National Organic Program (NOP); Amendments to the National List of Allowed and Prohibited Substances (Crops and Processing), 31815-31821 [2013-12504]

Agencies

• Agricultural Marketing Service
• DEPARTMENT OF AGRICULTURE

[Federal Register Volume 78, Number 102 (Tuesday, May 28, 2013)]
[Rules and Regulations]
[Pages 31815-31821]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12504]



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Federal Register / Vol. 78, No. 102 / Tuesday, May 28, 2013 / Rules 
and Regulations

[[Page 31815]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

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


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

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

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SUMMARY: This final rule amends the U.S. Department of Agriculture's 
(USDA's) National List of Allowed and Prohibited Substances (National 
List) to enact five recommendations submitted to the Secretary of 
Agriculture (Secretary) by the National Organic Standards Board (NOSB) 
on November 5, 2009, and December 2, 2011. This final rule amends the 
exemptions (uses) for one substance, peracetic acid, for organic crop 
production. This final rule also amends the exemptions for three 
substances used in organic handling: potassium hydroxide, silicon 
dioxide, and beta-carotene extract color. This final rule also removes 
the allowance for nonorganic annatto extract color from the National 
List for organic handling.

DATES: This rule is effective May 29, 2013, except for the amendment in 
instruction 4 to ``silicon dioxide'' in Sec.  205.605(b) and the 
amendment in instruction 6 to, Sec.  205.606(d), which are effective 
November 3, 2013. For more information on these effective dates, see 
SUPPLEMENTARY INFORMATION.

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

SUPPLEMENTARY INFORMATION:

I. Background

    On December 21, 2000, the Secretary established within the National 
Organic Program (NOP) (7 CFR part 205) the National List regulations 
sections 205.600 through 205.607. The 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 nonsynthetic nonagricultural, synthetic 
nonagricultural, and nonorganic agricultural substances that may be 
used in organic handling. The Organic Foods Production Act of 1990 
(OFPA), as amended (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 must also 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 final rule amends the National List to enact five 
recommendations submitted to the Secretary by the NOSB on November 5, 
2009, and December 2, 2011.

II. Overview of Amendments

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

Section 205.601 Synthetic Substances Allowed for Use in Organic Crop 
Production

    This final rule amends subparagraphs (a)(6) and (i)(8) of section 
205.601 by amending two listings for peracetic acid to read as follows:
    (a)(6) Peracetic acid--for use in disinfecting equipment, seed, and 
asexually propagated planting material. Also permitted in hydrogen 
peroxide formulations as allowed in Sec.  205.601(a) at concentration 
of no more than 6% as indicated on the pesticide product label.
    (i)(8) Peracetic acid--for use to control fire blight bacteria. 
Also permitted in hydrogen peroxide formulations as allowed in Sec.  
205.601(i) at concentration of no more than 6% as indicated on the 
pesticide product label.
    After consideration of the comments received, AMS determined that 
the substance's use annotation should be modified from the proposed 
rule. This final rule differs from the text originally proposed as 
follows for paragraph (a)(6) (emphasis added): ``Also permitted in 
hydrogen peroxide formulations as allowed in Sec.  205.601(a) at 
concentration of no more than 6% as indicated on the pesticide product 
label.'' Similarly, the use annotation for paragraph (i)(8) was 
modified as follows: ``Also permitted in hydrogen peroxide formulations 
as allowed in Sec.  205.601(i) at concentration of no more than 6% as 
indicated on the pesticide product label.'' Additional explanation for 
the modification is provided in the Comments Received section of this 
rule.

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 final rule amends paragraph (b) of section 205.605 of the 
National List regulations by amending the annotations for potassium 
hydroxide and silicon dioxide to read as follows:
    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.

Section 205.606 Nonorganically Produced Agricultural Products Allowed 
as Ingredients In or On Processed Products Labeled as ``Organic.''

    This final rule amends section 205.606 of the National List 
regulations by amending paragraph (d)(3) to read as follows:
    Beta-carotene extract color--derived from carrots or algae (pigment 
CAS 7235-40-7).
    This final rule also removes annatto extract color from paragraph 
(d)(1) and redesignates paragraphs (d)(2) through

[[Page 31816]]

(d)(19) as paragraphs (d)(1) through (d)(18).

