1980 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 

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: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Toni Strother, Agricultural 

Marketing Specialist, National Organic 

Program, USDA–AMS–NOP, 1400 

Independence Avenue SW., Room 2646- 

So., Ag Stop 0268, Washington, DC 

20250. 

Instructions: All submissions received 

must include the docket number AMS– 

NOP–10–0083; NOP–10–09PR, and/or 

Regulatory Information Number (RIN) 

0581–AD17 for this rulemaking. 

Comments should: 

• Directly relate to issues or questions 

raised by the proposed rule; 

• Clearly indicate if you are for or 

against the proposed rule or some 

portion of it and your reason for your 

position. Include recommended 

language changes as appropriate; and 

• Be supported by relevant 

information and data to support your 

position (e.g., scientific, environmental, 

manufacturing, industry impact 

information, etc.). Commenters may 

include a copy of articles or other 

references that support their comments. 

Only the supporting material relevant to 

your position will be considered. 

All comments received will be posted 

without change to http:// 

www.regulations.gov. The NOP is 

specifically seeking comments on: 

1. The actual economic impacts of 

this action on the industry, including 

any expected mitigation factors that the 

industry may use to comply with the 

proposed action. We are most interested 

in refining the upper limit estimates 

referenced in the Regulatory Impact 

Analysis to specify the actual costs and 

benefits of this proposal. This would 

include any comments on the 

proportion of sales for different sectors 

of the organic market (i.e. infant 

formula, baby food, fluid milk, breakfast 

cereals, and pet food) that will be 

impacted by this action; 

2. The adequacy of the estimated 

impact of the proposed action on small 

entities; and 

3. The length of the proposed 

compliance date. 

Please submit comments related to 

these topics using the numbering 

scheme indicated above. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov. Comments 

submitted in response to this proposed 

rule will also be available for viewing in 

person at USDA–AMS, National Organic 

Program, 1400 Independence Avenue 

SW., Room 2646-South Building, 

Washington, DC, from 9 a.m. to 12 noon 

and from 1 p.m. to 4 p.m., Monday 

through Friday (except official Federal 

holidays). Persons wanting to visit the 

USDA South Building to view 

comments received in response to this 

proposed rule are requested to make an 

appointment in advance by calling (202) 

720–3252. 

FOR FURTHER INFORMATION CONTACT: 

Melissa Bailey, Ph.D., Director, 

Standards Division, Telephone: (202) 

720–3252; Fax: (202) 205–7808. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Organic Foods Production Act of 

1990 (OFPA), (7 U.S.C. 6501–6522), 

authorizes the establishment of the 

National List. The National List 

identifies synthetic substances that are 

exempted (allowed) in organic 

production and nonsynthetic substances 

that are prohibited in organic crop and 

livestock production. The National List 

also identifies nonagricultural 

nonsynthetic, nonagricultural synthetic 

and nonorganic agricultural substances 

that may be used in organic handling. 

The exemptions and prohibitions 

granted under the OFPA are required to 

be reviewed every 5 years by the 

National Organic Standards Board 

(NOSB). The Secretary has authority 

under the OFPA to renew such 

exemptions and prohibitions. If the 

substances are not reviewed by the 

NOSB within 5 years of their inclusion 

on the National List and addressed by 

the Secretary, then their authorized use 

or prohibition expires under OFPA’s 

sunset provision. 

The exemption for the use of nutrient 

vitamins and minerals in ‘‘organic’’ and 

‘‘made with organic (specified 

ingredients or food group(s))’’ processed 

products is scheduled to expire on 

October 21, 2012. The NOP is taking 

this action to implement the NOSB 

recommendation to renew the 

allowance for nutrient vitamins and 

minerals through October 21, 2017. The 

NOP has also determined that, within 

the current listing for nutrient vitamins 

and minerals, the cross reference to the 

FDA’s fortification policy for food at 21 

CFR 104.20 was not accurate and that a 

correction to the current listing is 

necessary. This action would clarify 

what substances are covered under this 

exemption, consistent with the intent of 

the current listing as codified by the 

NOP final rule (65 FR 80548). This 

correction would facilitate compliance 

for organic operations, provide 

certifying agents greater certainty in 

assessing compliance and enable 

consumers to discern what substances 

may be used in organic foods. 

