Policy amendment procedures

The Secretary must ask the Directors of NCI, NIEHS, and/or NIOSH to review the policy and they must provide their opinions within 120 days. See 1990.106(a)(1).

• This review is required no later than every three years from the part’s effective date or the last general review.
• The 120-day period is the timeframe the Secretary requests for the institutes’ written opinion.

Yes. The Directors of NCI, NIEHS, and/or NIOSH may submit recommendations to the Secretary at any time if they believe scientific or technical advances justify amendments. See 1990.106(a)(2).

• This allows the institutes to prompt changes whenever new science or technology warrants it, not just during scheduled reviews.

Any interested person may petition the Secretary to amend this part based on substantial new issues or substantial new evidence. See 1990.106(a)(3)(i).

• "Interested person" can include workers, employers, researchers, public health organizations, or others with relevant information.
• The petition must focus on changes that are materially different from the information used to establish the part.

"Substantial new evidence" means evidence that differs significantly from what was presented when the part (including any amendments) was established. See 1990.106(a)(3)(ii).

• The evidence must be more than minor or incremental; it should materially change the factual basis for the existing policy.
• Examples could include major new epidemiological studies, new exposure science, or clear technological advances that were not previously available.

"Substantial new issues" are those that differ significantly from the issues on which the Secretary reached conclusions when the part was established (including preamble conclusions). See 1990.106(a)(3)(iii).

• The new issue must go beyond routine clarification and instead present a materially different policy question or regulatory concern.
• Examples include identifying a previously unconsidered exposure route or a different worker population affected.

A petition must include the petitioner’s name and address; the provisions believed inappropriate; all data, views, and arguments relied upon; and a detailed statement explaining why the submission constitutes substantial new issues or evidence and why it justifies amendment. See 1990.106(a)(3)(iv).

• Required subparts are listed at 1990.106(a)(3)(iv)(A)–(D).
• The petition should clearly connect the data and arguments to why they are significant enough to change the rule.

The petitioner must provide a detailed statement analyzing why their submission (1) constitutes substantial new issues or substantial new evidence and (2) is so significant that it warrants amendment of the part. See 1990.106(a)(3)(iv)(D).

• Specifically address both 1990.106(a)(3)(iv)(D)(1) and 1990.106(a)(3)(iv)(D)(2).
• Make a clear, evidence-based case linking new material to the need for regulatory change.

Within 120 days after receiving an institute recommendation, the Secretary must publish a Federal Register notice stating either why no rulemaking will be commenced, that rulemaking has been commenced, or that an Advisory Committee has been appointed. See 1990.106(b)(1).

• The notice must choose one of the options at 1990.106(b)(1)(i)–(iii).
• Publishing in the Federal Register makes the Secretary’s action public and provides transparency for the next steps.

The Secretary must either state reasons for not commencing rulemaking at that time, commence a rulemaking proceeding to consider the amendment, or appoint an Advisory Committee as provided in 1990.105 and sections 6(b) and 7 of the Act. See 1990.106(b)(1)(i)–(iii).

• Appointing an Advisory Committee references 1990.105 for committee procedures.
• The Secretary’s published notice must explain which of these paths was taken.

Within 90 days (or as soon as possible thereafter) after receiving a public petition, the Secretary must refer it to the institutes, appoint an advisory committee, deny the petition with brief reasons, or commence rulemaking to consider the amendment. See 1990.106(b)(2).

• The specific options are listed at 1990.106(b)(2)(i)–(iv).
• This sets a 90-day target for initial administrative action on petitions from the public.

The Secretary may refer the petition to one or more institute directors (applying the procedures of 1990.106(a)(1) and 1990.106(b)(1)), appoint an advisory committee, deny the petition with brief reasons, or commence a rulemaking proceeding to consider amendment. See 1990.106(b)(2)(i)–(iv).

• Referral triggers the institutes’ review and the 120-day response process in 1990.106(a)(1) and 1990.106(b)(1).
• Denial must briefly state the reasons per 1990.106(b)(2)(iii).

If the Secretary refers a petition to the institutes, the provisions of 1990.106(a)(1) and 1990.106(b)(1) apply, meaning the institutes will be asked to review and the Secretary has 120 days to publish the appropriate Federal Register notice. See 1990.106(b)(2)(i).

• Referral starts the formal institute review and the decision timeline for Secretary action.

Yes. The Secretary may, on his or her own motion, commence a rulemaking proceeding to amend the part at any time; there is no specified time limit in the text. See 1990.106(b)(3).

• This provision allows the Secretary to act proactively without waiting for institute recommendations or public petitions.

If the Secretary denies a petition, the public notice must briefly state the reasons for the denial. See 1990.106(b)(2)(iii).

• The notice does not require a long explanation, but it must provide a concise rationale so petitioners and the public understand the basis of the decision.

When the Secretary appoints an Advisory Committee, the appointment follows the advisory procedures provided in 1990.105, and the committee provides expert advice on whether and how to amend the part. See 1990.106(b)(1)(iii).

• Advisory Committees are used to gather technical and stakeholder input when issues are complex or contentious.
• The Secretary’s notice in the Federal Register will reflect the committee appointment and its charge.

A petitioner must include their name and address, identify which provisions they believe are inappropriate, and submit all data, views, and arguments relied upon. See 1990.106(a)(3)(iv)(A)–(C).

• Omitting these basic items makes it difficult for the Secretary or institutes to evaluate the petition.
• Including complete contact information and clear references to the provisions in question improves the likelihood the petition will be processed.

Yes. The text requires the Secretary to request institute reviews no later than every three years, which allows the Secretary to request reviews more frequently if desired. See 1990.106(a)(1).

• The provision sets a maximum interval (three years) rather than a fixed schedule, giving the Secretary flexibility to request earlier reviews when warranted.

Yes. Published scientific reports may form the basis of a petition, but they must be presented as evidence that differs significantly from what was used to establish the part to qualify as substantial new evidence. See 1990.106(a)(3)(ii) and 1990.106(a)(3)(iv)(C).

• Provide citations, data summaries, and an explanation comparing new findings to the evidence relied upon in the original rulemaking.
• Explain clearly why the new reports change the weight of evidence or the regulatory conclusion.

A petitioner should clearly analyze why the submitted materials (1) constitute substantial new issues or evidence and (2) are so significant that they justify amending the part. See 1990.106(a)(3)(iv)(D)(1)–(2).

• Use direct comparisons to the record used in the original rulemaking, highlight differences, and explain the practical regulatory impact.
• Include quantitative data, methodological details, and reasoned argument linking the new material to the need for a rule change.