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 addressed by this 
final 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). The proposal to amend the annotation for four substances in 
this final rule, along with the removal of one substance, was published 
as a proposed rule in the Federal Register on February 5, 2013 (78 FR 
8040).

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 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 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 
https://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 (OMB).

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 final 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 section 
6514(b) of the OFPA. States are also preempted under section 6503 
through 6507 of the OFPA 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 section 6507(b)(2) of the OFPA, 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 section 6519(f) of the OFPA, this final 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. 301-399), nor the authority of the 
Administrator of the Environmental Protection Agency under the Federal 
Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136-136(y)).
    Section 6520 of the OFPA 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.\1\ According to USDA, National Agricultural 
Statistics Service (NASS), certified organic acreage exceeded 3.5 
million acres in 2011.\2\ 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.
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    \1\ Organic Trade Association. 2012. Organic Industry Survey. 
www.ota.com.
    \2\ U.S. Department of Agriculture, National Agricultural 
Statistics Service. October 2012. 2011 Certified Organic Productions 
Survey. https://usda01.library.cornell.edu/usda/current/OrganicProduction/OrganicProduction-10-04-2012.pdf.
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    In addition, the USDA has 84 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 https://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.
    AMS considered the economic impact of this action on small 
entities. The effect of this final rule would be to expand the allowed 
uses of peracetic acid in organic crop production. AMS concluded that 
expanding the allowance for peracetic acid on the National List both 
addresses EPA relabeling issues for products used in organic crop 
production and enables organic

[[Page 31817]]

producers to continue using a substance for sanitation and plant 
disease control on organic farms. Therefore, this action will be 
beneficial to small agricultural service firms. This final rule also 
expands the use of potassium hydroxide and beta-carotene extract color 
in organic handling. AMS concluded 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 final rule amends 
the allowance for synthetic silicon dioxide such that organic rice 
hulls would be required as an alternative to silicon dioxide when 
commercially available. The rule continues to allow the use of 
synthetic silicon dioxide as a defoamer. The rule also allows the 
continued use of synthetic silicon dioxide when organic rice hulls are 
not available in an appropriate form, quality, or quantity to fulfill 
an essential function in a system of organic handling. This flexibility 
is intended to minimize the impact on small entities by allowing 
synthetic silicon dioxide if organic rice hulls are not commercially 
available, while still meeting the requirement under section 
205.600(b)(1) that synthetic substances can be used only when there are 
no organic substitutes. This final rule also removes the allowance for 
one nonorganic agricultural substance, annatto extract color, in 
organic handling. The NOSB has determined that annatto extract color is 
commercially available in organic form in sufficient quantities for 
organic handling. AMS concluded 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 final rule. Accordingly, OMB clearance is not 
required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, 
Chapter 35.

E. Executive Order 13175

    This final 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. Comments Received on Proposed Rule AMS-NOP-12-0016; NOP-12-07PR

