[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]



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Rules and Regulations
                                                Federal Register
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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.

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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) 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 <greek-i>-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 
<greek-i>-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 <greek-i>-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 <greek-i>-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 <greek-i>-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.
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    \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.
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    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\
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    \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.
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    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 <greek-i>-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 <greek-i>-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 <greek-i>-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 <greek-i> 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 <greek-i>-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