[Federal Register Volume 80, Number 146 (Thursday, July 30, 2015)]
[Proposed Rules]
[Pages 45449-45452]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-18699]


 ========================================================================
 Proposed Rules
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains notices to the public of 
 the proposed issuance of rules and regulations. The purpose of these 
 notices is to give interested persons an opportunity to participate in 
 the rule making prior to the adoption of the final rules.
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  Federal Register / Vol. 80, No. 146 / Thursday, July 30, 2015 / 
Proposed Rules  

[[Page 45449]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-15-0015; NOP-15-07]
RIN 0581-AD39


National Organic Program (NOP); Sunset 2015 Amendments to the 
National List

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would address recommendations submitted to 
the Secretary of Agriculture (Secretary) by the National Organic 
Standards Board (NOSB) following their October 2014 meeting. These 
recommendations pertain to the 2015 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 
recommendations from the NOSB, this proposed rule would remove two non-
organic agricultural substances from the National List for use in 
organic handling, fortified cooking wines--marsala wine and sherry 
wine. This proposed rule would also remove two listings for synthetic 
substances allowed for use in organic crop production on the National 
List, streptomycin and tetracycline, as their use exemptions expired on 
October 21, 2014.

DATES: Comments must be received by August 31, 2015.

ADDRESSES: Interested persons may comment on the proposed rule using 
the following procedures:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Robert Pooler, Standards Division, National Organic 
Program, USDA-AMS-NOP, 1400 Independence Ave. SW., Room 2642-So., Ag 
Stop 0268, Washington, DC 20250-0268.
    Instructions: All submissions received must include the docket 
number AMS-NOP-15-0015; NOP-15-07, and/or Regulatory Information Number 
(RIN) XXXX-XXXX for this rulemaking. You should clearly indicate the 
topic and section number of this proposed rule to which your comment 
refers. You should clearly indicate whether you support the action 
being proposed for the substances in this proposed rule. You should 
clearly indicate the reason(s) for your position. You should also 
supply information on alternative management practices, where 
applicable, that support alternatives to the proposed action. You 
should also offer any recommended language change(s) that would be 
appropriate to your position. Please include relevant information and 
data to support your position (e.g. scientific, environmental, 
manufacturing, industry, impact information, etc.). Only relevant 
material supporting your position should be submitted. All comments 
received and any relevant background documents will be posted without 
change to http://www.regulations.gov.
    Document: For access to the document and 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, 
Room 2642-South Building, 1400 Independence Ave. SW., 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: Robert Pooler, Standards Division, 
Telephone: (202) 720-3252; Fax: (202) 205-7808.

SUPPLEMENTARY INFORMATION:

I. Background

    The National Organic Program (NOP) is authorized by the Organic 
Foods Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501-6522). 
The USDA Agricultural Marketing Service (AMS) administers the NOP. 
Final regulations implementing the NOP, also referred to as the USDA 
organic regulations, were published December 21, 2000 (65 FR 80548), 
and became effective on October 21, 2002. Through these regulations, 
the AMS oversees national standards for the production, handling, and 
labeling of organically produced agricultural products. Since becoming 
fully effective, the USDA organic regulations have been frequently 
amended, mostly for changes to the National List in 7 CFR 205.601-
205.606.
    This National List identifies the synthetic substances that may be 
used and the nonsynthetic substances that may not be used in organic 
production. The National List also identifies synthetic, nonsynthetic 
nonagricultural, and nonorganic agricultural substances that may be 
used in organic handling. The OFPA and the USDA organic regulations, as 
indicated in Sec.  205.105, specifically prohibit the use of any 
synthetic substance in organic production and handling unless the 
synthetic substance is on the National List. Section 205.105 also 
requires that any nonorganic agricultural substance and any 
nonsynthetic nonagricultural substance used in organic handling appear 
on the National List.
    As stipulated by the OFPA, recommendations to propose amendment of 
the National List are developed by the 15 member NOSB, organized under 
the Federal Advisory Committee Act (5 U.S.C. App. 2 et seq.) to assist 
in the evaluation of substances to be used or not used in organic 
production and handling, and to advise the Secretary on the USDA 
organic regulations. The OFPA also requires a sunset review of all 
substances included on the National List within five years of their 
addition to or renewal on the list. If a listed substance is not 
reviewed by the NOSB and renewed by the USDA within the five year 
period, its allowance or prohibition on the National List is no longer 
in effect. Under the authority of the OFPA, the Secretary can amend the 
National List through rulemaking based upon proposed amendments 
recommended by the NOSB.
    The NOSB's recommendations to continue existing exemptions and 
prohibitions are based on consideration of public comments and 
applicable supporting evidence that express a continued need for the 
use or prohibition of the substance(s) as required by the OFPA.

