[Federal Register Volume 75, Number 238 (Monday, December 13, 2010)]
[Rules and Regulations]
[Pages 77521-77524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-31196]
========================================================================
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. 75, No. 238 / Monday, December 13, 2010 /
Rules and Regulations
[[Page 77521]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS-TM-09-0003; TM-08-06FR]
RIN 0581-AC91
National Organic Program; 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 amends the U.S. Department of Agriculture's
(USDA) National List of Allowed and Prohibited Substances (National
List) to enact six recommendations submitted to the Secretary of
Agriculture (Secretary) by the National Organic Standards Board (NOSB)
from November 30, 2007, and May 22, 2008. This final rule adds aqueous
potassium silicate and sodium carbonate peroxyhydrate, along with any
restrictive annotations, for use in organic crop production, and adds
gellan gum, fortified cooking wine--Marsala, fortified cooking wine--
sherry, and tragacanth gum, along with any restrictive annotations, for
use in organic handling. This final rule also removes the listing for
glycerine oleate (glycerol monooleate) as the use exemption for this
substance as a synthetic inert ingredient in organic crop production
expired on December 31, 2006.
DATES: Effective Date: This rule becomes effective December 14, 2010.
FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Director, Standards
Division, Telephone: (202) 720-3252; Fax: (202) 205-7808.
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Secretary established, within the
National Organic Program (NOP) [7 CFR part 205], the National List
regulations Sec. Sec. 205.600 through 205.607. This National List
identifies the synthetic substances that may be used and the
nonsynthetic (natural) substances that may not be used in organic
production. The National List also identifies synthetic, nonsynthetic
nonagricultural and nonorganic agricultural substances that may be used
in organic handling. The Organic Foods Production Act of 1990, as
amended, (7 U.S.C. 6501 et seq.), (OFPA), and NOP regulations, in Sec.
205.105, specifically prohibit the use of any synthetic substance in
organic production and handling unless the synthetic substance is on
the National List. Section 205.105 also requires that any nonorganic
agricultural and any nonsynthetic nonagricultural substance used in
organic handling must also be on the National List.
Under the authority of the OFPA, the National List can be amended
by the Secretary based on proposed amendments developed by the NOSB.
Since established, the National List has been amended thirteen times,
October 31, 2003 (68 FR 61987), November 3, 2003 (68 FR 62215), October
21, 2005 (70 FR 61217), June 7, 2006 (71 FR 32803), September 11, 2006
(71 FR 53299), June, 27, 2007 (72 FR 35137), October 16, 2007 (72 FR
58469), December 10, 2007 (72 FR 69569), December 12, 2007 (72 FR
70479), September 18, 2008 (73 FR 54057), October 9, 2008 (73 FR
59479), July 6, 2010 (75 FR 38693), and August 24, 2010 (75 FR 51919).
Additionally, a proposed amendment to the National List was published
on November 8, 2010 (75 FR 68505).
This final rule amends the National List to enact six
recommendations submitted to the Secretary by the NOSB on November 30,
2007, and May 22, 2008, and removes the listing of one substance, as
its use exemption has expired.
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 (a) of Sec. 205.601 of the
National List regulations by adding new paragraph (a)(8) for the
addition of one substance as follows: Sodium carbonate peroxyhydrate
(CAS -15630-89-4)--Federal law restricts the use of this
substance in food crop production to approved food uses identified on
the product label.
This final rule amends paragraphs (e) and (i) of Sec. 205.601 by:
(1) Redesignating paragraphs (e)(2) through (e)(9), and paragraphs
(i)(1) through (i)(11), as paragraphs (e)(3) through (e)(10) and (i)(2)
through (i)(12), respectively; and (2) adding new paragraphs (e)(2) and
(i)(1) to add one substance as follows: aqueous potassium silicate (CAS
-1312-76-1)--the silica used in the manufacture of potassium
silicate must be sourced from naturally occurring sand.
This final rule amends paragraph (m)(2) of Sec. 205.601 of the
National List regulations by: (1) Removing the expired exemption for
glycerine oleate (glycerol monooleate) (CAS -37220-82-9)--for
use only until December 31, 2006; and (2) redesignating paragraph
(m)(2)(ii) as new paragraph (m)(2).
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 National List
regulations by adding one substance in alphabetical order as follows:
Gellan gum (CAS -71010-52-1)--high-acyl form only.
Section 205.606 Nonorganically Produced Agricultural Products Allowed
as Ingredients in or on Processed Products Labeled as ``Organic.''
This final rule amends Sec. 205.606 of the National List
regulations by: (1) Redesignating paragraphs (g) through (t) and (u)
through (w) as paragraphs (h) through (u) and (w) through (y); and (2)
adding new paragraph (g) for the addition of two substances as follows:
Fortified cooking wines, (1) Marsala, (2) sherry; and (3) adding new
paragraph (v) for the addition of one
[[Page 77522]]
substance as follows: Tragacanth gum (CAS -9000-65-1).
