National Organic Program (NOP); Sunset Review (2012) for Nutrient Vitamins and Minerals, 1980-1996 [2012-354]
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Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules
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
Agricultural Marketing Service,
USDA.
ACTION: Proposed rule.
AGENCY:
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: https://
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 2646So., 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
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SUMMARY:
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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 https://
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 https://
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
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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
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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
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.
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.
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
1 NOSB, 1995. Nutrient Minerals Technical
Advisory Panel Review. NOP Web site, Petitioned
Substances Database, ‘‘N’’, available at https://
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: https://www.ams.
usda.gov/AMSv1.0/getfile?dDocName=STELPRDC
5067006&acct=nopgeninfo.
2 NOSB, 1995. Final Minutes of the National
Organic Standards Board Full Board Meeting
Austin, Texas, October 31–November 4, 1995,
available at: https://www.ams.usda.gov/AMSv1.0/
getfile?dDocName=STELPRDC5057496.
3 NOSB, 1995, Final Recommendation Addendum
Number 13, The Use of Nutrient Supplementation
in Organic Foods, available at: https://
www.ams.usda.gov/AMSv1.0/getfile?dDocName=
stelprdc5058973.
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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1981
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 FDAregulated 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
§ 205.602(b) Synthetics allowed, of the
NOP National List (nutrient vitamins
and minerals) * * * Nutrients allowed
under § 205.605(b) are not limited to the
nutrients listed in [21 CFR]
§ 104.20(d)(3), because [21 CFR]
§ 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
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: https://www.umm.edu/altmed/articles/
omega-3-000316.htm.
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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.’’
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 § 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] § 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 § 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 https://
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.
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
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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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
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 https://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 https://www.ams.usda.gov/
AMSv1.0/
getfile?dDocName=STELPRDC5089727&acct=nosb.
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recommended that the listing be
renewed as follows:
§ 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
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
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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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.
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.
11 FDA
Response to NOP—Questions and
Answers Regarding Nutrient Fortification of Foods.
April 14, 2011. Available at https://www.ams.
usda.gov/AMSv1.0/getfile?dDocName=
STELPRDC5090415.
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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
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 https://
www.ams.usda.gov/AMSv1.0/
getfile?dDocName=STELPRDC5091724.
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1983
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 https://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, https://
www.ams.usda.gov/nop.
II. Overview of Proposed Amendments
This proposed rule would amend
§ 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 § 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
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 § 205.605(b) of
the National List. In effect, that
provision permits the addition of
synthetic forms of nutrient vitamins and
13 The Guidelines on Submitting National List
Petitions is available at https://www.ams.usda.gov/
AMSv1.0/getfile?dDocName=STELPRDC
5048809&acct=nopgeninfo.
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tkelley on DSK3SPTVN1PROD with PROPOSALS2
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 § 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
§ 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: https://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
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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 selfdetermined 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
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 § 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
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.
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amend the current listing for nutrient
vitamins and minerals to include this
reference for fortification of foods.
Paragraph (c)(8)(iv) in § 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 § 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
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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 selfdetermination), 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
1985
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
tkelley on DSK3SPTVN1PROD with PROPOSALS2
Proposed reference for vitamins and minerals
Substance
Current reference for
nutrient vitamins and
minerals
per 21 CFR
104.20(d)(3)
Food
Essential per 21 CFR
101.9(c)(8) or
101.9(c)(9)
Infant formula
Required per 21 CFR
107.100 or 107.10
Vitamin A .................................................................................................
Vitamin C .................................................................................................
Calcium ....................................................................................................
Iron ...........................................................................................................
Vitamin D .................................................................................................
Vitamin E .................................................................................................
Vitamin K .................................................................................................
Thiamin ....................................................................................................
Riboflavin .................................................................................................
Niacin .......................................................................................................
Vitamin B6 ...............................................................................................
Folate .......................................................................................................
Vitamin B12 .............................................................................................
Biotin ........................................................................................................
Pantothenic acid ......................................................................................
Choline .....................................................................................................
Inositol ......................................................................................................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
....................................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
....................................
....................................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
....................................
....................................
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.*
Yes.
Yes.*
Yes.*
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Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules
TABLE 1—SUMMARY OF REGULATORY REFERENCES FOR VITAMINS AND MINERALS IN ORGANIC FOOD AND ORGANIC
INFANT FORMULA—Continued
Proposed reference for vitamins and minerals
Substance
Current reference for
nutrient vitamins and
minerals
per 21 CFR
104.20(d)(3)
Food
Essential per 21 CFR
101.9(c)(8) or
101.9(c)(9)
Infant formula
Required per 21 CFR
107.100 or 107.10
Phosphorus ..............................................................................................
Magnesium ..............................................................................................
Zinc ..........................................................................................................
Iodine .......................................................................................................
Copper .....................................................................................................
Sodium .....................................................................................................
Potassium ................................................................................................
Selenium ..................................................................................................
Manganese ..............................................................................................
Chromium ................................................................................................
Molybdenum ............................................................................................