    AMS received 43 comments on the proposed rule AMS-NOP-12-0016; NOP-
12-07PR. Comments were received from organic producers and handlers, 
manufacturers of peracetic acid and silicon dioxide products, a 
nonprofit organization, an industry group, specialty food ingredient 
processors and distributors, specialty food products manufacturers, 
three trade associations, accredited certifying agents, an organic 
consultant, and private citizens.
    Most comments favored amending the National List with the changes 
described in the proposed rule. Four comments stated general opposition 
to the allowance of any substance on the National List, but did not 
provide specific comments on the proposed amendments. Comments received 
for each substance are further described below. One comment opposed the 
use of genetically modified organisms (GMOs), which is outside the 
scope of this rulemaking action and is already prohibited under the 
USDA organic regulations at section 205.105(e).
    Comments on the proposed amendment for beta-carotene extract color 
and removal of annatto extract color were supportive of the actions as 
proposed. Therefore, AMS is finalizing the amendment and removal of 
these substances, respectively, as proposed through this final rule.
Changes Based on Comments
    Peracetic Acid
    AMS received 24 comments regarding the proposed change to peracetic 
acid. Most comments supported a continued allowance for peracetic acid 
in organic crop production. A few comments indicated that peracetic 
acid should not be allowed, but did not provide information on 
alternative practices or other materials that are available as 
alternatives to its use.
    The majority of commenters requested that AMS revise the proposed 
annotation for peracetic acid to include the word ``also'' at the 
beginning of the second sentence, and to cite the listings for hydrogen 
peroxide at sections (a)(4) and (i)(5). This amendment was suggested to 
clarify that peracetic acid in hydrogen peroxide formulas at 
concentrations less than the stated percentage will not be subject to 
the peracetic acid use restrictions. AMS agrees and has accepted this 
change, with modification. AMS has included the word ``also'' and the 
paragraphs letters that were requested, i.e., (a) and (i). AMS did not 
include the subsequent number in paragraph letter (i.e., (a)(6) or 
(i)(8)) in order to avoid the need to renumber these listings if 
substances are added or removed from paragraphs (a) or (i) of section 
205.601 at a later date.
    In the proposed rule, AMS specifically requested comments that 
identified any formulated hydrogen peroxide products labeled for 
agricultural use that contain more than 5% peracetic acid and that may 
be impacted by the rulemaking action. Three comments addressed this 
topic. AMS received one comment from an organic mushroom producer that 
uses a formulated product that contains 5.6% peracetic acid. AMS also 
received two comments from chemical suppliers that requested that the 
percentage of peracetic acid be raised to 6% and 17%. In reviewing the 
comments, AMS considered the intent of the NOSB recommendation to 
restrict the amount of peracetic acid by annotation to only allow 
hydrogen peroxide products that contain a small amount of peracetic 
acid and that are subject to new labeling requirements under EPA. The 
intent of the NOSB was not to allow organic peroxide products 
containing high levels of peracetic acid up to 17%. After consideration 
of the comments, AMS has amended the annotation for the final rule to 
increase the percentage of peracetic acid included in the annotation 
from 5% to 6% as indicated on the pesticide product label. AMS has 
increased this percentage up to 6% to ensure that the formulated 
products currently used in the marketplace would continue to be allowed 
in organic production.
Implementation Periods
    In the proposed rule, AMS requested comments that described 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 205.606.
    AMS received seven comments regarding the timeframe that organic 
handlers need to implement the amendment to silicon dioxide, ranging 
from immediately to four years. Two commenters requested an effective 
date of two years. One commenter requested 3-4 years, and another 
requested 4-6 months. One distributor of organic rice bran products in 
the EU did not suggest a specific timeframe, but noted that in general, 
its customers who use organic rice hulls as a replacement for silicon

[[Page 31818]]

