NOP Interim Rule Addresses Continued Use of Vitamins, Minerals in Organic Handling

The U.S. Department of Agriculture’s National Organic Program (NOP) has
issued an interim rule extending the use of nutrient vitamins and minerals
in organic handling while the agency considers a proposal to renew their
exemption (use) on the National List of Allowed and Prohibited Substances
(National List) for another five years. According to a September 27, 2012,
Federal Register notice, the Agricultural Marketing Service (AMS) previously
published a proposed rule during its 2012 sunset review that recommended
continuing the use of nutrient vitamins and minerals “as ingredients in or
on processed products labeled as ‘organic’ or ‘made with organic (specified
ingredients or food group(s))’” after their National List exemption expired on
October 21, 2012. The proposed rule also sought to correct “an inaccurate
cross-reference to U.S. Food and Drug Administration (FDA) regulations in the
listing for vitamins and minerals on the National List.”

The interim rule will allow handlers and processors to keep fortifying their
organic products with vitamins and minerals while the proposed rule is under
consideration. Meanwhile, the National Organic Standards Board has started
reviewing petitions for the ingredient annotations that would be affected by
the corrected cross-reference with FDA’s fortification policy. As FDA apparently
explained to NOP, the agency does not consider substances such as
omega-3 and omega-6 fatty acids, inositol, choline, carnitine, and taurine as
essential nutrients governed by its fortification policy at 21 CFR 104.20, which
also does not cover infant formula.

“Once the NSOB has completed its review and has issued recommendations
on all petitioned nutrients, the public will be able to more fully comment on
the implications of correcting the FDA cross-reference as proposed,” states
AMS. The petitions currently under review pertain to (i) docosahexanoic
acid (DHA) algal oil, (ii) arachidonic acid (ARA) single-cell oil, (iii) inositol, (iv)
choline, (v) ascorbyl palmitate, (vi) synthetic beta-carotene, (vii) L-camitine,
(viii) lycopene, (ix) lutein, (x) L-methionine, (xi) nucleotides, (xii) taurine, and
(xiii) amino acids for pet food. AMS will consider all comments received by
December 26, 2012, before issuing its final rule.