[Federal Register: September 16, 2005 (Volume 70, Number 179)]
[Proposed Rules]
[Page 54660-54668]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16se05-21]
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket Number TM-04-01]
RIN 0581-AC35
National Organic Program (NOP): 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
[[Page 54661]]
(National List) regulations to reflect recommendations submitted to the
Secretary of Agriculture (Secretary) by the National Organic Standards
Board (NOSB) from November 15, 2000, through March 3, 2005. Consistent
with the recommendations from the NOSB, this proposed rule would add
fifteen substances, along with any restrictive annotations, to the
National List. This proposed rule would also amend the mailing address
for where to file a Certification or Accreditation appeal.
DATES: Comments must be received by November 15, 2005.
ADDRESSES: Interested persons may comment on this proposed rule using
the following procedures:
Mail: Comments may be submitted by mail to: Arthur Neal,
Director of Program Administration, National Organic Program, USDA-AMS-
TMP-NOP, 1400 Independence Ave., SW., Room 4008-So., Ag Stop 0268,
Washington, DC 20250.
E-mail: Comments may be submitted via the Internet to:
National.List@usda.gov.
Internet: http://www.regulations.gov.
Fax: Comments may be submitted by fax to: (202) 205-7808.
Written comments on this proposed rule should be
identified with the docket number TMD-04-01. Commenters should identify
the topic and section number of this proposed rule to which the comment
refers.
Clearly indicate if you are for or against the proposed
rule or some portion of it and your reason for it. Include recommended
language changes as appropriate.
Include a copy of articles or other references that
support your comments. Only relevant material should be submitted.
It is our intention to have all comments to this proposed rule,
whether submitted by mail, e-mail, or fax, available for viewing on the
NOP homepage. Comments submitted in response to this proposed rule will
be available for viewing in person at USDA-AMS, Transportation and
Marketing, Room 4008-South Building, 1400 Independence Ave., SW.,
Washington, DC, from 9 a.m. to 12 noon and from 1 p.m. to 4 p.m.,
Monday through Friday (except 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: Arthur Neal, Director of Program
Administration, Telephone: (202) 720-3252; Fax: (202) 205-7808.
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Secretary established, within the NOP [7
CFR part 205], the National List regulations (Sec. Sec. 205.600
through 205.607). The National List regulations identify synthetic
substances and ingredients that are allowed and nonsynthetic (natural)
substances and ingredients that are prohibited for use in organic
production and handling. Under the authority of the Organic Foods
Production Act of 1990 (OFPA), as amended, (7 U.S.C. 6501 et seq.), 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 twice, October 31, 2003 (68 FR 61987), and November 3,
2003 (68 FR 62215).
This proposed rule would amend the National List to reflect
recommendations submitted to the Secretary by the NOSB from November
15, 2000, through March 3, 2005. Between the specified time period, the
NOSB has recommended that the Secretary add four substances to Sec.
205.601 and eleven substances to Sec. 205.605 of the National List
regulations. This proposed rule would also amend the mailing address
for where to file a Certification or Accreditation appeal pursuant to
Sec. 205.681(d).
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 paragraph (m)(2) of Sec. 205.601 of
the regulations by adding the following substances:
Glycerine oleate (Glycerol monooleate) (CAS s 25496-72-4;
111-03-5; 37220-82-9)--for use only until December 31, 2006. Glycerine
oleate was petitioned to be used as an anti-foaming agent (defoamer) in
organic crop production. Glycerine oleate is a clear amber or pale
yellow liquid that is insoluble in water, slightly soluble in cold
alcohol, and soluble in hot alcohol, chloroform, ether, and petroleum
ether. In crop production, Glycerin oleate would be used as an anti-
foaming agent (defoamer) in micronized wettable Sulfur that is used to
control scab and mildew in the production of apples, pears, grapes, and
raisins. The function of Glycerine oleate in the micronized wettable
Sulfur would be to enable the product to be mixed in a tank effectively
and sprayed on crops evenly.
Under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA), the Environmental Protection Agency (EPA) has classified
Glycerine oleate as a List 3 inert (Inerts of Unknown Toxicity). Under
the Food and Drug Administration (FDA), Glycerin monooleate (a synonym
for Glycerin oleate) has been classified as a substance that is
Generally Recognized As Safe (GRAS) for food production (21 CFR
184.1323).
The NOSB, at its May 13-14, 2003, meeting in Austin, TX,
recommended adding Glycerine oleate to Sec. 205.601(m) (2) of the
National List regulations. In this open meeting, the NOSB evaluated
Glycerine oleate 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; however, it
recommended that Glycerine oleate be added to the National List
regulations, for use in crop production, only until December 31, 2006.
The normal time period for the use of a substance under the NOP
regulations is 5 years, beginning the date the substance appears in the
National List regulations. The NOSB recommended the early expiration
date of December 31, 2006, because of the present efforts of the
Environmental Protection Agency (EPA) to reclassify inerts on List 2
(Potentially Toxic Inert Ingredients/High Priority for Testing Inerts)
and List 3 (Inerts of Unknown Toxicity) to either List 1 (Inert
Ingredients of Toxicological Concern) or List 4 (Inerts of Minimal
Concern) by December 31, 2006. With respect to the use of EPA regulated
inert ingredients in organic crop and livestock production, only
substances included on EPA's List 4 are categorically allowed on the
National List (Sec. 205.601(m)(i)); all other EPA inert ingredients
must be listed individually. Glycerine oleate is a List 3 inert; the
NOSB anticipates that EPA will conclude its reclassification of
Glycerine oleate to either a List 1 or List 4 status by December 31,
2006. If Glycerine oleate is reclassified as a List 1 inert, it will be
prohibited for use as an inert ingredient for organic crop production.
