National Organic Program (NOP); Sunset Review (2013), 61154-61161 [2013-24208]
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Federal Register / Vol. 78, No. 192 / Thursday, October 3, 2013 / Rules and Regulations
post-employment restrictions of 18
U.S.C. 207(c) and (f) if the rate of basic
pay for the position is equal to or greater
than 86.5 percent of the rate of basic pay
payable for level II of the Executive
Schedule.
As stated in 5 CFR 2641.301(j)(3)(ii),
the Director of OGE is required to
‘‘maintain a listing of positions or
categories of positions in Appendix A to
[5 CFR part 2641] for which the 18
U.S.C. 207(c) restriction has been
waived.’’ As such, Appendix A of this
part is being amended to remove
references to those SEC positions that
are no longer exempt from the
restrictions of 18 U.S.C. 207(c) and (f).
These positions include: Solicitor,
Office of General Counsel; Chief
Litigation Counsel, Division of
Enforcement; Deputy Chief Litigation
Counsel, Division of Enforcement; SK–
17 Positions; SK–16 and lower-graded
SK positions supervised by employees
in SK–17 positions; and SK–16 and
lower-graded SK positions not
supervised by employees in SK–17
positions.
I. Matters of Regulatory Procedure
Administrative Procedure Act
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Under 5 U.S.C. 553(a)(2), rules
relating to agency management or
personnel are exempt from the notice
and comment rulemaking requirements
of the Administrative Procedure Act
(APA). Further, under 5 U.S.C.
553(b)(3)(A), notice and comment
rulemaking requirements do not apply
to rules concerning matters of agency
organization, procedure, or practice.
Given that this rule concerns matters of
agency management or personnel, and
organization, procedure, or practice, the
notice and comment requirements of the
APA do not apply here. Even if this
rulemaking were subject to APA
proposed rulemaking procedures, OGE
finds good cause pursuant to 5 U.S.C.
553(b)(3)(B), to waive the notice and
comment requirements of the APA. The
codification of OGE’s revocation of
exempted positions is technical in
nature, and it is important and in the
public interest that the codification of
OGE’s revocation of exempted positions
be published in the Federal Register as
promptly as possible. For these reasons,
OGE is issuing this regulation as a final
rule effective 90 days after publication.
Regulatory Flexibility Act
As Director of the Office of
Government Ethics, I certify under the
Regulatory Flexibility Act (5 U.S.C.
chapter 6) that this final rule would not
have a significant economic impact on
a substantial number of small entities
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because it primarily affects current and
former Federal executive branch
employees.
Paperwork Reduction Act
The Paperwork Reduction Act (44
U.S.C. chapter 35) does not apply
because this regulation does not contain
information collection requirements that
require approval of the Office of
Management and Budget.
Unfunded Mandates Reform Act
For purposes of the Unfunded
Mandates Reform Act of 1995 (2 U.S.C.
chapter 5, subchapter II), this final rule
would not significantly or uniquely
affect small governments and will not
result in increased expenditures by
State, local, and tribal governments, in
the aggregate, or by the private sector, of
$100 million or more (as adjusted for
inflation) in any one year.
Executive Order 12866
In promulgating this final rule, the
Office of Government Ethics has
adhered to the regulatory philosophy
and the applicable principles of
regulation set forth in section 1 of
Executive Order 12866, Regulatory
Planning and Review. This rule has not
been reviewed by the Office of
Management and Budget under that
Executive order since it deals with
agency organization, management, and
personnel matters and is not
‘‘significant’’ under the order.
Executive Order 12988
As Director of the Office of
Government Ethics, I have reviewed this
final rule in light of section 3 of
Executive Order 12988, Civil Justice
Reform, and certify that it meets the
applicable standards provided therein.
List of Subjects in 5 CFR Part 2641
Conflict of interests, Government
employees.
Approved: September 19, 2013.
Walter M. Shaub, Jr.,
Director, Office of Government Ethics.
Accordingly, for the reasons set forth
in the preamble, the Office of
Government Ethics is amending part
2641 of subchapter B of chapter XVI of
title 5 of the Code of Federal
Regulations as follows:
PART 2641—POST-EMPLOYMENT
CONFLICT OF INTEREST
RESTRICTIONS
1. The authority citation for part 2641
continues to read as follows:
■
Authority: 5 U.S.C. App. (Ethics in
Government Act of 1978); 18 U.S.C. 207; E.O.
12674, 54 FR 15159, 3 CFR, 1989 Comp., p.
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215, as modified by E.O. 12731, 55 FR 42547,
3 CFR, 1990 Comp., p. 306.
2. Effective January 2, 2014, Appendix
A to part 2641 is amended by removing
the listing for the Securities and
Exchange Commission (and all positions
thereunder).
■
[FR Doc. 2013–23346 Filed 10–2–13; 8:45 am]
BILLING CODE 6345–03–P
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)
Agricultural Marketing Service,
USDA.
ACTION: Final rule.
AGENCY:
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:
SUMMARY:
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
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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
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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 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.
Renew.
205.601(a)(5) ....
