National Organic Program (NOP); Sunset Review (2011), 46595-46597 [2011-19659]
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46595
Rules and Regulations
Federal Register
Vol. 76, No. 149
Wednesday, August 3, 2011
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS–TM–07–0136; TM–
07–14FR]
RIN 0581–AC77
National Organic Program (NOP);
Sunset Review (2011)
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) on November 5, 2009, and April
29, 2010. The recommendations
addressed in this final rule pertain to
the continued exemption (use) of 12
substances in organic production and
handling. Consistent with the
recommendations from the NOSB, this
final rule continues the exemption (use)
of 12 substances (along with any
restrictive annotations) on the U.S.
Department of Agriculture’s (USDA)
National List of Allowed and Prohibited
Substances (National List).
DATES: Effective Date: This final rule
becomes effective September 12, 2011.
FOR FURTHER INFORMATION CONTACT:
Melissa Bailey, PhD, Director, Standards
Division, Telephone: (202) 720–3252;
Fax: (202) 205–7808.
SUPPLEMENTARY INFORMATION:
SUMMARY:
srobinson on DSK4SPTVN1PROD with RULES
I. Background
The Organic Foods Production Act of
1990 (OFPA), 7 U.S.C. 6501 et seq.,
authorizes the establishment of the
National List of Allowed and Prohibited
Substances (National List). The National
List identifies synthetic substances that
may be used in organic production and
nonsynthetic (natural) substances that
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Jkt 223001
are prohibited in organic crop and
livestock production. The National List
also identifies nonagricultural
nonsynthetic, nonagricultural synthetic
and nonorganic agricultural substances
that may be used in organic handling.
The exemptions and prohibitions
granted under the OFPA are required to
be reviewed every 5 years by the
National Organic Standards Board
(NOSB). The Secretary of Agriculture
has authority under the OFPA to renew
such exemptions and prohibitions. If
they are not reviewed by the NOSB
within 5 years of their inclusion on the
National List and renewed by the
Secretary, their authorized use or
prohibition expires. This means that
synthetic substances Hydrogen chloride
(CAS # 7647–01–0) and Ferric
phosphate (CAS # 10045–86–0),
currently allowed for use in organic
crop production, will no longer be
allowed for use after the sunset date,
September 12, 2011. This also means
that Egg white lysozyme (CAS # 9001–
63–2), L-Malic acid (CAS # 97–67–6),
Microorganisms, Activated charcoal
(CAS #s 7440–44–0; 64365–11–3),
Cyclohexylamine (CAS # 108–91–8),
Diethylaminoethanol (CAS # 100–37–8),
Octadecylamine (CAS # 124–30–1),
Peracetic acid/Peroxyacetic acid (CAS #
79–21–0), Sodium acid pyrophosphate
(CAS # 7758–16–9), and Tetrasodium
pyrophosphate (CAS # 7722–88–5),
currently allowed for use in organic
handling, will no longer be allowed for
use after the sunset date, September 12,
2011.
This final rule reflects
recommendations submitted to the
Secretary by the NOSB concerning the
continued use of 12 substances on the
National List in organic production and
handling. Consistent with the
recommendations from the NOSB, this
final rule renews 12 exemptions on the
National List (along with any restrictive
annotations).
Under the authority of the OFPA, as
amended (7 U.S.C. 6501 et seq.), the
National List can be amended by the
Secretary based on recommendations
developed by the NOSB. Since
established, the NOP has published
fourteen amendments to the National
List: October 31, 2003 (68 FR 61987);
November 3, 2003 (68 FR 62215);
October 21, 2005 (70 FR 61217); June 7,
2006 (71 FR 32803); September 11, 2006
(71 FR 53299); June 27, 2007 (72 FR
PO 00000
Frm 00001
Fmt 4700
Sfmt 4700
35137); October 16, 2007 (72 FR 58469);
December 10, 2007 (72 FR 69569);
December 12, 2007 (72 FR 70479);
September 18, 2008 (73 FR 54057);
October 9, 2008 (73 FR 59479); July 6,
2010 (75 FR 38693); August 24, 2010 (75
FR 51919); and December 13, 2010 (75
FR 77521). Additionally, proposed
amendments to the National List were
published on November 8, 2010 (75 FR
68505), and a final rule affirming a
previous amendment was published on
March 14, 2011 (76 FR 13504).
