[Federal Register Volume 77, Number 8 (Thursday, January 12, 2012)]
[Proposed Rules]
[Pages 1979-1996]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-354]



[[Page 1979]]

Vol. 77

Thursday,

No. 8

January 12, 2012

Part II





Department of Agriculture





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 Agricultural Marketing Service





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7 CFR Part 205





 National Organic Program (NOP); Sunset Review (2012) for Nutrient 
Vitamins and Minerals; Proposed Rule

Federal Register / Vol. 77 , No. 8 / Thursday, January 12, 2012 / 
Proposed Rules

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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-10-0083; NOP-10-09PR]
RIN 0581-AD17


National Organic Program (NOP); Sunset Review (2012) for Nutrient 
Vitamins and Minerals

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would address a recommendation submitted to 
the Secretary of Agriculture (Secretary) by the National Organic 
Standards Board (NOSB) on April 29, 2011. The recommendation pertains 
to the 2012 Sunset Review of the listing for nutrient vitamins and 
minerals on the U.S. Department of Agriculture's (USDA) National List 
of Allowed and Prohibited Substances (National List). As recommended by 
the NOSB, the proposed rule would continue the exemption (use) for 
nutrient vitamins and minerals for 5 years after the October 21, 2012 
sunset date. In addition, the proposed rule would amend the annotation 
to correct an inaccurate cross reference to U.S. Food and Drug 
Administration regulations (FDA). The proposed amendment to the 
annotation would clarify what synthetic substances are allowed as 
nutrient vitamins and minerals in organic products labeled as 
``organic'' or ``made with organic (specified ingredients or food 
group(s)).''

DATES: Comments must be received by March 12, 2012.

ADDRESSES: Interested persons may submit written comments on this 
proposed rule using the following addresses:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Toni Strother, Agricultural Marketing Specialist, 
National Organic Program, USDA-AMS-NOP, 1400 Independence Avenue SW., 
Room 2646-So., Ag Stop 0268, Washington, DC 20250.
    Instructions: All submissions received must include the docket 
number AMS-NOP-10-0083; NOP-10-09PR, and/or Regulatory Information 
Number (RIN) 0581-AD17 for this rulemaking. Comments should:
     Directly relate to issues or questions raised by the 
proposed rule;
     Clearly indicate if you are for or against the proposed 
rule or some portion of it and your reason for your position. Include 
recommended language changes as appropriate; and
     Be supported by relevant information and data to support 
your position (e.g., scientific, environmental, manufacturing, industry 
impact information, etc.). Commenters may include a copy of articles or 
other references that support their comments. Only the supporting 
material relevant to your position will be considered.
    All comments received will be posted without change to http://www.regulations.gov. The NOP is specifically seeking comments on:
    1. The actual economic impacts of this action on the industry, 
including any expected mitigation factors that the industry may use to 
comply with the proposed action. We are most interested in refining the 
upper limit estimates referenced in the Regulatory Impact Analysis to 
specify the actual costs and benefits of this proposal. This would 
include any comments on the proportion of sales for different sectors 
of the organic market (i.e. infant formula, baby food, fluid milk, 
breakfast cereals, and pet food) that will be impacted by this action;
    2. The adequacy of the estimated impact of the proposed action on 
small entities; and
    3. The length of the proposed compliance date.
    Please submit comments related to these topics using the numbering 
scheme indicated above.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov. Comments submitted 
in response to this proposed rule will also be available for viewing in 
person at USDA-AMS, National Organic Program, 1400 Independence Avenue 
SW., Room 2646-South Building, Washington, DC, from 9 a.m. to 12 noon 
and from 1 p.m. to 4 p.m., Monday through Friday (except official 
Federal holidays). Persons wanting to visit the USDA South Building to 
view comments received in response to this proposed rule are requested 
to make an appointment in advance by calling (202) 720-3252.

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

SUPPLEMENTARY INFORMATION: 

I. Background

    The Organic Foods Production Act of 1990 (OFPA), (7 U.S.C. 6501-
6522), authorizes the establishment of the National List. The National 
List identifies synthetic substances that are exempted (allowed) in 
organic production and nonsynthetic substances that are prohibited in 
organic crop and livestock production. The National List also 
identifies nonagricultural nonsynthetic, nonagricultural synthetic and 
nonorganic agricultural substances that may be used in organic 
handling. The exemptions and prohibitions granted under the OFPA are 
required to be reviewed every 5 years by the National Organic Standards 
Board (NOSB). The Secretary has authority under the OFPA to renew such 
exemptions and prohibitions. If the substances are not reviewed by the 
NOSB within 5 years of their inclusion on the National List and 
addressed by the Secretary, then their authorized use or prohibition 
expires under OFPA's sunset provision.
    The exemption for the use of nutrient vitamins and minerals in 
``organic'' and ``made with organic (specified ingredients or food 
group(s))'' processed products is scheduled to expire on October 21, 
2012. The NOP is taking this action to implement the NOSB 
recommendation to renew the allowance for nutrient vitamins and 
minerals through October 21, 2017. The NOP has also determined that, 
within the current listing for nutrient vitamins and minerals, the 
cross reference to the FDA's fortification policy for food at 21 CFR 
104.20 was not accurate and that a correction to the current listing is 
necessary. This action would clarify what substances are covered under 
this exemption, consistent with the intent of the current listing as 
codified by the NOP final rule (65 FR 80548). This correction would 
facilitate compliance for organic operations, provide certifying agents 
greater certainty in assessing compliance and enable consumers to 
discern what substances may be used in organic foods.
    The potential impact of this action, including potential costs that 
could be incurred, and the alternatives considered are presented as 
part of the Executive Order 12866 section of this proposed rule. Upon 
issuance of a final rule on this action, the NOP intends to provide a 
compliance date of two years from the effective date of the amended 
listing. Prohibitions on the use of ingredients affected by this action 
would not be enforced until the compliance date. This timeline is 
intended to allow time for the NOSB's review of petitions for 
substances not within the scope of the current listing or amended 
listing and provides the NOP with an opportunity to initiate rulemaking 
if the Board recommends that such substances be added to the

[[Page 1981]]

National List. In addition, the NOP believes this timeline would 
provide sufficient time for the organic trade to adjust product 
formulations based on the Board recommendations and rulemaking or to 
consider relabeling products.
    The Secretary appointed members to the NOSB for the first time in 
January 1992. The NOSB began holding formal committee meetings in May 
1992 and its first full Board meeting in September 1992. The NOSB's 
initial recommendations were presented to the Secretary on August 1, 
1994.
    In advance of the Board's November 1995 meeting, two technical 
advisory panel (TAP) reports, one for ``Nutrient Vitamins'' and one for 
``Nutrient Minerals'', were prepared. These reports were developed to 
inform the Board's assessment of nutrient vitamins and minerals in 
consideration of the evaluation criteria for substances considered for 
inclusion on the National List as established in section 2119(m) of 
OFPA. The vitamins identified in the TAP review included: vitamins A, 
D, E, K, C, B6, B12; folic acid; thiamin (B1); riboflavin (B2); and 
biotin. The minerals identified in the TAP report for nutrient minerals 
included: Calcium; phosphorus; magnesium; sulfur; copper; iodine; iron; 
manganese; and zinc.\1\
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    \1\ NOSB, 1995. Nutrient Minerals Technical Advisory Panel 
Review. NOP Web site, Petitioned Substances Database, ``N'', 
available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5067005&acct=nopgeninfo NOSB, 1995. 
Nutrient Vitamins Technical Advisory Panel Review. NOP Web site, 
Petitioned Substances Database, ``N'', available at: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5067006&acct=nopgeninfo.
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    During the NOSB's November 1995 meeting, the NOSB finalized two 
recommendations regarding the addition of nutrient substances to 
organic food. These recommendations were developed to inform the 
establishment of the National Organic Program (NOP) regulations, 
including the National List. The first recommendation supported the 
addition of nutrient vitamins and minerals to the National List with 
the following annotation, ``Accepted for use in organic foods for 
enrichment or fortification when required by regulation or recommended 
by an independent professional organization.'' \2\ During the 
deliberations on this recommendation, there was discussion about what 
was meant by ``independent professional organizations'' and a 
clarification was made that this recommendation did not mean that 
vitamins and minerals should be exempt from the National List process.
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    \2\ NOSB, 1995. Final Minutes of the National Organic Standards 
Board Full Board Meeting Austin, Texas, October 31-November 4, 1995, 
available at: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5057496.
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    The second recommendation entitled ``Final Recommendation Addendum 
Number 13, The Use of Nutrient Supplementation in Organic Food,'' 
articulated the Board's preference regarding the use of vitamins, 
minerals, and/or accessory nutrients.\3\ It stated, ``Upon 
implementation of the National Organic Program (NOP), the use of 
synthetic vitamins, minerals, and/or accessory nutrients in products 
labeled as organic must be limited to that which is required by 
regulation or recommended for enrichment and fortification by 
independent professional associations.'' The Board clarified that the 
term ``accessory nutrients'' referred to nutrients, ``not specifically 
classified as a vitamin or mineral but found to promote optimal 
health.'' The Board commented that excluding the use of accessory 
nutrients could limit the potential for organic foods to capitalize on 
future nutritional findings.
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    \3\ NOSB, 1995, Final Recommendation Addendum Number 13, The Use 
of Nutrient Supplementation in Organic Foods, available at: http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=stelprdc5058973.
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    Based on the NOSB's recommendations, the Agricultural Marketing 
Service (AMS) published a proposed rule on March 13, 2000 (65 FR 
13512).\4\ The rule proposed an allowance for nutrient vitamins and 
minerals in processed products labeled as ``organic'' or ``made with 
organic (specified ingredients or food group(s))'' with the following 
language: ``Nutrient vitamins and minerals in accordance with 21 CFR 
104.20, Nutritional Quality Guidelines for Foods.'' The regulation 
cited as part of this listing refers to the fortification policy for 
food under the FDA's jurisdiction. This policy establishes uniform 
principles for the rational addition of nutrients to foods. In response 
to the proposed rule, the NOSB submitted a comment recommending that 21 
CFR 104.20 ``not be the reference for the allowance of nutrient 
vitamins and minerals'', but did not provide additional context for 
this position or propose alternate regulatory references.\5\
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    \4\ The proposed rule published in March 2000, was the second 
proposed rule for the National Organic Program. The first proposed 
rule was published on December 16, 1997 (62 FR 65850). The National 
List section in the 1997 proposed rule contained an exemption for 
``Nutrient supplements.''
    \5\ NOSB Comments to Proposed Rule 7 CFR part 205 (Docket TMD-
00-02-PR); submitted June 12, 2000.
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    On December 21, 2000, AMS published a final rule establishing the 
National Organic Program (65 FR 80548). The final rule retained the 
listing for nutrient vitamins and minerals as proposed. In the 
discussion of comments received, the NOP acknowledged commenters' 
suggestions that 21 CFR 104.20 was not adequate and should be 
accompanied by a reference to 21 CFR 101.9(c)(8) for FDA-regulated 
foods. In the preamble to the final rule, the NOP stated that such 
suggestions were not appropriate because 21 CFR 101.9 pertained to the 
declaration of nutrition information on the label and in labeling of a 
food rather than provisions for nutritional supplementation (65 FR 
80615). However, as discussed below, recent consultation with the FDA 
clarified that 21 CFR 101.9 does identify essential vitamins and 
minerals.
    In 2006, the NOP received a complaint challenging the use of 
docosahexaenoic acid (DHA) and arachidonic acid (ARA) derived from 
algae and microbes, respectively (hereinafter referred to as DHA/ARA 
single-cell oils), in organic infant formulas.\6\ The review of the 
complaint also led to questions concerning the use of taurine and 
nucleotides in organic infant formula. In November 2006, the NOP closed 
the complaint stating, ``The NOP determined that accessory nutrients, 
that are non-agricultural, are allowed in the production of products to 
be sold, labeled or represented as organic under the NOP; provided, 
they are used in full compliance with Food and Drug Administration 
(FDA) rules and regulations. Non-agricultural accessory nutrients are 
covered under Sec.  205.602(b) Synthetics allowed, of the NOP National 
List (nutrient vitamins and minerals) * * * Nutrients allowed under 
Sec.  205.605(b) are not limited to the nutrients listed in [21 CFR] 
Sec.  104.20(d)(3), because [21 CFR] Sec.  104.20(f) provides that 
nutrients may be added to foods as permitted or required by applicable 
regulations established elsewhere by FDA; for example, 21 CFR Part 107 
Infant Formula * * * In summary, we have determined that if added 
ingredients

