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[Federal Register Volume 75, Number 215 (Monday, November 8, 2010)]
[Proposed Rules]
[Pages 68505-68510]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-28042]

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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

========================================================================


Federal Register / Vol. 75, No. 215 / Monday, November 8, 2010 / 
Proposed Rules

[[Page 68505]]

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-10-0079; NOP-09-02PR]
RIN 0581-AD06

National Organic Program; Proposed Amendments to the National 
List of Allowed and Prohibited Substances (Crops and Processing)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would amend the U.S. Department of 
Agriculture's (USDA) National List of Allowed and Prohibited Substances 
(National List) to reflect recommendations submitted to the Secretary 
of Agriculture (Secretary) by the National Organic Standards Board 
(NOSB) on May 22, 2008, November 19, 2008, and May 6, 2009. The 
recommendations addressed in this proposed rule pertain to establishing 
exemptions (uses) for four substances in organic crop production and 
organic processing, amending an annotation for one allowed substance, 
and removing an exemption for one allowed substance. Consistent with 
the recommendations from the NOSB, this proposed rule would add the 
following four substances, along with any restrictive annotations, to 
the National List: Microcrystalline cheesewax; acidified sodium 
chlorite; dried orange pulp; and Pacific kombu seaweed. This proposed 
rule would also amend the annotation for lecithin--unbleached, and 
remove lecithin--bleached, from the National List.

DATES: Comments must be received by January 7, 2011.

ADDRESSES: Interested persons may comment on this proposed rule using 
the following procedures:
     Internet: http://www.regulations.gov.
     Mail: Comments may be submitted by mail to: Toni Strother, 
Agricultural Marketing Specialist, National Organic Program, USDA-AMS-
NOP, Room 2646-So., Ag Stop 0268, 1400 Independence Ave., SW., 
Washington, DC 20250-0268.
    Written comments responding to this proposed rule should be 
identified with the document number AMS-NOP-10-0079; NOP-09-02. You 
should identify the topic and section number of this proposed rule to 
which your comment refers. You should clearly indicate whether or not 
you support the action being proposed for any or all of the substances 
in this proposed rule. You should clearly indicate the reason(s) for 
your position. You should also offer any recommended language changes 
that would be appropriate for your position. Please include relevant 
information and data to support your position, (e.g. scientific, 
environmental, manufacturing, industry impact information, etc.). Only 
relevant material supporting your position should be submitted.
    It is USDA's intention to have all comments concerning this 
proposed rule, including names and addresses when provided, regardless 
of submission procedure used, available for viewing on the 
Regulations.gov (http://www.regulations.gov) Internet site. Comments 
submitted in response to this proposed rule will also be available for 
viewing in person at USDA-AMS, National Organic Program, Room 2646-
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 official Federal holidays). Persons wanting to visit the USDA 
South Building 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: Melissa Bailey, Director, Standards 
Division, Telephone: (202) 720-3252; Fax: (202) 205-7808.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 21, 2000, the Secretary established, within the 
National Organic Program (NOP) [7 CFR part 205], the National List 
regulations Sec. Sec.  205.600 through 205.607. This National List 
identifies the synthetic substances that may be used and the 
nonsynthetic (natural) substances that may not be used in organic 
production. The National List also identifies synthetic, nonsynthetic 
nonagricultural and nonorganic agricultural substances that may be used 
in organic handling. The Organic Foods Production Act of 1990, as 
amended, (7 U.S.C. 6501 et seq.), (OFPA), and the NOP regulations, in 
Sec.  205.105, specifically prohibit the use of any synthetic substance 
in organic production and handling unless the synthetic substance is on 
the National List. Section 205.105 also requires that any nonorganic 
agricultural and any nonsynthetic nonagricultural substance used in 
organic handling be on the National List.
    Under the authority of the OFPA, the National List can be amended 
by the Secretary based on proposed amendments developed by the NOSB. 
Since established, the National List has been amended thirteen times, 
October 31, 2003 (68 FR 61987), November 3, 2003 (68 FR 62215), October 
21, 2005 (70 FR 61217), June 7, 2006 (71 FR 32803), September 11, 2006 
(71 FR 53299), June, 27, 2007 (72 FR 35137), October 16, 2007 (72 FR 
58469), December 10, 2007 (72 FR 69569), December 12, 2007 (72 FR 
70479), September 18, 2008 (73 FR 54057), October 9, 2008 (73 FR 
59479), July 6, 2010 (75 FR 38693), and August 24, 2010 (75 FR 51919).
    This proposed rule would amend the National List to reflect six 
recommendations submitted to the Secretary by the NOSB on May 22, 2008, 
November 19, 2008, and May 6, 2009. Based upon their evaluation of 
petitions submitted by industry participants, the NOSB recommended that 
the Secretary add one substance (microcrystalline cheesewax (CAS 
s 64742-42-3, 8009-03-08, and 8002-74-2)) for organic crop 
production to Sec.  205.601, one substance (acidified sodium chlorite) 
for organic processing to Sec.  205.605(b), and two substances (orange 
pulp, dried, and Pacific kombu seaweed) for organic processing to Sec.  
205.606 of the National List. This proposed rule would amend Sec.  
205.605(b) of the National List by removing one substance (lecithin--
bleached). This proposed rule would also amend Sec.  205.606 of the 
National List by amending one listing (lecithin--unbleached). The 
exemptions for use of each substance in organic production

