National Organic Program (NOP); Amendments to the National List of Allowed and Prohibited Substances (Crops and Processing), 53299-53303 [E6-14923]
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53299
Rules and Regulations
Federal Register
Vol. 71, No. 175
Monday, September 11, 2006
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
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new books are listed in the first FEDERAL
REGISTER issue of each week.
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket Number TM–04–01FR]
RIN 0581–AC35
National Organic Program (NOP);
Amendments to the National List of
Allowed and Prohibited Substances
(Crops and Processing)
Agricultural Marketing Service,
USDA.
ACTION: Final rule.
AGENCY:
This final rule would amend
the U.S. Department of Agriculture’s
(USDA) National List of Allowed and
Prohibited Substances (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
final rule adds thirteen substances,
along with any restrictive annotations,
to the National List. This final rule also
amends the mailing address for where to
file a Certification or Accreditation
appeal.
EFFECTIVE DATE: This rule becomes
effective September 12, 2006.
FOR FURTHER INFORMATION CONTACT: Bob
Pooler, Agricultural Marketing
Specialist, Telephone: (202) 720–3252;
Fax: (202) 205–7808.
SUPPLEMENTARY INFORMATION:
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SUMMARY:
I. Background
On December 21, 2000, the Secretary
established, within the NOP [7 CFR part
205], the National List regulations
(§§ 205.600 through 205.607). The
National List identifies synthetic
substances and ingredients that are
allowed and nonsynthetic (natural)
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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 three times, October 31,
2003 (68 FR 61987), November 3, 2003
(68 FR 62215), and October 21, 2005 (70
FR 61217).
This final rule amends 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 § 205.601 and eleven
substances to § 205.605 of the National
List regulations. This final rule also
amends the mailing address for where to
file a Certification or Accreditation
appeal pursuant to § 205.681(d).
II. Overview of Amendments
The following provides an overview
of the amendments made to designated
sections of the National List regulations:
Section 205.601 Synthetic Substances
Allowed for Use in Organic Crop
Production
This final rule amends the following
inert ingredient to § 205.601 of the
National List regulations:
Glycerine oleate (Glycerol
monooleate) (CAS # 37220–82–9)—for
use only until December 31, 2006.
This final rule amends the following
seed preparation to § 205.601 of the
National List regulations:
Hydrogen chloride (CAS # 7647–01–
0)—for delinting cotton seed for
planting.
This final rule amends the following
slug and snail bait to § 205.601 of the
National List regulations:
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 final rule amends § 205.605(a) of
the regulations by adding the following
substances:
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Egg white lysozyme (CAS # 9001–63–
2).
L-Malic acid (CAS # 97–67–6).
Microorganisms—any food grade
bacteria, fungi, and other
microorganisms.
This final rule also amends
§ 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.
Cyclohexylamine (CAS # 108–91–8)—
for use only as a boiler water additive
for packaging sterilization.
Diethylaminoethanol (CAS # 100–37–
8)—for use only as a boiler water
additive for packaging sterilization.
Octadecylamine (CAS # 124–30–1)—
for use only as a boiler water additive
for packaging sterilization.
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.
Sodium acid pyrophosphate (CAS #
7758–16–9)—for use only as a leavening
agent.
Tetrasodium pyrophosphate (CAS #
7722–88–5)—for use only in meat
analog products.
Section 205.681 Appeals
This final rule amends § 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 302-Annex, 1400 Independence
Avenue, SW., Washington, DC 20250–
0203.
III. Related documents
Seven notices and one proposed rule
(70 FR 54660, September 16, 2005) 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 final 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,
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(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 § 205.607 of the NOP regulations.
The current petition process (65 FR
43259) can be accessed through the NOP
Web site at https://www.ams.usda.gov/
nop.
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A. Executive Order 12866
This action has been determined to be
not significant for purposes of Executive
Order 12866, and therefore, has not
been reviewed by the Office of
Management and Budget.
B. Executive Order 12988
Executive Order 12988 instructs each
executive agency to adhere to certain
requirements in the development of new
and revised regulations in order to avoid
unduly burdening the court system.
This final rule is not intended to have
a retroactive effect.
States and local jurisdictions are
preempted under § 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 § 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
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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 final 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
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
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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 final rule would not be
significant. The effect of this final rule
would be to allow the use of additional
substances in agricultural production
and handling. This action would relax
the regulations published in 7 CFR part
205 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 $6,500,000 and small agricultural
producers are defined as those having
annual receipts of less than $750,000.
This final rule would have an impact on
a substantial number of small entities.
The U.S. organic industry at the end
of 2001 included nearly 6,949 certified
organic crop and livestock operations.
