National Organic Program (NOP); Sunset Review (2012), 33290-33303 [2012-13523]
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Federal Register / Vol. 77, No. 109 / Wednesday, June 6, 2012 / Rules and Regulations
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projected revenues sufficient to
reasonably cover budgeted costs—
adjusted for inflation—and allow for
adequate operating reserves to be
maintained. Costs considered in this
method include salaries, costs of
equipment and supplies, and other
overhead costs, such as facility costs
and costs for administration and
supervision. In addition to covering
expected costs, the user fee is set such
that projected revenues will generate an
operating reserve adequate to effectively
manage uncertainties related to crop
size and cash-flow timing while meeting
minimum reserve requirements set by
the Agricultural Marketing Service,
which require maintenance of a reserve
fund amount equal to at least four
months of projected operating costs.
The user fee charged to cotton
producers for cotton classification in
2012 is $2.20 per bale, which is the
same fee charged for the 2011 crop. This
fee is based on the preseason projection
that 14,475,000 bales will be classed by
the United States Department of
Agriculture during the 2012 crop year.
Accordingly, § 28.909, paragraph (b)
reflects the continuation of the cotton
classification fee at $2.20 per bale.
As provided for in the 1987 Act, a 5
cent per bale discount will continue to
be applied to voluntary centralized
billing and collecting agents as specified
in § 28.909(c).
Growers or their designated agents
receiving classification data will
continue to incur no additional fees if
classification data is requested only
once. The fee for each additional
retrieval of classification data in
§ 28.910 will remain at 5 cents per bale.
The fee in § 28.910(b) for an owner
receiving classification data from the
National Database will remain at 5 cents
per bale, and the minimum charge of
$5.00 for services provided per monthly
billing period will remain the same. The
provisions of § 28.910(c) concerning the
fee for new classification memoranda
issued from the National Database for
the business convenience of an owner
without reclassification of the cotton
will remain the same at 15 cents per
bale or a minimum of $5.00 per sheet.
The fee for review classification in
§ 28.911 is maintained at $2.20 per bale.
The fee for returning samples after
classification in § 28.911 will remain at
50 cents per sample.
Summary of Comments
A proposed rule was published in the
Federal Register on April 11, 2012, with
a comment period of April 11, 2012
through April 26, 2012 (77 FR 21684).
AMS received two comments: One from
a national trade organization that
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represents approximately 80 percent of
the U.S. cotton industry, including
cotton producers, ginners,
warehousemen, merchants,
cooperatives, cottonseed processors, and
textile manufacturers from Virginia to
California; and one from a national trade
organization comprised of eight state
and regional membership organizations
that represent approximately 680
individual cotton ginning operations in
17 cotton-producing states. Comments
from the national trade organizations
expressed support for the decision to
maintain the fee at the level established
for the 2011 crop. Comments may be
viewed at www.regulations.gov.
Pursuant to 5 U.S.C. 533, good cause
exists for not postponing the effective
date of this final rule until 30 days after
publication in the Federal Register
because this rule maintains uniform
user fees for 2012 crop cotton
classification services as mandated by
the Cotton Statistics and Estimates Act,
at the same level as 2011.
List of Subjects in 7 CFR Part 28
Administrative practice and
procedure, Cotton, Reporting and
recordkeeping requirements,
Warehouses.
For the reasons set forth in the
preamble, 7 CFR part 28 is amended to
read as follows:
PART 28—[AMENDED]
Subpart D—[Amended]
1. The authority citation for 7 CFR
part 28, Subpart D, continues to read as
follows:
■
Authority: 7 U.S.C. 51–65; 7 U.S.C. 471–
476.
2. In § 28.909, paragraph (b) is revised
to read as follows:
■
§ 28.909
Costs.
*
*
*
*
*
(b) The cost of High Volume
Instrument (HVI) cotton classification
service to producers is $2.20 per bale.
*
*
*
*
*
■ 3. In § 28.911, the last sentence of
paragraph (a) is revised to read as
follows:
§ 28.911
Review classification.
(a) * * * The fee for review
classification is $2.20 per bale.
*
*
*
*
*
Dated: May 30, 2012.
David R. Shipman,
Administrator, Agricultural Marketing
Service.
[FR Doc. 2012–13527 Filed 6–5–12; 8:45 am]
BILLING CODE 3410–02–P
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS–NOP–09–0074;
NOP–09–01FR]
RIN 0581–AC96
National Organic Program (NOP);
Sunset Review (2012)
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 April 29, 2010, October 28,
2010, and April 29, 2011. These
recommendations pertain to the 2012
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 NOSB recommendations, this
final rule continues, without change, the
exemptions (use) and prohibitions for
multiple listings on the National List for
5 years after their respective sunset
dates. This final rule also amends the
exemptions (use) for 7 substances and
removes the exemptions for 3
substances on the National List.
DATES: Effective Dates: This rule is
effective June 27, 2012, except for the
amendments to §§ 205.601(g) and
205.605(a), which are effective October
21, 2012. For more information on these
effective dates and renewals, see the
SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT:
Melissa R. 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 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
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Federal Register / Vol. 77, No. 109 / Wednesday, June 6, 2012 / Rules and Regulations
(NOSB). The Secretary of Agriculture
has authority under the OFPA to renew
such exemptions and prohibitions. If the
substances are not reviewed by the
NOSB within 5 years of their inclusion
on the National List and addressed by
the Secretary, then their authorized use
or prohibition expires under OFPA’s
sunset provision.
In response to the sunset provisions
in the OFPA, this final rule addresses
multiple recommendations submitted to
the Secretary by the NOSB pertaining to
substances due to expire from the
National List in 2012. AMS published
an Advanced Notice of Proposed
Rulemaking (ANPR) in the Federal
Register on March 26, 2010 (75 FR
14500), announcing the NOSB’s review
of exempted and prohibited substances
codified at the National List of the
National Organic Program (NOP)
regulations and set to expire in 2012.
AMS provided the comments received
in response to the ANPR to the NOSB
in advance of their review of these
substances. Based upon the NOSB’s
recommendations, AMS published a
proposed rule in the Federal Register on
January 12, 2012, (77 FR 1996) to
address the continued use of these
substances on the National List in
organic production and handling.
Consistent with the recommendations
from the NOSB, this final rule renews,
without change, multiple exemptions
(uses) and prohibitions on the National
List (along with any restrictive
annotations) for 5 years. This final rule
also amends the exemptions for 7
substances and removes the exemptions
for 3 substances on the National List. A
list of these substances is provided in
the Appendix to this final rule. As
referenced in the proposed rule for this
2012 Sunset Review, AMS notes that the
listings for nutrient vitamins and
minerals at section 205.605(b) and
sodium nitrate at section 205.602 will
be dealt with in separate actions.
Under the authority of the OFPA, the
National List can be amended by the
Secretary based on recommendations
developed by the NOSB. Since
established, the NOP has published
multiple 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), December 13, 2010 (75 FR
77521); March 14, 2011 (76 FR 13501);
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August 3, 2011 (76 FR 46595); and
February 14, 2012 (77 FR 8089).
Additionally, proposed amendments to
the National List were published on
May 5, 2011 (76 FR 25612); November
8, 2011 (76 FR 69141); January 12, 2012
(77 FR 1980); and February 6, 2012 (77
FR 5717).
II. Overview of Final Actions
A complete overview of final actions
for designated sections of the National
List regulations is presented in the
Appendix.1 In the proposed rule, AMS
indicated that proposed actions for each
listing would be effective on the sunset
date in 2012 for that listing (e.g. a listing
due to sunset on October 21, 2012
would be renewed effective October 21,
2012). However, AMS determined that
the effective dates for this sunset review
should be streamlined to the extent
possible through this final rule.
Therefore, the actions pertaining to all
listings, with the exception of the
amendment to yeast at section
205.605(a) and the removal of sulfur
dioxide at section 205.601, will be
effective on one date, June 27, 2012. The
effective date for each listing is
specified in the Appendix. In
accordance with the sunset provisions
in the OFPA, the new sunset date for all
listings is five years from the effective
date of their renewal or amendment.
Renewals
Consistent with the NOSB
recommendations and in consideration
of the public comments received on the
proposed rule (77 FR 1996), AMS is
renewing multiple listings pertaining to
the National List through this final rule.
This final rule continues the
exemptions at section 205.601, along
with any restrictive annotations, for the
synthetic substances allowed for use in
organic crop production as shown in the
Appendix.
This final rule continues the
prohibitions at section 205.602, along
with any restrictive annotations, for the
nonsynthetic substances prohibited for
use in organic crop production as
shown in the Appendix. It should be
noted that the nonsynthetic, prohibited
substance ‘‘Ash from manure burning’’
was listed incorrectly in Table 1 of the
proposed rule as ‘‘Ash for manure
burning’’ (emphasis added). The correct
listing is included in the Appendix of
this final rule.
This final rule continues the
exemptions at section 205.603, along
with any restrictive annotations, for the
1 The Appendix shows a simplified listing for
each substance; use categories and any restrictive
annotations are not included in this overview.
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synthetic substances allowed for use in
organic livestock production as shown
in the Appendix.
This final rule continues the
prohibition at section 205.604, for the
nonsynthetic substance prohibited for
use in organic livestock production as
shown in the Appendix.
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 the Appendix.
This final rule continues the
exemptions at section 205.605(b), along
with any restrictive annotations, for the
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))’’
as shown in the Appendix.
This final rule continues the
exemptions at section 205.606, along
with any restrictive annotations, for the
nonorganically produced agricultural
products allowed as ingredients in or on
processed products labeled as ‘‘organic’’
as shown in the Appendix.
Nonrenewals
This final rule amends the National
List by removing the exemptions as
shown in the Appendix for the
following 3 substances in organic
production and handling:
Section 205.601 Synthetic Substances
Allowed for Use in Organic Crop
Production
This final rule amends section
205.601 of the National List regulations
by removing the exemption for sulfur
dioxide at paragraph (g)(1) and
redesignating current paragraph (g)(2) as
(g) to read: (g) As rodenticides. Vitamin
D3. This amendment is effective on the
sunset date for sulfur dioxide, October
21, 2012.
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
regulations by removing the exemption
for pectin (low-methoxy), and the
exemption, along with its restrictive
annotation, for potassium iodide. These
amendments are effective on June 27,
2012.
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Federal Register / Vol. 77, No. 109 / Wednesday, June 6, 2012 / Rules and Regulations
Renewals With Amendment
This final rule amends the National
List regulations by amending the
exemptions as shown in the Appendix
for the following 7 substances in organic
production and handling:
Section 205.601 Synthetic Substances
Allowed for Use in Organic Crop
Production.
This final rule amends the listing for
chlorine materials at section
205.601(a)(2) to read as follows:
Chlorine materials—For pre-harvest use,
residual chlorine levels in the water in
direct crop contact or as water from
cleaning irrigation systems applied to
soil must not exceed the maximum
residual disinfectant limit under the
Safe Drinking Water Act, except that
chlorine products may be used in edible
sprout production according to EPA
label directions. (i) Calcium
hypochlorite. (ii) Chlorine dioxide. (iii)
Sodium hypochlorite. This amendment
is effective on June 27, 2012.
This final rule amends section
205.601(i)(11) to add an expiration date
to the listing for streptomycin to read as
follows: Streptomycin, for fire blight
control in apples and pears only until
October 21, 2014. This amendment is
effective on June 27, 2012.
This final rule amends the listing for
lignin sulfonate at section 205.601(j)(4)
to remove the words ‘‘floatation agent.’’
The new listing will read: Lignin
sulfonate—chelating agent, dust
suppressant. This amendment is
effective on June 27, 2012. It should be
noted that the amendatory language for
lignin sulfonate was incorrectly listed in
the proposed rule as ‘‘Lignin sulfate—
chelating agent, dust suppressant’’
(emphasis added). This error is
corrected in this final rule.
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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 the listing for
yeast section 205.605(a) to read as
follows: Yeast—When used as food or a
fermentation agent in products labeled
as ‘‘organic,’’ yeast must be organic if its
end use is for human consumption;
nonorganic yeast may be used when
organic yeast is not commercially
available. Growth on petrochemical
substrate and sulfite waste liquor is
prohibited. For smoked yeast,
nonsynthetic smoke flavoring process
must be documented. This amendment
is effective on the sunset date for yeast,
October 21, 2012.
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through the NOP Web site at https://
Section 205.606 Nonorganically
Produced Agricultural Products Allowed www.ams.usda.gov.
as Ingredients in or on Processed
A. Executive Order 12866
Products Labeled as ‘‘Organic ’’
This action has been determined not
This final rule adds a restrictive
significant for purposes of Executive
annotation to the listing for colors at
Order 12866, and therefore, has not
section 205.606(d) to read as follows:
been reviewed by the Office of
Colors derived from agricultural
Management and Budget.
products—Must not be produced using
synthetic solvents and carrier systems or
any artificial preservative. This
amendment is effective on the sunset
date for colors derived from agricultural
products, June 27, 2012.
This final rule adds an expiration date
to the listing for hops at section
205.606(l) to read as follows: Hops
(Humulus lupulus) until January 1,
2013. This amendment is effective on
the sunset date for hops, June 27, 2012.
This final rule amends the listing for
pectin at section 205.606(t) to read as
follows: Pectin (non-amidated forms
only). This amendment is effective on
June 27, 2012.
III. Related Documents
An Advance Notice of Proposed
Rulemaking with request for comments
was published in the Federal Register
on March 26, 2010 (75 FR 14500), to
make the public aware that the
exemptions and prohibitions for over
200 listings of synthetic and
nonsynthetic substances in organic
production and handling would expire,
if not reviewed by the NOSB and
addressed by the Secretary. Substances
and recommendations addressed
through this final rule were announced
for NOSB deliberation in the following
Federal Register notices: (1) March 17,
2010 (75 FR 12723); September 20, 2010
(75 FR 57194); and (2) March 4, 2011
(76 FR 12013). The proposal to address
the substances in this final rule was
published as a proposed rule in the
Federal Register on January 12, 2012
(77 FR 1996).
IV. Statutory and Regulatory Authority
The OFPA 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 NOP regulations. The
current petition process (72 FR 2167,
January 18, 2007) can be accessed
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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 the
OFPA (7 U.S.C. 6514(b)). States are also
preempted by 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 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 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.
601–624), 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 (FIFRA) (7 U.S.C. 136–136(y)).
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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.
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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 such
actions in order that small business will
not be unduly or disproportionately
burdened. Section 605 of the RFA
allows an agency to certify a rule, in lieu
of preparing an analysis, if the
rulemaking is not expected to have a
significant economic impact on a
substantial number of small entities.
Pursuant to the requirements set forth
in the RFA, AMS performed an
economic impact analysis on small
entities in the final rule published in the
Federal Register on December 21, 2000
(65 FR 80548). AMS has also considered
the economic impact of this final rule
on small entities and has determined
that this rule would not have a
significant economic impact on a
substantial number of small entities.
The effect of this final rule would be to
allow the continued use of multiple
substances in agricultural production
and handling. AMS concludes that the
economic impact of the renewals and
renewals with amendment of allowed
substances, if any, would be minimal
and beneficial to small agricultural
service firms. For the substances
removed or further restricted through
this final action, AMS determined that
their use is either not prevalent or that
alternatives to their use are available to
organic producers and handlers.
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
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producers are defined as those having
annual receipts of less than $750,000.
According to NOP’s Accreditation and
International Activities Division, the
number of certified U.S. organic crop
and livestock operations totaled over
17,000 in 2010. According to USDA,
Economic Research Service (ERS) data
based on information from USDAaccredited certifying agents, certified
organic acreage exceeded 4.8 million
acres in 2008.2 In 2009, U.S. certified
organic apple acreage exceeded 21,000
acres, primarily concentrated in
Washington and California.3 ERS, based
upon the list of certified operations
maintained by the NOP, estimated the
number of certified handling operations
was 3,225 in 2007.4 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 2008.5
The organic industry is viewed as the
fastest growing sector of agriculture,
representing over 3 percent of overall
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%.6
In addition, USDA has 93 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.
D. Paperwork Reduction Act
No additional collection or
recordkeeping requirements are
imposed on the public by this final rule.
Accordingly, OMB clearance is not
2 U.S. Department of Agriculture, Economic
Research Service. 2009. Data Sets: U.S. Certified
Organic Farmland Acreage, Livestock Numbers and
Farm Operations, 1992–2008. https://
www.ers.usda.gov/Data/Organic/.
3 Kirby, Elizabeth, and David Granatstein. Status
of Organic Tree Fruit in Washington State—2009,
Washington State University, March 2010.