[[Page 68506]]

were evaluated by the NOSB using the evaluation criteria specified in 
OFPA (7 U.S.C. Sec. Sec.  6517-6518). In addition, the amendment of one 
substance and removal of one substance were also evaluated by the NOSB 
using NOP criteria on commercial availability (72 FR 2167).

II. Overview of Proposed Amendments

    The following provides an overview of the proposed amendments to 
designated sections of the National List regulations:

Section 205.601 Synthetic Substances Allowed for Use in Organic Crop 
Production

    This proposed rule would amend Sec.  205.601 of the National List 
regulations by: Designating paragraph (o) for the purpose of adding the 
following substance as a production aid: Microcrystalline cheesewax 
(CAS s 64742-42-3, 8009-03-08, and 8002-74-2). A petition to 
add microcrystalline cheesewax for use in organic crop production as a 
production aid in log grown mushroom culture was submitted in January 
2007. Microcrystalline cheesewax is a colorless solid which is heated 
to its melting point and applied with a brush to inoculation sites on 
the mushroom production logs. This substance acts as a moisture barrier 
and is temporarily used to limit moisture loss from mushroom spawn 
inoculums and airborne contaminants from colonizing on the inoculation 
sites. On May 21, 2008, the NOSB recommended adding a blended form of 
microcrystalline cheesewax to the National List. This blended form is 
comprised of three synthetically-derived substances: Clay-treated 
microcrystalline wax (CAS  64742-42-3), petrolatum (CAS 
 8009-03-08), and paraffin wax (CAS  8002-74-2). 
Clay-treated microcrystalline wax, petrolatum and paraffin waxes range 
from solid to semi-solid state at room temperature, depending on the 
oil content. These three components are recovered from crude oil 
through a series of crystallization, filtration, solidification, and 
solvent extraction steps. According to the petition, all of the solvent 
is recovered during the extraction process and none of the solvent 
remains in the final product. These substances are then decolored, 
deodorized, blended, and a synthetic antioxidant preservative, 
Butylated hydroxytoluene (BHT) (CAS  9010-79-1), is added in a 
quantity less than 100 parts per million.\1\
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    \1\ The U.S. Food and Drug Administration (FDA) permits the 
addition of antioxidants permitted in food to petroleum wax (21 CFR 
172.886(c)).
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    Each of the three components of microcrystalline cheesewax is 
classified by the Food and Drug Administration (FDA) as food-grade 
petroleum wax. The FDA defines petroleum wax as a mixture of solid 
hydrocarbons, paraffinic in nature, derived from petroleum, and refined 
to meet the specifications prescribed in 21 CFR 172.886(b). The FDA has 
approved food-grade petroleum wax for direct addition to chewing gum 
base, on cheese and raw fruits and vegetables, as a defoamer in food 
and as a component of microcapsules for spice-flavoring substances 
added to food for human consumption in accordance with 21 CFR 172.886. 
Petroleum wax, in accordance with 21 CFR 178.3710, is also FDA-approved 
for use as an indirect food additive, i.e., a component of nonfood 
articles in contact with food. Occupational exposure to petroleum wax 
can result in dermal, eye, and respiratory irritation. This can be 
mitigated by the use of protective personal equipment and sufficient 
general local exhaust. References: NOSB final recommendations, May 21, 
2008, http://tiny.cc/rrmr3; NOSB meeting transcripts, May 2008, http://tinyurl.com/bqqzv8; Petition and Addendum for cheesewax, April and 
December 2006, http://tinyurl.com/34lp8to.
    At its May 20-22, 2008, meeting in Baltimore, MD, the NOSB 
recommended adding microcrystalline cheesewax to the National List for 
use in organic crop production as a production aid in log grown 
mushroom culture. In this open meeting, the NOSB evaluated 
microcrystalline cheesewax against the evaluation criteria of 7 U.S.C. 
6517 and 6518 of the OFPA, received public comment, and concluded that 
the substance is consistent with the OFPA evaluation criteria. The NOSB 
recommendation also specified that the microcrystalline cheesewax must 
be made without either ethylene-propylene co-polymer, a thickener, or 
synthetic colors.
    The Secretary has reviewed the NOSB recommendation and, consistent 
with this recommendation, proposes to add Microcrystalline cheesewax 
for organic crop production by amending Sec.  205.601 of the National 
List by adding new paragraph (o) as follows:
    (o) As production aids. Microcrystalline cheesewax (CAS 's 
64742-42-3, 8009-03-08, and 8002-74-2)--for use in log grown mushroom 
culture. Must be made without either ethylene-propylene co-polymer or 
synthetic colors.

