National Organic Program; Amendments to the National List of Allowed and Prohibited Substances per April 2018 NOSB Recommendations (Crops and Handling), 56673-56677 [2019-23035]
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56673
Rules and Regulations
Federal Register
Vol. 84, No. 205
Wednesday, October 23, 2019
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.
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS–NOP–18–0051;
NOP–18–02]
RIN 0581 AD80
National Organic Program;
Amendments to the National List of
Allowed and Prohibited Substances
per April 2018 NOSB
Recommendations (Crops and
Handling)
Agricultural Marketing Service,
USDA.
ACTION: Final rule.
AGENCY:
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
SUMMARY:
Secretary of Agriculture (Secretary) by
the National Organic Standards Board
(NOSB). This rule adds elemental sulfur
for use as a molluscicide in organic crop
production, adds polyoxin D zinc salt to
control fungal diseases in organic crop
production, and reclassifies magnesium
chloride from an allowed synthetic to an
allowed nonsynthetic ingredient in
organic handling.
DATES: This final rule is effective
November 22, 2019.
FOR FURTHER INFORMATION CONTACT:
Valerie Frances, 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
substance allowances and nonsynthetic
substance prohibitions in organic
farming. The National List also
identifies synthetic and nonsynthetic
nonagricultural substances, 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 § 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 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 developed 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 three amendments
to the National List that were submitted
to the Secretary on April 27, 2018. The
amendments in this final rule are
discussed in the section on Overview of
Amendments below.
II. Overview of Final 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 (84 FR 4377) and are not
included in this final rule. Table 1
summarizes the final changes to the
National List based on these NOSB
recommendations.
TABLE 1—FINAL AMENDMENTS TO THE NATIONAL LIST
Substance
National list section
Elemental sulfur ..............................
Polyoxin D zinc salt .........................
Magnesium chloride ........................
§ 205.601(h) ...................................
§ 205.601(i) ....................................
§ 205.605(b) to § 205.605(a) .........
The NOSB evaluated each substance
by applying the OFPA substance
evaluation criteria to determine if the
substance is compatible with organic
production and handling (7 U.S.C.
6517(c) and 6518(m)). 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
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Final rule action
Add to National List.
Add to National List.
Reclassify listing and move within National List.
described in this final rule meet these
conditions. Therefore, AMS accepted
each NOSB recommendation and
initiated this rulemaking.
AMS received thirteen comments on
the proposed rule. After considering the
received comments, AMS has
determined that the addition of
elemental sulfur and polyoxin D zinc
salt to the National List for organic crop
production and the reclassification of
magnesium chloride from an allowed
synthetic to an allowed nonsynthetic
ingredient in organic handling will be
finalized without change. Section E of
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this final rule provides an overview of
the public comments and AMS’s
response to these comments.
§ 205.601 Synthetic Substances
Allowed for Use in Organic Crop
Production
This final rule adds two substances to
§ 205.601, synthetic substances allowed
for use in organic crop production.
Elemental Sulfur
The final rule amends the National
List to add elemental sulfur to
§ 205.601(h) for use as a molluscicide
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bait to control slugs and snails. Table 2
illustrates the final rule action.
TABLE 2—FINAL RULE ACTION FOR
ELEMENTAL SULFUR
Current rule ...
Final rule action.
N/A.
Add elemental sulfur to
§ 205.601(h) as slug or
snail bait.
This permits the use of elemental
sulfur-based bait, providing an
additional tool to organic producers to
control slugs and snails when other
required preventive measures have
failed to provide sufficient control
(§ 205.206(e)). Elemental sulfur is also
on the National List for use in organic
crop production as an insecticide
(including mite control) in § 205.601(e);
as plant disease control in § 205.601(i);
as a plant or soil amendment in
§ 205.601(j); and in organic livestock
production for treatment of livestock
and livestock housing in § 205.603(b)(2).
The USDA organic regulations require
organic crop producers to describe
practices to prevent and control pests in
their organic system plan (OSP)
(§ 205.201(a)(1)). In addition, producers
must use preventive practices and
physical and mechanical means to
control pests before using an allowed
synthetic substance, such as elemental
sulfur. Finally, producers need to
describe the conditions under which
elemental sulfur may be used for slug
and snail control in their OSP
(§ 205.206(e)). Certifying agents must
ensure that producers comply with
these requirements.
Polyoxin D Zinc Salt
The final rule amends the National
List to add polyoxin D zinc salt to
control fungal diseases at § 205.601(i).
Table 3 illustrates the final rule change.
TABLE 3—FINAL RULE ACTION FOR
POLYOXIN D ZINC SALT
Current rule ...
Final rule action.
N/A.
Add polyoxin D zinc salt to
§ 205.601(i) as plant disease control.
This permits the use of polyoxin D
zinc salt in organic crop production.
The USDA organic regulations require
organic crop producers to describe
practices to prevent and control crop
diseases in their organic system plan
(OSP) (§ 205.201(a)(1)). In addition,
producers must use preventive practices
and management practices, or
nonsynthetic substances to suppress the
spread of plant disease before using an
allowed synthetic, such as polyoxin D
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zinc salt. Finally, producers need to
describe the conditions under which
polyoxin D zinc salt may be used for
disease control in their OSP
(§ 205.206(e)). Certifying agents must
ensure that producers comply with
these requirements.