These operations reported certified
acreage totaling more than 2.09 million
acres of organic farm production. Data
on the numbers of certified organic
handling operations (any operation that
transforms raw product into processed
products using organic ingredients)
were not available at the time of survey
in 2001; but they were estimated to be
in the thousands. By the end of 2004,
the number of certified organic crop,
livestock, and handling operations
totaled nearly 11,400 operations. Based
on 2003 data, certified organic acreage
increased to 2.2 million acres.
U.S. sales of organic food and
beverages have grown from $1 billion in
1990 to an estimated $12.2 billion in
2004. Organic food sales are projected to
reach $14.5 billion for 2005; total U.S.
organic sales, including nonfood uses,
are expected to reach $15 billion in
2005. The organic industry is viewed as
the fastest growing sector of agriculture,
representing 2 percent of overall food
and beverage sales. Since 1990, organic
retail sales have historically
demonstrated a growth rate between 20
to 24 percent each year. This growth
rate is projected to decline and fall to a
rate of 5 to 10 percent in the future.
In addition, USDA has accredited 96
certifying agents who have applied to
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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 https://
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
No additional collection or
recordkeeping requirements are
imposed on the public by this final rule.
Accordingly, OMB clearance is not
required by section 350(h) of the
Paperwork Reduction Act of 1995, 44
U.S.C. 3501, et seq., or OMB’s
implementing regulation at 5 CFR part
1320. AMS is committed to compliance
with the Government Paperwork
Elimination Act (GPEA), which requires
Government agencies in general to
provide the option of submitting
information of transaction business
electronically to the maximum extent
possible.
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E. Discussion of Comments Received
Twenty-nine (29) comments were
received on proposed rule TM–04–01.
In general, comments favored amending
the National List with the proposed
substances identified in the proposed
rule. However, there were some
commenters that raised concerns with
proposed restrictions to the use of
substances being added to § 205.605(b)
and the expiration date attached to the
use of ammonium hydroxide. A few
commenters, suggested technical
changes to the CAS numbers for
glycerine oleate. These same
commenters asserted that tetrasodium
pyrophosphate and sodium acid
pyrophosphate should not be added to
the National List. We also received a
comment asking the USDA to ‘‘clarify
that the category of ’microorganisms’’
also includes food grade by-products
derived from microorganisms that
exhibit similar characteristics or
functions as the microorganism.’’
Changes Made Based on Comments
The following changes are made
based on comments received.
First, Restriction to Use of Substances
on § 205.605(b). The proposed rule
restricted the use of synthetic
substances being added to § 205.605(b).
It restricted the synthetic substances to
the handling of agricultural products
labeled ‘‘made with organic (specified
ingredients or food group(s)) and
prohibited the use of the proposed
synthetic substances in handling
agricultural products labeled as
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‘‘organic.’’ Commenters, however, were
largely opposed to restricting the use of
the proposed synthetic substances to
products labeled as ‘‘made with organic
(specified ingredients or food group(s)).
The proposed rule restricted the use
of these substances because of the final
judgment and order in the case of
Harvey v. Johanns, issued on June 9,
2005, by the United States District
Court, District of Maine. The district
court ruled that 7 CFR 205.600(b) and
205.605(b) of the National List
regulations are contrary to the OFPA
and exceed the Secretary’s rulemaking
authority to the extent that they permit
the addition of synthetic ingredients
and processing aids in handling and
processing of agricultural products
which contain a minimum of 95 percent
organic content and which are eligible
to bear the USDA seal. Due to this ruling
by the district court, the USDA
determined that any new additions to
the National List would have to comply
with the court’s order.
However, in October 2005, Congress
voted to amend § 6517 of the OFPA to
permit the use of certain synthetic
substances in organic handling.
Therefore, we agree with the
commenters and have removed the
restrictive language from substances
being added to § 205.605(b) of the
National List.
Second, Glycerine Oleate CAS #. In
proposing glycerine oleate for addition
to the National List, the proposed rule
identified the substance with the
following CAS #s: 111–03–5, 25496–72–
4, and 37220–82–9. Commenters stated
that the listing of CAS #s 111–03–5 and
25496–72–4 are incorrect and not
necessary because they now appear on
the EPA’s List 4A. Inert substances that
appear on the EPA’s List 4a are already
permitted for use in organic crop
production under the National List
regulations.
We agree with the commenters and
have removed the CAS #s 111–03–5 and
25496–72–4 from the listing of glycerine
oleate.
