[Federal Register Volume 72, Number 93 (Tuesday, May 15, 2007)]
[Proposed Rules]
[Pages 27252-27264]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-2388]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Proposed
Rules
[[Page 27252]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket No. AMS-TM-07-0062; TM-07-06]
RIN 0581-AC71
National Organic Program (NOP)--Proposed Amendments to the
National List of Allowed and Prohibited Substances (Processing)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule.
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SUMMARY: This proposed rule proposes to amend the Department of
Agriculture's (USDA) National List of Allowed and Prohibited Substances
(National List) regulations to enact recommendations submitted to the
Secretary of Agriculture (Secretary) by the National Organic Standards
Board (NOSB) during public meetings held May 6-8, 2002, in Austin,
Texas, and March 27-29, 2007, in Washington, DC. Consistent with the
NOSB recommendations, this proposed rule proposes to add 38 substances,
along with any restrictive annotations, to the National List
regulations.
DATES: Comments must be received by May 22, 2007.
ADDRESSES: Interested persons may comment on this proposed rule using
any of the following procedures:
Mail: Comments may be submitted by mail to Robert Pooler,
Agricultural Marketing Specialist, National Organic Program, USDA/AMS/
TMP/NOP, 1400 Independence Ave., SW., Room 4008-So., Ag Stop 0268,
Washington, DC 20250.
Internet: www.regulations.gov.
Written comments on this proposed rule should be
identified with the docket number AMS-TM-07-0062. Commenters should
identify the topic and section number of this proposed rule to which
the comment refers.
Clearly indicate if you are for or against the proposed
rule or some portion of it and your reason for it. Include
recommendation changes as appropriate.
Include a copy of articles or other references that
support your comments. Only relevant material should be submitted.
All comments to this proposed rule, submitted by any procedure,
will be available for viewing at: www.regulations.gov. Comments
submitted in response to this proposed rule will also be available for
viewing in person at USDA-AMS, Transportation and Marketing, National
Organic Program, Room 4008-South Building, 1400 Independence Ave., SW.,
Washington, DC, from 9 a.m. to 12 noon and from 1 p.m. to 4 p.m.,
Monday through Friday, (except on official Federal holidays). Persons
wanting to view comments received in response to this proposed rule are
requested to make an appointment in advance by calling (202) 720-3252.
FOR FURTHER INFORMATION CONTACT: Robert Pooler, Agricultural Marketing
Specialist or Valerie Frances, NOSB Executive Director, National
Organic Program, USDA/AMS/TM/NOP, Room 4008-So., Ag Stop 0268, 1400
Independence Ave., SW., Washington, DC 20250. Phone: (202) 720-3252.
SUPPLEMENTARY INFORMATION:
I. Background
The Organic Foods Production Act of 1990 (OFPA), as amended, (7
U.S.C. 6501 et seq.), authorizes the establishment of the NOP
regulations. On December 21, 2000, the Secretary established, within
the NOP (7 CFR part 205), the National List regulations Sec. Sec.
205.600 through 205.607. This National List identifies the synthetic
substances that may be used and the non-synthetic substances that may
not be used in organic production. The National List also identifies
synthetic, non-synthetic and non-organic substances that may be used in
organic handling. The OFPA and NOP regulations, in Sec. 205.105,
specifically prohibit the use of any synthetic substance for organic
production and handling unless the synthetic substance is on the
National List. Section 205.105 also requires that any non-organic, non-
synthetic substance used in organic handling must also be on the
National List.
Until recently, producers, handlers and certifying agents may have
misinterpreted National List regulations Sec. 205.606 to mean that any
non-organic agricultural product which was determined by an accredited
certifying agent to be not commercially available in organic form could
be used in organic products, without being individually listed pursuant
to the National List procedures. In January 2005, the First Circuit
Court of Appeal's decision in Harvey v. Johanns found that such an
interpretation is contrary to the plain meaning of the OFPA and held
that 7 CFR 205.606 shall not be interpreted to create a blanket
exemption to the National List requirements specified in Sec. Sec.
6517 and 6518 of the OFPA (7 U.S.C. 6517-6518). Thereafter, consistent
with the district court's final judgment and order, dated June 9, 2005,
on July 1, 2005, the NOP published a notice regarding Sec. 205.606 (70
FR 38090), and on June 7, 2006, published a final rule (71 FR 32803)
revising Sec. 205.606 to clarify that the section shall be interpreted
to permit the use of a non-organically produced agricultural product
only when the product has been listed in Sec. 205.606 pursuant to
National List procedures, and when an accredited certifying agent has
determined that the organic form of the agricultural product is not
commercially available. As a result, any non-organic agricultural
substances that are being used in organic products that are not
specifically listed in Sec. 205.606 pursuant to National List
procedures will render currently certified products in non-compliance
when the district court's final order and judgment on Harvey v. Johanns
becomes fully effective on June 9, 2007.
Under the authority of OFPA and the NOP regulations, the National
List can be amended by the Secretary based upon proposed amendments
developed by the NOSB through the National List petition process. This
proposed rule proposes to amend the National List regulations to enact
recommendations submitted to the Secretary by the NOSB during public
meetings held May 6-8, 2002, and March 27-29, 2007. In these time
periods, the NOSB has recommended that the Secretary add 38 substances
to Sec. 205.606, along with any restrictive annotations, to the
National List regulations.
[[Page 27253]]
A 7-day comment period has been deemed appropriate to allow
interested persons to respond to this proposed rule. Seven days is
deemed appropriate because under the NOP regulations (7 CFR part
205.606) the allowed use of these 38 substances, pursuant to the
district court's final order and judgment on Harvey v. Johanns, will
expire on June 9, 2007. A 7-day comment period will help avoid lapses
in the eligibility of the petitioned substances to be used in organic
handling. Additionally, interested persons have already been provided
with 30 days of public comment on these 38 substances in advance of the
NOSB meetings held May 6-8, 2002, and March 27-29, 2007. The NOSB
considered these comments during their reviews and concluded that the
petitioners had provided sufficient evidence for adding these 38
substances to the National List. Final rulemaking to allow the use of
these 38 petitioned substances, if adopted, should be completed before
June 9, 2007. Any comments that are received timely will be considered
before final determinations are made on these petitioned substances.
II. Overview of Proposed Amendments
The following provides an overview of the proposed amendments to
designated sections of the National List regulations.
Section 205.606 Nonorganically Produced Agricultural Products Allowed
as Ingredients in or on Processed Products Labeled as ``Organic''
This proposed rule would amend Sec. 205.606 of the National List
regulations by adding the following substances:
Color Ingredients From Agricultural Products
Annatto extract color, (pigment CAS 1393-63-1). Annatto
extract color was petitioned for use as a non-organic agricultural
ingredient in or on processed products labeled as ``organic.'' Annatto
extract color is used as a natural color additive in a variety of
foods. Its use as a color additive in food products is regulated by the
Food and Drug Administration (FDA) (21 CFR 73.30). Depending on the
concentration used, annatto extract color adds a deep orange to light
yellow color to foods. Annatto extract color is a liquid derived from
physical or oil extraction of annatto seeds (Bixaceae bixa orellana).
The major pigments in annatto extract color are classified as
Carotenoids which are insoluble in water, partially soluble in ethanol,
and soluble in vegetable oils. Fruit and vegetable extracts containing
Carotenoids are heat and light sensitive, but also display antioxidant
properties that may be beneficial to human health.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding annatto extract color to the National List for use
in organic handling as a non-organic agricultural ingredient when the
organic form of annatto extract color is considered commercially
unavailable. In this open meeting, the NOSB evaluated annatto extract
color against evaluation criteria established by 7 U.S.C. 6517 and 6518
of the OFPA and NOP criteria (72 FR 2167) on commercial availability,
received public comment, and concluded that annatto extract color is
consistent with OFPA evaluation criteria and NOP commercial
availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of annatto extract color in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow annatto extract color as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
Beet juice extract color, (pigment CAS 7659-95-2). Beet
juice extract color was petitioned for use as a non-organic
agricultural ingredient in or on processed products labeled as
``organic.'' Beet juice extract color is used as a natural color
additive in a variety of foods. Its use as a color additive in food
products is regulated by FDA (21 CFR 73.40). Depending on the beet
source, concentration used and pH, beet juice extract color adds a
yellow, red or pink color to foods. Beet juice extract color is a
liquid derived from beets (Amaranthaceae beta vulgaris) through aqueous
and physical extraction. Powder forms are derived from drying extracts.
The principle pigment in beet juice extract color is Betanin or
beetroot red. This pigment is grouped in a class of pigments known as
Betalains. These pigments are soluble in water, insoluble in ethanol,
and are found only in a few plant families. Betalain pigments are well
suited for use in low acid foods, complement Anthocyanin pigments in
food coloring, and may have antioxidant capability that may be
beneficial to human health.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding beet juice extract color to the National List for
use in organic handling as a non-organic agricultural ingredient when
the organic form of beet juice extract color is considered commercially
unavailable. In this open meeting, the NOSB evaluated beet juice
extract color against evaluation criteria established by 7 U.S.C. 6517
and 6518 of the OFPA and NOP criteria (72 FR 2167) on commercial
availability, received public comment, and concluded that beet juice
extract color is consistent with OFPA evaluation criteria and NOP
commercial availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of beet juice extract color in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow beet juice extract color as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
Beta-Carotene extract color from carrots (CAS 1393-63-1).
