[Federal Register Volume 77, Number 188 (Thursday, September 27, 2012)]
[Rules and Regulations]
[Pages 59287-59291]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-23748]



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  Federal Register / Vol. 77, No. 188 / Thursday, September 27, 2012 / 
Rules and Regulations  

[[Page 59287]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

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


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

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Interim rule with request for comments.

-----------------------------------------------------------------------

SUMMARY: This interim rule addresses a recommendation submitted to the 
Secretary of Agriculture (Secretary) by the National Organic Standards 
Board (NOSB) on April 29, 2011. This recommendation pertains to the 
2012 Sunset Review for the exemption (use) of nutrient vitamins and 
minerals in organic handling on U.S. Department of Agriculture's (USDA) 
National List of Allowed and Prohibited Substances (National List). On 
January 12, 2012, AMS published a proposed rule on the 2012 Sunset 
Review which proposed to continue the exemption (use) for nutrient 
vitamins and minerals on the National List for 5 years after its 
October 21, 2012 sunset date. The proposed rule also proposed to 
correct an inaccurate cross reference to U.S. Food and Drug 
Administration (FDA) regulations in the listing for vitamins and 
minerals on the National List. AMS continues to review the public 
comments on the proposed rule and assess the extent of impacts on the 
industry that could result from correcting the cross reference to FDA 
regulations. Therefore, due to the impending sunset of the allowance 
for nutrients vitamins and minerals from the National List on October 
21, 2012, and based on the NOSB recommendation, this interim rule 
renews, without change, the exemption (use) for nutrient vitamins and 
minerals on the National List. This interim rule provides for the 
continued use of nutrients vitamins and minerals in organic products 
until the agency completes the January 12, 2012, rulemaking.

DATES: Effective Date: This interim rule becomes effective October 21, 
2012. All comments received by December 26, 2012 will be considered 
prior to the issuance of a final rule.

ADDRESSES: Interested persons may submit written comments on this 
interim 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-10-0083; NOP-10-09IR, and/or Regulatory Information 
Number (RIN) 0581-AD17 for this rulemaking. 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 interim 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 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.
    On March 26, 2010, the National Organic Program (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).\1\ 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 deliberations on the 
status of nutrient vitamins and minerals in

[[Page 59288]]

organic products after the 2012 sunset date.
---------------------------------------------------------------------------

    \1\ The Sunset 2012 ANPR also pertained to the exemptions for 
synthetic substances and prohibitions for nonsynthetic substances 
used in crop and livestock production.
---------------------------------------------------------------------------

    At their April 2011 public meeting, the NOSB approved a 
recommendation to renew the listing for nutrient vitamins and minerals 
after its October 21, 2012 sunset date. Their recommendation stated 
that the listing should be renewed as codified at 7 CFR 205.605(b): 
``Nutrient vitamins and minerals, in accordance with 21 CFR 104.20, 
Nutritional Quality Guidelines for Foods''.\2\ 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.
---------------------------------------------------------------------------

    \2\ NOSB, 2011, Formal Recommendation by the National Organic 
Standards Board (NOSB) to the National Organic Program (NOP), 
Nutrient Vitamins and Minerals Sunset, available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5091724.
---------------------------------------------------------------------------

    During their April 2011 deliberations on the renewal of nutrients 
vitamins and minerals, the NOSB explained that the Food and Drug 
Administration (FDA) had recently provided a response to the NOP 
regarding the reference to 21 CFR 104.20 in the current annotation for 
nutrient vitamins and minerals on the National List.\3\ The reference 
to 21 CFR 104.20 refers to the fortification policy for food under the 
FDA's jurisdiction. The NOP had requested the information from FDA to 
consider whether changes to the annotation were necessary to correct an 
inaccurate cross reference to FDA policy and to clarify what synthetic 
substances are allowed as vitamins and minerals in products labeled as 
``organic'' or ``made with organic (specified ingredients or food 
group(s)).'' The fortification policy at 21 CFR 104.20 provides for the 
rational addition of essential nutrients to food for human consumption. 
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 potassium and its corresponding Daily 
Reference Value (DRV). FDA stated that substances 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.
---------------------------------------------------------------------------

    \3\ FDA Response to NOP--Questions and Answers Regarding 
Nutrient Fortification of Foods. April 14, 2011. Available at http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5090415.
---------------------------------------------------------------------------

