[Federal Register Volume 78, Number 192 (Thursday, October 3, 2013)]
[Rules and Regulations]
[Pages 61154-61161]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24208]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

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


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

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

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

SUMMARY: This final rule addresses 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 final rule continues 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 rule also removes one synthetic 
substance from the National List.

DATES: This rule is effective November 3, 2013.

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 of Allowed and 
Prohibited Substances (National List). The National List, a subpart 
within the USDA organic regulations (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

[[Page 61155]]

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 
substances 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.
    On June 1, 2011, the Agricultural Marketing Service (AMS) published 
an Advanced Notice of Proposed Rulemaking (ANPR) (76 FR 31495) in the 
Federal Register, announcing the NOSB's review of exempted and 
prohibited substances due to sunset in 2013. AMS posted these comments 
for public review and provided these comments to the NOSB in advance of 
their review of these substances. At its November 2011 and May 2012 
meetings, the NOSB reviewed the substances shown in Table 1 under the 
2013 Sunset review. Based on its review, the NOSB provided the 
following recommendations for consideration by 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. 
The NOSB also issued second recommendations for EPA List--3 Inerts, 
cellulose, and carrageenan for the purpose of renewing their existing 
listings if carrying out the NOSB recommendations to restrict these 
substances was not feasible. Based on the NOSB recommendations, AMS 
published a proposed rule in the Federal Register (78 FR 25879) on May 
3, 2013, to address the continued use or prohibition of these 
substances on the National List in organic production and handling. 
Comments received on the proposed rule and AMS' response is addressed 
in COMMENTS RECEIVED ON PROPOSED RULE NOP-10-13PR.
    In response to the sunset provision in OFPA, this final rule 
addresses multiple recommendations submitted to the Secretary by the 
NOSB pertaining to substances due to sunset (i.e. expire) from the 
National List in 2013. In consideration of the impending Sunset date of 
November 3, 2013 for these substances, the information available, the 
requirements of OFPA, and the need to look at the potential impacts on 
small businesses, this final rule renews, without change, multiple 
exemptions (uses) and a prohibition on the National List (along with 
any restrictive annotations) for 5 years. A list of these substances 
and AMS' actions are provided in Table 1. This final rule also removes 
the exemption for one substance on the National List.
    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 May 28, 2013 (78 FR 31815).

II. Overview of Final Actions

    Table 1 provides an overview of final actions for designated 
sections of the National List. The actions pertaining to all listings 
will be effective on November 3, 2013. Pursuant to the sunset 
provisions in OFPA, the new sunset date for all listings is five years 
from the effective date of their renewal.

                               Table 1--Overview of Final Actions for Sunset 2013
----------------------------------------------------------------------------------------------------------------
     National list  section                       Substance listing                          Final action
----------------------------------------------------------------------------------------------------------------
                         Synthetic substances allowed for use in organic crop production
----------------------------------------------------------------------------------------------------------------
205.601(a)(3)..................  Copper sulfate--for use as an algicide in aquatic    Renew.
                                  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 an irrigation system cleaner   Renew.
                                  only.
205.601(a)(6)..................  Peracetic acid--for use in disinfecting equipment,   Addressed through separate
                                  seed, and asexually propagated planting              rulemaking action; see
                                  material.\1\                                         May 28, 2013 final rule
                                                                                       (78 FR 31815).
205.601(e)(4)..................  Copper sulfate--for use as tadpole shrimp control    Renew.
                                  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 use to control fire blight       Addressed through separate
                                  bacteria.\1\                                         rulemaking action; see
                                                                                       May 28, 2013 final rule
                                                                                       (78 FR 31815).
205.601(m)(2)..................  EPA List 3--Inerts of unknown toxicity--for use      Renew.
                                  only in passive pheromone dispensers..
----------------------------------------------------------------------------------------------------------------
                      Nonsynthetic substances prohibited for use in organic crop production
----------------------------------------------------------------------------------------------------------------
205.602(c).....................  Calcium chloride, brine process is natural and       Renew.
                                  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--(Rennet--animals derived; Catalase-- Renew.
                                  bovine liver; Animal lipase; Pancreatin; Pepsin;
                                  and Trypsin).
205.605(a).....................  Calcium sulfate--mined.............................  Renew.
205.605(a).....................  Carrageenan........................................  Renew.