[[Page 1982]]

such as DHA, ARA, nucleotides and taurine are used in full compliance 
with FDA rules and regulations, they would comply with the NOP National 
List as currently written.''
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    \6\ DHA and ARA are omega-3 and omega-6 fatty acids, 
respectively, which are naturally present in certain foods. Dietary 
sources of DHA include: cold water fatty fish, meats, and eggs. 
Dietary sources of ARA include: meat, poultry and eggs. Humans can 
convert the omega-3 fatty acid alpha-linolenic acid (ALA) to DHA and 
the omega-6 fatty acid linoleic acid (LA) to ARA. Natural sources of 
LA and ALA include: vegetable oils, nuts, seeds and some vegetables. 
Reference: University of Maryland Medical Center, Omega-3 Fatty 
Acids. Available online at: http://www.umm.edu/altmed/articles/omega-3-000316.htm.
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    In November 2008, the NOP received an inquiry from a certifying 
agent regarding the allowance of lutein ester (crystalline lutein), a 
carotenoid, under the listing for nutrient vitamins and minerals in 
Sec.  205.605(b). The NOP consulted with the FDA and provided a written 
response which stated, ``The FDA has determined that ``Crystalline 
Lutein'' does not fall under current fortification policy * * * The 
nutrients listed in [21 CFR] Sec.  104.20(d)(3) are those that fall 
under this policy.'' The NOP statement that the ``accessory nutrient'', 
lutein ester, is not allowed under the nutrient vitamin and mineral 
listing at Sec.  205.605(b) is in conflict with the 2006 NOP complaint 
closure letter that stated that ``accessory nutrients'' were allowed 
under the FDA fortification policy.
    On March 26, 2010, the NOP published an Advance Notice of Proposed 
Rulemaking (ANPR) to announce the pending sunset of substances on the 
National List and opened the public comment process on whether existing 
exemptions for specified synthetic and nonsynthetic substances in 
organic handling should be continued (75 FR 14500).\7\ The ANPR 
indicated that the exemption for the use of nutrient vitamins and 
minerals as ingredients in or on processed products labeled as 
``organic'' or ``made with organic (specified ingredients or food 
group(s))'' would expire after October 21, 2012, if the listing was not 
renewed. The public comment period lasted 60 days. Comments were 
received from organic handlers, ingredient suppliers and trade 
associations. Comments received supported the continued listing of 
nutrient vitamins and minerals in organic handling. The written 
comments can be retrieved at http://www.regulations.gov by searching 
for the document ID number: AMS-NOP-09-0074. The NOP provided the NOSB 
with these public comments to consider in their future deliberations on 
the status of nutrient vitamins and minerals in organic products after 
the 2012 sunset date.
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    \7\ The Sunset 2012 ANPR also pertained to the exemptions for 
synthetic substances and prohibitions for nonsynthetic substances 
used in crop and livestock production.
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    Because of continued confusion in the organic industry about the 
allowance of certain added ingredients, such as DHA, ARA, taurine, and 
nucleotides, in organic products, the NOP met with FDA staff from the 
Office of Nutrition, Labeling and Dietary Supplements in April 2010 for 
clarification of the scope of 21 CFR 104.20. The FDA explained that 
``nutrients'' as referenced in 21 CFR 104.20(f) is intended to pertain 
only to those nutrients listed in section 104.20(d)(3) and as specified 
in the standards of identity (21 CFR parts 130-169) for a food or class 
of foods. The standards of identity for enriched cereal-flours and 
related products, for example, require fortification at specified 
levels with thiamin, riboflavin, niacin, iron and folic acid (21 CFR 
part 137). The FDA noted that some foods have separate requirements, 
and are not subject to 21 CFR 104.20, such as infant formula which must 
comply with the nutrient requirements at 21 CFR 107.100. The NOP 
participated in a follow-up discussion with FDA in February 2011, the 
details of which are discussed below.
    In April 2010, the NOP issued an ``Action Memorandum to the 
Chairman of the National Organic Standards Board'' at the NOSB meeting 
to advise the NOSB about the clarifications provided by FDA.\8\ The 
memorandum conveyed FDA's interpretation of the fortification policy, 
as stated in the above paragraph, and requested that the NOSB reexamine 
the codified listing for nutrient vitamins and minerals to determine 
what substances are permitted under its scope as part of the scheduled 
sunset 2012 review. The NOP specifically asked the NOSB to consider: 
``Are the ``nutrient vitamins and minerals'' specified within 21 CFR 
104.20 aligned with the 1995 NOSB recommendation? If not, are there 
substances that should be prohibited or additional substances that 
should be allowed?'' This memo stated that the previous interpretation 
of 21 CFR 104.20 Nutritional Quality Guidelines for Foods was 
incorrect. The memo also conveyed the NOP's plan to issue guidance on 
nutrient vitamins and minerals that would align with the FDA 
fortification policy. On March 9, 2011, the NOSB Handling Committee's 
Sunset 2012 Proposed Recommendation for nutrient vitamins and minerals 
was posted for public review and comment.\9\ The NOSB Handling 
Committee recommended that the listing be renewed as follows:
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    \8\ NOP, 2010, Action Memorandum for the Chairman of the 
National Organic Standards Board, Scope of Nutrient Vitamins and 
Minerals in Organic Food, available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5084068&acct=nosb.
    \9\ NOSB, 2011, Handling Committee Sunset 2012 Proposed 
Recommendation Nutrient Vitamins and Minerals, available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5089727&acct=nosb.
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    Sec.  205.605(b): Nutrient Vitamins and Minerals, restricted to 
materials required or allowed by law for the purpose of enrichment, 
supplementation or fortification of foods including infant formula, and 
materials the use of which is supported by the FDA or the Institute of 
Medicine of the National Academies.'' The NOSB Handling Committee 
stated that they intended to ``restore the 1995 NOSB recommendation,'' 
and reasoned that, ``Review of the original recommendations, historical 
documents, and public comments does not reveal unacceptable risks to 
the environment, human, or animal health as a result of the use or 
manufacture of these materials.'' \10\
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    \10\ Prior to the April 2011 NOSB meeting, the Board indicated 
that nutrient vitamins and minerals would be withdrawn from the 
agenda and postponed until the next meeting in Fall 2011. The NOP 
voiced concern that delaying a sunset vote on nutrient vitamins and 
minerals would not allow adequate time to publish proposed and final 
rules to implement the Board's recommendation prior to the sunset 
date of October 21, 2012. In that scenario, the listing for nutrient 
vitamins and minerals would expire and use of synthetic vitamins and 
minerals would be prohibited in organic foods. The NOP urged the 
Board to complete the sunset recommendation at the April 2011 
meeting as originally scheduled to allow time for completion of 
rulemaking and to avoid significant disruption to the organic food 
industry. The NOSB agreed to retain the nutrient vitamins and 
minerals sunset recommendation on the April 2011 meeting agenda.
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    The NOSB Handling Committee received approximately 2,000 comments 
on their proposed recommendation to change the annotation for nutrient 
vitamins and minerals. The majority of comments opposed the NOSB 
Handling Committee's proposal. Many commenters voiced concern that the 
proposal would allow, without NOSB review, any synthetic nutrient 
additive to be allowed in organic products. These commenters stated 
that only essential nutrients required by the FDA should be allowed in 
organic products. A trade organization and an organic nonprofit 
organization specifically suggested that the Committee instead consider 
an annotation for nutrient vitamins and minerals that would allow 
essential vitamins and minerals required by FDA in infant formula and 
other foods. Some commenters further emphasized that the Committee's 
proposal would allow an open ended list of allowed substances. These 
commenters stated that the proposal was not consistent with the 
required petition and NOSB review process for the National List and, if 
passed, would provide for a list of substances that certifying agents 
would have difficulty verifying for compliance

[[Page 1983]]

during the organic certification process. These commenters advocated 
for the NOSB to individually review and approve any synthetic additives 
not provided for on the National List per the OFPA requirements. Other 
comments supported the proposal for an allowance for nutrient additives 
based upon the idea that certain additives may have health benefits and 
that, without these additives, consumers may consider organic products 
nutritionally inferior to conventional products. In response to these 
comments, the Committee withdrew the proposal prior to the April 26-30, 
2011, NOSB meeting.
    In April 2011, the FDA provided written responses to the questions 
posed by NOP concerning whether the FDA recognizes or defines 
``accessory nutrients'' and the scope of nutrients covered under the 
fortification policy. The letter, dated April 14, 2011, reflects the 
points of discussion during a February 2011 meeting between NOP and 
FDA.\11\ FDA's responses reiterated and expanded upon the information 
conveyed during an April 2010 NOSB meeting at which the NOP discussed 
their understanding of FDA's fortification policy.
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    \11\ FDA Response to NOP--Questions and Answers Regarding 
Nutrient Fortification of Foods. April 14, 2011. Available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5090415.
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    The FDA explained that the fortification policy at 21 CFR 104.20 
provides for the rational addition of essential nutrients to food for 
human consumption and the term, ``accessory nutrients,'' is not defined 
or used in the fortification policy. FDA considers only ``essential 
nutrients'' to be within the scope of its fortification policy at 21 
CFR 104.20. The nutrients which FDA has determined to be essential are 
enumerated in 21 CFR 101.9(c)(8)(iv) with corresponding Reference Daily 
Intakes (RDIs), and 21 CFR 101.9(c)(9), which includes protein and 
potassium and the corresponding Daily Reference Values (DRVs). FDA 
stated that substances identified by USDA as ``accessory nutrients'' 
such as omega-3 and omega-6 fatty acids, inositol, choline, carnitine, 
and taurine are not essential nutrients listed under 101.9(c)(8)(iv) 
and are, therefore, not within the scope of FDA's fortification policy 
at 21 CFR 104.20. The FDA also clarified that infant formula is not 
within the scope of the fortification policy; the requirements in 21 
CFR part 107 pertain to required and essential nutrients for infant 
formula and include minimum and maximum amounts for those nutrients.
    At the April 2011 NOSB meeting, the NOP suggested that the NOSB 
amend the annotation for nutrient vitamins and minerals to cite the 
regulatory references, 21 CFR 101.9, 21 CFR 107.10 and 21 CFR 107.100, 
which identify essential and approved vitamins, minerals and other 
nutrients for infant formula and fortification of food. The NOP 
suggested that an annotation change would correct an inaccurate cross 
reference to FDA fortification policy for food at 21 CFR 104.20. The 
NOP further explained that this annotation change would expand the 
allowance for certain nutrients by providing for the continued use of 
essential nutrients in organic infant formula; the use of essential 
nutrients in infant formula is not covered under the existing FDA 
reference in the NOP regulations. The NOP also stated that the listing 
for nutrient vitamins and minerals should encompass a clear, 
discernible list of permitted substances. The proposed change would 
convey the intent of the codified listing by coherently and accurately 
stating which synthetic nutrient substances may be added to organic 
food and organic infant formula.
    At the conclusion of the April 2011 meeting, the NOSB approved a 
recommendation to renew the listing for nutrient vitamins and minerals 
as presently codified without amendment.\12\ The Board signaled its 
intent to propose an annotation change to the nutrient vitamins and 
minerals listing at its November 2011 meeting, after considering the 
information provided by FDA and the numerous public comments addressing 
this issue. However, since NOP is taking action to amend the listing 
through this proposed rule, the NOSB has opted to remove proposing a 
recommendation for an annotation change on nutrient vitamins and 
minerals from their November 2011 meeting agenda. In addition to the 
ANPR for Sunset 2012 published on March 26, 2010, the NOSB received 
additional public comment concerning the pending sunset of this listing 
in response to three Federal Register notices announcing meetings of 
the NOSB and its planned deliberations on recommendations involving 
Sunset 2012 substances. The notices were published in the Federal 
Register as follows: March 17, 2010 (75 FR 12723), September 20, 2010 
(75 FR 57194), and March 4, 2011 (76 FR 12013). The NOSB received 
further written and oral testimony concerning nutrient vitamins and 
minerals at all three of these public business meetings which occurred 
in Woodland, CA on April 26-29, 2010, in Madison, WI on October 25-28, 
2010, and in Seattle, WA on April 26-29, 2011. The written comments can 
be retrieved via http://www.regulations.gov by searching for the 
document ID numbers: AMS-NOP-10-0021 (May 2010 meeting); AMS-NOP-10-
0068 (October 2010 meeting); and AMS-NOP-11-05 (April 2011 meeting). 
The oral comments were recorded in the meeting transcripts available on 
the NOP Web site, http://www.ams.usda.gov/nop.
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    \12\ NOSB, 2011, Formal Recommendation by the National Organic 
Standards Board (NOSB) to the National Organic Program (NOP), 
Nutrient Vitamins and Minerals Sunset, available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5091724.
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II. Overview of Proposed Amendments