III. Related Documents
Three notices were published regarding the meetings of the NOSB and
its deliberations on recommendations and substances petitioned for
amending the National List. Substances and recommendations included in
this final rule were announced for NOSB deliberation in the following
Federal Register Notices: (1) 72 FR 10971, March 12, 2007, (Gellan
gum); (2) 72 FR 58046, October 12, 2007, (Potassium silicate, Sodium
carbonate peroxyhydrate, Gellan gum); and (3) 73 FR 18491, April 4,
2008, (Marsala cooking wine, Sherry cooking wine, Tragacanth gum). The
recommendation to allow the use of the six substances in this final
rule, and the removal of the expired substance, was published as a
proposed rule on June 3, 2009 (74 FR 26591).
IV. Statutory and Regulatory Authority
The OFPA authorizes the Secretary to make amendments to the
National List based on proposed amendments developed by the NOSB.
Sections 6518(k)(2) and 6518(n) of the OFPA authorize the NOSB to
develop proposed amendments to the National List for submission to the
Secretary and establish a petition process by which persons may
petition the NOSB for the purpose of having substances evaluated for
inclusion on or deletion from the National List. The National List
petition process is implemented under Sec. 205.607 of the NOP
regulations. The current petition process (72 FR 2167, January 18,
2007) can be accessed through the NOP Web site at http://www.ams.usda.gov/nop.
A. Executive Order 12866
This action has been determined not significant for purposes of
Executive Order 12866, and therefore, has not been reviewed by the
Office of Management and Budget (OMB).
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 the OFPA from
creating programs of accreditation for private persons or State
officials who want to become certifying agents of organic farms or
handling operations. A governing State official would have to apply to
USDA to be accredited as a certifying agent, as described in Sec.
2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under
Sec. Sec. 2104 through 2108 of the OFPA (7 U.S.C. 6503 through 6507)
from creating certification programs to certify organic farms or
handling operations unless the State programs have been submitted to,
and approved by, the Secretary as meeting the requirements of the OFPA.
Pursuant to Sec. 2108(b)(2) of the OFPA (7 U.S.C. 6507(b)(2)), a
State organic certification program may contain additional requirements
for the production and handling of organically produced agricultural
products that are produced in the State and for the certification of
organic farm and handling operations located within the State under
certain circumstances. Such additional requirements must: (a) Further
the purposes of the OFPA, (b) not be inconsistent with the OFPA, (c)
not be discriminatory toward agricultural commodities organically
produced in other States, and (d) not be effective until approved by
the Secretary.
Pursuant to Sec. 2120(f) of the OFPA (7 U.S.C. 6519(f)), this
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 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. 601-612) 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
modify the regulations published in the final rule and would provide
small entities with more tools to use in day-to-day farming and
handling operations. The AMS concludes that the economic impact of this
addition of allowed substances, if any, would be minimal and beneficial
to small agricultural service firms. Accordingly, USDA certifies that
this rule will not have a significant economic impact on a substantial
number of small entities.
Small agricultural service firms, which include producers,
handlers, and accredited certifying agents, have been defined by the
Small Business Administration (SBA) (13 CFR 121.201) as those having
annual receipts of less than $7,000,000 and small agricultural
producers are defined as those having annual receipts of less than
$750,000.
According to USDA Economic Research Service (ERS) data based on
information from USDA-accredited certifying agents, the number of
certified U.S. organic crop and livestock operations totaled nearly
13,000 and certified organic acreage exceeded 4.8 million acres in
2008.\1\ ERS, based upon the list of certified operations maintained by
the National Organic Program, estimated the number of certified
handling operations was 3,225 in 2007.\2\ AMS believes that most of
these entities would be considered
[[Page 77523]]
small entities under the criteria established by the SBA.
---------------------------------------------------------------------------
\1\ U.S. Department of Agriculture, Economic Research Service,
2009. Data Sets: U.S. Certified Organic Farmland Acreage, Livestock
Numbers and Farm Operations, 1992-2008. http://www.ers.usda.gov/Data/Organic/.
\2\ U.S. Department of Agriculture, Economic Research Service,
2009. Data Sets: Procurement and Contracting by Organic Handlers:
Documentation. http://www.ers.usda.gov/Data/OrganicHandlers/Documentation.htm.
---------------------------------------------------------------------------
The U.S. sales of organic food and beverages have grown from $3.6
billion in 1997 to nearly $21.1 billion in 2008.\3\ The organic
industry is viewed as the fastest growing sector of agriculture,
representing over 3 percent of overall food sales in 2009. Between 1990
and 2008, organic food sales have historically demonstrated a growth
rate between 15 to 24 percent each year. In 2009, organic food sales
grew 5.1%.\4\
---------------------------------------------------------------------------
\3\ Dimitri, C., and L. Oberholtzer. 2009. Marketing U.S.
