National Organic Program (NOP); Sunset Review (2013), 25879-25886 [2013-10556]

Agencies

• Agricultural Marketing Service
• DEPARTMENT OF AGRICULTURE

[Federal Register Volume 78, Number 86 (Friday, May 3, 2013)]
[Proposed Rules]
[Pages 25879-25886]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-10556]


========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

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.

========================================================================


Federal Register / Vol. 78, No. 86 / Friday, May 3, 2013 / Proposed 
Rules

[[Page 25879]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-11-0003; NOP-10-13PR]
RIN 0581-AD13


National Organic Program (NOP); Sunset Review (2013)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This proposed rule would address recommendations submitted to 
the Secretary of Agriculture (Secretary) by the National Organic 
Standards Board (NOSB) following their November 2011 and May 2012 
meetings. These recommendations pertain to the 2013 Sunset Review of 
substances on the U.S. Department of Agriculture's (USDA) National List 
of Allowed and Prohibited Substances (National List). Consistent with 
the recommendations from the NOSB, this proposed rule would continue 
the allowed uses of multiple synthetic and nonsynthetic substances and 
the prohibition of one nonsynthetic substance on the National List 
(along with any restrictive annotations). This proposed rule would also 
remove one synthetic substance from the National List.

DATES: Comments must be received by June 3, 2013.

ADDRESSES: Interested persons may comment on the proposed rule using 
the following procedures:
     Federal eRulemaking Portal: https://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-11-0003; NOP-10-13PR, and/or Regulatory Information 
Number (RIN) 0581-AD13 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 and any relevant background documents will be posted without 
change to https://www.regulations.gov.
    Document: For access to the document and to read background 
documents or comments received, go to https://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 INFORMATION: 

I. Background

    The Organic Foods Production Act of 1990 (OFPA) (7 U.S.C. 6501-
6522) authorizes the establishment of the National List. The National 
List, codified within the USDA organic regulations at 7 CFR 205.600 
through 205.607, identifies synthetic substances that may be used in 
organic production and nonsynthetic (natural) substances that are 
prohibited in organic crop and livestock production. The National List 
also identifies nonagricultural nonsynthetic, nonagricultural synthetic 
and nonorganic agricultural substances that may be used in organic 
handling.
    The exemptions and prohibitions granted on the National List are 
required to be reviewed every 5 years under OFPA by the National 
Organic Standards Board (NOSB). The Secretary of Agriculture has 
authority under OFPA to renew such exemptions and prohibitions. If they 
are not reviewed by the NOSB within 5 years of their inclusion on the 
National List and renewed by the Secretary, their authorized use or 
prohibition expires. The Secretary published an Advanced Notice of 
Proposed Rulemaking (ANPR) (76 FR 31495) in the Federal Register on 
June 1, 2011, to announce the review of 11 exempt substances and one 
prohibited nonsynthetic substance authorized under the USDA organic 
regulations. This ANPR established November 3, 2013, as the date by 
which the Sunset 2013 review and renewal process must be concluded. The 
ANPR explained that the exemptions and prohibitions not renewed by this 
date will be removed from the National List. This ANPR also requested 
public comment on the continued use or prohibition of these substances. 
The public comment period lasted 60 days. A list of these substances is 
provided as Table 1 in the Overview of Proposed Actions section. These 
substances were originally added to the National List on November 3, 
2003 (68 FR 61987), and November 4, 2003 (68 FR 62215), and were 
previously renewed under the Sunset process on November 3, 2008 (73 FR 
59479).
    The Agricultural Marketing Service (AMS) received 25 comments on 
the substances in response to the ANPR. AMS received comments from 
producers, handlers, distributors, organic associations, a certifying 
agent, and various industry groups. Some of these comments addressed 
more than one substance. We received general comments stating that the 
listings should remain as they are currently codified. We received one 
general comment that did not address the substances under this Sunset 
review. Most comments indicated support for substances that the 
commenters' promoted, represented, or relied upon. Comments 
specifically supported a

[[Page 25880]]

continued allowance for the following substances: copper sulfate, ozone 
gas, peracetic acid, EPA List 3 Inerts,\1\ agar-agar, animal enzymes, 
calcium sulfate, carrageenan, glucono delta-lactone, tartaric acid, and 
cellulose. Two comments specifically supported a continued prohibition 
on calcium chloride as annotated on the National List. One commenter 
requested that the annotations for two listings of copper sulfate, one 
at section 205.601(a)(3) and one at section 205.601(e)(4) for use in 
aquatic rice systems, be amended to remove the restriction based on the 
number of applications during a specified timeframe. The commenter 
requested that the restriction limiting application rates to those 
which do not increase baseline soil test values for copper over a 
timeframe agreed upon by the producer and accredited certifying agent 
be maintained, but the restriction on number of applications during any 
24-month period be eliminated.
---------------------------------------------------------------------------

    \1\ EPA refers to the Environmental Protection Agency.
---------------------------------------------------------------------------