dioxide are rather quick to implement this change. The commenter noted 
that adjustment may be needed to find the right replacement amount, 
since it may vary from application to application. One commenter 
indicated that they use rice hulls as a flavor carrier and anti-caking 
agent and indicated that they were able to implement this ingredient 
substitution within a few weeks. Another commenter indicated their 
initial substitution trials for replacing silicon dioxide with organic 
rice concentrate took several months to collect and approve all data 
and update packaging. This handler now uses the rice substitute product 
in all new product development, and as such, and did not request 
additional time for implementation. After considering the comments 
received, AMS has established an effective date of November 3, 2013, 
for this action to ensure that industry is provided advanced 
notification of the change to the listing for silicon dioxide. In 
addition, based on comments that some product testing and reformulation 
will be needed, AMS considers a one year period from the effective date 
(i.e., until November 3, 2014) as reasonable and appropriate for the 
industry to reformulate products. This implementation period is 
intended to ensure that the amendment is effectively and rationally 
implemented by allowing time for handlers to test organic rice hulls as 
a replacement for silicon dioxide, and to allow for reformulation and 
label changes, if needed. AMS will be conducting outreach to the 
industry and training for certifying agents as appropriate.
    AMS received two comments addressing the time needed to implement 
the removal of annatto extract color from the National List. One 
commenter suggested 24 months from the date the final rule is released; 
the other suggested a minimum of two years. In consideration of the 
comments, AMS has established an effective date of November 3, 2013 for 
this removal. Further, AMS considers a one year period from the 
effective date (i.e., until November 3, 2014) as reasonable and 
appropriate for the industry to comply with this final rule. This 
implementation period is intended to ensure that the amendment is 
effectively and rationally implemented by allowing time for handlers to 
source organic annatto extract and to allow for ingredient substitution 
and label changes, if needed. AMS will be conducting outreach to the 
industry and training for certifying agents as appropriate.
Changes Requested But Not Made
Peracetic Acid
    One commenter indicated that it is not clear why peracetic acid 
should be allowed, but did not provide information on the availability 
of alternative practices or materials. AMS received many comments from 
certified organic growers indicating the need for this substance; 
therefore, this material should continue to be permitted in organic 
crop production.
    One commenter supported the proposed action, but indicated that 
limiting the allowance of peracetic acid to fire blight is not 
expansive enough, and that it should be allowed without any 
restriction. An expanded allowance for peracetic acid was requested in 
the petition considered by the NOSB.\3\ The expanded allowance 
requested was not recommended by the NOSB due to concerns over the 
impact of broad spectrum use on soil microbes. Upon review, AMS concurs 
with the NOSB recommendation and has not accepted the commenter's 
suggestion for an expanded use.\4\
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    \3\ The petition for peracetic acid is available on the NOP Web 
site at https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5071775&acct=nopgeninfo.
    \4\ NOSB Final Recommendation on Peracetic Acid (Expanded Use). 
November 2009. Available in Petitioned Substances Database under 
``P,'' at the NOP Web site: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5067081&acct=nopgeninfo.
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    One commenter supported the proposed action and proposed language 
that would add ``must be followed by a fresh water rinse'' to the text 
of the annotations for peracetic acid at paragraphs (a)(6) and (a)(8) 
of 205.601. However, no rationale for this addition was provided. We 
have not accepted this suggestion. This substance is used in organic 
crop production as sanitizer and fungicide and there is no requirement 
on the label for a freshwater rinse. Further, the added process of a 
freshwater rinse could diminish the effectiveness of the substance for 
its intended use.
    One commenter indicated that AMS should not restrict the percentage 
and use of peracetic acid, as the higher the percentage of peracetic 
acid, the less costly it is to use for a farmer that needs the 
substance in volume. In this action, AMS has retained a stated 
percentage of peracetic acid in the rule, in an effort to maintain the 
intent of the NOSB's recommendation to continue to allow hydrogen 
peroxide products that contain a small amount of peracetic acid. The 
allowance of higher concentrations of peracetic acid for control of 
fire blight and for use in disinfecting equipment, seed, and asexually 
propagated planting material are not impacted by this action.
Potassium hydroxide
    AMS received eight comments regarding the proposed change to 
potassium hydroxide. Some commenters supported the change as proposed. 
Some commenters opposed any expansion of the use of this substance in 
organic handling, but did not include data on available alternative 
materials or practices for peeling peaches.
    One commenter indicated that the allowance for potassium hydroxide 
should not be expanded since this material is toxic to human health and 
that its use has adverse effects on the environment. The commenter also 
noted that potassium hydroxide is not allowed in organic handling in 
the European Union or by the International Federation of Organic 
Agriculture Movements (IFOAM) standards. AMS has considered the 
comment, as well as the status of potassium hydroxide under the 
regulatory authority of the Food and Drug Administration (FDA). 
According to 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). As such, AMS agrees with the NOSB 
recommendation that the annotation for potassium hydroxide should be 
revised to allow its use in any peach processing (e.g., frozen, 
canned), as there are no commercially viable alternatives for peeling 
peaches. In comparison to the previous allowance for this substance to 
peel peaches that would be individually quick frozen, there is no 
additional risk to the human health or the environment by expanding the 
allowance of potassium hydroxide for peeling peaches for other types of 
processing (e.g., canning). Therefore, AMS has adopted the proposed 
annotation for potassium hydroxide as final rule without change.
    The same commenter indicated that they did not support the proposed 
rule because they believe there is a conflict of interest, suggesting 
that a contributor to the 2001 technical advisory panel (TAP) that 
informed the Board's recommendation on this substance worked on the 
petition related to the same substance ten years later in 2011. AMS 
does not agree that this is a conflict of interest. In its 
deliberations,

