[Federal Register: December 10, 2007 (Volume 72, Number 236)]
[Rules and Regulations]
[Page 69569-69572]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10de07-1]
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Rules and Regulations
Federal Register
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[[Page 69569]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Docket Number AMS-TM-07-0112; TM-06-04FR]
RIN 0581-AC61
National Organic Program (NOP); Amendments to the National List
of Allowed and Prohibited Substances (Crops and Livestock)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
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SUMMARY: This final rule amends 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) on August 17, 2005. Consistent with the recommendations from the
NOSB, this final rule adds one substance, along with any restrictive
annotations, to two sections of the National List. This final rule also
clarifies the use and prohibition of chitosan.
DATES: This rule becomes effective December 11, 2007.
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 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 five times, October 31, 2003 (68 FR 61987), November
3, 2003 (68 FR 62215), October 21, 2005 (70 FR 61217), September 11,
2006 (71 FR 53299), and June 27, 2007 (72 FR 35137). Additionally, an
amendment to the National List, proposed on July 17, 2006 (71 FR
40624), is currently pending.
This final rule amends the National List to reflect recommendations
submitted to the Secretary by the NOSB on August 17, 2005. On that date
the NOSB recommended that the Secretary add one substance to Sec.
205.601 and Sec. 205.603 of the National List regulations.
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 paragraph (e) of Sec. 205.601 of the
National List regulations by adding Sucrose octanoate esters (CAS
s--42922-74-7; 58064-47-4)--in accordance with approved
labeling.
Section 205.603 Synthetic Substances Allowed for Use in Organic
Livestock Production
This final rule amends paragraph (b) of Sec. 205.603 of the
National List regulations by adding Sucrose octanoate esters (CAS
s--42922-74-7; 58064-47-4)--in accordance with approved
labeling.
III. Related Documents
One notice was published regarding the meeting 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 Federal Register
Notice 70 FR 43116, July 26, 2005, and published as a proposed rule on
July 3, 2006 (71 FR 37854).
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 authorize the NOSB to develop proposed amendments to the National
List for submission to the Secretary and establish a petition process
by which persons may petition the NOSB for the purpose of having
substances evaluated for inclusion on or deletion from the National
List. The National List petition process is implemented under Sec.
205.607 of the NOP regulations. The current petition process (72 FR
2167, January 18, 2007) can be accessed through the NOP Web site at
http://www.ams.usda.gov/nop.
A. Executive Order 12866
This action has been determined not significant for purposes of
Executive Order 12866, and therefore, has not been reviewed by the
Office of Management and Budget.
B. Executive Order 12988
Executive Order 12988 instructs each executive agency to adhere to
certain requirements in the development of new and revised regulations
in order to avoid unduly burdening the court system. This proposed rule
is not intended to have a retroactive effect.
States and local jurisdictions are preempted under the OFPA from
creating programs of accreditation for private persons or State
officials who want to become certifying agents of organic farms or
handling operations. A governing State official would have to apply to
USDA to be accredited as a certifying agent, as described in Sec.
2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under
Sec. Sec. 2104 through 2108 of the OFPA (7 U.S.C. 6503 through 6507)
from creating certification programs to certify organic farms or
handling operations unless the State programs have been submitted to,
and approved by, the Secretary as meeting the requirements of the OFPA.
Pursuant to 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
[[Page 69570]]
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 (FIFRA) (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). 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 the final rule and would provide small
entities with more tools to use in day-to-day operations. 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. 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 2006, the number of certified organic
crop, livestock, and handling operations totaled over 14,800 operations
based on reports by certifying agents to the NOP as part of their
annual reporting requirements. AMS believes that most of these entities
would be considered small entities under the criteria established by
the SBA.
U.S. sales of organic food and beverages have grown from $1 billion
in 1990 to an estimated $12.2 billion in 2004, $13.8 billion in 2005,
and nearly $17 billion in 2006. The organic industry is viewed as the
fasting growing sector of agriculture, representing almost 3 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 including a 22 percent increase in 2006.
In addition, USDA has 98 accredited certifying agents (ACAs) who
provide certification services to producers and handlers. A complete
list of names and addresses of accredited certifying agents may be
found on the 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
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 regulations 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 public the option of submitting information or
transacting business electronically to the maximum extent possible.