Beta-Carotene extract color was petitioned for use as a non-organic
agricultural ingredient in or on processed products labeled as
``organic.'' Beta-Carotene extract color is used as a natural color
additive in a variety of foods. Its use as a color additive in food
products is regulated by FDA (21 CFR 73.95). Depending on the
concentration used, Beta-Carotene extract color adds a deep orange to
light yellow color to foods. Beta-Carotene extract color is a liquid
derived from carrots (Apiaceae daucus carota) through physical
extraction in vegetable oil. The final extract product is a dark orange
viscous concentrate. The major pigments in Beta-Carotene extract color
are Carotenoids.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding Beta-Carotene extract color from carrots to the
National List for use in organic handling as a non-organic agricultural
ingredient when the organic form of Beta-Carotene extract color is
considered commercially unavailable. In this open meeting, the NOSB
evaluated Beta-Carotene extract color against evaluation criteria
established by 7 U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72
FR 2167) on commercial availability, received public comment, and
concluded that Beta-Carotene extract color is consistent with OFPA
evaluation criteria and NOP commercial availability criteria.
Therefore, in response to the NOSB recommendation regarding the use of
Beta-Carotene extract color in organic handling, the Secretary proposes
to amend Sec. 205.606 of the National List regulations to allow Beta-
Carotene extract color from carrots as a non-organically produced
agricultural product allowed as an ingredient in or on processed
products labeled as ``organic.''
[[Page 27254]]
Black currant juice color (pigment CAS 's: 528-58-5, 528-
53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3). Black currant juice
color was petitioned for use as a non-organic agricultural ingredient
in or on processed products labeled as ``organic.'' Black currant juice
color is used as a natural color additive in a variety of foods. Its
use as a color additive in food products is regulated by FDA (21 CFR
73.250). Depending on the concentration used, Black currant juice color
adds a bright red to blue-purple color to foods. Black currant juice
color is a liquid derived from black currant fruit (Grossulariaceae
ribes nigrum) through aqueous and physical extraction. Powder forms are
derived from drying extracts. The major pigments in Black currant juice
color are classified as Anthocyanins which are soluble in water.
Anthocyanins are polyphenolic natural pigments that are present in many
plant species and frequently occur as glycosides in various
combinations that produce colors such as orange, red, blue or purple.
Fruit and vegetable extracts containing Anthocyanins are usually stable
to UV light and temperature, but are sensitive to the presence of
oxygen or metal ions such as iron or aluminum. Anthocyanin pigments may
have increased color intensity and stability in moderately acidic
solutions.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding Black currant juice color to the National List for
use in organic handling as a non-organic agricultural ingredient when
the organic form of Black currant juice color is considered
commercially unavailable. In this open meeting, the NOSB evaluated
Black currant juice color against evaluation criteria established by 7
U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72 FR 2167) on
commercial availability, received public comment, and concluded that
Black currant juice color is consistent with OFPA evaluation criteria
and NOP commercial availability criteria. Therefore, in response to the
NOSB recommendation regarding the use of Black currant juice color in
organic handling, the Secretary proposes to amend Sec. 205.606 of the
National List regulations to allow Black currant juice color as a non-
organically produced agricultural product allowed as an ingredient in
or on processed products labeled as ``organic.''
Black/Purple carrot juice color (pigment CAS 's: 528-58-5,
528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3). Black/Purple
carrot juice color was petitioned for use as a non-organic agricultural
ingredient in or on processed products labeled as ``organic.'' Black/
Purple carrot juice color is used as a natural color additive in a
variety of foods. Its use as a color additive in food products is
regulated by FDA (21 CFR 73.300). Depending on the concentration used,
black/purple carrot juice color adds a deep blue-purple-black color to
foods. Black/Purple carrot juice color is a liquid extract derived from
black or purple carrots (Apiaceae daucus carota) through aqueous and
physical extraction. Powder forms are derived from drying extracts. The
pigments in black/purple carrot juice color are water soluble
Anthocyanins.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding black/purple carrot juice color to the National List
for use in organic handling as a non-organic agricultural ingredient
when the organic form of black/purple carrot juice color is considered
commercially unavailable. In this open meeting, the NOSB evaluated
black/purple carrot juice color against evaluation criteria established
by 7 U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72 FR 2167) on
commercial availability, received public comment, and concluded that
black/purple carrot juice color is consistent with OFPA evaluation
criteria and NOP commercial availability criteria. Therefore, in
response to the NOSB recommendation regarding the use of black/purple
carrot juice color in organic handling, the Secretary proposes to amend
Sec. 205.606 of the National List regulations to allow black/purple
carrot juice color as a non-organically produced agricultural product
allowed as an ingredient in or on processed products labeled as
``organic.''
Blueberry juice color (pigment CAS 's: 528-58-5, 528-53-0,
643-84-5, 134-01-0, 1429-30-7, and 134-04-3). Blueberry juice color was
petitioned for use as a non-organic agricultural ingredient in or on
processed products labeled as ``organic.'' Blueberry juice color is
used as a natural color additive in a variety of foods. Its use as a
color additive in food products is regulated by FDA (21 CFR 73.250).
Depending on the concentration used, Blueberry juice color adds a blue
to red color to foods. Blueberry juice color is a liquid derived from
blueberry fruit (Vaccinium cyanococcus) through physical extraction.
The major pigments in Blueberry juice color are water soluble
Anthocyanins.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding Blueberry juice color to the National List for use
in organic handling as a non-organic agricultural ingredient when the
organic form of Blueberry juice color is considered commercially
unavailable. In this open meeting, the NOSB evaluated Blueberry juice
color against evaluation criteria established by 7 U.S.C. 6517 and 6518
of the OFPA and NOP criteria (72 FR 2167) on commercial availability,
received public comment, and concluded that Blueberry juice color is
consistent with OFPA evaluation criteria and NOP commercial
availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of Blueberry juice color in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow Blueberry juice color as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
Carrot juice color, (pigment CAS 1393-63-1). Carrot juice
color was petitioned for use as a non-organic agricultural ingredient
in or on processed products labeled as ``organic.'' Carrot juice color
is used as a natural color additive in a variety of foods. Its use as a
color additive in food products is regulated by FDA (21 CFR 73.300).
Depending on the concentration used, Carrot juice color adds a deep
organic to light yellow color to foods. Carrot juice color is a liquid
derived from carrots (Apiaceae daucus carota) through physical
extraction. The major pigments in Carrot juice color are Carotenoids.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding Carrot juice color to the National List for use in
organic handling as a non-organic agricultural ingredient when the
organic form of Carrot juice color is considered commercially
unavailable. In this open meeting, the NOSB evaluated Carrot juice
color against evaluation criteria established by 7 U.S.C. 6517 and 6518
of the OFPA and NOP criteria (72 FR 2167) on commercial availability,
received public comment, and concluded that Carrot juice color is
consistent with OFPA evaluation criteria and NOP commercial
availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of Carrot juice color in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow Carrot juice color as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
[[Page 27255]]
Cherry juice color, (pigment CAS 's: 528-58-5, 528-53-0,
643-84-5, 134-01-0, 1429-30-7, and 134-04-3). Cherry juice color was
petitioned for use as a non-organic agricultural ingredient in or on
processed products labeled as ``organic.'' Cherry juice color is used
as a natural color additive in a variety of foods. Its use as a color
additive in food products is regulated by FDA (21 CFR 73.250).
Depending on the concentration used and solution pH, cherry juice color
adds a pink to blue-red color to foods. Cherry juice color is a liquid
derived from cherry fruit (Prunus cerasus L.) through aqueous and
physical extraction. The major pigments in Cherry juice color are water
soluble Anthocyanins.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding cherry juice color to the National List for use in
organic handling as a non-organic agricultural ingredient when the
organic form of cherry juice color is considered commercially
unavailable. In this open meeting, the NOSB evaluated cherry juice
color against evaluation criteria established by 7 U.S.C. 6517 and 6518
of the OFPA and NOP criteria (72 FR 2167) on commercial availability,
received public comment, and concluded that cherry juice color is
consistent with OFPA evaluation criteria and NOP commercial
availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of cherry juice color in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow cherry juice color as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
Chokeberry--Aronia juice color (pigment CAS 's: 528-58-5,
528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3). Chokeberry--
Aronia juice color was petitioned for use as a non-organic agricultural
ingredient in or on processed products labeled as ``organic.''