205.601(a)(6) ....
Ozone gas—for use as an irrigation system cleaner only ..................................................
Peracetic acid—for use in disinfecting equipment, seed, and asexually propagated
planting material.1
205.601(e)(4) ....
205.601(i)(8) .....
Copper sulfate—for use as tadpole shrimp control in aquatic rice production, is limited
to one application per field during any 24-month period. Application rates are limited
to levels which do not increase baseline soil test values for copper over a timeframe
agreed upon by the producer and accredited certifying agent.
Peracetic acid—for use to control fire blight bacteria.1
Renew.
Addressed through separate rulemaking action; see May 28,
2013 final rule (78 FR 31815).
Renew.
205.601(m)(2) ...
EPA List 3—Inerts of unknown toxicity—for use only in passive pheromone dispensers.
Addressed through separate rulemaking action; see May 28,
2013 final rule (78 FR 31815).
Renew.
Nonsynthetic substances prohibited for use in organic crop production
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205.602(c) .........
Calcium chloride, brine process is natural and prohibited for use except as a foliar spray
to treat a physiological disorder associated with calcium uptake.
Renew.
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) .........
205.605(a) .........
205.605(a) .........
205.605(a) .........
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Agar-agar .............................................................................................................................
Animal enzymes—(Rennet—animals derived; Catalase—bovine liver; Animal lipase;
Pancreatin; Pepsin; and Trypsin).
Calcium sulfate—mined ......................................................................................................
Carrageenan ........................................................................................................................
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Renew.
Renew.
Renew.
Renew.
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TABLE 1—OVERVIEW OF FINAL ACTIONS FOR SUNSET 2013—Continued
National list
section
Substance listing
205.605(a) .........
Glucono delta-lactone—production by the oxidation of D-glucose with bromine water is
prohibited.
Tartaric acid—made from grape wine .................................................................................
205.605(a) .........
Final action
Renew.
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 anti-caking agent (non-chlorine
bleached) and filtering aid.
Renew.
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: agaragar, animal enzymes, carrageenan,
tartaric acid—made from grape wine,
calcium sulfate, and glucono deltalactone.
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.
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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
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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
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amendments to the National List based
on proposed amendments developed by
the NOSB. Sections 6518(k)(2) and
6518(n) of OFPA authorize the NOSB to
develop proposed amendments to the
National List for submission to the
Secretary and establish a petition
process by which persons may petition
the NOSB for the purpose of having
substances evaluated for inclusion on or
deletion from the National List. The
National List petition process is
implemented under section 205.607 of
the USDA organic regulations. The
current petition process was published
on January 18, 2007 (72 FR 2167) and
can be accessed through the NOP Web
site at https://www.ams.usda.gov/nop.
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
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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
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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 nonfood 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
In addition, the USDA has 84
accredited certifying agents who
provide certification services to
producers and handlers. A complete list
of names and addresses of accredited
certifying agents may be found on the
AMS NOP Web site, at https://
www.ams.usda.gov/nop. AMS believes
that most of these accredited certifying
agents would be considered small
entities under the criteria established by
the SBA.
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
2 U.S. Department of Agriculture, National
Agricultural Statistics Service. October 2012. 2011
Certified Organic Productions Survey. https://
usda01.library.cornell.edu/usda/current/
OrganicProduction/OrganicProduction-10-042012.pdf.
3 Organic Trade Association. 2012. Organic
Industry Survey. www.ota.com.
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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
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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
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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
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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.
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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
4 Handling Subcommittee Proposal on
Carrageenan. February, 21, 2012. Available at the
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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.
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
NOP Web site: https://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: https://
www.ams.usda.gov/AMSv1.0/
getfile?dDocName=STELPRDC5098921.
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61159
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 wellsupported with evidence illustrating
that copper products are toxic to aquatic
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Federal Register / Vol. 78, No. 192 / Thursday, October 3, 2013 / Rules and Regulations
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.
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.
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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
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: https://
www.ams.usda.gov/AMSv1.0/
getfile?dDocName=STELPRDC5101295.
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15:47 Oct 02, 2013
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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).
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.
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: https://www.ams.usda.gov/AMSv1.0/
getfile?dDocName=STELPRDC5103326.
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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.
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
8 Handling Subcommittee Proposal on Glucono
Delta-Lactone. March 20, 2012. Available at the
NOP Web site: https://www.ams.usda.gov/AMSv1.0/
getfile?dDocName=STELPRDC5097826&acct=nosb.
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Federal Register / Vol. 78, No. 192 / Thursday, October 3, 2013 / Rules and Regulations
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
1. The authority citation for 7 CFR
part 205 continues to read as follows:
■
Authority: 7 U.S.C. 6501–6522.
2. Section 205.605 is amended by
removing the entry ‘‘Tartaric acid—
made from malic acid’’ from paragraph
(b).
■
Federal Aviation
Administration (FAA), DOT.
ACTION: Final rule.
