[Federal Register Volume 82, Number 128 (Thursday, July 6, 2017)]
[Rules and Regulations]
[Pages 31241-31244]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-14006]



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 Rules and Regulations
                                                 Federal Register
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 This section of the FEDERAL REGISTER contains regulatory documents 
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  Federal Register / Vol. 82, No. 128 / Thursday, July 6, 2017 / Rules 
and Regulations  

[[Page 31241]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-16-0052; NOP-16-03]
RIN 0581-AD52


National Organic Program (NOP); Sunset 2017 Amendments to the 
National List

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Final rule.

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SUMMARY: This final rule amends the National List of Allowed and 
Prohibited Substances (National List) within the U.S. Department of 
Agriculture's (USDA) organic regulations, to prohibit the use of 8 
substances in organic production and handling after June 27, 2017: 
Lignin sulfonate (for use as a floating agent); furosemide; magnesium 
carbonate; and the nonorganic forms of chia, dillweed oil, frozen 
galangal, frozen lemongrass, and chipotle chile peppers. This action 
also renews 3 substances on the National List to continue to allow 
nonorganic forms of inulin-oligofructose enriched, Turkish bay leaves, 
and whey protein concentrate in organic products. This action addresses 
eleven recommendations submitted to the Secretary of Agriculture 
(Secretary) by the National Organic Standards Board (NOSB) following 
its October 2015 meeting. These recommendations pertain to the NOSB's 
2017 sunset review of a portion of the substances on the National List.

DATES: This final rule is effective on August 7, 2017. The renewal of 
the substances inulin-oligofructose enriched, Turkish bay leaves, and 
whey protein concentrate for inclusion on the National List is 
applicable beginning on June 27, 2017.

FOR FURTHER INFORMATION CONTACT: Paul Lewis, Ph.D., Director, Standards 
Division, Telephone: (202) 720-3252; Fax: (202) 260-9151.

SUPPLEMENTARY INFORMATION: 

I. Background

    The USDA Agricultural Marketing Service (AMS) administers the 
National Organic Program (NOP), under the authority of the Organic 
Foods Production Act of 1990 (OFPA), as amended (7 U.S.C. 6501-6522). 
The 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, AMS 
oversees national standards for the production, handling, and labeling 
of organically produced agricultural products.
    Since October 2002, the USDA organic regulations have been 
frequently amended, mostly for changes to the National List in 7 CFR 
205.601-205.606. The National List identifies synthetic substances that 
may be used and the nonsynthetic substances that must 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 USDA organic 
regulations 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.
    The OFPA authorizes the National Organic Standards Board (NOSB), 
operating in accordance with the Federal Advisory Committee Act (5 
U.S.C. App. 2 et seq.), to develop recommendations to amend the 
National List. The NOSB assists in the evaluation of substances for 
organic production and handling and advises 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 
valid. This periodic review of National List substances is referred to 
as ``sunset review.'' 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 sunset review of substances on the National List 
includes 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 developed by the NOSB based on 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.
    In accordance with the sunset review process published in the 
Federal Register on September 16, 2013 (78 FR 61154), this final rule 
would amend the National List to remove eight substances as recommended 
to the Secretary by the NOSB on October 29, 2015. Additionally, this 
final rule would renew three substances allowed for use in organic 
products based on information that there is a continued need for these 
materials.

II. Overview of Amendments

Removals

    This final rule amends the National List to remove eight exemptions 
(allowances) for: Lignin sulfonate, furosemide, magnesium carbonate, 
chia, dillweed oil, frozen galangal, frozen lemongrass, and chipotle 
chile peppers. The NOSB recommended that these substances should be 
removed from the National List based on its 2017 sunset review. In 
summary, the NOSB concluded that these substances are no longer needed 
in organic production or handling because there are alternative 
practices or materials. AMS concurs with these recommendations for 
removal as described below.
    The NOSB considered public comments and other information to

[[Page 31242]]

