National Organic Program; Amendments to the National List of Allowed and Prohibited Substances per October 2018 NOSB Recommendations (Crops and Handling), 70431-70435 [2020-22784]
Download as PDF
70431
Rules and Regulations
Federal Register
Vol. 85, No. 215
Thursday, November 5, 2020
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–19–0023;
NOP–19–01]
RIN 0581 AD83
National Organic Program;
Amendments to the National List of
Allowed and Prohibited Substances
per October 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. This rule adds non-organic
tamarind seed gum as an allowed
ingredient in organic products when
certified organic tamarind seed gum is
not commercially available.
DATES: This final rule is effective
December 7, 2020.
FOR FURTHER INFORMATION CONTACT:
Robert Pooler, Standards Division,
National Organic Program. Telephone:
(202) 720–3252.
SUPPLEMENTARY INFORMATION:
SUMMARY:
khammond on DSKJM1Z7X2PROD with RULES
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 allowed in organic farming
and the nonsynthetic substances
prohibited in organic farming. The
National List also identifies
nonagricultural and nonorganic
agricultural substances (ingredients)
that may be used in organic handling.
VerDate Sep<11>2014
18:31 Nov 04, 2020
Jkt 253001
The Organic Foods Production Act of
1990 (OFPA), as amended (7 U.S.C.
6501–6524), and the USDA organic
regulations (7 CFR part 205) specifically
prohibit the use of any synthetic
substance in organic production and
handling unless the synthetic substance
is on the National List (7 CFR 205.601–
205.606). Section 205.105 also requires
that any nonorganic agricultural
substance 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 addresses one NOSB
recommendation to amend the National
List that was submitted to the Secretary
on October 26, 2018. The amendment in
this final rule is discussed in the section
on Overview of Amendments below.
II. Overview of Amendments
The following provides an overview
of the amendment to a designated
section of the National List regulations.
This rule adds tamarind seed gum to the
National List. This rule does not add
blood meal made with sodium citrate or
natamycin to the National List, as
proposed by AMS (84 FR 55866,
October 18, 2019).
The background information on each
substance and the basis for each NOSB
recommendation was addressed in the
proposed rule. The NOSB evaluated
each substance by applying the OFPA
substance evaluation criteria to
determine if the substance was
compatible with organic production and
handling. For each substance, AMS
reviewed the recommendation
submitted by the NOSB 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.
AMS received 45 comments on the
proposed rule. After considering the
comments, AMS determined that the
addition of nonorganic tamarind seed
gum to the National List for use in
organic handling will be finalized as
proposed. The proposed amendments to
PO 00000
Frm 00001
Fmt 4700
Sfmt 4700
add blood meal made with sodium
citrate and to prohibit the use of
natamycin in organic production have
not been finalized for the reasons
discussed below. Section F of this final
rule provides an overview of the
comments received and AMS’s response
to these comments.
Tamarind Seed Gum
This rule amends the National List to
allow nonorganic tamarind seed gum
(by addition to § 205.606) in organic
products when organic tamarind seed
gum is not commercially available.
Tamarind seed gum is used as a
thickener, stabilizer, emulsifier or
gelling agent in processed foods. The
U.S. Food and Drug Administration
(FDA) has been informed that tamarind
seed is Generally Recognized as Safe
(GRAS) for the above uses.1 During its
October 24–26, 2018, public meeting,
the NOSB recommended adding
tamarind seed gum as an allowed
nonorganic agricultural ingredient to
§ 205.606 of the National List. As
required by the USDA organic
regulations (§ 205.606), the nonorganic
form of the ingredient will only be
permitted when organic tamarind seed
gum is not commercially available.2 To
use nonorganic forms of ingredients
listed at § 205.606, organic handling
operations must demonstrate and
document that organic forms of the
ingredient(s) are not commercially
available. Certifying agents (‘‘certifiers’’)
review the operation’s use of nonorganic
ingredients for compliance with the
regulations in the course of reviewing
an organic operation’s organic system
plan.
