[Federal Register Volume 77, Number 30 (Tuesday, February 14, 2012)]
[Rules and Regulations]
[Pages 8089-8092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-2938]

Rules and Regulations
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Federal Register / Vol. 77, No. 30 / Tuesday, February 14, 2012 / 
Rules and Regulations

[[Page 8089]]



Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-10-0079; NOP-09-02FR]
RIN 0581-AD06

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 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) 
on May 22, 2008, November 19, 2008, and May 6, 2009. This final rule 
adds one substance, microcrystalline cheesewax, along with any 
restrictive annotations, for use in organic mushroom production; and 
adds three substances, acidified sodium chlorite, dried orange pulp, 
and Pacific kombu seaweed, with any restrictive annotations, for use in 
organic handling. This final rule also amends the annotation for one 
substance used in organic handling, unbleached lecithin, and removes 
bleached lecithin from the National List.

DATES: Effective Date: This rule becomes effective March 15, 2012.

FOR FURTHER INFORMATION CONTACT: Melissa Bailey, Ph.D., Director, 
Standards Division, National Organic Program, Telephone: (202) 720-
3252; Fax: (202) 205-7808.


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 that may be 
used and the nonsynthetic (natural) substances that may not be used in 
organic production. The National List also identifies nonagricultural 
synthetic, nonsynthetic nonagricultural and nonorganic agricultural 
substances that may be used in organic handling. The Organic Foods 
Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501 et seq.), 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 NOP has published multiple amendments to the 
National List: 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); August 24, 2010 (75 FR 
51919); December 13, 2010 (75 FR 77521) and March 14, 2011 (76 FR 
13501). Additionally, a proposed amendment to the National List was 
published on May 5, 2011 (76 FR 25612).
    This final rule amends the National list to enact six 
recommendations submitted to the Secretary by the NOSB on May 22, 2008, 
November 19, 2008, and May 6, 2009.

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 

    This final rule amends Sec.  205.601 of the National List 
regulations by adding new paragraph (o) for the addition of one 
substance as follows: As production aids. Microcrystalline cheesewax 
(CAS s 64742- 42-3, 8009-03-08, and 8002-74-2)--for use in log 
grown mushroom production. Must be made without either ethylene-
propylene co-polymer or synthetic colors.
    The proposed rule to add microcrystalline cheesewax included an 
annotation specifying that the substance be ``for use in log grown 
mushroom culture.'' The NOP determined that the substance's use 
annotation should be modified ``for use in log grown mushroom 
production'' (emphasis added) in this final rule. This language change 
is consistent with terminology that will be utilized in a forthcoming 
proposed rule on organic mushroom standards.

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 Groups(s))''

    This final rule amends Sec.  205.605(b) of the National List 
regulations by removing Lecithin--bleached, and adding acidified sodium 
chlorite in alphabetical order as follows: Acidified sodium chlorite--
Secondary direct antimicrobial food treatment and indirect food contact 
surface sanitizing. Acidified with citric acid 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 revising paragraph (p) to read as follows: (p) 
Lecithin--de-oiled. Further, this final rule redesignates paragraphs 
(r) through (t) and paragraphs (u) through (y) as paragraphs (s) 
through (u) and (w) through (aa) respectively; and adds new paragraphs 
(r) and (v) for the addition of two substances as follows: (r) Orange 
pulp, dried, and (v) Seaweed, Pacific kombu.

[[Page 8090]]

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 proposed rule were announced for NOSB deliberation in the 
following Federal Register notices: (1) 74 FR 11904, March 20, 2009 
(bleached lecithin, acidified sodium chlorite, unbleached fluid 
lecithin); (2) 73 FR 54781, September 23, 2008 (dried orange pulp, 
acidified sodium chlorite); and (3) 73 FR 18491, April 4, 2008 
(microcrystalline cheesewax, acidified sodium chlorite, Pacific kombu 
seaweed). The proposal to allow the use of the four substances in this 
final rule, along with the deletion of one substance and the revised 
annotation of one substance, was published as a proposed rule on 
November 8, 2010 (75 FR 68505).

IV. Statutory and Regulatory Authority

    The OFPA, as amended (7 U.S.C. 6501-6522), 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 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. 601-624), the Poultry Products 
Inspection Act (21 U.S.C. 451-471), or the Egg Products Inspection Act 
(21 U.S.C. 1031-1056), 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 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 
    Pursuant to the requirements set forth in the RFA, 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 and clarify the use of one substance in 
agricultural production and handling. This action will modify the 
regulations published in the final rule and will provide small entities 
with more tools to use in day-to-day farming and handling operations. 
AMS concludes that the economic impact of this addition of allowed 
substances, if any, will be minimal and beneficial to small 
agricultural service firms. Accordingly, USDA certifies that this rule 
will not have a significant impact on a substantial number of small 
    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 
    According to USDA Economic Research Service (ERS) data based upon 
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\ The AMS believes that most of