    The NOSB reviewed the comments received from the ANPR and developed 
recommendations regarding the continued use and prohibition of the 
substances under review. The NOSB received additional public comments 
concerning the pending sunset of these substances in response to two 
Federal Register notices announcing meetings of the NOSB and its 
planned deliberations on Sunset 2013 recommendations. The notices were 
published in the Federal Register as follows: October 7, 2011 (76 FR 
62336), and April 9, 2012 (77 FR 21067). The NOSB received further 
written and oral testimony at both of these public meetings which 
occurred in Savannah, GA on November 29-December 2, 2011, and 
Albuquerque, NM on May 22-25, 2012. The written comments can be 
retrieved via https://www.regulations.gov by searching for the document 
ID numbers: AMS-NOP-11-0081 (November 2011 meeting) and AMS-NOP-12-0017 
(May 2012 meeting). The oral comments were recorded in the meeting 
transcripts which are available on the NOP Web site at https://www.ams.usda.gov/nop.
    At its November 2011 and May 2012 meetings, the NOSB addressed 
multiple National List exemptions and a prohibition under the 2013 
Sunset review. The NOSB recommended that the Secretary: (1) Renew 
multiple exemptions and one prohibition without change, (2) remove an 
exemption for one synthetic substance, tartaric acid, and (3) amend the 
exemptions for two synthetic substances, EPA List 3--Inerts of unknown 
toxicity and cellulose, and one nonsynthetic substance, carrageenan. In 
accordance with NOSB's published policies and procedures, it also 
issued a second round of recommendations to renew the existing listings 
for EPA List 3--Inerts of unknown toxicity, cellulose, and carrageenan 
without change.\2\ These second recommendations authorize the Secretary 
to renew these three listings ``as is'' considering the expiration date 
of November 3, 2013.
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    \2\ In October 2010, the NOSB changed its Sunset policy to 
enable the NOSB to make recommendations to add or change annotations 
(restrictions) on applicable National List substances under Sunset 
review. This change in policy ensures that the NOSB can address new 
use patterns and scientific information on substances allowed in 
organic production. This policy limits such annotations to those 
which clarify the existing annotation or make the annotation more 
restrictive. The policy does not provide for an annotation change 
that would result in expanded use of an exempted material. This is 
described starting on p. 56 of the NOSB Policies and Procedures 
Manual available on the NOP Web site at: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3013893.
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    Because the NOSB's sole justification for restricting the allowance 
of carrageenan was on the basis of food safety concerns, despite the 
fact that FDA regulations provide for its use as a safe food additive 
when used in accordance with 21 CFR 172.5, 21 CFR 172.620 and 21 CFR 
172.626, AMS is renewing carrageenan as codified based on the NOSB's 
second recommendation. Based on concern over the impact of changing the 
annotation for cellulose, AMS is renewing the listing for cellulose as 
codified based on the NOSB's second recommendation. For EPA List 3--
Inerts of unknown toxicity, AMS is concerned that including an 
expiration date as part of its annotation during the Sunset review 
would complicate the NOSB's established inerts review process. 
Therefore, AMS is renewing the listing for EPA List 3--Inerts of 
unknown toxicity as codified based on the NOSB's second recommendation. 
In summary, this rule proposes to renew multiple listings without 
change and remove one listing (tartaric acid--made from malic acid).
    Under the authority of OFPA, the National List can be amended by 
the Secretary based on proposed amendments developed by the NOSB. Since 
established, AMS has published multiple amendments to the National List 
beginning on October 31, 2003 (68 FR 61987). AMS published the most 
recent amendment to the National List on September 27, 2012 (77 FR 
59287).

II. Overview of Proposed Actions

    At its November 2011 and May 2012 meetings, the NOSB reviewed the 
listings set to sunset on November 3, 2013, for multiple exemptions and 
one prohibition that are authorized on the National List. On December 
2, 2011, the NOSB finalized its recommendations on the following 
substances: animal enzymes, calcium chloride, copper sulfate (two 
uses), glucono delta-lactone, ozone gas, peracetic acid (two uses), and 
tartaric acid (two sources). On May 25, 2012, the NOSB finalized its 
recommendations on agar-agar, calcium sulfate, carrageenan, cellulose, 
and EPA List 3--Inerts of unknown toxicity.
    The NOSB's recommendations to continue existing exemptions and 
prohibitions are based on consideration of public comments and 
applicable supporting evidence that express a continued need for the 
use or prohibition of the substance(s) as required by OFPA.
    Concerning OFPA criteria used to make recommendations regarding the 
discontinuation of an authorized exempted synthetic substance (7 U.S.C. 
6517(c)(1)), the NOSB's decision is based on consideration of public 
comments and applicable supporting evidence that demonstrates the 
currently authorized exempted substance is: (a) Harmful to human health 
or the environment; (b) no longer necessary for organic production due 
to the availability of alternative wholly nonsynthetic substitute 
products or practices; and (c) inconsistent with organic farming and 
handling practices.
    Based on the NOSB recommendations, AMS' proposed actions for the 
Sunset 2013 proposed rule are outlined in Table 1.