If Glycerin oleate is reclassified as a List 4 inert, then it will
automatically continue to be allowed for use in organic crop production
as an inert ingredient. In addition, if EPA does not complete its
reclassification of
[[Page 54662]]
Glycerine oleate by December 31, 2006, the substance will be prohibited
for use in organic crop production beginning on January 1, 2007.
Therefore, in response to the NOSB recommendation regarding the use
of Glycerine oleate in organic crop production, the Secretary accepts
the NOSB recommendation and proposes to amend Sec. 205.601(m)(2) of
the National List regulation as follows:
Glycerine oleate (Glycerol monooleate) (CAS s 25496-72-4;
111-03-5; 37220-82-9)--for use only until December 31, 2006.
Tetrahydrofurfuryl alcohol (CAS 97-99-4)--for use only
until December 31, 2006. Tetrahydrofurfuryl alcohol was petitioned for
use as an inert pesticidal ingredient for use in organic crop
production. Tetrahydrofurfuryl alcohol is a clear, colorless liquid
that is used extensively in various industries as a high-purity, water
miscible solvent, and as a chemical intermediate. If released to soil,
Tetrahydrofurfuryl alcohol is expected to exhibit high solubility.
Under FIFRA, the EPA has registered Tetrahydrofurfuryl alcohol as a
List 3 inert (Inerts of Unknown Toxicity). In addition, the FDA has
classified Tetrahydrofurfuryl alcohol as a direct food additive in
synthetic flavoring substances (21 CFR 172.515) and an indirect food
additive in adhesives and the manufacture of paper and paper adjuvants
(21 CFR 175.105 and 176.210).
The NOSB, at its May 13-14, 2003, meeting in Austin, TX,
recommended adding Tetrahydrofurfuryl alcohol to Sec. 205.601(m)(2) of
the National List regulations. In this open meeting, the NOSB evaluated
Tetrahydrofurfuryl alcohol 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; however,
it recommended that Tetrahydrofurfuryl alcohol be added to the National
List regulations, for use in crop production, only until December 31,
2006.
The normal time period for the use of a substance under the NOP
regulations is five years, beginning the date the substance appears in
the National List regulations. The NOSB recommended the early
expiration date of December 31, 2006, because of the present efforts of
the EPA to reclassify inerts on List 2 (Potentially Toxic Inert
Ingredients/High Priority for Testing inerts) and List 3 (Inerts of
Unkown Toxicity) to either List 1 (Inert Ingredients of Toxicological
Concern) or List 4 (Inerts of Minimal Concern) by December 31, 2006.
With respect to the use of EPA regulated inert ingredients in organic
crop and livestock production, only substances included on EPA's List 4
are categorically allowed on the National List (Sec. 205.601(m)(i));
all other EPA inert ingredients must be listed individually.
Tetrahydrofurfuryl alcohol is a List 3 inert; the NOSB anticipates that
EPA will conclude its reclassification of Tetrahydrofurfuryl alcohol to
either a List 1 or List 4 status by December 31, 2006. If
Tetrahydrofurfuryl alcohol is reclassified as a List 1 inert, it will
be prohibited for use as an inert ingredient for organic crop
production. If Tetrahydrofurfuryl alcohol is reclassified as a List 4
inert, then it will automatically continue to be allowed for use in
organic crop production as an inert ingredient. In addition, if EPA
does not complete its reclassification of Tetrahydrofurfuryl alcohol by
December 31, 2006, the substance will be prohibited for use in organic
crop production beginning on January 1, 2007.
Therefore, in response to the NOSB recommendation regarding the use
of Tetrahydrofurfurly alcohol in organic crop production, the Secretary
accepts the NOSB recommendation and proposes to amend Sec.
205.601(m)(2) of the National List regulation as follows:
Tetrahydrofurfurly alcohol (CAS 97-99-4)--for use only
until December 31, 2006.
Hydrogen chloride (CAS 7647-01-0)--for de-linting cotton
seed for planting. Hydrogen chloride was petitioned for use as a
synthetic to delint cotton seed for planting in organic crop
production. Hydrogen chloride is a colorless to slightly yellow gas
with a pungent, irritating odor. It is very soluble in water and
readily soluble in alcohol and ether. Hydrogen chloride has been
classified by the FDA as a substance that is GRAS when used as a buffer
and neutralizing agent in accordance with good manufacturing or feeding
practice (21 CFR 582.1057). In delinting cotton seeds intended for
planting organic acreage, Hydrogen chloride is released into a
delinting machine that contains linted cotton seeds. Seed is exposed to
the Hydrogen chloride for about eight to ten minutes to weaken the lint
and is then sent through buffers to remove the weakened lint from the
seed. After delinting, a neutralizing agent (often Calcium carbonate)
is used to prevent acid damage to the seed.
The NOSB, at its April 28-30, 2004, meeting in Chicago, IL,
recommended adding Hydrogen chloride to Sec. 205.601 of the National
List regulations. In this open meeting, the NOSB evaluated Hydrogen
chloride 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. Therefore, in response to
the NOSB recommendation regarding the use of Hydrogen chloride in
organic crop production, the Secretary accepts the NOSB recommendation
and proposes to amend Sec. 205.601 of the National List regulations by
adding (1) a new paragraph (n), Seed preparations, and (2) Hydrogen
chloride as follows:
(n) Seed preparations.