determine whether these substances continue to meet the OFPA criteria 
(7 U.S.C. 6517(c) and 6518(m)) for inclusion on the National List. With 
regard to (i) lignin sulfonate (Sec.  205.601(1)(l)--synthetic 
substance allowed as a floating agent in post-harveset handling), (ii) 
furosemide (Sec.  205.603(a)--synthetic substance allowed for livestock 
medical treatment), and (iii) magnesium carbonate (Sec.  205.605(b)--
synthetic ingredient allowed in or on organic processed proeducts), the 
NOSB concluded that these three substances are no longer necessary for 
organic production or postharvest handling and alternative substances 
are available.
    AMS received no public comments concerning the proposed removal of 
lignin sulfonate (as as floating agent in post-harvest handling), 
furosemide, and magnesium carbonate from the National List. AMS has 
reviewed and accepts the NOSB recommendations to remove these 
substances from the National List when the listings are due to sunset, 
or expire. Therefore, after June 27, 2017, lignin sulfonate (as as 
floating agent in post-harvest handling), furosemide, and magnesium 
carbonate will no longer be allowed for use in organic production or 
handling.\1\
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    \1\ The allowance for lignin sulftonate as a chelating agent or 
dust suppressant for plant or soil amendments in organic crop 
production remains on the National List (Sec.  205.601(j)(4)).
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    With regard to chia (Salvia hispanica L.), dillweed oil, galangal 
(frozen), lemongrass (frozen), and peppers (chipotle chile), the NOSB 
considered public comments and other information to determine whether 
these five substances continue to meet the OFPA criteria for inclusion 
on the National List. These substances appear in section 205.606 of the 
National List which allows the use of nonorganic forms of these 
substances when the organic form is not commercially available.\2\ The 
NOSB recommended that these substances be removed because adequate 
organic sources are available in the supply chain and nonorganic forms 
are not needed.
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    \2\ Definition of Commercially Available (Sec.  205.2): The 
ability to obtain a production input in an appropriate form, 
quality, or quantity to fulfill an essential function in a system of 
organic production or handling, as determined by the certifying 
agent in the course of reviewing the organic plan.
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    AMS received no public comments concerning the proposed removal of 
chia, dillweed oil, frozen galangal, frozen lemongrass, and chipotle 
chile peppers from the National List. AMS has reviewed and accepts the 
NOSB recommendations to remove these substances from the National List 
when the listings are due to sunset, or expire. Therefore, after June 
27, 2017, nonorganic forms of chia, dillweed oil, frozen galangal, 
frozen lemongrass, and chipotle chile peppers will no longer be allowed 
for use in organic products.

III. Related Documents

    Two notices announcing NOSB public meetings were published in the 
Federal Register on March 12, 2015 (80 FR 12975) and on September 8, 
2015 (80 FR 53759). These notices invited the public to provide 
comments to the NOSB for the 2017 sunset review. The notices informed 
the public that the listings discussed in this final rule would expire 
from the National List on June 27, 2017, if not reviewed by the NOSB 
and renewed by the Secretary.
    On January 18, 2017, AMS published a proposed rule in the Federal 
Register (82 FR 5431) to notify the public and solicit comments on AMS' 
proposed action to remove eleven substances from the National List 
based on the NOSB's 2017 sunset recommendations. The comment period for 
the proposed rule was extended an additional 30 days to April 19, 2017, 
per a Federal Register document published on February 17, 2017 (82 FR 
10967).

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 removal from the National 
List. The National List petition process is implemented under Sec.  
205.607 of the USDA organic regulations. The National List Petition 
Guidelines (NOP 3011) are published in the NOP Handbook which is 
available on the AMS Web site, http://www.ams.usda.gov/nop. The 
guidelines describe the information to be included for all types of 
petitions submitted to amend the National List. AMS published a revised 
sunset review process in the Federal Register on September 16, 2013 (78 
FR 56811).

A. Executive Orders 12866 and 13771, and Regulatory Flexibility Act

    This rule does not meet the definition of a significant regulatory 
action contained in section 3(f) of Executive Order 12866, and is not 
subject to review by the Office of Management and Budget (OMB). 
Additionally, because this rule does not meet the definition of a 
significant regulatory action it does not trigger the requirements 
contained in Executive Order 13771. See OMB's Memorandum titled 
``Interim Guidance Implementing Section 2 of the Executive Order of 
January 30, 2017 titled `Reducing Regulation and Controlling Regulatory 
Costs' '' (February 2, 2017).
    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 proposed rule would not be 
significant. The effect of this rule would be to prohibit the use of 
eight substances that have limited public support and may no longer be 
used because alternatives to these substances have been developed and 
implemented by organic producers or organic handlers (food processors). 
AMS concludes that the economic impact of removing lignin sulfonate, 
furosemide, magnesium carbonate, chia, dillweed oil, frozen galangal, 
frozen lemongrass, and chipotle chile peppers from the National List 
would be minimal to small agricultural firms because alternative 
practices or substances are commercially available. As such, these 
substances are to be removed from the National List under this rule.
    This rule would also allow for the continued use of three 
nonorganic agricultural susbstances: Turkish bay leaves, inulin-
oligofructose enriched, and whey protein concentrate. AMS concludes 
that renewing these three ingredients would minimize impact to small 
agricultural firms because alternative products or organic forms of 
these ingredients are not commercially available and handlers need to 
use the nonorganic forms. Accordingly, AMS certifies that this rule 
will not have a

[[Page 31243]]

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) as those having annual receipts of 
less than $7,500,000 and small agricultural producers are defined as 
those having annual receipts of less than $750,000. See 13 CFR 121.201.
    According to NOP's Accreditation and International Activities 
Division, the number of certified U.S. organic crop and livestock 
operations totaled over 24,669 in March 2017. The list of certified 
operations is available on the AMS NOP Web site at http://www.ams.usda.gov/nop. AMS believes that most of these entities would be 
considered small entities under the criteria established by the SBA. In 
addition, the USDA has 81 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.