4 U.S. Department of Agriculture, Economic
Research Service, 2009. Data Sets: Procurement and
Contracting by Organic Handlers: Documentation.
https://www.ers.usda.gov/Data/OrganicHandlers/
Documentation.htm.
5 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, https://www.ers.usda.gov/Publications/
EIB58.
6 Organic Trade Association’s 2011 Organic
Industry Survey, https://www.ota.com.
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required by the Paperwork Reduction
Act of 1995, 44 U.S.C. 3501, Chapter 35.
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–09–01
AMS received approximately 40
comments on the proposed rule. AMS
received comments from consumers,
organic producers and handlers, trade
representatives, certifying agents,
ingredient manufacturers, consultants,
and an environmental organization.
Most comments specifically addressed
proposed amendments for individual
substances. A few comments were
received in support of multiple or all of
the substances under this sunset review.
A few comments presented concerns
that were not within the scope of the
sunset review action.
All comments on the proposed
amendments for hops and lignin
sulfonate and the proposed removal of
potassium iodide were supportive of the
actions as proposed. Therefore, AMS is
finalizing the amendments and
removals as proposed through this final
rule.
Some comments suggested changes to
the proposal rule for specific
substances. These comments are
described below in conjunction with
AMS’ response, including any
amendments that will be addressed
through this final rule.
Chlorine Materials
AMS received six comments
regarding the amendment for chlorine
materials allowed in crop production at
section 205.601(a)(2). Comments were
received from trade associations, an
environmental organization and a
sprout producer. Four comments
supported the proposed amendment for
chlorine materials, while two comments
raised issues associated with the use of
chlorine in sprouts.
AMS requested comments in the
proposed rule on the use of chlorine in
treatment of seeds for organic sprout
production. Consistent with the NOSB
recommendation, the proposed rule
included an annotation change which,
in part, intended to clarify the use of
chlorine in edible sprout production.
AMS specifically asked commenters to
provide information on whether using
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the Environmental Protection Agency
(EPA) labeled rate of chlorine for
sprouts (20,000 ppm), followed by a
rinse of potable water, is appropriate for
organic production. AMS also sought
input from commenters on whether
there are other Food and Drug
Administration (FDA) and EPA
approved materials or methods suitable
for sprout treatment.
One commenter responded that
methods to ensure sprout safety are
complex and stated that no single
practice will completely eliminate
pathogens. This commenter supported
the clarification on chlorine as proposed
and urged further development of
criteria and procedures for assessing
alternatives that would be both
acceptable to FDA and in organic
products.
One commenter stated that there are
other equally effective alternatives that
would be more consistent with organic
principles. This commenter, however,
noted that the 20,000 ppm soak in
calcium hypochlorite, a chlorine
material currently allowed under the
NOP regulations, is the only treatment
for sprouts addressed by FDA in their
guidance document.7 This commenter
recommended that FDA clarify other
treatment options that are permitted and
effective for sprout treatment. AMS
believes that this comment is pertinent
to FDA’s guidance, rather than AMS’
proposed amendment for chlorine. In
the absence of comments demonstrating
acceptable alternatives for treatment of
seed for sprouting, AMS concludes that
the annotation change on chlorine
specifying its allowance in spout
production is appropriate and will
codify this change through this final
rule.
One commenter opposed all uses of
chlorine in organic production, other
than unavoidable residues of chlorine
from its use in treated drinking water.
This commenter stated that chlorine is
a reactive chemical that can combine
with organic matter to form persistent
organochlorines and other disinfection
byproducts. For this reason, the
commenter felt that added chlorine
should not be used in organic crop
production. The commenter requested
that AMS amend the annotation for
chlorine to restrict all chlorine used in
direct contact with crops, in irrigation
systems, and in disinfection of
equipment or tools to levels no greater
7 FDA, Guidance for Industry: Microbial Food
Safety Hazards for Sprouted Seeds. October 27,
1999. https://www.fda.gov/Food/
GuidanceComplianceRegulatoryInformation/
GuidanceDocuments/ProduceandPlanProducts/
ucm120244.htm.
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than the maximum residual disinfectant
limit under the Safe Drinking Water Act.
AMS disagrees with the commenter
on this issue. The NOSB reviewed and
recommended chlorine for inclusion on
the National List in 1995, 2003, 2006
and 2011, according to the OFPA
evaluation criteria in 7 U.S.C. 6517 and
6518. In these reviews, the NOSB
assessed the impact of using chlorine on
the environment and human health, but
concluded that the need for this
substance in some instances is
necessary to ensure prevention of food
borne pathogens. Consistent with the
April 2011 NOSB recommendation,
AMS proposed an annotation to
chlorine, which would limit its direct
use on crops and in soil contact to levels
no higher than those found in municipal
drinking water. The NOSB has not
recommended any limitation on the use
of chlorine for disinfecting tools and
equipment when necessary to prevent
spread of plant diseases. Therefore,
AMS is codifying the annotation change
to chlorine as proposed through this
final rule.
Pheromones
AMS received one comment about the
continued allowance for pheromones for
insect management at section 205.601(f).
The commenter objected to the
categorical relisting of pheromones and
indicated that the NOSB acted without
sufficient information. The commenter
indicated that although pheromone
products are valuable to organic
producers, there are many types of
pheromones, and that the different types
of pheromones were not reviewed by
the NOSB. The commenter also
indicated that the NOSB should address
the use of additional ingredients in
pheromone product formulations. The
commenter suggested that the
annotation be changed to list
pheromones for insect management on
section 205.601, provided that they are
exempt from regulation under FIFRA
(7 U.S.C. 136–136(y)) by 40 CFR
152.25(b).
AMS disagrees with the commenter
on this issue. The NOSB is responsible
for reviewing generic materials, not
specific product formulations. The
NOSB has previously reviewed and
recommended pheromones for inclusion
on the National List according to the
OFPA criteria. The NOP regulations
currently allow the use of inert
ingredients in pesticide formulations
under a separate listing at section
205.601(m). During their sunset
deliberations, the NOSB reviewed
pheromones against the evaluation
criteria in 7 U.S.C. 6517 and 6518 of the
OFPA and concluded that they remain
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essential to organic production since no
organic alternatives exist. The NOSB
recommended that the exemption for
pheromones continue as previously
allowed. AMS concurs with the NOSB’s
evaluation and recommendation of this
substance, and therefore, does not find
that sufficient information was provided
by the commenter to justify the addition
of an annotation to the listing for
pheromones on the National List.
Consistent with the NOSB
recommendation, AMS is renewing the
listing for pheromones through this final
rule as proposed.
Sulfur Dioxide
AMS received one comment that
objected to the removal of sulfur dioxide
from section 205.601(g) based upon its
use for rodent control on organic farms.
However, AMS did not receive any
comments from organic producers that
this substance is commonly used.
Furthermore, as explained in the
proposed rule, the NOSB determined
that the EPA does not register any
products for use as a rodenticide that
contain sulfur dioxide as an active
ingredient. Therefore, consistent with
the NOSB recommendation, AMS is
removing the listing for sulfur dioxide
as a rodenticide from the National List
through this final rule.
EPA List 4—Inerts of Minimal Concern
AMS received one comment about the
continued allowance for synthetic inert
ingredients under the listing at section
205.601(m)(1) for ‘‘EPA List 4—Inerts of
Minimal Concern.’’ The commenter
opposes the inclusion of EPA List 4 as
a category on the National List and
indicated that all substances included
on EPA List 4 should be individually
considered by the NOSB. The
commenter also objected to the use of
the term ‘‘inert’’ in describing other
ingredients in pesticide products. The
commenter noted that ‘‘inert’’
ingredients may be biologically active or
have toxicological affects. AMS
disagrees with the commenter on this
issue of redefining the term ‘‘inert
ingredient’’ at this time. The term ‘‘inert
ingredient,’’ is defined under the NOP
regulations for consistency with EPA
regulations under FIFRA. AMS does not
conclude that sufficient information was
provided by the commenter to justify
the removal of this listing from the
National List. Therefore, AMS is
renewing the listing for EPA List 4
through this final rule as proposed.
The commenter also suggested that
the NOSB adopt a policy to transition to
the individual review of inert
ingredients. This comment is outside
the scope of this rulemaking; however,
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AMS notes that a working group is
currently in place to address the
allowance of inerts that were previously
classified as EPA List 4, since the EPA
is no longer maintaining this list.
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Streptomycin
AMS received eight comments on the
proposed rule to relist streptomycin at
section 205.601(i)(11) with an
expiration date of October 21, 2014.
Comments were received from a
university-affiliated researcher, an
agricultural pest and disease
management specialist, an apple
producer, a trade association, certifying
agents, a streptomycin product
manufacturer and an environmental
organization.
One comment supported the proposal
to set October 21, 2014, as the
expiration date for the use of
streptomycin as recommended by the
NOSB.8 This comment cited the
following factors in support of phasing
out streptomycin in organic apple and
pear production: (i) Potential for the
substance’s continued use to result in
antibiotic resistance in human
pathogens; (ii) inconsistency with the
prohibition on antibiotic use in organic
livestock production; and, (iii)
incompatibility with organic and
sustainable agriculture. The commenter
further clarified the third point by
stating that streptomycin use
discourages cultural and biological
controls, such as disease-resistant
varieties and rootstock, site selection,
careful fertilization, adequate tree
spacing, proper pruning, as well as
newer biological control products.
Seven comments supported the
proposal to relist streptomycin, but
opposed the addition of the October 21,
2014 expiration date. These commenters
stated that a longer allowance time is
needed and provided the following
reasons for this opinion: (i) In practice,
applications of streptomycin are
coupled with management strategies to
reduce susceptibility to fire blight and
are generally limited to situations when
computer models warn that an infection
is likely to occur; (ii) there is a lack of
viable, commercially available
alternatives to streptomycin for fire
blight control in apple and pear
production; (iii) the research
community is engaged in an ongoing
effort to develop alternatives to
antibiotics for controlling fire blight; (iv)
streptomycin is particularly effective in
humid areas where fire blight has not
8 NOSB Formal Recommendation on
Streptomycin Sunset. April 29, 2011. Available on
the NOP Web site: https://www.ams.usda.gov/
AMSv1.0/getfile?dDocName=STELPRDC5091714.
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developed resistance; and, (v) without
the availability of streptomycin to treat
fire blight, some U.S. organic apple and
pear producers may exit organic
production and imported products
could compensate for any decrease in
U.S. production.
These commenters further stated that
there is no assurance that current
research efforts will yield any
commercially viable alternative(s) to
streptomycin in time for the October 21,
2014, expiration date. A number of
commenters specifically cited a USDAOrganic Agriculture Research and
Extension Initiative grant for the
development of non-antibiotic programs
for fire blight control in organic apple
and pear production. Commenters
explained that the findings of this
project, which started in September
2011, will not be available until 2016,
and would enable the NOSB to assess
the strategies for controlling fire blight
without antibiotics after that time.
Comments also addressed the efficacy
of several of alternatives to
streptomycin, including resistant
rootstocks and varieties, and biological
controls, all of which the NOSB cited in
its justification for recommending an
expiration date. Several commenters
explained that resistant rootstocks are
still in development and that resistance
would not convey to the upper part of
the tree where the fire blight infection
takes hold. Some commenters stated
that apple and pear varieties have
varying degrees of susceptibility to fire
blight, but none are immune. One
commenter reported that consumers
demand newer apple and pear varieties,
which are susceptible to fire blight, and
stated that there is no market for other
varieties. One commenter noted the
slow progress in developing new
varieties that exhibit favorable eating
and storage qualities, as well as fire
blight resistance. Some comments
described biological controls as a
component of an overall fire blight
management strategy, which are most
effective when supplemented with
antibiotics. Comments also contended
that years of research have not yielded
any biological control product that
matches the effectiveness of
streptomycin.
Commenters specifically requested
that the proposed expiration date for
streptomycin be deleted. In effect, such
an action would renew the current
listing for streptomycin on the National
List for five years, until 2017, when it
would be subject to sunset review.
Consistent with the NOSB
recommendation, AMS is maintaining
the proposed amendment to allow
streptomycin for fire blight control in
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33295
organic apple and pear production until
October 21, 2014. During deliberations,
the NOSB reviewed technical
information on streptomycin in
accordance with the criteria in OFPA
(7 U.S.C. 6517–6518) and the NOP
regulations for synthetic substances on
the National List (§ 205.600). The
Technical Report considered by the
NOSB addressed the same issues raised
by the commenters to the proposed rule
concerning the efficacy of alternatives to
streptomycin.9 These alternatives
include biological controls, allowed
synthetic substances, the selection of
varieties with low susceptibility to fire
blight, and agronomic practices
including careful and timely pruning,
maintaining well-drained soil, limiting
or excluding the use of manure and
blossom removal. The NOSB is
mandated by OFPA to evaluate whether
alternative practices make the use of a
substance such as streptomycin
unnecessary. In this case, the NOSB
found widespread fire blight resistance
to streptomycin in apple production and
continued use of apple and pear
varieties that are highly susceptible to
fire blight. Ultimately, the NOSB
recommendation conveyed the
expectation that preparation for the
removal of streptomycin would augment
the development and use of resistant
rootstocks and cultivars, preventive
management methods and the use of
allowed biological and chemical
controls.
The NOSB also considered additional
factors in its decision, including
antibiotic resistance in humans and the
high susceptibility of leading varieties
of organic apple and pears, in terms of
acreage, to fire blight. Consistent with
the OFPA, the NOSB evaluated the
effects of the use of streptomycin upon
human health. The NOSB considered
information from the Technical Report
that streptomycin sprays can leave
detectable residues in apple cores and
skins. Based on this information, the
NOSB was concerned that the continued
use of streptomycin could contribute to
antibiotic resistance which would be
inconsistent with the principles of
organic production and the OFPA
criteria. The NOSB also stated that
consumers expect that organic products
are not produced with antibiotics.
At the April 2011 meeting, the NOSB
Crops Committee put forth a proposal to
extend the exemption for streptomycin
until October 21, 2014. This proposal
was intended to phase out use of this
9 Technical Report on Streptomycin. March 8,
2011. Available in petitioned substances database,
under ‘‘S,’’ at the NOP Web site:
www.ams.usda.gov/nop.
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substance while providing a sufficient
timeframe for industry members to
prepare for the removal of streptomycin
from the National List. At the April
2011 NOSB meeting, the NOSB took two
votes on the proposal for streptomycin:
one vote on their recommendation to
list streptomycin with the October 21,
2014, expiration date, and one ‘‘back up
vote’’ to relist streptomycin without
restriction. The NOSB conducted these
votes in accordance with their sunset
review process.10 The April 2011 NOSB
recommendation for streptomycin
specified their intent to phase out use of
the substance over time through
addition of the October 21, 2014,
expiration date.11 Therefore, consistent
with the recommendation of the NOSB,
AMS published a rule proposing the
October 21, 2014, expiration date for
streptomycin.
While some commenters submitted
comments advocating for relisting
streptomycin without restriction, AMS
did not receive any new information
from commenters on this issue that the
NOSB had not considered during their
April 2011 deliberations on
streptomycin. Furthermore, AMS
believes that relisting streptomycin
without an expiration date would not
meet the intent of the NOSB to phase
out the use of this substance in organic
apple and pear production over time.
Therefore, consistent with the NOSB
recommendation, AMS is codifying the
addition of an expiration date to the
listing for streptomycin through this
final rule. Finally, AMS notes that
extending the allowance for the use of
streptomycin after the October 21, 2014,
expiration date would require a petition
to the NOSB. This process can be
initiated in accordance with the Notice
of Guidelines on Procedures for
Submitting National List Petitions
(72 FR 2167).
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Flavors
AMS received one comment from a
trade association that specifically
addressed the proposed relisting of
flavors, nonsynthetic sources only, on
section 205.605(a). The commenter
supported the continued listing of
10 The NOSB sunset review process is described
on pg. 54 of the NOSB Policy and Procedures
Manual. Available at NOP Web site: https://
www.ams.usda.gov/AMSv1.0/
getfile?dDocName=STELDEV3013893. This process
is further described in the October 28, 2010, NOSB
Recommendation on Sunset Review Process.
Available at NOP Web site: https://
www.ams.usda.gov/AMSv1.0/
getfile?dDocName=STELPRDC5088004&acct=nosb.
11 NOSB Recommendation on Streptomycin,
April 29, 2011. Available at NOP Web site:
https://www.ams.usda.gov/AMSv1.0/
getfile?dDocName=STELPRDC5091714.
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nonsynthetic flavors with the existing
restriction, ‘‘must not be produced using
synthetic solvents and carrier system or
any artificial preservatives.’’ AMS is
renewing the listing for flavors as
proposed through this final rule.
