[Federal Register Volume 77, Number 8 (Thursday, January 12, 2012)]
[Proposed Rules]
[Pages 1996-2010]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-362]


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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-09-0074; NOP-09-01PR]
RIN 0581-AC96


National Organic Program (NOP); Sunset Review (2012)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would address recommendations submitted to 
the Secretary of Agriculture (Secretary) by the National Organic 
Standards Board (NOSB) on April 29, 2010, October 28, 2010, and April 
29, 2011. These recommendations pertain to the 2012 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 NOSB recommendations, the proposed rule would continue, without 
change, the exemptions (use) and prohibitions for multiple listings on 
the National List for 5 years after their respective sunset dates. This 
proposed rule would amend the exemptions (use) or prohibition for 7 
substances and remove the exemption for 3 substances on the National 
List.

DATES: Comments must be received by February 13, 2012.

ADDRESSES: Interested persons may submit written comments on this 
proposed rule using the following addresses:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Toni Strother, Agricultural Marketing Specialist, 
National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW., 
Room 2646-So., Ag Stop 0268, Washington, DC 20250.
    Instructions: All submissions received must include the docket 
number AMS-NOP-09-0074; NOP-09-01, and/or Regulatory Information Number 
(RIN) 0581-AC96 for this rulemaking. Commenters should identify the 
topic and section number of this proposed rule to which the comment 
refers. You should clearly indicate your position to continue, 
discontinue or further restrict the allowance of any substances as 
identified in this proposed rule and the reasons for your position. You 
should include relevant information and data to support your position 
(e.g., scientific, environmental, manufacturing, industry impact 
information, etc.). You should also supply information on alternative 
substances or alternative management practices, where applicable, that 
support a change from the current exemption for the substance. Only the 
supporting material relevant to your position will be considered. All 
comments received will be posted without change to http://www.regulations.gov.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov. Comments submitted 
in response to this proposed rule will also be available for viewing in 
person at USDA-AMS, National Organic Program, 1400 Independence Ave. 
SW., Room 2646-South Building, Washington, DC, from 9 a.m. to 12 noon 
and from 1 p.m. to 4 p.m., Monday through Friday, (except official 
Federal holidays). Persons wanting to visit the USDA South Building to 
view comments received in response to this proposed rule are requested 
to make an appointment in advance by calling (202) 720-3252.

FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Ph.D., Director, 
Standards Division, Telephone: (202) 720-3252; Fax: (202) 205-7808.

SUPPLEMENTARY INFORMATION: 

I. 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 identifies synthetic substances that are exempted (allowed) in 
organic production and nonsynthetic 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 under the OFPA are 
required to be reviewed every 5 years by the National Organic Standards 
Board (NOSB). The Secretary of Agriculture has authority under the OFPA 
to renew such exemptions and prohibitions. If the substances are not 
reviewed by the NOSB within 5 years of their inclusion on the National 
List and addressed by the Secretary, then their authorized use or 
prohibition expires under OFPA's sunset provision.
    In response to the sunset provisions in the OFPA, the Secretary 
published an Advanced Notice of Proposed Rulemaking (ANPR) in the 
Federal Register on March 26, 2010 (75 FR 14500), announcing the review 
of exempted and prohibited substances codified at the National List of 
the National Organic Program (NOP) regulations and set to expire in 
2012. A list of these substances is provided as Table 1 in the Overview 
of Proposed Actions section.\1\ The ANPR explained that, unless 
reviewed and recommended by the NOSB, a synthetic substance exempted 
for use on the National List in 2007 and currently allowed for use in 
organic production would no longer be allowed for use after its 
respective sunset date in 2012; a nonsynthetic substance prohibited 
from use on the National List in 2007 and currently prohibited from use 
in organic production would be allowed after its respective sunset date 
in 2012; and a synthetic or nonsynthetic substance exempted for use on 
the National List in 2007 and currently allowed for use in organic 
handling would be prohibited after its respective sunset date in 2012. 
The ANPR announced the upcoming review of these substances by the NOSB 
and the NOP's intent to complete the sunset process based upon 
recommendations by the NOSB for all listings added to the National List 
in 2007. The ANPR notified the public that this rulemaking would be 
completed by the earliest respective sunset date, June 27, 2012. The 
ANPR also requested public comment on the continued use or prohibition 
of these substances. The public comment period lasted 60 days.
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    \1\ Table 1 shows a simplified listing for each substance; use 
categories and any restrictive annotations are not included in this 
overview.
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    The NOP received approximately 100 comments in response to the 
ANPR. Comments were received from consumers, organic crop producers, 
academia, accredited certifying agents, trade associations, retailers 
and organic

[[Page 1997]]

associations. Most comments voiced support for all substances 
considered under this sunset review. Some of these commenters provided 
specific information in support of one or more substances that they 
promoted, represented, or relied upon in organic production or 
handling. A few commenters recommended allowing a small number of 
substances to sunset. Some commenters also expressed the need for the 
clarification or further restrictions for a limited number of 
substances on the National List. These commenters recommended amending 
the listing or adding annotations as a potential approach for providing 
such clarifications. Some comments opposed the use of any synthetics in 
organic production, but did not provide documented support against 
individual substances for this position.
    The NOSB reviewed the comments received on 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 three 
Federal Register notices announcing meetings of the NOSB and its 
planned deliberations for sunset 2012 recommendations. The notices were 
published in the Federal Register as follows: March 17, 2010 (75 FR 
12723), September 20, 2010 (75 FR 57194), and March 4, 2011 (76 FR 
12013). The NOSB received further written and oral testimony at all 
three of these public business meetings which occurred in Woodland, CA 
on April 26-29, 2010, in Madison, WI on October 25-28, 2010, and in 
Seattle, WA on April 26-29, 2011. The written comments can be retrieved 
via http://www.regulations.gov by searching for the document ID 
numbers: AMS-NOP-10-0021 (May 2010 meeting); AMS-NOP-10-0068 (October 
2010 meeting); and AMS-NOP-11-05 (April 2011 meeting). The oral 
comments were recorded in the meeting transcripts available on the NOP 
Web site, http://www.ams.usda.gov/nop.
    Prior to the October 2010 meeting, NOSB policy specified that 
recommendations for substances under sunset review were limited to two 
options: (1) Renewal, or continuation of each exemption or prohibition 
as codified in the NOP regulations; or (2) removal, allowing the 
exemption or prohibition to expire. In October 2010, the NOSB changed 
their sunset policy to allow a third option for issuing a 
recommendation.\2\ The third option enables the Board to add or change 
annotations (restrictions) on National List substances under sunset 
review. This change in policy ensures that the Board can address new 
use patterns and scientific information on substances allowed or 
prohibited in organic production. The policy limits such annotation 
changes under sunset to those which clarify an existing annotation or 
make the annotation more restrictive. The new policy does not authorize 
an annotation change during the sunset review process that would result 
in expanded use of an exempted substance.
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    \2\ October 28, 2010, NOSB Recommendation on Sunset Review 
Process. Available at NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088004&acct=nosb.
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    As a result of their meetings in April and October 2010, and April 
2011, the NOSB recommended that the Secretary: (1) Renew, as currently 
codified in the NOP regulations, multiple listings for substances under 
the 2012 sunset review, (2) remove the exemption for three substances 
from the National List, and (3) amend the annotations for eight 
substances (seven exemptions and one prohibition) on the National List. 
For some annotation amendments, the NOSB recommendation on the 
amendment occurred concurrent to, rather than after, the institution of 
the new NOSB sunset policy in October 2010. As a way to streamline the 
regulatory process and expedite implementation of the NOSB 
recommendations, the NOP proposes to address all of the annotation 
changes for substances under sunset review as part of this proposed 
rule.
    The NOSB also recommended renewal of the listing for nutrient 
vitamins and minerals, as codified, at their April 2011 meeting. During 
the NOSB's deliberations on this substance, the NOP consulted with the 
Food and Drug Administration (FDA) about the regulatory citation that 
is currently incorporated by reference into the annotation for nutrient 
vitamins and minerals.\3\ As a result of this consultation, the NOP 
determined that current listing for nutrient vitamins and minerals was 
the result of a drafting error and that a correction to this listing is 
necessary to align the listing with the NOSB's 1995 original 
recommendation. Therefore, the NOP plans to address the sunset review 
for nutrient vitamins and minerals and correct the drafting error 
through a separate proposed rule.
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    \3\ April 14, 2011, Letter from FDA to NOP on the FDA 
Fortification Policy at 21 CFR 104.20. Available at NOP Web site: 
http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5090415.
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    USDA is engaging in this proposed rulemaking to reflect the 
recommendations of the NOSB from April 2010, October 2010 and April 
2011, for all listings for substances under sunset review, with the 
exception of nutrient vitamins and minerals and sodium nitrate which 
will be dealt with in separate actions. This rulemaking will solicit 
public comment on all renewals, removals, and annotation changes that 
are proposed.
    Under the authority of the OFPA, as amended, (7 U.S.C. 6501-6522), 
the National List can be amended by the Secretary based on 
recommendations developed by the NOSB. Since established, the NOP has 
published multiple amendments to the National List: October 31, 2003 
(68 FR 61987), November 3, 2003 (68 FR 62215), October 21, 2005 (70 FR 
61217), June 7, 2006 (71 FR 32803), September 11, 2006 (71 FR 53299), 
June, 27, 2007 (72 FR 35137), October 16, 2007 (72 FR 58469), December 
10, 2007 (72 FR 69569), December 12, 2007 (72 FR 70479), September 18, 
2008 (73 FR 54057), October 9, 2008 (73 FR 59479), July 6, 2010 (75 FR 
38693), August 24, 2010 (75 FR 51919), and December 13, 2010 (75 FR 
77521). Additionally, proposed amendments to the National List were 
published on November 8, 2010 (75 FR 68505), May 5, 2011 (76 FR 25612) 
and on November 8, 2011 (76 FR 69141).