    This proposed rule would amend Sec.  205.605 of the National List 
regulations by amending paragraph (b) that currently reads: ``Nutrient 
vitamins and minerals, in accordance with 21 CFR 104.20, Nutritional 
Quality Guidelines For Foods'' to be revised as follows: ``Vitamins and 
minerals. For food--vitamins and minerals identified as essential in 21 
CFR 101.9. For infant formula--vitamins and minerals as required by 21 
CFR 107.100 or 107.10.''
    This proposed change conveys the intent of the codified listing by 
coherently and accurately stating which synthetic nutrient substances 
may be added to organic food and organic infant formula. The parameters 
of the amended listing are based upon FDA's determination of which 
vitamins and minerals are essential for human nutrition and required in 
infant formula which is consistent with the intended purpose of the 
current listing. Nutrients which are not considered essential vitamins 
and minerals, by the FDA (under 21 CFR 101.9(c)(8)(iv)), would be 
subject to individual evaluation in accordance with the criteria set 
forth in sections 6517(c) and 6518(m) of OFPA and Sec.  205.600 of the 
NOP regulations. Petitions for the addition of such substances to the 
National List need to be submitted in accordance with the Guidelines on 
Submitting National List Petitions (72 FR 2167).\13\
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    \13\ The Guidelines on Submitting National List Petitions is 
available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5048809&acct=nopgeninfo.
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    The NOP regulations as promulgated, contained the listing for 
``Nutrient vitamins and minerals in accordance with 21 CFR 104.20, 
Nutritional Quality Guidelines for Foods,'' in Sec.  205.605(b) of the 
National List. In effect, that provision permits the addition of 
synthetic forms of nutrient vitamins and

[[Page 1984]]

minerals to processed products labeled ``organic'' or ``made with 
organic (specified ingredients or food group(s)).'' However, the NOP 
incorrectly interpreted FDA's fortification policy, codified at 21 CFR 
104.20, and allowed substances that are not authorized under the 
current reference in the NOP regulations.
    Two sections, 21 CFR 104.20(d)(3) and (f), have caused confusion 
and incorrect interpretations of which substances are allowed in 
organic foods. Section 104.20(d)(3) identifies 21 nutrients (19 
vitamins and minerals with a Recommended Dietary Intake (RDI), plus 
protein and potassium which each have a Dietary Reference Value (DRV)) 
which may be added to foods in accordance with conditions specified 
within section 104.20. The FDA fortification policy specifies the 
circumstances under which these 21 nutrients may be added to food: To 
correct a dietary insufficiency; restore nutrients to a level 
representative of the food prior to storage, handling and processing; 
maintain a balanced nutrient profile; improve the quality or a 
replacement food; or be added as permitted or required by another FDA 
regulation. In the context of organic production, the fortification 
policy referenced in the current nutrient vitamins and minerals listing 
covers only the vitamins and minerals identified in Sec.  104.20(d)(3).
    In 2006, the NOP incorrectly interpreted 21 CFR 104.20(f), which 
states, ``Nutrient(s) may be added to foods as permitted or required by 
applicable regulations established elsewhere in this chapter.'' The NOP 
interpreted ``or required by applicable regulations established 
elsewhere in this chapter,'' as allowing the addition of a broader 
range of nutrients to organic products than those specified in Sec.  
104.20(d)(3). According to this interpretation, the fortification 
policy for food included the nutrition specifications for infant 
formula and nutrients for which there is Generally Regarded as Safe 
(GRAS) notification or the manufacturer's self-determination of GRAS. 
The FDA maintains a GRAS Notice Inventory: http://www.fda.gov/Food/FoodIngredientsPackaging/GenerallyRecognizedasSafeGRAS/GRASListings/default.htm.

Fortification of Foods

    To correct the previous interpretation and provide firm guidance to 
the organic industry, the NOP sought clarification from FDA regarding 
the scope of nutrients, vitamins and minerals permitted by the 
fortification policy for addition to foods. The FDA informed the NOP 
that the fortification policy covers the nutrients identified in (i) 21 
CFR 104.20(d)(3), (ii) an additional 6 nutrients that have been 
determined essential listed in 21 CFR 101.9(c)(8)(iv), and (iii) 
nutrients as required by other FDA regulations, which include those 
pertaining to a common or usual name (21 CFR part 102), standard of 
identity (21 CFR parts 130-169), or nutritional quality guideline (21 
CFR 104.47). This contrasts with current practices in certain sectors 
of the organic industry which have added nutrients to types of organic 
products, such as infant formula or pet food, which are not covered 
under the fortification policy. Added ingredients which are confirmed 
or self-determined as GRAS, but not designated as essential nutrients 
by FDA, have also been added to organic products. Examples of 
ingredients added to organic products which are outside the parameters 
of FDAs fortification policy include certain forms of DHA and ARA in 
fluid milk and dairy products, and taurine in pet food.\14\
---------------------------------------------------------------------------

    \14\ Section 205.606 of the National List identifies two 
components of fish oil, by Chemical Abstracts Service (CAS) numbers, 
that are allowed as ingredients in organic products. These are the 
omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic 
acid (DHA). Forms of DHA which do not meet these criteria are not 
otherwise allowed in organic products as a nutrient vitamin or 
mineral, regardless of GRAS designation. FDA has not determined that 
either DHA or ARA are essential nutrients for the fortification of 
food. Pet food does not fall within the scope of FDA's fortification 
policy. The NOP will address nutrient vitamins and minerals in pet 
food through a separate rulemaking.
---------------------------------------------------------------------------

    Since the establishment of the fortification policy in 1980, the 
FDA has designated six other nutrients as ``essential'' and permitted 
for fortification in foods. These include Vitamin K, manganese, 
selenium, chromium, molybdenum and chloride. As indicated in 21 CFR 
104.20(a), the list of nutrients in (d)(3) was not expected to remain 
static: ``It is reasonable to anticipate that the Reference Daily 
Intakes (RDI's) as delineated in Sec.  101.9 of this chapter and in 
paragraph (d) of this section will be amended from time to time to list 
additional nutrients and/or to change the levels of specific RDI's as 
improved knowledge about human nutrient requirements and allowances 
develops.''
    Therefore, the FDA suggested to NOP that a more appropriate 
reference to capture all of the essential vitamins and minerals that 
may be permitted for fortification of food, in accordance with the 
conditions specified in the fortification policy, is 21 CFR 
101.9(c)(8)(iv) and potassium (101.9(c)(9)). The NOP is proposing to 
amend the current listing for nutrient vitamins and minerals to include 
this reference for fortification of foods. Paragraph (c)(8)(iv) in 
Sec.  101.9 identifies 25 vitamins and minerals which are essential in 
human nutrition and their corresponding Reference Daily Intake (RDI) 
values. Paragraph (c)(9) in Sec.  101.9 includes the listing for 
potassium and the corresponding Daily Reference Value (DRV). The RDI 
and potassium DRV values specified in 21 CFR 101.9 are based on the 
National Academy of Sciences' Recommended Daily Allowance and 
``Estimated Safe and Adequate Daily Dietary Intakes.'' The NOP expects 
that the NOSB will review any FDA updates or additions pertaining to 
the requirements for essential vitamins and minerals, as codified in 21 
CFR 101.9, during future sunset reviews of the vitamins and minerals 
listing.

Infant Formula

    The NOP is also proposing to amend the current listing for nutrient 
vitamins and minerals by adding the regulatory references that are 
applicable to the FDA nutrient specifications for infant formula. 
According to FDA, the fortification policy for food does not apply to 
infant formula. The FDA developed separate nutrient specifications for 
infant formula. The NOP allowance for nutrient vitamins and minerals, 
as codified, references only the fortification policy for food, and, 
therefore, does not provide for the addition of vitamins and minerals 
in organic infant formula.
    In practice, however, NOP-certified organic infant formulas which 
comply with the FDA nutrient requirements have been produced for years. 
This was based upon an interpretation advanced by the NOP that the FDA 
fortification policy extended to the nutrient specifications for infant 
formula. Most of the organic infant formulas in the current marketplace 
contain some added ingredients which are permitted, but not required by 
FDA, such as, ARA, DHA, nucleotides, taurine, carnitine, lutein and 
lycopene. This proposed action, incorporating the FDA nutrient 
requirements for infant formula, would ensure that there is no 
unintended impediment to the continued formulation of organic infant 
formula with vitamins and minerals to comply with FDA requirements. 
This proposed action would also prohibit the use of non-required 
ingredients added to organic infant formula, such as ARA, DHA, 
nucleotides, taurine, carnitine, lutein, and lycopene, unless the NOSB 
issues recommendations to add any such substances to the National List 
and

[[Page 1985]]

such recommendations are codified through rulemaking.
    The infant formula nutrient specifications at 21 CFR 107.100 
stipulate the required vitamins and minerals and the corresponding 
minimum and maximum levels at which these may be present in infant 
formula. Section 21 CFR 107.100 identifies all required vitamins and 
minerals for infant formula with the exception of selenium, the 
addition of which is allowed for in 21 CFR 107.10. Paragraph (b)(5) of 
section 107.10 provides that any additional vitamin or mineral may be 
declared on the label provided it has been identified as essential by 
the National Academy of Sciences or FDA and is provided at a level, if 
known, considered to have biological significance through publications 
by the National Academy of Sciences or by FDA in the Federal Register. 
Selenium has been identified as essential by the National Academy of 
Sciences. The FDA advised that sections 107.100 and 107.10, in 
combination, would account for all of the vitamins and minerals 
required in infant formula. The incorporation of section 107.10 will 
ensure that any vitamins and minerals which are declared essential and 
added to infant formula in the future will be allowed in organic infant 
formula. This will enable manufacturers of organic infant formula to 
apply significant nutritional findings concerning vitamin and mineral 
requirements without delay. Section 107.100 also requires certain 
levels of protein, fat and linoleic acid in infant formula. As these 
nutrients are available from agricultural sources, the NOP expects that 
these will be provided in organic form.
    As a result of this proposed action, the essential vitamins and 
minerals listed as RDI in 101.9(c)(8)(iv) and potassium listed as DRV 
(101.9(c)(9)) would be permitted for addition to organic foods; in 
addition, the vitamins and minerals required by FDA for infant formula, 
would be permitted for addition to organic infant formula. An essential 
vitamin or mineral must have a safe and lawful source, e.g., the 
substance must be an approved food additive or GRAS under the 
conditions of the intended use, and there should be no determination by 
FDA, in regulation or matter of policy, that fortification with that 
nutrient is inappropriate. To convey that vitamins and minerals are the 
only types of substances permitted under this categorical allowance, 
the proposed amendment omits the word ``nutrient'' because that term 
encompasses a wider range of substances.
    Over the last ten years, the NOP incorrectly allowed a broad 
allowance of ``accessory nutrients'' that is not aligned with the 
codified allowance for nutrient vitamins and minerals in organic 
products, as confirmed by FDA's clarification of the scope of the 
fortification policy. In practice, added ingredients, which are 
considered GRAS (either via GRAS notification submission or a 
manufacturer's self-determination), but are not designated as essential 
vitamins and minerals per FDA (21 CFR 101.9(c)(8)(iv)), are being added 
to organic products based upon an incorrect NOP interpretation of FDA 
fortification policy. The proposed action will clarify which vitamins 
and minerals are allowed in organic food products, allow organic infant 
formula to contain essential vitamins and minerals, and ensure the NOSB 
reviews and approves all substances used in organic production and 
handling. Moreover, this proposed action does not preclude the 
potential to add individual exemptions for additional nutrients to the 
National List. Such substances can be petitioned for inclusion on the 
National List and would be subject to individual evaluation by the NOSB 
according to the criteria established in OFPA and the NOP regulations 
for such purpose.
    In effect, this proposed action would permit the following vitamins 
and minerals in organic foods (in accordance with FDA specifications 
for use): Vitamins A, C, K, D, E, thiamin, riboflavin, niacin, B6, B12, 
biotin, folate, pantothenic acid, calcium, iron, phosphorus, magnesium, 
zinc, iodine, copper, potassium, selenium, manganese, chromium, 
molybdenum, and chloride. This proposed action would also permit the 
following vitamins and minerals in organic infant formula: Vitamins A, 
C, K, D, E, thiamin, riboflavin, niacin, B6, B12, biotin, folic acid, 
pantothenic acid, choline, inositol, calcium, iron, phosphorus, 
magnesium, zinc, iodine, copper, sodium, potassium, selenium, 
manganese, and chloride. Table 1 compares the vitamins and minerals 
allowed under the current 21 CFR 104.20 reference and illustrates the 
complete set of vitamins and minerals that would be permitted in 
organic food and infant formula per this proposed action.