[[Page 25881]]



          Table 1--Overview of Proposed Actions for Sunset 2013
------------------------------------------------------------------------
     National List Section         Substance listing     Proposed action
------------------------------------------------------------------------
    Synthetic substances allowed for use in organic crop production.
------------------------------------------------------------------------
205.601(a)(3).................  Copper sulfate--for     Renew.
                                 use as an algicide in
                                 aquatic rice systems,
                                 is limited to one
                                 application per field
                                 during any 24-month
                                 period. Application
                                 rates are limited to
                                 those which do not
                                 increase baseline
                                 soil test values for
                                 copper over a
                                 timeframe agreed upon
                                 by the producer and
                                 accredited certifying
                                 agent.
205.601(a)(5).................  Ozone gas--for use as   Renew.
                                 an irrigation system
                                 cleaner only.
205.601(a)(6).................  Peracetic acid--for     Addressed
                                 use in disinfecting     through
                                 equipment, seed, and    separate
                                 asexually propagated    rulemaking
                                 planting material.      action; see
                                                         February 5,
                                                         2013 proposed
                                                         rule (78 FR
                                                         8040).
205.601(e)(4).................  Copper sulfate--for     Renew.
                                 use as tadpole shrimp
                                 control in aquatic
                                 rice production, is
                                 limited to one
                                 application per field
                                 during any 24-month
                                 period Application
                                 rates are limited to
                                 levels which do not
                                 increase baseline
                                 soil test values for
                                 copper over a
                                 timeframe agreed upon
                                 by the producer and
                                 accredited certifying
                                 agent.
205.601(i)(8).................  Peracetic acid--for     Addressed
                                 use to control fire     through
                                 blight bacteria.        separate
                                                         rulemaking
                                                         action; see
                                                         February 5,
                                                         2013 proposed
                                                         rule (78 FR
                                                         8040).
205.601(m)(2).................  EPA List 3--Inerts of   Renew.
                                 unknown toxicity--for
                                 use only in passive
                                 pheromone dispensers.
------------------------------------------------------------------------
  Nonsynthetic substances prohibited for use in organic crop production
------------------------------------------------------------------------
205.602(c)....................  Calcium chloride,       Renew.
                                 brine process is
                                 natural and
                                 prohibited for use
                                 except as a foliar
                                 spray to treat a
                                 physiological
                                 disorder associated
                                 with calcium uptake.
------------------------------------------------------------------------
    Nonsynthetic, nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or ``made
        with organic (specified ingredients or food group(s)).''
------------------------------------------------------------------------
205.605(a)....................  Agar-agar.............  Renew.
205.605(a)....................  Animal enzymes--        Renew.
                                 (Rennet--animals
                                 derived; Catalase--
                                 bovine liver; Animal
                                 lipase; Pancreatin;
                                 Pepsin; and Trypsin).
205.605(a)....................  Calcium sulfate--mined  Renew.
205.605(a)....................  Carrageenan...........  Renew.
205.605(a)....................  Glucono delta-lactone-- Renew.
                                 production by the
                                 oxidation of D-
                                 glucose with bromine
                                 water is prohibited.
205.605(a)....................  Tartaric acid--made     Renew.
                                 from grape wine.
------------------------------------------------------------------------
      Synthetic, nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or ``made
        with organic (specified ingredients or food group(s)).''
------------------------------------------------------------------------
205.605(b)....................  Cellulose--for use in   Renew. NOSB
                                 regenerative casings,   recommendation
                                 as an anti-caking       for annotation
                                 agent (non-chlorine     change under
                                 bleached) and           consideration
                                 filtering aid.          for a separate
                                                         rulemaking
                                                         action.
205.605(b)....................  Tartaric acid--made     Remove.
                                 from malic acid.
------------------------------------------------------------------------

    The following Renewals and Nonrenewals sections provide 
explanations for AMS' proposed actions.

Renewals

    AMS has reviewed and accepts the NOSB recommendations for the 
continued exemption or prohibition of certain substances. Accordingly, 
this proposed rule would:
    1. Renew the exemptions at section 205.601, along with any 
restrictive annotations, for the following synthetic substances allowed 
for use in organic crop production as shown in Table 1: copper sulfate 
(2 uses), ozone gas, and EPA List 3 Inerts;
    2. Renew the prohibition at section 205.602, along with its 
restrictive annotation, for the following nonsynthetic substance 
prohibited for use in organic crop production as shown in Table 1: 
calcium chloride; and
    3. Renew the exemptions at section 205.605, along with any 
restrictive annotations, for the following nonagricultural (nonorganic) 
substances allowed as ingredients in or on processed products labeled 
as ``organic'' or ``made with organic (specified ingredients or food 
group(s))'' as shown in Table 1: agar-agar, animal enzymes, 
carrageenan, cellulose, calcium sulfate, glucono delta-lactone, and 
tartaric acid made from grape wine.
    AMS is accepting NOSB's second recommendations rather than the 
NOSB's first recommendations to add or amend restrictive annotations 
for the following substances under Sunset review: EPA List 3 Inerts, 
carrageenan, and cellulose. The specific circumstances for implementing 
the NOSB's second recommendations for these substances are outlined 
below.