Amendments Not Finalized in This Rule
Based upon public comments
received on the proposed rule, AMS is
not finalizing the proposed amendments
to (1) list blood meal made with sodium
citrate as an allowed synthetic
substance for organic crop production or
(2) prohibit natamycin use in crop
1 Agency Response Letter GRAS Notice No. GRN
000503, August 12, 2014; https://wayback.archiveit.org/7993/20171031004449/https://www.fda.gov/
Food/IngredientsPackagingLabeling/GRAS/
NoticeInventory/ucm413748.htm.
2 The USDA organic regulations (7 CFR 205.2)
define ‘‘commercially available’’ as, ‘‘The ability to
obtain a production input in an appropriate form,
quality, or quantity to fulfill an essential function
in a system of organic production or handling, as
determined by the certifying agent in the course of
reviewing the organic plan.’’
E:\FR\FM\05NOR1.SGM
05NOR1
70432
Federal Register / Vol. 85, No. 215 / Thursday, November 5, 2020 / Rules and Regulations
production. A summary of the
comments received on the proposed
rule and AMS’s responses to these
comments are included in Section F of
this final rule.
III. Related Documents
On October 18, 2019, AMS published
in the Federal Register (84 FR 55866) a
proposed rule to amend the National
List to include blood meal made with
sodium citrate; natamycin; and
nonorganic tamarind seed gum. On
August 9, 2018, AMS published a
Notice in the Federal Register (83 FR
39376) announcing the fall 2018 NOSB
meeting. One purpose of that meeting
was to deliberate recommendations for
the substances addressed in this rule.
khammond on DSKJM1Z7X2PROD with RULES
IV. Statutory and Regulatory Authority
The OFPA authorizes the Secretary to
make amendments to the National List
based on recommendations developed
by the NOSB (7 U.S.C. 6517(d)).
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 and
directs petitioners to obtain the petition
procedures from USDA. The current
petition procedures published in the
Federal Register (81 FR 12680, March
10, 2016) for amending the National List
can be accessed through the NOP
Program Handbook on the NOP website
at https://www.ams.usda.gov/rulesregulations/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 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
VerDate Sep<11>2014
18:31 Nov 04, 2020
Jkt 253001
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) 3 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 $1,00,000.
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 $16.5 million.
AMS has considered the economic
impact of this proposed rulemaking on
small agricultural entities. Data
collected by the USDA National
Agricultural Statistics Service and the
NOP indicate most of the certified
organic production operations in the
United States would be considered
small entities. According to the 2017
Census of Agriculture, 18,166 organic
farms in the United States reported sales
of organic products and total farmgate
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 $1,000,000 sales threshold to
qualify as a small business.
According to the NOP’s Organic
Integrity Database, there are 19,764
organic handlers that are certified under
the USDA organic regulations (10,492 of
3 North American Industry Classification System:
https://www.census.gov/eos/www/naics/.
4 U.S. Department of Agriculture, National
Agricultural Statistics Service. 2017 Census of
Agriculture. https://www.nass.usda.gov/
Publications/AgCensus/2017/Full_Report/Volume_
1,_Chapter_1_US/. The number of organic farms
includes both certified and exempt farms.
PO 00000
Frm 00002
Fmt 4700
Sfmt 4700
these handlers are based 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 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 $16.5 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 one substance in organic
handling. Adding this substance to the
National List would increase regulatory
flexibility and would give small entities
more tools to use in day-to-day
operations. 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 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
5 Organic Integrity Database: https://
organic.ams.usda.gov/Integrity/. Accessed on June
15, 2020.
E:\FR\FM\05NOR1.SGM
05NOR1
Federal Register / Vol. 85, No. 215 / Thursday, November 5, 2020 / Rules and Regulations
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 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 (U.S. 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 rule.