[[Page 61156]]

 
205.605(a).....................  Glucono delta-lactone--production by the oxidation   Renew.
                                  of D-glucose with bromine water is prohibited.
205.605(a).....................  Tartaric acid--made from grape wine................  Renew.
----------------------------------------------------------------------------------------------------------------
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 regenerative casings, as an    Renew.
                                  anti-caking agent (non-chlorine bleached) and
                                  filtering aid.
----------------------------------------------------------------------------------------------------------------
205.605(b).....................  Tartaric acid--made from malic acid................  Remove.
----------------------------------------------------------------------------------------------------------------
\1\ The current annotations for peracetic acid can be found at 7 CFR Part 205.601(a)(6) and (i)(8).

Renewals

    Consistent with the NOSB recommendations and in consideration of 
the public comments received on the proposed rule (78 FR 25879), this 
final rule renews multiple listings pertaining to the National List.
    This final rule continues 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.
    This final rule continues the prohibition at section 205.602, along 
with its restrictive use annotation, for the nonsynthetic substance 
prohibited for use in organic crop production as shown in Table 1: 
calcium chloride.
    This final rule continues the exemptions at section 205.605(a), 
along with any restrictive annotations, for the 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))'' as shown in Table 1: agar-
agar, animal enzymes, carrageenan, tartaric acid--made from grape wine, 
calcium sulfate, and glucono delta-lactone.
    This final rule continues the exemption at section 205.605(b), 
along with its restrictive annotation, for the nonorganically produced 
agricultural product allowed as an ingredient in or on processed 
products labeled as ``organic'' as shown in Table 1: cellulose.

Nonrenewals

Section 205.601 Synthetic Substances Allowed for Use in Organic Crop 
Production
    The renewals for peracetic acid are not addressed in this final 
rule for Sunset 2013. Instead, AMS completed rulemaking on a 2009 NOSB 
recommendation to ensure the listings for peracetic acid on the 
National List aligned with EPA labeling requirements. This final rule 
amended the section 205.601(a)(6) and 205.601(i)(8) exemptions for 
peracetic acid on May 28, 2013 (78 FR 31815). This amendment was 
completed prior to the November 3, 2013, sunset date for peracetic 
acid; therefore, the previous listings for peracetic acid do not need 
to be renewed under this rulemaking action.
Section 205.605 Nonagricultural (Nonorganic) Substances Allowed as 
Ingredients in or on Processed Products Labeled as ``Organic'' or 
``Made With Organic (Specified Ingredients or Food Group(s))''
    This final rule amends section 205.605(b) of the National List by 
removing the exemption for the listing for tartaric acid--made from 
malic acid. This amendment is effective on November 3, 2013.

III. Related Documents

    An Advance Notice of Proposed Rulemaking (ANPR) 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 final 
rule would expire on November 3, 2013 if not reviewed by the NOSB and 
renewed by the Secretary. Substances and recommendations addressed 
through this final rule were announced for NOSB deliberations in the 
following Federal Register notices: (1) October 7, 2011 (76 FR 62336); 
and (2) April 9, 2012 (77 FR 21067). The proposal to address the 
substances in this final rule was published as a proposed rule in the 
Federal Register on May 3, 2013 (78 FR 25879).

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 http://www.ams.usda.gov/nop.

A. Executive Order 12866 and Executive Order 13563

    AMS has determined that according to the criteria defined in 
Executive Order 12866 and Executive Order 13563, this rule change is 
not a significant regulatory action. As such, the rule is not subject 
to Office of Management and Budget review.