II. Overview of Renewals
The following provides an overview
of the renewals for designated sections
of the National List regulations:
Renewals
This final rule continues the
exemptions at § 205.601, along with any
restrictive annotations for the following
synthetic substances allowed for use in
organic crop production: Ferric
phosphate (CAS # 10045–86–0); and
Hydrogen chloride (CAS # 7647–01–0).
This final rule continues the exemptions
at § 205.605(a), along with any
restrictive annotations, for the following
nonsynthetic, nonagricultural
(nonorganic) substances allowed as
ingredients in or on processed products
labeled as ‘‘organic’’ or ‘‘made with
organic (specified ingredients or food
groups(s))’’: Egg white lysozyme (CAS #
9001–63–2); L-Malic acid (CAS # 97–
67–6); and Microorganisms. This final
rule continues the exemptions at
§ 205.605(b), along with any restrictive
annotations, for the following synthetic,
nonagricultural (nonorganic) substances
allowed as ingredients in or on
processed products labeled as ‘‘organic’’
or ‘‘made with organic (specified
ingredients or food groups(s))’’:
Activated charcoal (CAS #s 7440–44–0;
64365–11–3); Cyclohexylamine (CAS #
108–91–8); Diethylaminoethanol (CAS #
100–37–8); Octadecylamine (CAS #
124–30–1); Peracetic acid/Peroxyacetic
acid (CAS # 79–21–0); Sodium acid
pyrophosphate (CAS # 7758–16–9); and
Tetrasodium pyrophosphate (CAS #
7722–88–5).
Nonrenewals
The NOSB determined that a
continuing need was demonstrated for
the authorization of the 12 exemptions.
In addition, most comments received on
the proposed rule (76 FR 2880)
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03AUR1
46596
Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Rules and Regulations
supported renewal of all 12 exemptions.
Accordingly, there are no nonrenewals.
III. Related Documents
One advanced notice of proposed
rulemaking with request for comments
was published in the Federal Register
on March 14, 2008 (73 FR 13795), to
make the public aware that the
allowance for 12 synthetic and
nonsynthetic substances in organic
production and handling will expire, if
not reviewed by the NOSB and renewed
by the Secretary. The proposed rule for
this final rule was published in the
Federal Register on January 4, 2011 (76
FR 288).
IV. Statutory and Regulatory Authority
The OFPA, as amended (7 U.S.C. 6501
et seq.), 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 § 205.607
of the NOP regulations. The current
petition process (72 FR 2167, January
18, 2007) can be accessed through the
NOP Web site at http://
www.ams.usda.gov/AMSv1.0/.
srobinson on DSK4SPTVN1PROD with RULES
A. Executive Order 12866
This action has been determined not
significant for purposes of Executive
Order 12866, and therefore, has not
been reviewed by the Office of
Management and Budget.
B. Executive Order 12988
Executive Order 12988 instructs each
executive agency to adhere to certain
requirements in the development of new
and revised regulations in order to avoid
unduly burdening the court system.
This final rule is not intended to have
a retroactive effect.
States and local jurisdictions are
preempted under the OFPA from
creating programs of accreditation for
private persons or State officials who
want to become certifying agents of
organic farms or handling operations. A
governing State official would have to
apply to USDA to be accredited as a
certifying agent, as described in
§ 2115(b) of the OFPA (7 U.S.C.
6514(b)). States are also preempted
under §§ 2104 through 2108 of the
OFPA (7 U.S.C. 6503 through 6507)
from creating certification programs to
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16:09 Aug 02, 2011
Jkt 223001
certify organic farms or handling
operations unless the State programs
have been submitted to, and approved
by, the Secretary as meeting the
requirements of the OFPA.