Chokeberry--Aronia juice color is used as a natural color additive in a
variety of foods. Its use as a color additive in food products is
regulated by FDA (21 CFR 73.250). Depending on the concentration used,
chokeberry--aronia juice color adds a bright red to blue-purple color
to foods. Chokeberry--aronia juice color is a liquid derived from the
chokeberry fruit (Grossulariaceae ribes nigrum) through aqueous and
physical extraction. Powder forms are derived from drying extracts. The
major pigments in chokeberry--aronia juice color are Anthocynanins.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding chokeberry--aronia juice color to the National List
for use in organic handling as a non-organic agricultural ingredient
when the organic form of chokeberry--aronia juice color is considered
commercially unavailable. In this open meeting, the NOSB evaluated
chokeberry--aronia juice color against evaluation criteria established
by 7 U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72 FR 2167) on
commercial availability, received public comment, and concluded that
chokeberry--aronia juice color is consistent with OFPA evaluation
criteria and NOP commercial availability criteria. Therefore, in
response to the NOSB recommendation regarding the use of chokeberry--
aronia juice color in organic handling, the Secretary proposes to amend
Sec. 205.606 of the National List regulations to allow chokeberry--
aronia juice color as a non-organically produced agricultural product
allowed as an ingredient in or on processed products labeled as
``organic.''
Elderberry juice color (pigment CAS 's: 528-58-5, 528-53-
0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3). Elderberry juice color
was petitioned for use as a non-organic agricultural ingredient in or
on processed products labeled as ``organic.'' Elderberry juice color is
used as a natural color additive in a variety of foods. Its use as a
color additive in food products is regulated by FDA (21 CFR 73.250).
Depending on the concentration used, elderberry juice color adds a
bright red to blue-purple color to foods. Elderberry juice color is a
liquid derived from elderberry fruit (Adoxaceae sambucus nigra) through
aqueous and physical extraction. The major pigments in elderberry juice
color are Anthocyanins.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding elderberry juice color to the National List for use
in organic handling as a non-organic agricultural ingredient when the
organic form of elderberry juice color is considered commercially
unavailable. In this open meeting, the NOSB evaluated elderberry juice
color against evaluation criteria established by 7 U.S.C. 6517 and 6518
of the OFPA and NOP criteria (72 FR 2167) on commercial availability,
received public comment, and concluded that elderberry juice color is
consistent with OFPA evaluation criteria and NOP commercial
availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of elderberry juice color in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow elderberry juice color as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
Grape juice color (pigment CAS 's: 528-58-5, 528-53-0,
643-84-5, 134-01-0, 1429-30-7, and 134-04-3). Grape juice Color was
petitioned for use as a non-organic agricultural ingredient in or on
processed products labeled as ``organic.'' Grape juice color is used as
a natural color additive in a variety of foods. Its use as a color
additive in food products is regulated by FDA (21 CFR 73.169).
Depending on the concentration used, grape juice color adds a bright
pink to deep red color to foods. Grape juice color is a liquid derived
from grape fruit (Vitaceae vitis vinifera) through aqueous and physical
extraction. The major pigments in grape juice color are Anthocyanins.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding grape juice color to the National List for use in
organic handling as a non-organic agricultural ingredient when the
organic form of grape juice color is considered commercially
unavailable. In this open meeting, the NOSB evaluated grape juice color
against evaluation criteria established by 7 U.S.C. 6517 and 6518 of
the OFPA and NOP criteria (72 FR 2167) on commercial availability,
received public comment, and concluded that grape juice color is
consistent with OFPA evaluation criteria and NOP commercial
availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of grape juice color in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow grape juice color as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
Grape skin extract color (pigment CAS 's: 528-58-5, 528-
53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3). Grape skin extract
color was petitioned for use as a non-organic agricultural ingredient
in or on processed products labeled as ``organic.'' Grape skin extract
color is used as a natural color additive in a variety of foods. Its
use as a color additive in food products is regulated by FDA (21 CFR
73.170). Depending on the concentration used, grape skin extract color
adds a pink to deep purple color to foods. Grape skin extract color is
a liquid derived from grape fruit (Vitaceae vitis vinifera) through
aqueous and physical extraction. Powder forms are
[[Page 27256]]
derived from drying extracts. The major pigments in grape skin extract
color are Anthocyanins.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding grape skin extract color to the National List for
use in organic handling as a non-organic agricultural ingredient when
the organic form of grape skin extract color is considered commercially
unavailable. In this open meeting, the NOSB evaluated grape skin
extract color against evaluation criteria established by 7 U.S.C. 6517
and 6518 of the OFPA and NOP criteria (72 FR 2167) on commercial
availability, received public comment, and concluded that grape skin
extract color is consistent with OFPA evaluation criteria and NOP
commercial availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of grape skin extract color in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow grape skin extract color as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
Paprika color--dried powder and vegetable oil extract, (CAS
68917-78-2). Paprika color was petitioned for use as a non-
organic agricultural ingredient in or on processed products labeled as
``organic.'' Paprika color is used as a natural color additive in a
variety of foods. Its use as a color additive in food products is
regulated by FDA (21 CFR 73.340 and 73.345). Depending on the
concentration used, Paprika color adds a yellow orange to red orange
color to foods. Paprika color is a ground dried powder or vegetable oil
extracted liquid derived from Capsicium peppers (Capsicum annuum L.).
The principle coloring components of paprika color are considered to be
Carotenoids that are identified as Capsanthgin and Capsorubin.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding paprika color, dried powder and vegetable oil
extract, to the National List for use in organic handling as a non-
organic agricultural ingredient when the organic form of paprika color,
dried powder and vegetable oil extract, is considered commercially
unavailable. In this open meeting, the NOSB evaluated paprika color,
dried powder and vegetable oil extract, against evaluation criteria
established by 7 U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72
FR 2167) on commercial availability, received public comment, and
concluded that paprika color, dried powder and vegetable oil extract,
is consistent with OFPA evaluation criteria and NOP commercial
availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of paprika color, dried powder and
vegetable oil extract, in organic handling, the Secretary proposes to
amend Sec. 205.606 of the National List regulations to allow paprika
color, dried powder and vegetable oil extract, as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
Pumpkin juice color, (pigment CAS 127-40-2). Pumpkin juice
color was petitioned for use as a non-organic agricultural ingredient
in or on processed products labeled as ``organic.'' Pumpkin juice color
is used as a natural color additive in a variety of foods. Its use as a
color additive in food products is regulated by FDA (21 CFR 73.250).
Depending on the concentration used, pumpkin juice color adds a yellow
to orange red color to foods. Pumpkin juice color is a liquid derived
from pumpkin fruit (Concurbita L.) through physical extraction and
effluent concentration. The major pigments in pumpkin juice color are
Carotenoids.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding pumpkin juice color to the National List for use in
organic handling as a non-organic agricultural ingredient when the
organic form of pumpkin juice color is considered commercially
unavailable. In this open meeting, the NOSB evaluated pumpkin juice
color against evaluation criteria established by 7 U.S.C. 6517 and 6518
of the OFPA and NOP criteria (72 FR 2167) on commercial availability,
received public comment, and concluded that pumpkin juice color is
consistent with OFPA evaluation criteria and NOP commercial
availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of pumpkin juice color in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow pumpkin juice color as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
Purple potato juice color, (pigment CAS 's: 528-58-5, 528-
53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3). Purple potato juice
color was petitioned for use as a non-organic agricultural ingredient
in or on processed products labeled as ``organic.'' Purple potato juice
color is used as a natural color additive in a variety of foods. Its
use as a color additive in food products is regulated by FDA (21 CFR
73.260). Depending on solution pH and the concentration used, Purple
potato juice color adds a pink to purple color to foods. Purple potato
juice color is a liquid derived from purple potatoes (Ipomoea batatas
L.) through aqueous and physical extraction. Powder forms are derived
from drying extracts. The major pigments in purple potato juice color
are Anthocyanins.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding purple potato juice color to the National List for
use in organic handling as a non-organic agricultural ingredient when
the organic form of purple potato juice color is considered
commercially unavailable. In this open meeting, the NOSB evaluated
purple potato juice color against evaluation criteria established by 7
U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72 FR 2167) on
commercial availability, received public comment, and concluded that
purple potato juice color is consistent with OFPA evaluation criteria
and NOP commercial availability criteria. Therefore, in response to the
NOSB recommendation regarding the use of purple potato juice color in
organic handling, the Secretary proposes to amend Sec. 205.606 of the
National List regulations to allow purple potato juice color as a non-
organically produced agricultural product allowed as an ingredient in
or on processed products labeled as ``organic.''
Red cabbage extract color (pigment CAS 's: 528-58-5, 528-
53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3). Red cabbage extract
color was petitioned for use as a non-organic agricultural ingredient
in or on processed products labeled as ``organic.'' Red cabbage extract
color is used as a natural color additive in a variety of foods. Its
use as a color additive in food products is regulated by FDA (21 CFR
73.260). Depending on the concentration used, red cabbage extract color
adds a red or pink color to foods. Red cabbage extract color is a
liquid derived from red cabbage (Brassicadeae brissica oleracea)
through aqueous and physical extraction. Powder forms are derived from
drying extracts. The major pigments in red cabbage extract color are
Anthocyanins.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding red cabbage extract color to the National List for
use in organic handling as a non-organic
[[Page 27257]]
agricultural ingredient when the organic form of red cabbage extract
color is considered commercially unavailable. In this open meeting, the
NOSB evaluated red cabbage extract color against evaluation criteria
established by 7 U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72
FR 2167) on commercial availability, received public comment, and
concluded that Red cabbage extract color is consistent with OFPA
evaluation criteria and NOP commercial availability criteria.