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 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

[[Page 61157]]

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 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.
    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.\2\ 
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. There were also 10,850 certified organic 
handling operations worldwide 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.\3\
---------------------------------------------------------------------------

    \2\ U.S. Department of Agriculture, National Agricultural 
Statistics Service. October 2012. 2011 Certified Organic Productions 
Survey. http://usda01.library.cornell.edu/usda/current/OrganicProduction/OrganicProduction-10-04-2012.pdf.
    \3\ Organic Trade Association. 2012. Organic Industry Survey. 
www.ota.com.
---------------------------------------------------------------------------

    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 http://www.ams.usda.gov/nop. AMS 
believes that most of these accredited certifying agents would be 
considered small entities under the criteria established by the SBA.
    Pursuant to the requirements set forth in the RFA, AMS considered 
the economic impact of this action on small entities. The impact on 
entities affected by this final rule would not be significant. The 
effect of this final 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 synthetic substance, tartaric acid, would be minimal to 
small agricultural firms since a nonsynthetic form of tartaric acid 
from grape wine is commercially available and is the predominant form 
of this substance used in organic processed products. The allowance for 
nonsynthetic tartaric acid will 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.

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 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 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 NOP-10-13PR

    AMS received over 3,100 comments on proposed rule AMS-NOP-11-0003; 
NOP-10-13PR. Comments were received from organic crop producers, crop 
distributors, organic handlers, consumers, accredited certifying 
agents, trade associations, non-profit organizations, growers 
associations, and advocacy groups. AMS also received two comments that 
were submitted after the close of the comment period and therefore were 
not considered herein.
    Some comments presented concerns that are not within the scope of 
the sunset review action. Several comments stated their general 
opposition to the allowance of synthetics in organic production and 
some commenters restated this and specifically cited their opposition 
to all of the substances proposed for renewal in the proposed rule.
    All comments on the proposed renewal for animal enzymes, calcium 
chloride, ozone gas and tartaric acid made from grape wine were 
supportive of the action as proposed. Therefore, AMS is finalizing the 
amendments as proposed through this final rule.
    As stated in the proposed rule, the NOSB provided AMS with two 
recommendations for each of the following three substances--EPA List 3 
Inerts, carrageenan, and cellulose. The NOSB provided the two 
recommendations based on the ``Sunset Review Process'' section of the 
NOSB's

[[Page 61158]]