Accordingly, OMB clearance is not
required by the Paperwork Reduction
Act of 1995, 44 U.S.C. 3501, Chapter 35.
khammond on DSKJM1Z7X2PROD with RULES
D. Executive Order 13175
This rule has been reviewed in
accordance with the requirements of
Executive Order 13175, Consultation
and Coordination with Indian Tribal
Governments. The review reveals that
this regulation will not have substantial
and direct effects on tribal governments
and will not have significant tribal
implications.
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).
VerDate Sep<11>2014
18:31 Nov 04, 2020
Jkt 253001
F. Comments Received on Proposed
Rule
During a 60-day comment period that
closed on December 17, 2019, AMS
received 45 comments on the proposed
rule (84 FR 55866). These comments
were submitted by organic farmers and
handlers, certifying agents, researchers,
trade associations, nonprofit
organizations, and consumers. The
comments can be viewed at https://
www.regulations.gov by searching for
docket ID ‘‘AMS–NOP–19–0023.’’
Comments Received on the Proposed
Addition to § 205.601
AMS received several comments on
the proposed amendment to add blood
meal made with sodium citrate to the
National List for use in organic crop
production. Most of these comments
opposed the proposed listing. These
comments argued that classifying blood
meal made with sodium citrate as a
synthetic substance contradicts
guidance in NOP 5033 Classification of
Materials and NOP 5034–1 Materials for
Organic Crop Production, which lists
blood meal as a nonsynthetic
substance.6 Some comments noted that
the use of anticoagulants, such as
sodium citrate, is part of the ‘‘standard
of identity’’ of blood meal, and,
therefore, blood meal made with
anticoagulants should be considered a
nonsynthetic substance. Some
comments stated that the use of sodium
citrate in the making of blood meal has
no technical effect, does not transform
the blood into a different substance
through a chemical change, and is not
present in the final product. A few
comments stated that sodium citrate
binds with calcium in blood, making
blood meal processed with sodium
citrate the same as blood meal derived
from processed animal blood where no
anticoagulant was used. These
comments suggested that the blood meal
processed with sodium citrate is not
altered into a form that does not occur
in nature and should be classified as
nonsynthetic.
A few comments expressed concern
about the potential impact of adding
processing aids used to manufacture
crop inputs to the National List. These
comments postulate that adding blood
meal made with sodium citrate to the
National List sets a precedent for
reviewing and approving processing
aids that may be used in other currently
approved inputs that are considered to
be nonsynthetic, such as bone meal or
6 NOP 5033 and NOP 5034–1 are available in the
NOP Program Handbook: https://
www.ams.usda.gov/rules-regulations/organic/
handbook.
PO 00000
Frm 00003
Fmt 4700
Sfmt 4700
70433
feather meal, but which in turn, could
become prohibited.
Several comments opposed or
questioned the allowance of blood meal
in organic production generally. A
comment indicated that blood meal can
be made without the use of sodium
citrate and several comments were
concerned that there are no restrictions
on or required information about the
source of the blood meal used in organic
production, for example, to prohibit
blood meal from nonorganic animals.
One comment was concerned about
disease transmission resulting from the
use of blood meal and proposed that
blood meal should be added to
§ 205.602 as a prohibited nonsynthetic
substance.
AMS also received comments
supporting the addition of blood meal
made with sodium citrate to the
National List. However, supporting
comments noted concerns with
potential impacts of the proposed action
beyond blood meal and one suggested
revising guidance as an alternative to
rulemaking. One comment supported
the listing with the caveat that there was
public support for such action and
acknowledged the potential broader
implications of that action and
regulatory uncertainty about reviewing
substances used in the processing of
inputs.
Comments Received on the Proposed
Addition to § 205.602
Many of the public comments
addressed the proposal to list natamycin
as a prohibited substance in organic
crop production. Many comments
opposed natamycin’s listing in
§ 205.602 as a prohibited nonsynthetic
substance. These comments argued that
the NOSB’s determination that
natamycin use could increase fungal
resistance is flawed and is not
supported by research. Several
comments also included citations to
specific research findings which
conclude that natamycin use does not
contribute to fungal resistance.
Comments also stated that natamycin
has been used for many years with no
documented evidence of increased
fungal resistance.
