(AMS

- NOP

- 11

- 0058; NOP

- 11

- 09)

Stakeholder Communication for the Record

On Tuesday, January 3, 2012, Gwendolyn Wyard (Associate Director, Organic Standards & Industry Outreach, Organic Trade Association) contacted Shannon Nally (Agricultural Marketing Specialist, National Organic Program) by telephone with questions about the proposed rule for tetracycline (AMS

NOP

- 11

- 0058; NOP

- 11

- 09). The description below captures the general content of that conversation:

• Ms. Wyard asked whether the NOP had the authority to further extend the use of tetracycline beyond what the NOSB recommended, based on comments to the proposed rule. (The proposed rule addresses a recommendation of the NOSB to ext end the use of tetracycline until October 21, 2014; the current listing for tetracycline is set to expire on October 21, 2012). Ms. Nally explained that an answer to that question would require consultation with the Office of General Counsel since this is a synthetic substance and only the NOSB is authorized to recommend exemptions for the use of synthetic substances. Ms. Nally indicated it was likely, but not certain, that NOP action to further extend the use of tetracycline

– beyond 2014

- in this rulemak ing would be considered an expansion of the exemption that was recommended by NOSB, and therefore would not be authorized under OFPA. She further indicated that an NOSB recommendation would likely be required to achieve that outcome.

• Ms. Wyard indicated that she was aware of the petition process, whereby a petition could be submitted to the NOSB to extend the use of tetracycline, but given the October 21, 2012 expiration date, was interested in alternative options to achieve that outcome. Ms. Nally expla ined that rulemaking generally requires a minimum of 14 months and it would not be possible to complete a proposed and final rule before October 21, 2012, if the NOSB reviewed a tetracycline petition and issued a recommendation at the May 2012 meeting.

• M s. Wyard was also interested in the how a rule becomes significant and if a rule could be significant based on public comments. Ms. Nally explained that the Office of Management and Budget determines whether to classify a rule as significant, economically significant or non

significant. She also summarized the factors that contribute to the classification. Ms. Nally stated that OMB reviews a workplan

– essentially a summary of the proposed/intended action

to determine the classification. Ms. Wyard questio ned whether any rule that had been designated as non

- significant at the proposed rule stage was then designated significant for the final rule. Ms. Nally indicated that she had not seen this in her experience at NOP, but it most likely could happen since separate workplans need to be prepared and submitted for classification for each proposed and final rule.

Ms. Wyard indicated that she was writing something for distribution to OTA members and she was aware of concerns among them about extending the exe mption for tetracycline only until October 2014. She wanted to explain any other options for further extending the 2014 expiration date. Ms. Nally indicated that such concerns can be submitted as public comments which NOP will review for consideration in d eveloping the final rule.