II. Overview of Proposed Actions

    From April 26, 2010 through April 29, 2011, the NOSB reviewed the 
listings for exemptions and prohibitions that are authorized on the 
National List and set to expire on June 27, 2012, October 21, 2012, 
December 11, 2012, and December 13, 2012. Using the evaluation criteria 
specified in the ANPR for sunset review, the NOSB reviewed these 
exemptions and prohibitions for continued authorization in organic 
agricultural production and handling. As a result of the NOSB's review 
of public comment and meeting deliberations, the NOSB recommended that 
the Secretary renew most of the exemptions and prohibitions, with any 
restrictive annotations, as codified. In addition, the NOSB recommended 
that 3 exemptions not be renewed. The NOSB also recommended that 
exemptions or prohibition for 7 substances continue with amendment to 
their restrictive annotations. The Secretary is addressing these NOSB 
recommendations for sunset 2012 listings through this proposed rule as 
shown in Table 1.
    With respect to the criteria used to make recommendations regarding 
the continued authorization of exemptions and prohibitions, the NOSB's 
decisions are based on public comments and applicable supporting 
evidence that

[[Page 1998]]

express a continued need for the use or prohibition of the 
substance(s). In voting to change its sunset policy to allow for 
amendments to annotations during sunset review, the NOSB agreed that 
this policy would enable the Board to consider, as part of their 
decision making, changes in use patterns and scientific information for 
substances under review. Consistent with decisions on continued 
authorizations of exemptions and prohibitions, such annotation changes 
can only be made if public comment and applicable evidence demonstrate 
that the substance, with any restrictive annotations, continues to meet 
the overall criteria for listing under the OFPA.
    Concerning criteria used to make recommendations regarding the 
discontinuation of an authorized exempted synthetic substance, the 
NOSB's decision is based on 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; or (c) 
inconsistent with organic farming and handling practices.
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    \4\ Table 1 shows a simplified listing for each substance; use 
categories and any restrictive annotations are not included in this 
overview.

                            Table 1--Overview of Proposed Actions for Sunset 2012 \4\
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      National list section            Substance         NOSB Meeting       New sunset date     Proposed action
----------------------------------------------------------------------------------------------------------------
Sec.   205.601 Synthetic          Alcohols (Ethanol;  April 2011........  October 21, 2017..  Renew.
 substances allowed for use in     Isopropanol).      April 2010 *......  October 21, 2017..  Renew.
 organic crop production.         Ammonium carbonate  April 2010 *......  October 21, 2017..  Renew.
                                  Aquatic plant
                                   extracts (other
                                   than hydrolyzed).
                                  Boric acid........  April 2010 *......  October 21, 2017..  Renew.
                                  Chlorine materials  April 2011........  October 21, 2017..  Amend: Chlorine
                                   (Calcium                                                    materials--For
                                   hypochlorite;                                               pre-harvest use,
                                   chlorine dioxide;                                           residual chlorine
                                   sodium                                                      levels in the
                                   hypochlorite).                                              water in direct
                                                                                               crop contact or
                                                                                               as water from
                                                                                               cleaning
                                                                                               irrigation
                                                                                               systems applied
                                                                                               to soil must not
                                                                                               exceed the
                                                                                               maximum residual
                                                                                               disinfectant
                                                                                               limit under the
                                                                                               Safe Drinking
                                                                                               Water Act, except
                                                                                               that chlorine
                                                                                               products may be
                                                                                               used in edible
                                                                                               sprout production
                                                                                               according to EPA
                                                                                               label directions.
                                  Coppers, fixed      April 2011........  October 21, 2017..  Renew.
                                   (Copper
                                   hydroxide; copper
                                   oxide; copper
                                   oxychloride).
                                  Copper sulfate....  April 2011........  October 21, 2017..  Renew.
                                  Elemental sulfur    April 2010 *......  October 21, 2017..  Renew.
                                   (3 uses).
                                  EPA List 4--Inerts  October 2010......  October 21, 2017..  Renew.
                                   of Minimal
                                   Concern.
                                  Ethylene gas......  April 2010 *......  October 21, 2017..  Renew.
                                  Herbicides, soap-   April 2010 *......  October 21, 2017..  Renew.
                                   based.
                                  Humic acids.......  April 2010 *......  October 21, 2017..  Renew.
                                  Hydrated lime.....  April 2011........  October 21, 2017..  Renew.
                                  Hydrogen peroxide   April 2010 *......  October 21, 2017..  Renew.
                                   (2 uses).
                                  Lignin sulfonate    April 2011........  October 21, 2017..  Amend: Lignin
                                   on Sec.                                                     sulfonate-
                                   205.601(j)(4).                                              chelating agent,
                                                                                               dust suppressant.
                                  Lignin sulfonate    April 2011........  October 21, 2017..  Renew.
                                   on Sec.
                                   205.601(l)(1).
                                  Lime sulfur (2      April 2010 *......  October 21, 2017..  Renew.
                                   uses).
                                  Liquid fish         April 2010 *......  October 21, 2017..  Renew.
                                   products.
                                  Magnesium sulfate.  April 2011........  October 21, 2017..  Renew.
                                  Micronutrients      April 2010 *......  October 21, 2017..  Renew.
                                   (Soluble boron
                                   products;
                                   Sulfates,
                                   carbonates,
                                   oxides, or
                                   silicates of
                                   zinc, copper,
                                   iron, manganese,
                                   molybdenum,
                                   selenium, and
                                   cobalt).

[[Page 1999]]

 
                                  Mulches             April 2011........  October 21, 2017..  Renew.
                                   (Newspapers or
                                   other recycled
                                   paper, without
                                   glossy or colored
                                   inks; Plastic
                                   mulch and covers).
                                  Newspapers or       April 2011........  October 21, 2017..  Renew.
                                   other recycled
                                   paper, without
                                   glossy or colored
                                   inks.
                                  Oils,               April 2010 *......  October 21, 2017..  Renew.
                                   horticultural-
                                   narrow range oils
                                   as dormant,
                                   suffocating, and
                                   summer oils (2
                                   uses).
                                  Pheromones........  April 2011........  October 21, 2017..  Renew.
                                  Potassium           April 2010 *......  October 21, 2017..  Renew.
                                   bicarbonate.
                                  Soap-based          April 2010 *......  October 21, 2017..  Renew.
                                   algicide/
                                   demossers.
                                  Soaps, ammonium...  April 2010 *......  October 21, 2017..  Renew.
                                  Soaps,              April 2010 *......  October 21, 2017..  Renew.
                                   insecticidal.
                                  Sodium silicate...  April 2011........  October 21, 2017..  Renew.
                                  Sticky traps/       April 2010 *......  October 21, 2017..  Renew.
                                   barriers.
                                  Streptomycin......  April 2011........  ..................  Amend:
                                                                                               Streptomycin, for
                                                                                               fire blight
                                                                                               control in apples
                                                                                               and pears only
                                                                                               until October 21,
                                                                                               2014.
                                  Sucrose octanoate   April 2010 *......  December 11, 2017.  Renew.
                                   esters (CAS
                                   s--42922
                                   -74-7; 58064-47-
                                   4).
                                  Sulfur dioxide....  April 2011........  ..................  Remove.
                                  Vitamin B1, C, and  April 2010 *......  October 21, 2017..  Renew.
                                   E.
                                  Vitamin D3........  April 2011........  October 21, 2017..  Renew.
Sec.   205.602 Nonsynthetic       Arsenic...........  April 2010 *......  October 21, 2017..  Renew.
 substances prohibited for use    Ash for manure      April 2010 *......  October 21, 2017..  Renew.
 in organic crop production.       burning.           April 2010 *......  October 21, 2017..  Renew.
                                  Lead salts........  April 2010 *......  October 21, 2017..  Renew.
                                  Potassium chloride
                                  Sodium
                                   fluoaluminate
                                   (mined).
                                  Sodium nitrate....  April 2011........  October 21, 2017..  Addressed in
                                                                                               separate
                                                                                               rulemaking action
                                  Strychnine........  April 2010 *......  October 21, 2017..  Renew.
                                  Tobacco dust        April 2010 *......  October 21, 2017..  Renew.
                                   (nicotine
                                   sulfate).
Sec.   205.603 Synthetic          Alcohols (Ethanol;  October 2010......  October 21, 2017..  Renew.
 substances allowed for use in     Isopropanol).      October 2010......  October 21, 2017..  Renew.
 organic livestock production.    Aspirin...........  April 2010 *......  December 13, 2017.  Renew.
                                  Atropine (CAS       April 2010 *......  October 21, 2017..  Renew.
                                   -51-55-8.
                                  Biologics--Vaccine  April 2010 *......  December 13, 2017.  Renew.
                                   s.
                                  Butorphanol (CAS
                                   -42408-8
                                   2-2).
                                  Chlorhexidine.....  April 2010 *......  October 21, 2017..  Renew.
                                  Chlorine materials  October 2010......  October 21, 2017..  Renew.
                                   (Calcium
                                   hypochlorite;
                                   chlorine dioxide;
                                   sodium
                                   hypochlorite).
                                  Copper sulfate....  October 2010......  October 21, 2017..  Renew.
                                  Electrolytes......  April 2010 *......  October 21, 2017..  Renew.
                                  EPA List 4--Inerts  October 2010......  October 21, 2017..  Renew.
                                   of Minimal
                                   Concern.
                                  Excipients........  April 2010 *......  December 13, 2017.  Renew.
                                  Flunixin (CAS       April 2010 *......  December 13, 2017.  Renew.
                                   -38677-8
                                   5-9).
                                  Furosemide........  October 2010......  December 13, 2017.  Renew.
                                  Glucose...........  October 2010......  October 21, 2017..  Renew.
                                  Glycerine.........  October 2010......  October 21, 2017..  Renew.
                                  Hydrogen peroxide.  April 2010 *......  October 21, 2017..  Renew.
                                  Iodine (2 uses)...  April 2010 *......  October 21, 2017..  Renew.
                                  Ivermectin........  April 2010 *......  October 21, 2017..  Renew.
                                  Lidocaine.........  April 2010 *......  October 21, 2017..  Renew.
                                  Lime, hydrated....  April 2010 *......  October 21, 2017..  Renew.
                                  Magnesium           April 2010 *......  December 13, 2017.  Renew.
                                   hydroxide (CAS
                                   -1309-42
                                   -8).
                                  Magnesium sulfate.  October 2010......  October 21, 2017..  Renew.

