[Federal Register Volume 78, Number 24 (Tuesday, February 5, 2013)]
[Proposed Rules]
[Pages 8040-8047]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-02398]


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 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 78, No. 24 / Tuesday, February 5, 2013 / 
Proposed Rules  

[[Page 8040]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-12-0016; NOP-12-07PR]
RIN 0581-AD27


National Organic Program; Proposed Amendments to the National 
List of Allowed and Prohibited Substances (Crops and Processing)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would amend the U.S. Department of 
Agriculture's (USDA's) National List of Allowed and Prohibited 
Substances (National List) to address recommendations submitted to the 
Secretary of Agriculture (Secretary) by the National Organic Standards 
Board (NOSB) on November 5, 2009, and December 2, 2011. One 
recommendation addressed in this proposed rule pertains to amending the 
annotations for two exemptions (uses) for peracetic acid in organic 
crop production. Additional NOSB recommendations addressed in this 
proposed rule pertain to changing the annotations for three substances, 
potassium hydroxide, silicon dioxide, and beta-carotene extract color, 
which are currently allowed for use in organic handling. This proposed 
rule would also address the NOSB recommendation to remove the allowance 
on the National List for the use of nonorganic annatto extract color in 
organic handling.

DATES: Comments must be received by March 7, 2013.

ADDRESSES: Interested persons may comment on the proposed rule using 
the following procedures:
     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 20250-0268.
    Instructions: All submissions received must include the docket 
number AMS-NOP-12-0016; NOP-12-07PR, and/or Regulatory Information 
Number (RIN) 0581-AD27 for this rulemaking. You should clearly indicate 
the topic and section number of this proposed rule to which your 
comment refers. You should clearly indicate whether you support the 
action being proposed for the substances in this proposed rule. You 
should clearly indicate the reason(s) for your position. You should 
also supply information on alternative management practices, where 
applicable, that support alternatives to the proposed action. You 
should also offer any recommended language change(s) that would be 
appropriate to your position. Please include relevant information and 
data to support your position (e.g. scientific, environmental, 
manufacturing, industry, impact information, etc.). Only relevant 
material supporting your position should be submitted. All comments 
received will be posted without change to http://www.regulations.gov.
    AMS is particularly interested in comments that identify any 
formulated hydrogen peroxide products labeled for agricultural use that 
contain more than 5% peracetic acid and that may be impacted by this 
rulemaking action. AMS is also interested in comments that describe 
whether product reformulation will be necessary and the timeframe that 
will be needed to comply with the proposed amendment for silicon 
dioxide at section 205.605(b) and the proposed removal of annatto 
extract color from section 206.606. Such comments will be considered to 
determine appropriate effective dates for these changes to the National 
List if codified through a final rule.
    Document: For access to the document to read comments received or 
any related background documents, 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, 
Room 2646-South Building, 1400 Independence Ave. SW., 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 INFROMATION: 

I. Background

    On December 21, 2000, the Secretary established, within the 
National Organic Program (NOP) (7 CFR part 205), the National List 
regulations in sections 205.600 through 205.607. This National List 
identifies the synthetic substances that may be used and the 
nonsynthetic (natural) substances that may not be used in organic 
production. The National List also identifies synthetic, nonsynthetic 
nonagricultural and nonorganic agricultural substances that may be used 
in organic handling. The Organic Foods Production Act of 1990 (OFPA) (7 
U.S.C. 6501-6522), and USDA organic regulations, in section 205.105, 
specifically prohibit the use of any synthetic substance in organic 
production and handling unless the synthetic substance is on the 
National List. Section 205.105 also requires that any nonorganic 
agricultural and any nonsynthetic nonagricultural substance used in 
organic handling be on the National List.
    Under the authority of the OFPA, the National List can be amended 
by the Secretary based on recommendations developed by the NOSB. Since 
established, AMS has published multiple amendments to the National List 
beginning on October 31, 2003 (68 FR 61987). AMS published the most 
recent amendment to the National List on September 27, 2012 (77 FR 
59287).
    This proposed rule would amend the National List to reflect one 
recommendation submitted to the Secretary by the NOSB on November 5, 
2009, and four recommendations submitted to the Secretary by the NOSB 
on December 2, 2011. Based upon their evaluation of petitions submitted 
by industry participants, public comments, market surveillance, and 
review of technical reports and previous NOSB recommendations, the NOSB 
recommended that the Secretary revise the annotations for two listings 
for peracetic acid for organic crop

[[Page 8041]]

production at section 205.601, revise the annotations for two 
substances (potassium hydroxide, and silicon dioxide) for organic 
processing at section 205.605(b), and revise the annotation for one 
substance (beta-carotene extract color) for organic processing at 
section 205.606. In addition, the NOSB recommended removing one 
substance (annatto extract color) for organic processing from section 
205.606, which allows the nonorganic form to be used when the organic 
form is not commercially available. The exemptions for the use of each 
substance in organic crop production and handling were evaluated by the 
NOSB using the criteria specified in OFPA (7 U.S.C. 6517-6518).

