National Organic Program; Proposed Amendments to the National List of Allowed and Prohibited Substances (Crops and Processing), 68505-68510 [2010-28042]
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68505
Proposed Rules
Federal Register
Vol. 75, No. 215
Monday, November 8, 2010
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.
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)
Agricultural Marketing Service,
USDA.
ACTION: Proposed rule.
AGENCY:
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: https://
www.regulations.gov.
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• 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
(https://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 §§ 205.600
through 205.607. This National List
identifies the synthetic substances that
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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
§ 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 § 205.601, one substance
(acidified sodium chlorite) for organic
processing to § 205.605(b), and two
substances (orange pulp, dried, and
Pacific kombu seaweed) for organic
processing to § 205.606 of the National
List. This proposed rule would amend
§ 205.605(b) of the National List by
removing one substance (lecithin—
bleached). This proposed rule would
also amend § 205.606 of the National
List by amending one listing (lecithin—
unbleached). The exemptions for use of
each substance in organic production
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were evaluated by the NOSB using the
evaluation criteria specified in OFPA (7
U.S.C. §§ 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:
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Section 205.601 Synthetic Substances
Allowed for Use in Organic Crop
Production
This proposed rule would amend
§ 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). Claytreated 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–
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1), is added in a quantity less than 100
parts per million.1
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 foodgrade 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,
https://tiny.cc/rrmr3; NOSB meeting
transcripts, May 2008, https://
tinyurl.com/bqqzv8; Petition and
Addendum for cheesewax, April and
December 2006, https://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 § 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–
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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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 § 205.605 of the
National List regulations by removing
the exemption for the following
substance:
Lecithin—bleached. Bleached lecithin
was included in § 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 § 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 nonsynthetic 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—
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bleached in paragraph (b) of § 206.605.
The Board has recommended to
continue to allow nonorganic de-oiled
lecithin when an organic version is not
commercially available—see § 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
§ 205.605(b). References: NOSB
recommendations, May 2009, https://
tiny.cc/9wgkp; NOSB meeting
transcripts, May 2009, https://
tinyurl.com/bqqzv8; Petition to remove
bleached lecithin, June 2008, https://
tinyurl.com/32e638e.
This proposed rule would further
amend paragraph (b) of § 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 dairyprocessing equipment, food-processing
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.
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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,
https://tiny.cc/lq2gx; NOSB meeting
transcripts, May 2009, https://
tinyurl.com/bqqzv8; Petition for
acidified sodium chlorite, October 2006,
https://tinyurl.com/3x2wxpk; Acidified
Sodium Chlorite Technical Advisory
Panel Report compiled by AMS Science
and Technology Program, July 21, 2008,
https://tinyurl.com/359zdke.
At its May 4–6, 2009, meeting in
Washington, DC, the NOSB
recommended adding acidified sodium
chlorite to § 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 § 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
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.
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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68507
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 (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 § 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,
https://tiny.cc/6jmsq; NOSB meeting
transcripts, May 2009, https://
tinyurl.com/bqqzv8; Petition to remove
fluid lecithin from the general category
of unbleached lecithin, August 2008,
https://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 § 205.606 to Lecithin—
de-oiled. This proposed action would
prohibit the use of nonorganic fluid
lecithin and allow the use of bleached
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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 § 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 noncarbonated 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, https://tiny.cc/agsu7;
NOSB meeting transcripts, November
2008, https://tinyurl.com/bqqzv8;
Petition for dried orange pulp, January
2008, https://tinyurl.com/238e7lj.
At its November 17–19, 2008, meeting
in Washington, DC, the NOSB
recommended adding dried orange pulp
to § 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
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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 § 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, https://tiny.cc/0e1xo; NOSB
meeting transcripts, May 2008, https://
tinyurl.com/bqqzv8; Petition for kombu
seaweed, August 2007, https://
tinyurl.com/29l4oug.