[[Page 2000]]

 
                                  Mineral oil.......  April 2010 *......  October 21, 2017..  Renew.
                                  Oxytocin..........  April 2010 *......  October 21, 2017..  Renew.
                                  Peroxyacetic/       April 2010 *......  December 13, 2017.  Renew.
                                   peracetic acid
                                   (CAS -79-
                                   21-0).
                                  Phosphoric acid...  April 2010 *......  October 21, 2017..  Renew.
                                  Poloxalene (CAS     April 2010 *......  December 13, 2017.  Renew.
                                   -9003-11
                                   -6).
                                  Procaine..........  April 2010 *......  October 21, 2017..  Renew.
                                  Sucrose octanoate   April 2010 *......  December 11, 2017.  Renew.
                                   esters (CAS
                                   s--42922
                                   -74-7; 58064-47-
                                   4).
                                  Tolazoline (CAS     April 2010 *......  December 13, 2017.  Renew.
                                   -59-98-3
                                   ).
                                  Trace minerals....  April 2010 *......  October 21, 2017..  Renew.
                                  Vitamins..........  April 2010 *......  October 21, 2017..  Renew.
                                  Xylazine (CAS       April 2010 *......  December 13, 2017.  Renew.
                                   -7361-61
                                   -7).
Sec.   205.604 Nonsynthetic       Strychnine........  April 2010 *......  October 21, 2017..  Renew.
 substances prohibited for use
 in organic livestock production.
Sec.   205.605(a) Nonsynthetic,   Acids (Alginic;     April 2010 *......  October 21, 2017..  Renew.
 nonagricultural substances        citric; lactic).   April 2010 *......  October 21, 2017..  Renew.
 allowed as ingredients in or on  Bentonite.........  April 2010 *......  October 21, 2017..  Renew.
 processed products labeled as    Calcium carbonate.  April 2010 *......  October 21, 2017..  Renew.
 ``organic'' or ``made with       Calcium chloride..  April 2010 *......  October 21, 2017..  Renew.
 organic (specified ingredients   Dairy cultures....  April 2010 *......  October 21, 2017..  Renew.
 or food group(s))''.             diatomaceous earth  April 2010 *......  October 21, 2017..  Renew.
                                  Enzymes...........  October 2010......  October 21, 2017..  Renew.
                                  Flavors...........  April 2010 *......  October 21, 2017..  Renew.
                                  Kaolin............  October 2010......  October 21, 2017..  Renew.
                                  Magnesium sulfate.
                                  Nitrogen..........  April 2010 *......  October 21, 2017..  Renew.
                                  Oxygen............  April 2010 *......  October 21, 2017..  Renew.
                                  Perlite...........  April 2010 *......  October 21, 2017..  Renew.
                                  Potassium chloride  April 2010 *......  October 21, 2017..  Renew.
                                  Potassium iodide..  April 2011........  October 21, 2017..  Renew.
                                  Sodium bicarbonate  April 2010 *......  October 21, 2017..  Renew.
                                  Sodium carbonate..  April 2010 *......  October 21, 2017..  Renew.
                                  Waxes (Carnauba     April 2010 *......  October 21, 2017..  Renew.
                                   wax; Wood resin).
                                  Yeast (Autolysate;  October 2010......  October 21, 2017..  Amend: Yeast--When
                                   Bakers; Brewers;                                            used as food or a
                                   Nutritional;                                                fermentation
                                   Smoked).                                                    agent, yeast must
                                                                                               be organic if its
                                                                                               end use is for
                                                                                               human
                                                                                               consumption;
                                                                                               nonorganic yeast
                                                                                               may be used when
                                                                                               equivalent
                                                                                               organic yeast is
                                                                                               not commercially
                                                                                               available. Growth
                                                                                               on petrochemical
                                                                                               substrate and
                                                                                               sulfite waste
                                                                                               liquor is
                                                                                               prohibited. For
                                                                                               smoked yeast,
                                                                                               nonsynthetic
                                                                                               smoke flavoring
                                                                                               process must be
                                                                                               documented.
Sec.   205.605(b) Synthetic,      Alginates.........  April 2010 *......  October 21, 2017..  Renew.
 nonagricultural substances       Ammonium            April 2010 *......  October 21, 2017..  Renew.
 allowed as ingredients in or on   bicarbonate.       April 2010 *......  October 21, 2017..  Renew.
 processed products labeled as    Ammonium carbonate  April 2010 *......  October 21, 2017..  Renew.
 ``organic'' or ``made with       Ascorbic Acid.....  April 2010 *......  October 21, 2017..  Renew.
 organic (specified ingredients   Calcium citrate...  April 2010 *......  October 21, 2017..  Renew.
 or food group(s))''.             Calcium hydroxide.  April 2010 *......  October 21, 2017..  Renew.
                                  Calcium phosphates
                                   (monobasic;
                                   dibasic;
                                   tribasic).
                                  Carbon dioxide....  April 2010 *......  October 21, 2017..  Renew.
                                  Chlorine materials  October 2010......  October 21, 2017..  Renew.
                                   (Calcium
                                   hypochlorite;
                                   chlorine dioxide;
                                   sodium
                                   hypochlorite).

[[Page 2001]]

 
                                  Ethylene..........  April 2011........  October 21, 2017..  Renew.
                                  Ferrous sulfate...  October 2010......  October 21, 2017..  Renew.
                                  Glycerides (mono;   April 2010 *......  October 21, 2017..  Renew.
                                   di).
                                  Glycerin..........  April 2011........  October 21, 2017..  Renew.
                                  Hydrogen peroxide.  April 2010 *......  October 21, 2017..  Renew.
                                  Magnesium           April 2010 *......  October 21, 2017..  Renew.
                                   carbonate.
                                  Magnesium chloride  April 2010 *......  October 21, 2017..  Renew.
                                  Magnesium stearate  April 2010 *......  October 21, 2017..  Renew.
                                  Nutrient vitamins   April 2011........  ..................  Addressed in
                                   and minerals.                                               separate
                                                                                               rulemaking
                                                                                               action.
                                  Ozone.............  April 2010 *......  October 21, 2017..  Renew.
                                  Pectin (low-        October 2010......  ..................  Remove; included
                                   methoxy).                                                   in amended Sec.
                                                                                               205.606 listing
                                                                                               of Pectin (non-
                                                                                               amidated forms
                                                                                               only).
                                  Phosphoric acid...  October 2010......  October 21, 2017..  Renew.
                                  Potassium acid      April 2010 *......  October 21, 2017..  Renew.
                                   tartrate.
                                  Potassium           April 2010 *......  October 21, 2017..  Renew.
                                   carbonate.
                                  Potassium citrate.  April 2010 *......  October 21, 2017..  Renew.
                                  Potassium           April 2010 *......  October 21, 2017..  Renew.
                                   hydroxide.
                                  Potassium iodide..  April 2011........  ..................  Remove.
                                  Potassium           April 2010 *......  October 21, 2017..  Renew.
                                   phosphate.
                                  Silicon dioxide...  October 2010......  October 21, 2017..  Renew.
                                  Sodium citrate....  October 2010......  October 21, 2017..  Renew.
                                  Sodium hydroxide..  October 2010......  October 21, 2017..  Renew.
                                  Sodium phosphates.  October 2010......  October 21, 2017..  Renew.
                                  Sulfur dioxide....  October 2010......  October 21, 2017..  Renew.
                                  Tocopherols.......  April 2011........  October 21, 2017..  Renew.
                                  Xanthan gum.......  April 2010 *......  October 21, 2017..  Renew.
Sec.   205.606 Nonorganically     Casings, from       April 2010 *......  June 27, 2017.....  Renew.
 produced agricultural products    processed          ..................  ..................  ..................
 allowed as ingredients in or on   intestines.        April 2010 *......  June 27, 2017.....  Renew.
 processed products labeled as    Celery powder.....  April 2010 *......  June 27, 2017.....  Renew.
 ``organic''.                     Chia (Salvia        October 2010......  June 27, 2017.....  Amend: Colors
                                   hispanica L.).                                              derived from
                                  Colors (Annatto                                              agricultural
                                   extract color;                                              products--Must
                                   Beet juice                                                  not be produced
                                   extract color;                                              using synthetic
                                   Beta-carotene                                               solvents and
                                   extract color;                                              carrier systems
                                   Black currant                                               or any artificial
                                   juice color,                                                preservative.
                                   Black/purple
                                   carrot juice
                                   color; Blueberry
                                   juice color;
                                   Carrot juice
                                   color; Cherry
                                   juice color;
                                   Chokeberry--Aroni
                                   a juice color;
                                   Elderberry juice
                                   color; Grape
                                   juice color;
                                   Grape skin
                                   extract color;
                                   Paprika color;
                                   Pumpkin juice
                                   color; Purple
                                   potato juice
                                   color; Red
                                   cabbage extract
                                   color; Red radish
                                   extract color;
                                   Saffron extract
                                   color; Turmeric
                                   extract color).
                                   CAS numbers are
                                   provided in the
                                   Renewals with
                                   Amendment
                                   section..
                                  Cornstarch          October 2010......  October 21, 2017..  Renew.
                                   (native).
                                  Dillweed oil (CAS   April 2010 *......  June 27, 2017.....  Renew.
                                   8006-75-
                                   5).
                                  Fish oil (Fatty     April 2010 *......  June 27, 2017.....  Renew.
                                   acid CAS 's 10417-94-4
                                   and 25167-62-8).
                                  Fructooligosacchar  October 2010......  June 27, 2017.....  Renew.
                                   ides (CAS 308066-66-2).
                                  Galangal, frozen..  April 2010 *......  June 27, 2017.....  Renew.
                                  Gelatin (CAS        April 2010 *......  June 27, 2017.....  Renew.
                                   9000-70-
                                   8).
                                  Gums (Arabic;       April 2010 *......  October 21, 2017..  Renew.
                                   Guar; Locust
                                   bean; Carob bean).
                                  Hops (Humulus       October 2010......  ..................  Amend: Hops
                                   luplus).                                                    (Humulus lupulus)
                                                                                               until January 1,
                                                                                               2013.