Section 205.605 Nonagricultural (Nonorganic) Substances Allowed as 
Ingredients in or on Processed Products Labeled as ``Organic'' or 
``Made With Organic (Specified Ingredients or Food Group(s))''

    This proposed rule would amend paragraph (b) of Sec.  205.605 of 
the National List regulations by removing the exemption for the 
following substance:
    Lecithin--bleached. Bleached lecithin was included in Sec.  
205.605(b) of the National List as originally published on December 21, 
2000 (FR 65 80548), as an allowed synthetic ingredient in or on 
processed products labeled as ``organic'' or ``made with organic 
(specified ingredients or food group(s)).''
    In June 2008, a petition was submitted to the NOSB for the removal 
of bleached lecithin from Sec.  205.605(b). The petition claimed that 
certified organic lecithins had become available and could replace non-
organic bleached lecithin. Specifically, the petition cited the 
adequate supply of domestically-grown organic soybeans, and the use of 
lighter colored raw materials, reduced processing temperatures, and 
reduction of color pigments by filter media that enabled the production 
of an organic equivalent to conventional bleached lecithin.
    Lecithin is the primary emulsifier in a wide variety of organic 
products. Most commercial lecithin is made from soybeans. It can also 
be made from vegetable crops such as corn, canola and sunflower. 
Nonorganic soy lecithin is manufactured by using hexane to extract the 
oil from the soybeans. The fluid lecithin resulting from this 
extraction process can then be bleached with hydrogen peroxide or 
benzyl peroxide. Bleached lecithin is functionally equivalent to 
unbleached lecithin, but is used when a lighter color is preferred.
    At its May 4-6, 2009, meeting in Washington, DC, the NOSB 
considered public comments and determined that organic light-colored 
lecithins are commercially available in the appropriate form, quality, 
and quantity to fulfill essential uses in organic handling. 
Additionally, the NOSB noted that there are conventional non-synthetic 
gums that can serve the same or similar functions as bleached lecithin.
    The Secretary has reviewed the NOSB recommendation and, consistent 
with this recommendation, proposes to remove the exemption for 
lecithin--