Pursuant to § 2108(b)(2) of the 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 the OFPA, (b)
not be inconsistent with the OFPA, (c)
not be discriminatory toward
agricultural commodities organically
produced in other States, and (d) not be
effective until approved by the
Secretary.
Pursuant to § 2120(f) of the OFPA (7
U.S.C. 6519(f)), this final rule would not
alter the authority of the Secretary
under the Federal Meat Inspection Act
(21 U.S.C. 601 et seq.), the Poultry
Products Inspections Act (21 U.S.C. 451
et seq.), or the Egg Products Inspection
Act (21 U.S.C. 1031 et seq.), 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 et seq.), nor the authority
of the Administrator of EPA under the
Federal Insecticide, Fungicide and
Rodenticide Act (7 U.S.C. 136 et seq.).
Section 2121 of the 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. The OFPA also provides that
the U.S. District Court for the district in
which a person is located has
jurisdiction to review the Secretary’s
decision.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA)
(5 U.S.C. 601–612) requires agencies to
consider the economic impact of each
rule on small entities and evaluate
alternatives that would accomplish the
objectives of the rule without unduly
burdening small entities or erecting
barriers that would restrict their ability
to compete in the market. The purpose
is to fit regulatory actions to the scale of
businesses subject to the action. Section
605 of the RFA allows an agency to
certify a rule, in lieu of preparing an
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analysis, if the rulemaking is not
expected to have a significant economic
impact on a substantial number of small
entities.
Pursuant to the requirements set forth
in the RFA, the AMS performed an
economic impact analysis on small
entities in the final rule published in the
Federal Register on December 21, 2000
(65 FR 80548). The AMS has also
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.
The AMS concludes that the economic
impact of this addition of allowed
substances, if any, would be minimal
and beneficial to small agricultural
service firms. Accordingly, USDA
certifies that this rule will not have a
significant economic impact on a
substantial number of small entities.
Small agricultural service firms,
which include producers, handlers, and
accredited certifying agents, have been
defined by the Small Business
Administration (SBA) (13 CFR 121.201)
as those having annual receipts of less
than $7,000,000 and small agricultural
producers are defined as those having
annual receipts of less than $750,000.
According to USDA, Economic
Research Service (ERS) data based on
information from USDA-accredited
certifying agents, the number of certified
U.S. organic crop and livestock
operations totaled nearly 13,000 and
certified organic acreage exceeded 4.8
million acres in 2008.1 ERS, based upon
the list of certified operations
maintained by the NOP, estimated the
number of certified handling operations
was 3,225 in 2007.2 AMS believes that
most of these entities would be
considered small entities under the
criteria established by the SBA.
The U.S. sales of organic food and
beverages have grown from $3.6 billion
in 1997 to nearly $21.1 billion in 2008.3
The organic industry is viewed as the
fastest growing sector of agriculture,
representing over 3 percent of overall
1 U.S. Department of Agriculture, Economic
Research Service. 2009. Data Sets: U.S. Certified
Organic Farmland Acreage, Livestock Numbers and
Farm Operations, 1992–2008. http://
www.ers.usda.gov/Data/Organic/
2 U.S. Department of Agriculture, Economic
Research Service, 2009. Data Sets: Procurement and
Contracting by Organic Handlers: Documentation.
http://www.ers.usda.gov/Data/OrganicHandlers/
Documentation.htm.
3 Dimitri, C., and L. Oberholtzer. 2009. Marketing
U.S. Organic Foods: Recent Trends from Farms to
Consumers, Economic Information Bulletin No. 58,
U.S. Department of Agriculture, Economic Research
Service, http://www.ers.usda.gov/Publications/
EIB58.
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03AUR1
Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 / Rules and Regulations
food sales in 2009. Between 1990 and
2008, organic food sales historically
demonstrated a growth rate between 15
to 24 percent each year. In 2010, organic
food sales grew 7.7%.4
In addition, USDA has 94 accredited
certifying agents who provide
certification services to producers and
handlers. A complete list of names and
addresses of accredited certifying agents
may be found on the AMS NOP Web
site, at http://www.ams.usda.gov/nop.