In addition to disputing fungal
resistance, comments cited other
concerns with prohibiting the use of
natamycin, including reduced product
shelf-life, economic loss, and fewer
options for controlling diseases where
options are already very limited. The
comments also stated that natamycin is
generally not used for treatment of
human fungal infections.
AMS received several comments
claiming that the proposed listing to
E:\FR\FM\05NOR1.SGM
05NOR1
70434
Federal Register / Vol. 85, No. 215 / Thursday, November 5, 2020 / Rules and Regulations
khammond on DSKJM1Z7X2PROD with RULES
prohibit natamycin, and the
deliberations on the natamycin petition,
did not meet requirements for
prohibiting nonsynthetic substances
stipulated in OFPA (7 U.S.C. 6517). To
prohibit a nonsynthetic substance in
organic crop or livestock production,
OFPA requires that the USDA, in
consultation with the U.S. Department
of Health and Human Services and the
U.S. Environmental Protection Agency,
determine that the substance is harmful
to human health or the environment, or
is inconsistent with organic farming.
Comments stated that natamycin is not
harmful to and has negligible impact on
human health. In addition, comments
argued that the NOSB did not conclude
that the use of natamycin was
inconsistent with organic farming. Some
comments stated that the NOSB’s
recommendation to prohibit natamycin
because it is ‘‘non-essential for organic
production’’ is not valid because
essentiality is not an evaluation
criterion included in 7 U.S.C. 6517(c)(2)
for prohibiting nonsynthetic substances.
AMS did receive some comments in
support of adding natamycin to
§ 205.602 as a prohibited nonsynthetic
substance. These comments agreed with
the NOSB’s recommendation to list
natamycin as a prohibited nonsynthetic
because of hazards to human health and
the environment, and issues with
essentiality for and compatibility with
organic agriculture. Some comments
argued that natamycin should be
categorized as a synthetic substance
because of the potential for synthetic
substrates to be used in the fermentation
process to produce natamycin. One
comment requested guidance on
determining whether the use of
synthetic fermentation substrates in
natamycin production would result in a
nonsynthetic product. Another
comment supporting the listing
speculated on the possible impact
natamycin use could have on soil fungi.
Comments Received on the Proposed
Addition to § 205.606
AMS received five comments opposed
to the addition of nonorganic tamarind
seed gum to § 205.606 for use in organic
handling. Comments argued that
nonorganic ingredients should never be
allowed in the processing and handling
of organic products. Other comments
indicated that tamarind seed gum is not
essential for organic handling. Some
comments argued for a focus on
improved traceability of tamarind seed
supply chains (as cited by the tamarind
seed gum petitioner), noting that organic
tamarind seed is available, but poor
traceability makes confirmation of the
organic status of tamarind seed gum
VerDate Sep<11>2014
18:31 Nov 04, 2020
Jkt 253001
difficult. Other comments argued that
the tamarind seed gum petition review
process did not adequately determine
whether tamarind seed gum is
commercially available in organic form.
One comment more broadly noted that
the petition process for listing materials
on § 205.606 should include a review of
all barriers to the organic production
and commercial availability of a
substance, and that a substance should
be listed only if those barriers are
clearly shown to be insurmountable.
This comment also challenged the
NOSB review of tamarind seed gum,
stating that the petition review was not
robust enough.
AMS Response to Comments on Blood
Meal Made With Sodium Citrate and
Comments on Natamycin
Sodium citrate was the petitioned
substance for use as a processing aid
(anticoagulant) in spray-dried blood
products, such as blood meal. The
NOSB recommended adding sodium
citrate to the National List as an allowed
synthetic substance for that use and
requested that AMS review sodium
citrate to determine whether sodium
citrate used to process blood meal must
be on the National List in order for the
resulting blood meal to be allowed in
organic crop production. As such, AMS
proposed adding blood meal made with
sodium citrate as a synthetic substance
to the National List for use in organic
crop production.