II. Overview of Proposed Amendments

    The following provides an overview of the proposed amendments to 
designated sections of the National List regulations:

Section 205.601 Synthetic Substances Allowed for Use in Organic Crop 
Production

    This proposed rule would amend subparagraphs (a)(6) and (i)(8) of 
section 205.601 by amending two annotations for the following 
substance:
    Peracetic acid. Peracetic acid is a clear, colorless liquid. It is 
an oxidizing agent formed by a reaction of hydrogen peroxide with 
acetic acid in water. The reaction used to produce peracetic acid 
proceeds until equilibrium is reached, and all three species (i.e., 
peracetic acid, hydrogen peroxide, and acetic acid) are always 
simultaneously present in any formulated peracetic acid product. 
Peracetic acid is often used in the food industry as a sanitizer and 
disinfects by oxidizing the outer cell membrane of vegetative bacterial 
cells, endospores, yeast, and mold spores.\1\
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    \1\ Technical advisory panel report for peracetic acid. November 
6, 2000. Available in Petitioned Substances Database under ``P,'' at 
the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5067081&acct=nopgeninfo.
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    This proposed rule would implement a recommendation issued by the 
NOSB at its meeting on November 5, 2009, to amend two listings for 
peracetic acid in subparagraphs (a)(6) and (i)(8) in section 205.601 of 
the National List. This rule proposes an amendment to the annotation 
for peracetic acid to clarify that peracetic acid is also permitted 
with certain restrictions in hydrogen peroxide formulations. This 
change is necessary to align the USDA organic regulations with an 
updated labeling requirement of the Environmental Protection Agency 
(EPA). The EPA labeling requirement specifies that peracetic acid needs 
to be listed as an active ingredient in some products that were 
previously labeled with hydrogen peroxide as the sole active 
ingredient.
    Peracetic acid was first added to section 205.601 of the National 
List on November 3, 2003 (68 FR 61987). AMS added peracetic acid to the 
National List for use in disinfecting equipment, seed, and asexually 
propagated plant material and for use to control fire blight bacteria. 
In 2007, the NOSB reviewed these two listings for peracetic acid under 
the five-year sunset process required by OFPA and, consistent with the 
NOSB recommendation, AMS renewed both listings on November 3, 2008 (73 
FR 59479). Following their renewal in 2008, these two listings for 
peracetic acid are scheduled to sunset from the National List on 
November 3, 2013.
    On August 12, 2008, AMS received a petition from a manufacturer of 
sanitizer products requesting an amendment to the National List to 
expand the allowance for peracetic acid in organic crop production.\2\ 
The petition to amend the annotations for peracetic acid in sections 
205.601(a)(6) and 205.601(i)(8) was submitted in response to a change 
in the EPA labeling requirements for certain products registered under 
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) (7 
U.S.C. 136-136(y)). These products were previously labeled with 
hydrogen peroxide as the sole active ingredient. Some hydrogen peroxide 
labeled products also contain a small amount of peracetic acid. 
Peracetic acid is produced from the in situ reaction of acetic acid, an 
inert ingredient permitted under section 205.601(m) of the USDA organic 
regulations, with the active ingredient hydrogen peroxide. EPA now 
requires that these hydrogen peroxide products be relabeled to list 
both hydrogen peroxide and peracetic acid as active ingredients.
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    \2\ The petition was submitted by BioSafe Systems LLC, and is 
available on the NOP Web site at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5071775&acct=nopgeninfo.
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    Under the USDA organic regulations, hydrogen peroxide is permitted 
for plant disease control in organic crop production (Sec.  
205.601(i)(5)). However, the allowance for peracetic acid for plant 
disease control under the USDA organic regulations is limited to fire 
blight control (Sec.  205.601(i)(8)). Since EPA now requires that 
peracetic acid be listed as an active ingredient on the product label 
in some hydrogen peroxide formulations, certifying agents and material 
evaluation programs have had to limit the use of these products to that 
for fire blight control in organic crop production. In the course of 
their product review, certifying agents and material evaluation 
programs identify the active ingredients on the product label (i.e. 
both hydrogen peroxide and peracetic acid) and ensure that the 
producer's use aligns with the restrictive allowance for peracetic acid 
on the National List at section 205.601(i)(8).
    At its November 2009 public meeting, the NOSB reviewed the petition 
and public comment and, in response to the petition, issued a 
recommendation to amend the restrictive annotation for both listings of 
peracetic acid.\3\ A second motion to list peracetic acid without any 
restrictive annotation under the USDA organic regulations did not 
receive the required two-thirds majority to pass.\4\
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    \3\ Available on the NOP Web site at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5092050&acct=nosb.
    \4\ Available on the NOP Web site at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5092052&acct=nosb.
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    The NOSB indicated in its recommendation for peracetic acid that 
its intent was to amend the annotations for peracetic acid to continue 
the availability of certain hydrogen peroxide containing products that 
are now required by EPA to list peracetic acid as a second active 
ingredient on the label. The NOSB recommended that AMS amend the 
annotations for peracetic acid to limit the amount of peracetic acid to 
no more than 5% concentration in hydrogen peroxide products. Although 
the NOSB recommendation characterized the small amount of peracetic 
acid in hydrogen peroxide products as ``formerly allowed as inert,'' 
peracetic acid is not an inert ingredient under section 205.601(m) of 
the USDA organic regulations, since peracetic acid was not classified 
as a List 4 inert ingredient under the former classification system 
used by EPA.\5\ Instead, the peracetic acid may have always been 
present in some products from the in situ reaction of acetic acid (a 
List 4 inert ingredient) with the active ingredient hydrogen peroxide.
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    \5\ The former list of EPA List 4 inert ingredients is available 
at http://www.epa.gov/opprd001/inerts/cascomplete.pdf. This list was 
last updated in August 2004 and is no longer maintained by EPA.
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    At its December 2, 2011, public meeting, the NOSB recommended that 
the listings for peracetic acid in section 205.601 be renewed under the 
sunset process.\6\ The NOSB sunset