Policy and Procedures Manual. The first NOSB Sunset recommendation for 
each of these substances recommended new restrictions on their 
allowance in organic production or handling as follows:
    a. EPA List 3 Inerts: amend the current listing and also include an 
expiration date of October 21, 2017, after which these substances could 
not be used;
    b. carrageenan: (1) Indicate specific allowed forms of carrageenan 
by Chemical Abstracts Service (CAS) number; and (2) prohibit its use in 
organic infant formula; and
    c. cellulose: prohibit the microcrystalline form of this substance 
by specifying the forms that are allowed.
    The second NOSB recommendation for each substance recommended to 
renew the existing listings as codified. Based on our review, AMS 
proposed to implement the NOSB's second recommendations to renew the 
existing listings instead of adding new restrictions on these three 
substances. For this reason, over 2,400 comments requested the 
withdrawal of the proposed rule. The commenter's reasons for this 
request are described below in conjunction with AMS' response.
    Numerous comments asserted that the NOSB's second recommendations 
to renew EPA List 3 Inerts, carrageenan and cellulose were intended for 
the Secretary to act upon only if an unavoidable administrative delay 
makes completion of rulemaking regarding the first recommendations for 
these substances impossible before the November 3, 2013 sunset date. 
These comments state that AMS' action to implement the NOSB 
recommendations to renew on grounds other than an administrative delay 
is equivalent to a violation of OFPA. Most of these same commenters 
also stated that the NOSB first recommendations to amend the 
annotations for these three substances were based on NOSB's findings of 
unacceptable human health and environmental effects associated with 
their current allowance. Many commenters also cited that these renewals 
would constitute an addition of a synthetic substance to the National 
List by AMS, which would violate 7 U.S.C. 6517(d)(2).
    AMS disagrees with these positions. Carrageenan is listed as a 
nonsynthetic substance, and therefore its renewal could not be in 
violation of OFPA (7 U.S.C. 6517(d)(2)) because it is not a synthetic 
substance. The NOSB provided AMS with two NOSB recommendations for each 
of these substances--one to renew the listing and one to add new 
restrictions to its current use. Consistent with the provisions of 
OFPA, AMS has determined that the second recommendation in each case 
should be implemented. The proposed rule reflected AMS's independent 
review and explained in detail why accepting the NOSB's first 
recommendations to amend the annotations for EPA List 3 Inerts, 
carrageenan, and cellulose was not appropriate and, therefore, 
rulemaking action could not be implemented prior to the November 3, 
2013 sunset date. Further, AMS has collected additional feedback 
through public comment submitted in response to the proposed rule that 
supports its proposal. For these reasons, AMS is implementing the 
NOSB's second recommendations to renew these substances through this 
final rule. A summary of AMS' justification for each of the three 
substances is provided below.
EPA List 3--Inerts of Unknown Toxicity
    AMS received approximately 60 comments on the proposed action to 
renew the listing for EPA List 3 Inert ingredients. The majority of 
comments stated that AMS should not adopt the proposed rule; instead, 
the commenters supported the NOSB's first recommendation to add new 
restrictions on alternative EPA List 3 Inerts. A minority of commenters 
opposed the allowance of any synthetic materials in organic crop 
production, but did not provide information on alternative practices or 
alternative substances that may substitute for the use of EPA List 3 
inert ingredients. Two commenters supported the action as proposed by 
AMS.
    Comments that did not support the proposed action claimed that: (1) 
The proposed action violated OFPA; (2) AMS ignored an NOSB 
recommendation for EPA List 3 Inerts; and (3) the renewal of the 
listing without an expiration date would delay or prevent the NOSB 
review of inert ingredients.
    Some commenters indicated that AMS should issue a new proposed rule 
consistent with the NOSB's first recommendation for EPA List 3 Inerts. 
This recommendation included the following changes the listing for EPA 
List 3 Inerts: (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.
    In the proposed rule, AMS proposed renewal of the current listing 
for EPA List 3 Inerts, without any changes or addition of an expiration 
date. The NOSB provided two recommendations regarding EPA List 3 
Inerts, and the proposed rule, implemented as final through this 
action, aligns with the second recommendation, which meets the 
requirements under OFPA. As stated in the proposed rule, AMS recognizes 
the intent of the NOSB to address the complex challenges presented by 
the out-of-date listings for EPA List 3 and EPA List 4 Inerts in a 
timely manner. However, a rulemaking action to add an expiration date 
to the listing for EPA List 3 Inerts as part of the Sunset Review would 
not be appropriate if the timeline for the ongoing NOSB Inerts review 
takes longer than projected.
    One commenter noted that the NOSB's expiration date should not be 
problematic because there is only a small number of EPA List 3 
materials to review before October 2017 and that NOP and NOSB could 
prioritize this work. Other commenters indicated that the intent of the 
NOSB with its first recommendation was to ensure that inert ingredients 
are reviewed prior to October 2017.
    Currently, there is also ongoing work within the NOSB to review 
additional (e.g., EPA List 4) inert ingredients that will be addressed 
by the NOSB in other recommendations on inert ingredients. The NOSB, as 
part of an Inerts Working Group, is in the process of establishing 
reviews for all inert ingredients in pesticides used in organic 
production. These include former EPA List 3 and EPA List 4 Inerts. The 
overall review of inerts represents a larger number of substances than 
that which was indicated by one of the commenters. Given these 
circumstances, it is appropriate to accept the NOSB's second 
recommendation so that the NOSB has sufficient time to address inert 
ingredients and make additional recommendations.
    One commenter supported the proposed relisting of EPA List 3 Inerts 
as proposed by AMS and noted that the expiration date of October 21, 
2017 was arbitrary given that the NOSB review of inert ingredients may 
not complete by that date. The commenter noted that the expiration in 
2017 would have detrimental impacts on organic operators and input 
suppliers. AMS agrees with the commenter and is not adding the 2017 
expiration date to the EPA List 3 Inerts listing for this reason.