[[Page 2002]]

 
                                  Inulin,             October 2010......  June 27, 2017.....  Renew.
                                   oligofructose
                                   enriched (CAS
                                   9005-80-
                                   5).
                                  Kelp..............  April 2010 *......  October 21, 2017..  Renew.
                                  Konjac flour (CAS   April 2010 *......  June 27, 2017.....  Renew.
                                   37220-17
                                   -0).
                                  Lemongrass, frozen  April 2010 *......  June 27, 2017.....  Renew.
                                  Orange shellac--    April 2010 *......  June 27, 2017.....  Renew.
                                   unbleached (CAS
                                   9000-59-
                                   3).
                                  Pectin (high-       October 2010......  October 21, 2017..  Amend: Pectin (non-
                                   methoxy).                                                   amidated forms
                                                                                               only).
                                  Peppers (chipotle   April 2010 *......  June 27, 2017.....  Renew.
                                   chile).
                                  Sweet potato        April 2010 *......  June 27, 2017.....  Renew.
                                   starch.
                                  Turkish bay leaves  April 2010 *......  June 27, 2017.....  Renew.
                                  Wakame seaweed      April 2010 *......  June 27, 2017.....  Renew.
                                   (Undaria
                                   pinnatifida).
                                  Whey protein        October 2010......  June 27, 2017.....  Renew.
                                   concentrate.
----------------------------------------------------------------------------------------------------------------
* The NOSB originally recommended that these substances be relisted during their April 2010 meeting. Since
  public comments were still being accepted for these substances, the NOSB decided to reaffirm their
  recommendations on these substances at the October 2010 meeting after analyzing all public comments.

Renewals

    After considering all public comments and supporting evidence, the 
NOSB determined that many listings for exempted and prohibited 
substances demonstrated a continued need for authorization in organic 
agricultural production and handling.
    AMS has reviewed and accepts the NOSB recommendations for the 
continued exemption or prohibition of these listings. Accordingly, this 
proposed rule would renew the exemptions at Sec.  205.601, along with 
any restrictive annotations, for the synthetic substances allowed for 
use in organic crop production as shown in Table 1.
    This proposed rule would renew the prohibitions at Sec.  205.602, 
along with any restrictive annotations, for the nonsynthetic substances 
prohibited for use in organic crop production as shown in Table 1.
    This proposed rule would renew the exemptions at Sec.  205.603, 
along with any restrictive annotations, for the synthetic substances 
allowed for use in organic livestock production as shown in Table 1.
    This proposed rule would renew the prohibition at Sec.  205.604, 
for the one nonsynthetic substance, strychnine, prohibited for use in 
organic livestock production as shown in Table 1.
    This proposed rule would renew the exemptions at Sec.  205.605, 
along with any restrictive annotations, for the nonagricultural 
(nonorganic) substances allowed as ingredients in or on processed 
products labeled as ``organic'' or ``made with organic (specified 
ingredients or food group(s))'' as shown in Table 1.
    This proposed rule would renew the exemptions at Sec.  205.606, 
along with any restrictive annotations, for the nonorganically produced 
agricultural products allowed as ingredients in or on processed 
products labeled as ``organic'' as shown in Table 1.

Nonrenewals

    After considering all public comments and supporting evidence, the 
NOSB determined that three exemptions on the National List are no 
longer necessary for organic agricultural production and handling.
    The Agricultural Marketing Service (AMS) has reviewed and accepts 
the NOSB recommendations for removal of three exemptions from the 
National List. Based upon recommendations from the NOSB concerning 
substances identified for review under this sunset review process, this 
proposed rule would amend the USDA's National List to remove the 
exemptions as shown in Table 1 for the following substances in organic 
agricultural production and handling:

Section 205.601 Synthetic Substances Allowed for Use in Organic Crop 
Production

    The NOP regulation currently includes an exemption for sulfur 
dioxide as a rodenticide for use in crop production at Sec.  
205.601(g)(1) as follows:
    Sulfur dioxide--underground rodent control only (smoke bombs).
    The Environmental Protection Agency (EPA) registers smoke bomb 
products for underground rodent control with the active ingredients 
sulfur, charcoal carbon, and sodium nitrate or potassium nitrate 
(saltpeter). Smoke bombs are placed into rodent burrows and detonated. 
The detonation process produces sulfur dioxide smoke from the 
combustion of sulfur in the product. Sulfur dioxide is not listed as 
the active ingredient on labels for smoke bomb products. According to a 
Technical Report prepared for the NOSB on this use of sulfur dioxide, 
the EPA does not register products with the active ingredient listed as 
sulfur dioxide.\5\
---------------------------------------------------------------------------

    \5\ Technical Report on Sulfur Dioxide. January 14, 2011. 
Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5089145&acct=nopgeninfo.
---------------------------------------------------------------------------

    The NOSB Crops Committee considered the finding that EPA does not 
register products with sulfur dioxide as an active ingredient on the 
label sufficient justification for the removal of the exemption for 
this substance. The NOP agrees that the substances included on the 
National List should be named in the same convention that is used by 
other regulatory agencies that have jurisdiction, such as the EPA, to 
avoid confusion.
    A few public comments indicated that smoke bombs are an important 
part of rodent control for some organic crop operations. However, 
comments from one certifying agent indicated that they have not 
approved any smoke bomb products due to the presence of a detonator 
chemical in these products that contains a form of phosphorous that is 
not included on the National List. The NOSB expressed concern that 
exempting the effective substance, sulfur dioxide, on the National List 
instead of the EPA-recognized active

[[Page 2003]]

ingredients can be confusing and may contribute to inconsistency among 
certifying agents.
    The NOSB also discussed the variety of alternative methods and 
materials are used by organic growers for rodent control above and 
below ground. The NOSB noted that even though some organic growers may 
rely on smoke bombs in certain circumstances, other methods (such as 
trapping or baiting with approved materials from the National List) are 
available and could be used if sulfur dioxide is removed from the 
National List and smoke bombs became unavailable for use by organic 
growers. It was noted that the alternative use of Vitamin D3 
bait-type control is preferred when rodent control is needed in the 
close proximity to a building.
    After considering all input from the public and any applicable 
evidence, the NOSB concluded that sulfur dioxide should not remain on 
the National List as an authorized substance for organic crop 
production, due to the acknowledgement that EPA registered smoke bomb 
products do not list sulfur dioxide as an active ingredient for smoke 
bombs, the availability of alternatives, and the lack of evidence that 
the substance is essential to organic production.
    AMS accepts the NOSB's recommendation and proposes to remove the 
exemption for the use of sulfur dioxide. This proposed rule would amend 
Sec.  205.601 of the National List by removing the exemption at 
paragraph (g)(1) and redesignating current paragraph (g)(2) as (g) to 
read as follows: (g) As rodenticides. Vitamin D3.
    This amendment would be effective on the substance's current sunset 
date, October 21, 2012.

Section 205.605 Nonagricultural (Nonorganic) Substances Allowed as 
Ingredients in or on Processed Products Labeled as ``Organic'' or Made 
With Organic (Specified Ingredients or Food Group(s))'' Only in 
Accordance With Any Restrictions Specified in This Section

    The NOP regulation currently includes an exemption for pectin for 
use in organic handling at Sec.  205.605(b) as follows:
    Pectin (low-methoxy).
    There are currently two exemptions for pectin on the National List. 
One exemption at Sec.  205.605(b) is for low-methoxy pectin as a 
synthetic, nonagricultural (nonorganic) substance allowed as 
ingredients in or on processed products labeled as ``organic'' or 
``made with organic (specified ingredients or food groups(s)).'' The 
other exemption at Sec.  205.606 is for high-methoxy pectin as a 
nonorganically produced agricultural product allowed as ingredients in 
or on processed products labeled as ``organic.'' High-methoxy pectin is 
only permitted in organic processed products when it is not 
commercially available in organic form.
    Both high-methoxy and low-methoxy pectin are derived from apple 
pomace or citrus rinds by a similar extraction process. The degree of 
esterification determines their classification as a high- or low-
methoxy pectin. Low-methoxy pectin is commonly produced by using acid 
solutions to remove methyl groups (CH3) from the complex 
polysaccharide chain, and has a lower molecular weight than high-
methoxy pectin. In a 1995 NOSB recommendation, the Board considered the 
longer extraction process and reduction in molecular weight to be a 
substantive chemical change, and therefore, classified low-methoxy 
pectin as synthetic. Some forms of low-methoxy pectin may be 
manufactured by treating with ammonia to de-methylate the pectin, 
replacing the methyl groups with an amine group, resulting in amidated 
pectin. The NOSB considered the amidated forms of pectin during their 
1995 deliberations on this substance, but issued a final recommendation 
that low-methoxy pectin be allowed as a synthetic substance, without 
restricting use of the amidated forms. This recommendation resulted in 
a listing for low-methoxy pectin at Sec.  205.605(b). In the same 
recommendation, the NOSB classified high-methoxy pectin as 
nonsynthetic. Both pectins are used in organic handling according to 
their different functions; low-methoxy pectin is used for low sugar 
jams and high-methoxy pectin is used in high sugar jams.
    In developing their October 2010 recommendation for low-methoxy 
pectin, the NOSB Handling Committee considered public comments 
submitted by organic handlers. Organic handlers stated that there was 
no reason to use any form of amidated pectin in organic products, and 
that they supported the NOSB Handling Committee recommendation to 
reclassify non-amidated forms of low-methoxy pectin under Sec.  205.606 
as a nonsynthetic substance. During their October 2010 deliberations, 
the NOSB also considered amidated forms of low-methoxy pectin to be 
synthetic. Because the NOSB recommended non-amidated, low-methoxy 
pectin to be nonsynthetic and listed at Sec.  205.606, the NOSB 
recommended the removal of the exemption for low-methoxy from Sec.  
205.605(b), a section limited to synthetic, nonagricultural substances 
allowed in processed products. By deleting the exemption, the use of 
amidated, low-methoxy pectin would be prohibited in organic handling.
    During their deliberations, the NOSB clarified that all non-
amidated forms of pectin, including low-methoxy, should continue to be 
allowed under an amended Sec.  205.606 listing for pectin. The NOSB 
recommended a change in annotation to the current listing for pectin on 
Sec.  205.606, such that all non-amidated pectins, regardless of the 
methoxy level, would be available for use in organic products under 
Sec.  205.606, subject to commercial availability. This change in 
annotation is proposed as part of this proposed rule and is addressed 
in an upcoming section of the preamble.
    There was no public comment opposing the NOSB's approach for 
addressing the use of pectin in organic handling. Organic jam makers 
indicated unanimous support of the Board's recommendation. The NOSB's 
recommendation was also supported by a petition from an organic jam 
maker who proposed adding non-amidated, low-methoxy pectin to Sec.  
205.606. The petitioner suggested that amidated forms of pectin are 
unnecessary in organic handling because non-amidated forms are 
currently available for use in jam and low sugar fruit spreads and 
preparations.
    AMS accepts the NOSB's recommendation. This proposed rule would 
amend Sec.  205.605(b) of the National List by removing the exemption 
for pectin (low-methoxy).
    This amendment would be effective on the substance's current sunset 
date, October 21, 2012.
    The NOP regulation currently includes an exemption for potassium 
iodide for use in organic handling at Sec.  205.605(b) as follows:
    Potassium iodide--for use only in agricultural products labeled 
``made with organic (specified ingredients or food group(s)),'' 
prohibited in agricultural products labeled ``organic''.
    Potassium iodide has two listings on Sec.  205.605 for use in 
organic handling. It is listed as nonsynthetic on Sec.  205.605(a) and 
it is listed as synthetic on Sec.  205.605(b) of the National List. 
Under this sunset review, the NOSB voted unanimously to continue 
listing the substance on Sec.  205.605(a), as naturally mined potassium 
iodide is used in some organic products. One commenter supported the 
continued exemption for potassium iodide at Sec.  205.605(a) because 
the substance is also used as a sanitizer in some organic handling 
operations.

