[Federal Register Volume 84, Number 83 (Tuesday, April 30, 2019)]
[Rules and Regulations]
[Pages 18133-18136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08700]



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 Rules and Regulations
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  Federal Register / Vol. 84, No. 83 / Tuesday, April 30, 2019 / Rules 
and Regulations  

[[Page 18133]]



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: Amendments to the National List of 
Allowed and Prohibited Substances for 2017 NOSB Recommendations 
(Livestock and Handling)

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) 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 adds 
elemental sulfur to the National List for use in organic livestock 
production and reclassifies potassium acid tartrate from a non-
agricultural substance to an agricultural substance and requires the 
organic form of the ingredient when commercially available. This rule 
also corrects the amendatory instructions to ensure proper placement of 
the regulatory text.

DATES: This final rule is effective May 30, 2019.

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 final rule amends the National List to implement NOSB 
recommendations on two amendments to the National List that were 
submitted to the Secretary on November 2, 2017. The amendments in this 
final rule are discussed in the section on Overview of Amendments 
below.

II. Overview of Amendments

    The following provides an overview of the amendments to designated 
sections of the National List regulations. The background information 
on each substance and the basis for the NOSB recommendation were 
addressed in the proposed rule (83 FR 18744) and have not been included 
in this final rule. The NOSB evaluated each substance by applying the 
OFPA substance evaluation criteria to determine if the substance is 
compatible with organic production and handing. For each substance, AMS 
reviewed the recommendation submitted to the Secretary to determine if 
the OFPA evaluation criteria had been appropriately applied and whether 
the addition to or amendment of the National List would not supersede 
other federal regulations. Our review determined that the substances 
described in this final rule meet these conditions. Therefore, AMS 
accepted each NOSB recommendation and initiated this rulemaking.
    AMS received five comments on the proposed rule. After considering 
the received comments, AMS has determined that the addition of 
elemental sulfur to the National List for organic livestock production 
and amendment of potassium acid tartrate described in the proposed rule 
will be finalized without change. Section E of this final rule provides 
an overview of the received comments and AMS's response to these 
comments.

Sec.  205.603 Synthetic Substances Allowed for Use in Organic Livestock 
Production

    This final rule adds one substance, elemental sulfur, to Sec.  
205.603, synthetic substances allowed for use in organic livestock 
production.
Elemental Sulfur
    This final rule amends Sec.  205.603(b) of the National List to add 
elemental sulfur for use as a parasiticide to treat livestock and 
livestock housing as paragraph (b)(2). Elemental sulfur is added to the 
National List 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 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. Elemental sulfur is also on the National List 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). Organic 
livestock or poultry producers can use elemental sulfur as a topical 
treatment when preventive practices are inadequate to prevent mite, 
flea, or tick infestation. When organic livestock producers plan to use 
elemental sulfur as a topical pest control, certifying agents must 
ensure that preventive pest control practices along with the possible 
use of elemental sulfur are included in the producer's organic system 
plan. Agents must also verify implementation of preventive practices 
before approving the use of elemental sulfur during onsite inspection.

[[Page 18134]]

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 rule removes one substance, potassium acid tartrate, from 
Sec.  205.605 and relists this substance in Sec.  205.606.
Potassium Acid Tartrate
    This final rule amends the National List to reclassify potassium 
acid tartrate from a nonagricultural substance listed in Sec.  
205.605(b) to an agricultural substance listed in Sec.  205.606(q).
    Potassium acid tartrate is currently allowed as a synthetic 
substance for use in organic handling. Potassium acid tartrate has been 
on the National List in Sec.  205.605(b) since October 2002. A 2017 
technical report reviewed by the NOSB indicates that potassium acid 
tartrate is a byproduct of the wine making process and is extracted 
with water. Based upon this information, the NOSB during its October 
31-November 2, 2017 meeting recommended reclassifying potassium acid 
tartrate as an agricultural substance and moving it to Sec.  205.606 of 
the National List. This amendment to the USDA organic regulations 
requires organic handlers who use potassium acid tartrate to source an 
organic form of the ingredient. Only when organic potassium acid 
tartrate is not commercially available \1\ can nonorganic potassium 
acid tartrate be used in organic handling. When certifying agents 
review handling organic system plans that include the use of potassium 
acid tartrate, they must ensure that organic potassium acid tartrate is 
used unless it is documented that organic potassium acid tartrate is 
not commercially available. Sourcing of potassium acid tartrate must 
also be verified during inspection.
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    \1\ See 7 CFR 205.606 and 7 CFR 205.2 for definition of 
``Commercially available.''
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III. Related Documents

