Federal Register, Volume 78 Issue 192 (Thursday, October 3, 2013)

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

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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.

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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))''
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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\
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\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.
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In addition, the USDA has 84 accredited certifying agents who
provide certification services to producers and handlers. A complete
list of names and addresses of accredited certifying agents may be
found on the AMS NOP Web site, at 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.
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\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.
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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.
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\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).
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\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