The potential impact of this action, 

including potential costs that could be 

incurred, and the alternatives 

considered are presented as part of the 

Executive Order 12866 section of this 

proposed rule. Upon issuance of a final 

rule on this action, the NOP intends to 

provide a compliance date of two years 

from the effective date of the amended 

listing. Prohibitions on the use of 

ingredients affected by this action 

would not be enforced until the 

compliance date. This timeline is 

intended to allow time for the NOSB’s 

review of petitions for substances not 

within the scope of the current listing or 

amended listing and provides the NOP 

with an opportunity to initiate 

rulemaking if the Board recommends 

that such substances be added to the 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 1981 

1NOSB, 1995. Nutrient Minerals Technical 

Advisory Panel Review. NOP Web site, Petitioned 

Substances Database, ‘‘N’’, available at http:// 

www.ams.usda.gov/AMSv1.0/getfile?dDocName

=STELPRDC5067005&acct=nopgeninfo NOSB, 

1995. Nutrient Vitamins Technical Advisory Panel 

Review. NOP Web site, Petitioned Substances 

Database, ‘‘N’’, available at: http://www.ams.

usda.gov/AMSv1.0/getfile?dDocName=STELPRDC

5067006&acct=nopgeninfo. 

2NOSB, 1995. Final Minutes of the National 

Organic Standards Board Full Board Meeting 

Austin, Texas, October 31–November 4, 1995, 

available at: http://www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=STELPRDC5057496. 

3NOSB, 1995, Final Recommendation Addendum 

Number 13, The Use of Nutrient Supplementation 

in Organic Foods, available at: http:// 

www.ams.usda.gov/AMSv1.0/getfile?dDocName=

stelprdc5058973. 

4The 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.’’ 

5NOSB Comments to Proposed Rule 7 CFR part 

205 (Docket TMD–00–02–PR); submitted June 12, 

2000. 

6 DHA and ARA are omega-3 and omega-6 fatty 

acids, respectively, which are naturally present in 

certain foods. Dietary sources of DHA include: cold 

water fatty fish, meats, and eggs. Dietary sources of 

ARA include: meat, poultry and eggs. Humans can 

convert the omega-3 fatty acid alpha-linolenic acid 

(ALA) to DHA and the omega-6 fatty acid linoleic 

acid (LA) to ARA. Natural sources of LA and ALA 

include: vegetable oils, nuts, seeds and some 

vegetables. Reference: University of Maryland 

Medical Center, Omega-3 Fatty Acids. Available 

online at: http://www.umm.edu/altmed/articles/ 

omega-3-000316.htm. 

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

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 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
1982 Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 

7The Sunset 2012 ANPR also pertained to the 

exemptions for synthetic substances and 

prohibitions for nonsynthetic substances used in 

crop and livestock production. 

8NOP, 2010, Action Memorandum for the 

Chairman of the National Organic Standards Board, 

Scope of Nutrient Vitamins and Minerals in Organic 

Food, available at http://www.ams.usda.gov/ 

AMSv1.0/ 

getfile?dDocName=STELPRDC5084068&acct=nosb. 

9NOSB, 2011, Handling Committee Sunset 2012 

Proposed Recommendation Nutrient Vitamins and 

Minerals, available at http://www.ams.usda.gov/ 

AMSv1.0/ 

getfile?dDocName=STELPRDC5089727&acct=nosb. 

10Prior 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. 

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 http:// 

www.regulations.gov by searching for 

the document ID number: AMS–NOP– 

09–0074. The NOP provided the NOSB 

with these public comments to consider 

in their future deliberations on the 

status of nutrient vitamins and minerals 

in organic products after the 2012 

sunset date. 

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: 

§ 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 


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11FDA Response to NOP—Questions and 

Answers Regarding Nutrient Fortification of Foods. 

April 14, 2011. Available at http://www.ams.

usda.gov/AMSv1.0/getfile?dDocName=

STELPRDC5090415. 

12NOSB, 2011, Formal Recommendation by the 

National Organic Standards Board (NOSB) to the 

National Organic Program (NOP), Nutrient Vitamins 

and Minerals Sunset, available at http:// 

www.ams.usda.gov/AMSv1.0/ 

getfile?dDocName=STELPRDC5091724. 

13The Guidelines on Submitting National List 

Petitions is available at http://www.ams.usda.gov/ 

AMSv1.0/getfile?dDocName=STELPRDC

5048809&acct=nopgeninfo. 

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. 

At the April 2011 NOSB meeting, the 

NOP suggested that the NOSB amend 

the annotation for nutrient vitamins and 

minerals to cite the regulatory 

references, 21 CFR 101.9, 21 CFR 107.10 

and 21 CFR 107.100, which identify 

essential and approved vitamins, 

minerals and other nutrients for infant 

formula and fortification of food. The 

NOP suggested that an annotation 

change would correct an inaccurate 

cross reference to FDA fortification 

policy for food at 21 CFR 104.20. The 

NOP further explained that this 

annotation change would expand the 

allowance for certain nutrients by 

providing for the continued use of 

essential nutrients in organic infant 

formula; the use of essential nutrients in 

infant formula is not covered under the 

existing FDA reference in the NOP 

regulations. The NOP also stated that 

the listing for nutrient vitamins and 

minerals should encompass a clear, 

discernible list of permitted substances. 