AMS believes that most of these
accredited certifying agents would be
considered small entities under the
criteria established by the SBA.
srobinson on DSK4SPTVN1PROD with RULES
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 § 350(h) of the Paperwork
Reduction Act of 1995, 44 U.S.C. 3501,
et seq., or OMB’s implementing
regulations at 5 CFR part 1320.
E. Comments Received on Proposed
Rule AMS–TM–07–0136
AMS received nine comments on
proposed rule AMS–TM–07–0136.
Comments were received from an
organic producer, trade associations,
handlers, and private citizens. Most
comments expressed positions in
support of the 12 substances considered
under this sunset review. One
individual did not refer to subjects
within the scope of this rulemaking.
Some commenters specifically
supported substances that they promote,
represent, or rely on. A comment
submitted in support of Ferric
phosphate emphasized the importance
of the substance to reduce snail damage
on organic crops. A comment received
on Hydrogen chloride voiced that there
are no good alternatives to the use of the
substance for removal of residual lint
from ginned cottonseed, a process
necessary to facilitate mechanical
planting. A comment received on Egg
white lysozyme stated that the
substance is essential for organic wine
production. A comment submitted in
support of L-Malic acid underscored
that no alternatives exist for this
substance and stated its importance as
a processing aid for pH adjustment in
organic products. Multiple comments
received on Microorganisms
emphasized the critical need for
microorganisms in organic food
processing for production of dairy,
bread, fruit, vegetable, and meat
products. Comments received in
4 Organic Trade Association’s 2011 Organic
Industry Survey, http://www.ota.com.
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16:09 Aug 02, 2011
Jkt 223001
support of the allowance for Activated
charcoal confirmed the necessity of this
substance as a filtering aid in organic
processing. Comments submitted
supporting the allowance for the
substances Cyclohexylamine,
Diethylaminoethanol, and
Octadecylamine, all boiler water
additives, stated that these substances
are important for packaging
sterilization. Comments supporting the
use of Peracetic acid/Peroxyacetic acid
for sanitizing food contact surfaces
indicated that there are no alternative
materials with equivalent functionality.
One comment submitted in support of
Sodium acid pyrophosphate stated that
without the allowance for this substance
as a leavening agent, many organic
baked goods would no longer be
available because a satisfactory
alternative does not exist. The same
commenter also emphasized the
necessity of Tetrasodium pyrophosphate
in the manufacturing of meat analog
products to facilitate proper flow in the
extrusion process and ensure the
development of suitable product
texture. Overall, at least one comment
was received in favor of renewal for all
12 substances considered under this
sunset review.
Changes Requested But Not Made
One commenter opposed the
continued use of six of the 12
substances: Cyclohexylamine,
Diethylaminoethanol, Octadecylamine,
Peracetic acid/Peroxyacetic acid,
Sodium acid pyrophosphate, and
Tetrasodium pyrophosphate. The
commenter based their objection on the
safety of the substances as described in
the material safety data sheets (MSDS)
for each substance and recommended
removal of these substances from the
National List. However, the NOSB
reviewed these substances against the
evaluation criteria in 7 U.S.C. 6517 and
6518 of the OFPA, and found that when
these substances are used as limited by
the annotations for each substance, they
do not pose any danger to the
environment or to manufacturing
personnel or consumers. The NOSB
concluded that these substances remain
essential to organic production since no
organic alternatives exist and
recommended that the exemption for
these substances on the National List
continue. The NOP concurs with the
NOSB’s evaluation and
recommendation of these substances
and, therefore, does not find that
sufficient information was provided by
the commenter to justify the removal of
these substances from the National List.