The commenter, however, further
requested that the NOP issue a guidance
document to request that certifying
agents use a standardized industry
questionnaire to verify compliance of
the use of nonsynthetic flavors in
organic handling. AMS concludes this
request is beyond the scope of this final
rule.
Yeast
AMS received over twenty comments
in response to the proposed amendment
for yeast. The majority of comments
were supportive of the amendment in
the proposed rule.
One commenter noted that the
proposed amendment for yeast would
require producers of products labeled
‘‘made with organic (specified
ingredients or food group(s))’’ to be
subject to commercial availability before
using a nonorganic ingredient, which is
not required for products in this
labeling category. Under section
205.301(c) of the NOP regulations,
products sold, labeled, or represented as
‘‘made with organic (specified
ingredients or food group(s))’’ are not
subject to the requirement that the
product must not be produced using
nonorganic ingredients when organic
ingredients are available. AMS
concludes that a modification to the
proposed amendment for yeast is
necessary to ensure consistency with
the NOP regulations. Therefore, AMS
has amended the yeast annotation
through this final rule to clarify that the
requirement that yeast be organic when
commercially available is only
applicable to products labeled
‘‘organic.’’
One commenter noted that the use of
the term ‘‘equivalent organic yeast’’ in
the proposed amendment was unclear
since ‘‘equivalent’’ was not defined. The
commenter noted that organic yeast may
have lower leavening activity than
conventional yeast, or may only be
available in a specific form (e.g. dry and
not fresh), and therefore would not be
considered ‘‘equivalent.’’ AMS notes
that the amendment allows the use of
conventional yeast when organic yeast
is not commercially available. Under the
NOP regulations, ‘‘commercially
available’’ is defined as the ability to
obtain a production input in an
appropriate form, quality, or quantity to
fulfill an essential function in a system
of organic production or handling, as
determined by the certifying agent in
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the course of reviewing the organic
plan. Thus, organic yeast is not required
to be used if it is not available in the
appropriate form or quality, as noted in
the commenter’s examples. To reduce
confusion over the use of the term
‘‘equivalent,’’ AMS has removed this
term from the amendment in the final
rule as we believe the inclusion is
redundant with the existing criteria for
commercial availability.
One commenter requested that AMS
develop guidelines specifically for
changes to the National List for which
label revisions will be necessary. The
commenter specifically noted that an
operator presently using nonorganic
yeast that successfully sources organic
yeast will need to update the ingredient
statement in their product labels to
indicate the yeast is organic. The
commenter suggested these guidelines
allow at least one year for label
revisions.
AMS notes that the effective date of
this amendment requires that product
formulations be compliant by October
21, 2012. The publication of this final
rule provides almost four months of
notice to the industry about this change.
Sections 205.304–205.306 of the NOP
regulations require that each organic
ingredient in the ingredient statement
be identified with the word, ‘‘organic,’’
or with an asterisk or other reference
mark which is defined below the
ingredient statement to indicate the
ingredient is organically produced.
Therefore, if product formulations must
be compliant by October 21, 2012, then
the labels for these products should also
be compliant with the regulations at
sections 205.304–205.306 by the
effective date for this amendment.
Products entering the stream of
commerce prior to the effective date do
not have to be relabeled. AMS further
notes that development of broad
guidelines on label use up for any
National List change is beyond the
scope of this rulemaking.
Two commenters requested that yeast
be moved from section 205.605 of the
National List to section 205.606, as an
agricultural product. One commenter
noted that listing yeast on section
205.605 would allow products labeled
‘‘made with organic (specified
ingredients or food group(s))’’ to use
non-organic yeast without the
requirements for documenting
commercial availability. The NOP has
addressed the concerns for products
labeled ‘‘made with organic (specified
ingredients or food group(s))’’ by
clarifying that the annotation which
requires organic yeast is applicable only
to products labeled ‘‘organic.’’ One
commenter noted that yeast is an
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organism grown for food and that it
should be considered an agricultural
product for listing on section 205.606,
rather than section 205.605. Based on
review of the record, the NOSB
considered this perspective during its
deliberations before issuing its formal
recommendation to the NOP; therefore,
AMS has chosen to retain the listing on
section 205.605, as recommended by the
NOSB, rather than moving the listing to
section 205.606.
One commenter was opposed to the
proposed amendment for yeast and
supported the existing listing. The
commenter noted that organic yeast is
only available in dry form, not fresh. In
addition, the commenter claimed that
leavening activity in organic yeast is
much lower than conventional yeast
and that organic yeast is costly, and,
therefore, is not equivalent in
performance and cost. AMS notes that
the current annotation permits the use
of nonorganic yeast when organic yeast
is not commercially available. Under the
NOP regulations, section 205.2,
commercially available is defined as the
ability to obtain a production input in
an appropriate form, quality, or quantity
to fulfill an essential function in a
system of organic production or
handling, as determined by the
certifying agent in the course of
reviewing the organic plan. The
commenter’s concern about sourcing an
appropriate form (e.g. fresh, rather than
dry) or quality (e.g. better leavening
activity) could be considered by the
certifying agent to determine whether
nonorganic yeast would be allowed
under the regulations in specific
applications. The higher cost of organic
yeast is not one of the permitted criteria
for determining commercial availability
under the NOP regulations. The NOSB
considered the issues raised by the
commenters, and AMS concludes that
the inclusion of a commercial
availability clause addresses the
commenter’s concern about the
allowance for conventional yeast when
organic yeast is not available in an
appropriate form, quality, or quantity.
Silicon Dioxide
The NOP received one comment
stating that the listing for silicon
dioxide at section 205.605(b) should be
amended to reflect a December 2011
NOSB recommendation on this
substance. In their December 2011
recommendation, the NOSB
recommended the addition of a
restrictive annotation to specify that
silicon dioxide, a synthetic used in
processed products, could only be used
if a nonsynthetic alternative for certain
uses is not commercially available.
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However, the December 2011 NOSB
recommendation was not available
when drafting the proposed rule for this
2012 Sunset Review. Therefore,
consistent with the October 2010 NOSB
recommendation pertaining to the 2012
Sunset Review for this substance, AMS
published a proposed rule on January
12, 2012, to renew silicon dioxide at
section 205.605(b) as currently listed
(i.e. without annotation). Because the
proposal to amend the annotation for
silicon dioxide was not included in the
proposed rule and AMS did not receive
public comment on such a change, AMS
is not amending the annotation in this
final rule. AMS is, therefore, renewing
the existing listing for silicon dioxide
through this final rule as proposed.
AMS intends to address the December
2011 NOSB recommendation for this
substance through a separate
rulemaking action for National List
amendments.
Xanthan Gum
AMS received one comment from a
trade association in support of relisting
xanthan gum; however, this commenter
also suggested reclassifying the
substance as nonsynthetic and relisting
it at section 205.605(a) of the National
List. This commenter describes xanthan
gum as a natural extracellular
polysaccharide. The NOSB reviewed
xanthan gum in April 2010 and did not
propose any change in classification at
that time. Therefore, AMS is renewing
the listing for xanthan gum as codified.
Pectin
In accordance with the October 2010
NOSB recommendation, the NOP
proposed to remove the listing of
synthetic pectin (low methoxy) at
section 205.605(b), and to amend the
listing for pectin (high-methoxy) at
section 205.606(t) to ‘‘Pectin (nonamidated forms only).’’ The NOP
received five comments in support of
these proposed changes from trade
associations, a beverage and dairy
products manufacturer, and a consulting
firm. The commenters agreed generally
that non-amidated forms of pectin are
adequate for use in organic products.
One commenter opposed the
proposed changes for technical reasons.
This commenter disagreed with the
October 2010 NOSB recommendation
that considered both low-methoxy and
high-methoxy pectin to be derived from
a similar non-synthetic extraction
process, with the difference in the final
substance resulting from a longer
extraction period. The commenter
pointed out that the low-methoxy pectin
is produced as a result of esterification
(by removal of methyl groups, or
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33297
demethylation) of high-methoxy pectin
which is initially derived from citrus
peel or apple pomace.12 This
commenter agreed that amidated forms
of pectin (forms treated with ammonia)
are not necessary for use in organic
production, but noted that only lowmethoxy pectin is available in amidated
form. This commenter suggested that
the listing at section 205.605(b) be
amended to: ‘‘Low-methoxy pectin, nonamidated forms only’’ and that the
existing listing for high-methoxy pectin
be retained at section 205.606.
While AMS believes that the
commenter has merit regarding
technical classification of the substance,
the intent of the NOSB was to require
that all forms of pectin used in organic
products be subject to the requirement
that organic sources be used when
commercially available. Therefore,
consistent with the intent of the NOSB,
we have retained the proposed
amendments for pectin in this final rule.
Colors
AMS received four comments in
support of the proposed amendment to
the listing for colors at section
205.606(d). The proposed listing was
‘‘Colors derived from agricultural
products—Must not be produced using
synthetic solvents and carrier systems or
any artificial preservative.’’ These
commenters, however, requested that
AMS clarify whether synthetic
substances allowed under section
205.605(b) for solvent extraction, or as
carriers, preservatives or stabilizers, and
which are currently allowed for use in
organic colors, would also be allowed
for use in nonorganic colors at section
205.606. Commenters specifically
referenced ascorbic acid, carbon
dioxide, glycerin, silicon dioxide and
tocopherols, as examples of substances
listed at section 205.605(b), which are
currently allowed to produce organic
colors. These substances were
previously recommended by the NOSB
and are currently codified as allowed
synthetics at section 205.605(b) of the
National List. The commenters
requested clarification as to whether
such substances at section 205.605(b)
would still be allowed in the production
of nonorganic colors under the proposed
amendment.
At their October 2010 meeting, the
NOSB discussed the need for an
annotation to clarify the allowance of
synthetic solvents in the preparation of
12 This process is also described in the 2009
Technical Report for Non Amidated Low Methoxyl
Pectin. Available at NOP Web site: https://
www.ams.usda.gov/AMSv1.0/
getfile?dDocName=STELPRDC5087206.
E:\FR\FM\06JNR1.SGM
06JNR1
erowe on DSK2VPTVN1PROD with RULES
33298
Federal Register / Vol. 77, No. 109 / Wednesday, June 6, 2012 / Rules and Regulations
the colors listed on section 205.606.13
The NOSB recommended an
amendment to restrict the use of
synthetic solvents, carrier systems and
artificial preservatives in the production
of colors. However, in their
recommendation, the NOSB did not
address whether this restriction would
apply to synthetics already listed at
section 205.605(b).
The NOSB has already reviewed and
recommended the synthetics listed at
section 205.605(b) of the National List.
Therefore, the synthetics listed at
section 205.605(b) of the National List
are already allowed in organic
processed products, including in the
formulation of colors. AMS believes the
intent of the NOSB recommendation for
colors is to prevent the use of synthetic
substances that are not on the National
List in the formulation of colors.
Substances at section 205.605(b) of the
National List will still be allowed in the
production of nonorganic colors under
the amendment.
One commenter stated that
unrestricted use of synthetic solvents or
carriers permitted by FDA should be
acceptable in colors used for organic
production. AMS disagrees with this
comment. While certain synthetic
solvents or carriers may be permitted by
FDA, these synthetics would need to be
petitioned and reviewed by the NOSB
for inclusion on the National List under
the NOP regulations.
Some commenters requested that
AMS provide a one year compliance
date from the effective date of the
amendment to colors. Commenters
stated that, while they believe that
colors that comply with the amendment
are available, manufacturers will need
time to reformulate products that
contained colors produced with
synthetic solvents or carrier systems no
longer allowed under the amendment.
Based on the comments received, AMS
understands that some product
reformulation may be necessary. The
effective date for this amendment is
June 27, 2012, the sunset date for the
current listing for colors. While this
amendment is effective on June 27,
2012, AMS considers a one year period
from that date as reasonable and
appropriate for the industry to
reformulate products in order to ensure
that the amendment is effectively and
rationally implemented. AMS will be
conducting outreach to the industry and
training for certifying agents as
appropriate.
13 This NOSB discussion is available on the NOP
Web site in the meeting transcript for Oct. 26, 2010
at https://www.ams.usda.gov/AMSv1.0/
getfile?dDocName=STELPRDC5088302&acct=nosb.
VerDate Mar<15>2010
15:04 Jun 05, 2012
Jkt 226001
Cornstarch
AMS received one comment opposed
to the continued listing of cornstarch
(native) at section 205.606(w)(1) of the
National List. This commenter cited
several sources for organic cornstarch
that include a number of types for
different applications, and suggested
that nonorganic cornstarch should no
longer be given an exemption for
organic use. The commenter also
believes that nonorganic cornstarch
should not be included on the National
List since most nonorganic sources
could be derived from genetically
engineered corn.
During the October 2010 NOSB
deliberations on the 2012 Sunset
Review for cornstarch, the NOSB did
not receive public comments objecting
to relisting of cornstarch, and received
several in support of relisting on section
205.606. In their review, the NOSB did
not identify risks to the environment,
human or animal health resulting from
the use or manufacture of the substance.
Based upon the NOSB’s
recommendation, AMS is relisting
cornstarch as codified at section
205.606. AMS notes that all nonorganic
ingredients, including cornstarch, used
in products labeled ‘‘organic’’ or ‘‘made
with organic (specified ingredients or
food group(s)’’ must not be produced
using excluded methods, and that
organic cornstarch should be used if
commercially available.
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 renewed or
reauthorized with amended annotations
on the National List were most recently
reauthorized for use in organic
agriculture on June 27, 2007, October
21, 2007, December 11, 2007, and
December 13, 2007. In the case of
substances reauthorized for use on June
27, 2007 and due to expire on June 27,
2012, the substances being renewed and
amended are critical to organic
production and handling operations.
Accordingly, pursuant to 5 U.S.C.
553, it is found and determined that
good cause exists for not postponing the
effective date for amendments and
renewals contained in this rule that are
due to expire on June 27, 2012, until 30
days after publication in the Federal
Register. The effective dates for all
PO 00000
Frm 00010
Fmt 4700
Sfmt 4700
substances are indicated in the
Appendix.
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 205.601 is amended by:
A. Revising paragraph (a)(2);
■ B. Revising paragraph (g);
■ C. Revising paragraph (i)(11); and
■ D. Revising paragraph (j)(4) to read as
follows:
■
■
§ 205.601 Synthetic substances allowed
for use in organic crop production.
*
*
*
*
*
(a) * * *
(2) Chlorine materials—For preharvest use, residual chlorine levels in
the water in direct crop contact or as
water from cleaning irrigation systems
applied to soil must not exceed the
maximum residual disinfectant limit
under the Safe Drinking Water Act,
except that chlorine products may be
used in edible sprout production
according to EPA label directions.
(i) Calcium hypochlorite.
(ii) Chlorine dioxide.
(iii) Sodium hypochlorite.
*
*
*
*
*
(g) As rodenticides. Vitamin D3.
*
*
*
*
*
(i) * * *
(11) Streptomycin, for fire blight
control in apples and pears only until
October 21, 2014.
*
*
*
*
*
(j) * * *
(4) Lignin sulfonate—chelating agent,
dust suppressant.
*
*
*
*
*
■ 3. Section 205.605 is amended by:
■ A. Revising the annotation for ‘‘Yeast’’
under paragraph (a);
■ B. Removing ‘‘Pectin (low-methoxy)’’
from paragraph (b); and
■ C. Removing the paragraph for
‘‘Potassium iodide’’ from paragraph (b).
The revision reads as follows:
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06JNR1
Federal Register / Vol. 77, No. 109 / Wednesday, June 6, 2012 / Rules and Regulations
§ 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)).’’
*
*
*
*
*
(a) * * *
*
*
*
*
*
Yeast—When used as food or a
fermentation agent in products labeled
as ‘‘organic,’’ yeast must be organic if its
end use is for human consumption;
nonorganic yeast may be used when
organic yeast is not commercially
available. Growth on petrochemical
substrate and sulfite waste liquor is
33299
prohibited. For smoked yeast,
nonsynthetic smoke flavoring process
must be documented.
*
*
*
*
*
■ 4. Section 205.606 is amended by:
■ A. Revising paragraph (d);
■ B. Revising paragraph (l); and
■ C. Revising paragraph (t).
■ The revisions read as follows:
synthetic solvents and carrier systems or
any artificial preservative.
*
*
*
*
*
(l) Hops (Humulus lupulus) until
January 1, 2013.
*
*
*
*
*
(t) Pectin (non-amidated forms only).
*
*
*
*
*
§ 205.606 Nonorganically produced
agricultural products allowed as ingredients
in or on processed products labeled
‘‘organic’’.
Dated: May 30, 2012.
David R. Shipman,
Administrator, Agricultural Marketing
Service.