Chloride ....................................................................................................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
....................................
Yes ............................
....................................
....................................
....................................
....................................
....................................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
....................................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes ............................
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
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 ..............................................................................
Arachidonic Acid (ARA) single-cell oil .............................................................................
Taurine (separate petitions for infant formula and pet food) ...........................................
Inositol ..............................................................................................................................
Choline (two separate petitions for infant formula and infant food, and all other foods)
Ascorbyl Palmitate ...........................................................................................................
Beta-carotene * .................................................................................................................
L-carnitine ........................................................................................................................
Lycopene ..........................................................................................................................
Nucleotides ......................................................................................................................
Lutein ...............................................................................................................................
L-Methionine ....................................................................................................................
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Yes.
Submitted to NOP and under revision by petitioner.
Yes.
Yes.
Submitted to NOP and under revision by petitioner.
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.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
III. Related Documents
IV. Statutory and Regulatory Authority
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.
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: https://
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
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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
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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,
1987
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 sales of product categories that
would be impacted by this action.
Fosters certainty in determining whether a specific ingredient can be
used in an organic product.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
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
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
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.
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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
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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:
‘‘§ 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.
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
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).
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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
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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.
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
17 Organic Trade Association, 2011. 2011 Organic
Industry Survey. Brattleboro, VT.
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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
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
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 massmarket 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
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.
20 Organic Trade Association, 2011.
21 Ibid.
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.
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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
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
1989
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.
TABLE 4—2010 ORGANIC SALES AND GROWTH RATES FOR SELECT ORGANIC PRODUCTS
Category
2010 Sales
2010 Growth
Infant Formula a ................................................................................................
Baby Food a ......................................................................................................
Milk/cream a ......................................................................................................
Dry Breakfast Goods a* ....................................................................................
Pet Food b .........................................................................................................
$695 million .....................................................
296 million .......................................................
2.14 billion .......................................................
1 billion ............................................................
116 million .......................................................
1.9%
2.3%
10.2%
3.0%
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.
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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.
This proposed action would facilitate
the use of any additional vitamins or
minerals that the FDA may determine to
23 Ibid.
24 Organic
Trade Association, 2011.
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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
25 Organic Trade Association, 2011. Fortification
of Organic Foods, OTA Task Force White Paper.
26 NOP, 2010, Action Memorandum for the
Chairman of the National Organic Standards Board,
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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.
Scope of Nutrient Vitamins and Minerals in Organic
Food, available at https://www.ams.usda.gov/
AMSv1.0/getfile?dDocName=STELPRDC5084068&
acct=nosb.
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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.
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, betacarotene, L-carnitine, lycopene,
nucleotides, lutein and L-methionine.
The NOSB will consider the petitions
for DHA algal oil and ARA single-cell
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.
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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.
AMS believes that the two year
implementation phase would minimize
any disruption to the organic baby food
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.
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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
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
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refine the estimated impact of this
proposed action upon organic fluid milk
and dairy products.
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 singlecell 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
organic milk/cream category in 2010, to a narrower
price gap between organic and nonorganic milk as
a result of higher conventional commodity prices.
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$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.
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
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.
37 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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1991
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.
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.
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
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.’’
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.
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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
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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
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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 copacker 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
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
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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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
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.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
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
41 U.S. Department of Agriculture, Economic
Research Service. 2008. U.S. Organic Agriculture,
1992–2008, data set available at https://
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 https://www.ers.usda.gov/Data/
OrganicHandlers/Documentation.htm.
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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.
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.
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
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.
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.
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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.
One of the national organic milk
brands offers several organic milk
varieties with added DHA algal oil.
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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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 § 205.606
of the National List, and would be
available to organic handlers that want
to remain in or enter the DHA/omega3 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.
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.
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.
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.
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
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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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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.
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
54 This is available on the Organic Trade
Association Web site, https://www.ota.com.
55 Greene, Catherine, Carolyn Dimitri, BiingHwan 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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processed organic products as a result of
this proposed action.
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
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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
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1995
certifying agents. Specifically,
§ 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 § 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, § 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 § 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:
E:\FR\FM\12JAP2.SGM
12JAP2
1996
Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules
§ 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 § 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
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS–NOP–09–0074;
NOP–09–01PR]
RIN 0581–AC96
National Organic Program (NOP);
Sunset Review (2012)
Agricultural Marketing Service,
USDA.
ACTION: Proposed rule.
AGENCY:
This proposed rule would
address recommendations submitted to
the Secretary of Agriculture (Secretary)
by the National Organic Standards
Board (NOSB) on April 29, 2010,
October 28, 2010, and April 29, 2011.
These recommendations pertain to the
2012 Sunset Review of substances on
the U.S. Department of Agriculture’s
(USDA) National List of Allowed and
Prohibited Substances (National List).
Consistent with the NOSB
recommendations, the proposed rule
would continue, without change, the
exemptions (use) and prohibitions for
multiple listings on the National List for
5 years after their respective sunset
dates. This proposed rule would amend
the exemptions (use) or prohibition for
7 substances and remove the exemption
for 3 substances on the National List.