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46597
F. 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. Section 7 U.S.C.
6517(e) requires the NOSB to review
each substance on the National List
within 5 years of its publication. The
substances being reauthorized for use on
the National List were initially
authorized for use in organic agriculture
on September 12, 2006. 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
expiration date of September 12, 2011.
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
September 12, 2011.
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.
The authority citation for 7 CFR part
205 continues to read as follows:
Authority: 7 U.S.C. 6501–6522.
Dated: July 28, 2011.
David R. Shipman,
Acting Administrator, Agricultural Marketing
Service.
[FR Doc. 2011–19659 Filed 8–2–11; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF TRANSPORTATION
Federal Aviation Administration
14 CFR Part 39
[Docket No. FAA–2010–1307; Directorate
Identifier 2010–NM–049–AD; Amendment
39–16671; AD 2011–09–09]
RIN 2120–AA64
Airworthiness Directives; Bombardier,
Inc. Model CL–600–2A12 (CL–601) and
CL–600–2B16 (CL–601–3A, CL–601–
3R, and CL–604 Variants) Airplanes
Correction
In rule document 2011–17402
appearing on page 41653–41657, in the
issue of Friday, July 15, 2011, make the
following correction:
E:\FR\FM\03AUR1.SGM
03AUR1
Agencies
[Federal Register Volume 76, Number 149 (Wednesday, August 3, 2011)]
[Rules and Regulations]
[Pages 46595-46597]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19659]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 76, No. 149 / Wednesday, August 3, 2011 /
Rules and Regulations
[[Page 46595]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS-TM-07-0136; TM-07-14FR]
RIN 0581-AC77
National Organic Program (NOP); Sunset Review (2011)
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) on November 5, 2009, and April 29, 2010. The
recommendations addressed in this final rule pertain to the continued
exemption (use) of 12 substances in organic production and handling.
Consistent with the recommendations from the NOSB, this final rule
continues the exemption (use) of 12 substances (along with any
restrictive annotations) on the U.S. Department of Agriculture's (USDA)
National List of Allowed and Prohibited Substances (National List).
DATES: Effective Date: This final rule becomes effective September 12,
2011.
FOR FURTHER INFORMATION CONTACT: Melissa Bailey, PhD, 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 et
seq., authorizes the establishment of the National List of Allowed and
Prohibited Substances (National List). The National List identifies
synthetic substances that may be used in organic production and
nonsynthetic (natural) substances that are prohibited in organic crop
and livestock production. The National List also identifies
nonagricultural nonsynthetic, nonagricultural synthetic and nonorganic
agricultural substances that may be used in organic handling.
The exemptions and prohibitions granted under the OFPA are required
to be reviewed every 5 years by the National Organic Standards Board
(NOSB). The Secretary of Agriculture has authority under the OFPA to
renew such exemptions and prohibitions. If they are not reviewed by the
NOSB within 5 years of their inclusion on the National List and renewed
by the Secretary, their authorized use or prohibition expires. This
means that synthetic substances Hydrogen chloride (CAS 7647-
01-0) and Ferric phosphate (CAS 10045-86-0), currently
allowed for use in organic crop production, will no longer be allowed
for use after the sunset date, September 12, 2011. This also means that
Egg white lysozyme (CAS 9001-63-2), L-Malic acid (CAS
97-67-6), Microorganisms, Activated charcoal (CAS s
7440-44-0; 64365-11-3), Cyclohexylamine (CAS 108-91-8),
Diethylaminoethanol (CAS 100-37-8), Octadecylamine (CAS
124-30-1), Peracetic acid/Peroxyacetic acid (CAS
79-21-0), Sodium acid pyrophosphate (CAS 7758-16-9), and
Tetrasodium pyrophosphate (CAS 7722-88-5), currently allowed
for use in organic handling, will no longer be allowed for use after
the sunset date, September 12, 2011.
This final rule reflects recommendations submitted to the Secretary
by the NOSB concerning the continued use of 12 substances on the
National List in organic production and handling. Consistent with the
recommendations from the NOSB, this final rule renews 12 exemptions on
the National List (along with any restrictive annotations).