E. Discussion of Comments Received
Eleven (11) comments were received on proposed rule TM-06-04.
Comments were submitted by two (2) non-profit organizations, one (1)
state department of agriculture, one (1) private certifying agent, and
seven (7) consumers. One additional consumer comment was received but
because it addresses grass fed beef it was not considered in this
rulemaking. The comments can be viewed at http://www.ams.usda.gov/nop/PublicComments/NLAmendmentsCrops&LSTM=06=04/PublicCommentsCrops&LivestockTM=06=04.html
.
Sucrose Octanoate Esters
The seven (7) consumer comments opposed adding sucrose octanoate
esters (SOE) to Sec. Sec. 205.601 and 205.603 on the grounds that they
oppose the use of pesticides. Two other commenters favored the addition
of SOE to Sec. Sec. 205.601 and 205.603. The remaining two (2)
commenters did not address the addition of SOE and were assumed to take
no position regarding its addition to Sec. Sec. 205.601 and 205.603.
The seven (7) consumer comments provided brief statements of
opposition, to adding sucrose octanoate esters, expressed as one or
more of the following reasons: (1) Organic implies that no pesticides
were used, (2) the evidence cited is not convincing that sucrose is
safe, (3) organic does and should indicate that the substance is
unaltered, (4) no pesticides should be allowed in food labeled
certified organic, (5) do not favor pollution of
[[Page 69571]]
organic standards, (6) if special warnings come with the synthetic how
can it be used in organic production, and (7) people who buy organic
foods do so because they want food that is free of substances they
would not normally ingest.
We have considered these comments. The OFPA and NOP regulations
allow for the use of certain pesticides that have been reviewed and
evaluated for inclusion on the National List by the NOSB.
In organic crop and livestock production, insect pests are
controlled primarily through management practices including physical,
mechanical, and biological controls. When these practices are not
sufficient, a biological, botanical, or synthetic substance approved
for use on the National List may be used. To be added to the National
List the OFPA requires that the NOSB review the substance against the
criteria established under 7 U.S.C. 6517 and 6518. At its August 17,
2005, meeting in Washington, DC, the NOSB evaluated SOE against the
evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA, received
public comment, and concluded that SOE is consistent with the OFPA
evaluation criteria. Accordingly, the NOSB recommended adding SOE to
the National List for use in organic crop and livestock production as
an insecticide/miticide.
SOE was petitioned for use in organic crop and livestock production
as an insecticide/miticide. SOE exists as an amber-colored liquid. The
mixture of esters is manufactured from two biochemicals--sucrose (table
sugar) and an octanoic acid ester (commonly found in plants and
animals). The active ingredient acts by dissolving the waxy protective
coating (cuticle) of target pests, causing the insect or mite to dry
out and die.
Under FIFRA, the EPA has registered SOE as a biochemical that
targets mites and certain soft-bodied insects (e.g., aphids) at three
distinct commercial sites: Food and non-food crops, including certain
ornamentals; media for growing mushrooms; and adult honey bees (http://www.epa.gov/oppbppd1/biopesticides/ingredients/factsheets/factsheet_035300.htm
). In assessing risks to human health, the EPA has concluded
that no risks to humans are expected from the use of SOE as a pesticide
active ingredient. SOE are not toxic to mammals, but in high
concentrations, they are corrosive to the eye. To avoid irreversible
eye damage, exposed workers are required to wear appropriate protective
clothing. In assessing risks to the environment, the EPA determined
that no risks to the environment are expected from the use of SOE in
pesticide products because: (a) The esters biodegrade rapidly and
therefore do not persist in the environment, (b) the esters are not
toxic to mammals or other non-target organisms, (c) organisms are
already exposed because these sucrose esters are found in plants, and
(d) the tiny amounts used in pesticide products are not expected to
substantially increase the amount of these esters in the environment.
The NOP consulted with the EPA and Food and Drug Administration
(FDA) to ensure that the NOSB recommendation for the use of SOE in
organic crop and livestock production would be consistent with Federal
regulations governing the use of the substance. The EPA informed the
NOP that the recommended use of SOE in organic crop and livestock
production is consistent with EPA regulations. The FDA likewise
confirmed that the referenced sucrose octanoate ester product is
appropriately licensed by the EPA for its use.