[[Page 2004]]

    The listing as a synthetic on Sec.  205.605(b) restricts its use to 
products in the ``made with organic (specified ingredients or food 
groups(s)),'' labeling category. The NOSB concluded that the synthetic 
listing for potassium iodide at Sec.  205.605(b) is redundant and that 
its annotation is in conflict with the allowance for potassium iodide 
as a nutrient additive under a separate listing. Synthetic potassium 
iodide is the primary form of iodide allowed for fortification of food, 
and would be permitted under the listing for vitamins and minerals at 
Sec.  205.605(b). Therefore, the NOSB determined that a separate 
listing for synthetic potassium iodide was not necessary.
    AMS accepts the NOSB's recommendation. This proposed rule would 
amend Sec.  205.605(b) of the National List by removing the exemption, 
along with its restrictive annotation, for potassium iodide.
    This amendment would be effective on the substance's current sunset 
date, October 21, 2012.

Renewals With Amendment

    After considering all public comments and supporting evidence, the 
NOSB identified seven exemptions and one prohibition for which renewal 
is critical to organic agricultural production and handling, but for 
which amendments are needed to the current listings for these 
substances to clarify or restrict their use.
    AMS has reviewed and accepts the NOSB recommendations to renew, 
with amendment, seven exemptions and one prohibition on the National 
List. Based upon these recommendations from the NOSB, this proposed 
rule would amend the USDA's National List as shown in Table 1 for the 
following substances in organic agricultural production and handling:

Section 205.601 Synthetic Substances Allowed for Use in Organic Crop 
Production

    The NOP regulation currently includes an exemption for chlorine 
materials for use in crop production at Sec.  205.601(a)(2) as follows:
    Chlorine materials--Except, That, residual chlorine levels in the 
water shall not exceed the maximum residual disinfectant limit under 
the Safe Drinking Water Act.
    (i) Calcium hypochlorite.
    (ii) Chlorine dioxide.
    (iii) Sodium hypochlorite.
    The NOSB Crops Committee reviewed comments received on chlorine 
materials in response to the ANPR published on March 26, 2010 (75 FR 
14500), and issued a committee recommendation on March 7, 2011. The 
Board noted that the current annotation does not accurately represent 
the 1995 NOSB recommendation for chlorine materials, which stated that 
chlorine may be used to disinfect and sanitize food contact surfaces 
and that ``residual chlorine levels for wash water in direct crop or 
food contact and in flush water from cleaning irrigation systems that 
is applied to crops or fields cannot exceed the maximum residual 
disinfectant limit under the Safe Drinking Water Act (currently 4 mg/L 
expressed as Cl2).'' \6\ The NOSB Crops Committee also discussed a 2003 
NOSB recommendation that suggested modification of the chlorine 
materials annotation to reflect the NOSB's intention that water in 
direct crop or soil contact should not have higher levels of chlorine 
than those permitted for municipal drinking water.\7\ The NOP concurs 
with the NOSB that the current annotations for chlorine materials do 
not align precisely with the 1995 or 2003 recommendations of the Board.
---------------------------------------------------------------------------

    \6\ NOSB, 1995. Final Minutes of the NOSB Full Board Meeting, 
Austin TX, Oct. 31-Nov. 4 1995. Page 18, line 611. Available at the 
NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5057496.
    \7\ NOSB, 2003. Summary of Meeting Minutes, NOSB Meeting--May 
13-14, 2003, page 4. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5058538; NOSB, 
2003. Measuring Effluent: Clarification of Chlorine Contact with 
Organic Food, NOSB Processing Committee April 30, 2003. Available at 
the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3104548.
---------------------------------------------------------------------------

    At the April 2011 NOSB meeting, the Board received public comments 
on this issue and recommended the following change to the annotation 
for chlorine materials: ``For pre-harvest use, residual chlorine levels 
in the water in direct crop contact or as water from cleaning 
irrigation systems applied to soil must not exceed the maximum residual 
disinfectant limit under the Safe Drinking Water Act. For disinfecting 
or sanitizing equipment or tools or in edible sprout production, 
chlorine products may be used up to maximum labeled rates.'' The NOSB 
stated that this revised annotation would clarify the allowance for 
chlorine materials and align with past NOSB recommendations and NOP 
policy.
    The NOP agrees that this language addresses the intent of the NOSB 
to specify that water in direct contact with crops during production 
should not contain more chlorine than is permitted in municipal 
drinking water. The NOP issued final guidance (NOP 5026) on May 6, 
2011, that is consistent with the April 2011 NOSB recommendation on 
chlorine materials for crop use.\8\ This guidance document also 
clarifies that chlorine products may be used at labeled rates to 
disinfect or sanitize tools. The NOP also acknowledges that, while 
chlorine materials also have similar listings under Sec.  205.603(a) 
for use in livestock operations, and Sec.  205.605(b) for use in 
handling, the NOSB only voted to change the annotation for the use of 
chlorine in crops production.
---------------------------------------------------------------------------

    \8\ NOP 5026. Guidance: The Use of Chlorine Materials in Organic 
Production and Handling. May 9, 2011. Available at the NOP Web site: 
http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5090760.
---------------------------------------------------------------------------

    The NOSB's recommended annotation change includes a clarification 
on the use of chlorine in edible sprout production. The NOP proposes to 
amend the chlorine listing to include the Board's clarification on 
edible sprouts. However, the NOP consulted the EPA and learned that a 
number of calcium hypochlorite products are labeled for use in 
disinfecting seeds used for sprouts. EPA label directions for sprout 
seed state that seed should be soaked at 20,000 ppm available chlorine 
followed by a rinse with potable water. The NOP is seeking comments on 
the appropriateness of this type of chlorine treatment for organic 
sprout production. The NOP also seeks information regarding other FDA 
and EPA approved materials or methods that can be used to comply with 
FDA guidance regarding safety of sprouts.\9\ These specific uses and 
alternatives were not addressed by commenters in detail and may require 
additional clarification in the final rule.
---------------------------------------------------------------------------

    \9\ FDA. Guidance for Industry: Microbial Food Safety Hazards 
for Sprouted Seeds. October 27, 1999. Available at the FDA Web site: 
http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm120244.htm.
---------------------------------------------------------------------------

    AMS accepts the NOSB's recommendation, with a slight modification. 
The NOP clarified the use of chlorine on tools and equipment through 
guidance and, therefore, finds that including this language in the 
annotation change is unnecessary. This proposed rule would amend Sec.  
205.601(a)(2) to read as follows:
    Chlorine materials--For pre-harvest use, residual chlorine levels 
in the water in direct crop contact or as water from cleaning 
irrigation systems applied to soil must not exceed the maximum residual 
disinfectant limit under the Safe Drinking Water Act, except that 
chlorine products may be used in edible sprout production according to 
EPA label directions.
    (i) Calcium hypochlorite.
    (ii) Chlorine dioxide.

[[Page 2005]]

    (iii) Sodium hypochlorite.
    This amendment would be effective on the substance's current sunset 
date, October 21, 2012.
    The National List currently includes an exemption for streptomycin 
for plant disease control in organic crop production at Sec.  
205.601(i)(11) as follows:
    Streptomycin, for fire blight control in apples and pears only.
    Streptomycin is derived from the soil bacterium Streptomyces 
griseus and can be used to control bacterial disease in crops.\10\ In 
organic production, streptomycin is currently allowed as a synthetic 
substance to treat fire blight in apple and pear orchards. Streptomycin 
is one of two antibiotics (the other substance being tetracycline) on 
the National List that organic apple and pear growers can use for fire 
blight control. Fire blight is caused by the bacterium Erwinia 
amylovora, which is native to North America and lives on alternate 
hosts such as hawthorne and crabapple. It infects apple and pear 
blossoms and can spread rapidly through the tree vascular system to 
kill shoots and destroy trees. The bacterium can be moved from plant to 
plant by honeybees, other insects, birds, rain, wind, and hail.
---------------------------------------------------------------------------

    \10\ Technical Report on Streptomycin. March 8, 2011. Available 
at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5090468.
---------------------------------------------------------------------------