Therefore, in response to the NOSB recommendation regarding the use of
red cabbage extract color in organic handling, the Secretary proposes
to amend Sec. 205.606 of the National List regulations to allow red
cabbage extract color as a non-organically produced agricultural
product allowed as an ingredient in or on processed products labeled as
``organic.''
Red radish extract color (pigment CAS 's: 528-58-5, 528-
53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3). Red radish extract
color was petitioned for use as a non-organic agricultural ingredient
in or on processed products labeled as ``organic.'' Red radish extract
color is used as a natural color additive in a variety of foods. Its
use as a color additive in food products is regulated by FDA (21 CFR
73.260). Depending on the concentration used, red radish extract color
adds a red to pink color to foods. Red radish extract color is a liquid
derived from red radish (Brassicaceae raphinus sativus) through aqueous
and physical extraction. Powder forms are derived from drying extracts.
The major pigments in red radish extract color are water soluble
Anthocyanins.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding red radish extract color to the National List for
use in organic handling as a non-organic agricultural ingredient where
the organic form of red radish extract color is considered commercially
unavailable. In this open meeting, the NOSB evaluated red radish
extract color against evaluation criteria established by 7 U.S.C. 6517
and 6518 of the OFPA and NOP criteria (72 FR 2167) on commercial
availability, received public comment, and concluded that red radish
extract color is consistent with OFPA evaluation criteria and NOP
commercial availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of red radish extract color in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow red radish extract color as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
Saffron extract color (pigment CAS 1393-63-1). Saffron
extract color was petitioned for use as a non-organic agricultural
ingredient in or on processed products labeled as ``organic.'' Saffron
extract color is used as a natural color additive in a variety of
foods. Its use as a color additive in food products is regulated by FDA
(21 CFR 73.500). Depending on the concentration used, saffron extract
color adds a bright yellow to orange color to foods. Saffron extract
color is a powder derived from stigmas of the Autumn Crocus blossoms
(Crocus sativus) that are dried and ground. The predominant color
pigment in saffron extract color is Crocin, a tetraterpene Carotenoid.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding saffron extract color to the National List for use
in organic handling as a non-organic agricultural ingredient when the
organic form of saffron extract color is considered commercially
unavailable. In this open meeting, the NOSB evaluated saffron extract
color against evaluation criteria established by 7 U.S.C. 6517 and 6518
of the OFPA and NOP criteria (72 FR 2167) on commercial availability,
received public comment, and concluded that saffron extract color is
consistent with OFPA evaluation criteria and NOP commercial
availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of saffron extract color in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow saffron extract color as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
Turmeric extract color, (CAS 458-37-7). Turmeric extract
color was petitioned for use as a non-organic agricultural ingredient
in or on processed products labeled as ``organic.'' Turmeric extract
color is used as a natural color additive in a variety of foods. Its
use as a color additive in food products is regulated by FDA (21 CFR
73.600). Depending on the concentration used, turmeric extract color
adds a bright yellow color to foods. Turmeric extract color is a liquid
derived from the rhizomes of the plant Curcuma longa, a member of the
ginger family Zingiberaceae, through physical extraction in vegetable
oil. The major pigments in turmeric extract color are Curcumunoids
which are reported to be strong antioxidants.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding turmeric extract color to the National List for use
in organic handling as a non-organic agricultural ingredient when the
organic form of turmeric extract color is considered commercially
unavailable. In this open meeting, the NOSB evaluated turmeric extract
color against evaluation criteria established by 7 U.S.C. 6517 and 6518
of the OFPA and NOP criteria (72 FR 2167) on commercial availability,
received public comment, and concluded that turmeric extract color is
consistent with OFPA evaluation criteria and NOP commercial
availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of turmeric extract color in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow turmeric extract color as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
Ingredients or Processing Aids From Agricultural Products
Casings, from processed intestines (no CAS ). Casings,
from processed intestines was petitioned for use as a non-organic
agricultural ingredient in or on processed products labeled as
``organic.'' Casings from processed intestines are used as sheaths in
the manufacture of sausage and a variety of other meat products. Its
use in the manufacture of meat products is regulated by the USDA (9 CFR
parts 317 and 38). Casings are derived from processed intestines
primarily from the bovine, ovine or porcine animal species. The
justification for adding non-organic casings to the National List is
based upon insufficient availability of processed intestines from
organically produced animals.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding casings from processed intestines to the National
List for use in organic handling as a non-organic agricultural
ingredient where the organic form of casings is considered commercially
unavailable. In this open meeting, the NOSB evaluated casings from
processed intestines against evaluation criteria established by 7
U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72 FR 2167) on
commercial availability, received public comment, and concluded that
casings from processed intestines is consistent with OFPA evaluation
criteria and NOP commercial availability criteria. Therefore, in
response to the NOSB recommendation regarding the use of casings from
[[Page 27258]]
processed intestines in organic handling, the Secretary proposes to
amend Sec. 205.606 of the National List regulations to allow casings
from processed intestines as a non-organically produced agricultural
product allowed as an ingredient in or on processed products labeled as
``organic.''
Celery powder (No CAS ). Celery powder was petitioned for
use as a non-organic agricultural ingredient in or on processed
products labeled as ``organic.'' This substance is used on meat
products to facilitate the natural curing of meat. Its general use in
food products is regulated by FDA (21 CFR 182.10). When applied to meat
products, celery powder provides a concentrated source of nitrate that
is converted to nitrite by reacting with myoglobin, a component in the
meat tissue. This curing process inhibits growth of undesirable
microorganisms, retains color and preserves the flavors of meats.
Celery powder is a light green powder obtained from processing celery
plant tissue by cutting, grinding, drying, pulping, or similar
processing of tissues as described under FDA (21 CFR 101.22).
At its March 27-29, 2007 meeting in Washington, DC, the NOSB
recommended adding celery powder to the National List for use in
organic handling as a non-organic agricultural ingredient when the
organic form of celery powder is considered commercially unavailable.
In this open meeting, the NOSB evaluated celery powder against
evaluation criteria established by 7 U.S.C. 6517 and 6518 of the OFPA
and NOP criteria (72 FR 2167) on commercial availability, received
public comment, and concluded that celery powder is consistent with
OFPA evaluation criteria and NOP commercial availability criteria.
Therefore, in response to the NOSB recommendation regarding the use of
celery powder in organic handling, the Secretary proposes to amend
Sec. 205.606 of the National List regulations to allow celery powder
as a non-organically produced agricultural product allowed as an
ingredient in or on processed products labeled as ``organic.''
Chia (Salvia hispanica L.) (no CAS ). Chia was petitioned
for use as a non-organic agricultural ingredient in or on processed
products labeled as ``organic.'' Chia is used as an ingredient in a
variety of foods such as baked goods and beverages. Its use in food
products is regulated by FDA (21 CFR 182.10). Chia is an annual herb
grown in Central America, considered to be gluten free, provides both
soluble and insoluble dietary fiber, and is a good source of omega-3
fatty acids. In some regions, chia is primarily cultivated for its
seeds which are known to have a high concentration of omega-3 fatty
acids.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding chia to the National List for use in organic
handling as a non-organic agricultural ingredient where the organic
form of chia is considered commercially unavailable. In this open
meeting, the NOSB evaluated chia against evaluation criteria
established by 7 U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72
FR 2167) on commercial availability, received public comment, and
concluded that chia is consistent with OFPA evaluation criteria and NOP
commercial availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of chia in organic handling, the
Secretary proposes to amend Sec. 205.606 of the National List
regulations to allow chia as a non-organically produced agricultural
product allowed as an ingredient in or on processed products labeled as
``organic.''
Dillweed oil, (CAS 8006-75-5). Dillweed oil was petitioned
for use as a non-organic agricultural ingredient in or on processed
products labeled as ``organic.'' Dillweed oil is used as a flavoring
agent in organic dill pickle production. The flavor and aroma
components of dillweed oil are attributed to substances classified as
Monoterpenes--Carvone, Limonene and Phellandrene. Dillweed oil is a
colorless to pale yellow or yellow clear liquid that is insoluble in
water and its use in food products is regulated by FDA (21 CFR
184.1282). After harvest, the dillweed plant (Anethum graveolens) is
steam distilled and the dillweed oil is collected in the condensate.
This oil is then standardized to achieve the desired flavor properties.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding dillweed oil to the National List for use in organic
handling as a non-organic agricultural ingredient where the organic
form of dillweed oil is considered commercially unavailable. In this
open meeting, the NOSB evaluated dillweed oil against evaluation
criteria established by 7 U.S.C. 6517 and 6518 of the OFPA and NOP
criteria (72 FR 2167) on commercial availability, received public
comment, and concluded that dillweed oil is consistent with OFPA
evaluation criteria and NOP commercial availability criteria.
Therefore, in response to the NOSB recommendation regarding the use of
dillweed oil in organic handling, the Secretary proposes to amend Sec.
205.606 of the National List regulations to allow dillweed oil as a
non-organically produced agricultural product allowed as an ingredient
in or on processed products labeled as ``organic.''
Fish oil (Fatty acid CAS 's: 10417-94-4, and 25167-62-8).
