[Federal Register Volume 83, Number 83 (Monday, April 30, 2018)]
[Proposed Rules]
[Pages 18744-18747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-08991]


 ========================================================================
 Proposed Rules
                                                 Federal Register
 ________________________________________________________________________
 
 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. 83, No. 83 / Monday, April 30, 2018 / 
Proposed Rules  

[[Page 18744]]



DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-17-0080; NOP-17-09]
RIN 0581 AD78


National Organic Program; Proposed Amendments to the National 
List of Allowed and Prohibited Substances for 2017 NOSB Recommendations 
(Livestock and Handling)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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

SUMMARY: This proposed rule would amend the National List of Allowed 
and Prohibited Substances (National List) section of the United States 
Department of Agriculture's (USDA's) organic regulations to implement 
recommendations submitted to the Secretary of Agriculture (Secretary) 
by the National Organic Standards Board (NOSB). This rule proposes to: 
Add elemental sulfur to the National List for use in organic livestock 
production; and, reclassify potassium acid tartrate from a non-
agricultural substance to an agricultural substance and require the 
organic form of the ingredient when commercially available.

DATES: Comments must be received by June 29, 2018.

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-S., Ag Stop 
0268, Washington, DC 20250-0268. Telephone: (202) 720-3252.
    Instructions: All submissions received must include the docket 
number AMS-NOP-17-0080; NOP-17-09, and/or Regulatory Information Number 
(RIN) 0581-AD78 for this rulemaking. When submitting a comment, clearly 
indicate the proposed rule topic and section number to which the 
comment refers. In addition, comments should clearly indicate whether 
the commenter supports the action being proposed and also clearly 
indicate the reason(s) for the position. Comments can also include 
information on alternative management practices, where applicable, that 
support alternatives to the proposed amendments. Comments should also 
offer any recommended language change(s) that would be appropriate to 
the position. Please include relevant information and data to support 
the position such as scientific, environmental, manufacturing, 
industry, or impact information, or similar sources. Only relevant 
material supporting the position should be submitted. All comments 
received will be posted without change to http://www.regulations.gov.
    Document: To access the document and 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, 
National Organic Program. Telephone: (202) 720-3252.

SUPPLEMENTARY INFORMATION:

I. Background

    On December 21, 2000, the Secretary established the National List 
within part 205 of the USDA organic regulations (7 CFR 205.600 through 
205.607). The National List identifies the synthetic substances that 
may be used and the nonsynthetic (natural) 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 Organic Foods Production Act of 1990, as amended, (7 U.S.C. 
6501-6522) (OFPA), and Sec.  205.105 of the 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 and any nonsynthetic nonagricultural substance used in 
organic handling be on the National List. Under the authority of OFPA, 
the National List can be amended by the Secretary based on 
recommendations presented by the NOSB. Since the final rule 
establishing the National Organic Program (NOP) became effective on 
October 21, 2002, USDA's Agricultural Marketing Service (AMS) has 
published multiple rules amending the National List.
    This proposed rule would amend the National List to implement two 
NOSB recommendations on two amendments to the National List. These 
recommendations were submitted to the Secretary on November 7, 2017. 
Table 1 summarizes the proposed changes to the National List based on 
these NOSB recommendations.

                                 Table 1--Substances Being Added to the National List or Current Listings Being Amended
--------------------------------------------------------------------------------------------------------------------------------------------------------
                   Substance                      National List section                                Proposed rule action
--------------------------------------------------------------------------------------------------------------------------------------------------------
Elemental sulfur...............................        Sec.   205.603(b)  Add to National List.
Potassium acid tartrate........................    Sec.   205.605 & Sec.  Reclassify listing and move within National List.
                                                                 205.606
--------------------------------------------------------------------------------------------------------------------------------------------------------


[[Page 18745]]

II. Overview of Proposed Amendments

    The following provides an overview of the proposed amendments to 
designated sections of the National List regulations:
    Sec.  205.603 Synthetic substances allowed for use in organic 
livestock production.
    This proposed rule would add one substance to Sec.  205.603, 
synthetic substances allowed for use in organic livestock production.

Elemental Sulfur

    The proposed rule would amend the National List to add elemental 
sulfur for use as a parasiticide to treat livestock and livestock 
housing. Table 2 illustrates the proposed listing.