[[Page 61159]]

    One commenter suggested that AMS adopt the renewed listing as an 
interim rule, and secondarily ask the NOSB to reconsider the sunset 
extension based on the specific agency concerns. AMS has not adopted 
this suggestion. The NOSB should continue its review of EPA List 3 
Inerts under its current process for reviewing Inerts, rather than 
redirect its efforts to provide additional support for its previous 
sunset recommendation to change the listing in advance of completion of 
this work.
    In summary, after consideration of the recommendation and the 
comments received, AMS is implementing the second NOSB recommendation 
to renew the existing listing for EPA List 3 Inerts through this final 
rule as proposed.
Carrageenan
    AMS received approximately 130 comments specific to the proposed 
action to renew the existing listing for carrageenan. The majority of 
comments stated that AMS should not adopt the proposed rule; instead, 
the commenters supported either the NOSB's first recommendation to 
prohibit the use of carrageenan in infant formula and add CAS numbers 
or a prohibition of the use of the substance in organic processed 
products altogether. AMS also received a comment from a non-profit 
organization which had gathered over 14,000 signatures in support of 
removing carrageenan from the National List. Approximately 40 
commenters supported the action as proposed.
    Comments that did not support the proposed action claimed that: (1) 
Carrageenan in food and infant formula is not safe for human 
consumption; and (2) the proposed action is not based on sound science. 
One commenter stated that he had submitted two petitions to the FDA 
requesting (1) that the food additive regulations be amended to 
prohibit the use of carrageenan in infant formula; and (2) that the FDA 
designation of ``Generally recognized as safe'' (GRAS) for carrageenan 
in infant formula be reconsidered.
    Prior to the May 2012 NOSB meeting, the Handling Subcommittee 
conducted a review of past NOSB recommendations, technical reports, 
historical documents, and public comments and concluded that the 
available information indicates that the substance is essential for 
organic production, is compatible with organic production practices, 
and does not reveal unacceptable risks to the environment, human, or 
animal health as a result of its use or manufacture.\4\ Neither the 
Handling Subcommittee proposal submitted prior to the NOSB meeting nor 
the full NOSB issued a recommendation stating that carrageenan use in 
food should be prohibited.\5\ AMS concurs with this determination.
---------------------------------------------------------------------------

    \4\ Handling Subcommittee Proposal on Carrageenan. February, 21, 
2012. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5097825&acct=nosb.
    \5\ NOSB Recommendation on Carrageenan. May 25, 2012. Available 
at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5098921.
---------------------------------------------------------------------------

    Both commenters and the FDA have identified many deficiencies in 
the literature regarding the gastrointestinal toxicity of carrageenan, 
concluding there is no information clearly demonstrating that there is 
evidence for a carcinogenic effect for food grade carrageenan use in 
foods or infant formula. Other commenters stated that subsequent 
research has continued to support the conclusion that food grade 
carrageenan is safe. AMS conducted an independent review which included 
consultation with the FDA to gain a detailed understanding of the 
relevant regulations allowing for the use of carrageenan in foods or 
infant formula. The FDA, as the food safety authority in the U.S., 
maintains that carrageenan is safe for use in foods and infant formulas 
as codified. If in the future the FDA does issue a finding supporting a 
prohibition of carrageenan in any or all foods, AMS will take 
appropriate action, if needed, to come into alignment with this 
finding. A request to amend the annotation for this substance or remove 
it from the National List would require a petition to the NOSB.
    In summary, the NOSB provided two recommendations regarding 
carrageenan, and the proposed rule aligns with the second 
recommendation, which meets the requirements under OFPA. After 
consideration of the recommendation and the comments received, AMS has 
determined that it is appropriate to accept the NOSB's second 
recommendation and renew the listing for carrageenan through this final 
rule as proposed.
Cellulose
    AMS received approximately 20 comments on the proposed action 
specific to cellulose. Roughly half of these comments opposed the 
proposed action. These statements concurred with the NOSB's first 
recommendation that contrary to the powdered form of cellulose, the 
microcrystalline form of cellulose is a heavily processed substance and 
the impacts of its use would be incompatible with organic production. 
One commenter requested that USDA evaluate the data concerning 
availability of nonsynthetic and organic forms of cellulose for these 
uses, including organic rice concentrate, and for USDA to exercise its 
authority to develop a more restrictive standard in this case. Another 
commenter asked that AMS consider restricting the use of 
microcrystalline cellulose in future rulemaking. The remaining public 
comments supported the proposed action but did not state whether they 
used or supported the use of microcrystalline cellulose. To date, AMS 
has not received information to indicate that the organic industry is 
using the microcrystalline form of cellulose; however, AMS has not 
completed its research of this topic and needs more information from 
the industry to confirm that the microcrystalline form of cellulose is 
not currently in use in organic processed products and will consider a 
restriction on its use for future rulemaking.
    The NOSB provided two recommendations regarding cellulose, which 
meets the requirements under OFPA. Consistent with the NOSB's second 
recommendation, AMS is renewing listing for cellulose through this 
final rule as proposed.
    Other comments suggesting changes to the proposed rule for other 
substances under sunset review are described below in conjunction with 
AMS' response, including any amendments that will be addressed through 
this final rule. Some commenters requested changes to substance 
annotations which were either different from the NOSB recommendation or 
would result in the expanded use of an exempted material. Such requests 
would require a petition to the NOSB, which can be initiated in 
accordance with the Notice of Guidelines on Procedures for Submitting 
National List Petitions (72 FR 2167).
Copper Sulfate
    The Crops Subcommittee put forth a proposal prior to the Fall 2011 
NOSB meeting to further restrict the use of copper sulfate. The 
proposal stated that conversations with rice growers led them to 
believe that cultural practices (drill-seeding) would eliminate the 
need for copper sulfate use except in particular weather conditions. 
AMS received one comment stating that the use of copper sulfate in 
organic rice production is inconsistent with organic agricultural 
practices. This comment stated that the Crops Subcommittee proposal for 
placing further restrictions on the use of this substance was well-
supported with evidence illustrating that copper products are toxic to 
aquatic