§ 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 final rule reclassifies magnesium
chloride from an allowed synthetic
ingredient in § 205.605(b) to an allowed
nonsynthetic ingredient in § 205.605(a).
Magnesium Chloride
This final rule reclassifies magnesium
chloride as a nonsynthetic substance
that may be used in organic handling. It
also removes the annotation that
magnesium chloride must be ‘‘derived
from sea water.’’ Table 4 illustrates the
final rule change.
TABLE 4—FINAL RULE ACTION FOR
MAGNESIUM CHLORIDE
Current rule ...
Final rule action.
§ 205.605(b) Magnesium
chloride—derived from sea
water.
Remove magnesium chloride
from § 205.605(b) and insert magnesium chloride
under § 205.605(a) without
annotation.
The primary uses of magnesium
chloride in organic food processing are
as a firming agent in tofu processing and
as a source of the essential mineral
magnesium in organic infant formula.
Magnesium chloride is the simple salt of
the halogen chlorine and the alkaline
earth metal magnesium. Magnesium
chloride can be derived from terminal
lake brines, subsurface brine deposits,
and mined mineral deposits, as well as
seawater.1 This substance is
nonsynthetic when derived from natural
sources and manufactured in a way that
does not chemically change the
substance (see § 205.2 definitions of
nonsynthetic (natural) and synthetic).
Guidance documents NOP 5033,
Classification of Materials, and NOP
5033–1, the Decision Tree for the
Classification of Materials as Synthetic
or Nonsynthetic,2 describe a procedure
1 NOSB Recommendations 2018 Spring Meeting:
https://www.ams.usda.gov/sites/default/files/
media/HSMagnesiumChlorideReclassRec.pdf.
2 NOP 5033 Classification of Materials & NOP
5033–1 Decision Tree for the Classification of
Materials as Synthetic or Nonsynthetic: https://
www.ams.usda.gov/sites/default/files/media/
Program%20Handbk_TOC.pdf.
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to classify materials as synthetic or
nonsynthetic. This final rule prohibits
the use of synthetic forms of magnesium
chloride in organic handling.
Organic handlers who use magnesium
chloride must ensure that the product is
a nonsynthetic, compliant form of this
substance prior to use. Certifying agents
must also verify that the magnesium
chloride used is compliant with the
nonsynthetic classification. Information
about the source of the magnesium
chloride and its manufacturing process
could provide sufficient details to
determine compliance.
III. Related Documents
On January 17, 2018, a Notice was
published in the Federal Register (83
FR 2373) announcing the spring 2018
NOSB meeting. One purpose of the
meeting was to deliberate on
recommendations on current substances
on the National List, and substances
petitioned as amendments. The
proposal to add elemental sulfur for use
as a molluscicide in organic crop
production, add polyoxin D zinc salt to
control fungal diseases in organic crop
production, and reclassify magnesium
chloride from an allowed synthetic to an
allowed nonsynthetic ingredient in
organic handling was published in the
Federal Register (84 FR 4377) on
February 15, 2019. Additional
information on or about the substances
in this final rule, including petitions,
technical reports, and NOSB
recommendations, is available on the
AMS website at https://
www.ams.usda.gov/rules-regulations/
organic/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 permits any person to
petition to add or remove a substance
from the National List. The current
petition procedures for amending the
National List published in the Federal
Register (81 FR 12680, March 10, 2016)
can also be accessed through the NOP
Program Handbook on the NOP website
at https://www.ams.usda.gov/rulesregulations/organic/handbook.
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A. Executive Orders 12866 and 13771,
and Regulatory Flexibility Act
This final rule falls within a category
of regulatory actions that the Office of
Management and Budget (OMB) has
designated as not a significant
regulatory action under Executive Order
12866. Consequently, this action 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.3 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 final 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
3 U.S. Small Business Administration regulations:
https://www.ecfr.gov/cgi-bin/text-idx?
rgn=div5;node=13%3A1.0.1.1.17#se13.1.121_1104.
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to the 2017 Census of Agriculture,
18,166 organic farms in the U.S.
reported sales of organic products and
total farm gate sales in excess of $7.2
billion.4 Based on that data, organic
sales average $400,000 per farm.
Assuming a normal distribution of
producers, we expect that most of these
producers would fall under the
$750,000 sales threshold to qualify as a
small business.
According to the NOP’s Organic
Integrity Database, there are 18,137
certified handlers in the U.S.5 The
Organic Trade Association’s 2018
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.
The USDA has approximately 78
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 would
allow the use of additional and widely
available 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 dayto-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.
4 U.S. Department of Agriculture, National
Agricultural Statistics Service. 2017 Census of
Agriculture. https://www.nass.usda.gov/
Publications/AgCensus/2017/index.php.
5 Organic Integrity Database: https://
organic.ams.usda.gov/Integrity/. Accessed on May
31, 2019.
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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 (EPA)
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 final rule.
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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. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), the Office of
Information and Regulatory Affairs
designated this rule as not a major rule,
as defined by 5 U.S.C. 804(2).