DATES: Comments must be received by
February 13, 2012.
ADDRESSES: Interested persons may
submit written comments on this
proposed rule using the following
addresses:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
tkelley on DSK3SPTVN1PROD with PROPOSALS2
SUMMARY:
VerDate Mar<15>2010
17:05 Jan 11, 2012
Jkt 226001
• Mail: Toni Strother, Agricultural
Marketing Specialist, National Organic
Program, USDA–AMS–NOP, 1400
Independence Ave. SW., Room 2646–
So., Ag Stop 0268, Washington, DC
20250.
Instructions: All submissions received
must include the docket number AMS–
NOP–09–0074; NOP–09–01, and/or
Regulatory Information Number (RIN)
0581–AC96 for this rulemaking.
Commenters should identify the topic
and section number of this proposed
rule to which the comment refers. You
should clearly indicate your position to
continue, discontinue or further restrict
the allowance of any substances as
identified in this proposed rule and the
reasons for your position. You should
include relevant information and data to
support your position (e.g., scientific,
environmental, manufacturing, industry
impact information, etc.). You should
also supply information on alternative
substances or alternative management
practices, where applicable, that
support a change from the current
exemption for the substance. Only the
supporting material relevant to your
position will be considered. All
comments received will be posted
without change to https://
www.regulations.gov.
Docket: For access to the docket to
read background documents or
comments received, go to https://
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 Ave. 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
PO 00000
Frm 00018
Fmt 4701
Sfmt 4702
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 of Agriculture
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.
In response to the sunset provisions
in the OFPA, the Secretary published an
Advanced Notice of Proposed
Rulemaking (ANPR) in the Federal
Register on March 26, 2010 (75 FR
14500), announcing the review of
exempted and prohibited substances
codified at the National List of the
National Organic Program (NOP)
regulations and set to expire in 2012. A
list of these substances is provided as
Table 1 in the Overview of Proposed
Actions section.1 The ANPR explained
that, unless reviewed and recommended
by the NOSB, a synthetic substance
exempted for use on the National List in
2007 and currently allowed for use in
organic production would no longer be
allowed for use after its respective
sunset date in 2012; a nonsynthetic
substance prohibited from use on the
National List in 2007 and currently
prohibited from use in organic
production would be allowed after its
respective sunset date in 2012; and a
synthetic or nonsynthetic substance
exempted for use on the National List in
2007 and currently allowed for use in
organic handling would be prohibited
after its respective sunset date in 2012.
The ANPR announced the upcoming
review of these substances by the NOSB
and the NOP’s intent to complete the
sunset process based upon
recommendations by the NOSB for all
listings added to the National List in
2007. The ANPR notified the public that
this rulemaking would be completed by
the earliest respective sunset date, June
27, 2012. The ANPR also requested
public comment on the continued use or
prohibition of these substances. The
public comment period lasted 60 days.
The NOP received approximately 100
comments in response to the ANPR.
Comments were received from
consumers, organic crop producers,
academia, accredited certifying agents,
trade associations, retailers and organic
1 Table 1 shows a simplified listing for each
substance; use categories and any restrictive
annotations are not included in this overview.
E:\FR\FM\12JAP2.SGM
12JAP2
]]>Agencies
[Federal Register Volume 77, Number 8 (Thursday, January 12, 2012)]
[Proposed Rules]
[Pages 1980-1996]
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
-----------------------------------------------------------------------
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
[[Page 1980]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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: https://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 https://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 https://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\
---------------------------------------------------------------------------
\1\ NOSB, 1995. Nutrient Minerals Technical Advisory Panel
Review. NOP Web site, Petitioned Substances Database, ``N'',
available at https://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: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5067006&acct=nopgeninfo.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\2\ NOSB, 1995. Final Minutes of the National Organic Standards
Board Full Board Meeting Austin, Texas, October 31-November 4, 1995,
available at: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5057496.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\3\ NOSB, 1995, Final Recommendation Addendum Number 13, The Use
of Nutrient Supplementation in Organic Foods, available at: https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=stelprdc5058973.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.''
---------------------------------------------------------------------------
\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: https://www.umm.edu/altmed/articles/omega-3-000316.htm.
---------------------------------------------------------------------------
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 https://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.
---------------------------------------------------------------------------
\7\ The Sunset 2012 ANPR also pertained to the exemptions for
synthetic substances and prohibitions for nonsynthetic substances
used in crop and livestock production.
---------------------------------------------------------------------------
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:
---------------------------------------------------------------------------
\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 https://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 https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5089727&acct=nosb.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\11\ FDA Response to NOP--Questions and Answers Regarding
Nutrient Fortification of Foods. April 14, 2011. Available at https://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5090415.
---------------------------------------------------------------------------
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 https://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, https://www.ams.usda.gov/nop.
---------------------------------------------------------------------------
\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 https://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 https://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: https://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\
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\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: https://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\
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\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.
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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).
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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
subs