    Based on this information, the NOSB signaled its intent to issue 
another recommendation for an annotation change to the listing for 
nutrients vitamins and minerals at their November 2011 public meeting. 
However, since NOP intended to take action to amend the listing through 
a proposed rule, the NOSB opted to remove proposing a recommendation 
for an annotation change on nutrient vitamins and minerals from their 
November 2011 meeting agenda.
    On January 12, 2012, AMS published a proposed rule on the 2012 
Sunset Review for nutrient vitamins and minerals (77 FR 1980). The rule 
proposed to address the April 2011 NOSB recommendation and to revise 
the cross reference to FDA regulations to specify that only vitamins 
and minerals which are declared essential for food in 21 CFR 101.9 and 
vitamins and minerals that are required for infant formula in 21 CFR 
107.10 and 107.100, may be used in organic products. As a result, under 
the proposal, any ingredient not specified by these cross references to 
FDA regulations would be excluded from use in organic products and 
would need to be petitioned to the NOSB for separate exemptions on the 
National List. Examples of affected ingredients which would need 
separate exemptions on the National List include docosahexanoic acid 
(DHA) algal oil, arachidonic acid (ARA) single-cell oil, taurine, 
inositol, choline, ascorbyl palmitate, synthetic beta-carotene, L-
carnitine, lycopene, nucleotides, lutein, and L-methionine. Further, 
AMS would need to conduct separate rulemaking to codify the exemptions 
based on NOSB recommendations for any petitioned substances. A detailed 
discussion of the proposal, including further discussion of the 
examples of ingredients that would be affected and an initial 
assessment of the impacts of correcting the cross references to FDA 
regulations, is available in the proposed rule (77 FR 1980).
    The proposed rule provided a 60 day comment period, which closed on 
March 12, 2012. Comments were specifically requested on: (i) The actual 
economic impacts of the proposed action; (ii) the adequacy of the 
estimated impact of the proposed action on small entities; and (iii) 
the length of the proposed compliance date. AMS received 26 written 
comments in response to the proposed rule. The written comments can be 
retrieved via www.regulations.gov by searching for the document ID 
number: AMS-NOP-10-0083. Persons wanting to visit the USDA South 
Building to view comments in response to the proposed rule are 
requested to make an appointment in advance by calling (202) 720-3252.
    AMS continues to assess the public comments on the proposed rule 
and evaluate the impact of clarifying the cross reference to FDA 
regulations. Given that the current allowance for nutrient vitamins and 
minerals is due to sunset (``expire'') from the National List on 
October 21, 2012, AMS is issuing this interim rule with request for 
comments to provide continuity to the organic industry and avoid 
widespread disruption that would result if the allowance for vitamins 
and minerals were to sunset. For example, if the current allowance for 
vitamins and minerals was to sunset, Vitamins A and D, used to fortify 
fluid milk, and B-vitamins, used in bread and cereal to replace 
vitamins lost during processing, could no longer be added to organic 
products.
    AMS believes that renewing the current listing for nutrient 
vitamins and minerals on the National List is the most appropriate 
action at this time. When AMS published the proposed rule in January 
2012, the agency requested comments on the adequacy of the economic 
analysis that was presented and the two year compliance date that was 
proposed. AMS received limited public comment on the impacts of 
correcting the cross reference to FDA regulations. The NOSB has made 
final recommendations to AMS on four

[[Page 59289]]

petitioned substances, petitions for eight substances remain 
outstanding. A summary of the status of these petitions is provided in 
Table 1.