Under the authority of the OFPA, as amended (7 U.S.C. 6501 et
seq.), the National List can be amended by the Secretary based on
recommendations developed by the NOSB. Since established, the NOP has
published fourteen amendments to the National List: October 31, 2003
(68 FR 61987); November 3, 2003 (68 FR 62215); October 21, 2005 (70 FR
61217); June 7, 2006 (71 FR 32803); September 11, 2006 (71 FR 53299);
June 27, 2007 (72 FR 35137); October 16, 2007 (72 FR 58469); December
10, 2007 (72 FR 69569); December 12, 2007 (72 FR 70479); September 18,
2008 (73 FR 54057); October 9, 2008 (73 FR 59479); July 6, 2010 (75 FR
38693); August 24, 2010 (75 FR 51919); and December 13, 2010 (75 FR
77521). Additionally, proposed amendments to the National List were
published on November 8, 2010 (75 FR 68505), and a final rule affirming
a previous amendment was published on March 14, 2011 (76 FR 13504).
II. Overview of Renewals
The following provides an overview of the renewals for designated
sections of the National List regulations:
Renewals
This final rule continues the exemptions at Sec. 205.601, along
with any restrictive annotations for the following synthetic substances
allowed for use in organic crop production: Ferric phosphate (CAS
10045-86-0); and Hydrogen chloride (CAS 7647-01-0).
This final rule continues the exemptions at Sec. 205.605(a), along
with any restrictive annotations, for the following nonsynthetic,
nonagricultural (nonorganic) substances allowed as ingredients in or on
processed products labeled as ``organic'' or ``made with organic
(specified ingredients or food groups(s))'': Egg white lysozyme (CAS
9001-63-2); L-Malic acid (CAS 97-67-6); and
Microorganisms. This final rule continues the exemptions at Sec.
205.605(b), along with any restrictive annotations, for the following
synthetic, nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food groups(s))'':
Activated charcoal (CAS s 7440-44-0; 64365-11-3);
Cyclohexylamine (CAS 108-91-8); Diethylaminoethanol (CAS
100-37-8); Octadecylamine (CAS 124-30-1); Peracetic
acid/Peroxyacetic acid (CAS 79-21-0); Sodium acid
pyrophosphate (CAS 7758-16-9); and Tetrasodium pyrophosphate
(CAS 7722-88-5).
Nonrenewals
The NOSB determined that a continuing need was demonstrated for the
authorization of the 12 exemptions. In addition, most comments received
on the proposed rule (76 FR 2880)
[[Page 46596]]
supported renewal of all 12 exemptions. Accordingly, there are no
nonrenewals.
III. Related Documents
One advanced notice of proposed rulemaking with request for
comments was published in the Federal Register on March 14, 2008 (73 FR
13795), to make the public aware that the allowance for 12 synthetic
and nonsynthetic substances in organic production and handling will
expire, if not reviewed by the NOSB and renewed by the Secretary. The
proposed rule for this final rule was published in the Federal Register
on January 4, 2011 (76 FR 288).
IV. Statutory and Regulatory Authority
The OFPA, as amended (7 U.S.C. 6501 et seq.), 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 Sec.
205.607 of the NOP regulations. The current petition process (72 FR
2167, January 18, 2007) can be accessed through the NOP Web site at
http://www.ams.usda.gov/AMSv1.0/.
A. Executive Order 12866
This action has been determined not significant for purposes of
Executive Order 12866, and therefore, has not been reviewed by the
Office of Management and Budget.
B. Executive Order 12988
Executive Order 12988 instructs each executive agency to adhere to
certain requirements in the development of new and revised regulations
in order to avoid unduly burdening the court system. This final rule is
not intended to have a retroactive effect.
States and local jurisdictions are preempted under the OFPA from
creating programs of accreditation for private persons or State
officials who want to become certifying agents of organic farms or
handling operations. A governing State official would have to apply to
USDA to be accredited as a certifying agent, as described in Sec.