Note: The following Appendix will
not appear in the Code of Federal
Regulations.
*
*
*
*
*
(d) Colors derived from agricultural
products—Must not be produced using
APPENDIX—OVERVIEW OF FINAL ACTIONS FOR SUNSET 2012 14
National list section
Substance
NOSB meeting
Effective date
§ 205.601 Synthetic substances allowed for use in organic crop production.
Alcohols (Ethanol; Isopropanol)
Ammonium carbonate ...............
Aquatic plant extracts (other
than hydrolyzed).
Boric acid ..................................
Chlorine
materials
at
§ 205.601(a)(2) (Calcium
hypochlorite; chlorine dioxide;
sodium hypochlorite).
April 2011 ..............
April 2010 * ............
April 2010 * ............
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
Renew.
Renew.
Renew.
April 2010 * ............
April 2011 ..............
June 27, 2012 .......
June 27, 2012 .......
April 2011 ..............
June 27, 2012 .......
Renew.
Amend: Chlorine materials—For
pre-harvest use, residual
chlorine levels in the water in
direct crop contact or as
water from cleaning irrigation
systems applied to soil must
not exceed the maximum residual disinfectant limit under
the Safe Drinking Water Act,
except that chlorine products
may be used in edible sprout
production according to EPA
label directions.
Renew.
April 2011 ..............
April 2010 * ............
October 2010 ........
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
Renew.
Renew.
Renew.
April
April
April
April
April
April
June
June
June
June
June
June
erowe on DSK2VPTVN1PROD with RULES
Coppers, fixed (Copper hydroxide; copper oxide; copper
oxychloride, includes products exempted from EPA tolerance).
Copper sulfate ...........................
Elemental sulfur (3 uses) ..........
EPA List 4—Inerts of Minimal
Concern.
Ethylene gas .............................
Herbicides, soap-based ............
Humic acids ..............................
Hydrated lime ............................
Hydrogen peroxide (2 uses) .....
Lignin
sulfonate
at
§ 205.601(j)(4).
Lignin
sulfonate
at
§ 205.601(l)(1).
Lime sulfur (2 uses) ..................
Liquid fish products ...................
Magnesium sulfate ....................
Micronutrients (Soluble boron
products; Sulfates, carbonates, oxides, or silicates of
zinc, copper, iron, manganese, molybdenum, selenium, and cobalt).
2011 ..............
2010 * ............
2010 * ............
2010 * ............
2010 * ............
2011 ..............
April 2011 ..............
June 27, 2012 .......
Renew.
Renew.
Renew.
Renew.
Renew.
Amend: Lignin sulfonate—
chelating agent, dust suppressant.
Renew.
April
April
April
April
June
June
June
June
Renew.
Renew.
Renew.
Renew.
2010 * ............
2010 * ............
2011 ..............
2010 * ............
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
14 This Appendix shows a simplified listing for
each substance; use categories and any restrictive
annotations are not included in this overview.
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15:04 Jun 05, 2012
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Final action
Fmt 4700
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06JNR1
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Federal Register / Vol. 77, No. 109 / Wednesday, June 6, 2012 / Rules and Regulations
APPENDIX—OVERVIEW OF FINAL ACTIONS FOR SUNSET 2012 14—Continued
National list section
erowe on DSK2VPTVN1PROD with RULES
§ 205.603 Synthetic substances allowed for use in organic livestock production.
VerDate Mar<15>2010
15:04 Jun 05, 2012
NOSB meeting
Effective date
Mulches (Newspapers or other
recycled
paper,
without
glossy or colored inks; Plastic
mulch and covers).
Newspapers or other recycled
paper, without glossy or colored inks.
Oils, horticultural-narrow range
oils as dormant, suffocating,
and summer oils (2 uses).
Pheromones ..............................
Potassium bicarbonate .............
Soap-based algicide/demossers
Soaps, ammonium ....................
Soaps, insecticidal ....................
Sodium silicate ..........................
Sticky traps/barriers ..................
Streptomycin .............................
§ 205.602 Nonsynthetic substances prohibited for use in
organic crop production.
Substance
April 2011 ..............
June 27, 2012 .......
Renew.
April 2011 ..............
June 27, 2012 .......
Renew.
April 2010 * ............
June 27, 2012 .......
Renew.
April
April
April
April
April
April
April
April
June
June
June
June
June
June
June
June
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Amend: Streptomycin, for fire
blight control in apples and
pears only until October 21,
2014.
Renew.
Sucrose octanoate esters (CAS
#s—42922–74–7; 58064–47–
4).
Sulfur dioxide ............................
Vitamin B1, C, and E .................
Vitamin D3 .................................
Arsenic ......................................
Ash from manure burning .........
Lead salts ..................................
Potassium chloride ....................
Sodium fluoaluminate (mined) ..
Sodium nitrate ...........................
Strychnine .................................
Tobacco dust (nicotine sulfate)
Alcohols (Ethanol; Isopropanol)
Aspirin .......................................
Atropine (CAS #–51–55–8) .......
Biologics—Vaccines ..................
Butorphanol (CAS #–42408–
82–2).
Chlorhexidine ............................
Chlorine materials (Calcium hypochlorite; chlorine dioxide;
sodium hypochlorite).
Copper sulfate ...........................
Electrolytes ................................
EPA List 4—Inerts of Minimal
Concern.
Excipients ..................................
Flunixin (CAS #–38677–85–9) ..
Furosemide ...............................
Glucose .....................................
Glycerine ...................................
Hydrogen peroxide ....................
Iodine (2 uses) ..........................
Ivermectin ..................................
Lidocaine ...................................
Lime, hydrated ..........................
Magnesium hydroxide (CAS #–
1309–42–8).
Magnesium sulfate ....................
Mineral oil ..................................
Oxytocin ....................................
Peroxyacetic/peracetic
acid
(CAS #–79–21–0).
Phosphoric acid ........................
Poloxalene (CAS #–9003–11–
6).
Procaine ....................................
Jkt 226001
PO 00000
Frm 00012
2011 ..............
2010 * ............
2010 * ............
2010 * ............
2010 * ............
2011 ..............
2010 * ............
2011 ..............
27,
27,
27,
27,
27,
27,
27,
27,
2012
2012
2012
2012
2012
2012
2012
2012
.......
.......
.......
.......
.......
.......
.......
.......
April 2010 * ............
June 27, 2012 .......
April
April
April
April
April
April
April
April
April
October 21, 2012 ..
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
............................
2011 ..............
2010 * ............
2011 ..............
2010 * ............
2010 * ............
2010 * ............
2010 * ............
2010 * ............
2011 ..............
June
June
June
June
June
June
June
April 2010 * ............
October 2010 ........
June 27, 2012 .......
June 27, 2012 .......
Renew.
Renew.
October 2010 ........
April 2010 * ............
October 2010 ........
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
Renew.
Renew.
Renew.
April 2010 * ............
April 2010 * ............
October 2010 ........
October 2010 ........
October 2010 ........
April 2010 * ............
April 2010 * ............
April 2010 * ............
April 2010 * ............
April 2010 * ............
April 2010 * ............
June
June
June
June
June
June
June
June
June
June
June
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
October 2010 ........
April 2010 * ............
April 2010 * ............
April 2010 * ............
June
June
June
June
27,
27,
27,
27,
2012
2012
2012
2012
.......
.......
.......
.......
Renew.
Renew.
Renew.
Renew.
April 2010 * ............
April 2010 * ............
June 27, 2012 .......
June 27, 2012 .......
Renew.
Renew.
April 2010 * ............
June 27, 2012 .......
Renew.
Sfmt 4700
2012
2012
2012
2012
2012
2012
2012
E:\FR\FM\06JNR1.SGM
.......
.......
.......
.......
.......
.......
.......
Remove.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Addressed in separate rulemaking action.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
April 2010 * ............
April 2010 * ............
October 2010 ........
October 2010 ........
April 2010 * ............
April 2010 * ............
April 2010 * ............
Fmt 4700
27,
27,
27,
27,
27,
27,
27,
Final action
06JNR1
Federal Register / Vol. 77, No. 109 / Wednesday, June 6, 2012 / Rules and Regulations
33301
APPENDIX—OVERVIEW OF FINAL ACTIONS FOR SUNSET 2012 14—Continued
National list section
erowe on DSK2VPTVN1PROD with RULES
§ 205.605(b) Synthetic, nonagricultural substances allowed as ingredients in or on
processed products labeled
as ‘‘organic’’ or ‘‘made with
organic (specified ingredients
or food group(s))’’.
VerDate Mar<15>2010
15:04 Jun 05, 2012
NOSB meeting
Effective date
Sucrose octanoate esters (CAS
#s—42922–74–7; 58064–47–
4).
Tolazoline (CAS #–59–98–3) ....
Trace minerals ..........................
Vitamins ....................................
Xylazine (CAS #–7361–61–7) ..
Strychnine .................................
April 2010 * ............
June 27, 2012 .......
Renew.
April
April
April
April
April
............
............
............
............
............
June
June
June
June
June
27,
27,
27,
27,
27,
2012
2012
2012
2012
2012
.......
.......
.......
.......
.......
Renew.
Renew.
Renew.
Renew.
Renew.
Acids (Alginic; citric; lactic) .......
Bentonite ...................................
Calcium carbonate ....................
Calcium chloride .......................
Dairy cultures ............................
Diatomaceous earth ..................
Enzymes ...................................
Flavors ......................................
Kaolin ........................................
Magnesium sulfate ....................
Nitrogen .....................................
Oxygen ......................................
Perlite ........................................
Potassium chloride ....................
Potassium iodide .......................
Sodium bicarbonate ..................
Sodium carbonate .....................
Waxes (Carnauba wax; Wood
resin).
Yeast
(Autolysate;
Bakers;
Brewers; Nutritional; Smoked).
April 2010 * ............
April 2010 * ............
April 2010 * ............
April 2010 * ............
April 2010 * ............
April 2010 * ............
April 2011 ..............
October 2010 ........
April 2010 * ............
October 2010 ........
April 2010 * ............
April 2010 * ............
April 2010 * ............
April 2010 * ............
April 2011 ..............
April 2010 * ............
April 2010 * ............
April 2010 * ............
June
June
June
June
June
June
June
June
June
June
June
June
June
June
June
June
June
June
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
October 2010 ........
October 21, 2012 ..
Alginates ...................................
Ammonium bicarbonate ............
Ammonium carbonate ...............
Ascorbic Acid ............................
Calcium citrate ..........................
Calcium hydroxide ....................
Calcium
phosphates
(monobasic; dibasic; tribasic).
Carbon dioxide ..........................
Chlorine materials (Calcium hypochlorite; chlorine dioxide;
sodium hypochlorite).
Ethylene ....................................
Ferrous sulfate ..........................
Glycerides (mono; di) ................
Glycerin .....................................
Hydrogen peroxide ....................
Magnesium carbonate ..............
Magnesium chloride ..................
Magnesium stearate .................
Nutrient vitamins and minerals
April
April
April
April
April
April
April
April
June
June
June
June
June
June
June
June
October 2010 ........
June 27, 2012 .......
Renew.
April 2010 * ............
October 2010 ........
April 2010 * ............
April 2010 * ............
April 2010 * ............
April 2010 * ............
April 2010 * ............
April 2010 * ............
April 2011 ..............
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
...............................
Ozone ........................................
Pectin (low-methoxy) ................
Phosphoric acid ........................
Potassium acid tartrate .............
Potassium carbonate ................
Potassium citrate ......................
Potassium hydroxide .................
§ 205.604 Nonsynthetic substances prohibited for use in
organic livestock production.
§ 205.605(a) Nonsynthetic,
nonagricultural substances allowed as ingredients in or on
processed products labeled
as ‘‘organic’’ or ‘‘made with
organic (specified ingredients
or food group(s))’’.
Substance
April 2010 * ............
October 2010 ........
October 2010 ........
April 2010 * ............
April 2010 * ............
April 2010 * ............
April 2010 * ............
June
June
June
June
June
June
June
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Addressed in separate rulemaking action.
Renew.
Remove.
Renew.
Renew.
Renew.
Renew.
Renew.
Jkt 226001
PO 00000
Frm 00013
Fmt 4700
2010 *
2010 *
2010 *
2010 *
2010 *
2010 *
2010 *
2010 *
2010 *
2010 *
2010 *
2010 *
2010 *
............
............
............
............
............
............
............
............
Sfmt 4700
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
E:\FR\FM\06JNR1.SGM
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.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
06JNR1
Final action
Amend: Yeast—When used as
food or a fermentation agent
in products labeled ‘‘organic’’,
yeast must be organic if its
end use is for human consumption; nonorganic yeast
may be used when organic
yeast is not commercially
available. Growth on petrochemical substrate and sulfite
waste liquor is prohibited. For
smoked yeast, nonsynthetic
smoke flavoring process must
be documented.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
33302
Federal Register / Vol. 77, No. 109 / Wednesday, June 6, 2012 / Rules and Regulations
APPENDIX—OVERVIEW OF FINAL ACTIONS FOR SUNSET 2012 14—Continued
National list section
NOSB meeting
Potassium iodide .......................
Potassium phosphate ...............
Silicon dioxide ...........................
Sodium citrate ...........................
Sodium hydroxide .....................
Sodium phosphates ..................
Sulfur dioxide ............................
Tocopherols ..............................
Xanthan gum .............................
Casings, from processed intestines.
Celery powder ...........................
Chia (Salvia hispanica L.) .........
Colors (Annatto extract color;
Beet juice extract color; Betacarotene extract color; Black
currant juice color; Black/purple carrot juice color; Blueberry juice color; Carrot juice
color; Cherry juice color;
Chokeberry—Aronia
juice
color; Elderberry juice color;
Grape juice color; Grape skin
extract color; Paprika color;
Pumpkin juice color; Purple
potato juice color; Red cabbage extract color; Red radish extract color; Saffron extract color; Turmeric extract
color). CAS numbers are provided in the Renewals with
Amendment section.
Cornstarch (native) ...................
Dillweed oil (CAS # 8006–75–5)
Fish oil (Fatty acid CAS #’s
10417–94–4 and 25167–62–
8).
Fructooligosaccharides (CAS #
308066–66–2).
Galangal, frozen ........................
Gelatin (CAS # 9000–70–8) .....
Gums (Arabic; Guar; Locust
bean; Carob bean).
Hops (Humulus luplus) at
§ 205.606(l).
April 2011 ..............
April 2010 * ............
October 2010 ........
October 2010 ........
October 2010 ........
October 2010 ........
October 2010 ........
April 2011 ..............
April 2010 * ............
April 2010 * ............
April 2010 * ............
April 2010 * ............
October 2010 ........
June
June
June
June
June
June
June
June
June
June
June
June
June
October 2010 ........
April 2010 * ............
April 2010 * ............
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
Renew.
Renew.
Renew.
October 2010 ........
June 27, 2012 .......
Renew.
April 2010 * ............
April 2010 * ............
April 2010 * ............
June 27, 2012 .......
June 27, 2012 .......
June 27, 2012 .......
Renew.
Renew.
Renew.
October 2010 ........
June 27, 2012 .......
Inulin, oligofructose enriched ....
(CAS # 9005–80–5) ..................
Kelp ...........................................
Konjac flour (CAS # 37220–17–
0).
Lemongrass, frozen ..................
Orange
shellac—unbleached
(CAS # 9000–59–3).
Pectin (high-methoxy) ...............
§ 205.606 Nonorganically produced agricultural products allowed as ingredients in or on
processed products labeled
as ‘‘organic’’.
Substance
October 2010 ........
June 27, 2012 .......
Amend: Hops (Humulus
lupulus) until January 1,
2013.
Renew.
April 2010 * ............
April 2010 * ............
June 27, 2012 .......
June 27, 2012 .......
Renew.
Renew.
April 2010 * ............
April 2010 * ............
June 27, 2012 .......
June 27, 2012 .......
Renew.
Renew.
October 2010 ........
June 27, 2012 .......
April
April
April
April
June
June
June
June
Amend: Pectin (non-amidated
forms only).
Renew.
Renew.
Renew.
Renew.
erowe on DSK2VPTVN1PROD with RULES
Peppers (chipotle chile) ............
Sweet potato starch ..................
Turkish bay leaves ....................
Wakame seaweed (Undaria
pinnatifida).
Whey protein concentrate .........
2010 *
2010 *
2010 *
2010 *
............
............
............
............
October 2010 ........
Effective date
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
27,
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
2012
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
.......
June 27, 2012 .......
Final action
Remove.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Renew.
Amend: Colors derived from agricultural products—Must not
be produced using synthetic
solvents and carrier systems
or any artificial preservative.
