[Federal Register Volume 80, Number 239 (Monday, December 14, 2015)]
[Rules and Regulations]
[Pages 77231-77234]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-31413]



 ========================================================================
 Rules and Regulations
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains regulatory documents 
 having general applicability and legal effect, most of which are keyed 
 to and codified in the Code of Federal Regulations, which is published 
 under 50 titles pursuant to 44 U.S.C. 1510.
 
 The Code of Federal Regulations is sold by the Superintendent of Documents. 
 Prices of new books are listed in the first FEDERAL REGISTER issue of each 
 week.
 
 ========================================================================
 

  Federal Register / Vol. 80, No. 239 / Monday, December 14, 2015 / 
Rules and Regulations  

[[Page 77231]]



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: Final rule.

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

SUMMARY: This final rule addresses 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 final rule removes two nonorganic 
agricultural substances from the National List for use in organic 
handling, fortified cooking wines--marsala wine and sherry wine. This 
final rule also removes 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: Effective Date: This final rule is effective on December 14, 
2015.

FOR FURTHER INFORMATION CONTACT: Robert Pooler, Standards Division, 
National Organic Program, USDA-AMS-NOP, 1400 Independence Ave. SW., 
Room 2642-So., Ag Stop 0268, Washington, DC 20250-0268. 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 
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 NOSB, operating 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 as 
recommended by the NOSB.
    The NOSB's recommendations to continue existing exemptions and 
prohibitions include 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. 
Recommendations to either continue or discontinue an authorized 
exempted synthetic substance (7 U.S.C. 6517(c)(1)) are determined by 
the NOSB's evaluation of technical information, public comments, and 
supporting evidence that demonstrate that 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.
    This rule removes the expired listings of two substances, 
streptomycin and tetracycline, as their National List exemptions 
expired on October 21, 2014. After this expiration date, the use of 
streptomycin and tetracycline in organic production is prohibited. 
While USDA accredited certifying agents are enforcing the prohibition 
of streptomycin and tetracycline, delisting of these substances from 
the National List reduces the likelihood of noncompliant use by organic 
producers.
    Following their October 2014 public meeting, the NOSB submitted 
their 2015 Sunset Review recommendations to the Secretary. This rule 
amends the National List to implement two NOSB recommendations to 
remove the substances, marsala wine and sherry wine, allowed as 
ingredients in or on processed products labeled as ``organic'' in Sec.  
205.606. The National List exemptions of these substances for use in 
organic production and handling that were considered by the NOSB during 
the 2015 Sunset Review process were evaluated according to the 
evaluation criteria specified on the OFPA (7 U.S.C. 6517-6518).

II. Overview of Amendments

    The following provides an overview of the amendments made to 
designated sections of the National List regulations:

[[Page 77232]]

Sec.  205.601 Synthetic Substances Allowed for Use in Organic Crop 
Production

    This final rule amends Sec.  205.601 of the National List 
regulations by removing (1) the expired substance exemption for 
streptomycin, for fire blight control in apples and pears only until 
October 21, 2014, in Sec.  205.601(i)(11), and (2) the expired 
substance exemption for tetracycline, for fire blight control in apples 
and pears only until October 21, 2014, in Sec.  205.601(i)(12).

Streptomycin

    This rule amends 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. In 1995, streptomycin was 
recommended by the NOSB for addition as a plant disease control to the 
National List. 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). The listing for streptomycin was amended, as 
recommended by the NOSB, on June 6, 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 
rule removes the listing for streptomycin that expired on October 21, 
2014 from Sec.  205.601. Since the prohibition against the use of 
streptomycin has been effective since October 21, 2014, removal of this 
exempted substance from the National List has no new regulatory effect.

Tetracycline

    This rule amends 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. 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 August 2, 2012 (77 FR 45903) to add an 
expiration date to the tetracycline annotation: Tetracycline, for fire 
blight control in apples and pears only until October 21, 2014. This 
rule removes the exempted listing for tetracycline from Sec.  205.601 
that expired on October 21, 2014. Since the prohibition against the use 
of tetracycline has been effective since October 21, 2014, the removal 
of this exempted substance from the National List has no new regulatory 
effect.

Sec. 205.606 Nonorganically Produced Agricultural Products Allowed as 
Ingredients In or On Processed Products Labeled as ``Organic''

    This final rule amends Sec.  205.606 of the National List by 
removing two substance exemptions listed in Sec.  205.606(g): Fortified 
cooking wines, (1) marsala, (2) sherry.
    This rule implements two NOSB recommendations from their 2015 
Sunset review that were submitted to the Secretary on October 30, 2014. 
During their 2015 Sunset Review, the NOSB determined that two substance 
exemptions for marsala wine and sherry wine included on Sec.  205.606 
of the National List are no longer necessary for organic handling.

Marsala Wine

    The USDA organic regulations have included 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. During their sunset 
review deliberation, the NOSB received no public comments supporting 
the continued need for the use of nonorganic 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 this information, the NOSB determined that the 
exemption for marsala wine on Sec.  205.606 is no longer necessary or 
essential for organic processed products and voted for the removal of 
marsala wine from the National List, effective on December 14, 2015.

Sherry Wine

    The USDA organic regulations have included 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. During their 
sunset review deliberation, the NOSB received no public comments 
supporting the continued need for the use of nonorganic 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 this information, the NOSB determined 
that the exemption for sherry wine as listed on Sec.  205.606 is no 
longer necessary or essential for organic processed products and voted 
for the removal of sherry wine from the National List, effective on 
December 14, 2015.
    This rule amends Sec.  205.606 by redesignating paragraphs (h) 
through (z) as (g) through (y), respectively.