2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under
Sec. Sec. 2104 through 2108 of the OFPA (7 U.S.C. 6503 through 6507)
from creating certification programs to certify organic farms or
handling operations unless the State programs have been submitted to,
and approved by, the Secretary as meeting the requirements of the OFPA.
Pursuant to Sec. 2108(b)(2) of the 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 the OFPA, (b) not be inconsistent with the OFPA, (c)
not be discriminatory toward agricultural commodities organically
produced in other States, and (d) not be effective until approved by
the Secretary.
Pursuant to Sec. 2120(f) of the OFPA (7 U.S.C. 6519(f)), this
final rule would not alter the authority of the Secretary under the
Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
Products Inspections Act (21 U.S.C. 451 et seq.), or the Egg Products
Inspection Act (21 U.S.C. 1031 et seq.), 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 et seq.), nor the authority of the Administrator of EPA under the
Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et
seq.).
Section 2121 of the 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. The OFPA also provides that the
U.S. District Court for the district in which a person is located has
jurisdiction to review the Secretary's decision.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires
agencies to consider the economic impact of each rule on small entities
and evaluate alternatives that would accomplish the objectives of the
rule without unduly burdening small entities or erecting barriers that
would restrict their ability to compete in the market. The purpose is
to fit regulatory actions to the scale of businesses subject to the
action. Section 605 of the RFA allows an agency to certify a rule, in
lieu of preparing an analysis, if the rulemaking is not expected to
have a significant economic impact on a substantial number of small
entities.
Pursuant to the requirements set forth in the RFA, the AMS
performed an economic impact analysis on small entities in the final
rule published in the Federal Register on December 21, 2000 (65 FR
80548). The AMS has also 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. The AMS concludes that the economic impact of
this addition of allowed substances, if any, would be minimal and
beneficial to small agricultural service firms. Accordingly, USDA
certifies that this rule will not have a significant economic impact on
a substantial number of small entities.
Small agricultural service firms, which include producers,
handlers, and accredited certifying agents, have been defined by the
Small Business Administration (SBA) (13 CFR 121.201) as those having
annual receipts of less than $7,000,000 and small agricultural
producers are defined as those having annual receipts of less than
$750,000.
According to USDA, Economic Research Service (ERS) data based on
information from USDA-accredited certifying agents, the number of
certified U.S. organic crop and livestock operations totaled nearly
13,000 and certified organic acreage exceeded 4.8 million acres in
2008.\1\ ERS, based upon the list of certified operations maintained by
the NOP, estimated the number of certified handling operations was
3,225 in 2007.\2\ AMS believes that most of these entities would be
considered small entities under the criteria established by the SBA.
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\1\ U.S. Department of Agriculture, Economic Research Service.
2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock
Numbers and Farm Operations, 1992-2008. http://www.ers.usda.gov/Data/Organic/
\2\ U.S. Department of Agriculture, Economic Research Service,
2009. Data Sets: Procurement and Contracting by Organic Handlers:
Documentation. http://www.ers.usda.gov/Data/OrganicHandlers/Documentation.htm.
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The U.S. sales of organic food and beverages have grown from $3.6
billion in 1997 to nearly $21.1 billion in 2008.\3\ The organic
industry is viewed as the fastest growing sector of agriculture,
representing over 3 percent of overall
[[Page 46597]]
food sales in 2009. Between 1990 and 2008, organic food sales
historically demonstrated a growth rate between 15 to 24 percent each
year. In 2010, organic food sales grew 7.7%.\4\
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\3\ Dimitri, C., and L. Oberholtzer. 2009. Marketing U.S.
Organic Foods: Recent Trends from Farms to Consumers, Economic
Information Bulletin No. 58, U.S. Department of Agriculture,
Economic Research Service, http://www.ers.usda.gov/Publications/EIB58.
\4\ Organic Trade Association's 2011 Organic Industry Survey,
http://www.ota.com.