[[Page 8042]]

recommendation noted that the 2009 NOSB recommendation to amend the 
listing for peracetic acid had not yet been implemented by AMS. Since 
both NOSB recommendations for peracetic acid are outstanding, AMS is 
proposing to implement the 2009 NOSB recommendation for peracetic acid 
through this proposed rule. AMS intends to complete rulemaking prior to 
the November 3, 2013, sunset date for both listings of peracetic acid 
in section 205.601 of the National List. The amended listings for 
peracetic acid in section 205.601 would then be subject to review again 
within five years of their amendment, in accordance with the OFPA 
provision for the sunset of National List substances (7 U.S.C. 
6517(e)).
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    \6\ The NOSB recommendation for peracetic acid for Sunset 2013 
is available on the NOP Web site at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5097089.
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    The proposed changes are necessary to ensure that some formulated 
products that were previously compliant with the USDA organic 
regulations will continue to be permitted for many applications 
currently in use by organic crop producers. Such applications are in 
addition to those for disinfection of equipment, seed, and asexually 
propagated planting material, and for control of fire blight. 
Implementing the NOSB recommendation continues the use of certain 
hydrogen peroxide products for plant diseases which would not otherwise 
be permitted if the product has been relabeled in accordance with EPA 
requirements to list peracetic acid as an active ingredient.
    If this proposed amendment is not adopted as final, some hydrogen 
peroxide products that contain small amounts (i.e., 5% or less) of 
peracetic acid will become prohibited under the USDA organic 
regulations for most applications. Once these products are labeled in 
accordance with new EPA labeling guidelines, these products will be 
subject to the more restrictive allowances for peracetic acid under the 
USDA organic regulations. AMS has not identified any formulated 
hydrogen peroxide products which are labeled for agricultural use and 
contain more than 5% peracetic acid as an active ingredient on the 
product label. Furthermore, under this proposed action, formulated 
peracetic acid products, including hydrogen peroxide products that 
contain more than 5% peracetic acid, would continue to be subject to 
the same restrictive annotations for peracetic acid under the USDA 
organic regulations. Formulated hydrogen peroxide products that do not 
contain peracetic acid are not impacted by this rulemaking.
    The NOSB recommended the addition of the following text to the 
current annotations for the peracetic acid listings in section 205.601: 
``Permitted in hydrogen peroxide formulations at concentration of no 
more than 5%.'' In this proposed rule, AMS is proposing a modification 
to the NOSB's recommended text as follows (emphasis added): ``Permitted 
in hydrogen peroxide formulations at concentration of no more than 5% 
as indicated on the pesticide product label.'' This amendment is 
intended to clarify the point that the 5% concentration of peracetic 
acid should be verified in the formulated product itself, not after the 
product has been diluted according to label directions prior to its 
application.
    AMS has reviewed and proposes to address the NOSB recommendations 
with the modification described. This proposed rule would amend 
subparagraphs (a)(6) and (i)(8) of section 205.601 of the National List 
by adding the following text to the current annotations for peracetic 
acid: ``Permitted in hydrogen peroxide formulations at concentration of 
no more than 5% as indicated on the pesticide product label.'' If 
finalized, the listings for peracetic acid in section 205.601 would be 
subject to review within five years of their amendment, in accordance 
with the OFPA provision for the sunset of National List substances (7 
U.S.C. 6517(e)).
    AMS is particularly interested in comments that identify any 
impacted hydrogen peroxide products labeled for agricultural use that 
contain more than 5% peracetic acid.

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 groups(s)).''

    This proposed rule would amend section 205.605(b) by changing an 
annotation to expand the use for the following substance:
    Potassium hydroxide. Potassium hydroxide is a white, caustic solid 
which is highly absorbent to the point that it dissolves into solution. 
It is alkaline in solution and available in pellets, flakes, sticks, 
lumps and powder. Commercially, food grade potassium hydroxide is 
obtained from the electrolysis of potassium chloride solution in the 
presence of a porous diaphragm. According to the Food and Drug 
Administration (FDA), potassium hydroxide is generally recognized as 
safe (GRAS) when used as a formulation aid, a pH control agent, a 
processing aid or a stabilizer and thickener (21 CFR 184.1631). The FDA 
regulations further provide that substances generally regarded as safe 
in food may be used to wash or to assist in the peeling of fruits and 
vegetables (21 CFR 173.315).\7\ In the lye peeling of fruits and 
vegetables, potassium hydroxide works by weakening the glycolic bonds 
of pectin responsible for peel adhesion so that the peel can be removed 
by water spray and other mechanical methods.
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    \7\ Technical Report on Potassium hydroxide. May 21, 2001. 
Available in Petitioned Substances Database, under ``P,'' at the NOP 
Web site: http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
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    An allowance for potassium hydroxide was codified on the National 
List on December 21, 2000 (65 FR 80548). The allowance permitted 
potassium hydroxide in organic processing but prohibited its use in lye 
peeling of fruits and vegetables.\8\ On November 3, 2003, AMS published 
a final rule which amended the annotation for potassium hydroxide to 
allow its use for peeling peaches during the Individually Quick Frozen 
(IQF) production process (68 FR 62215). AMS based this amendment on a 
2001 NOSB recommendation to allow potassium hydroxide for IQF peaches. 
The NOSB recommendation stated that there were no commercially viable 
alternatives to lye peeling of peaches. The NOSB also concluded that 
the low pH of the peaches would help neutralize the pH of the 
wastewater from organic processing and, therefore, mitigate any 
potentially adverse environmental effects of the potassium hydroxide 
use.
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    \8\ In 1995, the NOSB recommended the addition of potassium 
hydroxide to section 205.605 for use in organic processing with an 
annotation prohibiting its use in the lye peeling of fruits and 
vegetables. The NOSB based the restriction on concerns about the 
environmental effects of the waste products of the lye peeling 
process, and their understanding that mechanical and non-chemical 
alternatives were available for peeling most fruits and vegetables.
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    On April 19, 2011, AMS received a petition requesting that 
potassium hydroxide be permitted as a processing aid in the lye peeling 
of fresh peaches for canning.\9\ The petition explained that the 
peeling processes for freezing or canning peaches are identical. 
Therefore, the petition claimed that an allowance to use potassium 
hydroxide to peel peaches for canning is consistent with the existing 
allowance for the use of potassium hydroxide in peeling of organic 
peaches for frozen products.