Hydrogen chloride (CAS 7647-01-0)--for de-linting cotton
seed for planting.
Ferric phosphate (CAS 10045-86-0). Ferric phosphate was
petitioned for use as a pesticide (molluscicide) to bait slugs and
snails in organic crop production. It is an odorless, yellowish-white
powder that is not very soluble in water. Ferric phosphate is normally
applied to soil as part of a pellet that includes a wheat-based bait to
attract snails and slugs. After the pellets are consumed, Ferric
phosphate interferes with calcium metabolism in the digestive tract of
the snails and slugs, causing them to stop eating. Shortly thereafter,
the snails and slugs die.
Under the FIFRA, the EPA has registered ferric phosphate as a
biochemical molluscicide that targets a wide range of slugs and snails
(63 FR 43936). In assessing risks to human health, EPA has concluded
that there are no known or expected adverse effects to humans from the
use of ferric phosphate. In assessing risks to the environment, the EPA
has concluded that there are no known or expected harmful effects of
the use of Ferric phosphate on the environment if users follow the
application rates and use directions on the label. In addition to the
assessments of the EPA, the FDA has classified Ferric phosphate as a
substance that is GRAS for food use (21 CFR 184.1301).
The NOSB, at its February 28-March 3, 2005, meeting in Washington,
DC, recommended adding Ferric phosphate to Sec. 205.601(h) of the
National List regulations without restriction. In this open meeting,
the NOSB evaluated Ferric phosphate 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. Therefore, in response to the NOSB recommendation regarding
the use of Ferric phosphate in organic crop production, the Secretary
accepts the NOSB recommendation and proposes to
[[Page 54663]]
amend Sec. 205.601(h) of the National List regulations as follows:
Ferric phosphate (CAS 10045-86-0).
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 Sec. 205.605 (a) of the regulations
by adding the following substances:
Egg white lysozyme (CAS 9001-63-2). Egg white lysozyme
was petitioned for use as an enzyme in organic processing. It is a
white powder with no distinct odor. It is readily soluble in water and
practically insoluble in alcohol, chloroform, and ether. Egg white
lysozyme is considered to be GRAS by the FDA for use as an
antimicrobial agent in casings for frankfurters and on cooked meat and
poultry products. Egg white lysozyme is used in casings for
frankfurters at a concentration of 2.5 milligram (mg) lysozyme per
pound (lb) of frankfurter (equivalent to 5.5 mg Lysozyme per kilogram
(kg) of food) and in cooked meat and poultry products sold as ready-to-
eat at a concentration of 2.0 mg of Lysozyme per lb of cooked meat or
poultry product (equivalent to 4.4 mg of Lysozyme per kg of food). The
FDA acknowledged in GRAS Notice No. (GRN) 000064 that it had no
question, at the time of review, that Egg white lysozyme is GRAS under
the intended conditions of use; provided, that the ingredient statement
of food products that contain Egg white lysozyme contain the name ``Egg
white lysozyme'' to identify the source of the protein.
The NOSB, at its May 13-14, 2003, meeting in Austin, TX,
recommended adding Egg white lysozyme to Sec. 205.605(a) of the
National List regulations without restriction. In this open meeting,
the NOSB evaluated Egg white lysozyme 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. Therefore, in response to the NOSB recommendation regarding
the use of Egg white lysozyme in organic handling, the Secretary
accepts the NOSB recommendation and proposes to amend Sec. 205.605(a)
of the National List regulations as follows:
Egg white lysozyme (CAS 9001-63-2).
L-Malic acid (CAS 97-67-6). DL-Malic acid was originally
petitioned for use as a synthetic processing aid in organic handling.
It is a white or colorless powder with no odor. It is readily
biodegradable in water and in soil. DL-Malic acid is considered to be
GRAS by FDA (21 CFR 184.1069). It is a processing aid that is used in
bottled iced tea, dry mix beverages, carbonated beverages, bakery
products, fruit juices, candies, gelatins, desserts, frozen
specialties, sports drinks, and other food products.
The NOSB, at its May 13-14, 2003, meeting in Austin, TX, evaluated
DL-Malic acid in an open meeting, received public comment, and
concluded that the substance was not consistent with the evaluation
criteria of 7 U.S.C. 6517 and 6518 of the OFPA. This determination was
made because of an identified available natural alternative, L-Malic
acid. As a result of having identified a natural alternative to DL-
malic acid, the NOSB asked the petitioner whether L-Malic acid, a
natural, could be substituted for DL-Malic acid for inclusion on the
National List. The petitioner concurred and the NOSB recommended L-
Malic acid for inclusion in section 205.605(a) of the National List.
Therefore, in response to the NOSB recommendation regarding the use of
L-Malic acid in organic handling, the Secretary accepts the NOSB
recommendation and proposes to amend Sec. 205.605 (a) of the National
List regulations as follows:
L-Malic acid (CAS 97-67-6).
Microorganisms--any food grade bacteria, fungi, and other
microorganisms. Seed mold, a microorganism, was petitioned for use as a
processing aid in organic handling. Seed mold is used as a culture
starter in food processing. In the evaluation of seed mold, the NOSB
recognized that they had previously evaluated and determined other
types of food-grade microorganisms (e.g., dairy cultures and yeast) and
certain by-products derived from them (e.g., enzymes) to be consistent
with OFPA criteria and the NOP regulations. These microorganisms are
already included on the National List.