The proposed change would convey the 

intent of the codified listing by 

coherently and accurately stating which 

synthetic nutrient substances may be 

added to organic food and organic infant 

formula. 

At the conclusion of the April 2011 

meeting, the NOSB approved a 

recommendation to renew the listing for 

nutrient vitamins and minerals as 

presently codified without 

amendment.12 The Board signaled its 

intent to propose an annotation change 

to the nutrient vitamins and minerals 

listing at its November 2011 meeting, 

after considering the information 

provided by FDA and the numerous 

public comments addressing this issue. 

However, since NOP is taking action to 

amend the listing through this proposed 

rule, the NOSB has opted to remove 

proposing a recommendation for an 

annotation change on nutrient vitamins 

and minerals from their November 2011 

meeting agenda. In addition to the 

ANPR for Sunset 2012 published on 

March 26, 2010, the NOSB received 

additional public comment concerning 

the pending sunset of this listing in 

response to three Federal Register 

notices announcing meetings of the 

NOSB and its planned deliberations on 

recommendations involving Sunset 

2012 substances. The notices were 

published in the Federal Register as 

follows: March 17, 2010 (75 FR 12723), 

September 20, 2010 (75 FR 57194), and 

March 4, 2011 (76 FR 12013). The NOSB 

received further written and oral 

testimony concerning nutrient vitamins 

and minerals at all three of these public 

business meetings which occurred in 

Woodland, CA on April 26–29, 2010, in 

Madison, WI on October 25–28, 2010, 

and in Seattle, WA on April 26–29, 

2011. The written comments can be 

retrieved via http://www.regulations.gov 

by searching for the document ID 

numbers: AMS–NOP–10–0021 (May 

2010 meeting); AMS–NOP–10–0068 

(October 2010 meeting); and AMS– 

NOP–11–05 (April 2011 meeting). The 

oral comments were recorded in the 

meeting transcripts available on the 

NOP Web site, http:// 

www.ams.usda.gov/nop. 

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 


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14Section 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. 

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: http://www.fda.gov/ 

Food/FoodIngredientsPackaging/ 

GenerallyRecognizedasSafeGRAS/ 

GRASListings/default.htm. 

Fortification of Foods 

To correct the previous interpretation 

and provide firm guidance to the 

organic industry, the NOP sought 

clarification from FDA regarding the 

scope of nutrients, vitamins and 

minerals permitted by the fortification 

policy for addition to foods. The FDA 

informed the NOP that the fortification 

policy covers the nutrients identified in 

(i) 21 CFR 104.20(d)(3), (ii) an 

additional 6 nutrients that have been 

determined essential listed in 21 CFR 

101.9(c)(8)(iv), and (iii) nutrients as 

required by other FDA regulations, 

which include those pertaining to a 

common or usual name (21 CFR part 

102), standard of identity (21 CFR parts 

130–169), or nutritional quality 

guideline (21 CFR 104.47). This 

contrasts with current practices in 

certain sectors of the organic industry 

which have added nutrients to types of 

organic products, such as infant formula 

or pet food, which are not covered 

under the fortification policy. Added 

ingredients which are confirmed or 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 

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 

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

Substance 

Current reference for 

nutrient vitamins and 

minerals 

per 21 CFR 

104.20(d)(3) 

Proposed reference for vitamins and minerals 

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 ................................................................................................. 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.* 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
1986 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 

Substance 

Current reference for 

nutrient vitamins and 

minerals 

per 21 CFR 

104.20(d)(3) 

Proposed reference for vitamins and minerals 

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 .............................................................................................. 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 formula and pet food) ........................................... Yes. 

Inositol .............................................................................................................................. Yes. 

Choline (two separate petitions for infant formula and infant food, and all other foods) Yes. 

Ascorbyl Palmitate ........................................................................................................... Yes. 

Beta-carotene * ................................................................................................................. Yes. 

L-carnitine ........................................................................................................................ Submitted to NOP and under revision by petitioner. 

Lycopene .......................................................................................................................... Yes. 

Nucleotides ...................................................................................................................... Yes. 

Lutein ............................................................................................................................... Submitted to NOP and under revision by petitioner. 

L-Methionine .................................................................................................................... Yes. 

* The beta-carotene petition is for the synthetic form. Beta-carotene extract color is currently listed in section 205.606 as a nonorganically produced agricultural ingredient allowed in products labeled ‘‘organic’’ when an organic version is not commercially available. 

III. Related Documents 

Three notices were published 

announcing meetings of the NOSB and 

its planned deliberations on 

recommendations involving Sunset 

2012 substances including nutrient 

vitamins and minerals. The notices were 

published in the Federal Register as 

follows: (1) March 17, 2010 (75 FR 

12723); (2) September 20, 2010 (75 FR 

57194); and (3) March 4, 2011 (76 FR 

12013). 