EPA List 3--Inerts of Unknown Toxicity

    An inert ingredient is defined in section 205.2 the USDA organic

[[Page 25882]]

regulations as ``any substance (or group of substances with similar 
chemical structures if designated by the Environmental Protection 
Agency) other than an active ingredient which is intentionally included 
in any pesticide product (40 CFR 152.3(m)).'' There are currently two 
categories of inert ingredients allowed on the National List with 
restrictive annotations: EPA List 3--Inerts of unknown toxicity 
(section 205.601(m)), and EPA List 4--Inerts of minimal concern 
(sections 205.601(m) and 205.603(e)).
    In 2006, EPA reassessed all inert ingredients used in pesticide 
formulations allowed on food crops. This reassessment resulted in a new 
classification system which made the EPA List system obsolete. This 
means that the National List references to EPA List 3 and EPA List 4 
inerts are now out-of-date when compared with current EPA 
regulations.\3\ In June 2010, NOP convened an NOSB-NOP-EPA inerts 
working group (IWG) for the purpose of addressing these obsolete 
references to EPA inert lists.
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    \3\ On September 30, 2010, NOP issued NOP 5008: Reassessed Inert 
Ingredients, a guidance document describing the applicability of 
NOP's regulatory references to List 3 and 4 inerts (EPA is no longer 
using these lists in their classification system) used in pesticide 
products. Available at the NOP Web site: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5086874.
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    At the NOSB May 2012 meeting, the NOSB recommended several changes 
to the allowance for inerts as part of its Sunset review for EPA List 3 
Inerts.\4\ The changes included: (1) Modification to the introductory 
text at section 205.601(m); (2) amending the listing and annotation for 
EPA List 3 Inerts to read as follows: ``Inert ingredients exempt from 
the requirement of a tolerance under 40 CFR 180.1122 that were formerly 
on EPA List 3 in passive polymeric dispenser products may be used until 
October 21, 2017;'' and (3) amending section 205.2 to add a definition 
for ``passive polymeric dispenser products'' that is intended to be 
removed in coordination with the proposed expiration date of October 
21, 2017, at section 205.601(m). Concurrent with Sunset Review policy, 
the NOSB also issued a second recommendation to renew the existing 
listing for EPA List 3 Inerts.
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    \4\ NOSB Recommendation on List 3 Inert Ingredients. May 2012. 
Available at the NOP Web site: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5098912.
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    On October 16, 2012, the NOSB passed a recommendation which 
outlined the procedure by which the NOSB would review both EPA List 3 
and EPA List 4 inerts over a four-year timespan, with the goal of 
completing the majority of the reviews by October 2017, the sunset date 
for EPA List 4 inerts. As of October 2012, the IWG had compiled a list 
of 16 classes or groups comprising 126 individual substances for 
review. In its recommendation, the NOSB acknowledged that, ``Given the 
scope of [technical evaluation reports] and NOSB evaluation of these 
materials, it is recognized that the completion of this process will 
take substantial resources and time . . . Because of the challenge that 
this represents, the NOSB will assess the viability of the timeline 
after it completes the recommendation on the first few groups of 
materials.'' AMS recognizes the recommendation's intent to address the 
complex challenges presented by the out-of-date listings in a timely 
manner. However, a rulemaking action to add an expiration date at this 
time may be problematic in the event that the timeline for inerts 
review takes longer than the projected four years; therefore, we are 
not proposing the addition of an expiration date to the exemption for 
EPA List 3 Inerts. This rule proposes to implement the NOSB's second 
recommendation to renew the exemption for EPA List 3--Inerts of unknown 
toxicity at section 205.601 as codified, along with its current 
restrictive annotation. This approach would meet the timeframe required 
by the sunset provision of OFPA and the listing for EPA List 3 Inerts 
would subsequently have a sunset date of November 3, 2018. Furthermore, 
the IWG's continuing review of inerts may result in additional outcomes 
beyond the NOSB's other recommendations to modify the introductory text 
for section 205.601(m) and add a definition in section 205.2 for 
passive polymeric dispenser products. This may in turn influence AMS' 
future considerations for a rulemaking on EPA List 3 Inerts.