Renew.
* The NOSB originally recommended that these substances be relisted during their April 2010 meeting. Since public comments were still being
accepted for these substances, the NOSB decided to reaffirm their recommendations on these substances at the October 2010 meeting after
analyzing all public comments.
[FR Doc. 2012–13523 Filed 6–5–12; 8:45 am]
BILLING CODE 3410–02–P
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Federal Register / Vol. 77, No. 109 / Wednesday, June 6, 2012 / Rules and Regulations
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 930
[Doc. No. AO–370–A9; 11–0093; AMS–FV–
10–0087; FV10–930–5]
Tart Cherries Grown in the States of
Michigan, New York, Pennsylvania,
Oregon, Utah, Washington, and
Wisconsin; Order Amending Marketing
Order No. 930
Agricultural Marketing Service,
USDA.
ACTION: Final rule.
AGENCY:
This final rule amends
Marketing Order No. 930 (order), which
regulates the handling of tart cherries
grown in Michigan, New York,
Pennsylvania, Oregon, Utah,
Washington, and Wisconsin. These
amendments were proposed by the
Cherry Industry Administrative Board
(CIAB), which is responsible for local
administration of the order. These
amendments revise: the definition of
‘‘Handle’’; and regulations concerning
‘‘Marketing Policy’’ and ‘‘Grower
Diversion Privilege.’’ The amendments
are intended to improve the operation
and administration of the order.
DATES: This rule is effective June 7,
2012.
SUMMARY:
erowe on DSK2VPTVN1PROD with RULES
FOR FURTHER INFORMATION CONTACT:
Parisa Salehi, Marketing Order and
Agreement Division, Fruit and
Vegetable Program, AMS, USDA, 1400
Independence Avenue SW., Stop 0237,
Washington, DC 20250–0237;
Telephone: (202) 270–9918, Fax: (202)
720–8938, or Email:
Parisa.Salehi@ams.usda.gov; or Martin
Engeler, Marketing Order and
Agreement Division, Fruit and
Vegetable Program, AMS, USDA, 2202
Monterey Street, Fresno, California,
93721; Telephone: (559) 487–5110, Fax:
(559) 487–5110, or Email:
Martin.Engeler@ams.usda.gov.
Small businesses may request
information on this proceeding by
contacting Laurel May, Marketing Order
and Agreement Division, Fruit and
Vegetable Program, AMS, USDA, 1400
Independence Avenue SW., Stop 0237,
Washington, DC 20250–0237;
Telephone: (202) 720–2491, Fax: (202)
720–8938, or Email:
Laurel.May@ams.usda.gov.
Prior
documents in this proceeding: Notice of
Hearing issued on March 4, 2011, and
published in the March 14, 2011, issue
of the Federal Register (76 FR 13528).
SUPPLEMENTARY INFORMATION:
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The Recommended Decision was issued
on November 3, 2011, and published in
the November 9, 2011, issue of the
Federal Register (76 FR 69673), and a
Secretary’s Decision and Referendum
Order issued on February 28, 2012, and
published in the March 5, 2012 issue of
the Federal Register (77 FR 13015).
This action is governed by the
provisions of sections 556 and 557 of
title 5 of the United States Code and is
therefore excluded from the
requirements of Executive Order 12866.
Preliminary Statement
This final rule was formulated on the
record of a public hearing held April 20
and 21, 2011, in Grand Rapids,
Michigan, and a second public hearing
held April 26, 2011, in Provo, Utah. The
hearing was held pursuant to the
provisions of the Agricultural Marketing
Agreement Act of 1937, as amended (7
U.S.C. 601–674), hereinafter referred to
as the ‘‘Act’’, and the applicable rules of
practice and procedure governing the
formulation of marketing agreements
and orders (7 CFR Part 900). Notice of
this hearing was published in the
Federal Register on March 14, 2011 (76
FR 13528). The notice of hearing
contained the proposal submitted by
CIAB and one proposal by the
Agricultural Marketing Service (AMS).
Upon the basis of evidence
introduced at the hearings and the
record thereof, the Administrator of
AMS issued a Recommended Decision
published in the Federal Register on
November 9, 2011 (76 FR 69673). An
opportunity to file written exceptions
was provided through November 25,
2011. Two comments were received
during that period in support of these
amendments.
A Secretary’s Decision and
Referendum Order was issued on
February 28, 2012, and published in the
March 5, 2012, issue of the Federal
Register (77 FR 13015). This document
directed that a referendum among tart
cherry growers and processors be
conducted during the period March 19,
2012, through March 30, 2012, to
determine whether they favor the
proposed amendments to the order. To
become effective, the amendments had
to be approved by at least two-thirds of
the growers voting in the referendum or
two thirds of the production represented
by such growers. In addition, processors
who had frozen or canned at least fifty
percent of the volume of tart cherries
had to vote in favor of the amendments
for them to become effective. All of the
proposed amendments were approved
by growers and processors. The
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33303
amendments included in this final order
will:
1. Amendment 1 revises the term
‘‘handle’’ within the order. This
amendment revises existing section
930.10, Handle, to exclude handler
acquisition of grower diversion
certificates from the definition of
handle.
2. Amendment 2 revises the
‘‘marketing policy’’ provisions in
section 930.50 of the order so that
grower-diverted cherries are not
counted as production in the volume
control formula.
3. Amendment 3 revises the existing
section 930.58, so grower-diverted
cherries are not treated as actual
harvested cherries.
In addition to the proposed
amendments to the order, AMS
proposed to make any additional
changes to the order as may be
necessary to conform to any amendment
that may result from the hearings.
A marketing agreement was
subsequently mailed to all tart cherry
handlers in the production area for their
approval. The marketing agreement was
approved by handlers representing more
than 50 percent of the volume of tart
cherries handled by all handlers during
the representative period of July 1, 2010,
to June 30, 2011.
Small Business Considerations
Pursuant to the requirements set forth
in the Regulatory Flexibility Act (RFA),
AMS has considered the economic
impact of this action on small entities.
Accordingly, AMS has prepared this
final regulatory flexibility analysis.
The purpose of the RFA is to fit
regulatory actions to the scale of
business subject to such actions so that
small businesses will not be unduly or
disproportionately burdened. Marketing
orders and amendments thereto are
unique in that they are normally
brought about through group action of
essentially small entities for their own
benefit.
There are approximately 40 handlers
of tart cherries subject to regulation
under the order and approximately 600
producers of tart cherries in the
regulated area. Small agricultural
service firms, which include handlers,
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. A majority of the tart cherry
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]]>Agencies
[Federal Register Volume 77, Number 109 (Wednesday, June 6, 2012)]
[Rules and Regulations]
[Pages 33290-33303]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-13523]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS-NOP-09-0074; NOP-09-01FR]
RIN 0581-AC96
National Organic Program (NOP); Sunset Review (2012)
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 April 29, 2010, October 28, 2010, and April 29, 2011.
These recommendations pertain to the 2012 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 NOSB
recommendations, this final rule continues, without change, the
exemptions (use) and prohibitions for multiple listings on the National
List for 5 years after their respective sunset dates. This final rule
also amends the exemptions (use) for 7 substances and removes the
exemptions for 3 substances on the National List.
DATES: Effective Dates: This rule is effective June 27, 2012, except
for the amendments to Sec. Sec. 205.601(g) and 205.605(a), which are
effective October 21, 2012. For more information on these effective
dates and renewals, see the SUPPLEMENTARY INFORMATION.
FOR FURTHER INFORMATION CONTACT: Melissa R. 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 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
[[Page 33291]]
(NOSB). The Secretary of Agriculture has authority under the OFPA to
renew such exemptions and prohibitions. If the substances are not
reviewed by the NOSB within 5 years of their inclusion on the National
List and addressed by the Secretary, then their authorized use or
prohibition expires under OFPA's sunset provision.
In response to the sunset provisions in the OFPA, this final rule
addresses multiple recommendations submitted to the Secretary by the
NOSB pertaining to substances due to expire from the National List in
2012. AMS published an Advanced Notice of Proposed Rulemaking (ANPR) in
the Federal Register on March 26, 2010 (75 FR 14500), announcing the
NOSB's review of exempted and prohibited substances codified at the
National List of the National Organic Program (NOP) regulations and set
to expire in 2012. AMS provided the comments received in response to
the ANPR to the NOSB in advance of their review of these substances.
Based upon the NOSB's recommendations, AMS published a proposed rule in
the Federal Register on January 12, 2012, (77 FR 1996) to address the
continued use of these substances on the National List in organic
production and handling.
Consistent with the recommendations from the NOSB, this final rule
renews, without change, multiple exemptions (uses) and prohibitions on
the National List (along with any restrictive annotations) for 5 years.
This final rule also amends the exemptions for 7 substances and removes
the exemptions for 3 substances on the National List. A list of these
substances is provided in the Appendix to this final rule. As
referenced in the proposed rule for this 2012 Sunset Review, AMS notes
that the listings for nutrient vitamins and minerals at section
205.605(b) and sodium nitrate at section 205.602 will be dealt with in
separate actions.
Under the authority of the OFPA, the National List can be amended
by the Secretary based on recommendations developed by the NOSB. Since
established, the NOP has published multiple 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),
December 13, 2010 (75 FR 77521); March 14, 2011 (76 FR 13501); August
3, 2011 (76 FR 46595); and February 14, 2012 (77 FR 8089).
Additionally, proposed amendments to the National List were published
on May 5, 2011 (76 FR 25612); November 8, 2011 (76 FR 69141); January
12, 2012 (77 FR 1980); and February 6, 2012 (77 FR 5717).
II. Overview of Final Actions
A complete overview of final actions for designated sections of the
National List regulations is presented in the Appendix.\1\ In the
proposed rule, AMS indicated that proposed actions for each listing
would be effective on the sunset date in 2012 for that listing (e.g. a
listing due to sunset on October 21, 2012 would be renewed effective
October 21, 2012). However, AMS determined that the effective dates for
this sunset review should be streamlined to the extent possible through
this final rule. Therefore, the actions pertaining to all listings,
with the exception of the amendment to yeast at section 205.605(a) and
the removal of sulfur dioxide at section 205.601, will be effective on
one date, June 27, 2012. The effective date for each listing is
specified in the Appendix. In accordance with the sunset provisions in
the OFPA, the new sunset date for all listings is five years from the
effective date of their renewal or amendment.
---------------------------------------------------------------------------
\1\ The Appendix shows a simplified listing for each substance;
use categories and any restrictive annotations are not included in
this overview.
---------------------------------------------------------------------------
Renewals
Consistent with the NOSB recommendations and in consideration of
the public comments received on the proposed rule (77 FR 1996), AMS is
renewing multiple listings pertaining to the National List through this
final rule.
This final rule continues the exemptions at section 205.601, along
with any restrictive annotations, for the synthetic substances allowed
for use in organic crop production as shown in the Appendix.
This final rule continues the prohibitions at section 205.602,
along with any restrictive annotations, for the nonsynthetic substances
prohibited for use in organic crop production as shown in the Appendix.
It should be noted that the nonsynthetic, prohibited substance ``Ash
from manure burning'' was listed incorrectly in Table 1 of the proposed
rule as ``Ash for manure burning'' (emphasis added). The correct
listing is included in the Appendix of this final rule.
This final rule continues the exemptions at section 205.603, along
with any restrictive annotations, for the synthetic substances allowed
for use in organic livestock production as shown in the Appendix.
This final rule continues the prohibition at section 205.604, for
the nonsynthetic substance prohibited for use in organic livestock
production as shown in the Appendix.
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 the Appendix.
This final rule continues the exemptions at section 205.605(b),
along with any restrictive annotations, for the 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))'' as shown in the Appendix.
This final rule continues the exemptions at section 205.606, along
with any restrictive annotations, for the nonorganically produced
agricultural products allowed as ingredients in or on processed
products labeled as ``organic'' as shown in the Appendix.
Nonrenewals
This final rule amends the National List by removing the exemptions
as shown in the Appendix for the following 3 substances in organic
production and handling:
Section 205.601 Synthetic Substances Allowed for Use in Organic Crop
Production
This final rule amends section 205.601 of the National List
regulations by removing the exemption for sulfur dioxide at paragraph
(g)(1) and redesignating current paragraph (g)(2) as (g) to read: (g)
As rodenticides. Vitamin D3. This amendment is effective on
the sunset date for sulfur dioxide, October 21, 2012.
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
regulations by removing the exemption for pectin (low-methoxy), and the
exemption, along with its restrictive annotation, for potassium iodide.
These amendments are effective on June 27, 2012.
[[Page 33292]]
Renewals With Amendment
This final rule amends the National List regulations by amending
the exemptions as shown in the Appendix for the following 7 substances
in organic production and handling:
Section 205.601 Synthetic Substances Allowed for Use in Organic Crop
Production.
This final rule amends the listing for chlorine materials at
section 205.601(a)(2) to read as follows: Chlorine materials--For pre-
harvest use, residual chlorine levels in the water in direct crop
contact or as water from cleaning irrigation systems applied to soil
must not exceed the maximum residual disinfectant limit under the Safe
Drinking Water Act, except that chlorine products may be used in edible
sprout production according to EPA label directions. (i) Calcium
hypochlorite. (ii) Chlorine dioxide. (iii) Sodium hypochlorite. This
amendment is effective on June 27, 2012.
This final rule amends section 205.601(i)(11) to add an expiration
date to the listing for streptomycin to read as follows: Streptomycin,
for fire blight control in apples and pears only until October 21,
2014. This amendment is effective on June 27, 2012.
This final rule amends the listing for lignin sulfonate at section
205.601(j)(4) to remove the words ``floatation agent.'' The new listing
will read: Lignin sulfonate--chelating agent, dust suppressant. This
amendment is effective on June 27, 2012. It should be noted that the
amendatory language for lignin sulfonate was incorrectly listed in the
proposed rule as ``Lignin sulfate--chelating agent, dust suppressant''
(emphasis added). This error is corrected in this final rule.
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 the listing for yeast section 205.605(a) to
read as follows: Yeast--When used as food or a fermentation agent in
products labeled as ``organic,'' yeast must be organic if its end use
is for human consumption; nonorganic yeast may be used when organic
yeast is not commercially available. Growth on petrochemical substrate
and sulfite waste liquor is prohibited. For smoked yeast, nonsynthetic
smoke flavoring process must be documented. This amendment is effective
on the sunset date for yeast, October 21, 2012.
Section 205.606 Nonorganically Produced Agricultural Products Allowed
as Ingredients in or on Processed Products Labeled as ``Organic ''
This final rule adds a restrictive annotation to the listing for
colors at section 205.606(d) to read as follows: Colors derived from
agricultural products--Must not be produced using synthetic solvents
and carrier systems or any artificial preservative. This amendment is
effective on the sunset date for colors derived from agricultural
products, June 27, 2012.
This final rule adds an expiration date to the listing for hops at
section 205.606(l) to read as follows: Hops (Humulus lupulus) until
January 1, 2013. This amendment is effective on the sunset date for
hops, June 27, 2012.
This final rule amends the listing for pectin at section 205.606(t)
to read as follows: Pectin (non-amidated forms only). This amendment is
effective on June 27, 2012.
III. Related Documents
An Advance Notice of Proposed Rulemaking with request for comments
was published in the Federal Register on March 26, 2010 (75 FR 14500),
to make the public aware that the exemptions and prohibitions for over
200 listings of synthetic and nonsynthetic substances in organic
production and handling would expire, if not reviewed by the NOSB and
addressed by the Secretary. Substances and recommendations addressed
through this final rule were announced for NOSB deliberation in the
following Federal Register notices: (1) March 17, 2010 (75 FR 12723);
September 20, 2010 (75 FR 57194); and (2) March 4, 2011 (76 FR 12013).
The proposal to address the substances in this final rule was published
as a proposed rule in the Federal Register on January 12, 2012 (77 FR
1996).
IV. Statutory and Regulatory Authority
The OFPA 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 NOP
regulations. The current petition process (72 FR 2167, January 18,
2007) can be accessed through the NOP Web site at https://www.ams.usda.gov.
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 the OFPA
(7 U.S.C. 6514(b)). States are also preempted by 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 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 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. 601-624), 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 (FIFRA) (7 U.S.C. 136-136(y)).
[[Page 33293]]
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 of
the RFA is to fit regulatory actions to the scale of businesses subject
to such actions in order that small business will not be unduly or
disproportionately burdened. Section 605 of the RFA allows an agency to
certify a rule, in lieu of preparing an analysis, if the rulemaking is
not expected to have a significant economic impact on a substantial
number of small entities.
