§ 1990.145 Consideration of substantial new issues or substantial new evidence.

(a) Substantial new issues. Notwithstanding any other provision of this part, the Secretary will consider in a rulemaking proceeding on a specific substance any substantial new issues upon which the Secretary did not reach a conclusion in the rulemaking proceeding(s) underlying this part including conclusions presented in the preamble.

(b) Substantial new evidence. Notwithstanding any other provision of this part, the Secretary will consider in a rulemaking proceeding on a specific substance any arguments, data or views which he determines are based upon substantial new evidence which may warrant the amendment of one or more provisions of this part. For the purposes of this part, “substantial new evidence” is evidence directly relevant to any provision of this part and is based upon data, views or arguments which differ significantly from those presented in establishing this part, including amendments thereto.

(c) Petitions for consideration of substantial new evidence —

(1) Petition. Any interested person may file a written petition with the Secretary to consider “substantial new evidence” or one or more “substantial new issues” which contains the information specified in paragraph (c)(2) of this section. The Secretary shall treat such a petition as a request to amend this part, as well as a petition to consider “substantial new evidence”.

(2) Contents. Each petition for consideration of “substantial new evidence” or one or more “substantial new issues” shall contain at least the following information:

(i) Name and address of the petitioner;

(ii) All of the data, views and arguments that the petitioner would like the Secretary to consider;

(iii) The provision or provisions that petitioner believes are inappropriate or should be added to this part in light of the new data, views, and arguments;

(iv) A statement which demonstrates that the data, views, and arguments relied upon by petitioners are directly relevant to the substance or class of substances that is the subject of a rulemaking or an Advance Notice of Proposed Rulemaking;

(v) A detailed statement and analysis as to why the petitioner believes that the data, views, and arguments presented by the petitioner:

(A) Differ significantly from those presented in the proceeding(s) which establish this part;

(B) Are so substantial as to warrant amendment of this part; and

(C) Constitute a new issue or new evidence within the meaning of paragraphs (a) and (b) of this section.

(3) Deadline for petitions.

(i) Petitions which comply with paragraph (c) of this section, shall be filed in accordance with the schedule set forth in the Advanced Notice of Proposed Rulemaking.

(ii) In extraordinary cases the Secretary may consider evidence submitted after the deadline if the petitioner establishes that the evidence relied upon was not available and could not have reasonably been available in whole or substantial part by the deadline and that it is being submitted at the earliest possible time.

(d) Secretary's response.

(1) The Secretary shall respond to petitions under this paragraph in accordance with § 1990.106.

(2) Whenever the Secretary determines that the “substantial new issue” or the “substantial new evidence” submitted under this paragraph is sufficient to initiate a proceeding to amend this part, the Secretary shall:

(i) Issue a notice to consider amendment to this part and not proceed on the rulemaking concerning the individual substance until completion of the amendment proceeding; or

(ii) Issue a notice to consider amendment to this part and consolidate it with the proceeding on the individual substance.