 Table 1--Summary of Regulatory References for Vitamins and Minerals in Organic Food and Organic Infant Formula
----------------------------------------------------------------------------------------------------------------
                                                               Proposed reference for vitamins and minerals
                                 Current reference for   -------------------------------------------------------
          Substance              nutrient vitamins and                                  Infant formula Required
                                  minerals per 21 CFR      Food Essential per 21 CFR     per 21 CFR 107.100 or
                                     104.20(d)(3)         101.9(c)(8) or 101.9(c)(9)            107.10
----------------------------------------------------------------------------------------------------------------
Vitamin A...................  Yes.......................  Yes.......................  Yes.
Vitamin C...................  Yes.......................  Yes.......................  Yes.
Calcium.....................  Yes.......................  Yes.......................  Yes.
Iron........................  Yes.......................  Yes.......................  Yes.
Vitamin D...................  Yes.......................  Yes.......................  Yes.
Vitamin E...................  Yes.......................  Yes.......................  Yes.
Vitamin K...................  ..........................  Yes.......................  Yes.
Thiamin.....................  Yes.......................  Yes.......................  Yes.
Riboflavin..................  Yes.......................  Yes.......................  Yes.
Niacin......................  Yes.......................  Yes.......................  Yes.
Vitamin B6..................  Yes.......................  Yes.......................  Yes.
Folate......................  Yes.......................  Yes.......................  Yes.
Vitamin B12.................  Yes.......................  Yes.......................  Yes.
Biotin......................  Yes.......................  Yes.......................  Yes.*
Pantothenic acid............  Yes.......................  Yes.......................  Yes.
Choline.....................  ..........................  ..........................  Yes.*
Inositol....................  ..........................  ..........................  Yes.*

[[Page 1986]]

 
Phosphorus..................  Yes.......................  Yes.......................  Yes.
Magnesium...................  Yes.......................  Yes.......................  Yes.
Zinc........................  Yes.......................  Yes.......................  Yes.
Iodine......................  Yes.......................  Yes.......................  Yes.
Copper......................  Yes.......................  Yes.......................  Yes.
Sodium......................  ..........................  ..........................  Yes.
Potassium...................  Yes.......................  Yes.......................  Yes.
Selenium....................  ..........................  Yes.......................  Yes.
Manganese...................  ..........................  Yes.......................  Yes.
Chromium....................  ..........................  Yes.......................  ..........................
Molybdenum..................  ..........................  Yes.......................  ..........................
Chloride....................  ..........................  Yes.......................  Yes.
----------------------------------------------------------------------------------------------------------------
* Required only for non-milk based infant formulas.

    Table 2 shows examples, but is not an exhaustive list, of 
ingredients which are used in organic products and would be prohibited 
from use under this action. This table also indicates whether a 
petition to add the substance to the National List has been submitted 
to the National Organic Standards Board.

      Table 2--Examples of Affected Ingredients in Organic Products
------------------------------------------------------------------------
               Ingredient                   Petition submitted to NOSB
------------------------------------------------------------------------
Docosahexanoic Acid (DHA) algal oil.....  Yes.
Arachidonic Acid (ARA) single-cell oil..  Yes.
Taurine (separate petitions for infant    Yes.
 formula and pet food).
Inositol................................  Yes.
Choline (two separate petitions for       Yes.
 infant formula and infant food, and all
 other foods).
Ascorbyl Palmitate......................  Yes.
Beta-carotene *.........................  Yes.
L-carnitine.............................  Submitted to NOP and under
                                           revision by petitioner.
Lycopene................................  Yes.
Nucleotides.............................  Yes.
Lutein..................................  Submitted to NOP and under
                                           revision by petitioner.
L-Methionine............................  Yes.
------------------------------------------------------------------------
* The beta-carotene petition is for the synthetic form. Beta-carotene
  extract color is currently listed in section 205.606 as a
  nonorganically produced agricultural ingredient allowed in products
  labeled ``organic'' when an organic version is not commercially
  available.

III. Related Documents

    Three notices were published announcing meetings of the NOSB and 
its planned deliberations on recommendations involving Sunset 2012 
substances including nutrient vitamins and minerals. The notices were 
published in the Federal Register as follows: (1) March 17, 2010 (75 FR 
12723); (2) September 20, 2010 (75 FR 57194); and (3) March 4, 2011 (76 
FR 12013).
    On March 26, 2010, the NOP published an Advance Notice of Proposed 
Rulemaking (75 FR 14500) to make the public aware that the allowance 
for synthetic nutrient vitamins and minerals, among other substances, 
will expire for use in organic handling, if not reviewed by the NOSB 
and renewed by the Secretary.

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. Section 6518(k) 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 a substances 
evaluated for inclusion on or deletion from the National List. 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. The Sunset 
Provision in section 6517(e) of the OFPA provides that no exemption or 
prohibition on the National List will remain valid after 5 years unless 
the exemption or prohibition has been reviewed and the Secretary renews 
the listing.

A. Executive Order 12866 and Executive Order 13563

    Executive Orders 13563 and 12866 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Executive 
Order 13563 emphasizes the importance of quantifying both costs and 
benefits, of reducing costs, of harmonizing rules, and of promoting 
flexibility. This rule has been designated an ``economically 
significant regulatory action'' under

[[Page 1987]]

section 3(f) of Executive Order 12866. Accordingly, the rule has been 
reviewed by the Office of Management and Budget.
    AMS is specifically seeking comments on the actual economic impacts 
of this action on the industry, including any expected mitigation 
factors that the industry may use to comply with the proposed action. 
We are most interested in refining the upper limit estimates referenced 
in the Regulatory Impact Analysis to specify the actual costs and 
benefits of this proposal. The costs and benefits are summarized in 
Table 3, below, and described in detail in this section. Comments on 
the proportion of sales for different sectors of the organic market 
(i.e. infant formula, baby food, fluid milk, breakfast cereals, and pet 
food) that will be impacted by this action would be pertinent.

                 Table 3--Summary of Costs and Benefits
------------------------------------------------------------------------
             Costs (range)                           Benefits
------------------------------------------------------------------------
$500 million-$4.2 billion..............  Establishes a clear, finite
                                          list of essential and required
                                          vitamins and mineral for use
                                          in organic food and infant
                                          formula.
                                        --------------------------------
                                         Facilitates the use of
                                          essential or required vitamins
                                          and minerals in organic food
                                          and infant formula.
                                        --------------------------------
The upper limit is the upper limit for   Fosters certainty in
 sales of product categories that would   determining whether a specific
 be impacted by this action.              ingredient can be used in an
                                          organic product.
                                        --------------------------------
                                         Facilitates enforcement of
                                          organic product composition
                                          standards.
------------------------------------------------------------------------

Need for the Rule
    The National List within the NOP regulations provides for the use 
of ``Nutrient vitamins and minerals, in accordance with 21 CFR 104.20, 
Nutritional Quality Guidelines For Foods,'' under 7 CFR 205.605(b). The 
reference to 21 CFR 104.20 is to FDA's fortification policy. In 2006, 
the NOP asserted that the scope of the FDA fortification policy 
provided for the use of a broader range of nutrients than those 
explicitly listed in those guidelines. The NOP interpretation affected 
an allowance for ``accessory nutrients,'' permitting the use of 
substances which are Generally Recognized As Safe (GRAS), but are 
neither vitamin or mineral, nor required by regulation. In 2010, the 
NOP consulted with FDA to clarify the parameters of the fortification 
policy and confirmed that the NOP interpretation did not align with the 
intent of the FDA guidelines. The FDA clarified that the fortification 
policy provides for the use of only essential vitamins and minerals 
(under 21 CFR 101.9(c)(8)(iv)) plus potassium and protein (21 CFR 101.9 
(c)(9)), which is a more prescribed set of substances than permitted 
under the NOP interpretation of that policy.\15\
---------------------------------------------------------------------------

    \15\ Correspondence from Office of Nutrition, Labeling and 
Dietary Supplements, Center for Food Safety and Applied Nutrition, 
U.S. Food and Drug Administration to National Organic Program, U.S. 
Department of Agriculture. April 14, 2011. Available at 
www.ams.usda.gov/nop.
---------------------------------------------------------------------------

    The NOP's interpretation facilitated the potential for the use of a 
wide spectrum of substances, having unique properties and functions. It 
incorrectly suggested to organic producers and handlers that a number 
of unspecified substances could qualify for use under the nutrient 
vitamins and minerals exemption and be added to organic products. It 
also suggests that the exemption provides an allowance for an open list 
of substances, potentially encompassing dozens of nutrients, the 
complete inventory of which is difficult for the NOP and consumers to 
discern. As a result, the existing exemption remains vulnerable to 
misinterpretation, which undermines the ability of the certifying 
agents and NOP to make consistent decisions about the use of nutrient 
substances in organic products. It is imperative to eliminate 
uncertainty and enable organic operations to make confident business 
decisions and to demonstrate effective oversight of organic production 
to maintain consumer trust.
    Furthermore, the NOP thought that the fortification policy provided 
for the addition of nutrients to infant formula. The FDA indicated that 
this was inaccurate as the nutrient specifications for infant formula, 
provided at 21 CFR part 107, are separate from the fortification policy 
at 21 CFR 104.20. Absent this reference to 21 CFR part 107, the NOP 
regulations do not correctly provide for the formulation of infant 
formula that would meet FDA requirements. Therefore, this action is 
also necessary to incorporate the correct FDA citation with respect to 
the addition of required vitamins and minerals to organic infant 
formula.
    The NOP and NOSB have provided four opportunities for public 
comment on this issue and the total number of comments submitted 
exceeds two thousand.\16\ Public comment surged in response to the NOSB 
April 2011 meeting notice which announced that the NOSB Handling 
Committee would present a recommendation for nutrient vitamins and 
minerals. The NOSB Handling Committee recommended that the listing be 
renewed as follows: ``Sec.  205.605(b): Nutrient Vitamins and Minerals, 
restricted to materials required or allowed by law for the purpose of 
enrichment, supplementation or fortification of foods including infant 
formula, and materials the use of which is supported by the FDA or the 
Institute of Medicine of the National Academies.'' As described 
earlier, the majority of comments opposed the NOSB Handling Committee's 
proposal. Some expressed the preference for a complete prohibition on 
nutrient additives in organic products, while others advocated for the 
review of each individual nonagricultural substance for inclusion on 
the National List. This proposed rule is responsive to numerous public 
comments advocating for a clearly defined exemption.
---------------------------------------------------------------------------

    \16\ An Advanced Notice of Proposed Rulemaking (ANPR) announcing 
the pending sunset of the nutrient vitamins and minerals listing was 
published in the Federal Register on March 26, 2010 (75 FR 14500) 
and requested comments. Three NOSB meeting notices also provided 
opportunity for public comment on this issue. The notices were 
published in the Federal Register as follows: March 17, 2010 (75 FR 
12723), September 20, 2010 (75 FR 57194), and March 4, 2011 (76 FR 
12013).
---------------------------------------------------------------------------

Regulatory Objective
    The primary purpose of this proposed action is to clarify and 
accurately provide for the parameters of the exemption for the use of 
nutrient vitamins and minerals in organic