    As part of their review of the current exemption for streptomycin 
on the National List, the NOSB considered written comments received in 
response to the ANPR published on March 26, 2010 (75 FR 14500), and 
oral comments from their April 2011 public meeting. Some commenters 
expressed concerns about the potential for antibiotic overuse, 
potential for development of antibiotic resistance, and the impact of 
antibiotic use on the environment. Some commenters stated that there 
are some rootstocks (e.g. the Geneva series) that may provide 
resistance to fire blight, which, if used by organic growers, could 
reduce the need for streptomycin in organic production systems. The 
majority of the NOSB Crops Committee stated that selection of fire 
blight resistant varieties suitable for organic production should be a 
grower's first choice for disease control, rather than the use of 
streptomycin.
    However, the NOSB also heard from other commenters who stated that 
research into alternatives to streptomycin for fire blight control is 
ongoing but has yet to deliver suitable alternatives. Public testimony 
at the April 2011 NOSB meeting suggested that, while there are apple 
varieties and rootstocks with differing degrees of resistance to fire 
blight, there is a lack of varieties that meet commercial demand for 
both good fruit quality and disease resistance. Other commenters 
pointed out that resistance is relative and all apple varieties are 
susceptible to fire blight to some extent. Red Delicious and Macoun are 
the least susceptible, with all newer commercial varieties being more 
susceptible. It was also pointed out that the resistance in the 
rootstock does not translate to resistance in the scion, leaving the 
tree vulnerable to infection. Varieties are normally replaced every 10-
15 years and thus cannot be switched like changing a spray product; the 
cost of replanting an orchard can exceed $20,000 per acre. Pears tend 
to be uniformly more susceptible to fire blight than apples, and 
resistant germplasm does not appear to be available. Many organic apple 
and pear growers as well as disease specialists stated that fire blight 
management is very challenging and additional research is needed to 
develop effective alternatives to antibiotics. Researchers who 
commented at the NOSB meeting described one such tool, a new yeast 
product that may be effective to control fire blight as an alternative 
to streptomycin; however, this product has only had preliminary field 
trials, is not commercially available, and has not received 
registration from the EPA.
    Organic growers further explained in their testimony to the NOSB 
that growers do not routinely apply streptomycin as a preventive every 
year, but only when conditions indicate risk of infection is high. Most 
growers use a predictive model such as Cougarblight or Maryblight to 
time antibiotic application with potential infection periods. Growers 
also stated that, while streptomycin has become ineffective in some 
growing areas due to resistance of the pathogen, it remains a critical 
tool in other regions of the U.S.
    Given that proven effective alternatives are limited, and the 
impact that failing to renew the allowance for streptomycin would have 
on the organic apple and pear industry, the NOSB recommended extending 
the allowance of streptomycin for a limited time period. This limited 
extension is intended to allow for further development of alternative 
methods or substances for fire blight control in organic production. 
While some commenters explained that development of alternatives to 
streptomycin is 3 to 5 years from commercialization, the NOSB did not 
agree that the exemption for streptomycin should continue for another 5 
years until the next sunset review in 2017. The NOSB opted to support a 
change in the annotation that would allow the use of streptomycin only 
until October 21, 2014. The NOSB anticipates that this expiration date 
will promote industry collaboration on the development of alternatives 
and prompt growers to use resistant varieties and other management 
practices for fire blight control on organic pear and apple operations. 
In response to the requests by the NOSB and the industry for additional 
resources to support research on alternatives to fire blight, the NOP 
issued letters to the USDA Agricultural Research Service (ARS) and 
National Institute of Food and Agriculture (NIFA) in May 2011 to 
request their assistance in prioritizing research on such 
alternatives.\11\
---------------------------------------------------------------------------

    \11\ May 2011 Letters submitted by NOP to USDA ARS and NIFA on 
fire blight research. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5091325.
---------------------------------------------------------------------------

    AMS accepts the NOSB's recommendation. This proposed rule would 
amend Sec.  205.601(i)(11) to read as follows:
    Streptomycin, for fire blight control in apples and pears only 
until October 21, 2014.
    This amendment would be effective on the substance's current sunset 
date, October 21, 2012.
    The National List currently includes an exemption for lignin 
sulfonate as a plant or soil amendment in organic crop production at 
Sec.  205.601(j)(4) as follows:
    Lignin sulfonate--chelating agent, dust suppressant, floatation 
agent.
    Lignin sulfonate is listed twice on the National List under Sec.  
205.601; the first listing is for use as a plant or soil amendment, the 
second listing is for use as a floatation agent in post-harvest 
handling. During the sunset review for lignin sulfonate, the NOSB noted 
that including ``floatation agent'' as an allowable use under the first 
listing is incorrect. The substance is not used as a floatation agent 
for plant or soil amendments. Public comment also stated that lignin 
sulfonate is used as a floatation agent for post-harvest handling, and 
this use is currently allowed under the second listing for the 
substance at Sec.  205.601(l)(1). Therefore, the NOSB recommended the 
first listing for lignin sulfonate at Sec.  205.601(j)(4) be corrected 
to remove the language ``floatation agent'' from the annotation. The 
change to this annotation has no effect on the allowance of lignin 
sulfonate as a floatation agent for post-harvest handling under Sec.  
205.601(l)(1).
    The Secretary accepts the NOSB's recommendation. This proposed rule

[[Page 2006]]

would amend Sec.  205.601(j)(4) to read as follows:
    Lignin sulfonate--chelating agent, dust suppressant.
    This amendment would be effective on the substance's current sunset 
date, October 21, 2012.

Section 205.605 Nonagricultural (Nonorganic) Substances Allowed as 
Ingredients in or on Processed Products Labeled as ``Organic'' or 
``Made With Organic (Specified Ingredients or Food Group(s))''

    The National List currently includes a listing for yeast as a 
nonsynthetic for use in or on processed products at Sec.  205.605(a) as 
follows:
    Yeast--nonsynthetic, growth on petrochemical substrate and sulfite 
waste liquor is prohibited (Autolysate; Bakers; Brewers; Nutritional; 
and Smoked--nonsynthetic smoke flavoring process must be documented).
    At their October 2010 public meeting, the NOSB issued a 
recommendation for yeast under sunset review and a recommendation on a 
petition to change the current listing for yeast. The NOP is responding 
to both recommendations through a single action in this proposed rule 
to streamline and efficiently address the regulatory changes requested 
by the NOSB.
    When the NOSB issued their 1995 recommendation for yeast, organic 
sources of yeast were not available. More recently, manufacturers have 
developed methods of production and obtained organic certification for 
yeast products.\12\ Manufacturers have since advocated that yeast 
should be considered an agricultural substance and included on Sec.  
205.606, rather than on Sec.  205.605(a). Inclusion of yeast on Sec.  
205.606 would require food processors to use organic yeast when it was 
commercially available. In August 2006, a petition was submitted to the 
NOSB requesting that yeast be removed from Sec.  205.605(a) and listed 
on Sec.  205.606.\13\
---------------------------------------------------------------------------

    \12\ The NOP issued guidance on March 2, 2010, (NOP 5014: 
Certification of Organic Yeast) to clarify that yeast may be labeled 
as organic provided certain guidelines are met. Available at the NOP 
Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5087121.
    \13\ The petition was submitted by Marroquin International 
Organic Commodity Services, Inc., and is available at the NOP Web 
site: http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
---------------------------------------------------------------------------

    In their October 2010 deliberations on the status of yeast on the 
National List, the NOSB Handling Committee favored the potential for 
expanded use of organic yeast in processed organic products. However, 
the NOSB also expressed concern that moving yeast to Sec.  205.606 
would classify it as an agricultural nonsynthetic substance, a 
classification that would impact the status of yeast used in the 
livestock feed industry. Under the NOP regulations at Sec.  205.237(a), 
all agricultural ingredients included in additives and supplements of 
livestock feed rations must be organic. If the NOSB were to recommend 
inclusion of yeast on Sec.  205.606, then all yeast used in livestock 
feed supplements would need to be organic. This action would not serve 
the interests of livestock producers who feed yeast to livestock as a 
non-agricultural, non-synthetic feed supplement.
    Based upon these considerations, the NOSB recommended an annotation 
change to the current listing for yeast at Sec.  205.605(a). This 
annotation change is intended to lead to greater demand for organic 
products in both the handling and crop categories without elimination 
of an important source of supplements for organic livestock rations. In 
the recommendation, yeast would remain on Sec.  205.605(a) with an 
amended annotation that would require yeast used as food or a 
fermentation agent to be organic if the end use is for human 
consumption, but would allow use of nonorganic yeast when equivalent 
organic yeast is not commercially available. Most comments received on 
yeast were supportive of this annotation change.
    AMS accepts the NOSB's recommendation. This proposed rule would 
amend Sec.  205.605(a) to read as follows:
    Yeast--When used as food or a fermentation agent, yeast must be 
organic if its end use is for human consumption; nonorganic yeast may 
be used when equivalent organic yeast is not commercially available. 
Growth on petrochemical substrate and sulfite waste liquor is 
prohibited. For smoked yeast, nonsynthetic smoke flavoring process must 
be documented.
    This amendment would be effective on the listing's current sunset 
date, October 21, 2012.

Section 205.606 Nonorganically Produced Agricultural Products Allowed 
as Ingredients in or on Processed Products Labeled as ``Organic''

    The National List currently includes a listing for colors allowing 
their use in or on processed products at Sec.  205.606(d) as follows:
    Colors derived from agricultural products.
    At their October 2010 public meeting, the NOSB issued a 
recommendation for colors under sunset review and a recommendation for 
an annotation change to the current listing for colors. The NOP is 
responding to both recommendations through a single action in this 
proposed rule to streamline and efficiently address the regulatory 
changes requested by the NOSB.
    In March 2007, the NOSB recommended the addition of colors from 
agricultural products to Sec.  205.606 of the National List. Their 
action was the result of several petitions submitted after the colors 
had been allowed to sunset from Sec.  205.605(a) in 2007.
    When the NOSB approved colors for addition to Sec.  205.606, the 
Board did not consider including a restriction on the use of synthetics 
solvents in color extraction because the petitions specified colors 
that were only oil or water extracted using physical processing such as 
cutting, drying, or grinding. Some NOSB members also felt it was not 
possible to place restrictions on a nonorganic substance listed as 
permitted under Sec.  205.606. At that time, some NOSB members 
emphasized that annotations on nonorganic substances should be limited 
to those which restrict the use of the listed substance instead of the 
process of producing it.
    Because of the lack in specificity in the colors annotation, 
stakeholders have advised the NOSB through public comment that there is 
confusion as to whether synthetic solvents may be used to extract 
colors and whether use of synthetic solvents in the preparation of the 
colors listed on Sec.  205.606 is within the intent of the listing. In 
response to this concern, the NOSB Handling Committee reviewed 
transcripts from the March 2007 meeting, petitions, and committee 
recommendations and concluded that the use of synthetic solvents was 
not reviewed by the NOSB and is, therefore, clearly outside of the 
intent of the current listing. In addition, the Handling Committee 
stated that solvent extraction of these colors is not necessary given 
that each color was petitioned as being available in the marketplace 
without synthetic solvent extraction. Public comments received at the 
October 2010 NOSB meeting also supported the NOSB's recommendation to 
change the annotation to prohibit solvent extraction and use of 
synthetic carriers or preservatives.
    As part of their October 2010 recommendation, the NOSB also 
requested that the NOP review the Chemical Abstract Service (CAS) 
registration numbers for each of these food colors for accuracy and 
make any technical corrections necessary. The NOP agrees that, in some 
cases, the CAS numbers are incorrect as they refer to pigments that can 
be produced from a variety of sources rather than the