Examining the AD Docket
You may examine the AD docket on
the Internet at https://
www.regulations.gov; or in person at the
Docket Management Facility between 9
a.m. and 5 p.m., Monday through
Friday, except Federal holidays. The AD
docket contains this AD, the regulatory
evaluation, any comments received, and
other information. The address for the
Docket Office (phone: 800–647–5527) is
Document Management Facility, U.S.
Department of Transportation, Docket
Operations, M–30, West Building
Ground Floor, Room W12–140, 1200
New Jersey Avenue SE., Washington,
DC 20590.
FOR FURTHER INFORMATION CONTACT:
Nenita Odesa, Aerospace Engineer,
Airframe Branch, ANM–120L, FAA, Los
Angeles Aircraft Certification Office,
3960 Paramount Boulevard, Lakewood,
CA 90712–4137; phone: (562) 627–5234;
fax: (562) 627–5210; email:
nenita.odesa@faa.gov.
SUPPLEMENTARY INFORMATION:
We are adopting a new
airworthiness directive (AD) for certain
The Boeing Company Model DC–10–10
and MD–10–10F airplanes. This AD was
prompted by a report that the safe life
Discussion
We issued a notice of proposed
rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would
apply to the specified products. The
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
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2012–0680; Directorate
Identifier 2011–NM–247–AD; Amendment
39–17602; AD 2013–19–20]
RIN 2120–AA64
Airworthiness Directives; The Boeing
Company Airplanes
AGENCY:
sroberts on DSK5SPTVN1PROD with RULES
limit on certain main landing gear
(MLG) upper torque link bolts is
reduced significantly due to those bolts
being fabricated from bar stock with a
machined head instead of from a forged
blank with an upset head. This AD
requires replacing certain MLG upper
torque link bolts with new or
serviceable parts. We are issuing this
AD to prevent damage to the MLG and
consequent damage to airplane
structure, which could adversely affect
the airplane’s continued safe flight and
landing.
DATES: This AD is effective November 7,
2013.
The Director of the Federal Register
approved the incorporation by reference
of a certain publication listed in the AD
as of November 7, 2013.
ADDRESSES: For service information
identified in this AD, contact Boeing
Commercial Airplanes, Attention: Data
& Services Management, 3855
Lakewood Boulevard, MC D800–0019,
Long Beach, CA 90846–0001; telephone
206–544–5000, extension 2; fax 206–
766–5683; Internet https://
www.myboeingfleet.com. You may
review copies of the referenced service
information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue
SW., Renton, WA. For information on
the availability of this material at the
FAA, call 425–227–1221.
SUMMARY:
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61161
NPRM published in the Federal
Register on July 11, 2012 (77 FR 40828).
The NPRM proposed to require
replacing certain MLG upper torque link
bolts with a new or serviceable part.
Comments
We gave the public the opportunity to
participate in developing this AD. The
following presents the comments
received on the proposal (77 FR 40828,
July 11, 2012) and the FAA’s response
to each comment.
Request To Revise the Unsafe Condition
Boeing requested that we revise the
unsafe condition in the NPRM (77 FR
40828, July 11, 2012). Boeing stated that
it disagrees with the SUMMARY section of
the NPRM where it states that the safe
life limit (SLL) of the bolt is reduced
significantly due to ‘‘incorrect’’
fabrication. Boeing stated that it
approved the fabrication of the bolts
from bar stock with a machined head;
however, this did not reduce the SLL at
that point in time. Boeing stated that the
fabrication therefore is not incorrect,
and that the SLL reduction was due to
fabrication from bar stock with a
machined head.
We partially agree with Boeing’s
request. We agree that the cause of the
unsafe condition is not incorrect
fabrication.
We disagree with the commenter’s
statement that the fabrication method of
the bolt is correct because with a
reduced SLL the discrepant bolts do not
meet the type design. The correct
fabrication process of the bolt, from
forged blank with an upset forged head,
would not have reduced the SLL. We
have changed the cause of the unsafe
condition throughout this final rule to
state that the SSL of the bolt is reduced
significantly because those bolts were
‘‘fabricated from bar stock with a
machined head.’’
Request To Allow Maintenance Records
Review
FedEx requested that in paragraph (g)
of the NPRM (77 FR 40828, July 11,
2012) operators be allowed to show
compliance by a records review.
We agree with the commenter that a
review of an airplane’s maintenance
record is acceptable if the part number
of the bolt can be conclusively
determined from that review. We have
changed paragraph (g) of this final rule
accordingly.
Request To Revise Applicability of the
NPRM (77 FR 40828, July 11, 2012)
FedEx stated that paragraphs (g) and
(h) of the NPRM (77 FR 40828, July 11,
2012) state to inspect the 18 airplanes
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]]>Agencies
[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 https://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. https://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 https://www.ams.usda.gov/nop. AMS
believes that most of these accredited certifying agents would be
considered small entities under the criteria established by the SBA.
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: https://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: https://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.
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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:
https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5101295.
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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:
https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5103326.
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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.
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\8\ Handling Subcommittee Proposal on Glucono Delta-Lactone.
March 20, 2012. Available at the NOP Web site: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5097826&acct=nosb.
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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