Fish oil was petitioned for use as a non-organic agricultural
ingredient in or on processed products labeled as ``organic.'' Fish oil
is used as an ingredient in a variety of foods such as baked goods,
cereals, cheese products, and soups. Its use in food products is
regulated by FDA (21 CFR 184). A primary purpose for adding fish oil as
an ingredient to foods is to elevate the omega-3 fatty acid content of
foods. Fish oil is a mixture of fatty acids with two omega-3 fatty
acids, Eicosapentaenoic acid and Docosahexaenoic acid as the principle
fatty acid components. It is a liquid that is extracted and refined
from fish by-product sourced from high fat containing fish species such
as salmon, tuna, anchovy and sardines.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding fish oil to the National List for use in organic
handling as a non-organic agricultural ingredient where the organic
form of fish oil is considered commercially unavailable. In this open
meeting, the NOSB evaluated fish oil against evaluation criteria
established by 7 U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72
FR 2167) on commercial availability, received public comment, and
concluded that fish oil is consistent with OFPA evaluation criteria and
NOP commercial availability criteria. Therefore, in response to the
NOSB recommendation regarding the use of fish oil in organic handling,
the Secretary proposes to amend Sec. 205.606 of the National List
regulations to allow fish oil as a non-organically produced
agricultural product allowed as an ingredient in or on processed
products labeled as ``organic.''
Fructooligosaccharides (CAS 308066-66-2).
Fructooligosaccharides was petitioned for use as a non-organic
agricultural ingredient in or on processed products labeled as
``organic.'' Fructooligosaccharides is used as an ingredient in a
variety of food products. Its use in food products is regulated by FDA
(21 CFR 172.892). A primary purpose for adding fructooligosaccharides
as an ingredient to foods is to serve as a bulking agent by providing
prebiotic fiber to foods. Fructooligosaccharides are naturally present
in several vegetables, fruits and
[[Page 27259]]
grains that may be components of standard diets. This substance is
commercially produced by subjecting sucrose to heated fermentation with
an Aspergillus japonicus derived enzyme. The inclusion of this non-
digestible carbohydrate is thought to promote a more favorable
intestinal microbial composition which may be beneficial to human
health.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding fructooligosaccharides to the National List for use
in organic handling as a non-organic agricultural ingredient where the
organic form of fructooligosaccharides is considered commercially
unavailable. In this open meeting, the NOSB evaluated
fructooligosaccharides against evaluation criteria established by 7
U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72 FR 2167) on
commercial availability, received public comment, and concluded that
fructooligosaccharides is consistent with OFPA evaluation criteria and
NOP commercial availability criteria. Therefore, in response to the
NOSB recommendation regarding the use of fructooligosaccharides in
organic handling, the Secretary proposes to amend Sec. 205.606 of the
National List regulations to allow fructooligosaccharides as a non-
organically produced agricultural product allowed as an ingredient in
or on processed products labeled as ``organic.''
Galangal--frozen (no CAS ). Galangal--frozen, was
petitioned for use as a non-organic agricultural ingredient in or on
processed products labeled as ``organic.'' Galangal is used as a
flavoring ingredient in a variety of foods. Its use as an ingredient in
food products is regulated by FDA (21 CFR 182.10). The essential oils
(aroma components) and flavoring capacity of galangal varies with the
source of galangal. Fresh or frozen galangal provides more of the aroma
essential oils and flavoring capacity compared to dried galangal.
Galangal is derived from knobby galanga rhizome or rootstock (Alpina
galanga, Alpina officinarum). It is a ginger-like rootstock with an
orange-brown or pale red surface and woody texture.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding frozen galangal to the National List for use in
organic handling as a non-organic agricultural ingredient where the
organic form of frozen galangal is considered commercially unavailable.
In this open meeting, the NOSB evaluated frozen galangal against
evaluation criteria established by 7 U.S.C. 6517 and 6518 of the OFPA
and NOP criteria (72 FR 2167) on commercial availability, received
public comment, and concluded that frozen galangal is consistent with
OFPA evaluation criteria and NOP commercial availability criteria.
Therefore, in response to the NOSB recommendation regarding the use of
frozen galangal, in organic handling, the Secretary proposes to amend
Sec. 205.606 of the National List regulations to allow frozen
galangal, as a non-organically produced agricultural product allowed as
an ingredient in or on processed products labeled as ``organic.''
Gelatin (CAS 9000-70-8). Gelatin was petitioned for use as
a non-organic agricultural ingredient in or on processed products
labeled as ``organic.'' Gelatin is used as a stabilizer, thickener, or
texturizer in a variety of foods. It can also be used as a processing
aid such as a beverage clarifier, or as a protective coating or
container for substances. Gelatin is considered to be a generally
recognized as safe (GRAS) substance as provided by FDA (21 CFR 170). It
can be manufactured from several different types of naturally derived
collagen that is subjected to partial hydrolysis and extraction
procedures. Gelatin is a heterogeneous mixture of high molecular weight
water soluble proteins. It is a colorless, tasteless, odorless and
considerably transparent substance that binds with water and swells to
form a gelatinous product.
At its May 6-8, 2002, meeting in Austin, Texas, the NOSB
recommended adding gelatin to the National List for use in organic
handling as a non-organic agricultural ingredient where the organic
form of gelatin is considered commercially unavailable. In this open
meeting, the NOSB evaluated gelatin against evaluation criteria
established by 7 U.S.C. 6517 and 6518 of the OFPA, assessed its
commercial availability, received public comment, and concluded that
gelatin is consistent with OFPA evaluation criteria and not
commercially available in organic form. Therefore, in response to the
NOSB recommendation regarding the use of gelatin in organic handling,
the Secretary proposes to amend Sec. 205.606 of the National List
regulations to allow gelatin as a non-organically produced agricultural
product allowed as an ingredients in or on processed products labeled
as ``organic.''
Hops (Humulus lupulus). Hops was petitioned for use as a non-
organic agricultural ingredient in or on processed products labeled as
``organic.'' Hops are a primary ingredient used in brewing beer.
Several varieties of hops are used in the manufacture of beer products.
Although the final brewing product is regulated by the Bureau of
Alcohol, Tobacco & Firearms, hops are processed and packaged according
to FDA (21 CFR 110), Current Good Manufacturing Practice in
Manufacturing, Packing or Holding Human Food. As used for the brewing
process, hops form varieties include whole hops, hop pellets, hop
powder pellets, modified hop powder pellets or hops extract. Hops
contribute unique flavors and aroma to brewing, and may serve as a
natural stabilizer. While hops are grown in diverse agricultural
regions, hop varieties vary in flavor and aroma characteristics, and
are selected based upon the unique characteristics contributed to
brewing. Due to these unique characteristics that are contributed to a
specific brewing process, brewers cannot interchange hop varieties
should a selected variety be commercially unavailable without
significant changes in the final product.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding hops to the National List for use in organic
handling as a non-organic agricultural ingredient where the organic
form of hops is considered commercially unavailable. In this open
meeting, the NOSB evaluated hops against evaluation criteria
established by 7 U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72
FR 2167) on commercial availability, received public comment, and
concluded that hops is consistent with OFPA evaluation criteria and NOP
commercial availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of hops in organic handling, the
Secretary proposes to amend Sec. 205.606 of the National List
regulations to allow hops as a non-organically produced agricultural
product allowed as an ingredient in or on processed products labeled as
``organic.''
Inulin, oligofructose enriched, (CAS 9005-80-5).
Oligofructose enriched inulin was petitioned for use as a non-organic
agricultural ingredient in or on processed products labeled as
``organic.'' Oligofructose enriched inulin is used as an ingredient in
a variety of foods. It is considered to be a GRAS substance and its use
in food products is regulated by FDA (21 CFR 172.892). A primary
purpose for adding oligofructose enriched inulin as an ingredient to
foods is to add soluble dietary fiber, and provide texture and
consistency to food products. Oligofructose enriched inulin is derived
[[Page 27260]]
from inulin which is a polymer of naturally occurring oligosaccharide
produced in many types of plants. Inulin is extracted from the root of
the chicory plant (Cichorium intybus) by a hot water diffusion process.
Subsequently, the extracted inulin is partially enzymatically
hydrolyzed to yield oligofructose enriched inulin. The hydrolyzate is
dried to a powder for application in foods. Enzyme hydrolyzation
reduces the chemical chain length of the oligosaccharide polymer
resulting in varying functional properties between inulin and the
oligofructose enriched form. The shorter polymer chain length increases
polymer solubility and facilitates product texture and consistency.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding oligofructose enriched inulin to the National List
for use in organic handling as a non-organic agricultural ingredient
where the organic form of oligofructose enriched inulin is considered
commercially unavailable. In this open meeting, the NOSB evaluated
oligofructose enriched inulin against evaluation criteria established
by 7 U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72 FR 2167) on
commercial availability, received public comment, and concluded that
oligofructose enriched inulin is consistent with OFPA evaluation
criteria and NOP commercial availability criteria. Therefore, in
response to the NOSB recommendation regarding the use of oligofructose
enriched inulin in organic handling, the Secretary proposes to amend
Sec. 205.606 of the National List regulations to allow oligofructose
enriched inulin as a non-organically produced agricultural product
allowed as an ingredient in or on processed products labeled as
``organic.''