[[Page 8091]]

these entities would be considered to be 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 grew from $3.6 billion 
in 1997 to nearly $21.1 billion in 2008.\3\ Between 1990 and 2008, 
organic food sales demonstrated an historic growth rate between 15 to 
24 percent each year. In 2010, organic food sales grew 7.7%.\4\

    \3\ Dimitri, C., and L. Oberholtzer. 2009. Marketing U.S. 
Organic Foods: Recent Trends from Farms to Consumers, Economic 
Information Information bulletin No. 58, U.S. Department of 
Agriculture, Economic Research Service, http://www.ers.suda.gov/PublicationsE1B58.
    \4\ Organic Trade Association's 2011 Organic Industry Survey, 

    In addition, USDA has 93 accredited certifying agents (ACA) 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 the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, 
Chapter 35.

E. Executive Order 13175

    This final rule has been reviewed in accordance with the 
requirements of Executive Order 13175, Consultation and Coordination 
with Indian Tribal Governments. The review reveals that this regulation 
will not have substantial and direct effects on Tribal governments and 
will not have significant Tribal implications.

F. Comments Received on Proposed Rule NOP-09-02

    AMS received 11 comments on the proposed rule AMS-NOP-10-0079; NOP-
09-02PR. Comments were received from specialty food ingredient 
processors and distributors, specialty food products manufacturers, an 
industrial sanitation supply firm, an organic consultant, a coalition 
of foreign governments and a private citizen. Comments were submitted 
in support of the proposed additions to the National List for all four 
of the proposed new use exemptions and the deletion of one substance. 
Comments in favor of the addition of acidified sodium chlorite to Sec.  
205.605(b) stated that it will increase the intervention options 
available for maintaining high sanitation standards in organic food 
processing and thereby further improve food safety for consumers of 
organic processed foods. While one comment expressed concern about the 
proposed exemption for the secondary direct antimicrobial food 
treatment use of acidified sodium chlorite, the commenter did not take 
a position for or against the specific proposal. A comment endorsing 
the addition of dried orange pulp to Sec.  205.606 stated that its use 
is consistent with organic principles, since an insufficient volume of 
organic oranges are grown and processed to produce organic orange pulp, 
which is a byproduct of extraction orange juice processing.
    Many comments addressed the proposed change in the lecithin 
annotation from unbleached to de-oiled on Sec.  205.606. Nonorganic 
forms of the substances listed under Sec.  205.606 are allowed as 
ingredients in or on processed products labeled as organic only when 
the nonorganic substance is not commercially available in organic form 
and only in accordance with any specified restrictions. Most comments 
submitted in support of the lecithin annotation change stated that the 
listing of de-oiled lecithin on Sec.  205.606 would prevent disruption 
in the availability or quality of a broad range of organic food 
products such as ice cream, pasta, bakery goods, cereals, sauces, soups 
and frozen desserts. They indicated that de-oiled is the appropriate 
annotation because this form of lecithin has a unique function and 
blander flavor in comparison to fluid or dry lecithin. The comments 
mentioned de-oiled lecithin's superiority in maintaining stability of 
water and oil emulsions. Furthermore, the comments informed that de-
oiled lecithin is not available as organic.
    Comments in support of removing bleached lecithin from Sec.  
205.605(b) indicated that this action will encourage the increased 
production and use of organic ingredients needed for organic food 
processing. They also argued that unbleached lecithin is now 
commercially available in organic forms, so the exemption for these 
substances is no longer crucial. Commenters stated that the use of 
nonorganic de-oiled lecithin on Sec.  205.606, instead of the 
nonorganic unbleached form previously allowed, would be subject to the 
determination of commercial availability of any organic form--once 
developed--in the processor's organic system plan and other specific 
restrictions. Commenters in favor of the amendment expressed 
frustration with discrepant use of organic unbleached lecithin and less 
expensive conventional unbleached lecithin in comparably priced 
multiple brands of the same processed organic products on retail 
shelves. These commenters conveyed expectations that this rule change 
will result in the replacement of nonorganic bleached lecithin with the 
organic form and thus encourage increased use and availability of 
organic ingredients.
    A few comments opposing the change in the unbleached lecithin 
annotation at Sec.  205.606 explained that the only current source of 
organic lecithin is soy, which is a food allergen. They cited a lack of 
availability of organic forms of lecithin from sunflower or canola and 
predicted that consumers with a soy allergy would not be able to eat 
organic products containing soy lecithin. These commenters noted that 
soy is identified in the U.S. Food Allergen Labeling and Consumer 
Protection Act of 2004 (Pub. L. 108-282, Title II) (21 U.S.C. 301) as 
one of 8 major food groups which account for 90 percent of life-
threatening food allergies. This legislation established mandatory 
disclosure requirements on labels for processed food containing any 
amounts of the eight named foods (milk, eggs, fish, shellfish, tree 
nuts, peanuts, wheat, and soybeans) listed in the 2004 Act. Food 
processors have become more aware of soy's allergenic potential and the 
federal labeling requirements when soy-based ingredients are used since 
passage of the 2004 Act. The opposing comments expressed concern that 
the annotation change would result in higher levels of soy lecithin 
being used in processed organic foods because it is more commonly 
available in organic form, but did not provide specific evidence to 
support this statement. Nonorganic lecithin from sunflower, rapeseed 
and canola is widely available commercially, and NOP believes that 
there is potential that any increased demand for non-soy lecithin will 
stimulate increased production of organic forms of bleached and 
unbleached lecithin from these alternative sources.
    A comment criticized the NOSB for omitting food allergies from the 
discussion in considering the lecithin petition. The NOSB did address 
this issue several times during its deliberation, as captured in the 
May 2009 NOSB meeting transcripts. The Board concluded that its 
recommended change to unbleached lecithin would still avail 
manufacturers with the option to use nonorganic, non-soy forms of de-
oiled lecithin. Commenters conveyed a preference to have non-
allergenic, nonorganic forms of lecithin available under Sec.  205.606. 
The change in

