(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 (AMSNOP-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 extend 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 

rulemaking 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 

explained 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. 

• Ms. 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 nonsignificant. 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 actionto determine the classification. Ms. Wyard questioned 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 exemption 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 developing the final rule.