           Table 2--Proposed Rule Action for Elemental Sulfur
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Current rule:                      N/A.
Proposed rule action:              Add elemental sulfur to Sec.
                                    205.603(b).
------------------------------------------------------------------------

    On March 1, 2016, AMS received a petition \1\ to add elemental 
sulfur to the National List in Sec.  205.603 for use as a topical 
pesticide treatment in organic livestock production to repel mites, 
fleas, and ticks from livestock and livestock living quarters. Mites, 
fleas, and ticks are vectors of livestock diseases and under favorable 
conditions may heavily infest livestock and livestock living quarters. 
Elemental sulfur is dusted on and rubbed into the feathers and hair of 
livestock and applied to interior surfaces of livestock housing. The 
USDA organic regulations allow elemental sulfur for use in organic crop 
production as an insecticide (including mite control), Sec.  
205.601(e); as a plant disease control, Sec.  205.601(i); and as a 
plant or soil amendment, Sec.  205.601(j).
---------------------------------------------------------------------------

    \1\ Elemental sulfur petition: https://www.ams.usda.gov/rules-regulations/organic/national-list/petitioned. Under ``S.''
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    At its November 2, 2017 public meeting, the NOSB considered the 
petition to add elemental sulfur to the National List for use in 
organic livestock production and received public comment. In its 
review, the NOSB also considered a March 2017 technical evaluation 
report (technical report) on elemental sulfur \2\ that described its 
manufacture, industry uses, regulation, and chemical properties.
---------------------------------------------------------------------------

    \2\ The technical report for elemental sulfur is available on 
the AMS website, organized in alphabetical order: https://www.ams.usda.gov/rules-regulations/organic/national-list/petitioned.
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    In consideration of the petition, technical report, and public 
comments, the NOSB determined that the use of elemental sulfur as a 
topical pesticide for organic livestock satisfies OFPA evaluation 
criteria for National List substances and recommended adding elemental 
sulfur to Sec.  205.603 as an external parasiticide in organic 
livestock production.\3\ AMS has reviewed and proposes to address this 
NOSB recommendation through this proposed rule. Consistent with the 
NOSB recommendation, this proposed rule would amend the National List 
by adding elemental sulfur to Sec.  205.603(b) as an external 
parasiticide. This would permit the use of elemental sulfur on 
livestock and livestock housing when preventive measures have failed 
(Sec.  205.238).\4\
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    \3\ NOSB elemental sulfur recommendation: https://www.ams.usda.gov/sites/default/files/media/LSSulfurFinalRec.pdf.
    \4\ Section 205.238(b) permits organic producers to use 
synthetic medications which are allowed for use in Sec.  205.603 
when preventive practices are inadequate.
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    Sec.  205.605 Nonagricultural (nonorganic) substances allowed as 
ingredients in or on processed products labeled as ``organic'' or 
``made with organic (specified ingredients or food group(s)).''
    This proposed rule would move one substance, currently listed in 
Sec.  205.605, to Sec.  205.606.

Potassium Acid Tartrate

    The proposed rule would amend the National List to reclassify 
potassium acid tartrate from a non-agricultural substance listed in 
Sec.  205.605(b) to an agricultural substance listed in Sec.  205.606.

        Table 3--Proposed Rule Action for Potassium Acid Tartrate
------------------------------------------------------------------------
 
------------------------------------------------------------------------
Current rule:                      Sec.   205.605(b), potassium acid
                                    tartrate.
Proposed rule action:              Remove potassium acid tartrate from
                                    Sec.   205.605(b) and insert
                                    potassium acid tartrate under Sec.
                                    205.606.
------------------------------------------------------------------------

