martes, 14 de abril de 2015

FDA Law Blog: Organic Stakeholders Sue the National Organic Program over Alleged Substantive Change in Sunset Review Process

FDA Law Blog: Organic Stakeholders Sue the National Organic Program over Alleged Substantive Change in Sunset Review Process



Posted: 14 Apr 2015 01:38 AM PDT
By Riëtte van Laack –

In an effort to stop the implementation of the National Organic Program’s (NOP’s) interpretation of the sunset review process, a coalition of organic “stakeholders” have filed a lawsuit in the U.S. District Court for Northern California.  The lawsuit alleges that the NOP violated the federal rulemaking process when it changed procedures for the sunset review of substances included in the National List of Allowed and Prohibited Substances (National List).  Plaintiffs allege that the “unilateral” action by the NOP to adopt a major policy change without a public process violates a foundational principle and practice of the Organic Food Production Act (OFPA), namely public participation in organic policy-making.  Plaintiffs request that the court require the NOP to reconsider its decision on the alleged rule change and reinstitute the “customary public hearing and comment process.”

The OFPA creates standards for organic certification and establishes the National Organic Standards Board (NOSB).  A major function of the NOSB is to oversee the allowance of synthetic and non-agricultural materials based on a determination that they do not harm human health and the environment and are necessary in organic food production and processing.  The National List identifies the synthetic substances that are allowed (exemptions) and the nonsynthetic (natural) substances that are not allowed (prohibitions) in organic production.  7 C.F.R. §§  205.601–604.  In addition, the National List identifies the nonorganic and nonagricultural substances that may be used in organic handling.  Id. §§ 205.605–205.606.

At issue in the lawsuit is the interpretation of the so-called sunset provision of the OFPA.  Under the OFPA, a review of substances on the National List takes place on a five-year cycle.  This “sunset” provision provides that “No exemption or prohibition contained in the National List shall be valid unless the National Organic Standards Board has reviewed such exemption or prohibition as provided in this section within 5 years of such exemption or prohibition being adopted or reviewed and the Secretary has renewed such exemption or prohibition.” 7 U.S.C. § 6517(e).  Plaintiffs allege that, until September 2013, this provision had been interpreted to require that all substances included in the National List cycle off the list after five years unless the NOSB votes by a two-thirds majority to relist them and NOP accepts the recommendation.

In September, 2013, NOP issued a notice that announced what plaintiffs characterize as a substantive change in the process NOP had been operating under since the inception of the organic program.  In its notice, NOP asserted that the previously used sunset review process did not allow for “robust” public participation and delayed the sunset review process.  Essentially, the pre-Sept. 2013 sunset review process treated sunset substances as newly petitioned substances and the sunset rulemaking process from start to finish took as long as 30 months.  However, adding a substance to the National List involves a rigorous rulemaking process.  Once a substance is on the list, organic farmers and processors invest significant time and money to update their organic system plans and adjust their product formulations to reflect the change.  NOP concluded that, in light of this rigorous process, and given the importance of the National List to organic farmers and processors, the process to remove a sunsetting substance from the National List should be an equally rigorous process.

Plaintiffs argue that the NOP 2013 notice represents a substantive rule under the Administrative Procedures Act (APA) and that NOP violated the APA rulemaking process when it changed procedures for reviewing the NOP’s sunset review process without using the notice and comment rulemaking procedures mandated by the APA and by the standards of the OFPA.

Because there are a significant number of substances subject to sunset in the next few years, the outcome of this lawsuit will be relevant for many organic farmers and processors.

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