Third, Ammonium Hydroxide
Expiration Date. Based on the
recommendation from the NOSB in
October 2001, ammonium hydroxide
was proposed for inclusion on the
National List with an expiration date of
October 21, 2005. Most commenters
supported the inclusion of ammonium
hydroxide on the National List and
requested that the expiration date be
amended to acknowledge the three years
that the NOSB had intended to allow
the use of the substance. Some
commenters expressed the view that
ammonium hydroxide should not be
added to the National List. They
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53301
asserted that processors have managed
without use of the substance in the last
four years and suggest that there are a
number of alternatives to ammonium
hydroxide for boiler maintenance.
We have taken into account the
concerns of the commenters. However,
the expiration date recommended by the
NOSB for the use of ammonium
hydroxide has lapsed. As a result,
ammonium hydroxide is not being
added to the National List at this time.
To be reconsidered for inclusion on the
National List, the NOSB will have to
submit a new recommendation to the
Secretary to amend the National List to
permit the use of ammonium hydroxide.
Fourth, Non-Inclusion of
Tetrahydrofurfyl Alcohol (THFA). The
NOSB recommended the inclusion of
THFA to the National List, with the
restriction that it could only be used
until December 21, 2006. THFA was
petitioned for use in organic crop
production as an inert pesticidal
ingredient. Under the Federal
Insecticide, Fungicide, and Rodenticide
Act (FIFRA), the EPA had registered
THFA as a List 3 inert (Inerts of
Unknown Toxicity). However, the EPA
is currently evaluating THFA for
reassessment under the Food Quality
Protection Act (FQPA) and has
identified risks of concern that require
the use of THFA as an inert ingredient
in pesticide products to be significantly
limited. Based on consultations with the
EPA concerning the future use of THFA,
the Secretary has been advised to
withhold listing THFA as an allowed
substance on the National List. Due to
potential risk issues associated with
THFA’s use in crop production, the
Secretary will wait until the EPA has
concluded its reassessment of the
substance before reconsidering its
inclusion to the National List. The
EPA’s proposed rulemaking for
proposed action on THFA can be found
in the Federal Register, 71 FR 18689
(April 12, 2006).
Changes Requested But Not Made
First, Sodium Acid Pyrophosphate.
The NOSB recommended the use of
sodium acid pyrophosphate at its May
2003, meeting in Austin, TX. After the
May meeting, the NOP requested that
the NOSB submit documentation that
would reflect how the recommended
substance met the evaluation criteria
specified in §§ 6517 and 6518 of the
OFPA, before the recommended
substance would be considered by the
Secretary for proposed rulemaking. The
NOSB submitted the documentation as
requested by the NOP. The NOP, in
turn, reviewed and used the
documentation to draft a proposed rule
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for adding sodium acid pyrophosphate
to the National List.
In response to the proposed rule, a
few commenters stated that the NOP did
not make all supporting documentation
(the NOSB decision sheet checklist and
a supplemental technical review used
by the NOSB to evaluate sodium acid
pyrophosphate) available to the public
for consideration in developing
comments regarding the addition of
sodium acid pyrophosphate to the
National List. They asserted that sodium
acid pyrophosphate should be tabled
until all supporting information for
sodium acid pyrophosphate is made
available to the public.
The NOSB decision sheet checklist
and supplemental technical review for
sodium acid pyrophosphate were not
posted on the NOP Web site during the
public comment period for the proposed
rule TM–04–01. However, all
documents related to the review of
substances for inclusion on the National
List are always available to the public
through the NOP office. If the public is
aware that such a document is not
available on the NOP Web site, a request
may always be submitted to the NOP to
receive the related documents. Taking
into account the commenters’ position
regarding easy accessibility to materials
review documents, we do not believe
their position warrants the NOP
deferring final action on the substance.
Evidence has not been submitted that
would suggest sodium acid
pyrophosphate violates the evaluation
criteria specified in the OFPA.
Second, Tetrasodium Pyrophosphate.
A few commenters opposed the addition
of tetrasodium pyrophosphate on the
National List because of reasons that
were expressed in an earlier proposed
rule (68 FR 27941, May 22, 2003).
Commenters had stated that the use of
tetrasodium pyrophosphate conflicts
with § 205.600(b)(4) of the NOP
regulations. They also stated that the
annotation associated with tetrasodium
pyrophosphate is too vague.
The NOP disagrees with the
commenters. The NOP specifically
referred tetrasodium pyrophosphate
back to the NOSB, as a result of
receiving such comments in response to
the May 2003, proposed rule. The NOP
charged the NOSB with determining
whether the proposed use of
tetrasodium pyrophosphate conflicts
with § 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
§ 205.600(b)(4) of the NOP regulations.
In response to the concerns of the
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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 § 205.600(b)(4) of the
regulations.