The NOSB acknowledged that there are many species of food-grade
microorganisms that are used in food processing that could be
petitioned for use in organic handling. As a result, a decision was
made by the NOSB to evaluate the categorical use of food-grade
microorganisms in organic handling and recommend their inclusion in
section 205.605(a) of the National List. This decision would obviate
the need for future review and evaluation of other individual food
grade microorganisms that exhibit similar characteristics and functions
as those already approved for use on the National List.
At its May 13-14, 2003, meeting in Austin, TX, the NOSB recommended
adding microorganisms to Sec. 205.605(a) of the National List
regulations without restriction. In this open meeting, the NOSB
evaluated the categorical use of microorganisms in organic handling
against 7 U.S.C. 6517 and 6518 of the OFPA, received public comment,
and concluded that the use of microorganisms in organic handling is
consistent with the evaluation criteria. Therefore, in response to the
NOSB recommendation regarding the use of microorganisms in organic
handling, the Secretary accepts the NOSB recommendation and proposes to
amend Sec. 205.605(a) of the National List regulations as follows:
Microorganisms--any food grade bacteria, fungi, and other
microorganisms.
This proposed rule would also amend Sec. 205.605(b) of the
regulations by adding the following substances:
Activated charcoal (CAS s 7440-44-0; 64365-11-3)--only
from vegetative sources; for use only as a filtering aid in handling
agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited in handling agricultural
products labeled ``organic.'' Activated charcoal was petitioned for use
as a processing aid in organic handling. Activated charcoal is a solid,
porous, black carbonaceous material that is used as a decolorizing
agent, taste- and odor-removing agent, and purification agent in food
processing. It is also used for the treatment of water, including
potable water. Activated charcoal is acknowledged by FDA in 21 CFR
173.25(b)(1)(ii) to be an allowed substance for use in ion exchange. It
is also recognized as an indirect food additive in closures with
sealing gaskets for food containers (21 CFR 177.1210).
At its September 17-19, 2002, meeting in Austin, TX, the NOSB
recommended adding activated charcoal to Sec. 205.605(b) of the
National List regulations for organic handling, with the restrictions
that the substance: (1) Comes from vegetative sources only; and (2)
only be used as a filtering aid. In this open meeting, the NOSB
evaluated the use of activated charcoal against the evaluation criteria
of Sec. 205.600(b) of the National List regulations, received public
comment, and concluded that the use of activated charcoal in organic
handling is consistent with the evaluation criteria.
Therefore, in response to the NOSB recommendation regarding the use
of activated charcoal in organic handling,
[[Page 54664]]
the Secretary proposes to amend Sec. 205.605(b) of the National List
regulations to allow activated charcoal as a synthetic ingredient in or
on processed products labeled as ``made with organic (specified
ingredients or food group(s))'' as follows:
Activated charcoal (CAS s 7440-44-0; 64365-11-3)--only
from vegetative sources; for use only as a filtering aid in handling
agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited in handling agricultural
products labeled ``organic.''
Ammonium hydroxide (CAS 1336-21-6)--for use only as a
boiler water additive until October 21, 2005. Restricted to handling
agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited in handling agricultural
products labeled ``organic.'' Ammonium hydroxide was petitioned as a
boiler water additive in organic handling. It is a colorless liquid
with an intense odor. It is used in preventing the corrosion of boiler
equipment used in food processing. Ammonium hydroxide is considered to
be GRAS by FDA and allowed as a boiler water additive under 21 CFR
184.1139.
At its October 15-17, 2001, meeting in Washington, DC, the NOSB
recommended adding Ammonium hydroxide to Sec. 205.605(b) of the
National List regulations, with the restriction that it can only be
used in organic handling until October 21, 2005. In this open meeting,
the NOSB evaluated the use of Ammonium hydroxide against the evaluation
criteria of Sec. 205.600(b) of the National List regulations, received
public comment, and concluded that the use of Ammonium hydroxide in
organic handling is consistent with the evaluation criteria.
Although the NOSB determined Ammonium hydroxide to be consistent
with the evaluation criteria of Sec. 205.600(b), it recommended an
early expiration date of October 21, 2005, for the use of the
substance, to encourage the organic processing industry to find an
alternative substance to use in place of the Ammonium hydroxide. The
normal time period for the use of a substance under the NOP regulations
is 5 years, beginning the date the substance appears in the National
List regulations.
Therefore, in response to the NOSB recommendation regarding the use
of Ammonium hydroxide in organic handling, the Secretary proposes to
amend Sec. 205.605(b) of the National List regulations to allow
Ammonium hydroxide as a synthetic ingredient in or on processed
products labeled as ``made with organic (specified ingredients or food
group(s))'' as follows:
Ammonium hydroxide (CAS 1336-21-6)--for use only as a
boiler water additive until October 21, 2005. Restricted to handling
agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited in handling agricultural
products labeled ``organic.''
Cyclohexylamine (CAS 108-91-8)--for use only as a boiler
water additive for packaging sterilization. Restricted to handling
agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited in handling agricultural
products labeled ``organic.'' Cyclohexylamine was petitioned as a
boiler water additive in organic handling. Cyclohexylamine is a
colorless to yellow liquid that has a strong, fishy odor. It is
miscible with water and with common organic solvents. It is used to
prevent the corrosion of boiler equipment used in food processing.
Cyclohexylamine is approved for use as a secondary direct food additive
and boiler water additive by FDA under 21 CFR 173.310.