[[Page 68507]]

bleached in paragraph (b) of Sec.  206.605. The Board has recommended 
to continue to allow nonorganic de-oiled lecithin when an organic 
version is not commercially available--see Sec.  205.606 discussion 
below. This proposed action would not prohibit nonorganic forms of 
bleached, de-oiled lecithin, nor would it prohibit bleaching of organic 
fluid lecithin with hydrogen peroxide, a bleaching agent, which is 
allowed for use in organic handling per Sec.  205.605(b). References: 
NOSB recommendations, May 2009, http://tiny.cc/9wgkp; NOSB meeting 
transcripts, May 2009, http://tinyurl.com/bqqzv8; Petition to remove 
bleached lecithin, June 2008, http://tinyurl.com/32e638e.
    This proposed rule would further amend paragraph (b) of Sec.  
205.605 of the National List regulations to add the following 
substance:
    Acidified sodium chlorite. In October 2006, a petition was 
submitted to the NOSB for the use of acidified sodium chlorite as a 
synthetic processing aid in organic handling in wash and rinse water, 
as well as, for direct food contact and food contact surfaces. This 
substance contains an aqueous solution of sodium chlorite and citric 
acid, both of which are listed as generally recognized as safe (GRAS) 
in 21 CFR 186.1750 and 21 CFR 184.1033, respectively. Acidified sodium 
chlorite solution is a colorless to light green solution that has a 
slight chlorine-like odor.
    The use of acidified sodium chlorite is regulated by other Federal 
agencies. The FDA permits uses of acidified sodium chlorite as a 
secondary direct food additive in accordance with the concentrations 
and other specified conditions in 21 CFR 173.325.\2\ The FDA-approved 
uses for acidified sodium chlorite as secondary direct antimicrobial 
food treatment include the processing of poultry, red meat, comminuted 
and formed meat products, seafood, and raw and processed fruits and 
vegetables. Acidified sodium chlorite is also permitted as a sanitizing 
agent on food-processing equipment, utensils and other food contact 
surfaces including dairy-processing equipment (21 CFR 178.1010(b)(46)). 
The EPA has approved the use of acidified sodium chlorite (as an 
oxychloro species) as an ingredient in antimicrobial pesticide 
formulations applied to dairy-processing equipment, food-processing 
equipment and utensils, if the end-use concentration does not exceed 
200 ppm chlorine dioxide, per 40 CFR 180.940(b) and (c). Finally, the 
USDA Food Safety and Inspection Service (FSIS) recognizes the use of 
acidified sodium chlorite for processing red meat and poultry. The FSIS 
Directive 7120.1 specifies that acidified sodium chlorite applied as 
spray or dip in red meat processing, must have pH of 5.0-7.5 and 
concentrations of sodium chlorite and chlorine dioxide must not exceed 
1200 and 300 ppm respectively.\3\ References: NOSB recommendations, May 
2009, http://tiny.cc/lq2gx; NOSB meeting transcripts, May 2009, http://tinyurl.com/bqqzv8; Petition for acidified sodium chlorite, October 
2006, http://tinyurl.com/3x2wxpk; Acidified Sodium Chlorite Technical 
Advisory Panel Report compiled by AMS Science and Technology Program, 
July 21, 2008, http://tinyurl.com/359zdke.
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    \2\ The FDA states that acidified sodium chlorite solutions are 
produced by mixing an aqueous solution of sodium chlorite and any 
GRAS acid. For the purposes of the NOP, only citric acid is 
permitted in acidified sodium chlorite for use in organic handling.
    \3\ For other uses of acidified sodium chlorite in poultry and 
red meat processing, the FSIS Directive 7120.1 refers to the 
concentration and pH requirements provided in FDA regulation 21 CFR 
173.325.
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    At its May 4-6, 2009, meeting in Washington, DC, the NOSB 
recommended adding acidified sodium chlorite to Sec.  205.605(b) of the 
National List regulations for secondary direct antimicrobial food 
treatment and indirect food contact surface sanitizing, with the 
restriction that only citric acid can be used for acidification. The 
Board considered that acidified sodium chlorite can have a short 
contact time with the product being treated, does not produce 
chloromethanes or chlorohalogen, and breaks down upon use to water, 
citric acid and sodium chloride with no resulting residual chlorine 
levels in water. During this open meeting, the NOSB evaluated acidified 
sodium chlorite against the evaluation criteria of 7 U.S.C. 6517 and 
6518 of the OFPA, received public comment, and concluded that the 
substance is consistent with the OFPA evaluation criteria.
    The Secretary has reviewed the NOSB recommendation and, consistent 
with this recommendation, proposes to accept the NOSB's recommendation 
and amend Sec.  205.605(b) of the National List by adding acidified 
sodium chlorite as follows:
    Acidified sodium chlorite--Secondary direct antimicrobial food 
treatment and indirect food contact surface sanitizing. Acidified with 
citric acid only.\4\
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    \4\ The NOSB recommended the listing of this substance as sodium 
chlorite, acidified. In this proposed rule, ``acidified'' was moved 
to precede sodium chlorite for consistency with the use of this term 
in other Federal regulations.
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Section 205.606 Nonorganically Produced Agricultural Products Allowed 
as Ingredients in or on Processed Products Labeled as ``Organic''