    The NOSB proposal to add elemental sulfur to the National List and 
to re-designate the listing of potassium acid tartrate as a non-organic 
agricultural product on the National List was published on April 30, 
2018. In addition, on May 30, 2017, a Notice was published in the 
Federal Register (82 FR 24659) announcing the fall 2017 NOSB meeting. 
One purpose of the meeting was to deliberate on substances either 
petitioned or recommended 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 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 rulemaking falls within a category of regulatory actions that 
the Office of Management and Budget (OMB) has exempted from Executive 
Order 12866. Additionally, because this final 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.
    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 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 farm gate sales in excess of $7.5 billion.\2\ 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.
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    \2\ 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.
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    According to the NOP's Organic Integrity Database there are 9,633 
certified handlers in the U.S.\3\ 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.
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    \3\ Organic Integrity Database: https://organic.ams.usda.gov/Integrity/. Accessed on March 23, 2018.
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    The USDA has 80 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

[[Page 18135]]

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 final 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 final 
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 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 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 final 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-17-0080; NOP-17-09

    During a 60-day comment period that closed on June 29, 2018, AMS 
received five comments on proposed rule AMS-NOP-17-0080. These comments 
were submitted by a certifying agent, a dairy producers' association, 
an egg producer, a trade association, and a dairy operation. The 
received comments can be viewed at https://www.regulations.gov/ by 
searching for the document AMS-NOP-17-0080.
Comments Received on Additions to Sec.  205.603
    All comments received by AMS indicated support for the addition of 
elemental sulfur to Sec.  205.603(b) for use as an external 
parasiticide to treat organic livestock and poultry for the control of 
mites, fleas, and ticks when preventive practices are ineffective. The 
certifying agent's comment noted that elemental sulfur is effective 
when dusted on or rubbed into the feathers of poultry or hair of 
livestock and applied to appropriate surfaces of livestock housing. The 
egg producer stated that elemental sulfur is the only effective 
substance for removing or repelling mite infestation in cage-free 
poultry. The dairy operation commented that elemental sulfur works as a 
repellant to mites, fleas, and ticks that may be vectors of disease 
that can be transmitted to livestock. The comment from the membership-
based trade association supported adding elemental sulfur to the 
National List for topical pest control since current available 
alternative topical control substances are limited to specific 
livestock species, such as dairy, or have limited efficacy in 
controlling lice or mites. Comments on elemental sulfur did not propose 
amending the elemental sulfur annotation to further restrict its 
application when use in organic production. Also, AMS did not receive 
comments that opposed the addition of elemental sulfur to Sec.  
205.603.
Comments Received on Amendment to Sec.  205.606
    AMS received only one comment on reclassifying potassium acid 
tartrate, also known as cream of tartar, as a synthetic substance 
listed in Sec.  205.605 to a nonorganic agricultural substance included 
in Sec.  205.606. In its comment, the member-based trade association 
noted that potassium acid tartrate's prior classification as a 
synthetic nonagricultural substance in Sec.  205.605 was not accurate 
given that potassium acid tartrate is produced through mechanical and 
natural processes utilizing hot water, filtering, cooling and 
precipitation associated with the winemaking process. The trade 
association also stated that the reclassification of potassium acid 
tartrate to Sec.  205.606 provides incentive for the development of 
organic potassium acid tartrate, because organic sources for this 
substance are currently scarce given the limited production of USDA 
certified organic wine.
AMS Response to Comments
    AMS agrees with the received comments supporting the addition of 
elemental sulfur to Sec.  205.603 and the reclassification of potassium 
acid tartrate for Sec.  205.605 to Sec.  205.606. AMS determined that 
the addition of elemental sulfur to the National List as a topical 
livestock treatment and the reassignment of potassium acid tartrate as 
a non-organic agricultural product met the OFPA substance evaluation 
criteria. AMS also determined that these amendments to the National 
List did not supersede other federal regulations. The comments received 
on the proposal supported the amendments and did not provide any basis 
for reconsidering the amendments. Consequently, this final rule makes 
no changes to the respective listings that were described in the 
proposed rule.

[[Page 18136]]

    On December 27, 2018, AMS published a rule amending Sec. Sec.  
205.603 and 205.606, effective January 28, 2019 (83 FR 66559). 
Therefore, the amendatory instructions in this final rule have been 
updated from those set out in the proposed rule that was published 
April 30, 2018.
F. General Notice of Public Rulemaking
    This final 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.

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 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 (10) 
as (b)(3) through (11) 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(b) by removing ``Potassium acid tartrate.''


0
4. Amend Sec.  205.606 by redesignating paragraphs (q) through (v) as 
(r) through (w) and adding new paragraph (q) to read as follows:


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

* * * * *
    (q) Potassium acid tartrate.
* * * * *

    Dated: April 25, 2019.
Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2019-08700 Filed 4-29-19; 8:45 am]
BILLING CODE 3410-02-P