On March 26, 2010, the NOP 

published an Advance Notice of 

Proposed Rulemaking (75 FR 14500) to 

make the public aware that the 

allowance for synthetic nutrient 

vitamins and minerals, among other 

substances, will expire for use in 

organic handling, if not reviewed by the 

NOSB and renewed by the Secretary. 

IV. Statutory and Regulatory Authority 

The OFPA, as amended [7 U.S.C. 

6501–6522], authorizes the Secretary to 

make amendments to the National List 

based on proposed amendments 

developed by the NOSB. Section 

6518(k) and 6518(n) of OFPA authorize 

the NOSB to develop proposed 

amendments to the National List for 

submission to the Secretary and 

establish a petition process by which 

persons may petition the NOSB for the 

purpose of having a substances 

evaluated for inclusion on or deletion 

from the National List. The current 

petition process (72 FR 2167, January 

18, 2007) can be accessed through the 

NOP Web site at: http:// 

www.ams.usda.gov/nop. The Sunset 

Provision in section 6517(e) of the 

OFPA provides that no exemption or 

prohibition on the National List will 

remain valid after 5 years unless the 

exemption or prohibition has been 

reviewed and the Secretary renews the 

listing. 

A. Executive Order 12866 and Executive 

Order 13563 

Executive Orders 13563 and 12866 

direct agencies to assess all costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. This rule 

has been designated an ‘‘economically 

significant regulatory action’’ under 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
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15Correspondence 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. 

16An 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). 

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 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. 

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 

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: 

‘‘§ 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 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
1988 Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 

17Organic Trade Association, 2011. 2011 Organic 

Industry Survey. Brattleboro, VT. 

18U.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. 

20Organic 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. 

products in accordance with FDA 

regulatory provisions. The FDA 

fortification policy is referenced in the 

current listing to establish parameters 

for what nutrient vitamins and minerals 

may be used in organic handling. The 

proposed rule would correct the 

regulatory references to clearly delineate 

that only essential vitamins and 

minerals are permitted in organic foods 

under this exemption. This proposed 

action would correctly identify FDA 

required vitamins and minerals that 

may be added to organic infant formula. 

Other synthetic substances that are not 

specifically referenced by the proposed 

exemption would be prohibited from 

use in organic products unless there is 

an explicit National List exemption for 

such use. 

This action would clarify for 

certifying agents, organic operations, 

consumers, and other interested persons 

which vitamins and minerals are 

permitted for use in organic products. It 

would also ensure that other nutrient 

substances are subject to the thorough 

and public review that is accorded all 

substances petitioned for addition to the 

National List. 

Alternatives Considered 

Alternatives to this proposed 

rulemaking that were considered 

include: (1) Renew the existing listing 

for nutrient vitamins and minerals; or 

(2) in lieu of a rule, issue guidance 

stating NOP’s intent to interpret the 

current listing for nutrient vitamins and 

minerals as proposed in this action. 

The first alternative considered was to 

renew the listing for ‘‘Nutrient vitamins 

and minerals, in accordance with 21 

CFR 104.20, Nutritional Quality 

Guidelines For Foods,’’ without change 

would extend the National List 

exemption for the use of nutrient 

vitamins and minerals until the next 

sunset date of October 21, 2017. The 

current listing contains an inaccurate 

reference to FDA’s fortification policy 

for food, the scope of which the NOP 

erroneously interpreted to be broader 

than intended by the original NOSB 

1995 recommendations on the nutrient 

fortification of foods. This option would 

leave in place a regulatory provision 

that remains vulnerable to 

misinterpretation regarding what 

substances are permitted in organic 

products. Failing to take action could 

perpetuate business decisions that are 

based on an inaccurate reading of the 

fortification policy resulting in the use 

of various ingredients which are not 

explicitly provided for on the National 

List. The continued use of synthetic 

ingredients which do not appear on the 

National List, whether by renewing the 

current listing or grandfathering in the 

affected substances, is not a plausible 

option because this is inconsistent with 

the Organic Foods Production Act of 

1990. The statute prohibits the Secretary 

from allowing synthetics substances in 

the National List other than those 

proposed by the National Organic 

Standards Board (7 U.S.C. 6517(d)(2)). 

Only the NOSB has the authority to 

recommend adding a synthetic 

substance to the National List and 

grandfathering in these substances 

would bypass the NOSB review process 

which is mandated in order for such 

substances to be used in organic 

handling. In addition, pursuing this 

alternative runs counter to the 

prevailing public support, as expressed 

through comments to the Sunset 2012 

ANPR and the NOSB meeting notices, 

for NOP action to precisely clarify the 

permitted nutrient vitamins and 

minerals in organic handling. 

Furthermore, the NOP is now 

cognizant that the FDA fortification 

policy does not cover infant formula. 