    This proposed rule would amend Sec.  205.606 of the National List 
regulations by (1) Revising the annotation at paragraph (p); (2) 
redesignating paragraphs (r) through (t) and paragraphs (u) through 
(y), as paragraphs (s) through (u) and (w) through (aa) respectively; 
and (3) adding new paragraphs (r) and (v) for the purpose of amending 
and adding the following substances:
    Lecithin--unbleached. Unbleached lecithin was included in Sec.  
205.606 of the National List as originally published on December 21, 
2000 (65 FR 80548), as an allowed nonorganic agricultural ingredient in 
``organic'' products, when the organic version is not commercially 
available. In August 2008, a petition was submitted to amend the 
listing for unbleached lecithin to reflect the availability of organic 
fluid lecithins. Lecithin is available in fluid or de-oiled form. After 
extraction from the raw material, fluid lecithin can further be de-
oiled with acetone as the solvent. Both fluid and de-oiled lecithin may 
be bleached or unbleached. De-oiled lecithin imparts crumb softening 
and dough lubricating and conditioning characteristics. De-oiled 
lecithin is the only form of lecithin appropriate for certain products 
such as cakes, cookies, doughs, sauces, chocolates, frostings, and 
canned meat products. References: NOSB recommendations, May 2009, 
http://tiny.cc/6jmsq; NOSB meeting transcripts, May 2009, http://tinyurl.com/bqqzv8; Petition to remove fluid lecithin from the general 
category of unbleached lecithin, August 2008, http://tinyurl.com/25zcry9.
    At its May 4-6, 2009, meeting in Washington, DC, the NOSB evaluated 
lecithin against the evaluation criteria of 7 U.S.C. 6517 and 6518 of 
the OFPA and NOP criteria (72 FR 2167, January 18, 2007) on commercial 
availability, received public comment, and concluded that de-oiled 
lecithin is consistent with the OFPA evaluation criteria. The NOSB 
acknowledged that the de-oiling process, rather than bleaching, 
differentiates the types of lecithin. Based upon the petition and 
public comments, the NOSB determined that de-oiled lecithin is not 
commercially available in organic form and recommended revising the 
annotation of the listing for Lecithin--unbleached in Sec.  205.606 to 
Lecithin--de-oiled. This proposed action would prohibit the use of 
nonorganic fluid lecithin and allow the use of bleached

[[Page 68508]]