    Potassium acid tartrate is currently allowed as a synthetic 
substance for use in organic handling. The U.S. Food and Drug 
Administration (FDA) allows potassium acid tartrate to be used as a 
leavening agent, pH control agent, or antimicrobial agent. Other uses 
that are permitted by the FDA include as an anticaking agent, a 
formulation aid, a humectant, a stabilizer and thickener, and a 
surface-active agent (21 CFR 184.1077). Potassium acid tartrate has 
been on the National List since October 2002. During its November 2017 
public meeting, the NOSB considered the proposal to reclassify 
potassium acid tartrate as an agricultural substance. Specifically, the 
NOSB considered new information in an updated January 2017 technical 
report on potassium acid tartrate.\5\ This report described how 
potassium acid tartrate is a byproduct of the wine making process and 
is extracted with water. Prior to and during this meeting, the NOSB 
also received and considered public comment on the proposal. The NOSB 
determined that potassium acid tartrate meets the definition of an 
``agricultural product'' in Sec.  205.2 of the USDA organic regulations 
because it is derived from an agricultural product (grapes) and does 
not undergo a chemical change during extraction.\6\ This is consistent 
with the USDA organic regulations and the NOP guidance on 
classification of agricultural and nonagricultural materials.\7\ 
Therefore, the NOSB recommended reclassifying potassium acid tartrate 
as an agricultural substance and moving it to section 205.606 of the 
National List. This action would require organic handlers who use 
potassium tartrate to source an organic form of the ingredient. If the 
ingredient is not commercially available,\8\ the nonorganic form may be 
used.
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    \5\ 2017 potassium acid tartrate technical report: https://www.ams.usda.gov/rules-regulations/organic/national-list/petitioned. 
Under ``P.''
    \6\ The USDA organic regulations define ``agricultural product'' 
as: ``Any agricultural commodity or product, whether raw or 
processed, including any commodity or product derived from 
livestock, that is marketing in the United States for human or 
livestock consumption.''
    \7\ NOP 5033, Classification of Materials: https://www.ams.usda.gov/sites/default/files/media/Program%20Handbk_TOC.pdf.
    \8\ See 7 CFR 205.606 and 7 CFR 205.2 for definition of 
``Commercially available.''
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    Consistent with the NOSB recommendation, this proposed rule would 
amend Sec.  205.605 by removing potassium acid tartrate from Sec.  
205.605(b) and inserting it in Sec.  205.606.

III. Related Documents

    On May 30, 2017, a Notice was published in the Federal Register (82 
FR 24659) announcing the fall 2017 NOSB meeting. The purpose of the 
meeting was to deliberate on recommendations on substances petitioned 
as amendments to the National List.

IV. Statutory and Regulatory Authority

    The OFPA authorizes the Secretary to make amendments to the 
National List based on recommendations developed by the NOSB. Sections 
6518(k) and 6518(n) of the OFPA authorize the NOSB to develop 
recommendations for submission to the Secretary to amend

[[Page 18746]]

the National List and establish a process by which persons may petition 
the NOSB for the purpose of having substances evaluated for inclusion 
on or deletion from the National List. Section 205.607 of the USDA 
organic regulations sets forth the National List petition process. The 
current petition process (81 FR 12680, March 10, 2016) can be accessed 
through the NOP Program Handbook on the NOP website at https://www.ams.usda.gov/rules-regulations/organic/handbook.

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

    This action falls within a category of regulatory actions that the 
Office of Management and Budget (OMB) has exempted from Executive Order 
12866. Additionally, because this proposal 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'[thinsp]'' (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.
    The Small Business Administration (SBA) sets size criteria for each 
industry described in the North American Industry Classification System 
(NAICS), to delineate which operations qualify as small businesses. The 
SBA has classified small agricultural producers that engage in crop and 
animal production as those with average annual receipts of less than 
$750,000. Handlers are involved in a broad spectrum of food production 
activities and fall into various categories in the NAICS Food 
Manufacturing sector. The small business thresholds for food 
manufacturing operations are based on the number of employees and range 
from 500 to 1,250 employees, depending on the specific type of 
manufacturing. Certifying agents fall under the NAICS subsector, ``All 
other professional, scientific and technical services.'' For this 
category, the small business threshold is average annual receipts of 
less than $15 million.
    AMS has considered the economic impact of this proposed rulemaking 
on small agricultural entities. Data collected by the USDA National 
Agricultural Statistics Service (NASS) and the NOP indicate most of the 
certified organic production operations in the U.S. would be considered 
small entities. According to the 2016 Certified Organic NASS Survey, 
13,954 certified organic farms in the U.S. reported sales of organic 
products and total farmgate sales in excess of $7.5 billion.\9\ Based 
on that data, organic sales average $541,000 per farm. Assuming a 
normal distribution of producers, we expect that most of these 
producers would fall under the $700,000 sales threshold to qualify as a 
small business.
---------------------------------------------------------------------------

    \9\ U.S. Department of Agriculture, National Agricultural 
Statistics Service. September 2017. Certified Organic Survey, 2016 
Summary. http://usda.mannlib.cornell.edu/usda/current/OrganicProduction/OrganicProduction-09-20-2017_correction.pdf.
---------------------------------------------------------------------------