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In addition, USDA has 94 accredited certifying agents who provide
certification services to producers and handlers. A complete list of
names and addresses of accredited certifying agents may be found on the
AMS NOP Web site, at http://www.ams.usda.gov/nop. AMS believes that
most of these accredited certifying agents would be considered small
entities under the criteria established by the SBA.
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 Sec. 350(h) of the Paperwork Reduction Act of 1995, 44
U.S.C. 3501, et seq., or OMB's implementing regulations at 5 CFR part
1320.
E. Comments Received on Proposed Rule AMS-TM-07-0136
AMS received nine comments on proposed rule AMS-TM-07-0136.
Comments were received from an organic producer, trade associations,
handlers, and private citizens. Most comments expressed positions in
support of the 12 substances considered under this sunset review. One
individual did not refer to subjects within the scope of this
rulemaking.
Some commenters specifically supported substances that they
promote, represent, or rely on. A comment submitted in support of
Ferric phosphate emphasized the importance of the substance to reduce
snail damage on organic crops. A comment received on Hydrogen chloride
voiced that there are no good alternatives to the use of the substance
for removal of residual lint from ginned cottonseed, a process
necessary to facilitate mechanical planting. A comment received on Egg
white lysozyme stated that the substance is essential for organic wine
production. A comment submitted in support of L-Malic acid underscored
that no alternatives exist for this substance and stated its importance
as a processing aid for pH adjustment in organic products. Multiple
comments received on Microorganisms emphasized the critical need for
microorganisms in organic food processing for production of dairy,
bread, fruit, vegetable, and meat products. Comments received in
support of the allowance for Activated charcoal confirmed the necessity
of this substance as a filtering aid in organic processing. Comments
submitted supporting the allowance for the substances Cyclohexylamine,
Diethylaminoethanol, and Octadecylamine, all boiler water additives,
stated that these substances are important for packaging sterilization.
Comments supporting the use of Peracetic acid/Peroxyacetic acid for
sanitizing food contact surfaces indicated that there are no
alternative materials with equivalent functionality. One comment
submitted in support of Sodium acid pyrophosphate stated that without
the allowance for this substance as a leavening agent, many organic
baked goods would no longer be available because a satisfactory
alternative does not exist. The same commenter also emphasized the
necessity of Tetrasodium pyrophosphate in the manufacturing of meat
analog products to facilitate proper flow in the extrusion process and
ensure the development of suitable product texture. Overall, at least
one comment was received in favor of renewal for all 12 substances
considered under this sunset review.
Changes Requested But Not Made
One commenter opposed the continued use of six of the 12
substances: Cyclohexylamine, Diethylaminoethanol, Octadecylamine,
Peracetic acid/Peroxyacetic acid, Sodium acid pyrophosphate, and
Tetrasodium pyrophosphate. The commenter based their objection on the
safety of the substances as described in the material safety data
sheets (MSDS) for each substance and recommended removal of these
substances from the National List. However, the NOSB reviewed these
substances against the evaluation criteria in 7 U.S.C. 6517 and 6518 of
the OFPA, and found that when these substances are used as limited by
the annotations for each substance, they do not pose any danger to the
environment or to manufacturing personnel or consumers. The NOSB
concluded that these substances remain essential to organic production
since no organic alternatives exist and recommended that the exemption
for these substances on the National List continue. The NOP concurs
with the NOSB's evaluation and recommendation of these substances and,
therefore, does not find that sufficient information was provided by
the commenter to justify the removal of these substances from the
National List.
F. 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. Section 7 U.S.C. 6517(e) requires the NOSB to
review each substance on the National List within 5 years of its
publication. The substances being reauthorized for use on the National
List were initially authorized for use in organic agriculture on
September 12, 2006. 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 expiration date of September 12, 2011.
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 September 12, 2011.
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.
The authority citation for 7 CFR part 205 continues to read as
follows:
Authority: 7 U.S.C. 6501-6522.
Dated: July 28, 2011.
David R. Shipman,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2011-19659 Filed 8-2-11; 8:45 am]
BILLING CODE 3410-02-P