In consideration of the preceding information the NOP has decided
to add SOE to Sec. Sec. 205.601 and 205.603.
Chitosan
In the July 3, 2006, proposed rule (71 FR 37854), the NOP stated it
``will not propose to specifically add chitosan to the National List as
an adjuvant, it is already permitted for use at Sec. 205.601(m) of the
National List regulations.'' Comments were received regarding this
statement and, as a result, the NOP is clarifying the use and
prohibition of chitosan in organic agriculture.
Chitosan (Poly-D Glucosamine) (CAS -9012-76-04) was
petitioned for use in organic crop production as an adhesive adjuvant
to be used with fungicides approved for use under the NOP regulations.
At its August 17, 2005, meeting in Washington, DC, the NOSB recommended
adding chitosan to the National List for use in organic crop production
as an insecticide, with the restriction that it only be used as an
adjuvant. In this open meeting, the NOSB evaluated chitosan against the
evaluation criteria of 7 U.S.C. 6517 and 6518 of the OFPA, received
public comment, and concluded that chitosan is consistent with the OFPA
evaluation criteria. The NOSB recommended restricting the use of
chitosan to an adjuvant only, due to the fact that chitosan could also
be used as a plant defense booster and plant growth enhancer.
The NOP consulted with the EPA concerning the NOSB's recommendation
to include chitosan on the National List for use as an adjuvant. The
EPA stated that, in addition to chitosan being registered as an active
ingredient, it is also approved as an EPA List 4B inert ingredient. The
EPA further informed the NOP that chitosan, used as an adjuvant, would
be considered an inert ingredient. The NOP regulations, at Sec.
205.601(m), permits the use of EPA List 4 inert ingredients with
nonsynthetic substances or synthetic substances approved for use under
the NOP regulations as an active pesticide ingredient. As a result, the
NOP stated ``it will not propose to specifically add chitosan to the
National List as an adjuvant; it is already permitted for use at Sec.
205.601(m) of the National List regulations.''
The two (2) non-profit organizations, one (1) state department of
agriculture, and one (1) private certifying agent commented on the
decision not to add chitosan for use in organic crop production as an
adhesive adjuvant to be used with fungicides approved for use under the
NOP regulations. The commenters did not oppose NOP's decision but
requested further explanation and elaboration on the factors that led
to that determination.
One commenter agreed that chitosan should be considered approved
for use as a List 4 inert ingredient under 205.601(m)(l). The commenter
believed that such an interpretation would allow for the use of
chitosan as an inert ingredient when it is a component of a final
product, e.g. listed as an inert ingredient in a Brand Name material
and functions as an adjuvant. However, the same commenter noted that
the NOP proposal to not specifically add chitosan to the National List
may pose challenges for some organic operators in some states because a
spray ``adjuvant'' (inert ingredient) may be regulated as a
``pesticide'' (active ingredient) in varying states. As a result, the
commenter suggested that the NOP modify language in 205.601 (m) to
explicitly recognize that ``adjuvants classified by the EPA,'' along
with inerts, are allowed to be combined with nonysnthetic or synthetic
substances approved for use in organic production.
We considered all of the comments. In addition to the comments, we
consulted further with the EPA concerning the use of chitosan as an
adjuvant. The EPA confirmed, as they had before, that chitosan, in
addition to its approved use as an active ingredient and plant defense
booster/plant growth regulator (enhancer), is also approved as an EPA
List 4B inert ingredient. It also reiterated
[[Page 69572]]
that chitosan could be used as an adjuvant and that adjuvants are
considered inert ingredients under the EPA. However, in cases where
chitosan would be combined with a fungicide, chitosan could not be
considered an inert ingredient or adjuvant, because chitosan has active
fungicidal properties and is labeled for use against fungal diseases
such as blight. The EPA also commented that for chitosan to be
considered an inert or adjuvant in a formulation, it could not exhibit
pesticidal activity. In that regard, the EPA determined that it could
not verify that chitosan does not have any fungicidal activity for the
intended use and at the proposed levels mentioned in the petition; data
does not support its non-fungicidal activity in such a use.