Konjac flour (CAS 37220-17-0). Konjac flour was petitioned
for use as a non-organic agricultural ingredient in or on processed
products labeled as ``organic.'' Konjac flour is used as an ingredient
in foods as a gelling agent, stabilizer, thickener, fat replacer, and
similar technological functions. Its use as an ingredient in non-meat
food products is regulated by FDA (21 CFR 170) and its use in meat
products is regulated by USDA Food Safety Inspection Service (FSIS) (9
CFR 381). Konjac flour is a dried powder derived from aqueous and
physical extraction of the glucomannan polysaccharide (mannose and
glucose units) from ground elephant yam (Amorphophallu) tuber (root).
The polysaccharide in konjac flour has a large molecular weight and can
have a high rate of hydration leading to increased viscosity of foods
when included as an ingredient. The degree of water gelling with konjac
flour is a function of the presence of acetyl groups within the
glucomannan molecule. De-acetylation of the molecule in the presence of
a weak base allows formation of stable gels.
At its May 6-8, 2002, meeting in Austin, Texas, the NOSB
recommended adding konjac flour to the National List for use in organic
handling as a non-organic agricultural ingredient where the organic
form of konjac flour is considered commercially unavailable. In this
open meeting, the NOSB evaluated konjac flour against evaluation
criteria established by 7 U.S.C. 6517 and 6518 of the OFPA, assessed
its commercial availability, received public comment, and concluded
that konjac flour is consistent with OFPA evaluation criteria and not
commercially available in organic form. Therefore, in response to the
NOSB recommendation regarding the use of konjac flour in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow konjac flour as a non-organically produced
agricultural product allowed as an ingredient in or on processed
products labeled as ``organic.''
Lemongrass, frozen (no CAS ). Lemongrass, frozen was
petitioned for use as a non-organic agricultural ingredient in or on
processed products labeled as ``organic.'' Frozen lemongrass is used as
a distinct citrus flavoring agent in a variety of foods. Its use in
food products is regulated by FDA (21 CFR 182.10). The flavor component
of frozen lemongrass is attributed to an oil substance classified as a
Terpenoid, Citral, also known as Lemonal. Lemongrass (Cymbopogon
citratus) is an aromatic plant with long slender blades grown in warm
temperate and tropical regions. When added to foods, the edible portion
of the plant is usually sliced or bruised to release the lemongrass
oil. Dried/powdered lemongrass sources may not provide the flavor
potential as either fresh or frozen lemongrass.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding frozen lemongrass to the National List for use in
organic handling as a non-organic agricultural ingredient where the
organic form of frozen lemongrass is considered commercially
unavailable. In this open meeting, the NOSB evaluated frozen lemongrass
against evaluation criteria established by 7 U.S.C. 6517 and 6518 of
the OFPA and NOP criteria (72 FR 2167) on commercial availability,
received public comment, and concluded that frozen lemongrass is
consistent with OFPA evaluation criteria and NOP commercial
availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of frozen lemongrass in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow frozen lemongrass as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
Orange shellac, unbleached (CAS 9000-59-3). Unbleached
orange shellac was petitioned for use as a non-organic agricultural
ingredient in or on processed products labeled as ``organic.''
Unbleached orange shellac is used principally as a coating agent and as
a glazing or polishing agent on fruits and vegetables. It may also be
used as a color dilutent or as an ingredient for the glazing of
confectionary products. Its use as an ingredient or processing aid is
regulated by FDA (21 CFR 184). Unbleached orange shellac is a hard,
durable, amorphous resin that is semi-impermeable to water. It is used
in combination with other ingredients in coatings on fruits and
vegetables to limit water loss and reduce gas exchange (natural
ethylene) resulting from fruit or vegetable ripening. Unbleached orange
shellac is a mixture of resins derived from secretions of the Lac
insect (Laccifer lacca Kerr) that are collected from resiniferous trees
and bushes, and further processed to yield shellac.
At its May 6-8, 2002, meeting in Austin, Texas, the NOSB
recommended adding unbleached orange shellac to the National List for
use in organic handling as a non-organic agricultural ingredient where
the organic form of unbleached orange shellac is considered
commercially unavailable. In this open meeting, the NOSB evaluated
unbleached orange shellac against evaluation criteria established by 7
U.S.C. 6517 and 6518 of the OFPA, assessed its commercial availability,
received public comment, and concluded that unbleached orange shellac
is consistent with OFPA evaluation criteria and not commercially
available in organic form. Therefore, in response to the NOSB
recommendation regarding the use of unbleached orange shellac in
organic handling, the Secretary proposes to amend Sec. 205.606 of the
National List regulations to allow unbleached orange shellac as a non-
organically produced agricultural product allowed as an ingredient in
or on processed products labeled as ``organic.''
[[Page 27261]]
Pepper, chipotle chile (no CAS ). Chipotle chile pepper
was petitioned for use as a non-organic agricultural ingredient in or
on processed products labeled as ``organic.'' Its use in food products
is regulated by FDA (21 CFR 182.1). Chipotle chile pepper is used as a
flavoring agent in a variety of food products. Chipotle chile peppers
are smoke dried jalapeno chile peppers (Capsicum annuum) that are
allowed to mature on the vine from a green to a red color. After
harvest, the red chile peppers are slowly dried and smoked. Chipotle
chile peppers are considered to have a sweet, smoky flavor with a
strong degree of ``hotness'' or spiciness. Spiciness is a function of
the concentration of Capsicum, a chemical that stimulates
thermoreceptor nerve endings in the skin. Authentic chipotle chile
peppers are produced primarily in Mexico. Chile pepper varieties that
are produced in other regions reportedly provide less flavoring or
different flavoring.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding chipotle chile pepper to the National List for use
in organic handling as a non-organic agricultural ingredient where the
organic form of chipotle chile pepper is considered commercially
unavailable. In this open meeting, the NOSB evaluated chipotle chile
pepper against evaluation criteria established by 7 U.S.C. 6517 and
6518 of the OFPA and NOP criteria (72 FR 2167) on commercial
availability, received public comment, and concluded that chipotle
chile pepper is consistent with OFPA evaluation criteria and NOP
commercial availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of chipotle chile pepper in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow chipotle chile pepper as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
Rice starch, unmodified (CAS 977000-08-0). Unmodified rice
starch was petitioned for use as a non-organic agricultural ingredient
in or on processed products labeled as ``organic.'' Unmodified rice
starch is affirmed for use as an ingredient in a variety of foods
through its inclusion on the FDA's ``Everything'' Added to Food in the
United States (EAFUS) list which is a list of ingredients that can be
added directly to food that are either approved as food additives or
affirmed as GRAS (21 CFR 182). Primary functions attributed to using
unmodified rice starch as an ingredient in foods is as a thickener,
stabilizer and gelling agent. Unmodified rice starch is derived from
alkali treated (Sodium hydroxide, National List, Sec. 205.605(b))
pulverized rice grain that is subsequently wet milled and centrifuged
to separate the rice starch from the rice protein. Unmodified rice
starch is a white powder, with a neutral taste and odor, and small
particle size. These attributes are reportedly not available from other
thickening agents that are presently included on the National List in
either Sec. Sec. 205.605 or 205.606.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding unmodified rice starch to the National List for use
in organic handling as a non-organic agricultural ingredient where the
organic form of unmodified rice starch is considered commercially
unavailable for two years. In this open meeting, the NOSB evaluated
unmodified rice starch against evaluation criteria established by 7
U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72 FR 2167) on
commercial availability, received public comment, and concluded that
unmodified rice starch is consistent with OFPA evaluation criteria and
NOP commercial availability criteria. Therefore, in response to the
NOSB recommendation regarding the use of unmodified rice starch in
organic handling, the Secretary proposes to amend Sec. 205.606 of the
National List regulations to allow unmodified rice starch as a non-
organically produced agricultural product allowed as an ingredient in
or on processed products labeled as ``organic'' for two years from May
15, 2007.
Sweet potato starch, for bean thread production only (no CAS
). Sweet potato starch was petitioned for use only in the
production of bean thread noodles as a non-organic agricultural
ingredient in or on processed products labeled as ``organic.'' Sweet
potato starch is used as an ingredient for use in the manufacture of
bean thread noodles used in Asian cuisine. Its use in food products is
regulated by FDA (21 CFR part 182). A primary purpose for adding sweet
potato starch as an ingredient for bean thread noodle production is to
provide texture and neutral flavor in noodle products. Many varieties
of noodle products exist as a result of differences in processing,
starch source and composition, and cultural cuisine preferences. In
general, starches are produced by grinding a starch rich plant source
followed by wet separation techniques. Dry starch is a white powder,
with a neutral taste and flavor, and is relatively insoluble in cold
water. Under suitable temperatures, starch can absorb a large volume of
water and, depending upon its chemical composition (acetyl groups in
the starch polysaccharide polymers), starch has a significant capacity
to gel. Variations in starch gelling capacity contribute to variations
in noodle product quality. Sweet potato starch is derived from sweet
potatoes (Ipomea batatas), which can be grown in a variety of climates.