or unbleached nonorganic de-oiled lecithin when an organic version is 
not commercially available.
    The Secretary has reviewed the NOSB recommendation and, consistent 
with this recommendation, proposes to amend Sec.  205.606 of the 
National List regulations to allow the use of de-oiled lecithin as a 
nonorganically produced agricultural substance allowed as an ingredient 
in or on processed products labeled as ``organic'' as follows:
    Lecithin--de-oiled.
    Orange pulp, dried. In February 2008, dried orange pulp was 
petitioned for use as a nonorganic agricultural ingredient in or on 
processed products labeled as ``organic.'' Dried orange pulp, which may 
also be identified as citrus flour or citrus fiber, is used in various 
processed products including fresh and frozen baked goods, pastas, 
salad dressings, confectionery, processed cheese spreads, frozen food 
entrees, and processed meat and poultry products. Dried orange pulp is 
a yellowish light and fluffy powder. It is a byproduct of the 
extraction of raw oranges for orange juice production. The remaining 
raw pulp is washed with water, stabilized with heat, mixed, dried and 
milled. No chemical extraction or treatment is used in its manufacture. 
It functions to retain moisture in baked goods, pastas, salad 
dressings, confectionery, processed cheese spreads, frozen food 
entrees, processed meat and poultry products and seasoning brines for 
meat and poultry products. It also functions as a flavor enhancing 
agent in non-carbonated beverages and fruit drinks. In June 2004, the 
petitioner informed the FDA that this material is GRAS (GRAS Notice no. 
GRN000154). Dried orange pulp is also considered a moisture retention 
agent and binder for use in ground meat and poultry products. The USDA 
FSIS permits the use of dried orange pulp as a binder provided it does 
not exceed 3.5% of the product formulation. Dried orange pulp may also 
be used in various ground meat and poultry products where binders are 
permitted as described in USDA, FSIS Directive 7120.1. References: NOSB 
recommendations, November 2008, http://tiny.cc/agsu7; NOSB meeting 
transcripts, November 2008, http://tinyurl.com/bqqzv8; Petition for 
dried orange pulp, January 2008, http://tinyurl.com/238e7lj.
    At its November 17-19, 2008, meeting in Washington, DC, the NOSB 
recommended adding dried orange pulp to Sec.  205.606 of the National 
List regulations for use in organic handling as a nonorganic 
agricultural ingredient when the organic form of dried orange pulp is 
determined to be commercially unavailable. The Board determined that 
the demand for the organic dried orange pulp exceeded the availability 
of organic oranges in quantities to yield sufficient organic dried 
orange pulp. Specifically, the NOSB considered that most pulp is 
incorporated into orange juice and the low yield ratio of raw to dried 
pulp. The Board also considered the potential for this substance to 
replace certain synthetic substances which are allowed in organic 
handling. In this open meeting, the NOSB evaluated dried orange pulp 
against the evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA 
and the NOP criteria (72 FR 2167, January 18, 2007) on commercial 
availability, received public comment, and concluded that the substance 
is consistent with the OFPA evaluation criteria.
    The Secretary has reviewed the NOSB recommendation and, consistent 
with this recommendation, proposes to amend Sec.  205.606 of the 
National List regulations to allow dried orange pulp, at new paragraph 
(r) as a nonorganically produced agricultural product allowed as an 
ingredient in or on processed products labeled as ``organic'' as 
follows:
    Orange pulp, dried.
    Seaweed, Pacific kombu. Pacific kombu seaweed was petitioned in 
August 2007, for use as a nonorganic agricultural ingredient in or on 
processed products labeled as ``organic.'' Pacific kombu seaweed has 
been consumed for centuries in Japan and is used for stock in 
traditional Japanese foods. Pacific kombu species impart a unique 
flavor, which is attributed to the glutamic acid content, and which is 
not achievable with other seaweed species or sea vegetables. Pacific 
kombu seaweed is wild harvested along the coast of Japan. After 
harvest, the seaweed is hot water extracted, condensed, heat sterilized 
and filtered. The FDA has classified Pacific kombu as brown algae and 
affirmed that brown algae is a GRAS direct food substance. Its use in 
spices, seasonings, and flavorings as a flavor enhancer and flavor 
adjuvant in food is regulated by the FDA at 21 CFR 184.1120. 
References: NOSB recommendations, May 2008, http://tiny.cc/0e1xo; NOSB 
meeting transcripts, May 2008, http://tinyurl.com/bqqzv8; Petition for 
kombu seaweed, August 2007, http://tinyurl.com/29l4oug.
    At its May 20-22, 2008, meeting in Baltimore, MD, the NOSB 
recommended adding Pacific kombu seaweed to Sec.  205.606 of the 
National List regulations for use in organic handling as a nonorganic 
agricultural ingredient when the organic form of Pacific kombu seaweed 
is determined to be commercially unavailable. In this open meeting, the 
NOSB evaluated Pacific kombu seaweed against the evaluation criteria of 
7 U.S.C. 6517 and 6518 of the OFPA and NOP criteria (72 FR 2167, 
January 18, 2007) on commercial availability, received public comment, 
and concluded that the substance is consistent with the OFPA evaluation 
criteria.
    The Secretary has reviewed the NOSB recommendation and, consistent 
with this recommendation, proposes to amend Sec.  205.606 of the 
National List regulations to allow Pacific kombu seaweed, at new 
paragraph (v) as a nonorganically produced agricultural product allowed 
as an ingredient in or on processed products labeled as ``organic'' as 
follows:
    Seaweed, Pacific kombu.