Carrageenan

    Carrageenan is currently permitted as a nonagricultural, 
nonsynthetic ingredient in organic handling in section 205.605(a) of 
the National List. Under U.S. Food and Drug Administration (FDA) 
regulations, carrageenan and its salts can be used as a food additive 
under the conditions specified at 21 CFR 172.5 (General Provisions for 
Direct Food Additives), and at 21 CFR 172.620 and 21 CFR 172.626 
(Specific Provisions for Carrageenan and Its Salts). In addition, 
Chondrus extract (carrageenin) \5\ is listed as Generally Recognized as 
Safe at 21 CFR 182.7255 when used in accordance with good manufacturing 
practice. Under FDA's prescribed conditions, carrageenan can be safely 
used in the amount necessary as an emulsifier, stabilizer, or thickener 
in foods, except those standardized foods that do not provide for such 
use.
---------------------------------------------------------------------------

    \5\ This is the spelling provided at this regulatory reference.
---------------------------------------------------------------------------

    Consistent with a 1995 NOSB recommendation, AMS first included 
carrageenan on the National List as an allowed nonsynthetic in organic 
processed products on November 3, 2003 (68 FR 61987).\6\ The NOSB 
reviewed carrageenan again as part of the 2008 Sunset Review and 
recommended that its allowance in organic handling be renewed without 
any restrictive annotation. Based on the NOSB recommendation, AMS 
renewed the allowance for carrageenan through a final rule effective on 
November 3, 2008 (73 FR 59479). In the November 3, 2008 final rule, AMS 
described the comments received on substances under the 2008 Sunset 
Review, citing that we received five comments specifically in support 
for renewing carrageenan on the National List. At that time, AMS did 
not receive any comments that opposed its continued use in organic 
processed products.
---------------------------------------------------------------------------

    \6\ This final rule added ``carageenan'' to the National List 
rather than the correct spelling ``carrageenan''. The spelling for 
this substance was corrected as a technical correction in the final 
rule for the 2008 Sunset Review (73 FR 59480).
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    On June 1, 2011, AMS published an ANPR to inform stakeholders that 
the NOSB would be reviewing carrageenan as part of its 2013 Sunset 
Review. AMS received 15 comments specifically supporting a continued 
allowance for carrageenan. Many comments cited carrageenan's function 
as a unique stabilizer in a range of organic foods, particularly in 
dairy products, as the basis for their support. Three of these comments 
stated that carrageenan has been used safely as an ingredient in foods 
for many years. Two comments specifically referenced FDA as the 
regulatory agency that authorizes the use of carrageenan as a safe food 
additive under the conditions specified in FDA regulations. At that 
time, AMS did not receive any comments that opposed its continued use 
in organic processed products.
    In preparation for its Sunset 2013 review, the NOSB Handling 
Subcommittee reviewed the comments submitted in response to the ANPR 
and obtained a new technical evaluation report for carrageenan.\7\ On 
February 21, 2012, the NOSB Handling

[[Page 25883]]

Subcommittee finalized its 2013 Sunset Review proposal for carrageenan; 
this proposal was published for public comment on April 9, 2012 in 
conjunction with the NOSB May 2012 public meeting notice (77 FR 21067). 
In its proposal, the NOSB Handling Subcommittee proposal stated that 
the technical evaluation report confirmed the food uses of carrageenan 
have not changed substantially since the original Technical Advisory 
Panel (TAP) review was conducted in 1995. The proposal explained that 
carrageenan continues to be an important material used by the organic 
community. The NOSB Handling Subcommittee proposal also stated that 
carrageenan may be safely used as a food additive for human consumption 
as long as its use is in accordance with FDA requirements at 21 CFR 
172.620. The NOSB Handling Subcommittee further stated that, based on 
information in the 2011 technical evaluation report, it believed that 
different manufacturing methods of carrageenan could change the 
classification of the substance from nonsynthetic to synthetic.\8\
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    \7\ Technical Evaluation Report on Carrageenan. October 3, 2011. 
Available at the NOP Web site: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5096567.
    \8\ NOSB Handling Subcommittee Proposal on Carrageenan. February 
21, 2012. Available at the NOP Web site: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5097825&acct=nosb.
---------------------------------------------------------------------------