F. Comments Received on Proposed
Rule AMS–NOP–18–0051; NOP–18–02
During a 60-day comment period that
closed on April 16, 2019, AMS received
13 comments on proposed rule AMS–
NOP–18–0051. Two of these comments
incorrectly discussed amendments not
related to this proposed rule and
therefore are not discussed. Of the
remaining 11 comments, 3 were from
trade or farmers’ associations, 1 was
from a membership-based advocacy
group, 1 was from an accredited
certifying agent, and 6 were from
unaffiliated commenters. The received
comments can be viewed at https://
www.regulations.gov/ by searching for
the document AMS–NOP–18–0051.
AMS General Response to Comments on
Amendments to § 205.601
Organic crop producers must describe
their management practices to prevent
specific pest infestations and plant
diseases, and the specific conditions
under which the use of the allowed
synthetic materials may be necessary in
their OSP (§§ 205.201(a)(1) and
205.206(e)). The USDA organic
regulations require that the producer
first use mechanical or physical
methods or nonsynthetic materials to
control pests and plant diseases. When
these are not sufficient, organic
producers may use synthetic materials
that are listed as allowed on § 205.601
and specified in their OSP. In addition,
nonsynthetic and allowed synthetic
materials must be used as specified on
their material safety data sheet (MSDS)
and product label. Certifying agents
must ensure that the preventive
mechanical and physical practices and
the nonsynthetic materials along with
the conditions for when synthetic
material use is necessary are all
described in the producer’s OSP.
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Certifying agents must also verify that
the preventive mechanical and physical
practices and the nonsynthetic materials
to address the target problems were
implemented prior to the use of the
synthetic material (§ 205.206(e)).
Comments Received on the Addition of
Elemental Sulfur to § 205.601 for Use as
Slug and Snail Bait
AMS received nine public comments
regarding the proposed addition of
elemental sulfur to § 205.601 as an
allowed synthetic substance for use in
crop production. Five of these
comments supported the proposed
addition, while four of the comments
opposed it.
The comments supporting the
proposed use of elemental sulfur cited
the substance’s proven effectiveness as
a molluscicide. Several commenters
argued that the proposed use of
elemental sulfur is essential to organic
agriculture because typical organic
farming practices (e.g., reduced tillage
and mulching) support slug and snail
populations. Supporting commenters
also noted that allowing elemental
sulfur as slug and snail bait would be
consistent with the current organic
regulations, which allow its use as a soil
amendment and insecticide.
Commenters opposed to the use of
elemental sulfur as a molluscicide
stated that the substance can be harmful
to farmworkers and that overuse could
lead to acidification of soil and water.
Several commenters noted that most
elemental sulfur production is a
byproduct of oil and natural gas
refining. One commenter also had
concerns that using elemental sulfur to
control slugs and snails could
inadvertently harm beneficial
organisms.
AMS Response to Comments on the
Addition of Elemental Sulfur to
§ 205.601 for Use as Slug and Snail Bait
AMS disagrees with comments
opposed to the use of elemental sulfur
in organic crop production as a
molluscicide. Elemental sulfur was
assessed according to the OFPA criteria
(7 U.S.C. 6518(m)). AMS determined
that elemental sulfur used as a
molluscicide meets the OFPA
evaluation criteria, when used as
labeled. There is a long history of
review and managed allowance of
elemental sulfur for a variety of uses in
organic crop production. Organic
producers must maintain or improve
soil and water quality (§ 205.200).
Further, organic producers must first
use mechanical or physical methods or
nonsynthetic materials to control pests
and plant diseases. When these are not
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sufficient, organic producers may use an
allowed synthetic, such as sulfur, under
the conditions described in their OSP
(§ 205.206(e)). Any use of nonsynthetic
or allowed synthetic materials must be
as specified on the material safety data
sheets (MSDS) and product labels to
prevent injury to humans, animals,
plants, and nontarget and beneficial
insects, and detrimental impacts on soil
health and air or water quality.
Producers should monitor their soil pH
and health with appropriate soil tests as
needed, or as requested by a certifying
agent. The requirements in the USDA
organic regulations and the application
instructions on the MSDS and product
labels support the use of sulfur as a
molluscicide in a manner that is safe for
human health and the environment.
Comments Received on the Addition of
Polyoxin D Zinc Salt to § 205.601 as
Plant Disease Control
AMS received nine public comments
regarding the addition of polyoxin D
zinc salt to § 205.601 for plant disease
control. Three of the comments
supported the proposed addition of this
substance, and six opposed its addition.
Comments in support of the proposed
addition of polyoxin D zinc salt
referenced the material’s effectiveness at
controlling plant pathogenic fungi, as
well as the material’s unique mode of
action. It does not kill fungi, but instead
prevents growth. Commenters argued
that polyoxin D zinc salt is needed in
organic agriculture as an alternative
form of plant disease control and cited
the material’s history of safe use in
foreign and domestic conventional
agriculture. Additionally, two
commenters noted that concerns
regarding possible harmful impacts on
soil-borne fungi and beneficial insects
caused by or resulting from the use of
polyoxin D zinc salt were adequately
addressed by the technical reports and
petitions reviewed by the NOSB.
Comments opposed to the use of
polyoxin D zinc salt cited an EPA report
that noted moderate toxicity to
freshwater invertebrates. A commenter
stated that there are alternative products
and practices other than polyoxin D
zinc salt available for plant disease
control. A commenter raised concern
that the broad-spectrum mode of action
of polyoxin D zinc salt may harm
beneficial soil-borne fungi and insects
such as pollinators. The same
commenter also was also concerned that
the material may degrade slowly and
accumulate in soil.