Infant formula is comprised of 

agricultural products and falls within 

the scope of NOP certification. It has 

developed into a robust organic product 

category and recorded a 2.3 percent 

growth in sales in 2010.17 The NOP 

believes that it is imperative to confirm 

the eligibility of infant formula for 

organic certification by accurately 

providing for the use of vitamins and 

minerals to meet FDA requirements for 

infant formula. Therefore, the NOP did 

not believe this alternative was 

appropriate. 

The second alternative considered 

would result in the issuance of 

guidance, rather than a regulatory 

change. Upon receiving FDA 

clarification on the fortification policy, 

the NOP considered conveying which 

nutrient vitamins and minerals would 

be permitted in organic processed food 

through guidance. However, upon 

further review, the NOP believes that 

this route would not adequately address 

the issue of correcting the incomplete 

and inaccurate FDA references in the 

regulatory annotations as well as the 

resultant overly broad NOP 

interpretations. The NOP believes that 

correcting the inaccuracies in the 

regulation is preferable and the 

appropriate course of action to bring 

certainty to the vitamins and mineral 

area of organic food production. 

Baseline 

Based on USDA data from the 

Economic Research Service (ERS), the 

total acreage of certified organic land 

grew from 1.8 million acres in 2000 to 

4.8 million acres in 2008, of which 

approximately 2.2 million acres was 

pasture and rangeland.18 The number of 

certified organic producers in the U.S. 

nearly doubled in that time period 

rising from approximately 7,000 in 2000 

to nearly 13,000 in 2008.19

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 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
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23 Ibid. 

24Organic Trade Association, 2011. 

25Organic Trade Association, 2011. Fortification 

of Organic Foods, OTA Task Force White Paper. 26NOP, 2010, Action Memorandum for the 

Chairman of the National Organic Standards Board, 

Scope of Nutrient Vitamins and Minerals in Organic 

Food, available at http://www.ams.usda.gov/

AMSv1.0/getfile?dDocName=STELPRDC5084068&

acct=nosb. 

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 

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 ................................................................................................ $695 million ..................................................... 1.9% 

Baby Food a ...................................................................................................... 296 million ....................................................... 2.3% 

Milk/cream a ...................................................................................................... 2.14 billion ....................................................... 10.2% 

Dry Breakfast Goods a* .................................................................................... 1 billion ............................................................ 3.0% 

Pet Food b ......................................................................................................... 116 million ....................................................... 18.4% 

Total .......................................................................................................... 4.2 billion ......................................................... ..............................

aFigures obtained from Organic Trade Association, ‘‘2011 Organic Industry Survey’’. 

bFigures obtained from Sundale Research, 2011. ‘‘State of the Industry: Natural and Organic Pet Food in the U.S., 4th Edition’’, Bayshore, 

N.Y. 

* For the purposes of this proposed action, the NOP used ‘‘dry breakfast goods’’ as a synonym for breakfast cereal. 

Benefits to the Proposed Rule 

The current regulatory provisions 

present challenges to certifying agents 

and organic operations in complying 

with and enforcing regulations 

regarding the use of nutrient vitamins 

and minerals. In April 2010, the NOP 

informed certifying agents of the 

corrected interpretation of the FDA 

fortification policy and the impact on 

the exemption for nutrient vitamins and 

minerals.26 This proposed correction 

provides certifying agents with a more 

clear direction for future certification 

decisions concerning vitamins, minerals 

and other substances in organic product 

formulations. Further, this proposed 

action also would ensure that 

exemptions for the use of vitamins, 

minerals and other nutrients are subject 

to NOSB evaluation in accordance with 

the criteria established in 7 U.S.C. 

6518(m). Finally, the proposed 

amendment also would correct the 

regulation with regard to infant formula 

under the NOP. Organic infant formula 

has been marketed since the 

implementation of the NOP regulations 

in 2002. The current NOP regulations, 

however, do not specifically provide a 

correct reference for the use of vitamins 

and minerals required by FDA in 

organic infant formula. 

This proposed action would facilitate 

the use of any additional vitamins or 

minerals that the FDA may determine to 

be required or essential for human 

nutrition. The FDA regulatory citations, 

21 CFR 101.9, 107.100 and 107.10, that 

would replace the current reference to 

21 CFR 104.20, contain lists of vitamins 

and minerals for food and infant 

formula. The lists within these sections 

are updated as warranted to incorporate 

additional nutrients which FDA has 

designated as essential or required. For 

example, since the implementation of 

the fortification policy in 1980, the FDA 

has modified the list of essential 

nutrients to include vitamin K, 

manganese, selenium, chromium, 

molybdenum and chloride. By 

including the proposed references to 21 

CFR 101.9, 107.100 and 107.10, any 

essential or required vitamins and 

minerals which are added to those 

regulations would also be allowed for 

use in organic food and infant formula. 

During the sunset review of the 

proposed listing for vitamins and 

minerals, the NOSB would review any 

updates to the vitamins and minerals 

listed in those sections. 