    As a result of this information, the NOSB Handling Subcommittee 
proposed to continue the allowance for carrageenan in all organic 
processed products by removing carrageenan as an allowed nonsynthetic 
from section 205.605(a) and instead listing carrageenan as an allowed 
synthetic without restriction under section 205.605(b) of the National 
List. The NOSB Handling Subcommittee proposed this classification 
change to address the different manufacturing processes described by 
the 2011 technical evaluation report.
    After publication of this NOSB Handling Subcommittee proposal, some 
public comments raised concerns regarding potential adverse health 
effects caused by the use of carrageenan, particularly degraded 
carrageenan, a low-molecular weight polysaccharide, in food. Other 
comments cited evidence in support of the safety of food-grade 
carrageenan in food, and stated that degraded carrageenan is not used 
in food products. Numerous other stakeholders stated that organic 
handlers producing a wide range of products that rely on carrageenan do 
not have functional alternatives to the substance. The comments in 
response to the NOSB Handling Subcommittee proposal can be retrieved at 
www.regulations.gov (search for docket number AMS-NOP-12-0017).
    At its May 2012 public meeting, the NOSB Handling Subcommittee 
chose to present a revised proposal. The NOSB Handling Subcommittee 
recommended to relist carrageenan as a nonsynthetic, rather than change 
its classification to synthetic, and to include new language in its 
listing that would specify the food grade forms of carrageenan using 
Chemical Abstract Service (CAS) numbers. The CAS numbers are intended 
to align with the forms that have been approved by FDA for use as food 
ingredients. The proposal also included an annotation that, if codified 
through rulemaking, would prohibit the use of any form of carrageenan 
in infant formula. The revised proposal from the NOSB Handling 
Subcommittee further stated that carrageenan would still be allowed in 
foods for older infants (older than six months) and ``weaning foods'' 
for ``young children''. The NOSB passed this proposal as its first 
recommendation with a vote of 10 ``yes'' and 5 ``no.'' Aligned with the 
NOSB's Sunset Review policy, the NOSB also issued a second 
recommendation with a vote of 11 ``yes'' and 4 ``no'' to renew the 
existing listing for carrageenan which does not have any restrictive 
annotation.\9\
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    \9\ NOSB Recommendation on Carrageenan. May 25, 2012. Available 
at the NOP Web site: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5098921.
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    In its first recommendation, the NOSB stated that the restrictive 
annotation to prohibit the use of carrageenan in infant formula was 
based on concerns, specifically related to newborns, raised by a March 
2003 opinion of the EU Scientific Committee on Food (SCF). The SCF 
provided scientific advice to the EU Commission.\10\ The NOSB stated 
that the SCF's concern was based on facts from the Pediatric Nutrition 
Handbook, a publication of American Association of Pediatrics (AAP), in 
that newborn infants have immature digestive systems that may absorb 
macromolecules.
---------------------------------------------------------------------------

    \10\ After 2003, the SCF was transferred to the European Food 
Safety Authority. https://ec.europa.eu/food/committees/scientific/index_en.htm.
---------------------------------------------------------------------------

    In considering the May 2012 NOSB recommendation, AMS reviewed the 
March 2003 opinion of the EU SCF as NOSB's justification for 
restricting the use of carrageenan. The EU SCF opinion cited in the May 
2012 NOSB recommendation concluded that ``there is no evidence of any 
adverse effects in humans from exposure to food-grade carrageenan, or 
that exposure to degraded carrageenan from use of food-grade 
carrageenan is occurring'' (p. 5).\11\ The EU SCF opinion cited in the 
May 2012 NOSB recommendation further states that, given the absence of 
information on potential absorption of carrageenan in the digestive 
system of young infants, carrageenan in infant formula is 
``inadvisable'' (p. 6). The EU SCF opinion, however, does not reference 
the AAP's Pediatric Nutrition Handbook, and the Handbook does not 
reference any concerns with carrageenan. Therefore, it is unclear how 
the Handbook is linked to the EU SCF opinion or supportive of the 
NOSB's proposed prohibition on the use of carrageenan in infant 
formula.
---------------------------------------------------------------------------

    \11\ Opinion of the Scientific Committee on Food on Carrageenan 
(2003). https://ec.europa.eu/food/fs/sc/scf/out164_en.pdf.
---------------------------------------------------------------------------

    In the U.S., carrageenan is allowed under FDA regulations at 21 CFR 
172.620 as a direct food additive and is considered safe when used in 
the amount necessary as an emulsifier, stabilizer, or thickener in 
foods, except those standardized foods that do not provide for such 
use. The FDA, as the U.S. food safety authority, has not prohibited the 
use of carrageenan in infant formula. If used in infant formula, FDA 
reviews carrageenan in a given formulation as part of the infant 
formula notification process required by section 412 of the Federal 
Food, Drug, and Cosmetic Act (FFDCA) (21 U.S.C. 350(a)).
    The NOSB's recommendation to prohibit the use of carrageenan in 
infant formula was based solely on food safety concerns despite 
carrageenan's status as a safe food additive when used as specified by 
FDA regulations and despite FDA's review of carrageenan in infant 
formula formulations under the FFDCA. Therefore, AMS is not 
implementing this recommendation. This proposed rule would implement 
the NOSB's second recommendation by renewing the exemption for 
carrageenan as currently listed as a nonsynthetic substance at section 
205.605(a).

Cellulose

    Cellulose is currently included on the National List in section 
205.605(a) as an allowed nonagricultural, synthetic substance for use 
in organic handling. As part of the 2013 Sunset review, the NOSB 
Handling Subcommittee reviewed the original NOSB recommendation, the 
2001 Technical Advisory Panel (TAP) review, historical documents, the 
2007 Sunset recommendation, and public comments on cellulose.\12\ The 
NOSB Handling

[[Page 25884]]