[[Page 45450]]

    Concerning OFPA criteria used to make recommendations regarding the 
discontinuation of an authorized exempted synthetic substance (7 U.S.C. 
6517(c)(1)), the NOSB's decision is based on consideration of public 
comments and applicable supporting evidence that demonstrates the 
substance is: (a) Harmful to human health or the environment; (b) no 
longer necessary for organic production due to the availability of 
alternative wholly nonsynthetic substitute products or practices; or 
(c) inconsistent with organic farming and handling practices.
    In accordance with the sunset review process published in the 
Federal Register on September 16, 2013 (78 FR 61154), this proposed 
rule would amend the National List to reflect two recommendations 
submitted to the Secretary by the NOSB on October 30, 2014, to amend 
the National List to remove two substances, marsala wine and sherry 
wine, allowed as ingredients in or on processed products labeled as 
``organic.'' This proposed rule would also remove listings of two 
substances, streptomycin and tetracycline, since their National List 
exemptions expired on October 21, 2014. The exemptions of each 
substance appearing on the National List for use in organic production 
and handling are evaluated by the NOSB using the evaluation criteria 
specified on the OFPA (7 U.S.C. 6517-6518).

II. Overview of Proposed Amendments

Nonrenewals

    After considering public comments and supporting documents, the 
NOSB determined that two substance exemptions on Sec.  205.606 of the 
National List are no longer necessary for organic handling. AMS has 
reviewed and accepts the NOSB recommendations for removal. Based upon 
these NOSB recommendations, this action proposes to amend the National 
List to remove the exemptions as indicated for marsala wine and sherry 
wine.

Marsala Wine

    The USDA organic regulations currently include an exemption on the 
National List for fortified cooking wines as an ingredient for use in 
organic processed products at Sec.  205.606(g) as follows: Fortified 
cooking wines, (1) Marsala. In 2007, marsala wine was petitioned for 
addition to Sec.  205.606 because it was considered a key flavor 
ingredient that was not commercially available in organic form and 
quantity. As required by the OFPA, the exemption for marsala wine was 
considered during the NOSB's 2015 sunset review. Two notices of the 
public meetings with request for comments were published in Federal 
Register on March 10, 2014 (79 FR 13272) and on September 8, 2014 (79 
FR 53162) to notify the public that the marsala wine exemption 
discussed in this proposed rule would expire on December 14, 2015, if 
not reviewed by the NOSB and renewed by the Secretary. During their 
sunset review deliberation, the NOSB considered written comments 
received prior to and during the public meetings on all substance 
exemptions included in the 2015 sunset review. These written comments 
can be viewed at http://www.regulations.gov by searching for the 
document ID numbers: AMS-NOP-14-0006 (March 2014 public meeting) and 
AMS-NOP-14-0063 (October 2014 public meeting). The NOSB also considered 
oral comments received during these public meetings which are included 
in the meeting transcripts available on the NOP Web site at http://www.ams.usda.gov/nop. As indicated on the National List and Petitioned 
Substance database on the NOP Web site, there is no technical report or 
technical advisory panel report on marsala wine. The NOSB did not 
request a new technical report for marsala wine for the 2015 sunset 
review.
    The NOSB received no public comments supporting the continued need 
for the use of non-organic marsala wine in organic processed products. 
In addition, the NOSB considered evidence that only a few operations 
use marsala wine as an ingredient in organic processed products. Based 
upon the lack of public comments requesting the continued use of 
marsala wine and supportive documents, the NOSB determined that the 
exemption for marsala wine on Sec.  205.606 is no longer necessary or 
essential for organic processed products. Subsequently, the NOSB 
recommended removal of marsala wine from the National List.
    AMS accepts the NOSB's recommendation on removing marsala wine from 
the National List. This proposed rule would amend Sec.  205.606 by 
removing the substance exemption for marsala wine. This amendment would 
be effective on marsala wine's current sunset date, December 14, 2015.