At its May 20–22, 2008, meeting in
Baltimore, MD, the NOSB recommended
adding Pacific kombu seaweed to
§ 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
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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 § 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 § 205.607
of the NOP regulations. The current
petition process (72 FR 2167, January
18, 2007), can be accessed through the
NOP Web site at https://
www.ams.usda.gov/nop.
A. Executive Order 12866
This action has been determined not
significant for purposes of Executive
Order 12866, and therefore, has not
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emcdonald on DSK2BSOYB1PROD with PROPOSALS
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
§ 2115(b) of the OFPA (7 U.S.C.
6514(b)). States are also preempted
under §§ 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 § 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 § 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
VerDate Mar<15>2010
18:48 Nov 05, 2010
Jkt 223001
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.
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68509
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.
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
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 https://www.ams.usda.gov/nop.
AMS believes that most of these
accredited certifying agents would be
considered small entities under the
criteria established by the SBA.
D. Paperwork Reduction Act
No additional collection or
recordkeeping requirements are
imposed on the public by this 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
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. https://
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.
https://www.ers.usda.gov/Data/OrganicHandlers/
Documentation.htm.
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, https://www.ers.usda.gov/Publications/
EIB58.
8 Organic Trade Association’s 2010 Organic
Industry Survey, https://www.ota.com.
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Federal Register / Vol. 75, No. 215 / Monday, November 8, 2010 / Proposed Rules
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:
2. Section 205.601 is amended by
adding paragraph (o) to read as follows:
§ 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:
§ 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)).’’
emcdonald on DSK2BSOYB1PROD with PROPOSALS
*
*
*
*
(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
Jkt 223001
*
*
*
*
(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
DEPARTMENT OF AGRICULTURE
[Doc. No. AMS–FV–10–0053; FV10–924–1
PR]
Authority: 7 U.S.C. 6501–6522.
18:48 Nov 05, 2010
*
7 CFR Part 924
1. The authority citation for 7 CFR
part 205 continues to read as follows:
VerDate Mar<15>2010
§ 205.606 Nonorganically produced
agricultural products allowed as ingredients
in or on processed products labeled as
‘‘organic.’’
Agricultural Marketing Service
PART 205—NATIONAL ORGANIC
PROGRAM
*
C. Adding new paragraphs (r) and (v)
to read as follows:
Fresh Prunes Grown in Designated
Counties in Washington and in
Umatilla County, OR; Termination of
Marketing Order 924
Agricultural Marketing Service,
USDA.
ACTION: Proposed rule.
AGENCY:
This rule invites comments
on the proposed termination of the
Federal marketing order regulating the
handling of fresh prunes grown in
designated counties in Washington and
in Umatilla County, Oregon, and the
rules and regulations issued thereunder.
Marketing Order No. 924 is
administered locally by the WashingtonOregon Fresh Prune Marketing
Committee (Committee), which
unanimously recommended termination
of the marketing order at a meeting held
on June 1, 2010. This recommendation
is based on the Committee’s
determination that this order is no
longer an effective marketing tool for the
fresh prune industry, and that
termination would best serve the
current needs of the industry while also
eliminating the costs associated with the
operation of the marketing order.
DATES: Comments must be received by
January 7, 2011.
ADDRESSES: Interested persons are
invited to submit written comments
concerning this proposal. Comments
must be sent to the Docket Clerk,
Marketing Order Administration
Branch, Fruit and Vegetable Programs,
SUMMARY:
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Frm 00006
Fmt 4702
Sfmt 4702
AMS, USDA, 1400 Independence
Avenue, SW., STOP 0237, Washington,
DC 20250–0237; Fax: (202) 720–8938; or
Internet: https://www.regulations.gov. All
comments should reference the
document number and the date and
page number of this issue of the Federal
Register and will be made available for
public inspection in the Office of the
Docket Clerk during regular business
hours, or can be viewed at: https://
www.regulations.gov. All comments
submitted in response to this rule will
be included in the record and will be
made available to the public. Please be
advised that the identity of the
individuals or entities submitting the
comments will be made public on the
Internet at the address provided above.