[[Page 61160]]

organisms. The NOSB deliberated on the available information as well as 
written and in-person public comment on copper sulfate at the November 
29-December 2, 2011 NOSB meeting in Savannah, GA. At this meeting, the 
Crops Subcommittee revised its proposal on the grounds that prescribing 
specific cultural practices within the annotation would be duplicative 
of the organic system plan requirements of the USDA organic 
regulations. As a result, the Crops Subcommittee put forward a motion 
to renew the current listing that received a unanimous vote of support. 
The Crops Subcommittee also requested that alternatives for copper 
sulfate in rice production be added to the next Materials Subcommittee 
Research Priorities proposal.\6\ The Crops Subcommittee's proposal was 
recommended by the full NOSB.
---------------------------------------------------------------------------

    \6\ The topic of ``Copper sulfate in rice production'' was 
included in the Materials Subcommittee's August 17, 2012 Proposal 
for Research Priorities for 2012. Available at the NOP Web site: 
http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5101295.
---------------------------------------------------------------------------

    AMS also received one comment stating that the current annotation 
for copper sulfate should be amended to change its listing from limited 
use of once per a 24-month period for rice shrimp control to allowing 
its use to be dependent upon the weather conditions that induce the 
growth of algae (also called scum) and rice shrimp. The commenter 
suggested the annotation should be amended to match the listing for 
fixed coppers at section 205.601(i), which allows the substance to be 
``used in a manner that minimizes accumulation of copper in the soil 
and shall not be used as herbicides.'' Commenter requests for changes 
to listings that would result in the expanded use or removal of an 
exempted material and would need to be petitioned and reviewed by the 
NOSB.
    Consistent with the NOSB's recommendation, AMS is renewing listing 
for copper sulfate through this final rule as proposed.
Animal Enzymes
    Eleven commenters submitted statements of support for the continued 
allowance of animal enzymes in organic handling and processing. 
Consistent with the NOSB's recommendation, AMS is renewing listing for 
animal enzymes through this final rule as proposed.
Agar-Agar
    The Handling Subcommittee's put forth a proposal prior to the Fall 
2011 NOSB meeting to relist agar-agar as a nonsynthetic on section 
205.605(a) and add an additional listing as a synthetic on section 
205.605(b). The Subcommittee based this proposal on information 
obtained from the most recent technical report. This report indicated 
that there are certain processing methods for agar-agar that would 
result in a chemical change that would render it synthetic. The 
Subcommittee then determined that it would withdraw the proposal to 
reclassify agar-agar and asked that the NOP revisit the classification 
of this substance following the publication of final guidance on the 
classification of materials.\7\ The NOSB then recommended to renew 
agar-agar as listed on section 205.605(a).
---------------------------------------------------------------------------