Organic Foods: Recent Trends from Farms to Consumers, Economic
Information Bulletin No. 58, U.S. Department of Agriculture,
Economic Research Service, http://www.ers.usda.gov/Publications/EIB58.
\4\ Organic Trade Association's 2010 Organic Industry Survey,
http://www.ota.com.
---------------------------------------------------------------------------
In addition, USDA has 98 accredited certifying agents (ACAs) who
provide certification services to producers and handlers under the NOP.
A complete list of names and addresses of ACAs may be found on the AMS
NOP Web site, at http://www.ams.usda.gov/nop. The AMS believes that
most of these accredited certifying agents would be considered small
entities under the criteria established by the SBA.
D. Paperwork Reduction Act
No additional collection or recordkeeping requirements are imposed
on the public by this 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.
The AMS is committed to compliance with the E-Government Act, to
promote the use of the Internet and other information technologies
increased opportunities for citizen access to Government information
and services, and for other purposes.
E. Received Comments on Proposed Rule
AMS received comments from 9 submitters on the proposed rule TM-08-
06. Comments were received from handlers, a trade association, a non-
profit organization, an accredited certifying agent, and an industry
group. There was support among the comments for the allowance of each
of the six proposed use exemptions. However, a few of those supporting
comments suggested modifications to the proposed amendments. One
comment also expressed support for the removal of the expired listing
for glycerol monooleate. One additional commenter expressed blanket
opposition to allowing these substances in organic production and
handling, but did not offer any specific objections. The comments can
be viewed at: http://www.regulations.gov/.
One comment in favor of the addition of aqueous potassium silicate
to Sec. 205.601 requested that the NOP clarify what measures would be
used to verify and enforce the source restriction, and what oversight
and technical assistance the NOP will provide to certifying agents and
their subcontractors. The comment refers to the annotation that the
silica used in the manufacture of potassium silicate must be sourced
from naturally occurring sand. The National List contains a number of
substances which have annotations that specify source or processing
restrictions, particularly for handling substances. The NOP has
previously advised that ACAs obtain written documentation from the
manufacturer(s) of the input product(s) to discern whether a substance/
product conforms to restrictive annotations.
One comment in favor of adding tragacanth gum to Sec. 205.606
requested that the NOSB further consider the impact of pesticides and
fertilizers in the production of nonorganic ingredients, such as
tragacanth gum and wine grapes (in reference to the cooking wines). The
commenter cited the criteria established in 7 U.S.C. 6518(m), which
includes the probability of environmental contamination during
manufacture, use, misuse, or disposal of the substance, effects of the
substance on biological and chemical interactions in the agroecosystem,
and its compatibility with a system of sustainable agriculture. During
the May 2008 meeting, the Board discussed how to consider the impact of
conventional production methods for substances petitioned for addition
to Sec. 205.606. In the context of wine grapes used to produce
fortified cooking wines, the Board clarified that its evaluation
covered the production and use of the finished wine product and not the
production of the raw ingredients in the wine. Thus, in accordance with
7 U.S.C. 6518(m), the Board considered potential adverse effects upon
the agroecosystem from the manufacture, use and disposal of the
fortified cooking wine and not the individual ingredients in the wine.
The Board determined that the fortified cooking wines, sherry and
Marsala, satisfied the OFPA criteria in section 6518(m). In regards to
tragacanth gum, the Board reviewed the production process for the gum
and found it to be identical to a water extracted gum that is currently
listed in Sec. 205.606. At its May 20-22, 2008, meeting in Baltimore,
MD, the NOSB evaluated tragacanth gum against the criteria established
under 7 U.S.C. 6517 and 6518, and concluded that tragacanth gum is
consistent with the OFPA evaluation criteria. Members of the public are
always invited to submit comments regarding specific production
concerns of any particular substance that has been petitioned for
addition to Sec. 205.606. The NOP solicits such comments in notices of
NOSB meetings and proposed rules, both of which are published in the
Federal Register and on the NOP Web site.
Changes Based on Comments
Gellan Gum
Several comments addressed gellan gum. These comments favored the
addition of gellan gum to Sec. 205.605, and several specifically
referenced support for the listing of gellan gum as nonsynthetic
substance on Sec. 205.605(a). One comment in support of the exemption
for gellan gum, recommended an annotation to allow only the native form
of gellan gum, i.e., the high-acyl form. The comment stated that low-
acyl gellan gum is chemically modified by alkali treatment prior to
alcohol precipitation and is, therefore, synthetic. The comment
indicated that a restriction of the exemption to the high-acyl form
aligns with the intent of the NOSB as conveyed during the November 27-
30, 2007 meeting discussion.