Third, Microorganisms. A commenter
requested the NOP to ‘‘clarify that the
category of ‘microorganisms’ also
includes food grade by-products derived
from microorganisms that exhibit
similar characteristics or functions as
the microorganism.’’ The NOP does not
have enough information to address this
commenter’s concern. His request must
be evaluated by the NOSB. As a result,
the NOP instructs the commenter to
submit a petition to the NOSB that
would request evaluation of the types of
substances for which he seeks
clarification.
F. Effective Date
This final rule reflects
recommendations submitted to the
Secretary by the NOSB. The thirteen
substances being added to the National
List were based on petitions from the
industry and evaluated by the NOSB
using criteria in the Act and the
regulations. 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.
Accordingly, AMS finds that good cause
exists under 5 U.S.C. 553(d)(3) for not
postponing the effective date of this rule
until 30 days after publication in the
Federal Register.
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.
I For the reasons set forth in the
preamble, 7 CFR part 205, Subpart G is
amended as follows:
PART 205—NATIONAL ORGANIC
PROGRAM
1. The authority citation for 7 CFR
part 205 continues to read as follows:
I
Authority: 7 U.S.C. 6501–6522.
I
I
I
I
I
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).
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The revisions and additions read as
follows:
§ 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 37220–82–9)—for
use only until December 31, 2006.
(ii) Inerts used in passive pheromone
dispensers.
(n) Seed preparations. Hydrogen
chloride (CAS # 7647–01–0)—for
delinting cotton seed for planting.
*
*
*
*
*
I 3. Section 205.605 is amended by:
I a. Adding three materials to paragraph
(a).
I b. Adding seven new substances to
paragraph (b).
The additions 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)).’’
*
*
*
*
*
(a) * * *
*
*
*
*
*
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.
*
*
*
*
*
Cyclohexylamine (CAS # 108–91–8)—
for use only as a boiler water additive
for packaging sterilization.
Diethylaminoethanol (CAS # 100–37–
8)—for use only as a boiler water
additive for packaging sterilization.
*
*
*
*
*
Octadecylamine (CAS # 124–30–1)—
for use only as a boiler water additive
for packaging sterilization.
*
*
*
*
*
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.
*
*
*
*
*
E:\FR\FM\11SER1.SGM
11SER1
Federal Register / Vol. 71, No. 175 / Monday, September 11, 2006 / Rules and Regulations
Sodium acid pyrophosphate (CAS #
7758–16–9)—for use only as a leavening
agent.
*
*
*
*
*
Tetrasodium pyrophosphate (CAS #
7722–88–5)—for use only in meat
analog products.
*
*
*
*
*
I 4. In § 205.681, paragraph (d)(1) is
revised to read as follows:
§ 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 302-Annex, 1400 Independence
Avenue, SW., Washington, DC 20250–
0203.
*
*
*
*
*
Dated: September 5, 2006.
Lloyd C. Day, Administrator,
Agricultural Marketing Service.
[FR Doc. E6–14923 Filed 9–8–06; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 1290
[Docket No. FV06–1290–1 FR]
RIN 0581–AC59
Specialty Crop Block Grant Program
Agricultural Marketing Service,
USDA.
ACTION: Final rule.
AGENCY:
This rule provides regulations
to implement the Specialty Crop Block
Grant Program (SCBGP) to enhance the
competitiveness of specialty crops. This
action establishes the eligibility and
application requirements, the review
and approval process, and grant
administration procedures for the
SCBGP.
The SCBGP is authorized under
Section 101 of the Specialty Crops
Competitiveness Act of 2004 (7 U.S.C.
1621 note).
EFFECTIVE DATE: October 11, 2006.
FOR FURTHER INFORMATION CONTACT:
Trista Etzig, Fruit and Vegetable
Programs, AMS, USDA, 1400
Independence Avenue, SW., Stop 0243,
Washington, DC 20250–0243;
Telephone: (202) 690–4942; Fax: (202)
690–0102; or e-mail:
trista.etzig@usda.gov.
bjneal on PROD1PC71 with RULES
SUMMARY:
SUPPLEMENTARY INFORMATION:
VerDate Aug<31>2005
16:10 Sep 08, 2006
Jkt 208001
Executive Order 12866
This proposed rule has been
determined to be not significant for the
purposes of Executive Order 12866 by
the Office of Management and Budget
(OMB).
Public Law 104–4
Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA), Pub. L.
104–4, establishes requirements for
Federal agencies to assess the effects of
their regulatory actions on State and
local governments and the private
sector. Under section 202 of the UMRA,
the Agricultural Marketing Service
(AMS) generally must prepare a written
statement, including a cost-benefit
analysis, for proposed and final rules
with ‘‘Federal mandates’’ that may
result in expenditures by State and local
governments, in the aggregate, or by the
private sector, of $100 million or more
in any one year (2 U.S.C. 1532). When
such a statement is needed for a rule,
section 205 of the UMRA generally
requires federal agencies to identify and
consider a reasonable number of
regulatory alternatives and adopt the
least costly, most cost-effective, or least
burdensome alternative that achieves
the objectives of the rule (2 U.S.C.
