0581-AD17 201110 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0581 Agricultural Marketing Service AMS 0500 Department of Agriculture USDA National Organic Program: Sunset Review for Nutrient Vitamins and Minerals (NOP-10-0083) This proposed rule would address a recommendation submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board (NOSB) on April 29, 2011. The recommendation pertains to the 2012 Sunset Review of the listing for nutrient vitamins and minerals on the U.S. Department of Agriculture's (USDA) National List of Allowed and Prohibited Substances (National List). As recommended by the NOSB, the proposed rule would continue the exemption (use) for nutrient vitamins and minerals for 5 years after the October 21, 2012, sunset date. In addition, the proposed rule would amend the annotation to correct an inaccurate cross reference to U.S. Food and Drug Administration regulations. The proposed amendment to the annotation would clarify what synthetic substances are allowed as nutrient vitamins and minerals in organic products labeled as "organic" or "made with organic (specified ingredients or food group(s))." Economically Significant First Time Published in The Unified Agenda Proposed Rule Stage Yes No 7 CFR 205 7 USC 6501 Yes The Agricultural Marketing Service (AMS) has determined that the current exemption for the use of nutrient vitamins and minerals in organic products in the National Organic Program (NOP) regulations (7 CFR part 205) is inaccurate. The proposed rule would amend the annotation for nutrient vitamins and minerals to correct an inaccurate cross reference to U.S. Food and Drug Administration (FDA) regulations. In effect, the proposed amendment would clarify what synthetic substances are allowed as nutrient vitamins and minerals in organic products. Further, the NOP regulations do not correctly provide for the fortification of infant formula that would meet FDA requirements. This proposed rule would incorporate the correct FDA citation with respect to the addition of required vitamins and minerals to organic infant formula. This proposed rule would address a recommendation submitted to the Secretary of Agriculture by the National Organic Standards Board (NOSB) on April 29, 2011, to continue the exemption for nutrient vitamins and minerals in organic products as provided by the NOP National List of Allowed and Prohibited Substances (National List). The Organic Foods Production Act of 1990 (OFPA) authorizes the Secretary to amend the National List based on proposed amendments developed by the NOSB. The Sunset Provision, in section 6517(e) of the OFPA, provides that no exemption or prohibition on the National List will remain valid after 5 years unless the exemption or prohibition has been reviewed and the Secretary renews the listing. The exemption for nutrient vitamins and minerals is scheduled to sunset on October 21, 2012. AMS considered two alternatives to this proposed rulemaking: (1) Renew the existing listing for nutrient vitamins and minerals or (2), in lieu of a rule, issue guidance stating NOP's intent to interpret the current listing for nutrient vitamins and minerals as proposed in this action. AMS determined that neither alternative is viable as both would retain a regulatory provision that is inaccurate and remains vulnerable to misinterpretations of what substances are permitted in organic products. This proposed rule would establish a finite list of essential and required vitamins and minerals for use in organic food and infant formula. The action addresses the requests of a broad spectrum of public commenters for clarification on the parameters for adding nutrient vitamins and minerals to organic products and is expected to reduce the submission of consumer complaints alleging the unlawful addition of substances to organic products. This proposed rule would also provide more certainty to certifying agents and organic operations in determining whether substances are acceptable for use in organic products. Further, this proposed action also would foster greater transparency by ensuring that exemptions for the use of vitamins, minerals, and other nutrients are subject to National Organic Standards Board (NOSB) evaluation in accordance with the criteria established in OFPA. This action could directly impact a subset of certified organic operations, which add substances to organic products that are not essential vitamins and minerals for human nutrition (21 CFR 101.9) or required vitamins and minerals for infant formula (21 CFR 107.100 or 107.10), as enumerated by FDA regulation. AMS believes the impacts will be concentrated within five categories of organic products in which nutrient supplementation has been more prevalent: Infant formula, baby food, milk, breakfast cereal, and pet food. The proposed rule could indirectly impact producers who supply organic agricultural commodities to affected product categories. However, AMS expects that there will be opportunities for producers to divert organic agricultural products to other purchasers to buffer the impact of any disruption to the manufacture of certain processed organic products as a result of this proposed action. There are several impact mitigation factors which are expected to reduce the costs of complying with this proposed action. AMS is proposing a 2-year implementation phase, which is intended to provide time for NOSB to consider petitions for substances that are affected by this action and for AMS to conclude any rulemaking to add substances to the National List. The implementation phase would also provide entities the time to explore reformulation of affected products. Further, if some products are discontinued as a result of this proposed rule, AMS anticipates that some consumers will purchase, as an alternative, an organic product within the same category rather than a nonorganic product. For the 2-year implementation phase to function as a mitigation measure, the timeframe may be tight to complete the review of petitions received by publication of this proposed rule and for any rulemaking action recommended by NOSB. Therefore, AMS has requested comments on the length of the implementation phase as part of this proposed rule. NPRM 01/12/2012 77 FR 1980 NPRM Comment Period End 03/12/2012 Final Action 10/00/2012 Undetermined Local State No No No 0581-AC96 Split from Melissa Bailey R 0581 Agricultural Marketing Service AMS 202 720-3252 202 205-7808 melissa.bailey@usda.gov 14th & Independence Avenue, SW, Rm. 2646-South Building, Washington DC 20250