[[Page 1988]]

products in accordance with FDA regulatory provisions. The FDA 
fortification policy is referenced in the current listing to establish 
parameters for what nutrient vitamins and minerals may be used in 
organic handling. The proposed rule would correct the regulatory 
references to clearly delineate that only essential vitamins and 
minerals are permitted in organic foods under this exemption. This 
proposed action would correctly identify FDA required vitamins and 
minerals that may be added to organic infant formula. Other synthetic 
substances that are not specifically referenced by the proposed 
exemption would be prohibited from use in organic products unless there 
is an explicit National List exemption for such use.
    This action would clarify for certifying agents, organic 
operations, consumers, and other interested persons which vitamins and 
minerals are permitted for use in organic products. It would also 
ensure that other nutrient substances are subject to the thorough and 
public review that is accorded all substances petitioned for addition 
to the National List.
Alternatives Considered
    Alternatives to this proposed rulemaking that were considered 
include: (1) Renew the existing listing for nutrient vitamins and 
minerals; or (2) in lieu of a rule, issue guidance stating NOP's intent 
to interpret the current listing for nutrient vitamins and minerals as 
proposed in this action.
    The first alternative considered was to renew the listing for 
``Nutrient vitamins and minerals, in accordance with 21 CFR 104.20, 
Nutritional Quality Guidelines For Foods,'' without change would extend 
the National List exemption for the use of nutrient vitamins and 
minerals until the next sunset date of October 21, 2017. The current 
listing contains an inaccurate reference to FDA's fortification policy 
for food, the scope of which the NOP erroneously interpreted to be 
broader than intended by the original NOSB 1995 recommendations on the 
nutrient fortification of foods. This option would leave in place a 
regulatory provision that remains vulnerable to misinterpretation 
regarding what substances are permitted in organic products. Failing to 
take action could perpetuate business decisions that are based on an 
inaccurate reading of the fortification policy resulting in the use of 
various ingredients which are not explicitly provided for on the 
National List. The continued use of synthetic ingredients which do not 
appear on the National List, whether by renewing the current listing or 
grandfathering in the affected substances, is not a plausible option 
because this is inconsistent with the Organic Foods Production Act of 
1990. The statute prohibits the Secretary from allowing synthetics 
substances in the National List other than those proposed by the 
National Organic Standards Board (7 U.S.C. 6517(d)(2)). Only the NOSB 
has the authority to recommend adding a synthetic substance to the 
National List and grandfathering in these substances would bypass the 
NOSB review process which is mandated in order for such substances to 
be used in organic handling. In addition, pursuing this alternative 
runs counter to the prevailing public support, as expressed through 
comments to the Sunset 2012 ANPR and the NOSB meeting notices, for NOP 
action to precisely clarify the permitted nutrient vitamins and 
minerals in organic handling.
    Furthermore, the NOP is now cognizant that the FDA fortification 
policy does not cover infant formula. Infant formula is comprised of 
agricultural products and falls within the scope of NOP certification. 
It has developed into a robust organic product category and recorded a 
2.3 percent growth in sales in 2010.\17\ The NOP believes that it is 
imperative to confirm the eligibility of infant formula for organic 
certification by accurately providing for the use of vitamins and 
minerals to meet FDA requirements for infant formula. Therefore, the 
NOP did not believe this alternative was appropriate.
---------------------------------------------------------------------------

    \17\ Organic Trade Association, 2011. 2011 Organic Industry 
Survey. Brattleboro, VT.
---------------------------------------------------------------------------

    The second alternative considered would result in the issuance of 
guidance, rather than a regulatory change. Upon receiving FDA 
clarification on the fortification policy, the NOP considered conveying 
which nutrient vitamins and minerals would be permitted in organic 
processed food through guidance. However, upon further review, the NOP 
believes that this route would not adequately address the issue of 
correcting the incomplete and inaccurate FDA references in the 
regulatory annotations as well as the resultant overly broad NOP 
interpretations. The NOP believes that correcting the inaccuracies in 
the regulation is preferable and the appropriate course of action to 
bring certainty to the vitamins and mineral area of organic food 
production.
Baseline
    Based on USDA data from the Economic Research Service (ERS), the 
total acreage of certified organic land grew from 1.8 million acres in 
2000 to 4.8 million acres in 2008, of which approximately 2.2 million 
acres was pasture and rangeland.\18\ The number of certified organic 
producers in the U.S. nearly doubled in that time period rising from 
approximately 7,000 in 2000 to nearly 13,000 in 2008.\19\
---------------------------------------------------------------------------

    \18\ U.S. Department of Agriculture, Economic Research Service. 
2008. U.S. Organic Agriculture, 1992-2008, data set, available at 
www.ers.usda.gov/data/organicERS.
    \19\ Ibid.
---------------------------------------------------------------------------

    The increasing production capacity for organic agricultural 
products parallels growth trends in sales of organic products. Since 
implementation of the NOP, the organic industry has experienced 
consecutive years of growth demonstrated by increasing sales to 
consumers. In 2010, U.S. retail sales of organic food and beverages 
totaled $26.7 billion.\20\ The pace of double-digit sales growth that 
persisted from 2002-2008 has dipped, but the 7.7 percent growth 
recorded from 2009-2010, marked an increase from the previous year. The 
top grossing organic food categories in terms of sales for 2010 are 
fruits and vegetables (39.7%), dairy (14.6%) and packaged/prepared 
foods, which includes baby formula and baby food (13.9%). Sales of dry 
breakfast goods, which includes cereals, grew 3.0% in the year 2010, 
exceeding $1 million. Organic frozen prepared foods account for the 
highest sales within the packaged/prepared foods category. According to 
the Organic Trade Association's Organic Industry Survey 2011, the most 
often cited barrier to growth in this category, is rising commodity 
costs.\21\
---------------------------------------------------------------------------

    \20\ Organic Trade Association, 2011.
    \21\ Ibid.
---------------------------------------------------------------------------

    The year-to-year increases in sales of organic foods coincides with 
changes in marketing, as organic products have become increasingly 
available through conventional marketing channels, in addition to 
natural product retailers. In 2006, nearly equal shares of organic 
products were sold in conventional venues and natural product outlets 
and by 2010, the balance shifted to mass-market groceries which sold 54 
percent of organic food.\22\ There is also evidence of a shift in 
consumer purchasing patterns, expanding beyond the traditional 
consumption of organic fruits and vegetables to other organic products, 
such as dairy, beverages, packaged foods, and breads and

[[Page 1989]]

grains.\23\ After fruits and vegetables, the organic food categories 
which experienced the greatest sales growth in 2010 were dairy, 
condiments, snack foods, and breads and grains.\24\
---------------------------------------------------------------------------

    \22\ Dimitri, Carolyn, and Lydia Oberholtzer. Marketing U.S. 
Organic Foods: Recent Trends From Farms to Consumers. Economic 
Information Bulletin No. 58. U.S. Dept. of Agriculture, Economic 
Research Service. September 2009.
    \23\ Ibid.
    \24\ Organic Trade Association, 2011.
---------------------------------------------------------------------------

    This Regulatory Impact Analysis (RIA) focuses on five product 
categories in which the NOP believes the impact of the proposed rule 
will be concentrated: infant formula; baby food; milk; breakfast 
cereal; and pet food. The NOP used the Organic Trade Association's 
April 2011 White Paper on the Fortification of Organic Foods to 
identify several product categories that would likely be impacted by 
regulatory action with respect to the listing for nutrient vitamins and 
minerals.\25\ A fuller description of current fortification in these 
products is provided in the discussion of costs below. Table 4 provides 
an overview of the recent market statistics for these product 
categories.
---------------------------------------------------------------------------

    \25\ Organic Trade Association, 2011. Fortification of Organic 
Foods, OTA Task Force White Paper.

Table 4--2010 Organic Sales and Growth Rates for Select Organic Products
------------------------------------------------------------------------
            Category                   2010 Sales         2010 Growth
------------------------------------------------------------------------
Infant Formula \a\..............  $695 million.......               1.9%
Baby Food \a\...................  296 million........               2.3%
Milk/cream \a\..................  2.14 billion.......              10.2%
Dry Breakfast Goods \a\*........  1 billion..........               3.0%
Pet Food \b\....................  116 million........              18.4%
                                 ---------------------------------------
    Total.......................  4.2 billion........  .................
------------------------------------------------------------------------
\a\ Figures obtained from Organic Trade Association, ``2011 Organic
  Industry Survey''.
\b\ Figures obtained from Sundale Research, 2011. ``State of the
  Industry: Natural and Organic Pet Food in the U.S., 4th Edition'',
  Bayshore, N.Y.
* For the purposes of this proposed action, the NOP used ``dry breakfast
  goods'' as a synonym for breakfast cereal.

Benefits to the Proposed Rule
    The current regulatory provisions present challenges to certifying 
agents and organic operations in complying with and enforcing 
regulations regarding the use of nutrient vitamins and minerals. In 
April 2010, the NOP informed certifying agents of the corrected 
interpretation of the FDA fortification policy and the impact on the 
exemption for nutrient vitamins and minerals.\26\ This proposed 
correction provides certifying agents with a more clear direction for 
future certification decisions concerning vitamins, minerals and other 
substances in organic product formulations. Further, this proposed 
action also would ensure that exemptions for the use of vitamins, 
minerals and other nutrients are subject to NOSB evaluation in 
accordance with the criteria established in 7 U.S.C. 6518(m). Finally, 
the proposed amendment also would correct the regulation with regard to 
infant formula under the NOP. Organic infant formula has been marketed 
since the implementation of the NOP regulations in 2002. The current 
NOP regulations, however, do not specifically provide a correct 
reference for the use of vitamins and minerals required by FDA in 
organic infant formula.
---------------------------------------------------------------------------

    \26\ NOP, 2010, Action Memorandum for the Chairman of the 
National Organic Standards Board, Scope of Nutrient Vitamins and 
Minerals in Organic Food, available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5084068&acct=nosb.
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    This proposed action would facilitate the use of any additional 
vitamins or minerals that the FDA may determine to be required or 
essential for human nutrition. The FDA regulatory citations, 21 CFR 
101.9, 107.100 and 107.10, that would replace the current reference to 
21 CFR 104.20, contain lists of vitamins and minerals for food and 
infant formula. The lists within these sections are updated as 
warranted to incorporate additional nutrients which FDA has designated 
as essential or required. For example, since the implementation of the 
fortification policy in 1980, the FDA has modified the list of 
essential nutrients to include vitamin K, manganese, selenium, 
chromium, molybdenum and chloride. By including the proposed references 
to 21 CFR 101.9, 107.100 and 107.10, any essential or required vitamins 
and minerals which are added to those regulations would also be allowed 
for use in organic food and infant formula. During the sunset review of 
the proposed listing for vitamins and minerals, the NOSB would review 
any updates to the vitamins and minerals listed in those sections.
Costs of Proposed Rule
    This action would impact any certified organic operation which adds 
substances to organic products that are not essential vitamins and 
minerals for human nutrition, as enumerated in 21 CFR 101.9, or 
required vitamins and minerals for infant formula, as enumerated in 21 
CFR 107.100 and 107.10. Based on information provided in the OTA White 
Paper on the Fortification of Organic Foods, the impacts would be 
concentrated within 5 categories of organic products discussed herein 
in which nutrient supplementation has been more prevalent: infant 
formula, baby food, milk, breakfast cereal, and pet food. In aggregate, 
we anticipate that the upper limit for sales of the organic product 
categories affected by this proposed action would be $4.1 billion. We 
emphasize that this is an estimated upper limit that reflects the total 
sales of the 5 categories of organic products. Because AMS believes 
that only a subset of these sales would be impacted by this action, the 
actual costs of mitigation to comply with the regulatory change are 
expected to be significantly lower than the total sales value. However, 
the AMS does not have sufficient data to estimate these costs and is 
therefore seeking public comment to further analyze the costs of the 
final rule. OTA provided a conservative estimate that the economic 
impact of fortified organic product sales is in the range of $500 
million annually. However, it is not possible for AMS to evaluate the 
accuracy of this estimate due to the use of proprietary data and lack 
of information of what assumptions were used to determine this economic 
impact.