Costs of Proposed Rule 

This action would impact any 

certified organic operation which adds 

substances to organic products that are 

not essential vitamins and minerals for 

human nutrition, as enumerated in 21 

CFR 101.9, or required vitamins and 

minerals for infant formula, as 

enumerated in 21 CFR 107.100 and 

107.10. Based on information provided 

in the OTA White Paper on the 

Fortification of Organic Foods, the 

impacts would be concentrated within 5 

categories of organic products discussed 

herein in which nutrient 

supplementation has been more 

prevalent: infant formula, baby food, 

milk, breakfast cereal, and pet food. In 

aggregate, we anticipate that the upper 

limit for sales of the organic product 

categories affected by this proposed 

action would be $4.1 billion. We 

emphasize that this is an estimated 

upper limit that reflects the total sales 

of the 5 categories of organic products. 

Because AMS believes that only a subset 

of these sales would be impacted by this 

action, the actual costs of mitigation to 

comply with the regulatory change are 

expected to be significantly lower than 

the total sales value. However, the AMS 

does not have sufficient data to estimate 

these costs and is therefore seeking 

public comment to further analyze the 

costs of the final rule. OTA provided a 

conservative estimate that the economic 

impact of fortified organic product sales 

is in the range of $500 million annually. 

However, it is not possible for AMS to 

evaluate the accuracy of this estimate 

due to the use of proprietary data and 

lack of information of what assumptions 

were used to determine this economic 

impact. 


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27According 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. 

28ERS determined this number from Neilsen 

Scantrack data which contains weekly sales 

information from a sample of over 14,000 U.S. 

grocery stores. 

29ERS 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. 

30For 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. 

31This 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. 

32ERS 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. 

33NOP 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. 

34The Organic Trade Association 2011 Organic 

Industry Survey attributes the strong growth of the 

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 

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 

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 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
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organic milk/cream category in 2010, to a narrower 

price gap between organic and nonorganic milk as 

a result of higher conventional commodity prices. 

35Organic Trade Association, 2011. The 2011 

Organic Industry Survey reported $1.049 billion in 

sales of ‘‘dry breakfast goods’’ for 2010. 

36ERS 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. 

37Sundale Research, 2011. State of the Industry: 

Natural and Organic Pet Food in the U.S., 4th 

Edition, Bayshore, N.Y. 

38The 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.’’ 

39Although 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. 

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 

$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 

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 


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40AMS 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. 

provide time for NOSB to consider 

petitions for substances that are affected 

by this action and for AMS to conclude 

rulemaking to add substances to the 

National List. The implementation 

phase would also provide affected 

entities time to explore reformulation or 

relabeling of affected products. AMS is 

seeking comments on the length of the 

proposed compliance date. Further, 

AMS believes that if some products are 

discontinued as a result of this proposed 

rule, some consumers will purchase, as 

an alternative, an organic product 

within the same category rather than a 

nonorganic product. 

B. Executive Order 12988 

Executive Order 12988 instructs each 

executive agency to adhere to certain 

requirements in the development of new 

and revised regulations in order to avoid 

unduly burdening the court system. 

This proposed rule is not intended to 

have a retroactive effect. 

States and local jurisdictions are 

preempted under the OFPA from 

creating programs of accreditation for 

private persons or State officials who 

want to become certifying agents of 

organic farms or handling operations. A 

governing State official would have to 

apply to USDA to be accredited as a 

certifying agent, as described in section 

2115(b) of the OFPA (7 U.S.C. 6514(b)). 

States are also preempted under 

sections 2104 through 2108 of the OFPA 

(7 U.S.C. 6503 through 6507) from 

creating certification programs to certify 

organic farms or handling operations 

unless the State programs have been 

submitted to, and approved by, the 

Secretary as meeting the requirements of 

the OFPA. 

Pursuant to section 2108(b)(2) of the 

OFPA (7 U.S.C. 6507(b)(2)), a State 

organic certification program may 

contain additional requirements for the 

production and handling of organically 

produced agricultural products that are 

produced in the State and for the 

certification of organic farm and 

handling operations located within the 

State under certain circumstances. Such 

additional requirements must: (a) 

Further the purposes of the OFPA, (b) 

not be inconsistent with the OFPA, (c) 

not be discriminatory toward 

agricultural commodities organically 

produced in other States, and (d) not be 

effective until approved by the 

Secretary. 

Pursuant to section 2120(f) of the 

OFPA (7 U.S.C. 6519(f)), this proposed 

rule would not alter the authority of the 

Secretary under the Federal Meat 

Inspection Act (21 U.S.C. 601–624), the 

Poultry Products Inspection Act (21 

U.S.C. 451–471), or the Egg Products 

Inspection Act (21 U.S.C. 1031–1056), 

concerning meat, poultry, and egg 

products, nor any of the authorities of 

the Secretary of Health and Human 

Services under the Federal Food, Drug 

and Cosmetic Act (21 U.S.C. 301–392), 

nor the authority of the Administrator of 

EPA under the Federal Insecticide, 

Fungicide and Rodenticide Act (7 U.S.C. 