Pursuant to the requirements set forth in the RFA, AMS performed an
economic impact analysis on small entities in the final rule published
in the Federal Register on December 21, 2000 (65 FR 80548). AMS has
also considered the economic impact of this final rule on small
entities and has determined that this rule would not have a significant
economic impact on a substantial number of small entities. The effect
of this final rule would be to allow the continued use of multiple
substances in agricultural production and handling. AMS concludes that
the economic impact of the renewals and renewals with amendment of
allowed substances, if any, would be minimal and beneficial to small
agricultural service firms. For the substances removed or further
restricted through this final action, AMS determined that their use is
either not prevalent or that alternatives to their use are available to
organic producers and handlers.
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 NOP's Accreditation and International Activities
Division, the number of certified U.S. organic crop and livestock
operations totaled over 17,000 in 2010. According to USDA, Economic
Research Service (ERS) data based on information from USDA-accredited
certifying agents, certified organic acreage exceeded 4.8 million acres
in 2008.\2\ In 2009, U.S. certified organic apple acreage exceeded
21,000 acres, primarily concentrated in Washington and California.\3\
ERS, based upon the list of certified operations maintained by the NOP,
estimated the number of certified handling operations was 3,225 in
2007.\4\ AMS believes that most of these entities would be considered
small entities under the criteria established by the SBA.
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\2\ U.S. Department of Agriculture, Economic Research Service.
2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock
Numbers and Farm Operations, 1992-2008. https://www.ers.usda.gov/Data/Organic/.
\3\ Kirby, Elizabeth, and David Granatstein. Status of Organic
Tree Fruit in Washington State--2009, Washington State University,
March 2010.
\4\ U.S. Department of Agriculture, Economic Research Service,
2009. Data Sets: Procurement and Contracting by Organic Handlers:
Documentation. https://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.\5\ The organic
industry is viewed as the fastest growing sector of agriculture,
representing over 3 percent of overall 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%.\6\
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\5\ 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, https://www.ers.usda.gov/Publications/EIB58.
\6\ Organic Trade Association's 2011 Organic Industry Survey,
https://www.ota.com.
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In addition, USDA has 93 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.
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 the Paperwork Reduction Act of 1995, 44 U.S.C. 3501,
Chapter 35.
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-09-01
AMS received approximately 40 comments on the proposed rule. AMS
received comments from consumers, organic producers and handlers, trade
representatives, certifying agents, ingredient manufacturers,
consultants, and an environmental organization. Most comments
specifically addressed proposed amendments for individual substances. A
few comments were received in support of multiple or all of the
substances under this sunset review. A few comments presented concerns
that were not within the scope of the sunset review action.
All comments on the proposed amendments for hops and lignin
sulfonate and the proposed removal of potassium iodide were supportive
of the actions as proposed. Therefore, AMS is finalizing the amendments
and removals as proposed through this final rule.
Some comments suggested changes to the proposal rule for specific
substances. These comments are described below in conjunction with AMS'
response, including any amendments that will be addressed through this
final rule.
Chlorine Materials
AMS received six comments regarding the amendment for chlorine
materials allowed in crop production at section 205.601(a)(2). Comments
were received from trade associations, an environmental organization
and a sprout producer. Four comments supported the proposed amendment
for chlorine materials, while two comments raised issues associated
with the use of chlorine in sprouts.
AMS requested comments in the proposed rule on the use of chlorine
in treatment of seeds for organic sprout production. Consistent with
the NOSB recommendation, the proposed rule included an annotation
change which, in part, intended to clarify the use of chlorine in
edible sprout production. AMS specifically asked commenters to provide
information on whether using
[[Page 33294]]
the Environmental Protection Agency (EPA) labeled rate of chlorine for
sprouts (20,000 ppm), followed by a rinse of potable water, is
appropriate for organic production. AMS also sought input from
commenters on whether there are other Food and Drug Administration
(FDA) and EPA approved materials or methods suitable for sprout
treatment.
One commenter responded that methods to ensure sprout safety are
complex and stated that no single practice will completely eliminate
pathogens. This commenter supported the clarification on chlorine as
proposed and urged further development of criteria and procedures for
assessing alternatives that would be both acceptable to FDA and in
organic products.
One commenter stated that there are other equally effective
alternatives that would be more consistent with organic principles.
This commenter, however, noted that the 20,000 ppm soak in calcium
hypochlorite, a chlorine material currently allowed under the NOP
regulations, is the only treatment for sprouts addressed by FDA in
their guidance document.\7\ This commenter recommended that FDA clarify
other treatment options that are permitted and effective for sprout
treatment. AMS believes that this comment is pertinent to FDA's
guidance, rather than AMS' proposed amendment for chlorine. In the
absence of comments demonstrating acceptable alternatives for treatment
of seed for sprouting, AMS concludes that the annotation change on
chlorine specifying its allowance in spout production is appropriate
and will codify this change through this final rule.
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\7\ FDA, Guidance for Industry: Microbial Food Safety Hazards
for Sprouted Seeds. October 27, 1999. https://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm120244.htm.
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One commenter opposed all uses of chlorine in organic production,
other than unavoidable residues of chlorine from its use in treated
drinking water. This commenter stated that chlorine is a reactive
chemical that can combine with organic matter to form persistent
organochlorines and other disinfection byproducts. For this reason, the
commenter felt that added chlorine should not be used in organic crop
production. The commenter requested that AMS amend the annotation for
chlorine to restrict all chlorine used in direct contact with crops, in
irrigation systems, and in disinfection of equipment or tools to levels
no greater than the maximum residual disinfectant limit under the Safe
Drinking Water Act.
AMS disagrees with the commenter on this issue. The NOSB reviewed
and recommended chlorine for inclusion on the National List in 1995,
2003, 2006 and 2011, according to the OFPA evaluation criteria in 7
U.S.C. 6517 and 6518. In these reviews, the NOSB assessed the impact of
using chlorine on the environment and human health, but concluded that
the need for this substance in some instances is necessary to ensure
prevention of food borne pathogens. Consistent with the April 2011 NOSB
recommendation, AMS proposed an annotation to chlorine, which would
limit its direct use on crops and in soil contact to levels no higher
than those found in municipal drinking water. The NOSB has not
recommended any limitation on the use of chlorine for disinfecting
tools and equipment when necessary to prevent spread of plant diseases.
Therefore, AMS is codifying the annotation change to chlorine as
proposed through this final rule.
Pheromones
AMS received one comment about the continued allowance for
pheromones for insect management at section 205.601(f). The commenter
objected to the categorical relisting of pheromones and indicated that
the NOSB acted without sufficient information. The commenter indicated
that although pheromone products are valuable to organic producers,
there are many types of pheromones, and that the different types of
pheromones were not reviewed by the NOSB. The commenter also indicated
that the NOSB should address the use of additional ingredients in
pheromone product formulations. The commenter suggested that the
annotation be changed to list pheromones for insect management on
section 205.601, provided that they are exempt from regulation under
FIFRA (7 U.S.C. 136-136(y)) by 40 CFR 152.25(b).
AMS disagrees with the commenter on this issue. The NOSB is
responsible for reviewing generic materials, not specific product
formulations. The NOSB has previously reviewed and recommended
pheromones for inclusion on the National List according to the OFPA
criteria. The NOP regulations currently allow the use of inert
ingredients in pesticide formulations under a separate listing at
section 205.601(m). During their sunset deliberations, the NOSB
reviewed pheromones against the evaluation criteria in 7 U.S.C. 6517
and 6518 of the OFPA and concluded that they remain essential to
organic production since no organic alternatives exist. The NOSB
recommended that the exemption for pheromones continue as previously
allowed. AMS concurs with the NOSB's evaluation and recommendation of
this substance, and therefore, does not find that sufficient
information was provided by the commenter to justify the addition of an
annotation to the listing for pheromones on the National List.
Consistent with the NOSB recommendation, AMS is renewing the listing
for pheromones through this final rule as proposed.
Sulfur Dioxide
AMS received one comment that objected to the removal of sulfur
dioxide from section 205.601(g) based upon its use for rodent control
on organic farms. However, AMS did not receive any comments from
organic producers that this substance is commonly used. Furthermore, as
explained in the proposed rule, the NOSB determined that the EPA does
not register any products for use as a rodenticide that contain sulfur
dioxide as an active ingredient. Therefore, consistent with the NOSB
recommendation, AMS is removing the listing for sulfur dioxide as a
rodenticide from the National List through this final rule.
EPA List 4--Inerts of Minimal Concern
AMS received one comment about the continued allowance for
synthetic inert ingredients under the listing at section 205.601(m)(1)
for ``EPA List 4--Inerts of Minimal Concern.'' The commenter opposes
the inclusion of EPA List 4 as a category on the National List and
indicated that all substances included on EPA List 4 should be
individually considered by the NOSB. The commenter also objected to the
use of the term ``inert'' in describing other ingredients in pesticide
products. The commenter noted that ``inert'' ingredients may be
biologically active or have toxicological affects. AMS disagrees with
the commenter on this issue of redefining the term ``inert ingredient''
at this time. The term ``inert ingredient,'' is defined under the NOP
regulations for consistency with EPA regulations under FIFRA. AMS does
not conclude that sufficient information was provided by the commenter
to justify the removal of this listing from the National List.
Therefore, AMS is renewing the listing for EPA List 4 through this
final rule as proposed.
The commenter also suggested that the NOSB adopt a policy to
transition to the individual review of inert ingredients. This comment
is outside the scope of this rulemaking; however,
[[Page 33295]]
AMS notes that a working group is currently in place to address the
allowance of inerts that were previously classified as EPA List 4,
since the EPA is no longer maintaining this list.
Streptomycin
AMS received eight comments on the proposed rule to relist
streptomycin at section 205.601(i)(11) with an expiration date of
October 21, 2014. Comments were received from a university-affiliated
researcher, an agricultural pest and disease management specialist, an
apple producer, a trade association, certifying agents, a streptomycin
product manufacturer and an environmental organization.
One comment supported the proposal to set October 21, 2014, as the
expiration date for the use of streptomycin as recommended by the
NOSB.\8\ This comment cited the following factors in support of phasing
out streptomycin in organic apple and pear production: (i) Potential
for the substance's continued use to result in antibiotic resistance in
human pathogens; (ii) inconsistency with the prohibition on antibiotic
use in organic livestock production; and, (iii) incompatibility with
organic and sustainable agriculture. The commenter further clarified
the third point by stating that streptomycin use discourages cultural
and biological controls, such as disease-resistant varieties and
rootstock, site selection, careful fertilization, adequate tree
spacing, proper pruning, as well as newer biological control products.
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\8\ NOSB Formal Recommendation on Streptomycin Sunset. April 29,
2011. Available on the NOP Web site: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5091714.
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Seven comments supported the proposal to relist streptomycin, but
opposed the addition of the October 21, 2014 expiration date. These
commenters stated that a longer allowance time is needed and provided
the following reasons for this opinion: (i) In practice, applications
of streptomycin are coupled with management strategies to reduce
susceptibility to fire blight and are generally limited to situations
when computer models warn that an infection is likely to occur; (ii)
there is a lack of viable, commercially available alternatives to
streptomycin for fire blight control in apple and pear production;
(iii) the research community is engaged in an ongoing effort to develop
alternatives to antibiotics for controlling fire blight; (iv)
streptomycin is particularly effective in humid areas where fire blight
has not developed resistance; and, (v) without the availability of
streptomycin to treat fire blight, some U.S. organic apple and pear
producers may exit organic production and imported products could
compensate for any decrease in U.S. production.
These commenters further stated that there is no assurance that
current research efforts will yield any commercially viable
alternative(s) to streptomycin in time for the October 21, 2014,
expiration date. A number of commenters specifically cited a USDA-
Organic Agriculture Research and Extension Initiative grant for the
development of non-antibiotic programs for fire blight control in
organic apple and pear production. Commenters explained that the
findings of this project, which started in September 2011, will not be
available until 2016, and would enable the NOSB to assess the
strategies for controlling fire blight without antibiotics after that
time.
Comments also addressed the efficacy of several of alternatives to
streptomycin, including resistant rootstocks and varieties, and
biological controls, all of which the NOSB cited in its justification
for recommending an expiration date. Several commenters explained that
resistant rootstocks are still in development and that resistance would
not convey to the upper part of the tree where the fire blight
infection takes hold. Some commenters stated that apple and pear
varieties have varying degrees of susceptibility to fire blight, but
none are immune. One commenter reported that consumers demand newer
apple and pear varieties, which are susceptible to fire blight, and
stated that there is no market for other varieties. One commenter noted
the slow progress in developing new varieties that exhibit favorable
eating and storage qualities, as well as fire blight resistance. Some
comments described biological controls as a component of an overall
fire blight management strategy, which are most effective when
supplemented with antibiotics. Comments also contended that years of
research have not yielded any biological control product that matches
the effectiveness of streptomycin.
Commenters specifically requested that the proposed expiration date
for streptomycin be deleted. In effect, such an action would renew the
current listing for streptomycin on the National List for five years,
until 2017, when it would be subject to sunset review.
Consistent with the NOSB recommendation, AMS is maintaining the
proposed amendment to allow streptomycin for fire blight control in
organic apple and pear production until October 21, 2014. During
deliberations, the NOSB reviewed technical information on streptomycin
in accordance with the criteria in OFPA (7 U.S.C. 6517-6518) and the
NOP regulations for synthetic substances on the National List (Sec.
205.600). The Technical Report considered by the NOSB addressed the
same issues raised by the commenters to the proposed rule concerning
the efficacy of alternatives to streptomycin.\9\ These alternatives
include biological controls, allowed synthetic substances, the
selection of varieties with low susceptibility to fire blight, and
agronomic practices including careful and timely pruning, maintaining
well-drained soil, limiting or excluding the use of manure and blossom
removal. The NOSB is mandated by OFPA to evaluate whether alternative
practices make the use of a substance such as streptomycin unnecessary.
In this case, the NOSB found widespread fire blight resistance to
streptomycin in apple production and continued use of apple and pear
varieties that are highly susceptible to fire blight. Ultimately, the
NOSB recommendation conveyed the expectation that preparation for the
removal of streptomycin would augment the development and use of
resistant rootstocks and cultivars, preventive management methods and
the use of allowed biological and chemical controls.
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\9\ Technical Report on Streptomycin. March 8, 2011. Available
in petitioned substances database, under ``S,'' at the NOP Web site:
www.ams.usda.gov/nop.
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The NOSB also considered additional factors in its decision,
including antibiotic resistance in humans and the high susceptibility
of leading varieties of organic apple and pears, in terms of acreage,
to fire blight. Consistent with the OFPA, the NOSB evaluated the
effects of the use of streptomycin upon human health. The NOSB
considered information from the Technical Report that streptomycin
sprays can leave detectable residues in apple cores and skins. Based on
this information, the NOSB was concerned that the continued use of
streptomycin could contribute to antibiotic resistance which would be
inconsistent with the principles of organic production and the OFPA
criteria. The NOSB also stated that consumers expect that organic
products are not produced with antibiotics.
At the April 2011 meeting, the NOSB Crops Committee put forth a
proposal to extend the exemption for streptomycin until October 21,
2014. This proposal was intended to phase out use of this
[[Page 33296]]
substance while providing a sufficient timeframe for industry members
to prepare for the removal of streptomycin from the National List. At
the April 2011 NOSB meeting, the NOSB took two votes on the proposal
for streptomycin: one vote on their recommendation to list streptomycin
with the October 21, 2014, expiration date, and one ``back up vote'' to
relist streptomycin without restriction. The NOSB conducted these votes
in accordance with their sunset review process.\10\ The April 2011 NOSB
recommendation for streptomycin specified their intent to phase out use
of the substance over time through addition of the October 21, 2014,
expiration date.\11\ Therefore, consistent with the recommendation of
the NOSB, AMS published a rule proposing the October 21, 2014,
expiration date for streptomycin.
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\10\ The NOSB sunset review process is described on pg. 54 of
the NOSB Policy and Procedures Manual. Available at NOP Web site:
https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELDEV3013893.
This process is further described in the October 28, 2010, NOSB
Recommendation on Sunset Review Process. Available at NOP Web site:
https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088004&acct=nosb.
\11\ NOSB Recommendation on Streptomycin, April 29, 2011.
Available at NOP Web site: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5091714.
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While some commenters submitted comments advocating for relisting
streptomycin without restriction, AMS did not receive any new
information from commenters on this issue that the NOSB had not
considered during their April 2011 deliberations on streptomycin.
Furthermore, AMS believes that relisting streptomycin without an
expiration date would not meet the intent of the NOSB to phase out the
use of this substance in organic apple and pear production over time.