Subcommittee issued a proposal to renew the listing for cellulose at 
section 205.605(b) that was considered by the NOSB at its May 2012 
meeting.\13\ At this meeting, the NOSB received public comment in 
support of relisting. One commenter requested that the NOSB ensure the 
microcrystalline form of cellulose is not allowed, and another 
commenter requested a new technical review and opposed the listing of 
the microcrystalline form of cellulose.\14\ The NOSB responded that the 
2001 TAP review examined three forms of cellulose that were considered 
for various uses: Powdered cellulose, regenerated cellulose casing, and 
microcrystalline cellulose, and the intent of the current annotation 
was to allow powdered cellulose and the form used in regenerative 
casings. At its meeting, the NOSB acknowledged that both powdered and 
microcrystalline cellulose can be used to serve the same functions, 
namely as a filtering aid or an anti-caking agent. The NOSB then 
recommended changing the annotation to explicitly state which forms are 
allowed, thereby prohibiting the use of the microcrystalline form.\15\ 
Concurrent with Sunset Review policy, the NOSB also issued a second 
recommendation to renew the existing listing for cellulose.
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    \12\ Technical Advisory Panel Report on Cellulose. September 28, 
2001. Available at the NOP Web site: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5066975&acct=nopgeninfo.
    \13\ NOSB Handling Subcommittee Proposal on Cellulose. March 20, 
2012. Available at the NOP Web site: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5097827&acct=nosb.
    \14\ Transcript from the May 22-25, 2012 NOSB meeting is 
available under the NOSB section of the NOP Web site at: https://www.ams.usda.gov/nop.
    \15\ NOSB Recommendation on Cellulose. May 25, 2012. Available 
at the NOP Web site: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5098923.
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    Evidence gathered at the meeting suggested that the organic 
industry is not using the microcrystalline form of cellulose. However, 
AMS needs more information from the industry to confirm that the 
microcrystalline form of cellulose is not currently in use in organic 
processed products. Therefore, through this proposed rule, AMS is 
proposing to address the NOSB's second recommendation to renew the 
exemption for cellulose as currently listed at section 205.605(b) and 
is seeking public comments on the NOSB's first recommendation to 
restrict its use in organic processed products. This approach would 
meet the timeframe required by the Sunset provision of OFPA and, based 
on the public comment, enable AMS to consider a restriction on its use 
for a future rulemaking.

Nonrenewals

Tartaric Acid
    As indicated in Table 1, there are two sources of tartaric acid 
currently on the National List: Nonsynthetic tartaric acid made from 
grape wine on section 205.605(a), and synthetic tartaric acid made from 
malic acid on section 205.605(b). As part of its Sunset 2013 review, 
the NOSB requested and obtained a new technical evaluation report for 
tartaric acid.\16\ The NOSB Handling Subcommittee also received a 
petition to remove the synthetic source of tartaric acid.\17\ The 
petition argued that: (1) The annotation for synthetic tartaric acid is 
incorrect; (2) the two listings of tartaric acid are the same form and 
serve the same function; and (3) tartaric acid made from grape wine is 
widely commercially available. The technical evaluation report findings 
confirmed the petitioner's three arguments: (1) Synthetic tartaric acid 
is typically manufactured from maleic anhydride, not malic acid as 
written in the current annotation; (2) both the nonsynthetic and 
synthetic listings are the same form of tartaric acid, which is 
generally referred to as the `dextro form'; and (3) tartaric acid from 
grape wine is commercially available from a large number of 
distributors throughout the world. Based on review of the technical 
report and public comment, the NOSB agreed there is insufficient 
evidence to support the continued need for the synthetic form of 
tartaric acid and recommended its removal from the National List at 
section 205.605(b). This rule proposes removal of this substance as 
part of this Sunset 2013 rulemaking.
---------------------------------------------------------------------------

    \16\ Technical Evaluation Report on Tartaric Acid. October 13, 
2011. Available at the NOP Web site: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5094932.
    \17\ The petition was submitted by Brenn-O-Kem and is available 
at the NOP Web site: https://www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
---------------------------------------------------------------------------

Peracetic Acid
    On August 12, 2008, a petition was submitted to NOP requesting that 
the annotation for peracetic acid be amended on the National List.\18\ 
The petition was submitted to ensure that hydrogen peroxide products 
can also list peracetic acid as an active ingredient on the product 
label. This would be consistent with EPA labeling requirements. The 
NOSB reviewed the petition in 2009 and issued a recommendation for an 
annotation change for the two peracetic acid listings at section 
205.601.\19\ To date, AMS has not implemented these recommendations for 
peracetic acid.
---------------------------------------------------------------------------

    \18\ The petition was submitted by BioSafe Systems LLC, and is 
available from the NOP Web site in the Petitioned Substances 
Database: http:www.ams.usda.gov/NOPPetitionedSubstancesDatabase.
    \19\ NOSB Recommendation on Peracetic Acid. November 2009. 
Available at the NOP Web site: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5092050&acct=nosb.
---------------------------------------------------------------------------

    During its Sunset 2013 deliberations, the NOSB received public 
comments in support of the continued need for peracetic acid. As a 
result, the NOSB recommended renewing the two listings for peracetic 
acid in organic crop production at section 205.601 of the National 
List. Given that OFPA recognizes the authority of the Administrator of 
the Environmental Protection Agency under the Federal Insecticide, 
Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136-136(y)), AMS 
addressed the two listings for peracetic acid in a proposed rule (78 FR 
8040) published on February 5, 2013 to implement the 2009 NOSB 
recommendation and ensure the listings for peracetic acid on the 
National List allow for conformance to EPA labeling requirements. AMS 
intends to conclude that rulemaking prior to the November 3, 2013 
sunset date. As a result, the renewals for peracetic acid are not 
addressed in this proposed rule for Sunset 2013.