[[Page 31819]]

the NOSB considers a wide range of information to make a recommendation 
on a particular substance. This includes the petition, any technical 
information such as TAPs and Technical Reports, and public comments. 
The comment also indicated that AMS should not implement the change for 
potassium hydroxide because the NOSB did not request a new technical 
report. However, the NOSB is not required to request a new or updated 
technical report for all petitioned substances. In this case, existing 
information was available in the form of a technical report, and the 
report was available on the NOP Web site to the NOSB and the public in 
advance of the public meeting at which the NOSB recommended that 
potassium hydroxide be allowed in any peach peeling process.\5\
---------------------------------------------------------------------------

    \5\ Technical Report on Potassium hydroxide. May 21, 2001. 
Available in Petitioned Substances Database, under ``P,'' at the NOP 
Web site: https://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
---------------------------------------------------------------------------

    One commenter proposed language that would add the following 
additional text to the proposed annotation for potassium hydroxide 
(emphasis added): ``Potassium hydroxide--prohibited for use in lye 
peeling of fruits and vegetables, except when used for peeling peaches. 
In this instance, potassium hydroxide is to be permitted and allowed 
for any peach peeling in organic process, including freezing and 
canning processes.'' No explanation was provided on the need for this 
additional clarification. AMS believes the text, as proposed and 
finalized through this rule, is adequate as the substance can be used 
to peel peaches, regardless of the type of processing (e.g., canned, 
frozen).
Silicon Dioxide
    AMS received 20 comments regarding the proposed amendment to the 
listing for silicon dioxide. One commenter indicated that silicon 
dioxide should not be allowed in any organic foods, but did not provide 
information on availability of alternative practices or materials.
    Several comments from organic handling operations indicated that 
AMS should not adopt the proposed rule, since organic rice hulls do not 
adequately substitute for silicon dioxide in all applications, and that 
that organic rice hulls may substitute for the use of silicon dioxide 
only in limited circumstances. Commenters indicated that rice hulls do 
not function as a one-for-one replacement for silicon dioxide, and that 
substitution may compromise quality, appearance, and stability of 
organic products or ingredients. Commenters also indicated that silicon 
dioxide is widely used in many food and beverage applications, 
including, dried fruit and vegetable powders, ground chili products, 
fish oil, soup powders, sugars, cake mixes, non-dairy creamers, salt, 
spices, hot chocolate, and many yeast/flour-based powdered mixes. Other 
commenters who supported the rule indicated that organic rice hulls 
were able to substitute for silicon dioxide in their applications.
    AMS believes the rule, as proposed and as adopted as final rule 
through this action, provides the flexibility that is needed by organic 
handlers. As indicated in the proposed rule, the annotation for silicon 
dioxide allows for the continued use of silicon dioxide in handling 
applications if organic rice hulls do not adequately substitute for the 
functionality provided by silicon dioxide. The term ``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 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. 
Inclusion of the commercial availability clause for organic rice hulls 
in the annotation provides the flexibility that was intended by the 
NOSB and does not exclude handlers from using silicon dioxide or other 
organic products in those applications where organic rice hulls do not 
provide the functionality needed. The annotation requires handlers to 
use organic rice hulls in place of silicon dioxide when it is available 
to substitute for synthetic silicon dioxide. In addition, the rule 
provides flexibility for handlers by allowing the continued use of 
silicon dioxide in those applications where organic rice hulls do not 
provide the functionality needed (e.g., as a defoamer). This rule 
implements the intent of the NOSB to limit the allowance of silicon 
dioxide to those functions where it is essential for the handling of 
organically produced agricultural products, as required by section 
205.600(b)(6).
    One commenter indicated concerns regarding the exclusive 
acceptability of organic rice hulls as the only acceptable anticaking 
agent because it may not perform in the applications in which silicon 
dioxide has been proven effective. AMS disagrees with this 
interpretation. The rule does not restrict the use of other organic 
ingredients as a substitute for silicon dioxide in organic product 
formulation. Instead, the rule implements a requirement that an organic 
alternative must be used in place of a synthetic substance on the 
National List when the organic alternative is commercially available.
    One commenter suggested text to replace ``organic rice hulls'' with 
``non-synthetic alternatives.'' As indicated in the proposed rule, AMS 
has specified the one particular nonsynthetic alternative (i.e., 
organic rice hulls) that was evaluated by the NOSB 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 alternatives 
to synthetic silicon dioxide were considered prior to its use.
    One commenter indicated that commercial availability should not 
apply to section 205.605 of the National List and that applying the 
rule to silicon dioxide would not be consistent with other materials on 
the list. AMS disagrees, as the listing for yeast on section 205.605(a) 
of the National List includes a clause regarding commercial 
availability. In addition, the NOSB recommendation to include 
commercial availability within the annotation for silicon dioxide was 
drafted after significant public comment to address the concerns from 
organic handlers that the alternative organic rice product may not 
function as a substitute for silicon dioxide in all applications. AMS 
concurs with the NOSB's justification for inclusion of this text 
regarding commercial availability; therefore, we have not accepted the 
suggestion of the commenter to remove this text.
    One commenter was concerned about the effect of the allowance of 
silicon dioxide in downstream products for companies that purchase 
ingredients that contain silicon dioxide, and the number of downstream 
products that may need to be reformulated based on this action. This 
commenter also indicated that their operation has conducted significant 
amounts of research and development in the past to find a way to 
incorporate rice hulls into their products as a viable substitute for 
silicon dioxide. The commenter indicated that organic rice hulls do not 
perform like silicon dioxide and that rice hulls do not serve the 
required purpose within the type of organic