At its October 15-17, 2001, meeting in Washington, DC, the NOSB
recommended adding Cyclohexlamine to Sec. 205.605(b) of the National
List regulations for organic handling, with the restriction that it be
used as a boiler water additive for packaging sterilization only. In
this open meeting, the NOSB evaluated the use of Cyclohexlamine against
the evaluation criteria of Sec. 205.600(b) of the National List
regulations, received public comment, and concluded that the use of
Cyclohexlamine in organic handling is consistent with the evaluation
criteria.
Therefore, in response to the NOSB recommendation regarding the use
of Cyclohexlamine in organic handling, the Secretary proposes to amend
Sec. 205.605(b) of the National List regulations to allow
Cyclohexlamine as a synthetic ingredient in or on processed products
labeled as ``made with organic (specified ingredients or food
group(s))'' as follows:
Cyclohexylamine (CAS 108-91-8)--for use only as a boiler
water additive for packaging sterilization. Restricted to handling
agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited in handling agricultural
products labeled ``organic.''
Diethylaminoethanol (CAS 100-37-8)--for use only as a
boiler water additive for packaging sterilization; restricted to
handling agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited for use in handling
agricultural products labeled ``organic.'' Diethlaminoethanol was
petitioned as a boiler water additive in organic handling.
Diethylaminoethanol is a colorless liquid with a weak ammonia odor. It
is hygroscopic soluble in water, alcohol, Acetone, Benzene, and
Petroleum ether. Diethlaminoethanol inhibits corrosion in boiler
chemical systems in return lines, by neutralizing Carbonic acid in
steam and steam condensates, and by scavenging free Oxygen. It is used
in conjunction with Cyclohexylamine, Morpholine, and Octadecylamine.
Diethylaminoethanol is approved for use as a secondary direct food
additive and boiler water additive by FDA under 21 CFR 173.310.
At its May 6-8, 2002, meeting in Austin, TX, the NOSB recommended
adding Diethylaminoethanol to Sec. 205.605(b) of the National List
regulations for organic handling, with the restriction that it be used
as a boiler water additive for packaging sterilization only. In this
open meeting, the NOSB evaluated the use of Diethylaminoethanol against
the evaluation criteria of Sec. 205.600(b) of the National List
regulations, received public comment, and concluded that the use of
Diethylaminoethanol in organic handling is consistent with the
evaluation criteria.
Therefore, in response to the NOSB recommendation regarding the use
of Diethylaminoethanol in organic handling, the Secretary proposes to
amend Sec. 205.605(b) of the National List regulations to allow
Diethylaminoethanol as a synthetic ingredient in or on processed
products labeled as ``made with organic (specified ingredients or food
group(s))'' as follows:
Diethylaminoethanol (CAS 100-37-8)--for use only as a
boiler water additive for packaging sterilization. Restricted to
handling agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited for use in handling
agricultural products labeled ``organic.''
Octadecylamine (CAS 124-30-1)--for use only as a boiler
water additive for packaging sterilization. Restricted to handling
agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited for use in handling
agricultural products labeled ``organic.'' Octadecylamine was
petitioned for use as a boiler water additive to prevent corrosion of
boiler equipment and distribution lines. Octadecylamine is an
[[Page 54665]]
opaque, off-white liquid with ammoniacal odor, insoluble in water but
soluble in alcohol, Ether, Benzene; very soluble in Chloroform; and
miscible in Acetone. Octadecylamine is approved for use as a secondary
direct food additive and boiler water additive by FDA under 21 CFR
173.310.
At its October 15-17, 2001, meeting in Washington, DC, the NOSB
recommended adding Octadecylamine to Sec. 205.605(b) of the National
List regulations for organic handling, with the restriction that it be
used as a boiler water additive for packaging sterilization only. In
this open meeting, the NOSB evaluated the use of Octadecylamine against
the evaluation criteria of Sec. 205.600(b) of the National List
regulations, received public comment, and concluded that the use of
Octadecylamine in organic handling is consistent with the evaluation
criteria.
Therefore, in response to the NOSB recommendation regarding the use
of Octadecylamine in organic handling, the Secretary proposes to amend
Sec. 205.605(b) of the National List regulations to allow
Octadecylamine as a synthetic ingredient in or on processed products
labeled as ``made with organic (specified ingredients or food
group(s))'' as follows:
Octadecylamine (CAS 124-30-1)--for use only as a boiler
water additive for packaging sterilization. Restricted to handling
agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited for use in handling
agricultural products labeled ``organic.''
Peracetic acid/Peroxyacetic acid (CAS 79-21-0)--for use
in wash and/or rinse water according to FDA limitations. For use as a
sanitizer on food contact surfaces. Restricted to use in handling
agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited in agricultural products
labeled ``organic.'' Peracetic acid was petitioned as an anti-microbial
water treatment additive and/or as an equipment sanitizer or
disinfectant. Its most common use in food processing and handling is as
a sanitizer for food contact surfaces and as a disinfectant for fruits,
vegetables, meats, and eggs. Other uses of Peracetic acid include
removing deposits, suppressing odor, and stripping biofilms from food
contact surfaces. Peracetic acid is a clear colorless liquid with no
foaming capability, and has a strong pungent odor. It is approved by
FDA as a secondary direct food additive used in the washing or peeling
of fruits and vegetables (21 CFR 173.315). It is also approved for use
as an indirect food additive, sanitizer, under 21 CFR 178.1010.