[[Page 8043]]

The petition also stated that no other treatment or process is 
equivalent to potassium hydroxide for peeling peaches, in terms of 
minimal loss of texture, flavor, appearance and aroma.
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    \9\ The petition was submitted by Pacific Coast Producers, and 
is available in the Petitioned Substances Database, under ``P,'' at 
the NOP Web site: http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
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    At its November 29-December 2, 2011 meeting, the NOSB considered 
the petition to amend the annotation for potassium hydroxide to allow 
its use in lye peeling of peaches to be canned. In its deliberations, 
the NOSB noted a lack of commercially viable alternatives for peeling 
peaches and stated that the acidity of the fruit and on-site buffering 
would mitigate any potential environmental impact of alkaline waste 
from a peach processing facility using potassium hydroxide. The NOSB 
also reasoned that freezing and canning are the primary commercial 
processes for peaches and that these processes are identical until the 
last step. Based upon the information in the petition and technical 
report, and prior NOSB action regarding potassium hydroxide, the NOSB 
recommended that potassium hydroxide be allowed for any peach peeling 
in organic processing, rather than limiting the allowance to peaches to 
be frozen using the IQF process.
    AMS has reviewed and proposes to address the NOSB recommendation 
through this proposed rule. Consistent with the NOSB recommendation, 
this proposed rule would amend the listing for potassium hydroxide in 
section 205.605(b) by deleting the words, ``during the Individually 
Quick Frozen (IQF) production process''. This change would, in effect, 
allow the use of potassium hydroxide in lye peeling of peaches for all 
types of organic peach processing, including canning and the IQF 
process. If finalized, the listing for potassium hydroxide in section 
205.605(b) would be subject to review within five years of its 
amendment, in accordance with the OFPA provision for the sunset of 
National List substances (7 U.S.C. 6517(e)).
    This proposed rule would further amend section 205.605(b) by adding 
an annotation to specify the permitted use of the following substance:
    Silicon dioxide. Silicon dioxide is currently listed as an allowed 
synthetic in organic processing in section 205.605(b). In accordance 
with applicable FDA requirements for its use as a food additive,\10\ 
the substance can serve many technical, functions including as an anti-
caking agent, a defoamer, a stabilizer, or an adjuvant.
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    \10\ There are multiple references in the FDA regulations that 
are relevant to silicon dioxide and its authorized use in food for 
human consumption. These are cited in the Technical Report prepared 
for the NOSB and include 21 CFR 172.480, 21 CFR 172.230, 21 CFR 
73.340, 21 CFR 160.105, 21 CFR 160.185, and 21 CFR 182.90. See 
Technical Report on Silicon Dioxide. November 12, 2010. Available in 
Petitioned Substances Database, under ``S,'' at the NOP Web site: 
http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
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    At its meeting November 29-December 2, 2011, the NOSB considered a 
petition requesting the removal of silicon dioxide from section 
205.605(b) of the National List. The petition was submitted by a 
manufacturer of an organic product derived from rice hulls. The 
petitioner stated that the rice hull product is an organic alternative 
for the use of synthetic silicon dioxide in some applications. The 
petitioner requested that silicon dioxide be removed from the National 
List based on the criteria provided under section 205.600(b)(1) of the 
USDA organic regulations. Section 205.600(b)(1) specifies that any 
synthetic substance used as a processing aid or adjuvant on the 
National List must be evaluated under the criteria that the substance 
cannot be produced from a natural source and there are no organic 
substitutes.
    During its deliberations, the NOSB stated that the alternative 
organic product, derived from organic rice hulls, could be a 
replacement for silicon dioxide in some, but not all, current 
applications of silicon dioxide in organic handling. Specifically, the 
NOSB noted that the alternative organic product does not function as a 
replacement for synthetic silicon dioxide as a defoamer. In addition, 
the NOSB also noted that there may be other applications where the 
continued use of silicon dioxide may be necessary if the alternative 
organic product does not provide the functionality needed.
    In order to recognize the availability of the alternative organic 
product as a substitute for some uses of silicon dioxide, the NOSB 
recommended that an annotation be added to the listing for silicon 
dioxide at section 205.605(b) as follows: ``Silicon dioxide--allowed 
for use as a defoamer. May be used in other applications when non-
synthetic alternatives are not commercially available.''
    AMS understands that the intent of the NOSB's recommendation is to 
allow the continued use of silicon dioxide as a defoamer and to require 
the use of a nonsynthetic substance instead of silicon dioxide when 
possible. To ensure clarity and consistency within the USDA organic 
regulations, AMS is proposing a modification to the NOSB's 
recommendation by proposing an annotation which would read as follows: 
``Silicon dioxide--Permitted as a defoamer. Allowed for other uses when 
organic rice hulls are not commercially available.''
    AMS is proposing this modification to specify the specific 
alternative substance (i.e., organic rice hulls) that the NOSB 
considered during its review, rather than including the general term 
``nonsynthetic alternatives.'' AMS has specified the particular 
nonsynthetic alternative within the annotation so that certifying 
agents can consistently verify that organic handlers are in compliance 
with the regulations. The clarification also reduces the burden on 
organic handlers since they would not be required to demonstrate that 
all nonsynthetic inputs were considered prior to the use of silicon 
dioxide.
    AMS has also specified in the annotation that the rice hulls must 
be organic, since the use of conventional (i.e., nonorganic) rice and 
rice products is not permitted in products labeled as ``organic'' under 
the USDA organic regulations. Section 205.606 of the National List 
specifies the nonorganically produced agricultural products that may be 
used as ingredients in or on processed products labeled as ``organic.'' 
Substances included in section 205.606 are only permitted when the 
product is not commercially available in organic form. Rice and rice 
hulls are not included at section 205.606 of the National List; 
therefore, the use of nonorganic rice products would not be permitted 
in products labeled as ``organic.'' This proposed rule does not change 
this requirement. Because section 205.606 does not apply to products 
labeled ``made with organic (specified ingredients or food group(s)),'' 
organic or nonorganic rice hulls would be permitted as a substitute for 
silicon dioxide in the 30 percent nonorganic content of a ``made with 
organic (specified ingredients or food group(s)),'' product under 
section 205.301(c) of the USDA organic regulations.
    AMS understands that the NOSB recommendation intended for silicon 
dioxide to continue to be allowed in applications when organic rice 
hulls do not adequately substitute for the functionality provided by 
silicon dioxide. Commercially available is defined under section 205.2 
of the USDA organic regulations as ``the ability to obtain a production 
input in an appropriate form, quality, or quantity to fulfill an 
essential function in a system of organic production or handling, as 
determined by the certifying agent in the course of reviewing the 
organic plan.'' Linking the use of silicon dioxide by annotation to the 
commercial availability of organic rice hulls reflects