136–137). 

Section 2121 of the OFPA (7 U.S.C. 

6520) provides for the Secretary to 

establish an expedited administrative 

appeals procedure under which persons 

may appeal an action of the Secretary, 

the applicable governing State official, 

or a certifying agent under this title that 

adversely affects such person or is 

inconsistent with the organic 

certification program established under 

this title. The OFPA also provides that 

the U.S. District Court for the district in 

which a person is located has 

jurisdiction to review the Secretary’s 

decision. 

C. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA) 

(5 U.S.C. 601–612) requires agencies to 

consider the economic impact of each 

rule on small entities and evaluate 

alternatives that would accomplish the 

objectives of the rule without unduly 

burdening small entities or erecting 

barriers that would restrict their ability 

to compete in the market. The purpose 

is to fit regulatory actions to the scale of 

businesses subject to the action. Section 

605 of the RFA allows an agency to 

certify a rule, in lieu of preparing an 

analysis if the rulemaking is not 

expected to have a significant impact on 

a substantial number of small entities. 

Pursuant to the requirements set forth 

in the RFA, AMS performed an 

economic impact analysis on small 

entities in the final rule published in the 

Federal Register on December 21, 2000 

(65 FR 80548). AMS has also considered 

the economic impact of this proposed 

action on small entities. Small entities 

include producers engaged in crop and 

animal production and handlers that 

process organic products or develop, 

market and sell organic products. AMS 

has determined that this proposed rule 

will not have a significant impact on a 

substantial number of small entities. 

AMS notes that several requirements 

to complete the RFA overlap with the 

Regulatory Impact Analysis (RIA) and 

the Paperwork Reduction Act (PRA). For 

example, the RFA requires a description 

of the reasons why action by the agency 

is being considered and an analysis of 

the proposed rule’s costs to small 

entities. The RIA describes the need for 

this proposed rule and provides an 

analysis of the benefits and costs of a 

proposed rule. Further, the RFA 

requires a description of the projected 

reporting and recordkeeping 

requirements of the proposed rule. The 

PRA provides an estimate of the 

reporting and recordkeeping 

(information collection) requirements of 

a proposed rule. In order to avoid 

duplication, we combine some analyses 

as allowed in section 605(b) of the RFA. 

The RIA also provides summary 

information on the size of the organic 

industry, production capacity and sales 

by category of organic products with a 

focus upon those products likely to be 

affected by this rulemaking. It also 

provides information on potential costs 

to handlers that have chosen to obtain 

organic certification. The RIA and PRA 

should be referred to for more detail. 

This proposed rule would affect 

handlers involved in manufacturing 

and/or marketing certain types of 

organic processed products including, 

infant formula, baby food, fluid milk, 

breakfast cereal and pet food. Organic 

handlers engage in the selling, 

processing and/or packaging of 

agricultural products. Some handlers 

have processing facilities, while others 

develop formulations and labels and 

market products, but contract with a 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 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
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41U.S. Department of Agriculture, Economic 

Research Service. 2008. U.S. Organic Agriculture, 

1992–2008, data set available at http:// 

www.ers.usda.gov/data/organicERS. 42 Ibid. 43U.S. Department of Agriculture, Economic 

Research Service, 2009. Data Sets: Procurement and 

Contracting by Organic Handlers: Documentation 

available at http://www.ers.usda.gov/Data/ 

OrganicHandlers/Documentation.htm. 

44Organic Trade Association, 2011. 2011 Organic 

Industry Survey. Brattleboro, VT. 

45ERS determined this number from Neilsen 

Scantrack data which contains weekly sales 

information from a sample of over 14,000 U.S. 

grocery stores. 

46Organic Trade Association, 2011. 2011 Organic 

Industry Survey. 

47ERS 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. 

48Organic 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. 

49ERS 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. 

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. 

Applicability of Proposal 

The population that would be directly 

impacted by this proposed rule is a 

subset of certified organic handlers of 

infant formula, baby food, milk, 

breakfast cereal and pet food. While we 

do not have precise data, AMS expects 

the number of organic handlers that 

could be affected by this proposed 

action to be substantially less than the 

entire population of organic handlers 

which ERS estimated to be 3,225 in 

2007. In general, AMS has ascertained 

that the use of substances that could no 

longer be added to organic products as 

a result of this proposed action tends to 

be concentrated among certain national 

brands. AMS believes that few of these 

handlers would be considered small 

entities under the criteria established by 

the SBA, as discussed below. AMS is 

seeking comments on the adequacy of 

the estimated impact of the proposed 

action on small entities. 

