientific opinion regarding TLV or BEI values or notations, the committee may revise the proposal(s) and recommend to the ACGIH Board of Directors that it be retained on the NIC.

Important Notice: The comment period for an NIC/NIE draft Documentation and its respective TLV(s), notation(s), or BEI(s) will be limited to a firm 3-month period twice a year, running from January 1 to March 31 and July 1 to September 30. ACGIH has structured the comment period to ensure all comments are received by ACGIH in time for full consideration by the appropriate committee before its spring and fall meetings. Because of the time required to properly review, evaluate, and consider comments during the meetings, any comments received after the deadlines will not be considered in committee deliberations regarding the outcome of the possible adoption of an NIC/NIE. As a general practice, ACGIH reviews all submissions regarding chemical substances and physical agents on the Under Study list, as well as NICs/NIEs, or currently adopted BEI(s) or TLV(s). All comments received before March 31 will be considered in the fall meeting, and those received before September 30 will be considered in the spring meeting of the following year. Draft Documentation will be available for review during the comment period.

When submitting comments, ACGIH requires that the submission be limited to 10 pages in length, including an executive summary. The submission may include appendices of citable material not included as part of the 10-page limit. It would be very beneficial to structure comments as follows:

  1. Executive Summary – Provide an executive summary with a limit of 250 words.
  2. List of Recommendations/Actions Identify, in a vertical list, specific recommendations/actions that are being requested.
  3. Rationale Provide specific rationale to justify each recommendation/ action requested.
  4. Citable Material Provide citable material to substantiate the rationale.

The above procedure will help ACGIH to more efficiently and productively review comments.

If the committee neither finds nor receives any substantive data that change its scientific opinion regarding an NIC TLV or BEI (or notation), the committee may then approve its recommendation to the ACGIH Board of Directors for adoption.

Summary: There are several important points to consider throughout the above process:

  1. The appropriate method for an interested party to contribute to the TLV and BEI process is through submitting peer-reviewed and public ACGIH strongly encourages interested parties to publish their studies and not rely on unpublished studies as input to the TLV and BEI process. Also, the best time to submit comments to ACGIH is in the early stages of the TLV and BEI Development Process, preferably while the substance or agent is on the Under Study list.
  2. An additional venue for presenting new data is an ACGIH-sponsored symposium or workshop that provides a platform for public discussion and scientific interpretation. ACGIH encourages input from external parties for suggestions on symposium topics, including suggestions about sponsors, speakers, and ACGIH employs several criteria to determine the appropriateness of a symposium. A key criterion is that the symposium must be the most efficient format to present the committee with information that will assist in the scientific judgment used for writing the Documentation and in setting the respective TLVs or BEIs. A symposium topic should be suggested while the substance/ agent is under study, as symposia require considerable time, commitment, and resources to develop. Symposium topic suggestions submitted while a substance is on the NIC/NIE will be considered, but this is usually too late in the decision-making process. A symposium topic will not be favorably considered if its purpose is to provide a forum merely for voicing opinions about existing data. Rather, there must be ongoing research, scientific uncertainty about currently available data, or another scientific reason for the symposium. Symposium topic suggestions should be sent to the ACGIH Science Group (science@acgih.org).
  3. ACGIH periodically receives requests from external parties to make a presentation to a committee about specific substances or It is strictly by exception that such requests are granted. While there are various reasons for this position, the underlying fact is that the committee focuses on data that have been peer-reviewed and published and not on data presented in a private forum. A committee may grant a request when the data are significantly new, have received peer review, are the best vehicle for receipt of the information, and are essential to the committee’s deliberations. The presentation is not a forum to merely voice opinions about existing data. In order for a committee to evaluate such a request, the external party must submit a request in writing that, at a minimum, addresses the following elements: (a) a detailed description of the presentation; (b) a clear demonstration of why the information is important to the committee’s deliberations; and (c) a clear demonstration of why a meeting is the necessary method of delivery. This request must be sent to the ACGIH Science Group (science@acgih.org). Also, the committee may initiate contact with outside experts (a) to meet with the committee to discuss specific issues or to obtain additional knowledge on the subject and (b) to provide written input or review of Documentation. This contact is only done on an as-needed basis, not as a routine practice.
  4. ACGIH does not commit to deferring consideration of a new or revised TLV or BEI pending the outcome of proposed or ongoing

Endnote

Sample permission statement granting ACGIH authorization to use, cite, and release unpublished studies:

[Name], [author or sponsor of the study**] grants permission to ACGIH to use and cite the documents listed below, and to fully disclose them to parties outside of ACGIH upon request. Permission to disclose the documents includes permission to make copies as needed.

Example: Joseph D. Doe, PhD, co-author of the study, grants permission to ACGIH to use and cite the document listed below, and to fully disclose this document to parties outside of ACGIH. Permission to disclose the document includes permission to make copies as needed.

“Effects of quartz status on pharmacokinetics of intratracheally instilled cristobalite in rats [unpublished data]. March 21, 2003.”

**This statement must be signed by an individual authorized to give this permission and should include contact information such as title and address.

Last revised November 2022

TLV-Proc-Chart
___________________________________________________________

Download the Word document of the Comment Submission Form. Fill in your comments and email to the ACGIH Science Group at science@acgih.org.