[[Page 8044]]

the NOSB's intent to permit the use of synthetic silicon dioxide when 
organic rice hulls do not fulfill an essential function in a system of 
organic handling, as determined by the certifying agent in the course 
of reviewing the organic plan. A difference in cost between synthetic 
silicon dioxide and organic rice hulls would not be considered a 
permitted justification for use of synthetic silicon dioxide under the 
proposed annotation.
    AMS has reviewed and proposes to address the NOSB recommendation 
with the modification described. This proposed rule would amend section 
205.605(b) by adding an annotation for silicon dioxide to read as 
follows: ``Silicon dioxide--Permitted as a defoamer. Allowed for other 
uses when organic rice hulls are not commercially available.'' AMS is 
seeking comments that describe whether product reformulation will be 
necessary and the timeframe that will be needed to comply with this 
change. Such comments will inform an appropriate effective date for 
this amendment if finalized. If finalized, the listing for silicon 
dioxide in section 205.605 would be subject to review within five years 
of its amendment, in accordance with the OFPA provision for the sunset 
of National List substances (7 U.S.C. 6517(e)).

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

    This proposed rule would amend subparagraph (d)(3), redesignated 
under this proposed action as (d)(2), of section 205.606 by changing 
the annotation to correct the Chemical Abstracts Service (CAS) number 
and to allow an additional source of the following substance:
    Beta-carotene extract color. Beta-carotene is a carotenoid. 
Carotenoids are natural pigments synthesized by plants that aid in 
photosynthesis by absorbing light and protect the plant from 
photosensitization. Carotenoids commonly exhibit antioxidant activity 
in food. In the human body, beta-carotene is converted to vitamin A. 
Beta-carotene is the most common carotenoid and the major colorant in 
carrot and palm oil seed extracts and is also found in cantaloupes, 
apricots, sweet potatoes and other orange, red and dark green fruits 
and vegetables.\11\
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    \11\ Technical Report on Beta-carotene extract color. July 15, 
2011. Available in Petitioned Substances Database, under ``C'' for 
colors, at the NOP Web site: http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
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    Beta-carotene can be produced through various methods including 
chemical synthesis, fermentation of microorganisms (fungi, yeasts, or 
bacteria), and extraction from certain algae (Dunnaliella salina) and 
vegetables. Obtaining beta-carotene from natural sources generally 
involves propagation and harvest of the source and solvent extraction 
of the beta-carotene. According to the 2011 Technical Report for beta-
carotene, only one preparation of crystalline beta-carotene from 
carrots is commercially available and the substance is not yet obtained 
commercially from other vegetable sources.
    Beta-carotene is used as a color additive and as a nutritive 
supplement in a variety of foods including dairy products, fats and 
oils, and processed fruits and fruit juices. As a colorant, it adds a 
deep orange to light yellow color to the food depending upon the 
concentration. The FDA regulations provide that beta-carotene, prepared 
synthetically or obtained from natural sources, may be safely used for 
coloring foods in amounts consistent with good manufacturing practices. 
It may not be used in foods for which there is an FDA standard of 
identity unless that standard of identity authorizes its use (21 CFR 
73.95).
    On June 27, 2007, a listing for beta-carotene extract color, 
derived from carrots, was added to section 205.606 of the National List 
through an interim final rule (72 FR 35137).\12\ This allowance 
provides for the use of the nonorganic form of beta-carotene extract 
color, derived from carrots, in organic processing when an organic form 
is not commercially available.\13\
---------------------------------------------------------------------------