At its November 15-17, 2000, meeting in Washington, DC, the NOSB
recommended adding Peracetic acid to Sec. 205.605(b) of the National
List regulations for organic handling, with the restrictions that it be
allowed: (1) For direct food contact only in wash and/or rinse water;
and (2) as a sanitizer on surfaces in contact with organic food. In
this open meeting, the NOSB evaluated the use of Peracetic acid against
the evaluation criteria of Sec. 205.600(b) of the National List
regulations, received public comment, and concluded that the use of
Peracetic acid in organic handling is consistent with the evaluation
criteria.
In accepting the NOSB recommendation to allow Peracetic acid in
organic handling, this proposed rule proposes language for including
Peracetic acid on the National List that differs from the original NOSB
recommendation. The original wording of the NOSB recommendation
submitted to the Secretary was as follows: ``Peracetic acid--for direct
food contact only in wash and/or rinse water, as a sanitizer on
surfaces in contact with organic food.'' The NOP did not elect to use
that language because of the confusion the language could cause when
referencing the use of Peracetic acid (Peroxyacetic acid) against FDA
regulations.
For instance, the recommended NOSB language references ``Peracetic
acid'' as the common name of the substance, but FDA regulations
reference ``Peroxyacetic acid,'' in 21 CFR 173.315, for the washing or
peeling of fruits and vegetables. Also, FDA regulations restrict the
use of Peracetic acid/Peroxyacetic acid on fruits and vegetables that
are not raw agricultural commodities. Based on this information, the
NOP determined that the original NOSB recommendation could cause
handlers that use Peracetic acid/Peroxyacetic acid to believe that the
substance could be used on all agricultural products. As a result, this
proposed rule attempts to limit confusion regarding the proposed use of
Peracetic acid/Peroxyacetic acid in the handling of ``made with * * *''
products by including language that acknowledges the FDA use
limitations.
Therefore, in response to the NOSB recommendation regarding the use
of Peracetic acid/Peroxyacetic acid in organic handling, the Secretary
proposes to amend Sec. 205.605(b) of the National List regulations to
allow Peracetic acid/Peroxyacetic acid as a synthetic ingredient in or
on processed products labeled as ``made with organic (specified
ingredients or food group(s))'' as follows:
Peracetic acid/Peroxyacetic acid (CAS 79-21-0)--for use
in wash and/or rinse water according to FDA limitations. For use as a
sanitizer on food contact surfaces. Restricted to use in handling
agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited in handling agricultural
products labeled ``organic.''
Sodium acid pyrophosphate (CAS 7758-16-9)--for use only
as a leavening agent in agricultural products labeled ``made with
organic (specified ingredients or food group(s));'' prohibited in
handling agricultural products labeled ``organic.'' Sodium acid
pyrophosphate was petitioned for use as a leavening agent in baked
goods. It helps to control the release of Carbon dioxide that leavens
baked goods. It can be either anhydrous or contain one or more
molecules of water of hydration. The anhydrous forms are white,
crystalline powders or granules. The hydrated forms occur as white or
transparent crystals or granules. When used in accordance with good
manufacturing practices, Sodium acid pyrophosphate is considered to be
GRAS by FDA under 21 CFR 182.1087.
At its May 13-14, 2003, meeting in Austin, TX, the NOSB recommended
adding Sodium acid pyrophosphate to Sec. 205.605(b) of the National
List regulations for organic handling, with the restriction that it
only be used as a leavening agent. In this open meeting, the NOSB
evaluated Sodium acid pyrophosphate against the evaluation criteria of
Sec. 205.600(b) of the National List regulations, received public
comment, and concluded that the use of Sodium acid pyrophosphate in
organic handling is consistent with the evaluation criteria.
Therefore, in response to the NOSB recommendation regarding the use
of Sodium acid pyrophosphate in organic handling, the Secretary
proposes to amend Sec. 205.605(b) of the National List regulations to
allow Sodium acid pyrophosphate as a synthetic ingredient in or on
processed products labeled as ``made with organic (specified
ingredients or food group(s))'' as follows:
Sodium acid pyrophosphate (CAS 7758-16-9)--for use only
as a leavening agent in agricultural products labeled ``made with
organic (specified ingredients or food group(s));'' prohibited in
handling agricultural products labeled ``organic.''
Tetrasodium pyrophosphate (CAS 7722-88-5)--for use only
in meat analog products labeled ``made with
[[Page 54666]]
organic (specified ingredients or food group(s));'' prohibited in
handling agricultural products labeled ``organic.'' In a proposed rule,
published May 22, 2003 (68 FR 27941), Sec. 205.605(b) of the
regulations was proposed to be amended by adding Tetrasodium
pyrophosphate to be used only in textured meat analog products. In
response to the proposal to add Tetrasodium pyrophospate on the
National List regulations, we received six public comments, three in
favor of and three opposed to its inclusion. Regarding the comments
that opposed the inclusion of Tetrasodium pyrophosphate on the National
List regulations, commenters expressed concern that the recommended
annotation was vague, confusing, undefined and needed clarification.
They stated that the primary use of Tetrasodium pyrophosphate, as
proposed, appeared to be to create texture that is similar to a meat
product. They also asserted that such a use would be in direct conflict
with the criterion in Sec. 205.600(b)(4) of the regulations that
emphasizes ``the substance's primary use is not as a preservative or to
recreate or improve flavors, colors, textures, or nutritive value lost
during processing, except where the replacement of nutrients is
required by law.''
