Substantial new issues or evidence

A substantial new issue is any matter relevant to a specific substance that the Secretary did not reach a conclusion on in the prior rulemaking, and the Secretary will consider such an issue during a rulemaking on that substance. See 1990.145(a).

• This means the Secretary can reopen consideration of topics or conclusions presented in earlier proceedings or in the preamble if they qualify as "substantial new issues."

Substantial new evidence is evidence directly relevant to any provision of this part that is based on data, views, or arguments which differ significantly from those used when the part was established. See 1990.145(b).

• To be "substantial," the evidence should be materially different from the record already considered and potentially strong enough to warrant changing a provision.

Any interested person may file a written petition requesting that the Secretary consider substantial new evidence or substantial new issues. See 1990.145(c)(1).

• "Interested person" can include employers, employees, labor organizations, researchers, advocacy groups, or members of the public.

A petition must include the name and address of the petitioner. See 1990.145(c)(2)(i).

• Include a complete mailing address and a contact person so the Secretary can communicate about the petition.

A petitioner must submit all data, views, and arguments they want the Secretary to consider. See 1990.145(c)(2)(ii).

• Provide full copies of studies, reports, analysis, and a clear explanation of how each item supports the petition.

A petitioner must identify the provision(s) they believe are inappropriate or should be added in light of the new data, views, and arguments. See 1990.145(c)(2)(iii).

• Be specific about section numbers or language you want changed or inserted to help the Secretary evaluate the request.

A petitioner must state how their data, views, and arguments are directly relevant to the substance or class of substances subject to the rulemaking or Advance Notice of Proposed Rulemaking. See 1990.145(c)(2)(iv).

• Explain the connection between the evidence and the specific health, exposure, or regulatory question under consideration.

A petitioner must provide a detailed statement and analysis explaining how their data, views, and arguments differ significantly from those presented in the proceedings that established the part. See 1990.145(c)(2)(v)(A).

• Identify specific points of departure, cite the original record, and show how the new material changes the factual or analytical basis.

A petitioner must analyze and explain why the new data, views, and arguments are substantial enough to justify amending the part. See 1990.145(c)(2)(v)(B).

• Show the likely regulatory impact: e.g., whether the new evidence would change exposure limits, hazard classifications, or required controls.

A petitioner must explain why the submitted material qualifies as a new issue or new evidence under paragraphs (a) and (b) of 1990.145. See 1990.145(c)(2)(v)(C).

• State clearly whether the petition raises factual findings, legal questions, or scientific interpretations not previously considered, and why they were not part of the earlier record.

A petition that complies with paragraph (c) must be filed according to the schedule set out in the Advance Notice of Proposed Rulemaking (ANPRM). See 1990.145(c)(3)(i).

• Check the ANPRM for the specific deadline; missing that schedule may affect consideration unless extraordinary circumstances apply.

An extraordinary case is one where the petitioner shows the evidence was not available and could not reasonably have been available by the deadline, and that it is being submitted at the earliest possible time. See 1990.145(c)(3)(ii).

• Provide dates, explanation of attempts to obtain the evidence earlier, and reasons why it only became available after the deadline.

The Secretary will respond to petitions under 1990.145(c) in accordance with 1990.106. See 1990.145(d)(1) and 1990.106.

• That means responses will follow the procedural rules and timelines set out in 1990.106 for petition handling and notices.

If the Secretary determines the submission is sufficient to initiate an amendment proceeding, the Secretary will issue a notice to consider amendment and not proceed on the individual-substance rulemaking until the amendment proceeding is complete. See 1990.145(d)(2)(i).

• This can pause the individual-substance rulemaking so the broader amendment is addressed first.

Yes; the Secretary may issue a notice to consider amendment and consolidate that amendment proceeding with the ongoing rulemaking for the individual substance. See 1990.145(d)(2)(ii).

• Consolidation allows the Secretary to address the new evidence or issue together with the substance-specific proceeding.

Yes; the Secretary treats a compliant petition as both a request to consider "substantial new evidence" or issues and as a petition to amend the part. See 1990.145(c)(1) and 1990.145(c)(2).

• Prepare the petition with amendment language or suggested changes to make the Secretary's review efficient.

Materials that count include scientific studies, exposure monitoring data, technical analyses, expert opinions, public health data, and reasoned legal or policy arguments. See 1990.145(c)(2)(ii).

• Provide full documentation and clear explanation linking each item to the rulemaking issue so the material can be evaluated for relevance and significance.

A strong petition should include a clear cover identifying the petitioner, full copies of all supporting data and studies, precise identification of provisions to be changed, a statement of direct relevance, and a detailed analysis explaining how and why the new information differs from the record and warrants amendment. See 1990.145(c)(2).

• Use numbered sections mirroring 1990.145(c)(2)(i)–(v) to make it easy for reviewers to confirm completeness.

A petitioner should provide dates, factual explanations, and any records showing the evidence was unavailable before the deadline and why it could not reasonably have been obtained, and then state when it was first available and why it is being submitted immediately. See 1990.145(c)(3)(ii).

• Include correspondence, production dates, or publication dates that support the timing claim.

The Secretary will either respond according to procedural rules in 1990.106 and, if the petition is sufficient, issue a notice to consider amendment and either postpone the substance rulemaking until the amendment proceeding is complete or consolidate the amendment consideration with the ongoing proceeding. See 1990.145(d) and 1990.106.

• The key outcomes are: (1) no further action, (2) amendment proceeding started and substance rulemaking paused, or (3) amendment proceeding started and consolidated with the substance rulemaking.