    \12\ The interim final rule was superseded by a final rule 
published June 6, 2012 (77 FR 33290) which renewed the listing for 
beta-carotene extract color as part of the 2012 sunset review. The 
final rule was effective June 27, 2012.
    \13\ In April 2007, the NOSB recommended adding beta-carotene 
color extract derived from carrots to 205.606. The NOSB concluded 
that this substance was not available in organic form because the 
specific varieties of carrots grown for beta-carotene production 
were not produced organically in sufficient quantities. NOSB Formal 
Recommendation on Beta-carotene color derived from carrots. April 
21, 2007. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5061991.
---------------------------------------------------------------------------

    On July 20, 2009, AMS received a petition to amend the annotation 
for beta-carotene extract color derived from carrots.\14\ The petition 
requested two changes to the listing for beta-carotene extract color: 
(i) Correction of the CAS number; and (ii) the inclusion of algae as a 
source of beta-carotene extract color. The petition indicated that the 
CAS number listed for beta-carotene extract color (CAS 1393-
63-1) is incorrect and refers to the pigment found in annatto extract 
color. The petition also stated that algae provide the only source of 
beta-carotene that can be produced with allowed solvents, such as 
nonsynthetic ethanol, vegetable oil, and carbon dioxide.
---------------------------------------------------------------------------

    \14\ The petition was submitted by D.D. Williamson & Co., Inc., 
and is available from the NOP Web site in the Petitioned Substances 
Database: http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase. A 
separate petition has been submitted by the International Formula 
Council for the use of the synthetic form of beta-carotene in 
organic processing.
---------------------------------------------------------------------------

    At its November 29-December 2, 2011 meeting, the NOSB considered 
the petition to amend the listing for beta-carotene extract color. In 
its deliberations, the NOSB considered its October 2010 recommendation 
to prohibit the use of synthetic solvents and carrier systems or any 
artificial preservative in the production of colors used in organic 
processing. The October 2010 NOSB recommendation specified that the 
listing for colors derived from agricultural products at section 
205.606 should include the following annotation: ``Must not be produced 
using synthetic solvents and carrier systems or any artificial 
preservative.\15\ This NOSB recommendation was codified through a final 
rule published on June 6, 2012 (77 FR 33290). The NOSB accepted the 
petition's justification for revision of the listing for beta-carotene 
extract color, which stated that the only method to extract beta-
carotene from carrots uses synthetic solvents and would not comply with 
the revised requirements for colors derived from agricultural products 
in section 205.606. The NOSB concluded that the production of beta-
carotene color from algae, as described in the petition, could comply 
with the amended annotation for colors in section 205.606 and be an 
acceptable source of beta-carotene extract color in organic products 
when an organic form was not commercially available. The NOSB also 
recommended that the CAS number be corrected to 7235-40-7 for this 
listing.\16\
---------------------------------------------------------------------------

    \15\ NOSB Formal Recommendation on Colors derived from 
agricultural ingredients. October 2010. Available at the NOP Web 
site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088018&acct=nosb.
    \16\ NOSB Formal Recommendation on Annatto Extract Color. 
December 2, 2011. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5097101.
---------------------------------------------------------------------------

    AMS has reviewed and proposes to address the NOSB recommendation 
through this proposed rule. Consistent with the NOSB recommendation, 
this proposed rule would amend paragraph (d)(3), redesignated under 
this action as paragraph (d)(2), of section 205.606 of the National 
List by: (i) Replacing the text, ``(CAS 1393-63-1)'' with the 
text

[[Page 8045]]

``(pigment CAS 7235-40-7)''; and (ii) adding the words, ``or 
algae'' between ``carrots'' and ``(pigment CAS 7235-40-7).'' 
If finalized, the listing for beta-carotene extract color at section 
205.606 would be subject to review within five years of its amendment, 
in accordance with the OFPA provision for the sunset of National List 
substances (7 U.S.C. 6517(e)).
    This proposed rule would further amend paragraph (d) of section 
205.606 by removing the exemption for the following substance:
    Annatto extract color. Annatto extract color is made from the dried 
seed of Bixa orellana L., an evergreen shrub native to Central and 
tropical South America, which is cultivated globally in tropical areas. 
The seed's coating contains carotenoid pigments, principally bixin, 
which are used to impart a deep orange to light yellow color, depending 
upon the concentration, to foods and beverages. The water soluble form 
is used as a colorant in foods, such as hard cheeses, bakery products, 
sauces, and sugar and flour confectionary. This form is available 
spray-dried on a carrier or is available in an aqueous solution. The 
oil soluble form is used in foods with a high fat content, such as 
salad dressings. This form is available dried or suspended in vegetable 
oil.\17\ Organic annatto extract seeds are hulled, crushed into small 
pieces and physically ground together in vegetable oil or mildly 
alkaline water. The oil and water are filtered and concentrated, and 
retain the pigments contained in the seed.
---------------------------------------------------------------------------

    \17\ Food and Agriculture Organization of the United Nations. 
1995. Non-Wood Forest Products, Natural Colourants and Dyestuffs, 
http://www.fao.org/docrep/v8879e/V8879e00.htm.
---------------------------------------------------------------------------