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AMS Response to Comments on the
Addition of Polyoxin D Zinc Salt to
§ 205.601 for Plant Disease Control
AMS disagrees with comments
opposed to the use of polyoxin D zinc
salt in organic crop production. As
stated in the 2017 technical report,
polyoxin D zinc salt prevents the growth
of fungi rather than destroying them. In
addition, studies on macroinvertebrates, including pollinators and
earthworms, indicated no or little toxic
effects. While the soil half-life from
aerobic microbial metabolism could be
upwards to 15.9 days, photolytic
degradation from sunlight was observed
as soon as 1.6 days in spring conditions,
and generally within 2–3 days,
especially in alkaline soil.
Consequently, polyoxin D zinc salt has
not been found to accumulate or persist
in soil. Polyoxin D zinc salt was
assessed according to the OFPA criteria
(7 U.S.C. 6518(m)). AMS determined
that the use of polyoxin D zinc salt for
plant disease control meets the OFPA
evaluation criteria.
In addition, like all synthetic
materials allowed for use in organic
agricultural production per § 205.601,
organic crop producers must describe
their management practices to prevent
specific pest infestations and plant
diseases, and the specific conditions
under which the use of polyoxin D zinc
salt may be necessary in their OSP
(§§ 205.201(a)(1) and 205.206(e)). The
USDA organic regulations require that
the producer first use mechanical or
physical methods or nonsynthetic
materials to control pests and plant
diseases. When these are not sufficient,
organic producers may use polyoxin D
salt as described in their OSP.
Nonsynthetic and allowed synthetic
materials must be use as specified on
their material safety data sheet (MSDS)
and product label to prevent injury to
humans, animals, plants, and nontarget
and beneficial insects, and detrimental
impacts on soil health and air or water
quality. Producers should monitor their
soil pH and health with appropriate soil
tests as needed, or as requested by a
certifying agent.
Comments Received on the Addition of
Magnesium Chloride to § 205.605 as an
Ingredient in or on Processed Products
AMS received eight public comments
regarding the proposed reclassification
of magnesium chloride as a
nonsynthetic allowed for use in
processed organic products.
Commenters broadly supported the
proposed reclassification, stating that
many nonsynthetic forms of magnesium
chloride are commercially available.
VerDate Sep<11>2014
16:04 Oct 22, 2019
Jkt 250001
One commenter was opposed to the
reclassification of magnesium chloride;
however, no substantive reason for the
opposition was given.
Two commenters who supported
reclassifying magnesium chloride as a
nonsynthetic for use in handling also
raised concerns that this reclassification
would allow its use in organic crop
production without restriction. They
cautioned against future rulemaking
allowing the use of magnesium chloride
in crop production, citing concerns that
chloride can accumulate in the soil and
that this would allow the application of
magnesium as an instantly available
micronutrient, which are contrary to
organic production practices. Both
commenters requested that AMS ask the
NOSB to consider prohibiting the use of
nonsynthetic forms of magnesium
chloride in organic crop production by
listing it on § 205.602.
AMS Response to Comments on
Magnesium Chloride
AMS disagrees with commenters that
allowing nonsynthetic magnesium
chloride for organic handling affects use
of magnesium chloride in organic crop
and livestock production. Nonsynthetic
forms of magnesium chloride have
always been allowed for organic crop
and livestock production because
magnesium chloride is not specifically
prohibited at either § 205.602 or
§ 205.604. Furthermore, this final rule
does not alter the definition of the terms
‘‘synthetic,’’ ‘‘nonsynthetic (natural),’’
or ‘‘chemical change’’ in the USDA
organic regulations (§ 205.2).
Commenters who are concerned about
the allowance of nonsynthetic forms of
magnesium chloride in organic crop or
livestock production can petition the
NOSB to consider prohibiting at
§ 205.602 or § 205.604.
F. General Notice of Public Rulemaking
This final rule reflects
recommendations submitted by the
NOSB to the Secretary to add two
substances 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, Archives and
records, Crops, Imports, Labeling,
National List, 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:
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
56677
PART 205—NATIONAL ORGANIC
PROGRAM
1. The authority citation for part 205
continues to read as follows:
■
Authority: 7 U.S.C. 6501–6522.
2. Amend § 205.601 by revising
paragraph (h) and adding (i)(11) to read
as follows:
■
§ 205.601 Synthetic substances allowed
for use in organic crop production.
*
*
*
*
*
(h) As slug or snail bait.
(1) Ferric phosphate (CAS # 10045–
86–0).
(2) Elemental sulfur.
(i) * * *
(11) Polyoxin D zinc salt.
*
*
*
*
*
■ 3. Amend § 205.605 as follows:
■ a. In paragraph (a), add in alphabetical
order an entry for ‘‘Magnesium
chloride’’; and
■ b. In paragraph (b), remove
‘‘Magnesium chloride—derived from
seawater’’.
The addition reads as follows:
§ 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)).’’
*
*
*
*
*
(a) * * *
Magnesium chloride.
*
*
*
*
*
Dated: October 17, 2019.
Bruce Summers,
Administrator, Agricultural Marketing
Service.