  Table 1--Status of National List Petitions for Affected Ingredients a
------------------------------------------------------------------------
                                     Petition
          Ingredient            submitted to NOSB   NOSB recommendation
------------------------------------------------------------------------
Docosahexanoic Acid (DHA)       Yes..............  NOSB recommended the
 algal oil \b\.                                     addition to Sec.
                                                    205.605(a): DHA
                                                    algal oil, not
                                                    hexane extracted;
                                                    other ingredients
                                                    that are
                                                    agricultural must be
                                                    organic.
Arachidonic Acid (ARA) single-  Yes..............  NOSB recommended the
 cell oil \b\.                                      addition to Sec.
                                                    205.605(a):
                                                    Arachidonic Acid
                                                    (ARA) from fungal
                                                    oil, not hexane
                                                    extracted; other
                                                    ingredients that are
                                                    agricultural must be
                                                    organic.
Inositol......................  Yes..............  NOSB recommended the
                                                    addition to Sec.
                                                    205.605(b): CAS
                                                    87-89-8
                                                    (myo-inositol) and
                                                    6917-35-7 (non-
                                                    specific isomer) for
                                                    use in infant
                                                    formula and medical
                                                    nutritional enteral
                                                    products labeled
                                                    organic or made with
                                                    organic (specified
                                                    ingredients or food
                                                    group(s)).
Choline (two separate           Yes..............  NOSB recommended the
 petitions for infant formula                       addition to Sec.
 and infant food, and all                           205.605(b): Choline
 other foods).                                      chloride (CAS 67-48-1) and
                                                    Choline bitartrate
                                                    (CAS 87-67-
                                                    2) for use in infant
                                                    formula and medical
                                                    nutritional enteral
                                                    products labeled
                                                    organic or made with
                                                    organic (specified
                                                    ingredients or food
                                                    group(s)).
Ascorbyl Palmitate............  Yes..............  NOSB Handling
                                                    Subcommittee
                                                    proposal posted;
                                                    NOSB Recommendation
                                                    expected at October
                                                    2012 public
                                                    meeting.\c\
Beta-carotene \d\.............  Yes..............  NOSB Handling
                                                    Subcommittee
                                                    proposal posted;
                                                    NOSB Recommendation
                                                    expected at October
                                                    2012 public meeting.
L-carnitine...................  Yes..............  NOSB Handling
                                                    Subcommittee
                                                    proposal posted;
                                                    NOSB Recommendation
                                                    expected at October
                                                    2012 public meeting.
Lycopene......................  Yes..............  NOSB Handling
                                                    Subcommittee
                                                    proposal posted;
                                                    NOSB Recommendation
                                                    expected at October
                                                    2012 public meeting.
Lutein........................  Yes..............  NOSB Handling
                                                    Subcommittee
                                                    proposal posted;
                                                    NOSB Recommendation
                                                    expected at October
                                                    2012 public meeting.
L-Methionine..................  Yes..............  NOSB Handling
                                                    Subcommittee
                                                    proposal posted;
                                                    NOSB Recommendation
                                                    expected at October
                                                    2012 public meeting.
Nucleotides...................  Yes..............  NOSB Handling
                                                    Subcommittee
                                                    proposal posted;
                                                    NOSB Recommendation
                                                    expected at October
                                                    2012 public meeting.
Taurine.......................  Yes..............  NOSB Handling
                                                    Subcommittee
                                                    proposal posted;
                                                    NOSB Recommendation
                                                    expected at October
                                                    2012 public meeting.
Amino Acids for pet food......  Yes..............  NOSB Livestock
                                                    Subcommittee
                                                    proposal posted;
                                                    NOSB Recommendation
                                                    expected at October
                                                    2012 public meeting.
------------------------------------------------------------------------
\a\ Petitions are available on the NOP Web site in the petitioned
  substances database: http://www.ams.usda.gov/NOPNationalList.
\b\ Some of the DHA and ARA used in organic products is derived from
  fish oil, currently provided for in section 205.606 of the National
  List, rather than algal and microbial sources.
\c\ All NOSB subcommittee proposals are available online at http://www.ams.usda.gov/NOSBCommitteeRecommendations. Information for the
  October 15-18, 2012 NOSB public meeting is available online at http://www.ams.usda.gov/NOSBMeetings.
\d\ 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.

    Once the NOSB completes its review and has issued recommendations 
on all petitioned nutrients, the public will be able to more fully 
comment on the implications of correcting the FDA cross reference as 
proposed. For this reason, we are requesting comments through this 
interim rule. After consideration of comments submitted to both the 
proposed rule and this interim rule, AMS intends to issue a final rule 
that will address the proposed correction to the listing for nutrient 
vitamins and minerals on the National List. As previously noted, AMS 
would need to conduct separate rulemaking to codify the exemptions 
based on recommendations by the NOSB for any petitioned substance.
    Therefore, consistent with the April 2011 NOSB recommendation, this 
interim rule continues the allowance for nutrient vitamins and minerals 
at section 205.605(b) as follows: ``Nutrient vitamins and minerals, in 
accordance with 21 CFR 104.20, Nutritional Quality Guidelines for 
Foods.'' This action enables the industry to continue with the status 
quo until additional public comments are received and a final rule is 
published. This action avoids the widespread disruption to the organic 
market that would occur if the allowance for any synthetic vitamins and 
minerals were to sunset (``expire'') from the National List on October 
21, 2012.

II. Statutory and Regulatory Authority

    The OFPA authorizes the Secretary to make amendments to the 
National List based on proposed amendments developed by the NOSB. 
Sections 6518(k)(2) and 6518(n) of OFPA authorize the NOSB to develop 
proposed amendments to the National List for submission to the 
Secretary and establish a petition process by which persons may 
petition the NOSB for the purpose of having substances evaluated for 
inclusion on or deletion from the National List. The National List 
petition process is implemented under section 205.607 of the NOP 
regulations. The current petition process (72 FR 2167, January 18, 
2007) can be accessed through the NOP Web site at http://www.ams.usda.gov.

A. Executive Order 12866

    This action has been determined not significant for purposes of 
Executive Order 12866, and therefore, has not been reviewed by the 
Office of Management and Budget.

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.