Natamycin was petitioned to be
classified as an allowed nonsynthetic
substance for use as a post-harvest
treatment to control fungal diseases on
certain commodities. The NOSB
determined that natamycin is
nonsynthetic and that it should be
prohibited in organic crop production
because it is not essential, is
inconsistent with sustainable
agriculture, and has the potential to
contribute to fungal resistance and the
associated negative effects on human
health. Therefore, AMS proposed listing
natamycin as a nonsynthetic substance
that is prohibited in organic crop
production.
AMS is not adopting two amendments
in the proposed rule. These
amendments would have listed (1)
blood meal made with sodium citrate as
an allowed synthetic substance in
organic crop production and (2)
natamycin as a prohibited nonsynthetic
in organic crop production. Commenters
raised significant concerns about each of
these proposals.
Specifically, many comments
opposed AMS’s classification of blood
meal made with sodium citrate as a
synthetic substance and explained that
PO 00000
Frm 00004
Fmt 4700
Sfmt 4700
there may be potential impacts of that
action which had not been considered
in the proposed rule. AMS does not
agree that information presented in
these comments conclusively shows
that blood meal made with sodium
citrate is a nonsynthetic substance.
However, AMS does agree that
classifying blood meal made with
sodium citrate as synthetic may have
negative implications for some other
materials used in organic production
and that such impacts were not
anticipated or considered in the
proposed rule.
Further, AMS is not finalizing the
proposed amendment based in part on
the fact that the NOSB did not
specifically recommend adding blood
meal made with sodium citrate as a
synthetic to the National List. The
NOSB recommended adding sodium
citrate for use as an anticoagulant in the
processing of blood meal, but did not
determine that blood meal made with
sodium citrate is a synthetic substance.
Based on new information received in
public comments about sodium citrate’s
action in blood meal, AMS determined
that further discussion and deliberation
by the NOSB are needed to determine
whether or not the use of sodium citrate
makes blood meal a synthetic substance.
Therefore, in the absence of an NOSB
recommendation that blood meal made
with sodium citrate should be added to
the National List as a synthetic
substance and because information
submitted in public comment raised
new questions about the proposed
classification of blood meal made with
sodium citrate as a synthetic substance,
AMS is not adopting the proposed
listing.
In regards to natamycin, several
public comments also presented
research findings to challenge the
conclusions that natamycin use in
organic crop production would increase
fungal resistance to antimicrobials, have
negative environmental or human
health impacts, and that a prohibition
meets the OFPA criteria for prohibiting
natural substances. AMS agrees that
these research findings should be
considered as part of the totality of the
information considered on natamycin,
and that the merits of those findings
should be discussed as part of any
regulatory action. AMS has not assessed
the validity of the research findings
presented in public comment, and AMS
believes that the availability of this
information warrants consideration
before finalizing a prohibition on
natamycin in organic production. As a
result, AMS is not finalizing the
proposed amendment to add natamycin
E:\FR\FM\05NOR1.SGM
05NOR1
Federal Register / Vol. 85, No. 215 / Thursday, November 5, 2020 / Rules and Regulations
as a nonsynthetic substance prohibited
for use in organic crop production.
AMS is not finalizing the proposed
amendments for blood meal with
sodium citrate and natamycin for
reasons discussed above. The
information presented in public
comments opposing the proposed
actions should be assessed before any
new proposal for regulatory action.
AMS may invite additional input from
the NOSB on these topics; the NOSB’s
work may include conducting further
study of the information and potential
impacts and risks presented in public
comments. AMS will not continue
rulemaking on these two substances
unless the NOSB forwards a new
recommendation(s) on these topics to
AMS.