[FR Doc. 2019–23035 Filed 10–22–19; 8:45 am]
BILLING CODE 3410–02–P
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
9 CFR Parts 201, 202, and 203
[Doc. No. AMS–FGIS–18–0073 FR]
Reorganization and Transfer of
Regulations; Correction
Agricultural Marketing Service;
Farm Service Agency; Grain Inspection,
Packers, and Stockyards
Administration; USDA.
ACTION: Final rule; correcting
amendments.
AGENCY:
The Agricultural Marketing
Service is making correcting
amendments pertaining to a final rule
that appeared in the Federal Register on
August 30, 2019. The final rule
SUMMARY:
E:\FR\FM\23OCR1.SGM
23OCR1
Agencies
[Federal Register Volume 84, Number 205 (Wednesday, October 23, 2019)]
[Rules and Regulations]
[Pages 56673-56677]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23035]
========================================================================
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.
========================================================================
Federal Register / Vol. 84, No. 205 / Wednesday, October 23, 2019 /
Rules and Regulations
[[Page 56673]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS-NOP-18-0051; NOP-18-02]
RIN 0581 AD80
National Organic Program; Amendments to the National List of
Allowed and Prohibited Substances per April 2018 NOSB Recommendations
(Crops and Handling)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
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 for use as a molluscicide in organic crop production,
adds polyoxin D zinc salt to control fungal diseases in organic crop
production, and reclassifies magnesium chloride from an allowed
synthetic to an allowed nonsynthetic ingredient in organic handling.
DATES: This final rule is effective November 22, 2019.
FOR FURTHER INFORMATION CONTACT: Valerie Frances, 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 substance
allowances and nonsynthetic substance prohibitions in organic farming.
The National List also identifies synthetic and nonsynthetic
nonagricultural substances, 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 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 developed 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 three amendments to the National List that were
submitted to the Secretary on April 27, 2018. The amendments in this
final rule are discussed in the section on Overview of Amendments
below.
II. Overview of Final 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 (84 FR 4377) and are not included in
this final rule. Table 1 summarizes the final changes to the National
List based on these NOSB recommendations.
Table 1--Final Amendments to the National List
------------------------------------------------------------------------
National list
Substance section Final rule action
------------------------------------------------------------------------
Elemental sulfur.............. Sec. 205.601(h) Add to National List.
Polyoxin D zinc salt.......... Sec. 205.601(i) Add to National List.
Magnesium chloride............ Sec. 205.605(b) Reclassify listing
to Sec. and move within
205.605(a). National List.
------------------------------------------------------------------------
The NOSB evaluated each substance by applying the OFPA substance
evaluation criteria to determine if the substance is compatible with
organic production and handling (7 U.S.C. 6517(c) and 6518(m)). 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 thirteen comments on the proposed rule. After
considering the received comments, AMS has determined that the addition
of elemental sulfur and polyoxin D zinc salt to the National List for
organic crop production and the reclassification of magnesium chloride
from an allowed synthetic to an allowed nonsynthetic ingredient in
organic handling will be finalized without change. Section E of this
final rule provides an overview of the public comments and AMS's
response to these comments.
Sec. 205.601 Synthetic Substances Allowed for Use in Organic Crop
Production
This final rule adds two substances to Sec. 205.601, synthetic
substances allowed for use in organic crop production.
Elemental Sulfur
The final rule amends the National List to add elemental sulfur to
Sec. 205.601(h) for use as a molluscicide
[[Page 56674]]
bait to control slugs and snails. Table 2 illustrates the final rule
action.
Table 2--Final Rule Action for Elemental Sulfur
------------------------------------------------------------------------
------------------------------------------------------------------------
Current rule.............................. N/A.
Final rule action......................... Add elemental sulfur to Sec.
205.601(h) as slug or
snail bait.
------------------------------------------------------------------------
This permits the use of elemental sulfur-based bait, providing an
additional tool to organic producers to control slugs and snails when
other required preventive measures have failed to provide sufficient
control (Sec. 205.206(e)). Elemental sulfur is also on the National
List for use in organic crop production as an insecticide (including
mite control) in Sec. 205.601(e); as plant disease control in Sec.
205.601(i); as a plant or soil amendment in Sec. 205.601(j); and in
organic livestock production for treatment of livestock and livestock
housing in Sec. 205.603(b)(2).
The USDA organic regulations require organic crop producers to
describe practices to prevent and control pests in their organic system
plan (OSP) (Sec. 205.201(a)(1)). In addition, producers must use
preventive practices and physical and mechanical means to control pests
before using an allowed synthetic substance, such as elemental sulfur.
Finally, producers need to describe the conditions under which
elemental sulfur may be used for slug and snail control in their OSP
(Sec. 205.206(e)). Certifying agents must ensure that producers comply
with these requirements.
Polyoxin D Zinc Salt
The final rule amends the National List to add polyoxin D zinc salt
to control fungal diseases at Sec. 205.601(i). Table 3 illustrates the
final rule change.
Table 3--Final Rule Action for Polyoxin D Zinc Salt
------------------------------------------------------------------------
------------------------------------------------------------------------
Current rule.............................. N/A.
Final rule action......................... Add polyoxin D zinc salt to
Sec. 205.601(i) as plant
disease control.