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 6, 2012 (77 FR 33290) and on August 2, 2012 (77 FR 
45903). The proposal to address the substances in this final rule was 
published in the Federal Register on July 30, 2015 (80 FR 45499).

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

[[Page 77233]]

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 final 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. 6503-6507) 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 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 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 rule would not be significant. 
The effect of this rule would be to prohibit the use of two nonorganic 
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/services/organic-certification/certifying-agents. 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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

D. Paperwork Reduction Act

    No additional collection or recordkeeping requirements are imposed 
on the public by this 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 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.

[[Page 77234]]

F. Comments Received on Proposed Rule AMS-NOP-15-0015; NOP-15-07

    AMS received two comments on proposed rule AMS-NOP-15-0015. Only 
one comment from a consumer addressed the 2015 Sunset review amendments 
to remove marsala and sherry wines from the National List. The second 
comment was from a California apple producer and it addressed removing 
the expired listings, streptomycin and tetracycline, from the National 
List.
    The consumer who commented on removing marsala and sherry wines 
from the National List agreed with the proposed amendment to prohibit 
the use of these nonorganic ingredients in foods labeled as organic. 
During their sunset review of marsala and sherry, the NOSB did not 
receive comments supporting the continued use of these wines as 
nonorganic ingredients in organic products. Additionally, since no 
comments were received opposing the removal of marsala and sherry wines 
from the National List, AMS is finalizing these amendments as proposed 
through this final rule.
    Additionally, the consumer who supported the removal of marsala and 
sherry wines also added that nonorganic ingredients should not be used 
in organic foods. AMS has considered this comment. The USDA organic 
regulations, in Sec.  205.301(b), requires that a raw or processed 
agricultural product sold, labeled, or represented as ``organic'' must 
contain not less than 95 percent organically produced raw or processed 
agricultural products. Any remaining product ingredients must be 
organically produced, unless not commercially available in organic 
form, or must be nonagricultural substances as listed in Sec.  205.605, 
or nonorganic agricultural products as listed in Sec.  205.606 on the 
National List. In essence, the USDA organic regulations requires 
organic producers or organic handlers to maximize organic ingredients 
before using nonorganic nonagricultural or nonorganic agricultural that 
are included on the National List.
Changes Requested But Not Made
    The commenter on the proposed removal of expired listings for 
streptomycin and tetracycline did not agree with this action and did 
not agree with the prohibition against the use of these antibiotics to 
control fire blight infestation in apple production. This commenter 
stated that the prohibition of streptomycin and tetracycline for use in 
apple production has had a significant impact on organic apple growers 
in California's central valley. According to this commenter, the 
alternatives to the use of streptomycin and tetracycline researched in 
the Pacific Northwest are ineffective in controlling fire blight in 
California's central valley. The commenter claims the amendment to 
prohibit the use of these antibiotics to control fire blight created a 
significant economic advantage for apple growers in the Pacific 
Northwest. The removal of the expired listings for streptomycin and 
tetracycline in the proposed rule is essentially a notice of a 
technical correction since the prohibition on the use of these two 
substances in organic crop production is already in effect.
    The final rule that established the effective date of 
streptomycin's expiration date as listed in Sec.  205.601(i)(11) was 
published in the Federal Register (77 FR 33290) on June 6, 2012. This 
final rule addressed comments received on the proposed rule to list 
streptomycin with an expiration date, including comments in support of 
or in opposition to the expiration date. AMS also addressed comments on 
commercially viable alternatives, including the efficacy of these 
alternatives, and addressed additional factors considered by the NOSB 
during their determination. Since the prohibition against the use of 
streptomycin has been in effect since October 22, 2014, AMS is 
finalizing this correction as noted in the proposed rule. Organic 
producers who have determined that there are no commercially available 
alternatives to streptomycin in controlling fire blight in apples or 
pear production for their region can submit a petition (http://www.ams.usda.gov/rules-regulations/organic/national-list/filing-petition) to add streptomycin back onto the National List.
    The final rule that established the effective date of 
tetracycline's expiration date as listed in Sec.  205.601(i)(12) was 
published in the Federal Register (77 FR 45903) on August 2, 2012. This 
final rule addressed comments received on the proposed rule to list 
tetracycline with an expiration date, including comments in support of 
or in opposition to the expiration date. AMS also addressed comments on 
commercially viable alternatives, including the efficacy of these 
alternatives, and addressed additional factors considered by the NOSB 
during their determination. Since the prohibition against the use of 
tetracycline has been in effect since October 22, 20014, AMS is 
finalizing this correction as noted in the proposed rule. Organic 
producers who have determined that there are no commercially available 
alternatives to tetracycline in controlling fire blight in apples or 
pear production for their region can submit a petition (http://www.ams.usda.gov/rules-regulations/organic/national-list/filing-petition) to add tetracycline back onto the National List.

List of Subjects in 7 CFR Part 205

    Administrative practice and procedure, Agricultural commodities, 
Imports, Labeling, Livestock, Reporting and recordkeeping requirements, 
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 (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: December 8, 2015.
Rex A. Barnes,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2015-31413 Filed 12-11-15; 8:45 am]
BILLING CODE 3410-02-P