Due to the merit of those comments, on March 3, 2003 (68 FR 62215),
we did not add Tetrasodium pyrophosphate on the National List and
referred the substance back to the NOSB for further deliberation as to
whether the proposed use of Tetrasodium pyrophosphate conflicts with
Sec. 205.600 (b)(4) of the NOP regulations. Through further review and
deliberation at their April 2004 meeting in Chicago, IL, the NOSB
determined that the proposed use of Tetrasodium pyrophosphate did not
conflict with Sec. 205.600 (b)(4) of the NOP regulations. In response
to the concerns of the commenters, the NOSB provided that the primary
use of Tetrasodium pyrophosphate, as petitioned, is not to serve as a
preservative, or to ``recreate'' flavor, color or texture. They
acknowledged that the substance may be used to create texture; however,
it is not being used to ``recreate'' texture, as is referenced in Sec.
205.600 (b)(4) of the regulations. Rather, it is being proposed to add
Tetrasodium pyrophosphate to Sec. 205.605(b) of the National List
regulations as follows:
Tetrasodium pyrophosphate (CAS 7722-88-5)--for use only
in meat analog products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited in handling agricultural
products labeled ``organic.''
Section 205.681 Appeals
This proposed rule would amend Sec. 205.681(d)(1) of the
regulations by updating the mailing address for where to file a
Certification or Accreditation appeal as follows:
Administrator, USDA, AMS, c/o NOP Appeals Staff, Stop 0203, Room
3529-S, 1400 Independence Avenue, SW., Washington, DC 20250-0203.
III. Related Documents
Seven 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) 65 FR 64657, October 30, 2000,
(Peracetic acid); (2) 66 FR 48654, September 21, 2001, (Ammonium
hydroxide, Cyclohexlamine, and Octadecylamine); (3) 67 FR 19375, April
19, 2002, (Diethylaminoethanol); (4) 67 FR 54784, August 26, 2002,
(Activated charcoal); (5) 68 FR 23277, May 1, 2003, (Egg white
lysozyme, Glycerine oleate, L-Malic acid, Microorganisms, Sodium acid
pyrophosphate and Tetrahydrofurfuryl alcohol); (6) 69 FR 18036, April
6, 2004, (Hydrogen Chloride, and Tetrasodium pyrophosphate); and (7) 70
FR 7224, February 11, 2005, (Ferric phosphate).
IV. Statutory and Regulatory Authority
The OFPA, as amended (7 U.S.C. 6501 et seq.), authorizes the
Secretary to make amendments to the National List based on proposed
amendments developed by the NOSB. Sections 6518(k)(2) and 6518(n) of
OFPA authorizes the NOSB to develop proposed amendments to the National
List for submission to the Secretary and establishes 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, respectively. The National List petition process is implemented
under Sec. 205.607 of the NOP regulations. The current petition
process (65 FR 43259) can be accessed through the NOP Web site at
http://www.ams.usda.gov/nop.
A. Executive Order 12866
This action has been determined to be non-significant for purposes
of Executive Order 12866, and therefore, has not been reviewed by the
Office of Management and Budget.
B. Executive Order 12988
Executive Order 12988 instructs each executive agency to adhere to
certain requirements in the development of new and revised regulations
in order to avoid unduly burdening the court system. This proposed rule
is not intended to have a retroactive effect.
States and local jurisdictions are preempted under section 2115 of
the OFPA (7 U.S.C. 6514) from creating programs of accreditation for
private persons or State officials who want to become certifying agents
of organic farms or handling operations. A governing State official
would have to apply to USDA to be accredited as a certifying agent, as
described in section 2115(b) of the OFPA (7 U.S.C. 6514(b)). States are
also preempted under sections 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 section 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 section 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
Environmental Protection Agency (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
[[Page 54667]]
may appeal an action of the Secretary, the applicable governing State
official, or a certifying agent under this title that adversely affects
such person or is inconsistent with the organic certification program
established under this title. The OFPA also provides that the U.S.
District Court for the district in which a person is located has
jurisdiction to review the Secretary's decision.
C. Regulatory Flexibility Act
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.)
requires agencies to consider the economic impact of each rule on small
entities and evaluate alternatives that would accomplish the objectives
of the rule without unduly burdening small entities or erecting
barriers that would restrict their ability to compete in the market.
The purpose is to fit regulatory actions to the scale of businesses
subject to the action. Section 605 of the RFA allows an agency to
certify a rule, in lieu of preparing an analysis, if the rulemaking is
not expected to have a significant economic impact on a substantial
number of small entities.
Pursuant to the requirements set forth in the RFA, the Agricultural
Marketing Service (AMS) performed an economic impact analysis on small
entities in the final rule published in the Federal Register on
December 21, 2000 (65 FR 80548). The AMS has also considered the
economic impact of this action on small entities. The impact on
entities affected by this proposed rule would not be significant. The
effect of this proposed rule would be to allow the use of additional
substances in agricultural production and handling. This action would
relax the regulations published in the final rule and would provide
small entities with more tools to use in day-to-day operations. The AMS
concludes that the economic impact of this addition of allowed
substances, if any, would be minimal and entirely beneficial to small
agricultural service firms. Accordingly, USDA certifies that this rule
will not have a significant economic impact on a substantial number of
small entities.
Small agricultural service firms, which include producers,
handlers, and accredited certifying agents, have been defined by the
Small Business Administration (SBA) (13 CFR 121.201) as those having
annual receipts of less than $6,000,000 and small agricultural
producers are defined as those having annual receipts of less than
$750,000. This proposed rule would have an impact on a substantial
number of small entities.