1535).
This rule contains no Federal
mandates (under the regulatory
provisions of Title II of the UMRA) for
State and local governments or the
private sector of $100 million or more
in any one year. Therefore, this rule is
not subject to the requirements of
sections 202 and 205 of the UMRA.
Executive Order 12988
This rule has been reviewed under
Executive Order 12988, Civil Justice
Reform. This action is not intended to
have retroactive effect. This rule will
not preempt any State or local laws,
regulations or policies, unless they
present an irreconcilable conflict with
this rule. There are no administrative
procedures which must be exhausted
prior to any judicial challenge to the
provisions of this rule.
Catalog of Federal Domestic Assistance
This program is listed in the Catalog
of Federal Domestic Assistance under
No. 10.169, Specialty Crop Block Grant
Program.
Executive Order 12372
This program is not subject to the
provisions of Executive Order 12372,
which requires intergovernmental
consultation with State and local
officials. See the Notice related to 7 CFR
part 3015, subpart V published at 48 FR
29115 (June 24, 1983).
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
53303
Executive Order 13132
It has been determined that this rule
does not have sufficient Federalism
implications to warrant the preparation
of a Federalism Assessment. The
provisions contained in this rule would
not have a substantial direct effect on
States or their political subdivisions or
on the distribution of power and
responsibilities among the various
levels of government.
Regulatory Flexibility Act
The AMS certifies that this rule will
not have a significant impact on a
substantial number of small entities as
defined in the Regulatory Flexibility
Act, Pub. L. 96–534, as amended (5
U.S.C. 601 et seq.). This rule only will
impact State departments of agriculture
that apply for grant funds. States
include the fifty States, the District of
Columbia, and the Commonwealth of
Puerto Rico. The States are not small
entities under the Act.
Authority for a Specialty Crop Block
Grant Program
This program is intended to
accomplish the goals of increasing fruit,
vegetable, and nut consumption and
improving the competitiveness of
United States specialty crop producers.
The SCBGP is authorized under section
101 of the Specialty Crops
Competitiveness Act of 2004 (7 U.S.C.
1621 note). Section 101 directs the
Secretary of Agriculture to make grants
to States for each of the fiscal years 2005
through 2009 to be used by State
departments of agriculture solely to
enhance the competitiveness of
specialty crops.
Background
The Fruit and Vegetable Program will
periodically announce that applications
may be submitted for participation in a
‘‘Specialty Crop Block Grant Program’’
(SCBGP), which will be administered by
personnel of the Agricultural Marketing
Service (AMS).
Periodically, funding may be
appropriated to the Secretary of
Agriculture to provide specialty crop
block grants. To the extent that funds
are available, each year the AMS will
publish a Federal Register notice
announcing the program and soliciting
grant applications.
Subject to the appropriation of funds,
each State that submits an application
that is reviewed and approved by AMS
is to receive at least $100,000 to
enhance the competitiveness of
specialty crops. In addition, each State
will receive an amount that represents
the proportion of the value of specialty
crop production in the state in relation
E:\FR\FM\11SER1.SGM
11SER1
Agencies
[Federal Register Volume 71, Number 175 (Monday, September 11, 2006)]
[Rules and Regulations]
[Pages 53299-53303]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-14923]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.
========================================================================
Federal Register / Vol. 71, No. 175 / Monday, September 11, 2006 /
Rules and Regulations
[[Page 53299]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket Number TM-04-01FR]
RIN 0581-AC35
National Organic Program (NOP); Amendments to the National List
of Allowed and Prohibited Substances (Crops and Processing)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule would amend the U.S. Department of
Agriculture's (USDA) National List of Allowed and Prohibited Substances
(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 final rule adds thirteen
substances, along with any restrictive annotations, to the National
List. This final rule also amends the mailing address for where to file
a Certification or Accreditation appeal.
EFFECTIVE DATE: This rule becomes effective September 12, 2006.
FOR FURTHER INFORMATION CONTACT: Bob Pooler, Agricultural Marketing
Specialist, 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 identifies 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 three
times, October 31, 2003 (68 FR 61987), November 3, 2003 (68 FR 62215),
and October 21, 2005 (70 FR 61217).
This final rule amends 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 final rule also amends the mailing address for where to file a
Certification or Accreditation appeal pursuant to Sec. 205.681(d).