[[Page 1990]]

    The following discussion explains the basis for AMS's estimate by 
product category, any underlying assumptions and potential mitigating 
factors.
    Infant Formula. Organic handlers which are not in compliance with 
this proposed rule would be required to reformulate or relabel their 
products or exit the organic infant formula market.\27\ According to 
measurements by the USDA Economic Research Service, 99.5 percent of 
organic infant formula contained DHA/ARA as of the first quarter in 
2009.\28\ The NOP assumes that the percentage of organic infant formula 
containing DHA algal oil and ARA single-cell oil has not fluctuated and 
for the purposes of this analysis, that essentially all organic infant 
formula contains DHA algal oil and ARA single-cell oil. The OTA 
reported that sales of organic infant formula were $689 million in 
2010. Therefore, we anticipate that the entire $689 million organic 
infant formula industry would be impacted by this proposed action.
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    \27\ According to NOP research, it appears that there are 5 
major entities which offer organic infant formula exclusively with 
DHA algal oil and ARA single-cell oil. Three of the five also market 
nonorganic infant formulas; therefore, the impact of this action to 
each entity could be buffered by sustained business related to the 
nonorganic formulas. Data from ERS which shows that organic infant 
formulas have a minimal share, 0.8 percent, of the total infant 
formula market supports the prediction of a more limited impact on 
the entities which offer both organic and nonorganic formulas.
    \28\ ERS determined this number from Neilsen Scantrack data 
which contains weekly sales information from a sample of over 14,000 
U.S. grocery stores.
---------------------------------------------------------------------------

    AMS believes the estimate impact of this proposed action on organic 
infant formula may be inflated for several reasons. At the April 2011 
NOSB meeting, the NOP informed the organic industry that the prior NOP 
interpretation of the listing for nutrient vitamins and minerals was 
incorrect. The NOP indicated its intent to implement the fortification 
policy, referenced in the codified listing as 21 CFR 104.20, in 
accordance with FDA's interpretation of that policy . The NOP also 
advised that other substances could be petitioned for addition to the 
National List. Since that announcement, six petitions have been 
submitted for substances that are added to organic infant formula, but 
are not required by FDA. As of the publication of this proposed action, 
petitions for the following substances have been submitted to the NOP: 
DHA algal oil, ARA single-cell oil, taurine, choline, inositol, 
ascorbyl palmitate, beta-carotene, L-carnitine, lycopene, nucleotides, 
lutein and L-methionine. The NOSB will consider the petitions for DHA 
algal oil and ARA single-cell oil at the November 29-December 2, 2011 
meeting.
    AMS proposes a two year implementation phase before this rule 
becomes effective. AMS believes that the NOP's advance disclosure of 
its intent with respect to nutrient vitamins and minerals, in 
combination with a proposed two year implementation phase, will 
minimize disruption to the organic industry. The length of time is 
calculated to provide time for the NOSB to conclude its recommendations 
on petitions for substances impacted by this rule and to complete any 
rulemaking necessitated by NOSB recommendations to add substances to 
the National List. AMS recognizes that a petition submission does not 
guarantee a favorable outcome for the petitioner, but the process 
provides ample opportunity for stakeholders to inform the NOSB and the 
public of the reasons to support a National List exemption. AMS does 
not have data to more accurately estimate the potential costs of this 
action on the organic infant formula market and seeks public comments 
to refine the estimated impact.
    Baby Food. The OTA 2011 Organic Industry Survey states that sales 
of organic baby food totaled $296 million in 2010. Organic baby food 
represents a small, but growing share of the baby food market. 
According to ERS data, sales of organic baby food accounted for 
approximately 12.2% of the supermarket sales of all baby food in the 
first quarter of 2009.\29\ The NOP has observed a range of organic baby 
food products in various forms, including canned, dry and frozen and 
has observed the addition of DHA algal oil, choline bitartrate and 
unidentified sources of DHA and ARA to a few organic baby food 
products. Within each type, there are organic baby food products which 
would comply with this proposed action with respect to the addition of 
vitamins and minerals.\30\ However, AMS does not have data to determine 
the proportion of baby food which would be affected by this proposed 
action and seeks comments to refine this estimate.
---------------------------------------------------------------------------

    \29\ ERS determined the market share for organic baby food by 
using data from Neilsen Scantrack, which contains weekly sales 
information from a sample of over 14,000 U.S. grocery stores.
    \30\ For the purpose of labeling, the amount/levels of essential 
vitamins and minerals in 21 CFR 101.9(c)(8)(iv) are for 4 years and 
above. Foods that are represented for use for infants (up to 12 
months of age), children 1 to 4 years of age, pregnant or lactating 
women, must use the Recommended Daily Intakes that are specified for 
the intended group.
---------------------------------------------------------------------------

    AMS believes that the two year implementation phase would minimize 
any disruption to the organic baby food industry. During this time, the 
impacted stakeholders have the opportunity to submit petitions to add 
substances to the National List that would be excluded from use in 
organic products. The implementation period also provides affected 
entities with time to consider reformulating products to comply with 
the proposed action.
    Fluid Milk and Dairy Products. The total sales of organic milk and 
cream sales for 2010 was reported to be $2.1 billion. \31\ ERS has 
calculated that 2.8 percent of the universal product codes (UPCs) for 
organic milk are codes for milk products which contain DHA.\32\ 
However, due to variability in the retail price and sales volume for 
different types of organic milk products, the percentage of UPCs cannot 
be extrapolated to the percentage of sales that would be affected by 
this proposed action. AMS does not have data to quantify the percent of 
organic milk sales that are attributed to milk with DHA and ARA. 
However, even assuming that the $2.1 billion in sales could be the 
upper limit cost of this proposed action, AMS believes that this 
significantly over estimates the impact of this proposed rule. As 
indicated by the organic milk UPC data from ERS, the organic fluid milk 
market includes many products which do not contain added DHA. In 
addition, not all organic milk products are available in a version 
containing added DHA. AMS is aware that retail prices for organic milk 
with added DHA are typically higher than prices for organic milk 
without added DHA.\33\ However, we lack numerical data to describe the 
economic impact of DHA in the organic milk market, particularly in 
comparison to other growth drivers such as a narrowing gap between 
organic and nonorganic milk prices.\34\ AMS seeks public comments to

[[Page 1991]]

refine the estimated impact of this proposed action upon organic fluid 
milk and dairy products.
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    \31\ This estimate does not include potential impacts to organic 
yogurt. The NOP believes such impact would be minimal as there 
appears to be very few organic yogurt products on the market which 
contain DHA algal oil. Organic yogurt which contains DHA derived 
from fish oil is available; this is acceptable for use in organic 
production currently and under this proposed action.
    \32\ ERS determined this estimate by utilizing data from the 
Gladson UPC (Universal Product Code) database which contains 160,000 
food UPC codes and detailed nutritional information. The 2.8% 
estimate is based on 2010 data. ERS searched that database for 
organic milk products containing one or more of the 11 nutrients 
specified by the NOP: docosaheaxaenoic acid (DHA), arachidonic acid 
(ARA), taurine, inositol, choline, ascorbyl palmitate, beta-
carotene, carnitine, lycopene, nucleotides, and lutein.
    \33\ NOP analysis of milk prices revealed that organic whole 
milk with added DHA generally ranged from 30 to 80 cents higher than 
prices for organic whole milk.
    \34\ The Organic Trade Association 2011 Organic Industry Survey 
attributes the strong growth of the organic milk/cream category in 
2010, to a narrower price gap between organic and nonorganic milk as 
a result of higher conventional commodity prices.
---------------------------------------------------------------------------

    AMS believes there are additional factors that would mitigate the 
projected $2.1 billion impact on the organic dairy sector. One factor 
is the existence of an alternative form of DHA, derived from fish oil, 
which is acceptable for use in organic milk and dairy products. Section 
205.606 of the National List provides for the use of two components of 
fish oil, specifically, the omega-3 fatty acids, DHA and 
eicosapentaenoic (EPA). This estimated cost to the organic dairy sector 
does not include organic milk which contains DHA from fish oil because 
the addition of those substances would not be prohibited by this 
proposed action. While AMS is aware that DHA algal oil has a unique 
market appeal as a vegetarian source of DHA, there is an allowed source 
of omega-3 fatty acids to enable operations affected by proposed action 
to maintain a stake in the niche market for omega-3 organic milk.
    AMS' estimate assumes that all sales attributed to organic milk 
with DHA could be potentially affected in the organic milk sector. 
However, the NOP believes, but does not have affirmative data that some 
portion of DHA organic milk purchases would transfer to other organic 
milk products without algal DHA, mitigating the potential loss of 
organic milk sales to the organic dairy sector. Further, AMS expects 
that some portion of consumers is chiefly motivated by the perceived 
benefits of organic certification and would keep their purchases within 
the organic dairy sector. Such consumer behavior would decrease the 
estimated sales impact of this proposed action.
    In addition, AMS is proposing a two year implementation period. As 
of the publication of this proposed rule, petitions have been submitted 
to the NOSB for the addition of DHA algal oil and ARA single-cell oil. 
During the implementation period, affected entities will have the 
opportunity to present their public comments to the NOSB regarding DHA 
algal oil and ARA single-cell oil. If the NOSB approves a 
recommendation to add these substances to the National List, the length 
of the implementation period is expected to be adequate to cover the 
necessary rulemaking and minimize disruption to the industry.
    Breakfast Cereal. The sales for organic breakfast cereal totaled 
approximately $1 billion in 2010.\35\ ERS has calculated that 2.8 
percent of the UPCs for organic breakfast cereals are codes for cereals 
which contain a substance that would be prohibited from use in organic 
products as a result of this proposed rule.\36\ AMS lacks data on 
market share of breakfast cereals with any of the identified substances 
(referred to ``added nutrients'' for the remainder of this section). 
While assuming an upper limit of $1 billion for the estimated impact of 
this proposed action on organic breakfast cereal, the agency considers 
that this figure is significantly inflated. As evidenced by the ERS 
data, not all organic breakfast cereals contain an added nutrient(s) 
that would be affected by this proposed action.
---------------------------------------------------------------------------

    \35\ Organic Trade Association, 2011. The 2011 Organic Industry 
Survey reported $1.049 billion in sales of ``dry breakfast goods'' 
for 2010.
    \36\ ERS determined this estimate by utilizing data from the 
Gladson UPC (Universal Product Code) database which contains 160,000 
food UPC codes and detailed nutritional information. The 2.8% 
estimate is based on 2010 data. See footnote 19 for a list of the 
substances included in the search criteria.
---------------------------------------------------------------------------

    AMS' estimate assumes that all sales attributed to organic 
breakfast cereal with added nutrients would potentially be affected in 
the organic breads and grains sector. However, the NOP believes, but 
does not have affirmative data, that some portion of these purchases 
would transfer to other organic breakfast cereals, mitigating any 
potential adverse impact. Further, AMS believes it is accurate to infer 
that some portion of purchases are motivated by perceived benefits of 
the organic certification rather than the nutrients added, which would 
decrease the estimated sales impact.
    In addition, the proposed two year implementation period is 
expected to be sufficient for NOSB consideration of petitions for added 
nutrients received as of publication of this rule and any rulemaking 
necessitated by NOSB recommendations on these petitions. As AMS does 
not have data to more accurately estimate the potential costs of this 
action on the organic breakfast cereal market, the agency is seeking 
public comments to refine the estimated impact.
    Pet Food. AMS estimates that the potential impact of this proposed 
action on the organic pet food industry to be $42 million. According to 
a Sundale Research report, the 2010 sales for organic pet food totaled 
$116 million, 36 percent of which was attributed to sales of cat 
food.\37\ The estimated impact of $42 million is equivalent to the 2010 
sales of organic cat food. AMS anticipates that all organic cat food 
would be impacted by this proposed action because cat food must contain 
the substance taurine. Taurine is an organic acid which is essential 
for healthy heart function and prevention of blindness in cats. The 
amount of taurine must meet the minimal requirement as established for 
cats by the National Research Council's Nutrient Requirements of Cats 
and Dogs (2006).\38\ The National List does not contain a specific 
exemption for the use of taurine, nor does the FDA fortification policy 
provide for the use of this substance because the policy does not 
pertain to pet foods.
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    \37\ Sundale Research, 2011. State of the Industry: Natural and 
Organic Pet Food in the U.S., 4th Edition, Bayshore, N.Y.
    \38\ The FDA considers the nutrients listed in Tables 15-10, 15-
12 and 15-14 to be essential nutrients for cats where a Minimal 
Requirement or Adequate Intake value has been established in order 
for the product to be labeled, ``complete and balanced.''
---------------------------------------------------------------------------

    The $42 million in sales of organic cat food includes sales of cat 
treats. According to the Sundale Research data, sales of cat food 
treats accounted for 12.5 percent of 2010 sales, or $5.25 million. Pet 
treats, however, are exempt from including a nutritional adequacy 
statement and cat treats are not required to include taurine. 
Therefore, AMS expects that some portion of organic cat treats would 
not be affected by this proposed action. AMS does not have data on the 
percent of cat treats that do or do not contain taurine to further 
refine this estimate. Therefore, the estimate is based on an underlying 
assumption that all cat treats contain taurine.\39\ Because AMS does 
not have data to more accurately estimate the potential costs for 
organic pet food, the agency is seeking public comments to refine the 
estimated impact.
---------------------------------------------------------------------------

    \39\ Although taurine is not a required nutrient for dog food, 
some organic dog foods may contain taurine. However, AMS believes 
the amount of organic dog food products affected would be minimal.
---------------------------------------------------------------------------

    AMS intends to address the overall use of nutrient vitamins and 
minerals in pet food through a separate rulemaking that would establish 
standards for organic pet food. A petition to add taurine to the 
National List for use in pet food was submitted to the NOP in September 
2010. AMS believes that the NOSB review of the petition and the 
promulgation of organic pet food regulations will conclude within the 
implementation phase of this proposed action to mitigate disruption to 
the organic pet food industry.
    In summary, AMS expects that potential impacts on sales of organic 
products in the aforementioned categories could be mitigated through 
several factors. The proposed two year implementation period is 
intended to

[[Page 1992]]

provide time for NOSB to consider petitions for substances that are 
affected by this action and for AMS to conclude rulemaking to add 
substances to the National List. The implementation phase would also 
provide affected entities time to explore reformulation or relabeling 
of affected products. AMS is seeking comments on the length of the 
proposed compliance date. Further, AMS believes that if some products 
are discontinued as a result of this proposed rule, some consumers will 
purchase, as an alternative, an organic product within the same 
category rather than a nonorganic product.