Therefore, consistent with the NOSB recommendation, AMS is codifying
the addition of an expiration date to the listing for streptomycin
through this final rule. Finally, AMS notes that extending the
allowance for the use of streptomycin after the October 21, 2014,
expiration date would require a petition to the NOSB. This process can
be initiated in accordance with the Notice of Guidelines on Procedures
for Submitting National List Petitions (72 FR 2167).
Flavors
AMS received one comment from a trade association that specifically
addressed the proposed relisting of flavors, nonsynthetic sources only,
on section 205.605(a). The commenter supported the continued listing of
nonsynthetic flavors with the existing restriction, ``must not be
produced using synthetic solvents and carrier system or any artificial
preservatives.'' AMS is renewing the listing for flavors as proposed
through this final rule.
The commenter, however, further requested that the NOP issue a
guidance document to request that certifying agents use a standardized
industry questionnaire to verify compliance of the use of nonsynthetic
flavors in organic handling. AMS concludes this request is beyond the
scope of this final rule.
Yeast
AMS received over twenty comments in response to the proposed
amendment for yeast. The majority of comments were supportive of the
amendment in the proposed rule.
One commenter noted that the proposed amendment for yeast would
require producers of products labeled ``made with organic (specified
ingredients or food group(s))'' to be subject to commercial
availability before using a nonorganic ingredient, which is not
required for products in this labeling category. Under section
205.301(c) of the NOP regulations, products sold, labeled, or
represented as ``made with organic (specified ingredients or food
group(s))'' are not subject to the requirement that the product must
not be produced using nonorganic ingredients when organic ingredients
are available. AMS concludes that a modification to the proposed
amendment for yeast is necessary to ensure consistency with the NOP
regulations. Therefore, AMS has amended the yeast annotation through
this final rule to clarify that the requirement that yeast be organic
when commercially available is only applicable to products labeled
``organic.''
One commenter noted that the use of the term ``equivalent organic
yeast'' in the proposed amendment was unclear since ``equivalent'' was
not defined. The commenter noted that organic yeast may have lower
leavening activity than conventional yeast, or may only be available in
a specific form (e.g. dry and not fresh), and therefore would not be
considered ``equivalent.'' AMS notes that the amendment allows the use
of conventional yeast when organic yeast is not commercially available.
Under the NOP regulations, ``commercially available'' is defined as the
ability to obtain a production input in an appropriate form, quality,
or quantity to fulfill an essential function in a system of organic
production or handling, as determined by the certifying agent in the
course of reviewing the organic plan. Thus, organic yeast is not
required to be used if it is not available in the appropriate form or
quality, as noted in the commenter's examples. To reduce confusion over
the use of the term ``equivalent,'' AMS has removed this term from the
amendment in the final rule as we believe the inclusion is redundant
with the existing criteria for commercial availability.
One commenter requested that AMS develop guidelines specifically
for changes to the National List for which label revisions will be
necessary. The commenter specifically noted that an operator presently
using nonorganic yeast that successfully sources organic yeast will
need to update the ingredient statement in their product labels to
indicate the yeast is organic. The commenter suggested these guidelines
allow at least one year for label revisions.
AMS notes that the effective date of this amendment requires that
product formulations be compliant by October 21, 2012. The publication
of this final rule provides almost four months of notice to the
industry about this change. Sections 205.304-205.306 of the NOP
regulations require that each organic ingredient in the ingredient
statement be identified with the word, ``organic,'' or with an asterisk
or other reference mark which is defined below the ingredient statement
to indicate the ingredient is organically produced. Therefore, if
product formulations must be compliant by October 21, 2012, then the
labels for these products should also be compliant with the regulations
at sections 205.304-205.306 by the effective date for this amendment.
Products entering the stream of commerce prior to the effective date do
not have to be relabeled. AMS further notes that development of broad
guidelines on label use up for any National List change is beyond the
scope of this rulemaking.
Two commenters requested that yeast be moved from section 205.605
of the National List to section 205.606, as an agricultural product.
One commenter noted that listing yeast on section 205.605 would allow
products labeled ``made with organic (specified ingredients or food
group(s))'' to use non-organic yeast without the requirements for
documenting commercial availability. The NOP has addressed the concerns
for products labeled ``made with organic (specified ingredients or food
group(s))'' by clarifying that the annotation which requires organic
yeast is applicable only to products labeled ``organic.'' One commenter
noted that yeast is an
[[Page 33297]]
organism grown for food and that it should be considered an
agricultural product for listing on section 205.606, rather than
section 205.605. Based on review of the record, the NOSB considered
this perspective during its deliberations before issuing its formal
recommendation to the NOP; therefore, AMS has chosen to retain the
listing on section 205.605, as recommended by the NOSB, rather than
moving the listing to section 205.606.
One commenter was opposed to the proposed amendment for yeast and
supported the existing listing. The commenter noted that organic yeast
is only available in dry form, not fresh. In addition, the commenter
claimed that leavening activity in organic yeast is much lower than
conventional yeast and that organic yeast is costly, and, therefore, is
not equivalent in performance and cost. AMS notes that the current
annotation permits the use of nonorganic yeast when organic yeast is
not commercially available. Under the NOP regulations, section 205.2,
commercially available is defined as the ability to obtain a production
input in an appropriate form, quality, or quantity to fulfill an
essential function in a system of organic production or handling, as
determined by the certifying agent in the course of reviewing the
organic plan. The commenter's concern about sourcing an appropriate
form (e.g. fresh, rather than dry) or quality (e.g. better leavening
activity) could be considered by the certifying agent to determine
whether nonorganic yeast would be allowed under the regulations in
specific applications. The higher cost of organic yeast is not one of
the permitted criteria for determining commercial availability under
the NOP regulations. The NOSB considered the issues raised by the
commenters, and AMS concludes that the inclusion of a commercial
availability clause addresses the commenter's concern about the
allowance for conventional yeast when organic yeast is not available in
an appropriate form, quality, or quantity.
Silicon Dioxide
The NOP received one comment stating that the listing for silicon
dioxide at section 205.605(b) should be amended to reflect a December
2011 NOSB recommendation on this substance. In their December 2011
recommendation, the NOSB recommended the addition of a restrictive
annotation to specify that silicon dioxide, a synthetic used in
processed products, could only be used if a nonsynthetic alternative
for certain uses is not commercially available. However, the December
2011 NOSB recommendation was not available when drafting the proposed
rule for this 2012 Sunset Review. Therefore, consistent with the
October 2010 NOSB recommendation pertaining to the 2012 Sunset Review
for this substance, AMS published a proposed rule on January 12, 2012,
to renew silicon dioxide at section 205.605(b) as currently listed
(i.e. without annotation). Because the proposal to amend the annotation
for silicon dioxide was not included in the proposed rule and AMS did
not receive public comment on such a change, AMS is not amending the
annotation in this final rule. AMS is, therefore, renewing the existing
listing for silicon dioxide through this final rule as proposed. AMS
intends to address the December 2011 NOSB recommendation for this
substance through a separate rulemaking action for National List
amendments.
Xanthan Gum
AMS received one comment from a trade association in support of
relisting xanthan gum; however, this commenter also suggested
reclassifying the substance as nonsynthetic and relisting it at section
205.605(a) of the National List. This commenter describes xanthan gum
as a natural extracellular polysaccharide. The NOSB reviewed xanthan
gum in April 2010 and did not propose any change in classification at
that time. Therefore, AMS is renewing the listing for xanthan gum as
codified.
Pectin
In accordance with the October 2010 NOSB recommendation, the NOP
proposed to remove the listing of synthetic pectin (low methoxy) at
section 205.605(b), and to amend the listing for pectin (high-methoxy)
at section 205.606(t) to ``Pectin (non-amidated forms only).'' The NOP
received five comments in support of these proposed changes from trade
associations, a beverage and dairy products manufacturer, and a
consulting firm. The commenters agreed generally that non-amidated
forms of pectin are adequate for use in organic products.
One commenter opposed the proposed changes for technical reasons.
This commenter disagreed with the October 2010 NOSB recommendation that
considered both low-methoxy and high-methoxy pectin to be derived from
a similar non-synthetic extraction process, with the difference in the
final substance resulting from a longer extraction period. The
commenter pointed out that the low-methoxy pectin is produced as a
result of esterification (by removal of methyl groups, or
demethylation) of high-methoxy pectin which is initially derived from
citrus peel or apple pomace.\12\ This commenter agreed that amidated
forms of pectin (forms treated with ammonia) are not necessary for use
in organic production, but noted that only low-methoxy pectin is
available in amidated form. This commenter suggested that the listing
at section 205.605(b) be amended to: ``Low-methoxy pectin, non-amidated
forms only'' and that the existing listing for high-methoxy pectin be
retained at section 205.606.
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\12\ This process is also described in the 2009 Technical Report
for Non Amidated Low Methoxyl Pectin. Available at NOP Web site:
https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5087206.
---------------------------------------------------------------------------
While AMS believes that the commenter has merit regarding technical
classification of the substance, the intent of the NOSB was to require
that all forms of pectin used in organic products be subject to the
requirement that organic sources be used when commercially available.
Therefore, consistent with the intent of the NOSB, we have retained the
proposed amendments for pectin in this final rule.
Colors
AMS received four comments in support of the proposed amendment to
the listing for colors at section 205.606(d). The proposed listing was
``Colors derived from agricultural products--Must not be produced using
synthetic solvents and carrier systems or any artificial
preservative.'' These commenters, however, requested that AMS clarify
whether synthetic substances allowed under section 205.605(b) for
solvent extraction, or as carriers, preservatives or stabilizers, and
which are currently allowed for use in organic colors, would also be
allowed for use in nonorganic colors at section 205.606. Commenters
specifically referenced ascorbic acid, carbon dioxide, glycerin,
silicon dioxide and tocopherols, as examples of substances listed at
section 205.605(b), which are currently allowed to produce organic
colors. These substances were previously recommended by the NOSB and
are currently codified as allowed synthetics at section 205.605(b) of
the National List. The commenters requested clarification as to whether
such substances at section 205.605(b) would still be allowed in the
production of nonorganic colors under the proposed amendment.
At their October 2010 meeting, the NOSB discussed the need for an
annotation to clarify the allowance of synthetic solvents in the
preparation of
[[Page 33298]]
the colors listed on section 205.606.\13\ The NOSB recommended an
amendment to restrict the use of synthetic solvents, carrier systems
and artificial preservatives in the production of colors. However, in
their recommendation, the NOSB did not address whether this restriction
would apply to synthetics already listed at section 205.605(b).
---------------------------------------------------------------------------
\13\ This NOSB discussion is available on the NOP Web site in
the meeting transcript for Oct. 26, 2010 at https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5088302&acct=nosb.
---------------------------------------------------------------------------
The NOSB has already reviewed and recommended the synthetics listed
at section 205.605(b) of the National List. Therefore, the synthetics
listed at section 205.605(b) of the National List are already allowed
in organic processed products, including in the formulation of colors.
AMS believes the intent of the NOSB recommendation for colors is to
prevent the use of synthetic substances that are not on the National
List in the formulation of colors. Substances at section 205.605(b) of
the National List will still be allowed in the production of nonorganic
colors under the amendment.
One commenter stated that unrestricted use of synthetic solvents or
carriers permitted by FDA should be acceptable in colors used for
organic production. AMS disagrees with this comment. While certain
synthetic solvents or carriers may be permitted by FDA, these
synthetics would need to be petitioned and reviewed by the NOSB for
inclusion on the National List under the NOP regulations.
Some commenters requested that AMS provide a one year compliance
date from the effective date of the amendment to colors. Commenters
stated that, while they believe that colors that comply with the
amendment are available, manufacturers will need time to reformulate
products that contained colors produced with synthetic solvents or
carrier systems no longer allowed under the amendment. Based on the
comments received, AMS understands that some product reformulation may
be necessary. The effective date for this amendment is June 27, 2012,
the sunset date for the current listing for colors. While this
amendment is effective on June 27, 2012, AMS considers a one year
period from that date as reasonable and appropriate for the industry to
reformulate products in order to ensure that the amendment is
effectively and rationally implemented. AMS will be conducting outreach
to the industry and training for certifying agents as appropriate.
Cornstarch
AMS received one comment opposed to the continued listing of
cornstarch (native) at section 205.606(w)(1) of the National List. This
commenter cited several sources for organic cornstarch that include a
number of types for different applications, and suggested that
nonorganic cornstarch should no longer be given an exemption for
organic use. The commenter also believes that nonorganic cornstarch
should not be included on the National List since most nonorganic
sources could be derived from genetically engineered corn.
During the October 2010 NOSB deliberations on the 2012 Sunset
Review for cornstarch, the NOSB did not receive public comments
objecting to relisting of cornstarch, and received several in support
of relisting on section 205.606. In their review, the NOSB did not
identify risks to the environment, human or animal health resulting
from the use or manufacture of the substance. Based upon the NOSB's
recommendation, AMS is relisting cornstarch as codified at section
205.606. AMS notes that all nonorganic ingredients, including
cornstarch, used in products labeled ``organic'' or ``made with organic
(specified ingredients or food group(s)'' must not be produced using
excluded methods, and that organic cornstarch should be used if
commercially available.
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 renewed or reauthorized with amended
annotations on the National List were most recently reauthorized for
use in organic agriculture on June 27, 2007, October 21, 2007, December
11, 2007, and December 13, 2007. In the case of substances reauthorized
for use on June 27, 2007 and due to expire on June 27, 2012, the
substances being renewed and amended are critical to organic production
and handling operations.
Accordingly, pursuant to 5 U.S.C. 553, it is found and determined
that good cause exists for not postponing the effective date for
amendments and renewals contained in this rule that are due to expire
on June 27, 2012, until 30 days after publication in the Federal
Register. The effective dates for all substances are indicated in the
Appendix.
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 205.601 is amended by:
0
A. Revising paragraph (a)(2);
0
B. Revising paragraph (g);
0
C. Revising paragraph (i)(11); and
0
D. Revising paragraph (j)(4) to read as follows:
Sec. 205.601 Synthetic substances allowed for use in organic crop
production.
* * * * *
(a) * * *
(2) Chlorine materials--For pre-harvest use, residual chlorine
levels in the water in direct crop contact or as water from cleaning
irrigation systems applied to soil must not exceed the maximum residual
disinfectant limit under the Safe Drinking Water Act, except that
chlorine products may be used in edible sprout production according to
EPA label directions.
(i) Calcium hypochlorite.
(ii) Chlorine dioxide.
(iii) Sodium hypochlorite.
* * * * *
(g) As rodenticides. Vitamin D3.
* * * * *
(i) * * *
(11) Streptomycin, for fire blight control in apples and pears only
until October 21, 2014.
* * * * *
(j) * * *
(4) Lignin sulfonate--chelating agent, dust suppressant.
* * * * *
0
3. Section 205.605 is amended by:
0
A. Revising the annotation for ``Yeast'' under paragraph (a);
0
B. Removing ``Pectin (low-methoxy)'' from paragraph (b); and
0
C. Removing the paragraph for ``Potassium iodide'' from paragraph (b).
The revision reads as follows:
[[Page 33299]]
Sec. 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)).''
* * * * *
(a) * * *
* * * * *
Yeast--When used as food or a fermentation agent in products
labeled as ``organic,'' yeast must be organic if its end use is for
human consumption; nonorganic yeast may be used when organic yeast is
not commercially available. Growth on petrochemical substrate and
sulfite waste liquor is prohibited. For smoked yeast, nonsynthetic
smoke flavoring process must be documented.
* * * * *
0
4. Section 205.606 is amended by:
0
A. Revising paragraph (d);
0
B. Revising paragraph (l); and
0
C. Revising paragraph (t).
0
The revisions read as follows:
Sec. 205.606 Nonorganically produced agricultural products allowed as
ingredients in or on processed products labeled ``organic''.
* * * * *
(d) Colors derived from agricultural products--Must not be produced
using synthetic solvents and carrier systems or any artificial
preservative.
* * * * *
(l) Hops (Humulus lupulus) until January 1, 2013.
* * * * *
(t) Pectin (non-amidated forms only).
* * * * *
Dated: May 30, 2012.
David R. Shipman,
Administrator, Agricultural Marketing Service.
Note: The following Appendix will not appear in the Code of Federal
Regulations.
---------------------------------------------------------------------------
\14\ This Appendix shows a simplified listing for each
substance; use categories and any restrictive annotations are not
included in this overview.
Appendix--Overview of Final Actions for Sunset 2012 \14\
----------------------------------------------------------------------------------------------------------------
National list section Substance NOSB meeting Effective date Final action
----------------------------------------------------------------------------------------------------------------
Sec. 205.601 Synthetic Alcohols April 2011............. June 27, 2012.......... Renew.
substances allowed for use (Ethanol; April 2010 *........... June 27, 2012.......... Renew.
in organic crop production. Isopropanol). April 2010 *........... June 27, 2012.......... Renew.