II. Overview of Amendments
The following provides an overview of the amendments made to
designated sections of the National List regulations:
Section 205.601 Synthetic Substances Allowed for Use in Organic Crop
Production
This final rule amends the following inert ingredient to Sec.
205.601 of the National List regulations:
Glycerine oleate (Glycerol monooleate) (CAS 37220-82-9)--
for use only until December 31, 2006.
This final rule amends the following seed preparation to Sec.
205.601 of the National List regulations:
Hydrogen chloride (CAS 7647-01-0)--for delinting cotton
seed for planting.
This final rule amends the following slug and snail bait to Sec.
205.601 of the National List regulations:
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 final rule amends Sec. 205.605(a) of the regulations by
adding the following substances:
Egg white lysozyme (CAS 9001-63-2).
L-Malic acid (CAS 97-67-6).
Microorganisms--any food grade bacteria, fungi, and other
microorganisms.
This final rule also amends 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.
Cyclohexylamine (CAS 108-91-8)--for use only as a boiler
water additive for packaging sterilization.
Diethylaminoethanol (CAS 100-37-8)--for use only as a
boiler water additive for packaging sterilization.
Octadecylamine (CAS 124-30-1)--for use only as a boiler
water additive for packaging sterilization.
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.
Sodium acid pyrophosphate (CAS 7758-16-9)--for use only
as a leavening agent.
Tetrasodium pyrophosphate (CAS 7722-88-5)--for use only
in meat analog products.
Section 205.681 Appeals
This final rule amends 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 302-Annex, 1400 Independence Avenue,
SW., Washington, DC 20250-0203.
III. Related documents
Seven notices and one proposed rule (70 FR 54660, September 16,
2005) 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
final 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,
[[Page 53300]]
(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
https://www.ams.usda.gov/nop.
A. Executive Order 12866
This action has been determined to be not significant for purposes
of Executive Order 12866, and therefore, has not been reviewed by the
Office of Management and Budget.
B. Executive Order 12988
Executive Order 12988 instructs each executive agency to adhere to
certain requirements in the development of new and revised regulations
in order to avoid unduly burdening the court system. This final rule is
not intended to have a retroactive effect.
States and local jurisdictions are preempted under Sec. 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 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
final 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 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 final rule would not be significant. The
effect of this final rule would be to allow the use of additional
substances in agricultural production and handling. This action would
relax the regulations published in 7 CFR part 205 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 $6,500,000 and small agricultural
producers are defined as those having annual receipts of less than
$750,000. This final rule would have an impact on a substantial number
of small entities.
The U.S. organic industry at the end of 2001 included nearly 6,949
certified organic crop and livestock operations. These operations
reported certified acreage totaling more than 2.09 million acres of
organic farm production. Data on the numbers of certified organic
handling operations (any operation that transforms raw product into
processed products using organic ingredients) were not available at the
time of survey in 2001; but they were estimated to be in the thousands.
By the end of 2004, the number of certified organic crop, livestock,
and handling operations totaled nearly 11,400 operations. Based on 2003
data, certified organic acreage increased to 2.2 million acres.
U.S. sales of organic food and beverages have grown from $1 billion
in 1990 to an estimated $12.2 billion in 2004. Organic food sales are
projected to reach $14.5 billion for 2005; total U.S. organic sales,
including nonfood uses, are expected to reach $15 billion in 2005. The
organic industry is viewed as the fastest growing sector of
agriculture, representing 2 percent of overall food and beverage sales.
Since 1990, organic retail sales have historically demonstrated a
growth rate between 20 to 24 percent each year. This growth rate is
projected to decline and fall to a rate of 5 to 10 percent in the
future.
In addition, USDA has accredited 96 certifying agents who have
applied to
[[Page 53301]]
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
https://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
No additional collection or recordkeeping requirements are imposed
on the public by this final rule. Accordingly, OMB clearance is not
required by section 350(h) of the Paperwork Reduction Act of 1995, 44
U.S.C. 3501, et seq., or OMB's implementing regulation at 5 CFR part
1320. AMS is committed to compliance with the Government Paperwork
Elimination Act (GPEA), which requires Government agencies in general
to provide the option of submitting information of transaction business
electronically to the maximum extent possible.
E. Discussion of Comments Received
Twenty-nine (29) comments were received on proposed rule TM-04-01.
In general, comments favored amending the National List with the
proposed substances identified in the proposed rule. However, there
were some commenters that raised concerns with proposed restrictions to
the use of substances being added to Sec. 205.605(b) and the
expiration date attached to the use of ammonium hydroxide. A few
commenters, suggested technical changes to the CAS numbers for
glycerine oleate. These same commenters asserted that tetrasodium
pyrophosphate and sodium acid pyrophosphate should not be added to the
National List. We also received a comment asking the USDA to ``clarify
that the category of 'microorganisms'' also includes food grade by-
products derived from microorganisms that exhibit similar
characteristics or functions as the microorganism.''