Although there is significant organic sweet potato production, starch
from organic sweet potatoes used for bean thread noodle products is
considered to be limited due to a lack of available organic sweet
potatoes to process for the sweet potato starch.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding sweet potato starch to the National List for use in
organic handling for use in bean thread production only as a non-
organic agricultural ingredient where the organic form of sweet potato
starch is considered commercially unavailable. In this open meeting,
the NOSB evaluated sweet potato starch against evaluation criteria
established by 7 U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72
FR 2167) on commercial availability, received public comment, and
concluded that sweet potato starch for use in bean thread noodle
production only is consistent with OFPA evaluation criteria and NOP
commercial availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of sweet potato starch for bean thread
production only in organic handling, the Secretary proposes to amend
Sec. 205.606 of the National List regulations to allow sweet potato
starch for use only in bean thread noodle production as a non-
organically produced agricultural product allowed as an ingredient in
or on processed products labeled as ``organic.''
Turkish bay leaves (no CAS ). Turkish bay leaves were
petitioned for use as a non-organic agricultural ingredient in or on
processed products labeled as ``organic.'' Turkish bay leaves are used
as a flavor agent in a variety of foods such as vegetables, meats and
soups. Its use as an ingredient in food products is regulated by FDA
(21 CFR 182.10). Sourced from the Evergreen Bay Laurel tree grown in
the Mediterranean region, Turkish bay leaves, after harvest, are dried
under a specific process to enhance flavor and reduce bitterness. Dried
bay leaves have lower concentrations of the bay leaf oil that provides
the flavoring to foods. The leaf oil provides a sweet, lemony
flavoring. Other varieties of Bay leaves
[[Page 27262]]
provide different flavor profiles that may be too bitter, astringent
and pungent compared to Turkish bay leaves.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding Turkish bay leaves to the National List for use in
organic handling as a non-organic agricultural ingredient where the
organic form of Turkish bay leaves is considered commercially
unavailable. In this open meeting, the NOSB evaluated Turkish bay
leaves against evaluation criteria established by 7 U.S.C. 6517 and
6518 of the OFPA and NOP criteria (72 FR 2167) on commercial
availability, received public comment, and concluded that Turkish bay
leaves is consistent with OFPA evaluation criteria and NOP commercial
availability criteria. Therefore, in response to the NOSB
recommendation regarding the use of Turkish bay leaves in organic
handling, the Secretary proposes to amend Sec. 205.606 of the National
List regulations to allow Turkish bay leaves as a non-organically
produced agricultural product allowed as an ingredient in or on
processed products labeled as ``organic.''
Wakame seaweed (Undaria pinnatifida) (no CAS ). Wakame
seaweed was petitioned for use as a non-organic agricultural ingredient
in or on processed products labeled as ``organic.'' Wakame seaweed is
affirmed for use as an ingredient in Asian cuisine foods such as soups
and salads. Its use in food products is regulated by FDA (21 CFR
182.10). Wakame seaweed is harvested from the coasts of Japan, Korea
and China. After harvest the seaweed is washed, rinsed with a salt
solution to extend shelf life, cut and dried. As an ingredient, Wakame
seaweed provides a unique flavor and texture to Asian foods.
Substitution of other seaweed species provides a different texture and
flavor profile to foods.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding Wakame seaweed to the National List for use in
organic handling as a non-organic agricultural ingredient where the
organic form of Wakame seaweed is considered commercially unavailable.
In this open meeting, the NOSB evaluated Wakame seaweed against
evaluation criteria established by 7 U.S.C. 6517 and 6518 of the OFPA
and NOP criteria (72 FR 2167) on commercial availability, received
public comment, and concluded that Wakame seaweed is consistent with
OFPA evaluation criteria and NOP commercial availability criteria.
Therefore, in response to the NOSB recommendation regarding the use of
Wakame seaweed in organic handling, the Secretary proposes to amend
Sec. 205.606 of the National List regulations to allow Wakame seaweed
as a non-organically produced agricultural product allowed as an
ingredient in or on processed products labeled as ``organic.''
Whey protein concentrate, (no CAS ). Whey protein
concentrations of 35% and 80% was petitioned for use as a non-organic
agricultural ingredient in or on processed products labeled as
``organic.'' Whey protein concentrate is used as an ingredient in a
variety of foods. Its use in food products is regulated by FDA (21 CFR
184.1979c). A primary purpose for adding whey protein concentrate as an
ingredient to foods is to provide texture and consistency to foods.
Whey protein concentrate can be used as a fat replacer when added to
foods as it mimics some properties of fat. Whey is a liquid by-product
of cheese manufacture. Removing the water from whey provides powdered
whey protein concentrate. Protein content of whey protein concentrate
can vary from 25 percent to 89.9 percent protein with milk fat content
of whey protein concentrate at or below 10 percent. Whey protein
concentrate is a white to cream color powder with little or no flavor
and a pH that cannot exceed 7.0. Organic cheese manufacturers
reportedly divert whey by-product to more lucrative markets than
currently exist with the manufacture of whey protein concentrate, thus
availability of whey by-product from organic cheese processing is
considered to be very limited.
At its March 27-29, 2007, meeting in Washington, DC, the NOSB
recommended adding Whey protein concentrate up to 80% to the National
List for use in organic handling as a non-organic agricultural
ingredient where the organic form of whey protein concentrate is
considered commercially unavailable. In this open meeting, the NOSB
evaluated whey protein concentrate against evaluation criteria
established by 7 U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72
FR 2167) on commercial availability, received public comment, and
concluded that Whey protein concentrate is consistent with OFPA
evaluation criteria and NOP commercial availability criteria.
Therefore, in response to the NOSB recommendation regarding the use of
whey protein concentrate in organic handling, the Secretary proposes to
amend Sec. 205.606 of the National List regulations to allow whey
protein concentrate as a non-organically produced agricultural product
allowed as an ingredient in or on processed products labeled as
``organic.''
III. Related Documents--FR Notices
Two notices were published regarding the meetings of the NOSB and
its deliberations on recommendations and substances petitioned for
amending the National List. Substances and recommendations included in
this proposed rule were announced for NOSB deliberation in the
following Federal Register Notices: (1) 67 FR 19375, April 12, 2002,
(Gelatin, Konjac flour, Orange shellac); (2) 72 FR 10971, March 12,
2007, (Casings, Celery powder, Chia (Salvia hispanica L.), Colors--from
agricultural products: Annatto extract; Beet juice; Beta-carotene
extract; Purple carrot juice; Black currant juice; Blueberry juice;
Carrot juice; Cherry juice; Chokeberry/Aronia juice; Elderberry juice;
Grape juice; Grape skin extract; Paprika; Pumpkin juice; Purple potato
juice; Red cabbage extract; Red radish extract; Saffron; Turmeric;
Dillweed oil, Fish oil, Fructooligosaccharides, Galangal--frozen, Hops,
Inulin--oligofructose enriched, Lemongrass--frozen, Pepper--chipotle
chile, Rice starch, Sweet potato starch, Turkish bay leaves, Wakame
seaweed (Undaria pinnatifida), and Whey protein concentrate).
IV. Statutory and Regulatory Authority
The OFPA, as amended (7 U.S.C. 6501 et seq.), authorizes the
Secretary to make amendments to the National List based on proposed
amendments developed by the NOSB. Sections 6518(k)(2) and 6518(n) of
OFPA authorize the NOSB to develop proposed amendments to the National
List for submission to the Secretary and establish a petition process
by which persons may petition the NOSB for the purpose of having
substances evaluated for inclusion on or deletion from the National
List. The National List petition process is implemented under Sec.
205.607 of the NOP regulations. The current petition process (72 FR
2167) can be accessed through the NOP website at http://www.ams.usda.gov/nop.
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
[[Page 27263]]
and revised regulations in order to avoid unduly burdening the court
system. This proposed rule is not intended to have a retroactive
effect.
States and local jurisdictions are preempted under section 6514 of
the OFPA (7 U.S.C. 6514) from creating programs of accreditation for
private persons or State officials who want to become certifying agents
of organic farms or handling operations. A governing State official
would have to apply to USDA to be accredited as a certifying agent, as
described in section 6514(b) of the OFPA (7 U.S.C. 6514(b)). States are
also preempted under sections 6503 through 6507 of the OFPA (7 U.S.C.
6503 through 6507) from creating certification programs to certify
organic farms or handling operations unless the State programs have
been submitted to, and approved by, the Secretary as meeting the
requirements of the OFPA.
Pursuant to section 6507(b)(2) of the OFPA (7 U.S.C. 6507(b)(2)), a
State organic certification program may contain additional requirements
for the production and handling of organically produced agricultural
products that are produced in the State and for the certification of
organic farm and handling operations located within the State under
certain circumstances. Such additional requirements must: (a) Further
the purposes of the OFPA, (b) not be inconsistent with the OFPA, (c)
not be discriminatory toward agricultural commodities organically
produced in other States, and (d) not be effective until approved by
the Secretary.
Pursuant to section 6519(f) of the OFPA (7 U.S.C. 6519(f)), this
proposed rule would not alter the authority of the Secretary under the
Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry
Products Inspections Act (21 U.S.C. 451 et seq.), or the Egg Products
Inspection Act (21 U.S.C. 1031 et seq.), concerning meat, poultry, and
egg products, nor any of the authorities of the Secretary of Health and
Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C.
