[Federal Register Volume 75, Number 215 (Monday, November 8, 2010)]
[Proposed Rules]
[Pages 68505-68510]
From the Federal Register Online via the Government Publishing 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.
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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.
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\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.
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The U.S. sales of organic food and beverages have grown from $3.6
billion in 1997 to nearly $21.1 billion in 2008.\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\
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\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.
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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