Notice of Modification to Proposed Regulation on Safe Harbor Warnings for Glyphosate and Addition of Documents to Rulemaking File

2022-04-13

The Office of Environmental Health Hazard Assessment (OEHHA) is providing notice of modifications made to a previously proposed regulation, Title 27, California Code of Regulations, new sections 25607.48 and 25607.49 and addition of documents to the rulemaking file. It is providing this notice pursuant to Government Code sections 11346.8(c) and 11347.1(b), and Title 1, California Code of Regulations, section 44.

OEHHA first proposed the regulation by publishing a Notice of Proposed Rulemaking in the California Regulatory Notice Register (CRNR) on July 23, 2021. In parallel, OEHHA issued an Initial Statement of Reasons (ISOR) for the proposal.

OEHHA provided a 76-day comment period on the original proposal, extending from July 23 to October 7, 2021. It held a public hearing on September 9, 2021.

Since the close of the comment period, OEHHA has determined modifications of the original regulatory text are needed. In addition, OEHHA is relying upon additional documents in this rulemaking and is adding these documents to the rulemaking file. The purpose of this notice is to provide the public with notice of (1) the modified proposed regulatory text and (2) the additional documents included in the rulemaking file, and to open a 15-day public comment period, running from April 13, 2022, through April 28, 2022. Consistent with the Administrative Procedure Act, OEHHA will only address comments received during this comment period that address the modifications to the text of the proposed regulation or documents added to the record. Details on how to submit comments are provided below.

In the Final Statement of Reasons, OEHHA will respond to all comments received during the comment periods on the original July 2021 proposal and on the modified proposal.

Summary of Proposed Modifications

OEHHA is modifying proposed Section 25607.49, subsection (a)(3) as shown below. Additions and deletions to the proposed text are shown in double-underline (example) and strike-out (example), respectively.   

(3) The words, “Using this product can expose you to glyphosate. The International Agency for Research on Cancer classified glyphosate as probably carcinogenic to humans. US EPA has determined that glyphosate is not likely to be carcinogenic to humans; other authorities have made similar determinations. Other authorities, including USEPA, have determined that glyphosate is unlikely to cause cancer, or that the evidence is inconclusive. A wide variety of factors affect your potential personal cancer risk, including the level and duration of exposure to the chemical. For more information, including ways to reduce your exposure, go to www.P65Warnings.ca.gov/glyphosate.”

A copy of the full proposed regulatory text (new sections 25607.48 and 25607.49), reflecting the modification, is provided as Attachment 1.

During the comment period on the original proposal, OEHHA received comments regarding the description of the conclusions by various scientific bodies regarding the carcinogenicity of glyphosate. OEHHA is addressing the points raised in these comments by: (1) separating the description of the conclusion reached by the U.S. Environmental Protection Agency (US EPA) from the description of the conclusions reached by other authorities; (2) more closely aligning the description of the conclusion reached by US EPA with the language US EPA used in its conclusion; and (3) changing the modifier of the term “risk” in a manner that accounts for the diverging conclusions US EPA and other authorities reached.

Over the years, OEHHA has worked with US EPA to facilitate pesticide registrants receiving permission from US EPA to add Proposition 65 warnings to pesticide product labels. Given this past coordination, OEHHA sought input from US EPA on whether it could approve the warning language as set forth in this modified proposal, if a pesticide registrant requested approval to include such language on labels of products containing glyphosate sold in California. US EPA responded that it could approve the proposed language. Specifically, US EPA indicated that:

“it has determined that the new glyphosate-specific safe harbor language proposed in OEHHA’s recent letter is sufficiently clear regarding EPA’s position and thus would not be considered false and misleading. Therefore, this revised language could be approved by EPA if pesticide registrants requested it for inclusion on glyphosate product labels, and the products would not be considered misbranded.”

OEHHA is adding the correspondence with US EPA referenced above to the rulemaking file as documents relied on for this rulemaking. 

Read More

OEHHA, 13-04-22
; https://oehha.ca.gov/proposition-65/crnr/notice-modification-proposed-regulation-safe-harbor-warnings-glyphosate-and