    \7\ U.S. Department of Agriculture. ``National Organic Program: 
Notice of Draft Guidance on Classification of Materials and 
Materials for Organic Crop Production.'' 78 Federal Register 63 
(April 2, 2013), pp. 19637-19638. Available at the NOP Web site: 
http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5103326.
---------------------------------------------------------------------------

    AMS received one comment which supported the Handling 
Subcommittee's proposal. AMS also received one comment in support for 
the continued allowance of agar-agar based on its physical properties 
that enable it to act as a replacement for gelatin in vegetarian 
formulations of processed products.
    Consistent with the NOSB's recommendation, AMS is renewing listing 
for agar-agar through this final rule as proposed.
Calcium Sulfate
    AMS received one comment requesting that the listing for calcium 
sulfate be restricted to use only as a coagulant for bean curd on the 
grounds that there was not sufficient evidence for its essentiality for 
the production of other processed products. The Handling Subcommittee 
conducted a review of past NOSB recommendations, technical reports, 
historical documents, and public comments and concluded that the 
available information indicates that the substance is essential for 
organic production, is compatible with organic production practices, 
and does not reveal unacceptable risks to the environment, human, or 
animal health as a result of its use or manufacture. AMS concurs with 
this determination.
    AMS also received one comment in support of the continued allowance 
of calcium sulfate as an aid in developing the texture of bean curd for 
the production of firm tofu. Another commenter stated that calcium 
sulfate allows them to produce a desired texture and flavor of tofu 
that is not achievable with alternative ingredients.
    Consistent with the NOSB's recommendation, AMS is renewing listing 
for calcium sulfate through this final rule as proposed.
Glucono Delta-Lactone
    AMS received one comment requesting that the listing for glucono 
delta-lactone be restricted to use only as a coagulant in bean curd on 
the grounds that there was not sufficient evidence for its essentiality 
for the production of other processed products. The Handling 
Subcommittee's review of previous technical reports, NOSB 
recommendations, historical documents, and public comments and 
concluded that the available information indicates that the substance 
is essential for organic production, is compatible with organic 
production practices, and does not reveal unacceptable risks to the 
environment, human, or animal health as a result of its use or 
manufacture.\8\ The NOSB's recommendation stated that there is no new 
information contradicting the original recommendation which was the 
basis for the previous NOSB decisions to list and again re-list this 
material, and no public comments were submitted that provided any 
information to the contrary.
---------------------------------------------------------------------------

    \8\ Handling Subcommittee Proposal on Glucono Delta-Lactone. 
March 20, 2012. Available at the NOP Web site: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5097826&acct=nosb.
---------------------------------------------------------------------------

    Consistent with the NOSB's recommendation, AMS is renewing listing 
for glucono delta-lactone through this final rule as proposed.
Tartaric Acid (Made From Malic Acid)
    There were two comments submitted from a trade association, one of 
which supported the proposed action, and the other did not support the 
proposed action. Another two comments on the proposed removal of 
tartaric acid made from malic acid were not supportive of the proposed 
action. There were no comments submitted that provided information 
justifying their position.
    Consistent with the NOSB's recommendation, AMS is removing the 
listing for tartaric acid made from malic acid through this final rule 
as proposed.

G. Effective Date

    This final rule reflects recommendations submitted to the Secretary 
by the NOSB for the purpose of fulfilling the requirements of 7 U.S.C. 
6517(e) of the OFPA. OFPA requires the NOSB to review each substance on 
the National List within 5 years of its adoption or review (7 U.S.C. 
6517(e)). The substances reauthorized for use on the National List were 
most recently

[[Page 61161]]

authorized for use in organic agriculture on November 3, 2008. Because 
these substances are critical to organic production and handling 
operations, producers and handlers should be able to continue to use 
these substances for a full 5-year period beyond their sunset date of 
November 3, 2013. Accordingly, pursuant to 5 U.S.C. 553, it is found 
and determined that good cause exists for not postponing the effective 
date of this rule until 30 days after publication in the Federal 
Register. This rule shall be effective on 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.


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

    Dated: September 30, 2013.
Rex A. Barnes,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2013-24208 Filed 10-2-13; 8:45 am]
BILLING CODE 3410-02-P