Ammonium
carbonate.
Aquatic plant
extracts
(other than
hydrolyzed).
Boric acid..... April 2010 *........... June 27, 2012.......... Renew.
Chlorine April 2011............. June 27, 2012.......... Amend: Chlorine
materials at materials--For
Sec. pre-harvest
205.601(a)(2) use, residual
(Calcium chlorine
hypochlorite; levels in the
chlorine water in
dioxide; direct crop
sodium contact or as
hypochlorite). water from
cleaning
irrigation
systems
applied to
soil must not
exceed the
maximum
residual
disinfectant
limit under
the Safe
Drinking Water
Act, except
that chlorine
products may
be used in
edible sprout
production
according to
EPA label
directions.
Coppers, fixed April 2011............. June 27, 2012.......... Renew.
(Copper
hydroxide;
copper oxide;
copper
oxychloride,
includes
products
exempted from
EPA tolerance).
Copper sulfate. April 2011............. June 27, 2012.......... Renew.
Elemental April 2010 *........... June 27, 2012.......... Renew.
sulfur (3
uses).
EPA List 4-- October 2010........... June 27, 2012.......... Renew.
Inerts of
Minimal
Concern.
Ethylene gas... April 2011............. June 27, 2012.......... Renew.
Herbicides, April 2010 *........... June 27, 2012.......... Renew.
soap-based.
Humic acids.... April 2010 *........... June 27, 2012.......... Renew.
Hydrated lime.. April 2010 *........... June 27, 2012.......... Renew.
Hydrogen April 2010 *........... June 27, 2012.......... Renew.
peroxide (2
uses).
Lignin April 2011............. June 27, 2012.......... Amend: Lignin
sulfonate at sulfonate--che
Sec. lating agent,
205.601(j)(4). dust
suppressant.
Lignin April 2011............. June 27, 2012.......... Renew.
sulfonate at
Sec.
205.601(l)(1).
Lime sulfur (2 April 2010 *........... June 27, 2012.......... Renew.
uses).
Liquid fish April 2010 *........... June 27, 2012.......... Renew.
products.
Magnesium April 2011............. June 27, 2012.......... Renew.
sulfate.
Micronutrients April 2010 *........... June 27, 2012.......... Renew.
(Soluble boron
products;
Sulfates,
carbonates,
oxides, or
silicates of
zinc, copper,
iron,
manganese,
molybdenum,
selenium, and
cobalt).
[[Page 33300]]
Mulches April 2011............. June 27, 2012.......... Renew.
(Newspapers or
other recycled
paper, without
glossy or
colored inks;
Plastic mulch
and covers).
Newspapers or April 2011............. June 27, 2012.......... Renew.
other recycled
paper, without
glossy or
colored inks.
Oils, April 2010 *........... June 27, 2012.......... Renew.
horticultural-
narrow range
oils as
dormant,
suffocating,
and summer
oils (2 uses).
Pheromones..... April 2011............. June 27, 2012.......... Renew.
Potassium April 2010 *........... June 27, 2012.......... Renew.
bicarbonate.
Soap-based April 2010 *........... June 27, 2012.......... Renew.
algicide/
demossers.
Soaps, ammonium April 2010 *........... June 27, 2012.......... Renew.
Soaps, April 2010 *........... June 27, 2012.......... Renew.
insecticidal.
Sodium silicate April 2011............. June 27, 2012.......... Renew.
Sticky traps/ April 2010 *........... June 27, 2012.......... Renew.
barriers.
Streptomycin... April 2011............. June 27, 2012.......... Amend:
Streptomycin,
for fire
blight control
in apples and
pears only
until October
21, 2014.
Sucrose April 2010 *........... June 27, 2012.......... Renew.
octanoate
esters (CAS
s--42
922-74-7;
58064-47-4).
Sulfur dioxide. April 2011............. October 21, 2012....... Remove.
Vitamin B1, C, April 2010 *........... June 27, 2012.......... Renew.
and E.
Vitamin D3..... April 2011............. June 27, 2012.......... Renew.
Sec. 205.602 Nonsynthetic Arsenic........ April 2010 *........... June 27, 2012.......... Renew.
substances prohibited for Ash from manure April 2010 *........... June 27, 2012.......... Renew.
use in organic crop burning. April 2010 *........... June 27, 2012.......... Renew.
production. Lead salts.....
Potassium April 2010 *........... June 27, 2012.......... Renew.
chloride.
Sodium April 2010 *........... June 27, 2012.......... Renew.
fluoaluminate
(mined).
Sodium nitrate. April 2011............. ....................... Addressed in
separate
rulemaking
action.
Strychnine..... April 2010 *........... June 27, 2012.......... Renew.
Tobacco dust April 2010 *........... June 27, 2012.......... Renew.
(nicotine
sulfate).
Sec. 205.603 Synthetic Alcohols October 2010........... June 27, 2012.......... Renew.
substances allowed for use (Ethanol; October 2010........... June 27, 2012.......... Renew.
in organic livestock Isopropanol). April 2010 *........... June 27, 2012.......... Renew.
production. Aspirin........ April 2010 *........... June 27, 2012.......... Renew.
Atropine (CAS
-51-5
5-8).
Biologics--Vacc
ines.
Butorphanol April 2010 *........... June 27, 2012.......... Renew.
(CAS -
42408-82-2).
Chlorhexidine.. April 2010 *........... June 27, 2012.......... Renew.
Chlorine October 2010........... June 27, 2012.......... Renew.
materials
(Calcium
hypochlorite;
chlorine
dioxide;
sodium
hypochlorite).
Copper sulfate. October 2010........... June 27, 2012.......... Renew.
Electrolytes... April 2010 *........... June 27, 2012.......... Renew.
EPA List 4-- October 2010........... June 27, 2012.......... Renew.
Inerts of
Minimal
Concern.
Excipients..... April 2010 *........... June 27, 2012.......... Renew.
Flunixin (CAS April 2010 *........... June 27, 2012.......... Renew.
-3867
7-85-9).
Furosemide..... October 2010........... June 27, 2012.......... Renew.
Glucose........ October 2010........... June 27, 2012.......... Renew.
Glycerine...... October 2010........... June 27, 2012.......... Renew.
Hydrogen April 2010 *........... June 27, 2012.......... Renew.
peroxide.
Iodine (2 uses) April 2010 *........... June 27, 2012.......... Renew.
Ivermectin..... April 2010 *........... June 27, 2012.......... Renew.
Lidocaine...... April 2010 *........... June 27, 2012.......... Renew.
Lime, hydrated. April 2010 *........... June 27, 2012.......... Renew.
Magnesium April 2010 *........... June 27, 2012.......... Renew.
hydroxide (CAS
-1309
-42-8).
Magnesium October 2010........... June 27, 2012.......... Renew.
sulfate.
Mineral oil.... April 2010 *........... June 27, 2012.......... Renew.
Oxytocin....... April 2010 *........... June 27, 2012.......... Renew.
Peroxyacetic/ April 2010 *........... June 27, 2012.......... Renew.
peracetic acid
(CAS -
79-21-0).
Phosphoric acid April 2010 *........... June 27, 2012.......... Renew.
Poloxalene (CAS April 2010 *........... June 27, 2012.......... Renew.
-9003
-11-6).
Procaine....... April 2010 *........... June 27, 2012.......... Renew.
[[Page 33301]]
Sucrose April 2010 *........... June 27, 2012.......... Renew.
octanoate
esters (CAS
s--42
922-74-7;
58064-47-4).
Tolazoline (CAS April 2010 *........... June 27, 2012.......... Renew.
-59-9
8-3).
Trace minerals. April 2010 *........... June 27, 2012.......... Renew.
Vitamins....... April 2010 *........... June 27, 2012.......... Renew.
Xylazine (CAS April 2010 *........... June 27, 2012.......... Renew.
-7361
-61-7).
Sec. 205.604 Nonsynthetic Strychnine..... April 2010 *........... June 27, 2012.......... Renew.
substances prohibited for
use in organic livestock
production.
Sec. 205.605(a) Acids (Alginic; April 2010 *........... June 27, 2012.......... Renew.
Nonsynthetic, citric; April 2010 *........... June 27, 2012.......... Renew.
nonagricultural substances lactic). April 2010 *........... June 27, 2012.......... Renew.
allowed as ingredients in Bentonite...... April 2010 *........... June 27, 2012.......... Renew.
or on processed products Calcium April 2010 *........... June 27, 2012.......... Renew.
labeled as ``organic'' or carbonate. April 2010 *........... June 27, 2012.......... Renew.
``made with organic Calcium April 2011............. June 27, 2012.......... Renew.
(specified ingredients or chloride. October 2010........... June 27, 2012.......... Renew.
food group(s))''. Dairy cultures. April 2010 *........... June 27, 2012.......... Renew.
Diatomaceous
earth.
Enzymes........
Flavors........
Kaolin.........
Magnesium October 2010........... June 27, 2012.......... Renew.
sulfate.
Nitrogen....... April 2010 *........... June 27, 2012.......... Renew.
Oxygen......... April 2010 *........... June 27, 2012.......... Renew.
Perlite........ April 2010 *........... June 27, 2012.......... Renew.
Potassium April 2010 *........... June 27, 2012.......... Renew.
chloride.
Potassium April 2011............. June 27, 2012.......... Renew.
iodide.
Sodium April 2010 *........... June 27, 2012.......... Renew.
bicarbonate.
Sodium April 2010 *........... June 27, 2012.......... Renew.
carbonate.
Waxes (Carnauba April 2010 *........... June 27, 2012.......... Renew.
wax; Wood
resin).
Yeast October 2010........... October 21, 2012....... Amend: Yeast--
(Autolysate; When used as
Bakers; food or a
Brewers; fermentation
Nutritional; agent in
Smoked). products
labeled
``organic'',
yeast must be
organic if its
end use is for
human
consumption;
nonorganic
yeast may be
used when
organic yeast
is not
commercially
available.
Growth on
petrochemical
substrate and
sulfite waste
liquor is
prohibited.
For smoked
yeast,
nonsynthetic
smoke
flavoring
process must
be documented.
Sec. 205.605(b) Synthetic, Alginates...... April 2010 *........... June 27, 2012.......... Renew.
nonagricultural substances Ammonium April 2010 *........... June 27, 2012.......... Renew.
allowed as ingredients in bicarbonate. April 2010 *........... June 27, 2012.......... Renew.
or on processed products Ammonium April 2010 *........... June 27, 2012.......... Renew.
labeled as ``organic'' or carbonate. April 2010 *........... June 27, 2012.......... Renew.
``made with organic Ascorbic Acid.. April 2010 *........... June 27, 2012.......... Renew.
(specified ingredients or Calcium citrate April 2010 *........... June 27, 2012.......... Renew.
food group(s))''. Calcium April 2010 *........... June 27, 2012.......... Renew.
hydroxide.
Calcium
phosphates
(monobasic;
dibasic;
tribasic).
Carbon dioxide.
Chlorine October 2010........... June 27, 2012.......... Renew.
materials
(Calcium
hypochlorite;
chlorine
dioxide;
sodium
hypochlorite).
Ethylene....... April 2010 *........... June 27, 2012.......... Renew.
Ferrous sulfate October 2010........... June 27, 2012.......... Renew.
Glycerides April 2010 *........... June 27, 2012.......... Renew.
(mono; di).
Glycerin....... April 2010 *........... June 27, 2012.......... Renew.
Hydrogen April 2010 *........... June 27, 2012.......... Renew.
peroxide.
Magnesium April 2010 *........... June 27, 2012.......... Renew.
carbonate.
Magnesium April 2010 *........... June 27, 2012.......... Renew.
chloride.
Magnesium April 2010 *........... June 27, 2012.......... Renew.
stearate.
Nutrient April 2011............. ....................... Addressed in
vitamins and separate
minerals. rulemaking
action.
Ozone.......... April 2010 *........... June 27, 2012.......... Renew.
Pectin (low- October 2010........... June 27, 2012.......... Remove.
methoxy).
Phosphoric acid October 2010........... June 27, 2012.......... Renew.
Potassium acid April 2010 *........... June 27, 2012.......... Renew.
tartrate.
Potassium April 2010 *........... June 27, 2012.......... Renew.
carbonate.
Potassium April 2010 *........... June 27, 2012.......... Renew.
citrate.
Potassium April 2010 *........... June 27, 2012.......... Renew.
hydroxide.
[[Page 33302]]
Potassium April 2011............. June 27, 2012.......... Remove.
iodide.
Potassium April 2010 *........... June 27, 2012.......... Renew.
phosphate.
Silicon dioxide October 2010........... June 27, 2012.......... Renew.
Sodium citrate. October 2010........... June 27, 2012.......... Renew.
Sodium October 2010........... June 27, 2012.......... Renew.
hydroxide.
Sodium October 2010........... June 27, 2012.......... Renew.
phosphates.
Sulfur dioxide. October 2010........... June 27, 2012.......... Renew.
Tocopherols.... April 2011............. June 27, 2012.......... Renew.
Xanthan gum.... April 2010 *........... June 27, 2012.......... Renew.
Sec. 205.606 Casings, from April 2010 *........... June 27, 2012.......... Renew.
Nonorganically produced processed April 2010 *........... June 27, 2012.......... Renew.
agricultural products intestines. April 2010 *........... June 27, 2012.......... Renew.
allowed as ingredients in Celery powder.. October 2010........... June 27, 2012.......... Amend: Colors
or on processed products Chia (Salvia derived from
labeled as ``organic''. hispanica L.). agricultural
Colors (Annatto products--Must
extract color; not be
Beet juice produced using
extract color; synthetic
Beta-carotene solvents and
extract color; carrier
Black currant systems or any
juice color; artificial
Black/purple preservative.
carrot juice
color;
Blueberry
juice color;
Carrot juice
color; Cherry
juice color;
Chokeberry--Ar
onia juice
color;
Elderberry
juice color;
Grape juice
color; Grape
skin extract
color; Paprika
color; Pumpkin
juice color;
Purple potato
juice color;
Red cabbage
extract color;
Red radish
extract color;
Saffron
extract color;
Turmeric
extract
color). CAS
numbers are
provided in
the Renewals
with Amendment
section.
Cornstarch October 2010........... June 27, 2012.......... Renew.
(native).
Dillweed oil April 2010 *........... June 27, 2012.......... Renew.
(CAS
8006-75-5).
Fish oil (Fatty April 2010 *........... June 27, 2012.......... Renew.
acid CAS
's
10417-94-4 and
25167-62-8).
Fructooligosacc October 2010........... June 27, 2012.......... Renew.
harides (CAS
308066-66-2).
Galangal, April 2010 *........... June 27, 2012.......... Renew.
frozen.
Gelatin (CAS April 2010 *........... June 27, 2012.......... Renew.
9000-
70-8).
Gums (Arabic; April 2010 *........... June 27, 2012.......... Renew.
Guar; Locust
bean; Carob
bean).
Hops (Humulus October 2010........... June 27, 2012.......... Amend: Hops
luplus) at (Humulus
Sec. lupulus) until
205.606(l). January 1,
2013.
Inulin, October 2010........... June 27, 2012.......... Renew.
oligofructose
enriched.
(CAS
9005-80-5).
Kelp........... April 2010 *........... June 27, 2012.......... Renew.
Konjac flour April 2010 *........... June 27, 2012.......... Renew.
(CAS
37220-17-0).
Lemongrass, April 2010 *........... June 27, 2012.......... Renew.
frozen.
Orange shellac-- April 2010 *........... June 27, 2012.......... Renew.
unbleached
(CAS
9000-59-3).
Pectin (high- October 2010........... June 27, 2012.......... Amend: Pectin
methoxy). (non-amidated
forms only).
Peppers April 2010 *........... June 27, 2012.......... Renew.
(chipotle
chile).
Sweet potato April 2010 *........... June 27, 2012.......... Renew.
starch.
Turkish bay April 2010 *........... June 27, 2012.......... Renew.
leaves.
Wakame seaweed April 2010 *........... June 27, 2012.......... Renew.
(Undaria
pinnatifida).
Whey protein October 2010........... June 27, 2012.......... Renew.
concentrate.
----------------------------------------------------------------------------------------------------------------
* The NOSB originally recommended that these substances be relisted during their April 2010 meeting. Since
public comments were still being accepted for these substances, the NOSB decided to reaffirm their
recommendations on these substances at the October 2010 meeting after analyzing all public comments.
[FR Doc. 2012-13523 Filed 6-5-12; 8:45 am]
BILLING CODE 3410-02-P