Changes Made Based on Comments
The following changes are made based on comments received.
First, Restriction to Use of Substances on Sec. 205.605(b). The
proposed rule restricted the use of synthetic substances being added to
Sec. 205.605(b). It restricted the synthetic substances to the
handling of agricultural products labeled ``made with organic
(specified ingredients or food group(s)) and prohibited the use of the
proposed synthetic substances in handling agricultural products labeled
as ``organic.'' Commenters, however, were largely opposed to
restricting the use of the proposed synthetic substances to products
labeled as ``made with organic (specified ingredients or food
group(s)).
The proposed rule restricted the use of these substances because of
the final judgment and order in the case of Harvey v. Johanns, issued
on June 9, 2005, by the United States District Court, District of
Maine. The district court ruled that 7 CFR 205.600(b) and 205.605(b) of
the National List regulations are contrary to the OFPA and exceed the
Secretary's rulemaking authority to the extent that they permit the
addition of synthetic ingredients and processing aids in handling and
processing of agricultural products which contain a minimum of 95
percent organic content and which are eligible to bear the USDA seal.
Due to this ruling by the district court, the USDA determined that any
new additions to the National List would have to comply with the
court's order.
However, in October 2005, Congress voted to amend Sec. 6517 of the
OFPA to permit the use of certain synthetic substances in organic
handling. Therefore, we agree with the commenters and have removed the
restrictive language from substances being added to Sec. 205.605(b) of
the National List.
Second, Glycerine Oleate CAS . In proposing glycerine
oleate for addition to the National List, the proposed rule identified
the substance with the following CAS s: 111-03-5, 25496-72-4,
and 37220-82-9. Commenters stated that the listing of CAS s
111-03-5 and 25496-72-4 are incorrect and not necessary because they
now appear on the EPA's List 4A. Inert substances that appear on the
EPA's List 4a are already permitted for use in organic crop production
under the National List regulations.
We agree with the commenters and have removed the CAS s
111-03-5 and 25496-72-4 from the listing of glycerine oleate.
Third, Ammonium Hydroxide Expiration Date. Based on the
recommendation from the NOSB in October 2001, ammonium hydroxide was
proposed for inclusion on the National List with an expiration date of
October 21, 2005. Most commenters supported the inclusion of ammonium
hydroxide on the National List and requested that the expiration date
be amended to acknowledge the three years that the NOSB had intended to
allow the use of the substance. Some commenters expressed the view that
ammonium hydroxide should not be added to the National List. They
asserted that processors have managed without use of the substance in
the last four years and suggest that there are a number of alternatives
to ammonium hydroxide for boiler maintenance.
We have taken into account the concerns of the commenters. However,
the expiration date recommended by the NOSB for the use of ammonium
hydroxide has lapsed. As a result, ammonium hydroxide is not being
added to the National List at this time. To be reconsidered for
inclusion on the National List, the NOSB will have to submit a new
recommendation to the Secretary to amend the National List to permit
the use of ammonium hydroxide.
Fourth, Non-Inclusion of Tetrahydrofurfyl Alcohol (THFA). The NOSB
recommended the inclusion of THFA to the National List, with the
restriction that it could only be used until December 21, 2006. THFA
was petitioned for use in organic crop production as an inert
pesticidal ingredient. Under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA), the EPA had registered THFA as a List 3 inert
(Inerts of Unknown Toxicity). However, the EPA is currently evaluating
THFA for reassessment under the Food Quality Protection Act (FQPA) and
has identified risks of concern that require the use of THFA as an
inert ingredient in pesticide products to be significantly limited.
Based on consultations with the EPA concerning the future use of THFA,
the Secretary has been advised to withhold listing THFA as an allowed
substance on the National List. Due to potential risk issues associated
with THFA's use in crop production, the Secretary will wait until the
EPA has concluded its reassessment of the substance before
reconsidering its inclusion to the National List. The EPA's proposed
rulemaking for proposed action on THFA can be found in the Federal
Register, 71 FR 18689 (April 12, 2006).
Changes Requested But Not Made
First, Sodium Acid Pyrophosphate. The NOSB recommended the use of
sodium acid pyrophosphate at its May 2003, meeting in Austin, TX. After
the May meeting, the NOP requested that the NOSB submit documentation
that would reflect how the recommended substance met the evaluation
criteria specified in Sec. Sec. 6517 and 6518 of the OFPA, before the
recommended substance would be considered by the Secretary for proposed
rulemaking. The NOSB submitted the documentation as requested by the
NOP. The NOP, in turn, reviewed and used the documentation to draft a
proposed rule
[[Page 53302]]
for adding sodium acid pyrophosphate to the National List.