[[Page 59290]]

This interim 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 the OFPA 
(7 U.S.C. 6514(b)). States are also preempted by 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 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 the OFPA (7 U.S.C. 6519(f)), this interim 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. 301-399), nor the 
authority of the Administrator of EPA under the Federal Insecticide, 
Fungicide and Rodenticide Act (FIFRA) (7 U.S.C. 136-136(y)).
    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 final 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 of 
the RFA is to fit regulatory actions to the scale of businesses subject 
to such actions in order that small business will not be unduly or 
disproportionately burdened. Section 605 of the RFA allows an agency to 
certify a rule, in lieu of preparing an analysis, if the rulemaking is 
not expected to have a significant economic impact on a substantial 
number of small entities.
    Pursuant to the requirements set forth in the RFA, 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 interim rule on small 
entities. The effect of this rule would be to allow the continued use 
of nutrients vitamins and minerals in organic handling. AMS concludes 
that the economic impact of continuing this allowance for nutrient 
vitamins and minerals in organic handling would avoid market disruption 
and would be beneficial to small agricultural service firms. Therefore, 
AMS certifies that this rule would not have a significant economic 
impact on a substantial number of small entities.
    Small agricultural service firms, which include producers, 
handlers, and accredited certifying agents, have been defined by the 
Small Business Administration (SBA) (13 CFR 121.201) as those having 
annual receipts of less than $7,000,000 and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000.
    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.\4\ The number of certified organic 
producers in the U.S. has more than doubled in that time period rising 
from approximately 7,000 in 2000 to nearly 17,700 by the end of 
2011.\5\ ERS, based upon the list of certified operations maintained by 
the NOP, estimated the number of certified handling operations was 
3,225 in 2007. AMS believes that most of these entities would be 
considered small entities under the criteria established by the SBA.
---------------------------------------------------------------------------

    \4\ U.S. Department of Agriculture, Economic Research Service. 
2008. U.S. Organic Agriculture, 1992-2008, data set, available at 
www.ers.usda.gov/data/organicERS. The number of U.S. organic 
operations at the end of 2011 is from data compiled by the National 
Organic Program, http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5097523.
    \5\ Ibid.
---------------------------------------------------------------------------

    The increasing production capacity for organic agricultural 
products parallels growth trends in sales of organic products. Since 
implementation of the NOP, the organic industry has experienced 
consecutive years of growth demonstrated by increasing sales to 
consumers. In 2011, U.S. retail sales of organic food and beverages 
totaled over $29.2 billion.\6\ The pace of double-digit sales growth 
that persisted from 2002-2008 has dipped, but the 7.7 percent growth 
recorded from 2009-2010, and the 9.4 percent growth recorded from 2010-
2011, marked increases from previous years. The top grossing organic 
food categories in terms of sales for 2011 are fruits and vegetables 
(40.5%), dairy (14.6%) and packaged/prepared foods, which includes baby 
formula and baby food (13.6%). Sales of dry breakfast goods, which 
includes cereals, grew 6.2% in the year 2011, exceeding $1 billion. 
Organic frozen prepared foods account for the highest sales within the 
packaged/prepared foods category. Nutrient vitamins and minerals are 
used to fortify products in the dairy, packaged/prepared foods, and 
breakfast goods product categories.
---------------------------------------------------------------------------

    \6\ Organic Trade Association, 2012. 2012 Organic Industry 
Survey. Brattleboro, VT.
---------------------------------------------------------------------------

    In addition, USDA has 91 accredited certifying agents who provide 
certification services to producers and handlers. A complete list of 
names and addresses of accredited certifying agents may be found on the 
AMS NOP Web site, at http://www.ams.usda.gov/nop. AMS believes that 
most of these accredited certifying agents would be considered small 
entities under the criteria established by the SBA.

D. Paperwork Reduction Act

    No additional collection or recordkeeping requirements are imposed 
on the public by this interim rule. Accordingly, OMB clearance is not 
required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, 
Chapter 35.

E. Executive Order 13175

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

[[Page 59291]]

and direct effects on Tribal governments and will not have significant 
Tribal implications.

F. Effective Date

    This interim rule reflects a recommendation submitted to the 
Secretary by the NOSB for the purpose of fulfilling the requirements of 
7 U.S.C. 6517(e) of the OFPA. Section 7 U.S.C. 6517(e) requires the 
NOSB to review each substance on the National List within 5 years of 
its publication. Pursuant to 5 U.S.C. 553, it is found and determined 
upon good cause that it is impracticable and contrary to the public 
interest to give preliminary notice prior to putting this rule into 
effect in order to ensure the continued use of nutrients vitamins and 
minerals in organic products after October 21, 2012, and avoid 
widespread disruption to the organic market. Accordingly, this rule 
shall be effective on October 21, 2012.

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

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

    Dated: September 21, 2012.
David R. Shipman,
Administrator, Agricultural Marketing Service.
[FR Doc. 2012-23748 Filed 9-26-12; 8:45 am]
BILLING CODE 3410-02-P