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.
    Pursuant to section 6519(f) of OFPA, 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 the U.S. Environmental Protection Agency (EPA) under 
the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 136-
136(y)).

C. Paperwork Reduction Act

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

D. 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.

E. Comments Received on Proposed Rule AMS-NOP-16-0052; NOP-16-03

    AMS received seven public comments from ingredient manufacturers, 
organic handlers, and a trade association on the proposal to remove the 
following three substances from the National List: Turkish bay leaves, 
inulin-oligofructose enriched, and whey protein concentrate. These 
substances are listed in section 205.606 of the National List, which 
allows nonorganic forms to be used in organic products when organic 
forms are not commercially available. Removing these substances from 
the National List would mean that only organic forms of these 
ingredients could be used in organic products.
Changes Made Based on Comments
    AMS received public comments which opposed the removal of Turkish 
bay leaves from the National List. These public comments stated that 
organic Turkish bay leaves are not available in the quantity or quality 
needed to meet organic handling needs. The comments explained that the 
different flavor profile of ground organic Turkish bay leaves would 
negatively impact finished products. Comments requested that AMS 
maintain the allowance for nonorganic Turkish bay leaves while 
suppliers pursue sources of organic Turkish bay leaves in sufficient 
quality and quantity to meet industry needs.
    AMS also received public comments opposing the proposed removal of 
inulin-oligofructose enriched from the National List. Comments 
acknowledged that there are organic or alternate forms of inulin 
available, such as inulin from organic agave and 
fructooligosaccharides, but explained that these are not equivalent to 
inulin-oligofructose enriched, which is sourced only from chicory root 
and provides unique functionality for use as a prebiotic in organic 
infant formula. The comments indicated that an adequate supply of 
organic chicory root is not commercially available.
    AMS received public comment opposing the removal of whey protein 
concentrate from the National List. Whey protein concentrate is used as 
an ingredient in various products including bakery, confectionary, 
processed meat, infant formula, and dairy products. Public comments 
submitted indicated that whey protein concentrate is essential to 
organic processed products and is not commercially available in organic 
form at this time.
    In consideration of the new information presented in public 
comments, AMS has determined that nonorganic forms of Turkish bay 
leaves, inulin-oligofructose enriched, and whey protein concentrate are 
essential to organic production and handling and should remain on the 
National List. The USDA organic regulations may allow the use of 
nonorganic substances that are not commercially available in organic 
form, quality, or quantity, and are necessary to organic handling. As 
with other substances in section 205.606 of the National List, organic 
handlers are permitted to use the nonorganic substance only if the 
organic substance is not commercially available. Handlers will need to 
demonstrate, and certifiers will need to verify, that the organic 
substance is not available in the form, quality or quantity needed. 
Further, any member of the public may petition to remove an 
agricultural substance from the National List if an organic substance 
becomes commercially available.\3\
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    \3\ The AMS Web site describes how to submit a petition: https://www.ams.usda.gov/rules-regulations/organic/national-list/filing-petition. See also NOP 3011 National List Petition Guidelines.
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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.

0
2. Amend Sec.  205.601 by revising paragraph (l) to read as follows:


Sec.  205.601  Synthetic substances allowed for use in organic crop 
production.

* * * * *
    (l) As floating agents in postharvest handling. Sodium silicate--
for tree fruit and fiber processing.
* * * * *


Sec.  205.603  [Amended]

0
3. Amend Sec.  205.603 by:

[[Page 31244]]

0
a. Removing paragraph (a)(10); and
0
b. Redesignating paragraphs (a)(11) through (23) as paragraphs (a)(10) 
through (22).


Sec.  205.605  [Amended]

0
4. Amend Sec.  205.605(b) by removing the substance ``Magnesium 
carbonate--for use only in agricultural products labeled ``made with 
organic (specified ingredients or food group(s)),'' prohibited in 
agricultural products labeled ``organic''.''


Sec.  205.606  [Amended]

0
5. Amend Sec.  205.606 by:
0
a. Removing paragraphs (c), (e), (h), (o), and (s); and
0
b. Redesignating paragraphs (d), (f), (g), (i) through (n), (p) through 
(r), and (t) through (y) as paragraphs (c) through (t), respectively.

    Dated: June 28, 2017.
Bruce Summers,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2017-14006 Filed 7-5-17; 8:45 am]
 BILLING CODE 3410-02-P