There are 2 forms of gellan gum: High- and low-acyl. To manufacture
the low-acyl form, an alkali is added and the temperature is raised to
remove acetyl groups. A strong acid is then used to lower the pH and
the gum is recovered from solution by clarification and precipitation.
The high-acyl form is not subject to deacetylation with an alkali salt.
After fermentation, the high-acyl form is precipitated out of solution
with isopropyl alcohol.
We believe the different manufacturing processes for high- and low-
acyl gellan gum merits a revision to the proposed amendment to clarify
that only the high-acyl form of gellan gum may be classified as
nonsynthetic. Deacetylation, the removal of acetyl group(s) from
molecules, results in chemical change. Thus, in accordance with the NOP
definition of synthetic, the resulting substance would be synthetic.
Based upon this reasoning, we agree with the comment that the
recommendation to add gellan gum as a nonsynthetic substance pertains
only to the high-acyl form. Therefore, we have amended the listing by
adding the annotation ``high-acyl form only.''
[[Page 77524]]
Changes Requested But Not Made
Fortified Cooking Wines--Marsala and Sherry
Two comments addressed Marsala and sherry fortified cooking wines.
One comment did not support the listing on the basis that organic
versions of these cooking wines are commercially available, but failed
to provide documentation to support this claim. One comment requested
an annotation to prohibit fortified wines that contain synthetic
sulfites, such as sulfur dioxide or potassium metabisulfite. The
comment referenced the restriction of sulfur dioxide to wines that are
``made with organic grapes'' in questioning the legal basis for
allowing cooking wines containing sulfites to be listed on Sec.
205.606 and, therefore, to be used to produce ``organic'' products.
In its discussion at the May 20-22, 2008 meeting, the NOSB
acknowledged that the manufacturer cited in the fortified cooking wine
petitions did not add sulfites to its sherry and Marsala cooking wines.
However, the NOSB did not recommend prohibiting sherry or Marsala
cooking wines which contain added sulfites. We believe the
recommendation is consistent with OFPA, Sec. 6510(a)(3), which
prohibits the addition of sulfites except in the production of wine.
Therefore, we are not adopting the proposed annotation to prohibit
conventional forms of Marsala and sherry fortified cooking wines which
contain added sulfites.
F. Effective Date
This final rule reflects recommendations submitted to the Secretary
by the NOSB. The 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 crucial to
organic crop production and processing 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.
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. Adding new paragraph (a)(8);
0
B. Redesignating paragraphs (e)(2) through (e)(9) as (e)(3) through
(e)(10) and adding new paragraph (e)(2);
0
C. Redesignating paragraphs (i)(1) through (i)(11) as (i)(2) through
(i)(12) and adding new paragraph (i)(1); and
0
D. Revising paragraph (m)(2).
The additions and revisions read as follows:
Sec. 205.601 Synthetic substances allowed for use in organic crop
production.
* * * * *
(a) * * *
(8) Sodium carbonate peroxyhydrate (CAS -15630-89-4)--
Federal law restricts the use of this substance in food crop production
to approved food uses identified on the product label.
* * * * *
(e) * * *
(2) Aqueous potassium silicate (CAS -1312-76-1)--the
silica, used in the manufacture of potassium silicate, must be sourced
from naturally occurring sand.
* * * * *
(i) * * *
(1) Aqueous potassium silicate (CAS -1312-76-1)--the
silica, used in the manufacture of potassium silicate, must be sourced
from naturally occurring sand.
* * * * *
(m) * * *
(2) EPA List 3--Inerts of unknown toxicity--for use only in passive
pheromone dispensers.
* * * * *
0
2. Section 205.605 is amended by adding one new substance in
alphabetical order to paragraph (a) to read as follows:
Sec. 205.605 Nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food group(s)).''
* * * * *
(a) * * *
* * * * *
Gellan gum (CAS 71010-52-1)--high-acyl form only.
* * * * *
0
3. Section 205.606 is amended by:
0
A. Redesignating paragraphs (g) through (t) and (u) through (w) as
paragraphs (h) through (u) and (w) through (y) respectively;
0
B. Adding new paragraphs (g) and (v) to read as follows:
Sec. 205.606 Nonorganically produced agricultural products allowed as
ingredients in or on processed products labeled as ``organic.''
* * * * *
(g) Fortified cooking wines.
(1) Marsala.
(2) Sherry.
* * * * *
(v) Tragacanth gum (CAS -9000-65-1).
* * * * *
Dated: December 7, 2010.
David R. Shipman,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2010-31196 Filed 12-10-10; 8:45 am]
BILLING CODE 3410-02-P