III. Related Documents

    Three 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) 74 FR 11904, March 20, 2009, 
(bleached lecithin, acidified sodium chlorite, unbleached fluid 
lecithin); (2) 73 FR 54781, September 23, 2008, (dried orange pulp, 
acidified sodium chlorite); and (3) 73 FR 18491, April 4, 2008, 
(microcrystalline cheesewax, acidified sodium chlorite, Pacific kombu 
seaweed).

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 
the OFPA authorize the NOSB to develop proposed amendments to the 
National List for submission to the Secretary and establish a petition 
process by which persons may petition the NOSB for the purpose of 
having substances evaluated for inclusion on or deletion from the 
National List. The National List petition process is implemented under 
Sec.  205.607 of the NOP regulations. The current petition process (72 
FR 2167, January 18, 2007), can be accessed through the NOP Web site at 
http://www.ams.usda.gov/nop.

A. Executive Order 12866

    This action has been determined not significant for purposes of 
Executive Order 12866, and therefore, has not

[[Page 68509]]

been reviewed by the Office of Management and Budget.

B. Executive Order 12988

    Executive Order 12988 instructs each executive agency to adhere to 
certain requirements in the development of new and revised regulations 
in order to avoid unduly burdening the court system. This proposed rule 
is not intended to have a retroactive effect.
    States and local jurisdictions are preempted under the OFPA from 
creating programs of accreditation for private persons or State 
officials who want to become certifying agents of organic farms or 
handling operations. A governing State official would have to apply to 
USDA to be accredited as a certifying agent, as described in Sec.  
2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under 
Sec. Sec.  2104 through 2108 of the OFPA (7 U.S.C. 6503 through 6507) 
from creating certification programs to certify organic farms or 
handling operations unless the State programs have been submitted to, 
and approved by, the Secretary as meeting the requirements of the OFPA.
    Pursuant to Sec.  2108(b)(2) of the OFPA (7 U.S.C. 6507(b)(2)), a 
State organic certification program may contain additional requirements 
for the production and handling of organically produced agricultural 
products that are produced in the State and for the certification of 
organic farm and handling operations located within the State under 
certain circumstances. Such additional requirements must: (a) Further 
the purposes of the OFPA, (b) not be inconsistent with the OFPA, (c) 
not be discriminatory toward agricultural commodities organically 
produced in other States, and (d) not be effective until approved by 
the Secretary.
    Pursuant to Sec.  2120(f) of the OFPA (7 U.S.C. 6519(f)), this 
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 EPA under 
the Federal Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136 et 
seq.).
    Section 2121 of the OFPA (7 U.S.C. 6520) provides for the Secretary 
to establish an expedited administrative appeals procedure under which 
persons may appeal an action of the Secretary, the applicable governing 
State official, or a certifying agent under this title that adversely 
affects such person or is inconsistent with the organic certification 
program established under this title. The OFPA also provides that the 
U.S. District Court for the district in which a person is located has 
jurisdiction to review the Secretary's decision.

C. Regulatory Flexibility Act

    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 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 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 relax the regulations published in the 
final rule and would provide small entities with more tools to use in 
day-to-day operations. The removal of lecithin-bleached is not expected 
to have a significant economic impact on small entities as alternative 
forms of lecithin are commercially available. The AMS concludes that 
the economic impact of this addition of allowed substances, if any, 
would be minimal and beneficial to small agricultural service firms. 
Accordingly, USDA certifies that this rule will not have a significant 
economic impact on a substantial number of small entities.
    Small agricultural service firms, which include producers, 
handlers, and accredited certifying agents, have been defined by the 
Small Business Administration (SBA) (13 CFR 121.201) as those having 
annual receipts of less than $7,000,000 and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000.
    According to USDA, Economic Research Service (ERS) data based on 
information from USDA-accredited certifying agents, the number of 
certified U.S. organic crop and livestock operations totaled nearly 
13,000 and certified organic acreage exceeded 4.8 million acres in 
2008.\5\ ERS, based upon the list of certified operations maintained by 
the National Organic Program, estimated the number of certified 
handling operations was 3,225 in 2007.\6\ AMS believes that most of 
these entities would be considered small entities under the criteria 
established by the SBA.
---------------------------------------------------------------------------