In response to the proposed rule, a few commenters stated that the
NOP did not make all supporting documentation (the NOSB decision sheet
checklist and a supplemental technical review used by the NOSB to
evaluate sodium acid pyrophosphate) available to the public for
consideration in developing comments regarding the addition of sodium
acid pyrophosphate to the National List. They asserted that sodium acid
pyrophosphate should be tabled until all supporting information for
sodium acid pyrophosphate is made available to the public.
The NOSB decision sheet checklist and supplemental technical review
for sodium acid pyrophosphate were not posted on the NOP Web site
during the public comment period for the proposed rule TM-04-01.
However, all documents related to the review of substances for
inclusion on the National List are always available to the public
through the NOP office. If the public is aware that such a document is
not available on the NOP Web site, a request may always be submitted to
the NOP to receive the related documents. Taking into account the
commenters' position regarding easy accessibility to materials review
documents, we do not believe their position warrants the NOP deferring
final action on the substance. Evidence has not been submitted that
would suggest sodium acid pyrophosphate violates the evaluation
criteria specified in the OFPA.
Second, Tetrasodium Pyrophosphate. A few commenters opposed the
addition of tetrasodium pyrophosphate on the National List because of
reasons that were expressed in an earlier proposed rule (68 FR 27941,
May 22, 2003). Commenters had stated that the use of tetrasodium
pyrophosphate conflicts with Sec. 205.600(b)(4) of the NOP
regulations. They also stated that the annotation associated with
tetrasodium pyrophosphate is too vague.
The NOP disagrees with the commenters. The NOP specifically
referred tetrasodium pyrophosphate back to the NOSB, as a result of
receiving such comments in response to the May 2003, proposed rule. The
NOP charged the NOSB with determining 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.
Third, Microorganisms. A commenter requested the NOP to ``clarify
that the category of `microorganisms' also includes food grade by-
products derived from microorganisms that exhibit similar
characteristics or functions as the microorganism.'' The NOP does not
have enough information to address this commenter's concern. His
request must be evaluated by the NOSB. As a result, the NOP instructs
the commenter to submit a petition to the NOSB that would request
evaluation of the types of substances for which he seeks clarification.
F. Effective Date
This final rule reflects recommendations submitted to the Secretary
by the NOSB. The thirteen substances being added to the National List
were based on petitions from the industry and evaluated by the NOSB
using criteria in the Act and the regulations. 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. Accordingly, AMS finds that good cause exists under 5 U.S.C.
553(d)(3) for not postponing the effective date of this rule until 30
days after publication in the Federal Register.
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.
0
For the reasons set forth in the preamble, 7 CFR part 205, Subpart G is
amended as follows:
PART 205--NATIONAL ORGANIC PROGRAM
0
1. The authority citation for 7 CFR part 205 continues to read as
follows:
Authority: 7 U.S.C. 6501-6522.
0
2. Section 205.601 is amended by:
0
a. Revising paragraph (h).
0
b. Revising paragraph (m)(2).
0
c. Adding a new paragraph (n).
0
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 37220-
82-9)--for use only until December 31, 2006.
(ii) Inerts used in passive pheromone dispensers.
(n) Seed preparations. Hydrogen chloride (CAS 7647-01-
0)--for delinting cotton seed for planting.
* * * * *
0
3. Section 205.605 is amended by:
0
a. Adding three materials to paragraph (a).
0
b. Adding seven 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) * * *
* * * * *
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.
* * * * *
Cyclohexylamine (CAS 108-91-8)--for use only as a boiler
water additive for packaging sterilization.
Diethylaminoethanol (CAS 100-37-8)--for use only as a
boiler water additive for packaging sterilization.
* * * * *
Octadecylamine (CAS 124-30-1)--for use only as a boiler
water additive for packaging sterilization.
* * * * *
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.
* * * * *
[[Page 53303]]
Sodium acid pyrophosphate (CAS 7758-16-9)--for use only
as a leavening agent.
* * * * *
Tetrasodium pyrophosphate (CAS 7722-88-5)--for use only
in meat analog products.
* * * * *
0
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 302-Annex, 1400 Independence Avenue, SW., Washington, DC
20250-0203.
* * * * *
Dated: September 5, 2006.
Lloyd C. Day, Administrator,
Agricultural Marketing Service.
[FR Doc. E6-14923 Filed 9-8-06; 8:45 am]
BILLING CODE 3410-02-P