[[Page 8092]]

annotation does not specify the plant source of lecithin and, 
therefore, nonorganic de-oiled lecithin from non-soy and nonorganic 
sources may be used when organic equivalents are not available. A 
substance is considered commercially available if it is available in an 
appropriate form, quality, or quantity to fulfill an essential function 
in a system of organic production or handling, as determined by the 
certifying agent in the course of reviewing the organic plan. In 
summary, this annotation change would not limit the use of lecithin to 
organic de-oiled soy lecithin. Non-soy sources that are non-GMO and 
nonorganic would remain acceptable under Sec.  205.606, and accredited 
certifying agents would continue to require any nonorganic de-oiled 
lecithin to be sourced from non-GMO sources as long as de-oiled 
lecithin is not commercially available in organic form.
Changes Requested But Not Made
    Commenters requested that the proposed action be amended for Sec.  
205.606 to allow the use of non-GMO, non-allergenic lecithin. We have 
not made that change because we believe this request is mostly 
accommodated by the proposed action. Nonorganic forms of de-oiled 
lecithin can be used when the organic version is not commercially 
available. The NOP regulations define commercially available as a 
production input in an appropriate form, quality, or quantity to 
fulfill an essential function in a system of organic production or 
handling, as determined by the certifying agent in the course of 
reviewing the organic plan. Therefore, if a processor intends to make a 
soy-free product containing lecithin, in which de-oiled is the 
appropriate form, the processor may use nonorganic de-oiled lecithin 
from sunflower, canola or other sources if lecithin from the preferred 
sources is not available in organic form. If a product requires a form 
of lecithin other than de-oiled, such as fluid or powered, the lecithin 
must be sourced organically. The NOSB recommendation was finalized in 
May 2009. We believe that processors have had adequate notice to pursue 
the procurement of non-soy forms of organic lecithin if their products 
are intended to be soy free.

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:


1. The authority citation for 7 CFR part 205 continues to read as 

    Authority:  7 U.S.C. 6501-6522.

2. In Sec.  205.601 add new paragraph (o) to read as follows:

Sec.  205.601  Synthetic substances allowed for use in organic crop 

* * * * *
    (o) As production aids. Microcrystalline cheesewax (CAS 's 
64742-42-3, 8009-03-08, and 8002-74-2)-for use in log grown mushroom 
production. Must be made without either ethylene-propylene co-polymer 
or synthetic colors.
* * * * *

3. Section 205.605 is amended by:
A. Removing ``Lecithin-bleached'' from paragraph (b); and
B. Adding one new substance ``Acidified sodium chlorite'', in 
alphabetical order, to paragraph (b) 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)).''

* * * * *
    (b) * * *
    Acidified sodium chlorite--Secondary direct antimicrobial food 
treatment and indirect food contact surface sanitizing. Acidified with 
citric acid only.
* * * * *

4. Section 205.606 is amended by:
A. Revising paragraph (p);
B. Redesignating paragraphs (r) through (t) and paragraphs (u) through 
(y) as paragraphs (s) through (u) and (w) through (aa) respectively; 
C. Adding new paragraphs (r) and (v).
    The revisions read as follows:

Sec.  205.606  Nonorganically produced agricultural products allowed as 
ingredients in or on processed products labeled as ``organic.''

* * * * *
    (p) Lecithin--de-oiled.
* * * * *
    (r) Orange pulp, dried.
* * * * *
    (v) Seaweed, Pacific kombu.
* * * * *

    Dated: February 3, 2012.
Robert C. Keeney,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2012-2938 Filed 2-13-12; 8:45 am]