[Federal Register Volume 77, Number 8 (Thursday, January 12, 2012)]
[Proposed Rules]
[Pages 1996-2010]
From the Federal Register Online via the Government Printing 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
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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\
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\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.
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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.
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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.
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\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.
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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.
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\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.
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\10\ Technical Report on Streptomycin. March 8, 2011. Available
at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5090468.
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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\
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\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.
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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\
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\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.
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\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.
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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.
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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\
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\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.
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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