    According to FDA, annatto extract may be safely used for coloring 
foods generally in amounts consistent with good manufacturing 
practices, except where a standard of identity does not authorize its 
use. The FDA has also determined that annatto extract color is exempt 
from color certification (21 CFR 73.30). Under section 721(c) of the 
Federal Food, Drug and Cosmetic Act (FFDCA), the FDA exempts certain 
color additives from certification if FDA approval is not necessary for 
the protection of the public health.
    On June 27, 2007, a listing for annatto extract color (pigment CAS 
1393-63-1), water and oil soluble, was added in section 
205.606 of the National List through an interim final rule (72 FR 
35137).\18\ This allowance provides for the use of the nonorganic forms 
of water and oil soluble annatto extract color in organic processing 
when an organic form is not commercially available. The 2007 rule 
stated that the global supply production of annatto seeds was 
insufficient to consistently provide organic sources of this substance.
---------------------------------------------------------------------------

    \18\ The interim final rule was superseded by a final rule 
published June 6, 2012 (77 FR 33290) which renewed the listing for 
annatto extract color as part of the 2012 sunset review. The final 
rule was effective June 27, 2012.
---------------------------------------------------------------------------

    In September 2010, AMS received a petition for the removal of 
annatto extract color from the National List.\19\ The petition stated 
that the use of nonorganic annatto extract in organic processing was no 
longer warranted because there is an adequate supply of organic annatto 
seed from which organic annatto extract can be produced. The petition 
explained that the geographic diversity in organic annatto seed 
production protects the supply from interruptions due to weather. In 
addition, the petition indicated that the availability of water 
soluble, oil soluble, oil soluble suspensions and powdered forms of 
annatto extract are adequate for the needs of the organic industry.
---------------------------------------------------------------------------

    \19\ The petition was submitted by D.D. Williamson & Co., Inc. 
and is available from the NOP Web site in the Petitioned Substances 
Database under ``C'' for colors: http://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
---------------------------------------------------------------------------

    On June 6, 2012, AMS published a final rule, renewing the listing 
for annatto extract color at section 205.606, prior to its sunset date 
on June 27, 2012 (77 FR 33290). The final rule is consistent with the 
October 2010 NOSB sunset recommendation to continue the allowance for 
the use of nonorganic annatto extract color. In the justification for 
recommending renewal in 2010, the NOSB explained its uncertainty about 
the commercial availability of organic powdered annatto extract based 
upon public comment at that time. The NOSB indicated that it would 
address the commercially availability of liquid and dry forms of 
annatto extract color during its future consideration of the September 
2010 petition to remove annatto extract color from the National 
List.\20\
---------------------------------------------------------------------------

    \20\ NOSB Formal Recommendation: Colors derived from 
agricultural products--Annotation Change. October 28, 2010. 
Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088018&acct=nosb.
---------------------------------------------------------------------------

    At the November 29-December 2, 2011 NOSB meeting, the NOSB 
considered the September 2010 petition to remove annatto extract from 
the National List. The NOSB Handling Committee conducted market 
research to verify that the forms of annatto extract used by organic 
handlers are available organically. Their findings indicated that 
liquid forms of organic annatto extract were widely available, and the 
powdered form of organic annatto extract was available, but not widely 
used. The NOSB Handling Committee proposed that the annotation for 
annatto extract be revised from water and oil soluble to liquid and 
powdered forms to reflect the forms found in the marketplace. To ensure 
that the NOSB considered all forms of annatto extract needed by organic 
handlers, the Committee solicited public comment on any specific needs 
for a continued allowance of nonorganic annatto extract.\21\ During the 
November 29-December 2, 2011, NOSB meeting, the Handling Committee 
explained that it had not received public comment indicating that 
nonorganic forms of annatto extract were needed. Therefore, the NOSB 
approved a recommendation to remove annatto extract color from section 
205.606(d).\22\
---------------------------------------------------------------------------

    \21\ NOSB Handling Committee recommendation on Annatto extract 
color. September 29, 2011. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5094391.
    \22\ NOSB Formal recommendation on Annatto extract color, 
December 2, 2011. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5097099.
---------------------------------------------------------------------------

    AMS has reviewed and proposes to address the NOSB's recommendation 
through this proposed rule. Consistent with the NOSB recommendation, 
this proposed rule would amend paragraph (d) of section 205.606 by 
removing annatto extract color (pigment CAS 1393-63-1)--water 
and oil soluble and redesignating paragraphs (d)(2) through (d)(19) as 
paragraphs (d)(1) through (d)(18). AMS is seeking comments that 
describe whether product reformulation will be necessary and the 
timeframe that will be needed to comply with this change. Such comments 
will inform an appropriate effective date for this amendment if 
finalized.

III. Related Documents

    Two notices were published regarding meetings of the NOSB and its 
deliberations on recommendations and substances petitioned for amending 
the National List. Substances and recommendations included in this 
proposed rule were announced for NOSB deliberation in the following 
Federal Register notices: (1) 74 FR 46411, September 9, 2009 (peracetic 
acid); and (2) 76 FR 62336, October 17, 2011 (potassium hydroxide, 
silicon dioxide, beta-carotene extract color, and annatto extract 
color).