Sherry Wine

    The USDA organic regulations currently include an exemption on the 
National List for fortified cooking wine, sherry wine, as an ingredient 
for use in organic processed products at Sec.  205.606(g) as follows: 
Fortified cooking wines, (2) Sherry. In 2007, sherry wine was 
petitioned for addition to Sec.  205.606 because it was considered a 
key flavor ingredient that was not commercially available in organic 
form or quantity. As required by the OFPA, the exemption for sherry 
wine was considered during the NOSB's 2015 sunset review. Two notices 
of the public meetings with request for comments were published in 
Federal Register on March 10, 2014 (79 FR 13272) and on September 8, 
2014 (79 FR 53162) to notify the public that the sherry wine listing 
discussed in this proposed rule would expire on December 14, 2015, if 
not reviewed by the NOSB and renewed by the Secretary. During their 
sunset review deliberation, the NOSB considered written comments 
received prior to and during the public meetings on all substance 
exemptions included in the 2015 sunset review. These written comments 
can be viewed at http://www.regulations.gov by searching for the 
document ID numbers: AMS-NOP-14-0006 (March 2014 meeting) and AMS-NOP-
14-0063 (October 2014 meeting). The NOSB also considered oral comments 
received during these public meetings which are included in the meeting 
transcripts available on the NOP Web site at http://www.ams.usda.gov/nop. As indicated on the National List and Petitioned Substance 
database on the NOP Web site, there is no technical report or technical 
advisory panel report on sherry wine. The NOSB did not request new 
technical report for sherry wine for the 2015 sunset review.
    The NOSB received no public comments supporting the continued need 
for the use of non-organic sherry wine in organic processed products. 
In addition, the NOSB considered evidence that only a few operations 
use sherry wine as an ingredient in organic processed products. Based 
upon the lack of public comments requesting the continued use of sherry 
wine and supportive documents, the NOSB determined that the exemption 
for sherry wine on Sec.  205.606 is no longer necessary or essential 
for organic processed products. Subsequently, the NOSB recommended 
removal of sherry wine from the National List.
    AMS accepts the NOSB's recommendation on removing sherry wine from 
the National List. This proposed rule would amend Sec.  205.606 by 
removing the substance exemption for sherry wine. This amendment would 
be effective on sherry wine's current sunset date, December 14, 2015.
    This proposed rule would further amend Sec.  205.606 by 
redesignating paragraphs (h) through (z) as (g) through (y), 
respectively.

[[Page 45451]]

Expired Listings

Streptomycin
    This proposed rule would amend Sec.  206.601 of the National List 
by removing the expired exemption for ``Streptomycin, for fire blight 
control in apples and pears only until October 21, 2014.'' Streptomycin 
was considered by the NOSB at their October 31-November 4, 1995, 
meeting. At this 1995 meeting, the NOSB recommended adding streptomycin 
as a plant disease control to the National List and also indicated that 
the exemption listing should be reviewed in two years by the NOSB. The 
NOSB recommendation was accepted by the Secretary and streptomycin was 
included, as a plant disease control, in the initial final rule 
establishing the NOP that was published on December 21, 2000 (65 FR 
80548). Subsequently, as recommended by the NOSB, the listing for 
streptomycin was amended on June 27, 2012 (77 FR 33290) to add an 
expiration date to the streptomycin annotation: Streptomycin, for fire 
blight control in apples and pears only until October 21, 2014. This 
proposed rule would remove the listing for streptomycin that expired on 
October 21, 2014 from Sec.  205.601. Removal of this exempted substance 
from the National List has no new regulatory effect.
Tetracycline
    This proposed rule would amend Sec.  206.601 of the National List 
by removing the expired exemption for ``Tetracycline, for fire blight 
control in apples and pears only until October 21, 2014.'' Tetracycline 
was considered by the NOSB at their October 31-November 4, 1995, 
meeting. At this 1995 meeting, the NOSB recommended adding tetracycline 
as a plant disease control to the National List and also indicated that 
the exemption listing should be reviewed in two years by the NOSB. The 
NOSB recommendation was accepted by the Secretary and tetracycline was 
included, as a plant disease control, in the initial final rule 
establishing the NOP that was published on December 21, 2000 (65 FR 
80548). Subsequently, as recommended by the NOSB, the listing for 
tetracycline was amended on June 27, 2012 (77 FR 33290) to add an 
expiration date to the tetracycline annotation: Tetracycline, for fire 
blight control in apples and pears only until October 21, 2014. This 
proposed rule would remove the listing for tetracycline from section 
205.601 that expired on October 21, 2014. Removal of this exempted 
substance from the National List has no new regulatory effect.