[[Page 2007]]

nonsynthetic colors derived from agricultural sources that the NOSB 
reviewed. The NOP plans to correct these numbers through a future 
rulemaking action. This proposed rule would not amend the CAS numbers 
for colors; all CAS numbers for colors included under Sec.  205.606(d) 
would continue to be listed as follows: Annatto extract color (pigment 
CAS  1393-63-1)--water and oil soluble 107, Beet juice extract 
color (pigment CAS  7659-95-2), Beta-carotene extract color 
from carrots (CAS  1393-63-1), Black currant juice color 
(pigment CAS 's: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-
30-7, and 134-04-3), Black/purple carrot juice color (pigment CAS 
's: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 
134-04-3), Blueberry juice color (pigment CAS 's: 528-58-5, 
528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3), Carrot juice 
color (pigment CAS  1393-63-1), Cherry juice color (pigment 
CAS 's: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 
134-04-3), Chokeberry--Aronia juice color (pigment CAS 's: 
528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3), 
Elderberry juice color (pigment CAS 's: 528-58-5, 528-53-0, 
643-84-5, 134-01-0, 1429-30-7, and 134-04-3), Grape juice color 
(pigment CAS 's: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-
30-7, and 134-04-3), Grape skin extract color (pigment CAS 's: 
528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3), 
Paprika color--dried powder and vegetable oil extract (CAS  
68917-78-2), Pumpkin juice color (pigment CAS  127-40-2), 
Purple potato juice color (pigment CAS 's: 528-58-5, 528-53-0, 
643-84-5, 134-01-0, 1429-30-7, and 134-04-3), Red cabbage extract color 
(pigment CAS 's: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-
30-7, and 134-04-3), Red radish extract color (pigment CAS 's 
528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3), 
Saffron extract color (pigment CAS  1393-63-1), and Turmeric 
extract color (CAS  458-37-7).
    AMS accepts the NOSB's recommendation to change the annotation for 
colors. This proposed rule would amend Sec.  205.606(d) to read as 
follows:
    Colors derived from agricultural products--Must not be produced 
using synthetic solvents and carrier systems or any artificial 
preservative.
    This amendment would be effective on the listing's current sunset 
date, June 27, 2012.
    The Secretary specifically seeks comments on this proposed 
amendment with regard to the extent of use of carbon dioxide, a 
synthetic solvent that is on the National List at Sec.  205.605(b), 
which may be used in a liquid state (supercritical carbon dioxide) to 
extract colors.
    The National List currently includes a listing for hops allowing 
its use in or on processed products at Sec.  205.606(l) as follows:
    Hops (Humulus luplus).
    At their October 2010 public meeting, the NOSB issued a 
recommendation for hops under sunset review and a recommendation on a 
petition to add an expiration date to the current listing for hops. The 
NOP is responding to both recommendations through a single action in 
this proposed rule to streamline and efficiently address the regulatory 
changes requested by the NOSB.
    Hops are a perennial crop that is customarily grown under contract. 
Most hops are sold on forward contracts before planting. Hops plantings 
do not reach optimum production in one season of growth, so growers are 
unable to switch varieties on an annual basis. The variety of hops used 
dramatically influences the flavor of different beers, and the 
different varieties of hops grown distinguish many styles of beers.
    Hops was added to the National List at Sec.  205.206 in 2007 to 
enable brewers to make organic beer with conventionally grown hops in 
the absence of a commercially available supply of organically grown 
hops. At that time, industry comments indicated that a sufficient 
volume of organic hops in the varieties needed did not exist. After the 
2007 listing of hops on Sec.  205.606, grower expectations that brewers 
would begin to seek additional organic hops contracts did not 
materialize. In December 2009, growers petitioned the NOSB to remove 
hops from Sec.  205.606 to expedite growth in the organic hops 
market.\14\ This petition was reviewed by the NOSB concurrently with 
the sunset listing for hops.
---------------------------------------------------------------------------

    \14\ The petition was submitted by the American Organic Hop 
Growers Association and is available at the NOP Web site: http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
---------------------------------------------------------------------------

    The initial recommendation from the NOSB Handling Committee 
concerning hops was to renew its listing on Sec.  205.606 of the 
National List without change. When this recommendation was published in 
the October 2010 NOSB meeting notice with a request for public comments 
(FR 75 57194), over 100 comments against the continuation of hops on 
Sec.  205.606 were submitted by consumers, growers, organic 
associations, and academics. Hops brokers and growers commented that 
few brewers actively sought organic hops and voiced dissatisfaction 
with this situation, as it was commonly described as an effort to 
maximize profit by the brewers who wanted to produce organic beer at a 
premium price, but did not seek organic hops for their beer.
    At their October 2010 public meeting, the NOSB heard comments from 
some organic brewers who stated they always used organic hops, and that 
there was no difficulty in obtaining the specific varieties of hops 
needed in commercial quantities. These brewers supported the removal of 
hops from Sec.  205.606, and felt that sourcing all organic hops would 
not impede the growth and progress of their business. Other comments 
also indicated that, since organic beer labels are not required to list 
ingredients, customers and purveyors of beer rarely know whether the 
hops in their organic beer are organic. A majority of these commenters 
supported the removal of hops from Sec.  205.606 so that consumers 
could be assured that organic hops is used in organic beer.
    Many commenters also indicated that the availability of organic 
hops is now sufficient to supply the organic beer market. A few 
comments were received from brewers who maintained that an adequate 
organic supply of the varieties of hops needed for their beer varieties 
could not be sourced by the June 27, 2012, sunset date for hops.
    In consideration of the comments received, and in acknowledgement 
of the time needed to establish a perennial crop and forward contracts, 
the NOSB determined that the best approach would be to relist hops on 
the National List at Sec.  205.606 until January 1, 2013. This 
extension of the listing would allow brewers to source, when organic 
hops is not commercially available, from the 2011 and 2012 year supply 
of conventional hops, while fostering the development of purchasing 
arrangements for organic varieties from crops in 2013.
    AMS accepts the NOSB's recommendation. The NOP also proposes a 
spelling correction to the binomial name for hops, currently misspelled 
at Sec.  205.606. This proposed rule would amend Sec.  205.606(l) to 
read as follows:
    Hops (Humulus lupulus) until January 1, 2013.
    This amendment would be effective on the current sunset date for 
hops, June 27, 2012.
    The National List currently includes a listing for pectin allowing 
its use in or on processed products at Sec.  205.606(s) as follows:
    Pectin (high-methoxy).

[[Page 2008]]

    At their October 2010 public meeting, the NOSB issued a 
recommendation for pectin (high-methoxy) under sunset review and a 
recommendation on a petition to change the forms of pectin allowed in 
organic handling. As discussed in the Removals section on low-methoxy 
pectin, the NOP is responding to both recommendations through a single 
action in this proposed rule. This is intended to streamline and 
efficiently address the regulatory changes requested by the NOSB. The 
result of this proposed rule would list all non-amidated (nonsynthetic) 
forms of pectin on Sec.  205.606.
    During the 2012 sunset review, the NOSB reviewed a petition 
requesting that the listing at Sec.  205.605(b) for low-methoxy pectin 
be moved to Sec.  205.606. The petitioner proposed that non-amidated 
forms of low-methoxy pectin are not synthetic.\15\ The petitioner 
explained that the use of ammonia in the extraction process for 
producing pectin is limited to amidated forms of pectin and, therefore, 
only amidated forms should be considered synthetic. In consideration of 
this petition, the NOSB reviewed a Technical Report and a Supplemental 
Technical Report, both of which supported the petitioner's 
position.\16\ The NOSB determined that amidation is a better indicator 
of whether the pectin is synthetic. Since all forms of pectin currently 
on the National List are available in non-amidated (nonsynthetic) form, 
the NOSB recommended that a single listing for non-amidated forms of 
pectin on Sec.  205.606 would be more appropriate. If implemented, all 
amidated forms of pectin would be prohibited. Comments by organic food 
processors supported the NOSB recommendation and agreed that amidated 
pectin is not needed for organic processing.
---------------------------------------------------------------------------

    \15\ The petition was submitted by Crofters Food Ltd. and is 
available at the NOP Web site: http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
    \16\ Technical Report on Non Amidated Low Methoxyl Pectin. 
August 17, 2009. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5087206; 
Supplemental Report on Non Amidated Low Methoxyl Pectin. July 30, 
2010. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5087205.
---------------------------------------------------------------------------

    AMS accepts the NOSB's recommendation. This proposed rule would 
amend Sec.  205.606(s) to read as follows:
    Pectin (non-amidated forms only).
    This amendment would be effective on the current sunset date for 
pectin (high-methoxy), October 21, 2012.

III. Related Documents

    An Advance Notice of Proposed Rulemaking (ANPR) was published in 
the Federal Register on March 26, 2010, (75 FR 14500) to make the 
public aware that the exemptions and prohibitions for 232 listings of 
synthetic and non-synthetic substances in organic production and 
handling will expire, if not reviewed by the NOSB and renewed by the 
USDA.

IV. Statutory and Regulatory Authority

    The OFPA, as amended (7 U.S.C. 6501-6522), authorizes the Secretary 
to make amendments to the National List based on proposed amendments 
developed by the NOSB. Sections 6518(k)(2) and 6518(n) of OFPA 
authorize the NOSB to develop proposed amendments to the National List 
for submission to the Secretary and establish a petition process by 
which persons may petition the NOSB for the purpose of having 
substances evaluated for inclusion on or deletion from the National 
List. The National List petition process is implemented under Sec.  
205.607 of the NOP regulations. The current petition process (72 FR 
2167, January 18, 2007) can be accessed through the NOP Web site at: 
http://www.ams.usda.gov/nop.