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

[[Page 8046]]

based on proposed amendments developed by the NOSB. Sections 6518(k) 
and 6518(n) of the 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 section 205.607 of the USDA organic 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/AMSv1.0/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 the OFPA 
(7 U.S.C. 6514(b)). States are also preempted by 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 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 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 
FFDCA (21 U.S.C. 301-399), nor the authority of the Administrator of 
EPA under the FIFRA (7 U.S.C. 136-136(y)).
    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 final 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.
    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.
    U.S. sales of organic food and non-food have grown from $1 billion 
in 1990 to $31.4 billion in 2011. Sales in 2011 represented 9.5 percent 
growth over 2010 sales.\23\ According to USDA, National Agricultural 
Statistics Service (NASS), certified organic acreage exceeded 3.5 
million acres in 2011.\24\ According to NOP's Accreditation and 
International Activities Division, the number of certified organic 
operations in the U.S. has more than doubled over time from 
approximately 7,000 operations in 2000 to over 17,000 operations by the 
end of 2011. Of these operations, over 4,900 are organic handlers, over 
10,000 are organic crop producers, and over 1,900 are organic livestock 
producers. AMS believes that most of these entities would be considered 
small entities under the criteria established by the SBA.
---------------------------------------------------------------------------

    \23\ Organic Trade Association. 2012. Organic Industry Survey. 
www.ota.com.
    \24\ U.S. Department of Agriculture, National Agricultural 
Statistics Service. October 2012. 2011 Certified Organic Productions 
Survey. http://usda01.library.cornell.edu/usda/current/OrganicProduction/OrganicProduction-10-04-2012.pdf.
---------------------------------------------------------------------------

    In addition, the USDA has 87 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. 
Certifying agents reported approximately 29,000 certified operations 
worldwide in 2011.
    AMS has considered the economic impact of this action on small 
entities. The effect of this proposed rule would be to expand the 
allowed uses of peracetic acid in organic crop production. AMS 
concludes that expanding the allowance for peracetic acid on the 
National List both addresses EPA relabeling issues for products used in 
organic crop production and continues access to a substance used for 
plant disease control on organic farms. Therefore, this action will be 
beneficial to small agricultural service firms. This proposed rule also 
would expand the use of potassium hydroxide and beta-carotene extract 
color in organic handling. AMS concludes that expanding the allowance 
for these substances on the National List provides organic handlers 
with more tools for processing organic products and, therefore, will be 
beneficial to small agricultural service firms. This proposed rule 
would amend the allowance for synthetic silicon dioxide such that 
organic rice hulls would be required as an alternative to silicon 
dioxide when commercially available. The proposal would continue to 
allow the use of silicon dioxide as a defoamer and would allow the use 
of silicon dioxide when organic rice hulls are not available in an 
appropriate form, quality, or quantity to fulfill an essential function 
in a system

[[Page 8047]]

of organic handling. This flexibility is intended to minimize the 
impact on small entities. This proposed rule would also remove the 
allowance for one nonorganic agricultural substance, annatto extract, 
in organic handling. The NOSB has determined that annatto extract is 
commercially available in organic form in sufficient quantities for 
organic handling. AMS concludes that the economic impact of this 
amendment to the National List, if any, would be minimal to small 
agricultural service firms and may spur further development of organic 
annatto production. Accordingly, AMS certifies that this rule will not 
have a significant economic impact on a substantial number of small 
entities.

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 the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, and 
Chapter 35.

E. Executive Order 13175

    This proposed rule has been reviewed in accordance with the 
requirements of Executive Order 13175, Consultation and Coordination 
with Indian Tribal Governments. The review reveals that this regulation 
will not have substantial and direct effects on Tribal governments and 
will not have significant Tribal implications.

F. General Notice of Public Rulemaking

    This proposed rule addresses recommendations submitted to the 
Secretary by the NOSB for substances on the National List of Allowed 
and Prohibited Substances. A 30-day period for interested persons to 
comment on this rule is provided. Thirty days is deemed appropriate 
because potential changes to these listings were widely publicized 
through two NOSB meetings. Further, certain proposed amendments, one 
for potassium hydroxide in organic handling, and those for peracetic 
acid in organic crop production, are considered time sensitive and 
critical to organic production. The proposed amendment to the listing 
for potassium hydroxide would provide more tools for organic peach 
processors by allowing use of this substance to peel peaches for 
canning, in addition to its current allowance to peel peaches for 
frozen products. The proposed amendments to the listings for peracetic 
acid would ensure consistency with EPA labeling requirements for 
hydrogen peroxide products containing peracetic acid.

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, Subpart 
G is proposed to be amended as follows:

PART 205--NATIONAL ORGANIC PROGRAM

0
1. The authority citation for 7 CFR part 205 continues to read as 
follows:

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

0
2. Section 205.601 is amended by revising paragraphs (a)(6) and (i)(8) 
to read as follows:


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

* * * * *
    (a) * * *
    (6) Peracetic acid--for use in disinfecting equipment, seed, and 
asexually propagated planting material. Permitted in hydrogen peroxide 
formulations at concentration of no more than 5% as indicated on the 
pesticide product label.
* * * * *
    (i) * * *
    (8) Peracetic acid--for use to control fire blight bacteria. 
Permitted in hydrogen peroxide formulations at concentration of no more 
than 5% as indicated on the pesticide product label.
* * * * *
0
3. In Sec.  205.605 paragraph (b), revise the entry for ``Potassium 
hydroxide'' and ``Silicon dioxide'' to read 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 group(s)).''

* * * * *
    (b) * * *
    Potassium hydroxide--prohibited for use in lye peeling of fruits 
and vegetables except when used for peeling peaches.
* * * * *
    Silicon dioxide--Permitted as a defoamer. Allowed for other uses 
when organic rice hulls are not commercially available.
* * * * *
0
4. Section 205.606 is amended by:
0
A. Removing paragraph (d)(1);
0
B. Redesignating (d)(2) through (d)(19) as (d)(1) through (d)(18); and
0
C. Revising paragraph (d)(2) to read as follows:


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

* * * * *
    (d) * * *
    (2) Beta-carotene extract color--derived from carrots or algae 
(pigment CAS 7235-40-7).
* * * * *

    Dated: January 30, 2013.
Rex A. Barnes,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2013-02398 Filed 2-4-13; 8:45 am]
BILLING CODE 3410-02-P