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.

Proposed Rules Federal Register

27252 

Vol. 72, No. 93 

Tuesday, May 15, 2007 

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. 

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 

§§ 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 § 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, nonsynthetic 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 

§ 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 

§§ 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 § 205.606 (70 FR 38090), and 

on June 7, 2006, published a final rule 

(71 FR 32803) revising § 205.606 to 

clarify that the section shall be 

interpreted to permit the use of a nonorganically produced agricultural 

product only when the product has been 

listed in § 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 § 205.606 pursuant 

to National List procedures will render 

currently certified products in noncompliance 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 § 205.606, along with any 

restrictive annotations, to the National 

List regulations. 


jlentini on PROD1PC65 with PROPOSALS
Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Proposed Rules 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 

§ 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 § 205.606 of the 

National List regulations to allow 

annatto extract color as a nonorganically 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 § 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). BetaCarotene 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 § 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.’’


jlentini on PROD1PC65 with PROPOSALS
27254 Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Proposed Rules 

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 § 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 nonorganic 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-purpleblack 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 § 205.606 of the 

National List regulations to allow black/ 

purple carrot juice color as a nonorganically 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 § 205.606 of the 

National List regulations to allow 

Blueberry juice color as a nonorganically 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 § 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.’’


jlentini on PROD1PC65 with PROPOSALS
Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Proposed Rules 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 bluered 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 § 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 nonorganic 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 bluepurple 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 § 205.606 

of the National List regulations to allow 

chokeberry—aronia juice color as a nonorganically 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 § 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 § 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 


jlentini on PROD1PC65 with PROPOSALS
27256 Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Proposed Rules 

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 § 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 § 205.606 of the 

National List regulations to allow 

paprika color, dried powder and 

vegetable oil extract, as a nonorganically 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 § 205.606 of the 

National List regulations to allow 

pumpkin juice color as a nonorganically 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 § 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 


jlentini on PROD1PC65 with PROPOSALS
Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Proposed Rules 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 § 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 § 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 § 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 § 205.606 of the 

National List regulations to allow 

turmeric extract color as a nonorganically 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 nonorganic 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 


jlentini on PROD1PC65 with PROPOSALS
27258 Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Proposed Rules 

processed intestines in organic 

handling, the Secretary proposes to 

amend § 205.606 of the National List 

regulations to allow casings from 

processed intestines as a nonorganically 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 nonorganic 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 § 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 nonorganic 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 § 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 § 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 § 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 


jlentini on PROD1PC65 with PROPOSALS
Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Proposed Rules 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 § 205.606 of the National List 

regulations to allow 

fructooligosaccharides as a nonorganically 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 orangebrown 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 § 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 § 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 § 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 nonorganic 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 


jlentini on PROD1PC65 with PROPOSALS
27260 Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Proposed Rules 

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 § 205.606 

of the National List regulations to allow 

oligofructose enriched inulin as a nonorganically 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 nonorganic 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 § 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 § 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 nonorganic 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 semiimpermeable 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 § 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.’’


jlentini on PROD1PC65 with PROPOSALS
Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Proposed Rules 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 § 205.606 

of the National List regulations to allow 

chipotle chile pepper as a nonorganically 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, § 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 

§§ 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 § 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 

§ 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 


jlentini on PROD1PC65 with PROPOSALS
27262 Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Proposed Rules 

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 § 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 § 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 byproduct 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 § 205.606 

of the National List regulations to allow 

whey protein concentrate as a nonorganically 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; Betacarotene 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 § 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 


jlentini on PROD1PC65 with PROPOSALS
Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Proposed Rules 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 


jlentini on PROD1PC65 with PROPOSALS
27264 Federal Register / Vol. 72, No. 93 / Tuesday, May 15, 2007 / Proposed Rules 

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 

§ 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: 

§ 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, §§ 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 

DEPARTMENT OF HOMELAND 

SECURITY 

Coast Guard 

33 CFR Part 117 

[CGD07–06–011] 

RIN 1625–AA09 

Drawbridge Operation Regulations; 

Little River (S–20) Bridge, Atlantic 

Intracoastal Waterway Mile 347.3, 

Horry County, SC 

AGENCY: Coast Guard, DHS. 

ACTION: Notice of proposed rulemaking; 

withdrawal. 

SUMMARY: The Coast Guard is 

withdrawing its notice of proposed 

rulemaking concerning the proposed 

change to the regulation of the Little 

River (S–20) Bridge. The requested 

change was to place a twenty minute 

regulation on the bridge in lieu of ‘‘on 

demand’’. The withdrawal is based on 

limited vessel openings, comments 

received from the public, and the 

addition of a new high level fixed bridge 

within close proximity of the draw 

bridge which should help alleviate 

traffic congestion. 


jlentini on PROD1PC65 with PROPOSALS