Abstract Below is the abstract of this Proposed Rule.
This proposed rule would address recommendations submitted to the Secretary of Agriculture (Secretary) by the National Organic Standards Board (NOSB) following their November 2011 and May 2012 meetings. These recommendations pertain to the 2013 Sunset Review of substances on the U.S. Department of Agriculture's (USDA) National List of Allowed and Prohibited Substances (National List). Consistent with the recommendations from the NOSB, this proposed rule would continue the allowed uses of multiple synthetic and nonsynthetic substances and the prohibition of one nonsynthetic substance on the National List (along with any restrictive annotations). This proposed rule would also remove one synthetic substance from the National List.
Background: The Organic Foods Production Act of 1990 (OFPA) (7 U.S.C. 6501-6522) authorizes the establishment of the National List. The National List, codified within the USDA organic regulations at 7 CFR 205.600 through 205.607, identifies synthetic substances that may be used in organic production and nonsynthetic (natural) substances that are prohibited in organic crop and livestock production. The National List also identifies nonagricultural nonsynthetic, nonagricultural synthetic and nonorganic agricultural substances that may be used in organic handling.
The exemptions and prohibitions granted on the National List are required to be reviewed every 5 years under OFPA by the National Organic Standards Board (NOSB). The Secretary of Agriculture has authority under OFPA to renew such exemptions and prohibitions. If they are not reviewed by the NOSB within 5 years of their inclusion on the National List and renewed by the Secretary, their authorized use or prohibition expires. The Secretary published an Advanced Notice of Proposed Rulemaking (ANPR) (76 FR 31495) in the Federal Register on June 1, 2011, to announce the review of 11 exempt substances and one prohibited nonsynthetic substance authorized under the USDA organic regulations. This ANPR established November 3, 2013, as the date by which the Sunset 2013 review and renewal process must be concluded. The ANPR explained that the exemptions and prohibitions not renewed by this date will be removed from the National List. This ANPR also requested public comment on the continued use or prohibition of these substances. The public comment period lasted 60 days. A list of these substances is provided as Table 1 in the Overview of Proposed Actions section. These substances were originally added to the National List on November 3, 2003 (68 FR 61987), and November 4, 2003 (68 FR 62215), and were previously renewed under the Sunset process on November 3, 2008 (73 FR 59479).
The Agricultural Marketing Service (AMS) received 25 comments on the substances in response to the ANPR. AMS received comments from producers, handlers, distributors, organic associations, a certifying agent, and various industry groups. Some of these comments addressed more than one substance. We received general comments stating that the listings should remain as they are currently codified. We received one general comment that did not address the substances under this Sunset review. Most comments indicated support for substances that the commenters' promoted, represented, or relied upon. Comments specifically supported acontinued allowance for the following substances: copper sulfate, ozone gas, peracetic acid, EPA List 3 Inerts, [1] agar-agar, animal enzymes, calcium sulfate, carrageenan, glucono delta-lactone, tartaric acid, and cellulose. Two comments specifically supported a continued prohibition on calcium chloride as annotated on the National List. One commenter requested that the annotations for two listings of copper sulfate, one at section 205.601(a)(3) and one at section 205.601(e)(4) for use in aquatic rice systems, be amended to remove the restriction based on the number of applications during a specified timeframe. The commenter requested that the restriction limiting application rates to those which do not increase baseline soil test values for copper over a timeframe agreed upon by the producer and accredited certifying agent be maintained, but the restriction on number of applications during any 24-month period be eliminated.
The NOSB reviewed the comments received from the ANPR and developed recommendations regarding the continued use and prohibition of the substances under review. The NOSB received additional public comments concerning the pending sunset of these substances in response to two Federal Register notices announcing meetings of the NOSB and its planned deliberations on Sunset 2013 recommendations. The notices were published in the Federal Register as follows: October 7, 2011 (76 FR 62336), and April 9, 2012 (77 FR 21067). The NOSB received further written and oral testimony at both of these public meetings which occurred in Savannah, GA on November 29-December 2, 2011, and Albuquerque, NM on May 22-25, 2012. The written comments can be retrieved via http://www.regulations.gov by searching for the document ID numbers: AMS-NOP-11-0081 (November 2011 meeting) and AMS-NOP-12-0017 (May 2012 meeting). The oral comments were recorded in the meeting transcripts which are available on the NOP Web site at http://www.ams.usda.gov/nop.
At its November 2011 and May 2012 meetings, the NOSB addressed multiple National List exemptions and a prohibition under the 2013 Sunset review. The NOSB recommended that the Secretary: (1) Renew multiple exemptions and one prohibition without change, (2) remove an exemption for one synthetic substance, tartaric acid, and (3) amend the exemptions for two synthetic substances, EPA List 3—Inerts of unknown toxicity and cellulose, and one nonsynthetic substance, carrageenan. In accordance with NOSB's published policies and procedures, it also issued a second round of recommendations to renew the existing listings for EPA List 3—Inerts of unknown toxicity, cellulose, and carrageenan without change. [2] These second recommendations authorize the Secretary to renew these three listings "as is" considering the expiration date of November 3, 2013.
Because the NOSB's sole justification for restricting the allowance of carrageenan was on the basis of food safety concerns, despite the fact that FDA regulations provide for its use as a safe food additive when used in accordance with 21 CFR 172.5, 21 CFR 172.620 and 21 CFR 172.626, AMS is renewing carrageenan as codified based on the NOSB's second recommendation. Based on concern over the impact of changing the annotation for cellulose, AMS is renewing the listing for cellulose as codified based on the NOSB's second recommendation. For EPA List 3—Inerts of unknown toxicity, AMS is concerned that including an expiration date as part of its annotation during the Sunset review would complicate the NOSB's established inerts review process. Therefore, AMS is renewing the listing for EPA List 3—Inerts of unknown toxicity as codified based on the NOSB's second recommendation. In summary, this rule proposes to renew multiple listings without change and remove one listing (tartaric acid—made from malic acid).
Under the authority of OFPA, the National List can be amended by the Secretary based on proposed amendments developed by the NOSB. Since established, AMS has published multiple amendments to the National List beginning on October 31, 2003 (68 FR 61987). AMS published the most recent amendment to the National List on September 27, 2012 (77 FR 59287).
II. Overview of Proposed Actions
At its November 2011 and May 2012 meetings, the NOSB reviewed the listings set to sunset on November 3, 2013, for multiple exemptions and one prohibition that are authorized on the National List. On December 2, 2011, the NOSB finalized its recommendations on the following substances: animal enzymes, calcium chloride, copper sulfate (two uses), glucono delta-lactone, ozone gas, peracetic acid (two uses), and tartaric acid (two sources). On May 25, 2012, the NOSB finalized its recommendations on agar-agar, calcium sulfate, carrageenan, cellulose, and EPA List 3—Inerts of unknown toxicity.
The NOSB's recommendations to continue existing exemptions and prohibitions are based on consideration of public comments and applicable supporting evidence that express a continued need for the use or prohibition of the substance(s) as required by OFPA.
Concerning OFPA criteria used to make recommendations regarding the discontinuation of an authorized exempted synthetic substance (7 U.S.C. 6517(c)(1)), the NOSB's decision is based on consideration of public comments and applicable supporting evidence that demonstrates the currently authorized exempted substance is: (a) Harmful to human health or the environment; (b) no longer necessary for organic production due to the availability of alternative wholly nonsynthetic substitute products or practices; and (c) inconsistent with organic farming and handling practices.
Based on the NOSB recommendations, AMS' proposed actions for the Sunset 2013 proposed rule are outlined in Table 1.