301 et seq.), nor the authority of the Administrator of the
Environmental Protection Agency (EPA) under the Federal Insecticide,
Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.).
Section 6520 of the OFPA (7 U.S.C. 6520) provides for the Secretary
to establish an expedited administrative appeals procedure under which
persons may appeal an action of the Secretary, the applicable governing
State official, or a certifying agent under this title that adversely
affects such person or is inconsistent with the organic certification
program established under this title. The OFPA also provides that the
U.S. District Court for the district in which a person is located has
jurisdiction to review the Secretary's decision.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.)
requires agencies to consider the economic impact of each rule on small
entities and evaluate alternatives that would accomplish the objectives
of the rule without unduly burdening small entities or erecting
barriers that would restrict their ability to compete in the market.
The purpose is to fit regulatory actions to the scale of businesses
subject to the action. Section 605 of the RFA allows an agency to
certify a rule, in lieu of preparing an analysis, if the rulemaking is
not expected to have a significant economic impact on a substantial
number of small entities.
Pursuant to the requirements set forth in the RFA, the Agricultural
Marketing Service (AMS) performed an economic impact analysis on small
entities in the final rule published in the Federal Register on
December 21, 2000 (65 FR 80548). The AMS has also considered the
economic impact of this action on small entities. The impact on
entities affected by this proposed rule would not be significant. The
effect of this proposed rule would be to allow the use of additional
substances in agricultural production and handling. This action would
modify the regulations to provide small entities with more tools to use
in day-to-day operations. The AMS concludes that the economic impact of
this addition of allowed substances, if any, would be minimal and
entirely beneficial to small agricultural service firms. Accordingly,
USDA certifies that this rule will not have a significant economic
impact on a substantial number of small entities.
Small agricultural service firms, which include producers,
handlers, and accredited certifying agents, have been defined by the
Small Business Administration (SBA) (13 CFR 121.201) as those having
annual receipts of less than $6,500,000 and small agricultural
producers are defined as those having annual receipts of less than
$750,000. This proposed rule would have an impact on a substantial
number of small entities.
Based upon USDA's Economic Research Service and AMS data compiled
between 2001 to 2005, the U.S. organic industry at the end of 2005
included nearly 8,500 certified organic crop and livestock operations,
plus more than 2,900 handling operations. Organic crop and livestock
operations reported certified acreage totaling more than 4.05 million
acres of organic farm production. Total number of organic crop and
livestock operations increased by more than 18 percent from 2001 to
2005, while total certified acreage more than doubled during this time
period. AMS estimates that these trends continued through 2006 and will
be higher in 2007.
U.S. sales of organic food and beverages have grown from $1 billion
in 1990 to an estimated $14 billion in 2006. Organic food sales are
projected to reach $23.8 billion for 2010. The organic industry is
viewed as the fastest growing sector of agriculture, currently
representing 2 percent of overall food and beverage sales. Since 1990,
organic retail sales have historically demonstrated a growth rate
between 20 to 24 percent each year. This growth rate is projected to
decline and fall to a rate of 5 to 10 percent in the future.
In addition, USDA has accredited 99 certifying agents who have
applied to USDA to be accredited in order to provide certification
services to producers and handlers. A complete list of names and
addresses of accredited certifying agents may be found on the AMS NOP
web site, at http://www.ams.usda.gov/nop. AMS believes that most of
these entities would be considered small entities under the criteria
established by the SBA.
D. Paperwork Reduction Act
Under the OFPA, no additional collection or recordkeeping
requirements are imposed on the public by this proposed rule.
Accordingly, OMB clearance is not required by section 350(h) of the
Paperwork Reduction Act of 1995, 44 U.S.C. 3501, et seq., or OMB's
implementing regulation at 5 CFR part 1320.
AMS is committed to compliance with the Government Paperwork
Elimination Act (GPEA), which requires Government agencies in general
to provide the public the option of submitting information or
transacting business electronically to the maximum extent possible.
E. General Notice of Public Rulemaking
This proposed rule reflects recommendations submitted to the
Secretary by the NOSB. The 38 substances proposed to be added to the
National List were based on petitions from the industry. The NOSB
evaluated each petition using criteria in the OFPA and NOP criteria on
commercially availability published in the Federal Register, (72 FR
2167). Because these substances are critical to organic
[[Page 27264]]
production and handling operations, producers and handlers should be
able to use them in their operations as soon as possible. A 7-day
period for interested persons to comment on this rule is provided.
Interested persons have already been provided with 30 days of public
comment on these 38 substances in advance of the NOSB meetings held May
6-8, 2002 and March 27-29, 2007. The NOSB considered these comments
during their reviews and concluded that the petitioners had provided
sufficient evidence for adding these 38 substances to the National
List. Since many producers, handlers and certifying agents may have
misinterpreted National List regulations Sec. 205.606 to mean that any
non-organic agricultural product that was not commercially available in
organic form could be used in organic products without being
individually listed on the National List, these 38 substances currently
are being used in organic products. These 38 substances will be
prohibited for use in organic products beginning June 9, 2007, unless
they are added to the National List. Loss of the use of any of these
products would disrupt the trade of food products currently being
labeled as ``organic''. Therefore, the continued allowed use of these
products as ingredients in foods labeled as ``organic'' is necessary to
prevent possible significant business disruption for organic producers
and handlers. AMS believes that a 7-day period for interested persons
to comment on this proposed rule is appropriate.
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, Subpart
G is proposed to be 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 205.606 is revised to read as follows:
Sec. 205.606 Nonorganically produced agricultural products allowed as
ingredients in or on processed products labeled as ``organic.''
Only the following nonorganically produced agricultural products
may be used as ingredients in or on processed products labeled as
``organic,'' only in accordance with any restrictions specified in this
section, and only when the product is not commercially available in
organic form.
(a) Casings, from processed intestines.
(b) Celery powder.
(c) Chia (Salvia hispanica).
(d) Colors derived from agricultural products.
(1) Annatto extract (pigment CAS 1393-63-1)--water and oil
soluble.
(2) Beet juice (pigment CAS 7659-95-2).
(3) Beta-carotene (CAS 1393-63-1) derived from carrots.
(4) Black currant juice (pigment CAS 's: 528-58-5, 528-53-
0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(5) Black/Purple carrot juice (pigment CAS 's: 528-58-5,
528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(6) Blueberry juice (pigment CAS 's: 528-58-5, 528-53-0,
643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(7) Carrot juice (pigment CAS 1393-63-1).
(8) Cherry juice (pigment CAS 's: 528-58-5, 528-53-0, 643-
84-5, 134-01-0, 1429-30-7, and 134-04-3).
(9) Chokeberry--Aronia juice (pigment CAS 's: 528-58-5,
528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(10) Elderberry juice (pigment CAS 's: 528-58-5, 528-53-0,
643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(11) Grape juice (pigment CAS 's: 528-58-5, 528-53-0, 643-
84-5, 134-01-0, 1429-30-7, and 134-04-3).
(12) Grape skin extract (pigment CAS 's: 528-58-5, 528-53-
0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(13) Paprika (CAS 68917-78-2)--dried, and oil extracted.
(14) Pumpkin juice (pigment CAS 127-40-2).
(15) Purple potato juice (pigment CAS 's: 528-58-5, 528-
53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(16) Red cabbage extract (pigment CAS 's: 528-58-5, 528-
53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(17) Red radish extract (pigment CAS 's: 528-58-5, 528-53-
0, 643-84-5, 134-01-0, 1429-30-7, and 134-04-3).
(18) Saffron (pigment CAS 1393-63-1).
(19) Turmeric (CAS 458-37-7).
(e) Dillweed oil (CAS 8006-75-5).
(f) Fish oil (Fatty acid CAS 's: 10417-94-4, and 25167-62-
8)--stabilized with organic ingredients or only with ingredients on the
National List, Sec. Sec. 205.605 and 205.606.
(g) Fructooligosaccharides (CAS 308066-66-2).
(h) Galangal, frozen.
(i) Gelatin (CAS 9000-70-8).
(j) Gums--water extracted only (Arabic; Guar; Locust bean; and
Carob bean).
(k) Hops.
(l) Inulin--oligofructose enriched (CAS 9005-80-5).
(m) Kelp--for use only as a thickener and dietary supplement.
(n) Konjac flour (CAS 37220-17-0).
(o) Lecithin--unbleached.
(p) Lemongrass--frozen.
(q) Orange shellac--unbleached (CAS 9000-59-3).
(r) Pectin (high-methoxy).
(s) Peppers (Chipotle chile).
(t) Starches.
(1) Cornstarch (native).
(2) Rice starch, unmodified (CAS 977000-08-0)--for use in
organic handling until [date two years after effective date of final
rule].
(3) Sweet potato starch--for bean thread production only.
(u) Turkish bay leaves.
(v) Wakame seaweed (Undaria pinnatifada).
(w) Whey protein concentrate.
Dated: May 10, 2007.
Kenneth C. Clayton,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 07-2388 Filed 5-10-07; 2:51 pm]
BILLING CODE 3410-02-P