III. Related Documents

    Two notices of public meeting with request for comments were 
published in Federal Register on March 10, 2014 (79 FR 13272) and on 
September 8, 2014 (79 FR 53162) to notify the public that the 2015 
sunset review listings discussed in this proposed rule would expire on 
December 14, 2015, if not reviewed by the NOSB and renewed by the 
Secretary. The listing for both streptomycin and tetracycline was added 
to the National List by the final rule (65 FR 80548) published in the 
Federal Register on December 21, 2000. Subsequently, an expiration date 
of October 21, 2014 was added to the streptomycin and tetracycline 
annotations on June 27, 2012 (77 FR 33290).

IV. Statutory and Regulatory Authority

    OFPA, as amended (7 U.S.C. 6501-6522), authorizes the Secretary to 
make amendments to the National List based on proposed recommendations 
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 Sec.  
205.607 of the USDA organic regulations. The current petition process 
was published on January 18, 2007 (72 FR 2167) and can be accessed 
through the NOP Web site at http://www.ams.usda.gov/nop. AMS published 
a revised sunset review process in the Federal Register on September 
16, 2013 (78 FR 56811).

A. Executive Order 12866

    This action has been determined to be 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. This proposed rule 
is not intended to have a retroactive effect.
    States and local jurisdictions are preempted under 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 OFPA (7 U.S.C. 6514(b)). States are also preempted under 
section 2104 through 2108 of 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 OFPA.
    Pursuant to section 2108(b)(2) of 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 OFPA, (b) not be inconsistent with 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 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. 301-399), nor 
the authority of the Administrator of EPA under the Federal 
Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136-136(y)).
    Section 2121 of 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. 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

[[Page 45452]]

to compete in the market. The purpose of the RFA is to fit regulatory 
actions to the scale of businesses subject to the action. Section 605 
of the RFA allows an agency to certify a rule, in lieu of preparing an 
analysis, if the rulemaking is not expected to have a significant 
economic impact on a substantial number of small 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 action on small entities. 
The impact on entities affected by this proposed rule would not be 
significant. The effect of this proposed rule would be to prohibit the 
use of two non-organic agricultural products that may be available in 
organic form for use in organic processed products. AMS concludes that 
the economic impact of removing the nonorganic agricultural products, 
marsala wine and sherry wine, would be minimal to small agricultural 
firms since organic form of these agricultural products or organic 
forms of alternative agricultural products may be commercially 
available and, as such, their nonorganic forms are proposed to be 
removed from the National List under this rule. Accordingly, AMS 
certifies that this rule will 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.
    According to USDA, National Agricultural Statistics Service (NASS), 
certified organic acreage exceeded 3.5 million acres in 2011.\1\ 
According to NOP's Accreditation and International Activities Division, 
the number of certified U.S. organic crop and livestock operations 
totaled over 19,470 in 2014. The list of certified operations is 
available on the NOP Web site at http://apps.ams.usda.gov/nop/. AMS 
believes that most of these entities would be considered small entities 
under the criteria established by the SBA. U.S. sales of organic food 
and non-food have grown from $1 billion in 1990 to $39.1 billion in 
2014, an 11.3 percent growth over 2013 sales.\2\ In addition, the USDA 
has 80 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. Certifying agents reported 27,810 certified 
operations worldwide in 2014.
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    \1\ U.S. Department of Agriculture, National Agricultural 
Statistics Service. October 2012. 2011 Certified Organic Productions 
Survey.
    \2\ Organic Trade Association. 2014. Organic Industry Survey. 
www.ota.com.
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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 regulations at 5 CFR 
part 1320.

E. Executive Order 13175

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

F. General Notice of Public Rulemaking

    This proposed rule reflects recommendations submitted to the 
Secretary by the NOSB for substances on the National List of Allowed 
and Prohibited Substances that, under the Sunset review provisions of 
OFPA, would otherwise expire on December 14, 2015. A 30-day period for 
interested persons to comment on this rule is provided. Thirty days is 
deemed appropriate because the review of these listings was widely 
publicized through two NOSB meeting notices; the use or prohibition of 
these substances, as applicable, are critical to organic production and 
handling; and this rulemaking must be completed before the sunset date 
of December 14, 2015.

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 
amended as follows:

PART 205--NATIONAL ORGANIC PROGRAM

0
1. The authority citation for 7 CFR part 205 continues to read as 
follows:

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


Sec.  205.601  [Amended]

0
2. Section 205.601 is amended by removing paragraphs (i)(11) and 
(i)(12).


Sec.  205.606  [Amended]

0
3. Section 205.606 is amended by removing paragraph (g) and 
redesignating paragraphs (h) through (z) as (g) through (y).

    Dated: July 27, 2015.
Rex A. Barnes,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2015-18699 Filed 7-29-15; 8:45 am]
 BILLING CODE 3410-02-P