------------------------------------------------------------------------
This permits the use of polyoxin D zinc salt in organic crop
production. The USDA organic regulations require organic crop producers
to describe practices to prevent and control crop diseases in their
organic system plan (OSP) (Sec. 205.201(a)(1)). In addition, producers
must use preventive practices and management practices, or nonsynthetic
substances to suppress the spread of plant disease before using an
allowed synthetic, such as polyoxin D zinc salt. Finally, producers
need to describe the conditions under which polyoxin D zinc salt may be
used for disease control in their OSP (Sec. 205.206(e)). Certifying
agents must ensure that producers comply with these requirements.
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 final rule reclassifies magnesium chloride from an allowed
synthetic ingredient in Sec. 205.605(b) to an allowed nonsynthetic
ingredient in Sec. 205.605(a).
Magnesium Chloride
This final rule reclassifies magnesium chloride as a nonsynthetic
substance that may be used in organic handling. It also removes the
annotation that magnesium chloride must be ``derived from sea water.''
Table 4 illustrates the final rule change.
Table 4--Final Rule Action for Magnesium Chloride
------------------------------------------------------------------------
------------------------------------------------------------------------
Current rule.............................. Sec. 205.605(b) Magnesium
chloride--derived from sea
water.
Final rule action......................... Remove magnesium chloride
from Sec. 205.605(b) and
insert magnesium chloride
under Sec. 205.605(a)
without annotation.
------------------------------------------------------------------------
The primary uses of magnesium chloride in organic food processing
are as a firming agent in tofu processing and as a source of the
essential mineral magnesium in organic infant formula. Magnesium
chloride is the simple salt of the halogen chlorine and the alkaline
earth metal magnesium. Magnesium chloride can be derived from terminal
lake brines, subsurface brine deposits, and mined mineral deposits, as
well as seawater.\1\ This substance is nonsynthetic when derived from
natural sources and manufactured in a way that does not chemically
change the substance (see Sec. 205.2 definitions of nonsynthetic
(natural) and synthetic). Guidance documents NOP 5033, Classification
of Materials, and NOP 5033-1, the Decision Tree for the Classification
of Materials as Synthetic or Nonsynthetic,\2\ describe a procedure to
classify materials as synthetic or nonsynthetic. This final rule
prohibits the use of synthetic forms of magnesium chloride in organic
handling.
---------------------------------------------------------------------------
\1\ NOSB Recommendations 2018 Spring Meeting: https://www.ams.usda.gov/sites/default/files/media/HSMagnesiumChlorideReclassRec.pdf.
\2\ NOP 5033 Classification of Materials & NOP 5033-1 Decision
Tree for the Classification of Materials as Synthetic or
Nonsynthetic: https://www.ams.usda.gov/sites/default/files/media/Program%20Handbk_TOC.pdf.
---------------------------------------------------------------------------
Organic handlers who use magnesium chloride must ensure that the
product is a nonsynthetic, compliant form of this substance prior to
use. Certifying agents must also verify that the magnesium chloride
used is compliant with the nonsynthetic classification. Information
about the source of the magnesium chloride and its manufacturing
process could provide sufficient details to determine compliance.
III. Related Documents
On January 17, 2018, a Notice was published in the Federal Register
(83 FR 2373) announcing the spring 2018 NOSB meeting. One purpose of
the meeting was to deliberate on recommendations on current substances
on the National List, and substances petitioned as amendments. The
proposal to add elemental sulfur for use as a molluscicide in organic
crop production, add polyoxin D zinc salt to control fungal diseases in
organic crop production, and reclassify magnesium chloride from an
allowed synthetic to an allowed nonsynthetic ingredient in organic
handling was published in the Federal Register (84 FR 4377) on February
15, 2019. Additional information on or about the substances in this
final rule, including petitions, technical reports, and NOSB
recommendations, is available on the AMS website at https://www.ams.usda.gov/rules-regulations/organic/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
permits any person to petition to add or remove a substance from the
National List. The current petition procedures for amending the
National List published in the Federal Register (81 FR 12680, March 10,
2016) can also be accessed through the NOP Program Handbook on the NOP
website at https://www.ams.usda.gov/rules-regulations/organic/handbook.
[[Page 56675]]
A. Executive Orders 12866 and 13771, and Regulatory Flexibility Act
This final rule falls within a category of regulatory actions that
the Office of Management and Budget (OMB) has designated as not a
significant regulatory action under Executive Order 12866.
Consequently, this action 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.\3\
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.
---------------------------------------------------------------------------
\3\ U.S. Small Business Administration regulations: https://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=13%3A1.0.1.1.17#se13.1.121_1104.
---------------------------------------------------------------------------
AMS has considered the economic impact of this final 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 2017 Census of Agriculture, 18,166
organic farms in the U.S. reported sales of organic products and total
farm gate sales in excess of $7.2 billion.\4\ Based on that data,
organic sales average $400,000 per farm. Assuming a normal distribution
of producers, we expect that most of these producers would fall under
the $750,000 sales threshold to qualify as a small business.
---------------------------------------------------------------------------
\4\ U.S. Department of Agriculture, National Agricultural
Statistics Service. 2017 Census of Agriculture. https://www.nass.usda.gov/Publications/AgCensus/2017/index.php.
---------------------------------------------------------------------------
According to the NOP's Organic Integrity Database, there are 18,137
certified handlers in the U.S.\5\ The Organic Trade Association's 2018
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.
---------------------------------------------------------------------------
\5\ Organic Integrity Database: https://organic.ams.usda.gov/Integrity/. Accessed on May 31, 2019.