    \5\ U.S. Department of Agriculture, Economic Research Service. 
2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock 
Numbers and Farm Operations, 1992-2008. http://www.ers.usda.gov/Data/Organic/.
    \6\ U.S. Department of Agriculture, Economic Research Service, 
2009. Data Sets: Procurement and Contracting by Organic Handlers: 
Documentation. http://www.ers.usda.gov/Data/OrganicHandlers/Documentation.htm.
---------------------------------------------------------------------------

    The U.S. sales of organic food and beverages have grown from $3.6 
billion in 1997 to nearly $21.1 billion in 2008.\7\ The organic 
industry is viewed as the fastest growing sector of agriculture, 
representing over 3 percent of overall food sales in 2009. Between 1990 
and 2008, organic food sales have historically demonstrated a growth 
rate between 15 to 24 percent each year. In 2009, organic food sales 
grew 5.1%.\8\
---------------------------------------------------------------------------

    \7\ Dimitri, C., and L. Oberholtzer. 2009. Marketing U.S. 
Organic Foods: Recent Trends from Farms to Consumers, Economic 
Information Bulletin No. 58, U.S. Department of Agriculture, 
Economic Research Service, http://www.ers.usda.gov/Publications/EIB58.
    \8\ Organic Trade Association's 2010 Organic Industry Survey, 
http://www.ota.com.
---------------------------------------------------------------------------

    In addition, USDA has 97 accredited certifying agents who provide 
certification services to producers and handlers. A complete list of 
names and addresses of accredited certifying agents may be found on the 
AMS NOP Web site, at http://www.ams.usda.gov/nop. AMS believes that 
most of these accredited certifying agents would be considered small 
entities under the criteria established by the SBA.

D. Paperwork Reduction Act

    No additional collection or recordkeeping requirements are imposed 
on the public by this 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.
    The AMS is committed to compliance with the Government Paperwork 
Elimination Act (GPEA), which requires Government agencies in general 
to

[[Page 68510]]

provide the public the option of submitting information or transacting 
business electronically to the maximum extent possible.
    The AMS is committed to complying with the E-Government Act to 
promote the use of the Internet and other information technologies to 
provide increased opportunities for citizen access to Government 
information and services, and for other purposes.

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 205.601 is amended by adding paragraph (o) to read as 
follows:

Sec.  205.601  Synthetic substances allowed for use in organic crop 
production.

* * * * *
    (o) As production aids. Microcrystalline cheesewax (CAS 's 
64742-42-3, 8009-03-08, and 8002-74-2)--for use in log grown mushroom 
culture. Must be made without either ethylene-propylene co-polymer or 
synthetic colors.
* * * * *
    3. Section 205.605, paragraph (b), is amended by:
    A. Removing ``Lecithin--bleached.''; and
    B. Adding one new substance to paragraph (b) to read as follows:

Sec.  205.605  Nonagricultural (nonorganic) substances allowed as 
ingredients in or on processed products labeled as ``organic'' or 
``made with organic (specified ingredients or food group(s)).''

* * * * *
    (b) * * *
    Acidified sodium chlorite--Secondary direct antimicrobial food 
treatment and indirect food contact surface sanitizing. Acidified with 
citric acid only.
* * * * *
    4. Section 205.606 is amended by:
    A. Revising paragraph (p);
    B. Redesignating paragraphs (r) through (t) and paragraphs (u) 
through (y) as paragraphs (s) through (u) and (w) through (aa) 
respectively; and
    C. Adding new paragraphs (r) and (v) to read as follows:

Sec.  205.606  Nonorganically produced agricultural products allowed as 
ingredients in or on processed products labeled as ``organic.''

* * * * *
    (p) Lecithin--de-oiled.
* * * * *
    (r) Orange pulp, dried.
* * * * *
    (v) Seaweed, Pacific kombu.
* * * * *

    Dated: November 2, 2010.
David R. Shipman,
Acting Administrator.
[FR Doc. 2010-28042 Filed 11-5-10; 8:45 am]
BILLING CODE 3410-02-P
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