[[Page 31820]]

products that they produce. As previously stated, the new annotation 
would allow the continued use of silicon dioxide when organic rice 
hulls are not commercially available to perform an essential function 
in organic handling.
    One commenter did not support the rule, but indicated that, if 
implemented, AMS should modify the proposed annotation as follows 
(emphasis added): ``Silicon dioxide--Permitted as a defoamer. Allowed 
for other uses when organic rice hulls are not commercially available 
or do not function adequately in the product application.'' AMS 
believes that the annotation adopted in this final rule provides the 
flexibility that is intended by the commenter's suggestion. The 
definition of ``commercially available'' under section 205.2 already 
includes 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. We find the phrases ``fulfill an 
essential function'' and ``function adequately'' to be equivalent; 
therefore, the suggested text has not been adopted.
    One commenter noted that there are various forms of silicon 
dioxide, including precipitated silica, fumed silicas, aerogels, 
naturally occurring silicas, and mined mineral silicas. The commenter 
indicated that AMS should reach out to other industry groups and 
document other various silica types currently approved for use in the 
organic industry before a decision to eliminate one silica dioxide 
form. AMS understands that there may be multiple types of silicon 
dioxide in use in organic products, as the regulations do not specify 
Chemical Abstracts Service (CAS) numbers for different forms of silicon 
dioxide on the National List. As this action does not restrict the 
forms of synthetic silicon dioxide that are permitted for use, we have 
not accepted the suggestion of the commenter on this issue.
    One commenter indicated that they support the use of agricultural 
products as a replacement for silicon dioxide, but expressed concerns 
about the levels of arsenic in rice products. The commenter indicated 
that additional testing and review should be required prior to its 
approval and implementation. The commenter cited data published in 
November 2012 by Consumer Reports of arsenic levels in rice 
products.\6\ Under section 205.602(b) of the USDA organic regulations, 
the use of arsenic is prohibited in the production of organic crops, 
including rice. AMS understands that as a result of the study cited by 
the commenter, the U.S. Food and Drug Administration (FDA) is currently 
investigating arsenic levels in foods.\7\ As all food must comply with 
FDA food safety requirements, AMS did not adopt the suggestion of the 
commenter to require additional testing and review of organic rice 
hulls used in organic products prior to implementation of this rule.
---------------------------------------------------------------------------

    \6\ ``Arsenic in Your Food,'' Consumer Reports Magazine, 
November 2012. Available at https://www.consumerreports.org/cro/magazine/2012/11/arsenic-in-your-food/index.htm
    \7\ Questions & Answers: FDA's Analysis of Arsenic in Rice and 
Rice Products; available at https://www.fda.gov/Food/FoodborneIllnessContaminants/Metals/ucm319948.htm
---------------------------------------------------------------------------