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 section 
2115(b) of the OFPA (7 U.S.C. 6514(b)). States are also preempted under 
sections 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 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. 601-624), 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. 301-392), nor 
the authority of the Administrator of EPA under the Federal 
Insecticide, Fungicide and Rodenticide Act (7 U.S.C. 136-137).
    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 impact on a substantial number of small entities.
    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 proposed action on small 
entities. Small entities include producers engaged in crop and animal 
production and handlers that process organic products or develop, 
market and sell organic products. AMS has determined that this proposed 
rule will not have a significant impact on a substantial number of 
small entities.
    AMS notes that several requirements to complete the RFA overlap 
with the Regulatory Impact Analysis (RIA) and the Paperwork Reduction 
Act (PRA). For example, the RFA requires a description of the reasons 
why action by the agency is being considered and an analysis of the 
proposed rule's costs to small entities. The RIA describes the need for 
this proposed rule and provides an analysis of the benefits and costs 
of a proposed rule. Further, the RFA requires a description of the 
projected reporting and recordkeeping requirements of the proposed 
rule. The PRA provides an estimate of the reporting and recordkeeping 
(information collection) requirements of a proposed rule. In order to 
avoid duplication, we combine some analyses as allowed in section 
605(b) of the RFA. The RIA also provides summary information on the 
size of the organic industry, production capacity and sales by category 
of organic products with a focus upon those products likely to be 
affected by this rulemaking. It also provides information on potential 
costs to handlers that have chosen to obtain organic certification. The 
RIA and PRA should be referred to for more detail.
    This proposed rule would affect handlers involved in manufacturing 
and/or marketing certain types of organic processed products including, 
infant formula, baby food, fluid milk, breakfast cereal and pet food. 
Organic handlers engage in the selling, processing and/or packaging of 
agricultural products. Some handlers have processing facilities, while 
others develop formulations and labels and market products, but 
contract with a co-packer for the manufacturing. For the purposes of 
this analysis, AMS considered co-packers and marketing operations to be 
a single handling entity due to the inter-dependent relationship for 
producing organic products. The Small Business Administration (SBA) (13 
CFR 121.201), defines small food manufacturers by the number of 
employees. SBA identifies various subsectors of the food manufacturing 
industry by the North American Industry Classification System 
(Subsector 311--Food Manufacturing). Entities which manufacture the 
organic products listed above, with the exception of breakfast cereal, 
would qualify as a small business if the number of employees does not 
exceed 500. The small business threshold for breakfast cereal 
manufacturing is a maximum of 1,000 employees.\40\
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    \40\ AMS determined that the following North American Industry 
Classification System categories, from among those listed in the SBA 
regulations, are relevant to the manufacturing activity that could 
be affected by this proposed rulemaking: Dry, condensed and 
evaporated dairy product manufacturing (organic infant formula); 
Miscellaneous food manufacturing (organic baby food); Fluid milk 
manufacturing, Breakfast cereal manufacturing, Dog and cat food 
manufacturing.
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    Based on USDA data, the total acreage of certified organic land 
grew from 1.8 million acres in 2000 to 4.8 million acres in 2008, of 
which approximately 2.2 million acres was pasture and

[[Page 1993]]

rangeland.\41\ The number of certified organic producers in the U.S. 
nearly doubled in that time period rising from approximately seven 
thousand in 2000 to nearly 13,000 in 2008.\42\ ERS estimated the number 
of certified handling operations was 3,225 in 2007.\43\
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    \41\ U.S. Department of Agriculture, Economic Research Service. 
2008. U.S. Organic Agriculture, 1992-2008, data set available at 
http://www.ers.usda.gov/data/organicERS.
    \42\ Ibid.
    \43\ U.S. Department of Agriculture, Economic Research Service, 
2009. Data Sets: Procurement and Contracting by Organic Handlers: 
Documentation available at http://www.ers.usda.gov/Data/OrganicHandlers/Documentation.htm.
---------------------------------------------------------------------------

Legal Basis and Objective of Proposal
    In 1990, Congress enacted the Organic Foods Production Act of 1990, 
as amended (OFPA) (7 U.S.C. 6501-6522). The OFPA requires all 
agricultural products labeled as ``organically produced'' to originate 
from farms or handling operations certified by a State or private 
agency that has been accredited by USDA. The OFPA authorizes the 
Secretary of Agriculture to establish a National List of approved and 
prohibited substances that meet criteria enumerated in the Act. The 
exemptions for the use of synthetic substances must be based on 
proposed amendments of the National Organic Standards Board.
    This proposed rule would correct the National List exemption for 
nutrient vitamins and minerals by replacing the reference to FDA's 
fortification policy (21 CFR 104.20) with references to the FDA 
regulatory provisions that clearly convey what substances are permitted 
for fortification of food (21 CFR 101.9). This proposed action would 
also add references for the FDA regulations for the required vitamins 
and minerals for infant formula (21 CFR 107.100 and 107.10) because the 
fortification policy does not address the addition of nutrients to 
infant formula.
Applicability of Proposal
    The population that would be directly impacted by this proposed 
rule is a subset of certified organic handlers of infant formula, baby 
food, milk, breakfast cereal and pet food. While we do not have precise 
data, AMS expects the number of organic handlers that could be affected 
by this proposed action to be substantially less than the entire 
population of organic handlers which ERS estimated to be 3,225 in 2007. 
In general, AMS has ascertained that the use of substances that could 
no longer be added to organic products as a result of this proposed 
action tends to be concentrated among certain national brands. AMS 
believes that few of these handlers would be considered small entities 
under the criteria established by the SBA, as discussed below. AMS is 
seeking comments on the adequacy of the estimated impact of the 
proposed action on small entities.
Costs of Proposed Rule--Direct Costs to Handlers
    Infant Formula. The Organic Trade Association reported that sales 
of organic infant formula were $689 million for the year 2010.\44\ 
According to measurements by ERS, as of the first quarter in 2009, 99.5 
percent of organic infant formula contained added DHA and ARA.\45\ AMS 
believes that approximately five brands of organic infant formula 
produced by two manufacturers dominate the U.S. organic infant formula 
market. Organic infant formula sold under five of these brands contains 
ingredients, such as, DHA algal oil, ARA single-cell oil, taurine and 
inositol, which would not be permitted by this proposed action. AMS is 
confident that two of these entities would not be considered a small 
business under the SBA criteria.
---------------------------------------------------------------------------

    \44\ Organic Trade Association, 2011. 2011 Organic Industry 
Survey. Brattleboro, VT.
    \45\ ERS determined this number from Neilsen Scantrack data 
which contains weekly sales information from a sample of over 14,000 
U.S. grocery stores.
---------------------------------------------------------------------------

    Baby Food. The Organic Trade Association disclosed that sales of 
organic baby food totaled $296 million in 2010.\46\ According to ERS 
data, sales of organic baby food accounted for approximately 12.2 
percent of the supermarket sales of all baby food in the first quarter 
of 2009.\47\ The baby food category includes products in a variety of 
forms and ingredients for different age groups ranging from cereals, 
pureed fruits, vegetables, grains and proteins, snacks and yogurt. 
According to the database of NOP certified operations, the number of 
U.S. operations handling organic baby food is less than 20.
---------------------------------------------------------------------------

    \46\ Organic Trade Association, 2011. 2011 Organic Industry 
Survey.
    \47\ ERS determined the market share for organic baby food by 
using Neilsen Scantrack data, which contains weekly sales 
information from a sample of over 14,000 U.S. grocery stores.
---------------------------------------------------------------------------

    AMS has observed DHA algal oil, choline bitartrate and unidentified 
sources of DHA and ARA as ingredients in a few organic baby food 
products. These ingredients would not be permitted in organic formula 
by this proposed action unless and until there are specific exemptions 
on the National List for these substances. In general, however, 
prevalent use of substances that would be prohibited as a result of 
this proposed action in organic baby food has not been detected. AMS 
believes that approximately three entities, which distribute products 
nationally, would be impacted by this proposed rule. AMS is confident 
that one of these entities would not meet the criteria for a small 
business. Based upon the extent of the distribution of products and the 
marketing channels, AMS is uncertain whether either of the two other 
entities would qualify as a small business. The products that would be 
affected by this proposed rule, however, represent only a portion of 
the organic baby food offerings of these entities. Therefore, AMS 
believes the impact of this rule, if any, on small entities in the 
organic baby food category would be negligible. AMS welcomes comments 
to further inform its determination.
    Fluid Milk. The total sales of organic milk and cream for the year 
2010 were reported to be $2.1 billion.\48\ ERS has calculated that 2.8 
percent of the universal product codes for organic milk are codes for 
milk products which contain DHA.\49\ According to ERS, as of May 2007, 
two suppliers were providing about 75 percent of the nationally branded 
organic milk.\50\ That balance has likely shifted due to the growth in 
private label brands, many of which are supplied by one organic milk 
handler. Based on ERS analysis, AMS believes that three organic dairy 
handlers supply most of the organic milk in the U.S. market (two 
supplying national brands and one supplying various private label 
milk). AMS is aware of other organic dairy handlers which distribute on 
a smaller scale and that the dairy handlers may collect milk from 
hundreds of organic producers.
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    \48\ Organic Trade Association, 2011. 2011 Organic Industry 
Survey. This estimate does not include potential impacts to organic 
yogurt. The NOP believes such impact would be minimal as there 
appears to be very few organic yogurt products on the market which 
contain DHA algal oil or other substances that would not be allowed 
per this proposed action. Organic yogurt which contains DHA or 
omega-3 fatty acids derived from fish oil is available; this is 
acceptable for use in organic production currently and would 
continue to remain compliant under this proposed action.
    \49\ ERS determined this estimate by utilizing data from the 
Gladson UPC (Universal Product Code) database which contains 160,000 
food UPC codes and detailed nutritional information. The 2.8% 
estimate is based on 2010 data. ERS searched that database for 
organic milk products containing one or more of the 11 nutrients 
specified by the NOP: docosaheaxaenoic acid (DHA), arachidonic acid 
(ARA), taurine, inositol, choline, ascorbyl palmitate, beta-
carotene, carnitine, lycopene, nucleotides, and lutein.
    \50\ Dimitri, Carolyn, and Venezia, Kathryn M. Retail and 
Consumer Aspects of the Organic Milk Market/LDP-M-155-01. U.S. 
Department of Agriculture, Economic Research Service, May 2007.
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    One of the national organic milk brands offers several organic milk 
varieties with added DHA algal oil.