The U.S. organic industry at the end of 2001 included nearly 6,600
certified crop and livestock operations, including organic production
and handling operations, producers, and handlers. These operations
reported certified acreage totaling more than 2.34 million acres,
72,209 certified livestock, and 5.01 million certified poultry. Data on
the numbers of certified handling operations are not yet available, but
likely number in the thousands, as they would include any operation
that transforms raw product into processed products using organic
ingredients. Growth in the U.S. organic industry has been significant
at all levels. From 1997 to 2001, the total organic acreage grew by 74
percent; livestock numbers certified organic grew by almost 300 percent
over the same period, and poultry certified organic increased by 2,118
percent over this time. Sales growth of organic products has been
equally significant, growing on average around 20 percent per year.
Sales of organic products were approximately $1 billion in 1993, but
reached $15 billion in 2004. In addition, USDA has accredited 97
certifying agents who have applied to USDA to be accredited in order to
provide certification services to producers and handlers. A complete
list of names and addresses of accredited certifying agents may be
found on the AMS NOP Web site, at http://www.ams.usda.gov/nop. AMS
believes that most of these entities would be considered small entities
under the criteria established by the SBA.
D. Paperwork Reduction Act
Pursuant to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, et
seq., the existing information collection requirements for the NOP are
approved under OMB number 0581-0191. 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, or OMB's implementing regulation at 5 CFR
part 1320.
E. General Notice of Public Rulemaking
This proposed rule reflects recommendations submitted to the
Secretary by the NOSB and includes an amendment to the mailing address
for where to file a Certification or Accreditation Appeal. The seven
substances proposed to be added to the National List were based on
petitions from the industry. The NOSB evaluated each petition using
criteria in the OFPA. Because these substances are critical to organic
production and handling operations, producers and handlers should be
able to use them in their operations as soon as possible. A 60-day
period for interested persons to comment on this rule is provided.
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:
a. Revising paragraph (h).
b. Revising paragraph (m)(2).
c. Adding a new paragraph (n).
d. Reserving paragraphs (o)-(z).
The revisions and additions read as follows:
Sec. 205.601 Synthetic substance allowed for use in organic crop
production.
* * * * *
(h) As slug or snail bait. Ferric phosphate (CAS 10045-
86-0).
* * * * *
(m) * * *
(2) EPA List 3--Inerts of Unknown Toxicity allowed:
(i) Glycerine Oleate (Glycerol monooleate) (CAS s 25496-
72-4; 111-03-5; 37220-82-9)--for use only until December 31, 2006.
(ii) Inerts used in passive pheromone dispensers.
(iii) Tetrahydrofurfuryl alcohol (CAS 97-99-4)--for use
only until December 31, 2006.
(n) Seed preparations. Hydrogen chloride (CAS 7647-01-
0)--for delinting cotton seed for planting.
* * * * *
3. Section 205.605 is amended by:
a. Adding three materials to paragraph (a).
b. Adding 8 new substances to paragraph (b).
The additions 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)).''
* * * * *
(a) * * *
* * * * *
[[Page 54668]]
Egg white lysozyme (CAS 9001-63-2)
* * * * *
L-Malic acid (CAS 97-67-6).
* * * * *
Microorganisms--any food grade bacteria, fungi, and other
microorganism.
* * * * *
(b) * * *
Activated charcoal (CAS s 7440-44-0; 64365-11-3)--only
from vegetative sources; for use only as a filtering aid in handling
agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited in handling agricultural
products labeled ``organic.''
* * * * *
Ammonium hydroxide (CAS 1336-21-6)--for use only as a
boiler water additive until October 21, 2005. Restricted to handling
agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited in handling agricultural
products labeled ``organic.''
* * * * *
Cyclohexylamine (CAS 108-91-8)--for use only as a boiler
water additive for packaging sterilization. Restricted to handling
agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited in handling agricultural
products labeled ``organic.''
Diethylaminoethanol (CAS 100-37-8)--for use only as a
boiler water additive for packaging sterilization. Restricted to
handling agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited for use in handling
agricultural products labeled ``organic.''
* * * * *
Octadecylamine (CAS 124-30-1)--for use only as a boiler
water additive for packaging sterilization. Restricted to handling
agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited for use in handling
agricultural products labeled ``organic.''
* * * * *
Peracetic acid/Peroxyacetic acid (CAS 79-21-0)--for use
in wash and/or rinse water according to FDA limitations. For use as a
sanitizer on food contact surfaces. Restricted to use in handling
agricultural products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited in handling agricultural
products labeled ``organic.''
* * * * *
Sodium acid pyrophosphate (CAS 7758-16-9)--for use only
as a leavening agent in agricultural products labeled ``made with
organic (specified ingredients or food group(s));'' prohibited in
handling agricultural products labeled ``organic.''
* * * * *
Tetrasodium pyrophosphate (CAS 7722-88-5)--for use only
in meat analog products labeled ``made with organic (specified
ingredients or food group(s));'' prohibited in handling agricultural
products labeled ``organic.''
* * * * *
4. In Sec. 205.681, paragraph (d)(1) is revised to read as
follows:
Sec. 205.681 Appeals.
* * * * *
(d) * * * (1) Appeals to the Administrator must be filed in writing
and addressed to: Administrator, USDA, AMS, c/o NOP Appeals Staff, Stop
0203, Room 3529-S, 1400 Independence Avenue, SW., Washington, DC 20250-
0203
* * * * *
Dated: September 12, 2005.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
[FR Doc. 05-18381 Filed 9-15-05; 8:45 am]
BILLING CODE 3410-02-P