In addition to the concerns raised about chitosan's use as an
adjuvant in combination with another fungicide, the issue of whether
chitosan should be considered an insecticide (as recommended by the
NOSB) or a plant disease control was mentioned. The EPA informed the
NOP that data does not reveal chitosan having insecticidal properties.
Instead, chitosan is considered more of a systemic acquired response
inducer and demonstrates fungicidal activity. As a result, for the
purpose of the NOP regulations, chitosan would be better characterized
as a plant disease control.
Based on the information submitted through public comment and
gathered in further consultation with the EPA, we have determined that
chitosan, when used in combination with another fungicide, cannot be
considered an inert or adjuvant. It is considered an active ingredient
in such cases. However, in cases where chitosan is used in combination
with an approved active ingredient on the National List and does not
demonstrate any pesticidal/fungicidal activity, it could be considered
an inert ingredient or adjuvant.
The preceding chitosan discussion is summarized as follows:
Chitosan was petitioned for use in organic crop production as an
adhesive ``adjuvant'' to be used with fungicides approved for use under
the NOP regulations. The NOSB recommended adding chitosan to the
National List for use in organic crop production as an ``insecticide,''
with the restriction that it only be used as an ``adjuvant.'' The EPA
informed the NOP that data does not reveal chitosan having insecticidal
properties. Because the NOSB recommended the use of chitosan as an
adjuvant, the recommendation restricts the use of the substance to the
capacity of an inert ingredient. AMS, in consultation with EPA, has
determined that chitosan, when used as an ``adjuvant'' (not
demonstrating any pesticidal activity), is already allowed under the
existing inert ingredient provisions of Sec. 205.601(m) of the NOP
regulations. However, chitosan, when used in combination with a
fungicide, cannot be considered an inert or adjuvant, because chitosan
has fungicidal properties and is considered an active ingredient in
such cases. Accordingly, unless specifically added to Sec. 205.601 of
the National List as an active ingredient, chitosan cannot be used with
a fungicide.
Therefore, AMS has decided to refer the chitosan recommendation
back to the NOSB so that it can reconsider the intended use of the
substance and its inclusion on the National List (i.e., should it be
considered a plant disease control; and should it be included on the
National List as an approved active ingredient?). In the meantime,
chitosan, under the inert ingredient provisions of Sec. 205.601(m) of
the NOP regulations, can be used as an ``adjuvant'' (not demonstrating
any pesticidal activity) in combination with approved active
ingredients on the National List, provided the approved active
ingredient is not a registered fungicide. Chitosan, when used in
combination with a fungicide, is an active ingredient and remains a
prohibited substance that shall not be used in organic agriculture.
Further, chitosan remains prohibited for use as a plant defense
booster, a plant growth enhancer, and as an active ingredient in any
other capacity. If readers have questions concerning when a substance
qualifies to be an active or inert ingredient, they should contact the
EPA for further information and guidance.
F. Effective Date
This final rule reflects recommendations submitted to the Secretary
by the NOSB. The substance being added to the National List was based
on a petition from the industry and evaluated by the NOSB using
criteria in the Act and the regulations. Because this substance is
crucial to organic crop and livestock production operations, producers
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 adding new paragraph (e)(9) to read as
follows:
Sec. 205.601 Synthetic substances allowed for use in organic crop
production.
* * * * *
(e) * * *
(9) Sucrose octanoate esters (CAS s--42922-74-7; 58064-47-
4)--in accordance with approved labeling.
* * * * *
0
3. Section 205.603 is amended by adding new paragraph (b)(7) to read as
follows:
Sec. 205.603 Synthetic substances allowed for use in organic
livestock production.
* * * * *
(b) * * *
(7) Sucrose octanoate esters (CAS s--42922-74-7; 58064-47-
4)--in accordance with approved labeling.
* * * * *
Dated: December 5, 2007.
Lloyd C. Day,
Administrator, Agricultural Marketing Service.
[FR Doc. E7-23880 Filed 12-7-07; 8:45 am]
BILLING CODE 3410-02-P