---------------------------------------------------------------------------
The USDA has approximately 78 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 would allow the use of additional
and widely available 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 (EPA) 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 final rule.
[[Page 56676]]
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. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a major rule, as defined by 5 U.S.C. 804(2).
F. Comments Received on Proposed Rule AMS-NOP-18-0051; NOP-18-02
During a 60-day comment period that closed on April 16, 2019, AMS
received 13 comments on proposed rule AMS-NOP-18-0051. Two of these
comments incorrectly discussed amendments not related to this proposed
rule and therefore are not discussed. Of the remaining 11 comments, 3
were from trade or farmers' associations, 1 was from a membership-based
advocacy group, 1 was from an accredited certifying agent, and 6 were
from unaffiliated commenters. The received comments can be viewed at
https://www.regulations.gov/ by searching for the document AMS-NOP-18-
0051.
AMS General Response to Comments on Amendments to Sec. 205.601
Organic crop producers must describe their management practices to
prevent specific pest infestations and plant diseases, and the specific
conditions under which the use of the allowed synthetic materials may
be necessary in their OSP (Sec. Sec. 205.201(a)(1) and 205.206(e)).
The USDA organic regulations require that the producer first use
mechanical or physical methods or nonsynthetic materials to control
pests and plant diseases. When these are not sufficient, organic
producers may use synthetic materials that are listed as allowed on
Sec. 205.601 and specified in their OSP. In addition, nonsynthetic and
allowed synthetic materials must be used as specified on their material
safety data sheet (MSDS) and product label. Certifying agents must
ensure that the preventive mechanical and physical practices and the
nonsynthetic materials along with the conditions for when synthetic
material use is necessary are all described in the producer's OSP.
Certifying agents must also verify that the preventive mechanical and
physical practices and the nonsynthetic materials to address the target
problems were implemented prior to the use of the synthetic material
(Sec. 205.206(e)).
Comments Received on the Addition of Elemental Sulfur to Sec. 205.601
for Use as Slug and Snail Bait
AMS received nine public comments regarding the proposed addition
of elemental sulfur to Sec. 205.601 as an allowed synthetic substance
for use in crop production. Five of these comments supported the
proposed addition, while four of the comments opposed it.
The comments supporting the proposed use of elemental sulfur cited
the substance's proven effectiveness as a molluscicide. Several
commenters argued that the proposed use of elemental sulfur is
essential to organic agriculture because typical organic farming
practices (e.g., reduced tillage and mulching) support slug and snail
populations. Supporting commenters also noted that allowing elemental
sulfur as slug and snail bait would be consistent with the current
organic regulations, which allow its use as a soil amendment and
insecticide.
Commenters opposed to the use of elemental sulfur as a molluscicide
stated that the substance can be harmful to farmworkers and that
overuse could lead to acidification of soil and water. Several
commenters noted that most elemental sulfur production is a byproduct
of oil and natural gas refining. One commenter also had concerns that
using elemental sulfur to control slugs and snails could inadvertently
harm beneficial organisms.
AMS Response to Comments on the Addition of Elemental Sulfur to Sec.
205.601 for Use as Slug and Snail Bait
AMS disagrees with comments opposed to the use of elemental sulfur
in organic crop production as a molluscicide. Elemental sulfur was
assessed according to the OFPA criteria (7 U.S.C. 6518(m)). AMS
determined that elemental sulfur used as a molluscicide meets the OFPA
evaluation criteria, when used as labeled. There is a long history of
review and managed allowance of elemental sulfur for a variety of uses
in organic crop production. Organic producers must maintain or improve
soil and water quality (Sec. 205.200). Further, organic producers must
first use mechanical or physical methods or nonsynthetic materials to
control pests and plant diseases. When these are not sufficient,
organic producers may use an allowed synthetic, such as sulfur, under
the conditions described in their OSP (Sec. 205.206(e)). Any use of
nonsynthetic or allowed synthetic materials must be as specified on the
material safety data sheets (MSDS) and product labels to prevent injury
to humans, animals, plants, and nontarget and beneficial insects, and
detrimental impacts on soil health and air or water quality. Producers
should monitor their soil pH and health with appropriate soil tests as
needed, or as requested by a certifying agent. The requirements in the
USDA organic regulations and the application instructions on the MSDS
and product labels support the use of sulfur as a molluscicide in a
manner that is safe for human health and the environment.
Comments Received on the Addition of Polyoxin D Zinc Salt to Sec.
205.601 as Plant Disease Control
AMS received nine public comments regarding the addition of
polyoxin D zinc salt to Sec. 205.601 for plant disease control. Three
of the comments supported the proposed addition of this substance, and
six opposed its addition.
Comments in support of the proposed addition of polyoxin D zinc
salt referenced the material's effectiveness at controlling plant
pathogenic fungi, as well as the material's unique mode of action. It
does not kill fungi, but instead prevents growth. Commenters argued
that polyoxin D zinc salt is needed in organic agriculture as an
alternative form of plant disease control and cited the material's
history of safe use in foreign and domestic conventional agriculture.
Additionally, two commenters noted that concerns regarding possible
harmful impacts on soil-borne fungi and beneficial insects caused by or
resulting from the use of polyoxin D zinc salt were adequately
addressed by the technical reports and petitions reviewed by the NOSB.