A. Executive Order 12866

    This action has been determined not significant for purposes of 
Executive Order 12866, and therefore, has not been reviewed by the 
Office of Management and Budget.

B. Executive Order 12988

    Executive Order 12988 instructs each executive agency to adhere to 
certain requirements in the development of new and revised regulations 
in order to avoid unduly burdening the court system. This proposed rule 
is not intended to have a retroactive effect.
    States and local jurisdictions are preempted under the OFPA from 
creating programs of accreditation for private persons or State 
officials who want to become certifying agents of organic farms or 
handling operations. A governing State official would have to apply to 
USDA to be accredited as a certifying agent, as described in Sec.  
2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under 
Sec. Sec.  2104 through 2108 of the OFPA (7 U.S.C. 6503 through 6507) 
from creating certification programs to certify organic farms or 
handling operations unless the State programs have been submitted to, 
and approved by, the Secretary as meeting the requirements of the OFPA.
    Pursuant to Sec.  2108(b)(2) of the OFPA (7 U.S.C. 6507(b)(2)), a 
State organic certification program may contain additional requirements 
for the production and handling of organically produced agricultural 
products that are produced in the State and for the certification of 
organic farm and handling operations located within the State under 
certain circumstances. Such additional requirements must: (a) Further 
the purposes of the OFPA, (b) not be inconsistent with the OFPA, (c) 
not be discriminatory toward agricultural commodities organically 
produced in other States, and (d) not be effective until approved by 
the Secretary.
    Pursuant to Sec.  2120(f) of the OFPA (7 U.S.C. 6519(f)), this 
proposed rule would not alter the authority of the Secretary under the 
Federal Meat Inspection Act (21 U.S.C. 601-624), the Poultry Products 
Inspection Act (21 U.S.C. 451-471), or the Egg Products Inspection Act 
(21 U.S.C. 1031-1056), concerning meat, poultry, and egg products, nor 
any of the authorities of the Secretary of Health and Human Services 
under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), 
nor the authority of the Administrator of EPA under the Federal 
Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.).
    Section 2121 of the OFPA (7 U.S.C. 6520) provides for the Secretary 
to establish an expedited administrative appeals procedure under which 
persons may appeal an action of the Secretary, the applicable governing 
State official, or a certifying agent under this title that adversely 
affects such person or is inconsistent with the organic certification 
program established under this title. The OFPA also provides that the 
U.S. District Court for the district in which a person is located has 
jurisdiction to review the Secretary's decision.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires 
agencies to consider the economic impact of each rule on small entities 
and evaluate alternatives that would accomplish the objectives of the 
rule without unduly burdening small entities or erecting barriers that 
would restrict their ability to compete in the market. The purpose is 
to fit regulatory actions to the scale of businesses subject to the 
action. Section 605 of the RFA allows an agency to certify a rule, in 
lieu of preparing an analysis, if the rulemaking is not expected to 
have a significant economic impact on a substantial number of small 
entities.

[[Page 2009]]

    Pursuant to the requirements set forth in the RFA, AMS performed an 
economic impact analysis on small entities in the final rule published 
in the Federal Register on December 21, 2000 (65 FR 80548). AMS has 
also considered the economic impact of this action on small entities. 
The impact on entities affected by this proposed rule would not be 
significant. The effect of this proposed rule would be to allow the 
continued use of additional substances in agricultural production and 
handling. AMS concludes that the economic impact of this addition of 
allowed substances, if any, would be minimal and beneficial to small 
agricultural service firms. Accordingly, USDA certifies that this rule 
will not have a significant economic impact on a substantial number of 
small entities.
    Small agricultural service firms, which include producers, 
handlers, and accredited certifying agents, have been defined by the 
Small Business Administration (SBA) (13 CFR 121.201) as those having 
annual receipts of less than $7,000,000 and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000.
    According to USDA, Economic Research Service (ERS) data based on 
information from USDA-accredited certifying agents, the number of 
certified U.S. organic crop and livestock operations totaled nearly 
13,000 and certified organic acreage exceeded 4.8 million acres in 
2008.\17\ ERS, based upon the list of certified operations maintained 
by the NOP, estimated the number of certified handling operations was 
3,225 in 2007.\18\ AMS believes that most of these entities would be 
considered small entities under the criteria established by the SBA.
---------------------------------------------------------------------------

    \17\ U.S. Department of Agriculture, Economic Research Service. 
2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock 
Numbers and Farm Operations, 1992-2008. Available at: http://www.ers.usda.gov/Data/Organic/.
    \18\ U.S. Department of Agriculture, Economic Research Service, 
2009. Data Sets: Procurement and Contracting by Organic Handlers: 
Documentation. Available at: http://www.ers.usda.gov/Data/OrganicHandlers/Documentation.htm.
---------------------------------------------------------------------------

    The U.S. sales of organic food and beverages have grown from $3.6 
billion in 1997 to nearly $21.1 billion in 2008.\19\ The organic 
industry is viewed as the fastest growing sector of agriculture, 
representing over 3 percent of overall food sales in 2009. Between 1990 
and 2008, organic food sales historically demonstrated a growth rate 
between 15 to 24 percent each year. In 2010, organic food sales grew 
7.7%.\20\
---------------------------------------------------------------------------

    \19\ Dimitri, C., and L. Oberholtzer. 2009. Marketing U.S. 
Organic Foods: Recent Trends from Farms to Consumers, Economic 
Information Bulletin No. 58, U.S. Department of Agriculture, 
Economic Research Service. Available at: http://www.ers.usda.gov/Publications/EIB58.
    \20\ Organic Trade Association's 2011 Organic Industry Survey. 
Available at: http://www.ota.com.
---------------------------------------------------------------------------

    In addition, USDA has 94 accredited certifying agents who provide 
certification services to producers and handlers. A complete list of 
names and addresses of accredited certifying agents may be found on the 
AMS NOP web site, at http://www.ams.usda.gov/nop. AMS believes that 
most of these accredited certifying agents would be considered small 
entities under the criteria established by the SBA.

D. Paperwork Reduction Act

    No additional collection or recordkeeping requirements are imposed 
on the public by this proposed rule. Accordingly, OMB clearance is not 
required by section 350(h) of the Paperwork Reduction Act of 1995, 44 
U.S.C. 3501-3520, or OMB's implementing regulations at 5 CFR part 1320.

E. General Notice of Public Rulemaking

    This proposed rule reflects recommendations submitted to the 
Secretary by the NOSB for substances on the National List of Allowed 
and Prohibited Substances that, under the sunset review provisions of 
OFPA, would otherwise expire in 2012. A 30-day period for interested 
persons to comment on this rule is provided. Thirty days is deemed 
appropriate because the review of these listings was widely publicized 
through three NOSB meetings and an ANPR, the use, prohibition, and 
amendments to these substances, as applicable, are critical to organic 
production, and this rulemaking should be completed before the earliest 
2012 sunset date, June 27, 2012.

List of Subjects in 7 CFR Part 205

    Administrative practice and procedure, Agriculture, Animals, 
Archives and records, Imports, Labeling, Organically produced products, 
Plants, Reporting and recordkeeping requirements, Seals and insignia, 
Soil conservation.

    For the reasons set forth in the preamble, 7 CFR part 205, is 
proposed to be amended as follows:

PART 205--NATIONAL ORGANIC PROGRAM

    1. The authority citation for 7 CFR part 205 continues to read as 
follows:

    Authority: 7 U.S.C. 6501-6522.

    2. Section 205.601 is amended by:
    A. Revise paragraph (a)(2);
    B. Revise paragraph (g);
    C. Revise paragraph (i)(11); and
    D. Revise paragraph (j)(4) to read as follows:


Sec.  205.601  Synthetic substances allowed for use in organic crop 
production.

    (a) * * *
    (2) Chlorine materials--For pre-harvest use, residual chlorine 
levels in the water in direct crop contact or as water from cleaning 
irrigation systems applied to soil must not exceed the maximum residual 
disinfectant limit under the Safe Drinking Water Act, except that 
chlorine products may be used in edible sprout production according to 
EPA label directions.
    (i) Calcium hypochlorite.
    (ii) Chlorine dioxide.
    (iii) Sodium hypochlorite.
* * * * *
    (g) As rodenticides. Vitamin D3.
* * * * *
    (i) * * *
    (11) Streptomycin, for fire blight control in apples and pears only 
until October 21, 2014.
* * * * *
    (j) * * *
    (4) Lignin sulfate--chelating agent, dust suppressant.
* * * * *
    4. Section 205.605 is amended by:
    A. Revise the annotation for ``Yeast'' under paragraph (a);
    B. Remove ``Pectin (low-methoxy)'' from paragraph (b); and
    C. Remove ``Potassium iodide'' from paragraph (b). The revision 
reads as follows:


Sec.  205.605  Nonagricultural (nonorganic) substances allowed as 
ingredients in or on processed products labeled as ``organic'' or 
``made with organic (specified ingredients or food groups(s)).''

* * * * *
    (a) * * *
* * * * *
    Yeast--When used as food or a fermentation agent, yeast must be 
organic if its end use is for human consumption; nonorganic yeast may 
be used when equivalent organic yeast is not commercially available. 
Growth on petrochemical substrate and sulfite waste liquor is 
prohibited. For smoked yeast; nonsynthetic smoke flavoring process must 
be documented.
* * * * *
    5. Section 205.606 is amended by:
    A. Revise paragraph (d);
    B. Revise paragraph (l); and
    C. Revise paragraph (s), the revisions read as follows:

[[Page 2010]]

Sec.  205.606  Nonorganically produced agricultural products allowed as 
ingredients in or on processed products labeled ``organic''.

* * * * *
    (d) Colors derived from agricultural products--Must not be produced 
using synthetic solvents and carrier systems or any artificial 
preservative.
    * * *
* * * * *
    (l) Hops (Humulus lupulus) until January 1, 2013.
* * * * *
    (s) Pectin (non-amidated forms only).
* * * * *

    Dated: January 6, 2012.
David R. Shipman,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2012-362 Filed 1-11-12; 8:45 am]
BILLING CODE 3410-02-P