[[Page 1994]]

There is at least one other organic milk brand which contains DHA algal 
oil, but which is not distributed on a national scale. Both of these 
entities would be impacted by the proposed action because DHA algal oil 
would not be allowed in organic milk unless and until there is a 
specific exemption on the National List for this substance. AMS 
believes that one of these companies, which is part of a multinational 
corporation, would not qualify as a small business as defined by the 
SBA for fluid milk manufacturing. AMS expects that this action could 
impact some small milk handlers which offer organic milk with DHA algal 
oil. However, the Agency concludes that this proposed action would not 
have a significant impact on these entities as organic milk brands have 
diversified organic dairy offerings and do not produce or market 
organic milk with DHA exclusively. The diversification in the product 
line could help to offset any costs impacts of reformulating or 
discontinuing some products within a brand. Furthermore, there are 
alternative sources of DHA from fish oil, which are allowed as 
ingredients in organic products per section Sec.  205.606 of the 
National List, and would be available to organic handlers that want to 
remain in or enter the DHA/omega-3 organic milk market niche.
    Breakfast cereal. The sales for organic breakfast cereal totaled 
approximately $1 billion in 2010.\51\ ERS has calculated that 2.8 
percent of the universal product codes for organic breakfast cereals 
are codes for cereals which contain a substance that would be 
prohibited from use in organic products as a result of this proposed 
rule.\52\ AMS has not identified which organic cereals, other than 
those marketed for babies, contain substances which would be prohibited 
from use in organic products as a result of this proposed action. The 
projected impacts to organic baby food are described above and in the 
Regulatory Impact Analysis. AMS believes that this proposed rule would 
not have a significant impact on a substantial number of small 
breakfast cereal manufacturers for several reasons. Due to the numerous 
varieties of organic breakfast cereal on the market, the estimated 2.8 
percent of universal product codes which would be impacted by this 
proposed action represents few products. Organic cereal brands 
typically offer a variety of cereals, improving the likelihood that not 
all formulations would be adversely affected by this proposed action. 
AMS welcomes comments to further inform our consideration of the 
impacts of this proposed rule upon the organic breakfast cereal market.
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    \51\ Organic Trade Association, 2011. The 2011 Organic Industry 
Survey reported $1.049 billion in sales of ``dry breakfast goods'' 
for 2010.
    \52\ ERS determined this estimate by utilizing data from the 
Gladson UPC (Universal Product Code) database which contains 160,000 
food UPC codes and detailed nutritional information. The 2.8% 
estimate is based on 2010 data. See footnote 19 for a list of the 
substances included in the search criteria.
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    Pet Food. According to a report by Sundale Research, the 2010 sales 
for organic pet food totaled $116 million, growing approximately 18 
percent over the previous year. AMS believes that this action would 
adversely impact organic cat food, which accounts for 36 percent of the 
organic pet food market.\53\ Organic cat food must contain the 
substance taurine, an organic acid which is essential for healthy heart 
function and prevention of blindness in cats. The amount of taurine 
must meet the minimal requirement as established for cats by the 
National Research Council's Nutrient Requirements of Cats and Dogs 
(2006). The National List does not contain a specific exemption for the 
use of taurine, nor does the FDA fortification policy provide for the 
use of this substance because the policy does not pertain to pet foods.
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    \53\ Sundale Research, 2011. State of the Industry: Natural and 
Organic Pet Food in the U.S., 4th Edition, Bayshore, N.Y.
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    AMS has observed that pet food companies which market organic pet 
foods also offer natural pet food products. AMS is not aware of any pet 
food companies that exclusively manufacture organic pet foods and 
believes that the product and market diversification within individual 
entities to include pet treats, organic dog food and natural pet foods, 
respectively, provides insulation from the impacts of this proposed 
action. Furthermore, AMS intends to address the use of nutrient 
vitamins and minerals in pet food through a separate rulemaking that 
would establish standards for organic pet food. A petition to add 
taurine to the National List for use in pet food was submitted to the 
NOP in September 2010. AMS believes that the NOSB review of any 
petitions and the promulgation of organic pet food regulations will 
conclude within the implementation phase of this proposed action to 
mitigate disruption to the organic pet food industry.
Indirect Costs to Organic Producers
    OTA's April 2011 White Paper on the Fortification of Organic Foods 
includes an estimate of the sales of organic commodities used as 
ingredients in fortified organic products, which could potentially be 
impacted by regulatory action to restrict substances used for 
supplementation in foodstuffs.\54\ OTA calculated the estimated farm 
gate sales as $11 million dollars based on a ratio of 1:4:8, for the 
variables, farm-gate sales, retail sales and total size of the 
industry, respectively. The OTA White Paper also identifies the range 
of commodities which supply impacted organic categories. The organic 
commodity supply stream includes meats and poultry, grains, tree fruit, 
vegetables, nuts, fluid milk and milk powder, and soy.
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    \54\ This is available on the Organic Trade Association Web 
site, http://www.ota.com.
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    Small agricultural producers are defined by the Small Business 
Administration (SBA) (12 CFR 121.201) as those having receipts of less 
than $750,000. The majority of organic ingredient producers whose 
agricultural products are diverted to organic infant formula, baby 
food, milk, breakfast cereal and pet food would likely qualify as small 
agricultural producers. While we do not have precise data, AMS expects 
the number of producers of organic ingredients that could be affected 
by this proposed action to be substantially less than the entire 
population of organic producers which ERS estimated to be nearly 13,000 
in 2008. This proposed rule is not expected to have an impact on a 
substantial number of small agricultural producers. According to ERS, 
the demand for organic products has historically exceeded the supply of 
organic ingredients. In 2004, ERS conducted a survey of organic 
handlers and found that 13% experienced critical shortages for one of 
their organic products and concluded that 38% were importing raw, 
organic materials produced outside the U.S.\55\ That discrepancy 
persists according to the OTA ``2011 Organic Industry Survey'' which 
reported difficulty, ranging from major to occasional, with the supply 
of organic raw materials. This report also indicated that 62 percent of 
companies surveyed in 2010 intended to increase their use of organic 
ingredients over the next three years. Given the projections for 
continued expansion of the organic sector, AMS expects that there will 
be opportunities for producers to divert organic agricultural products 
to other purchasers to buffer the impact of any disruption to the 
manufacture of certain

[[Page 1995]]

processed organic products as a result of this proposed action.
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    \55\ Greene, Catherine, Carolyn Dimitri, Biing-Hwan Lin, William 
McBride, Lydia Oberholtzer, and Travis Smith. Emerging Issues in the 
U.S. Organic Industry. EIB-55. U.S. Dept. of Agriculture, Economic 
Research Service. June 2009.
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    Organic meat and poultry producers that supply the organic pet food 
industry, however, could face more formidable challenges. The organic 
pet food market facilitates carcass utilization for organic meat and 
poultry parts which do not enter human food chain. Poultry producers, 
in particular, would be prone to experience a greater impact because 
chicken comprises most of the protein in organic pet food. AMS does not 
know the number of organic poultry producers that supply the organic 
pet food sector.
Conclusion
    This proposed rule would correct the National List exemption for 
nutrient vitamins and minerals by replacing the reference to FDA's 
fortification policy (21 CFR 104.20) with references to the FDA 
regulatory provisions that clearly convey what substances are permitted 
for fortification of food (21 CFR 101.9). This proposed action would 
also add references for the FDA regulations for the required vitamins 
and minerals for infant formula (21 CFR 107.100 and 107.10) because the 
fortification policy does not address the addition of nutrients to 
infant formula. Overall, this proposed action would narrow the number 
of potential substances for addition to organic foods in comparison of 
NOP's current interpretation of the exemption for nutrient vitamins and 
minerals. This proposed rule would establish a finite list of essential 
and required vitamins and minerals for food and infant formula. 
Sustained consumer demand is essential to the economic stability of 
organic producers and handlers, and this proposed action would bridge 
consumer expectations and the innovation of organic operations.
    The proposed revisions to the exemption for nutrient vitamins and 
minerals could entail costs for certified operations which are 
manufacturing and/or marketing organic products that contain substances 
which fall outside the revised parameters for nutrient vitamins and 
minerals. The costs associated with this proposed rule could include 
reformulating products to remove nonagricultural ingredients that are 
clearly prohibited by the National List and relabeling products to 
reflect formulation changes. The types of substances that would be 
restricted by this proposed action are nutrients which are not added to 
have a functional effect on the product, but for nutrient content and 
may be associated with a nutritional claim. Therefore, the removal of 
these ingredients from product formulations is not expected to 
necessitate procurement of substitute ingredients. Due to the diversity 
of products and ingredients that may be affected by this rule, AMS is 
not attempting to quantify the range of possible of reformulation and 
relabeling to individual operations.
    AMS believes that this proposed rule would facilitate increased 
consumer confidence in organic products. This proposed action would 
clearly delineate the requirements for adding vitamins and minerals to 
organic foods and infant formula, and foster the consistent 
implementation and enforcement of these requirements. Furthermore, this 
proposed action does not preclude the potential for substances excluded 
from use to be considered for future use in organic products, but it 
would require that use be predicated upon the review and recommendation 
of the NOSB. That process will ultimately bolster the certainty of 
organic handlers about the regulatory status of ingredients, deter 
consumer skepticism and improve the competitiveness of the market for 
organic foods.

D. Paperwork Reduction Act

    No additional collection or recordkeeping requirements are imposed 
on the public by this proposed rule. Accordingly, OMB clearance is not 
required by section 350(h) of the Paperwork Reduction Act of 1995, 44 
U.S.C. 3501, Chapter 35, or OMB's implementing regulation at 5 CFR part 
1320.
    AMS is committed to complying with the E-Government Act to promote 
the use of the Internet and other information technologies to provide 
increased opportunities for citizen access to Government information 
and services, and for other purposes.

E. Civil Rights Impact Analysis

    AMS has reviewed this proposed rule in accordance with the 
Department Regulation 4300-4, Civil Rights Impact Analysis (CRIA), to 
address any major civil rights impacts the rule might have on 
minorities, women, and persons with disabilities. After a careful 
review of the rule's intent and provisions, AMS has determined that 
this rule would only impact the organic practices of handlers and that 
this rule has no potential for affecting handlers in protected groups 
differently than the general population of handlers. This rulemaking 
was initiated to clarify a regulatory requirement and enable consistent 
implementation and enforcement.
    Protected individuals have the same opportunity to participate in 
the NOP as non-protected individuals. The NOP regulations prohibit 
discrimination by certifying agents. Specifically, Sec.  205.501(d) of 
the current regulations for accreditation of certifying agents provides 
that ``No private or governmental entity accredited as a certifying 
agent under this subpart shall exclude from participation in or deny 
the benefits of the NOP to any person due to discrimination because of 
race, color, national origin, gender, religion, age, disability, 
political beliefs, sexual orientation, or marital or family status.'' 
Paragraph 205.501(a)(2) requires ``certifying agents to demonstrate the 
ability to fully comply with the requirements for accreditation set 
forth in this subpart'' including the prohibition on discrimination. 
The granting of accreditation to certifying agents under Sec.  205.506 
requires the review of information submitted by the certifying agent 
and an on-site review of the certifying agent's operation. Further, if 
certification is denied, Sec.  205.405(d) requires that the certifying 
agent notify the applicant of their right to file an appeal to the AMS 
Administrator in accordance with Sec.  205.681. These regulations 
provide protections against discrimination, thereby permitting all 
handlers, regardless of race, color, national origin, gender, religion, 
age, disability, political beliefs, sexual orientation, or marital or 
family status, who voluntarily choose to adhere to the proposed rule 
and qualify, to be certified as meeting NOP requirements by an 
accredited certifying agent. This proposed rule in no way changes any 
of these protections against discrimination.

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, is 
proposed to be amended as follows:

PART 205--NATIONAL ORGANIC PROGRAM

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

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

    2. Section 205.605(b) is amended by:
    A. Removing the listing for ``Nutrient vitamins and minerals''.
    B. Adding a listing for ``Vitamins and minerals''.
    The addition reads as follows:

[[Page 1996]]

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 groups(s)).''

* * * * *
    (b) * * *
* * * * *
    Vitamins and minerals. For food--vitamins and minerals identified 
as essential in 21 CFR 101.9. For infant formula--vitamins and minerals 
as required by 21 CFR 107.100 or Sec.  107.10.
* * * * *

    Dated: January 6, 2012.
David R. Shipman,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2012-354 Filed 1-11-12; 8:45 am]
BILLING CODE 3410-02-P