Comments opposed to the use of polyoxin D zinc salt cited an EPA
report that noted moderate toxicity to freshwater invertebrates. A
commenter stated that there are alternative products and practices
other than polyoxin D zinc salt available for plant disease control. A
commenter raised concern that the broad-spectrum mode of action of
polyoxin D zinc salt may harm beneficial soil-borne fungi and insects
such as pollinators. The same commenter also was also concerned that
the material may degrade slowly and accumulate in soil.
[[Page 56677]]
AMS Response to Comments on the Addition of Polyoxin D Zinc Salt to
Sec. 205.601 for Plant Disease Control
AMS disagrees with comments opposed to the use of polyoxin D zinc
salt in organic crop production. As stated in the 2017 technical
report, polyoxin D zinc salt prevents the growth of fungi rather than
destroying them. In addition, studies on macro-invertebrates, including
pollinators and earthworms, indicated no or little toxic effects. While
the soil half-life from aerobic microbial metabolism could be upwards
to 15.9 days, photolytic degradation from sunlight was observed as soon
as 1.6 days in spring conditions, and generally within 2-3 days,
especially in alkaline soil. Consequently, polyoxin D zinc salt has not
been found to accumulate or persist in soil. Polyoxin D zinc salt was
assessed according to the OFPA criteria (7 U.S.C. 6518(m)). AMS
determined that the use of polyoxin D zinc salt for plant disease
control meets the OFPA evaluation criteria.
In addition, like all synthetic materials allowed for use in
organic agricultural production per Sec. 205.601, organic crop
producers must describe their management practices to prevent specific
pest infestations and plant diseases, and the specific conditions under
which the use of polyoxin D zinc salt may be necessary in their OSP
(Sec. Sec. 205.201(a)(1) and 205.206(e)). The USDA organic regulations
require that the producer first use mechanical or physical methods or
nonsynthetic materials to control pests and plant diseases. When these
are not sufficient, organic producers may use polyoxin D salt as
described in their OSP. Nonsynthetic and allowed synthetic materials
must be use as specified on their material safety data sheet (MSDS) and
product label to prevent injury to humans, animals, plants, and
nontarget and beneficial insects, and detrimental impacts on soil
health and air or water quality. Producers should monitor their soil pH
and health with appropriate soil tests as needed, or as requested by a
certifying agent.
Comments Received on the Addition of Magnesium Chloride to Sec.
205.605 as an Ingredient in or on Processed Products
AMS received eight public comments regarding the proposed
reclassification of magnesium chloride as a nonsynthetic allowed for
use in processed organic products. Commenters broadly supported the
proposed reclassification, stating that many nonsynthetic forms of
magnesium chloride are commercially available. One commenter was
opposed to the reclassification of magnesium chloride; however, no
substantive reason for the opposition was given.
Two commenters who supported reclassifying magnesium chloride as a
nonsynthetic for use in handling also raised concerns that this
reclassification would allow its use in organic crop production without
restriction. They cautioned against future rulemaking allowing the use
of magnesium chloride in crop production, citing concerns that chloride
can accumulate in the soil and that this would allow the application of
magnesium as an instantly available micronutrient, which are contrary
to organic production practices. Both commenters requested that AMS ask
the NOSB to consider prohibiting the use of nonsynthetic forms of
magnesium chloride in organic crop production by listing it on Sec.
205.602.
AMS Response to Comments on Magnesium Chloride
AMS disagrees with commenters that allowing nonsynthetic magnesium
chloride for organic handling affects use of magnesium chloride in
organic crop and livestock production. Nonsynthetic forms of magnesium
chloride have always been allowed for organic crop and livestock
production because magnesium chloride is not specifically prohibited at
either Sec. 205.602 or Sec. 205.604. Furthermore, this final rule
does not alter the definition of the terms ``synthetic,''
``nonsynthetic (natural),'' or ``chemical change'' in the USDA organic
regulations (Sec. 205.2). Commenters who are concerned about the
allowance of nonsynthetic forms of magnesium chloride in organic crop
or livestock production can petition the NOSB to consider prohibiting
at Sec. 205.602 or Sec. 205.604.
F. General Notice of Public Rulemaking
This final rule reflects recommendations submitted by the NOSB to
the Secretary to add two substances 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, Archives and
records, Crops, Imports, Labeling, National List, 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 part 205 continues to read as follows:
Authority: 7 U.S.C. 6501-6522.
0
2. Amend Sec. 205.601 by revising paragraph (h) and adding (i)(11) to
read as follows:
Sec. 205.601 Synthetic substances allowed for use in organic crop
production.
* * * * *
(h) As slug or snail bait.
(1) Ferric phosphate (CAS # 10045-86-0).
(2) Elemental sulfur.
(i) * * *
(11) Polyoxin D zinc salt.
* * * * *
0
3. Amend Sec. 205.605 as follows:
0
a. In paragraph (a), add in alphabetical order an entry for ``Magnesium
chloride''; and
0
b. In paragraph (b), remove ``Magnesium chloride--derived from
seawater''.
The addition reads as follows:
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)).''
* * * * *
(a) * * *
Magnesium chloride.
* * * * *
Dated: October 17, 2019.
Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2019-23035 Filed 10-22-19; 8:45 am]
BILLING CODE 3410-02-P