    According to the NOP's Organic Integrity Database there are 9,633 
certified handlers in the U.S.\10\ The Organic Trade Association's 2017 
Organic Industry Survey has information about employment trends among 
organic manufacturers. The reported data are stratified into three 
groups by the number of employees per company: Less than 5; 5 to 49; 
and 50 plus. These data are representative of the organic manufacturing 
sector and the lower bound (50) of the range for the larger 
manufacturers is significantly smaller than the SBA's small business 
thresholds (500 to 1,250). Therefore, AMS expects that most organic 
handlers would qualify as small businesses.
---------------------------------------------------------------------------

    \10\ Organic Integrity Database: https://organic.ams.usda.gov/Integrity/. Accessed on March 23, 2018.
---------------------------------------------------------------------------

    The USDA has 82 accredited certifying agents who provide organic 
certification services to producers and handlers. The certifying agent 
that reports the most certified operations, nearly 3,500, would need to 
charge approximately $4,200 in certification fees in order to exceed 
the SBA's small business threshold of $15 million. The costs for 
certification generally range from $500 to $3,500, depending on the 
complexity of the operation. Therefore, AMS expects that most of the 
accredited certifying agents would qualify as small entities under the 
SBA criteria.
    The economic impact on entities affected by this rule would not be 
significant. The effect of this rule, if implemented as final, would be 
to allow the use of additional substances in organic crop or livestock 
production and organic handling. This action would increase regulatory 
flexibility and would give small entities more tools to use in day-to-
day operations. AMS concludes that the economic impact of this 
addition, if any, would be minimal and beneficial to small agricultural 
service firms. Accordingly, USDA certifies that this rule would not 
have a significant economic impact on a substantial number of small 
entities.

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. Accordingly, to prevent 
duplicative regulation, states and local jurisdictions are preempted 
under the OFPA from creating programs of accreditation for private 
persons or state officials who want to become certifying agents of 
organic farms or handling operations. A governing state official would 
have to apply to USDA to be accredited as a certifying agent, as 
described in section 6514(b) of the OFPA. States are also preempted 
under sections 6503 through 6507 of the OFPA from creating 
certification programs to certify organic farms or handling operations 
unless the state programs have been submitted to, and approved by, the 
Secretary as meeting the requirements of the OFPA.
    Pursuant to section 6507(b)(2) of the OFPA, a state organic 
certification program that has been approved by the Secretary may, 
under certain circumstances, contain additional requirements for the 
production and handling of agricultural products organically produced 
in the state and for the certification of organic farm and handling 
operations located within the state. 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.
    In addition, pursuant to section 6519(c)(6) of the OFPA, this 
proposed rule would not supersede or 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, respectively, nor any of the authorities of 
the Secretary of Health and Human Services

[[Page 18747]]

under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.), 
nor the authority of the Administrator of the Environmental Protection 
Agency under the Federal Insecticide, Fungicide and Rodenticide Act (7 
U.S.C. 136 et seq.).

C. 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 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. General Notice of Public Rulemaking

    This proposed rule reflects recommendations submitted by the NOSB 
to the Secretary to add one substance to the National List and to 
reclassify one substance on the National List. A 60-day period for 
interested persons to comment on this rule is provided.

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, subpart 
G is proposed to be 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.  205.603 by redesignating paragraphs (b)(2) through 
(b)(8) as (b)(3) through (b)(9) and adding new paragraph (b)(2) to read 
as follows:


Sec.  205.603   Synthetic substances allowed for use in organic 
livestock production.

* * * * *
    (b) * * *
    (2) Elemental sulfur--for treatment of livestock and livestock 
housing.
* * * * *


Sec.  205.605  [Amended]

0
3. Amend Sec.  205.605 paragraph (b) by removing ``Potassium acid 
tartrate.''
0
4. Amend Sec.  205.606, by redesignating paragraphs (o) through (t) as 
(p) through (u) and adding new paragraph (o) to read as follows:


Sec.  205.606   Nonorganically produced agricultural products allowed 
as ingredients in or on processed products labeled as ``organic.''

* * * * *
    (o) Potassium acid tartrate.
* * * * *

    Dated: April 24, 2018.
Bruce Summers,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2018-08991 Filed 4-27-18; 8:45 am]
 BILLING CODE 3410-02-P