FOR FURTHER INFORMATION CONTACT:
Martin Engeler, Marketing Order
Administration Branch, Fruit and
Vegetable Programs, AMS, USDA, 2202
Monterey Street, Suite 102–B, Fresno,
California 93721, Telephone: (559) 487–
5110, Fax: (559) 487–5906, or E-mail:
Martin.Engeler@ams.usda.gov; or Robert
Curry, Marketing Order Administration
Branch, Fruit and Vegetable Programs,
AMS, USDA, 1220 SW Third Avenue,
Suite 385, Portland, Oregon 97068,
Telephone: (503) 326–2724, Fax: (503)
326–7440, or E-mail:
Robert.Curry@ams.usda.gov.
Small businesses may request
information on complying with this
regulation by contacting Antoinette
Carter, Marketing Order Administration
Branch, Fruit and Vegetable Programs,
AMS, USDA, 1400 Independence
Avenue, SW., STOP 0237, Washington,
DC 20250–0237; telephone: (202) 720–
2491, Fax: (202) 720–8938, or E-mail:
Antoinette.Carter@ams.usda.gov.
SUPPLEMENTARY INFORMATION: This
proposed rule is governed by
§ 608c(16)(A) of the Agricultural
Marketing Agreement Act of 1937, as
amended (7 U.S.C. 601–674), hereinafter
referred to as the ‘‘Act’’, and § 924.64 of
Marketing Agreement and Order No.
924, both as amended (7 CFR part 924),
effective under the Act and hereinafter
referred to as the ‘‘order’’.
The Department of Agriculture
(USDA) is issuing this rule in
conformance with Executive Order
12866.
This proposal to terminate the order
has been reviewed under Executive
Order 12988, Civil Justice Reform. This
rule is not intended to have retroactive
effect.
The Act provides that administrative
proceedings must be exhausted before
parties may file suit in court. Under
section 608c(15)(A) of the Act, any
handler subject to an order may file
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]]>Agencies
[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]
========================================================================
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.
-----------------------------------------------------------------------
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: https://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 (https://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\
---------------------------------------------------------------------------
\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)).
---------------------------------------------------------------------------
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, https://tiny.cc/rrmr3; NOSB meeting transcripts, May 2008, https://tinyurl.com/bqqzv8; Petition and Addendum for cheesewax, April and
December 2006, https://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, https://tiny.cc/9wgkp; NOSB meeting
transcripts, May 2009, https://tinyurl.com/bqqzv8; Petition to remove
bleached lecithin, June 2008, https://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, https://tiny.cc/lq2gx; NOSB meeting transcripts, May 2009, https://tinyurl.com/bqqzv8; Petition for acidified sodium chlorite, October
2006, https://tinyurl.com/3x2wxpk; Acidified Sodium Chlorite Technical
Advisory Panel Report compiled by AMS Science and Technology Program,
July 21, 2008, https://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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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,
https://tiny.cc/6jmsq; NOSB meeting transcripts, May 2009, https://tinyurl.com/bqqzv8; Petition to remove fluid lecithin from the general
category of unbleached lecithin, August 2008, https://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, https://tiny.cc/agsu7; NOSB meeting
transcripts, November 2008, https://tinyurl.com/bqqzv8; Petition for
dried orange pulp, January 2008, https://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, https://tiny.cc/0e1xo; NOSB
meeting transcripts, May 2008, https://tinyurl.com/bqqzv8; Petition for
kombu seaweed, August 2007, https://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
https://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. https://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. https://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\
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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, https://www.ers.usda.gov/Publications/EIB58.
\8\ Organic Trade Association's 2010 Organic Industry Survey,
https://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 https://www.ams.usda.gov/nop. AMS believes that
most of these accredited certifying agents would be considered small
entities under the criteria established by the SBA.
D. Paperwork Reduction Act
No additional collection or recordkeeping requirements are imposed
on the public by this 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