Costs of Proposed Rule—Direct Costs to 

Handlers 

Infant Formula. The Organic Trade 

Association reported that sales of 

organic infant formula were $689 

million for the year 2010.44 According 

to measurements by ERS, as of the first 

quarter in 2009, 99.5 percent of organic 

infant formula contained added DHA 

and ARA.45 AMS believes that 

approximately five brands of organic 

infant formula produced by two 

manufacturers dominate the U.S. 

organic infant formula market. Organic 

infant formula sold under five of these 

brands contains ingredients, such as, 

DHA algal oil, ARA single-cell oil, 

taurine and inositol, which would not 

be permitted by this proposed action. 

AMS is confident that two of these 

entities would not be considered a small 

business under the SBA criteria. 

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 

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. 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
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51Organic Trade Association, 2011. The 2011 

Organic Industry Survey reported $1.049 billion in 

sales of ‘‘dry breakfast goods’’ for 2010. 

52ERS 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. 

53Sundale Research, 2011. State of the Industry: 

Natural and Organic Pet Food in the U.S., 4th 

Edition, Bayshore, N.Y. 

54This is available on the Organic Trade 

Association Web site, http://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. 

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. 

Indirect Costs to Organic Producers 

OTA’s April 2011 White Paper on the 

Fortification of Organic Foods includes 

an estimate of the sales of organic 

commodities used as ingredients in 

fortified organic products, which could 

potentially be impacted by regulatory 

action to restrict substances used for 

supplementation in foodstuffs.54 OTA 

calculated the estimated farm gate sales 

as $11 million dollars based on a ratio 

of 1:4:8, for the variables, farm-gate 

sales, retail sales and total size of the 

industry, respectively. The OTA White 

Paper also identifies the range of 

commodities which supply impacted 

organic categories. The organic 

commodity supply stream includes 

meats and poultry, grains, tree fruit, 

vegetables, nuts, fluid milk and milk 

powder, and soy. 

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 


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Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 1995 

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 

is not expected to necessitate 

procurement of substitute ingredients. 

Due to the diversity of products and 

ingredients that may be affected by this 

rule, AMS is not attempting to quantify 

the range of possible of reformulation 

and relabeling to individual operations. 

AMS believes that this proposed rule 

would facilitate increased consumer 

confidence in organic products. This 

proposed action would clearly delineate 

the requirements for adding vitamins 

and minerals to organic foods and infant 

formula, and foster the consistent 

implementation and enforcement of 

these requirements. Furthermore, this 

proposed action does not preclude the 

potential for substances excluded from 

use to be considered for future use in 

organic products, but it would require 

that use be predicated upon the review 

and recommendation of the NOSB. That 

process will ultimately bolster the 

certainty of organic handlers about the 

regulatory status of ingredients, deter 

consumer skepticism and improve the 

competitiveness of the market for 

organic foods. 

D. Paperwork Reduction Act 

No additional collection or 

recordkeeping requirements are 

imposed on the public by this proposed 

rule. Accordingly, OMB clearance is not 

required by section 350(h) of the 

Paperwork Reduction Act of 1995, 44 

U.S.C. 3501, Chapter 35, or OMB’s 

implementing regulation at 5 CFR part 

1320. 

AMS is committed to complying with 

the E-Government Act to promote the 

use of the Internet and other 

information technologies to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

E. Civil Rights Impact Analysis 

AMS has reviewed this proposed rule 

in accordance with the Department 

Regulation 4300–4, Civil Rights Impact 

Analysis (CRIA), to address any major 

civil rights impacts the rule might have 

on minorities, women, and persons with 

disabilities. After a careful review of the 

rule’s intent and provisions, AMS has 

determined that this rule would only 

impact the organic practices of handlers 

and that this rule has no potential for 

affecting handlers in protected groups 

differently than the general population 

of handlers. This rulemaking was 

initiated to clarify a regulatory 

requirement and enable consistent 

implementation and enforcement. 

Protected individuals have the same 

opportunity to participate in the NOP as 

non-protected individuals. The NOP 

regulations prohibit discrimination by 

certifying agents. Specifically, 

§ 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: 


tkelley on DSK3SPTVN1PROD with PROPOSALS2
1996 Federal Register / Vol. 77, No. 8 / Thursday, January 12, 2012 / Proposed Rules 

1Table 1 shows a simplified listing for each 

substance; use categories and any restrictive 

annotations are not included in this overview. 

§ 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) 

AGENCY: Agricultural Marketing Service, 

USDA. 

ACTION: Proposed rule. 

SUMMARY: 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: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• 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 http:// 

www.regulations.gov. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.regulations.gov. Comments 

submitted in response to this proposed 

rule will also be available for viewing in 

person at USDA–AMS, National Organic 

Program, 1400 Independence 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 

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 


tkelley on DSK3SPTVN1PROD with PROPOSALS2