    One commenter proposed language that would add the following 
additional text to the proposed annotation for silicon dioxide: ``In 
food products, concentration limited to 5 mg per serving.'' We have not 
accepted the suggestion of the commenter as no explanation was provided 
on the need for this limitation.
    Two commenters noted that the proposed text did not specify that 
the use of organic rice hulls is only required in products making an 
``organic claim,'' and recommended that the annotation be amended since 
commercial availability does not apply to products in the ``made with 
organic (specified ingredients or food group(s))'' labeling category. 
AMS has not adopted this suggestion. As specified under section 
205.600, synthetic substances are evaluated under the criteria 
specified by OFPA; in addition, processing aids and adjuvants are 
evaluated against additional criteria, including the availability of 
organic alternatives. OFPA and the USDA organic regulations do not 
include separate criteria for evaluation of synthetic substances used 
in the different labeling categories. As explained in the proposed 
rule, AMS 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. Organic or nonorganic rice hulls would be 
permitted as a substitute for silicon dioxide in a ``made with organic 
(specified ingredients or food group(s)),'' product under section 
205.301(c) of the USDA organic regulations.
    One commenter, who supported the proposed action, expressed concern 
regarding certifying agents that may permit an overly liberal reading 
of the commercial availability clause. AMS believes the existing 
accreditation requirements for certifying agents are sufficient for NOP 
to address any compliance issues with certifying agents who are not 
adequately implementing the USDA organic regulations, including 
annotations for substances on the National List.

G. Effective Date

    This final rule reflects recommendations submitted to the Secretary 
by the NOSB. The substances being amended or removed from on the 
National List were based upon petitions from the industry and were 
evaluated by the NOSB using criteria in the OFPA and the USDA organic 
regulations. Because these substances have been subject to such 
extensive discussion and comment, AMS believes that producers should be 
able to use the expanded allowances for peracetic acid, potassium 
hydroxide, and beta-carotene extract color in their operations as soon 
as possible. Further, the harvest season for organic peaches will begin 
in June; without this final action, potassium hydroxide can only be 
used to peel peaches for frozen product. This final rule will enable 
organic peach producers to commercially process and market canned 
organic peaches. It is also important for AMS to expeditiously address 
EPA relabeling issues for hydrogen peroxide products used in organic 
crop production, and this will be achieved by finalizing the amendment 
to peracetic acid. Accordingly, AMS finds good cause exists under 5 
U.S.C. 553(d)(3) for not postponing the effective date of this rule for 
these three substances until 30 days after publication in the Federal 
Register.
    As discussed above in Section F, the effective date for the new 
annotation for silicon dioxide and for removal of annatto extract color 
is established as November 3, 2013.

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 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.


[[Page 31821]]


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. Also permitted in hydrogen 
peroxide formulations as allowed in Sec.  205.601(a) at concentration 
of no more than 6% as indicated on the pesticide product label.
* * * * *
    (i) * * *
    (8) Peracetic acid--for use to control fire blight bacteria. Also 
permitted in hydrogen peroxide formulations as allowed in Sec.  
205.601(i) at concentration of no more than 6% as indicated on the 
pesticide product label.
* * * * *

0
3. In Sec.  205.605, the entry for ``potassium hydroxide'' in paragraph 
(b) is revised 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.
* * * * *

0
4. In Sec.  205.605, effective November 3, 2013, the entry for 
``silicon dioxide'' in paragraph (b) is revised 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) * * *
    Silicon dioxide--Permitted as a defoamer. Allowed for other uses 
when organic rice hulls are not commercially available.
* * * * *

0
5. In Sec.  205.606, paragraph (d)(3) is revised to read as follows:


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

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


Sec.  205.606  [Amended]

0
6. In Sec.  205.606, effective November 3, 2013, paragraph (d) is 
amended by removing paragraph (d)(1) and redesignating (d)(2) through 
(19) as (d)(1) through (18).
* * * * *

    Dated: May 21, 2013.
Rex A. Barnes,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2013-12504 Filed 5-24-13; 8:45 am]
BILLING CODE 3410-02-P