III. Related Documents

    An advanced notice of proposed rulemaking with request for comments 
was published in Federal Register on June 1, 2011 (76 FR 31495) to 
notify the public that the listings discussed in this proposed rule 
would expire on November 3, 2013 if not reviewed by the NOSB and 
renewed by the Secretary.

IV. Statutory and Regulatory Authority

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

[[Page 25885]]

A. Executive Order 12866

    This action has been determined to be 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 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 
2115(b) of OFPA (7 U.S.C. 6514(b)). States are also preempted under 
section 2104 through 2108 of 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 OFPA.
    Pursuant to section 2108(b)(2) of 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 OFPA, (b) not be inconsistent with 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 2120(f) of OFPA (7 U.S.C. 6519(f)), this 
proposed rule would not alter the authority of the Secretary under the 
Federal Meat Inspection Act (21 U.S.C. 601-624), the Poultry Products 
Inspection Act (21 U.S.C. 451-471), or the Egg Products Inspection Act 
(21 U.S.C. 1031-1056), concerning meat, poultry, and egg products, nor 
any of the authorities of the Secretary of Health and Human Services 
under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301-399), nor 
the authority of the Administrator of EPA under the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136-136(y)).
    Section 2121 of 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. OFPA also provides that the U.S. 
District Court for the district in which a person is located has 
jurisdiction to review the Secretary's decision.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires 
agencies to consider the economic impact of each rule on small entities 
and evaluate alternatives that would accomplish the objectives of the 
rule without unduly burdening small entities or erecting barriers that 
would restrict their ability to compete in the market. The purpose of 
the RFA 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.
    Pursuant to the requirements set forth in the RFA, AMS performed an 
economic impact analysis on small entities in the final rule published 
in the Federal Register on December 21, 2000 (65 FR 80548). AMS has 
also considered the economic impact of this action on small entities. 
The impact on entities affected by this proposed rule would not be 
significant. The effect of this proposed rule would be to allow the 
continued use of additional substances in agricultural production and 
handling. AMS concludes that the economic impact of continuing the 
allowance for Sunset 2013 substances would avoid market disruption and 
would be beneficial to small agricultural service firms. The effect of 
the removal of one substance, tartaric acid, would be minimal to small 
agricultural firms since another form of tartaric acid from grape wine 
is commercially available and is proposed to be renewed under this 
rule. Accordingly, AMS certifies that this rule will not have a 
significant economic impact on a substantial number of small entities.
    Small agricultural service firms, which include producers, 
handlers, and accredited certifying agents, have been defined by the 
Small Business Administration (SBA) (13 CFR 121.201) as those having 
annual receipts of less than $7,000,000 and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000.
    According to USDA, National Agricultural Statistics Service (NASS), 
certified organic acreage exceeded 3.5 million acres in 2011.\20\ 
According to NOP's Accreditation and International Activities Division, 
the number of certified U.S. organic crop and livestock operations 
totaled over 17,750 in 2012. AMS believes that most of these entities 
would be considered small entities under the criteria established by 
the SBA. 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.\21\ In addition, the USDA has 85 
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. Certifying agents reported approximately 25,000 
certified operations worldwide in 2012.
---------------------------------------------------------------------------

    \20\ 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.
    \21\ Organic Trade Association. 2012. Organic Industry Survey. 
www.ota.com.
---------------------------------------------------------------------------

D. Paperwork Reduction Act

    No additional collection or recordkeeping requirements are imposed 
on the public by this proposed rule. Accordingly, OMB clearance is not 
required by section 350(h) of the Paperwork Reduction Act of 1995, 44 
U.S.C. 3501, Chapter 35, or OMB's implementing regulations at 5 CFR 
part 1320.

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 reflects recommendations submitted to the 
Secretary by the NOSB for substances on the National List of Allowed 
and Prohibited Substances that, under the Sunset review provisions of 
OFPA, would otherwise expire on November 3, 2013. A 30-day period for 
interested

[[Page 25886]]

persons to comment on this rule is provided. Thirty days is deemed 
appropriate because the review of these listings was widely publicized 
through an ANPR and two NOSB meeting notices; the use or prohibition of 
these substances, as applicable, are critical to organic production and 
handling; and this rulemaking must be completed before the sunset date 
of 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 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.


Sec.  205.605  [Amended]

0
2. Section 205.605 is amended by removing ``Tartaric acid--made from 
malic acid'' from paragraph (b).

    Dated: April 30, 2013.
David R. Shipman,
Administrator, Agricultural Marketing Service.
[FR Doc. 2013-10556 Filed 5-2-13; 8:45 am]
BILLING CODE 3410-02-P