khammond on DSKJM1Z7X2PROD with RULES
AMS Response to Comments on
Tamarind Seed Gum
This rule will add tamarind seed gum
to the National List. AMS received few
comments on tamarind seed gum. These
comments expressed concern about the
traceability of organic tamarind seed
gum, and one comment argued that the
NOSB did not conduct a robust review
of the tamarind seed gum petition when
determining organic tamarind seed gum
availability. AMS disagrees with these
comments. The NOSB comprehensively
reviewed information on the potential
sources of tamarind seed gum to
determine if there were adequate
sources of organic tamarind seed gum
available to organic handlers in form,
quantity, and quality. Based on the
Organic INTEGRITY Database, which
identifies no organic producers or
handlers of tamarind seed gum, the
NOSB determined there were
insufficient sources of organic tamarind
seed gum and recommended that
tamarind seed gum be added to the
National List in § 205.606. AMS agrees
that the absence of organic tamarind
seed gum handlers in the Organic
INTEGRITY Database demonstrates that
this ingredient is not currently
commercially available in organic form.
The USDA organic regulations require
organic handlers to use organic
agricultural ingredients when available
before using any nonorganic agricultural
ingredients that are included under
§ 205.606. Tamarind seed gum that is
sold, labeled or represented as organic
must be verified as organically
produced and handled.
G. 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.
VerDate Sep<11>2014
18:31 Nov 04, 2020
Jkt 253001
List of Subjects in 7 CFR Part 205
Administrative practice and
procedure, Agriculture, Animals,
Archives and records, Imports, Labeling,
Organically produced products, Plants,
Reporting and recordkeeping
requirements, Seals and insignia, Soil
conservation.
For the reasons set forth in the
preamble, 7 CFR part 205 is amended as
follows:
PART 205—NATIONAL ORGANIC
PROGRAM
1. The authority citation for part 205
is revised to read as follows:
■
Authority: 7 U.S.C. 6501–6522.
2. Amend § 205.606 by redesignating
paragraphs (t) through (w) as paragraphs
(u) through (x) and adding new
paragraph (t) to read as follows:
■
§ 205.606 Nonorganically produced
agricultural products allowed as ingredients
in or on processed products labeled as
‘‘organic.’’
*
*
*
*
*
(t) Tamarind seed gum.
*
*
*
*
*
Bruce Summers,
Administrator,Agricultural Marketing
Service.
[FR Doc. 2020–22784 Filed 11–4–20; 8:45 am]
BILLING CODE P
NUCLEAR REGULATORY
COMMISSION
10 CFR Part 2
[NRC–2020–0033]
RIN 3150–AK46
Non-Substantive Amendments to
Adjudicatory Proceeding
Requirements
Nuclear Regulatory
Commission.
ACTION: Direct final rule.
AGENCY:
The U.S. Nuclear Regulatory
Commission (NRC) is amending its
regulations to revise and clarify the
agency’s rules of practice and procedure
to reflect current Atomic Safety and
Licensing Board Panel practice,
Commission case law, and a decision of
the Supreme Court of the United States
and to enhance consistency within the
NRC’s regulations.
DATES: This final rule is effective
January 19, 2021, unless significant
adverse comments are received by
December 7, 2020. If the direct final rule
SUMMARY:
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
70435
is withdrawn as a result of such
comments, timely notice of the
withdrawal will be published in the
Federal Register. Comments received
after this date will be considered if it is
practical to do so, but the NRC is able
to ensure consideration only for
comments received on or before this
date. Comments received on this direct
final rule will also be considered to be
comments on a companion proposed
rule published in the Proposed Rules
section of this issue of the Federal
Register.
ADDRESSES: You may submit comments
by any of the following methods:
• Federal Rulemaking Website: Go to
https://www.regulations.gov and search
for Docket ID NRC–2020–0033. Address
questions about NRC dockets to Dawn
Forder; telephone: 301–415–3407;
email: Dawn.Forder@nrc.gov. For
technical questions, contact the
individual listed in the FOR FURTHER
INFORMATION CONTACT section of this
document.
• Email comments to:
Rulemaking.Comments@nrc.gov. If you
do not receive an automatic email reply
confirming receipt, then contact us at
301–415–1677.
• Mail comments to: Secretary, U.S.
Nuclear Regulatory Commission,
Washington, DC 20555–0001, ATTN:
Rulemakings and Adjudications Staff.
For additional direction on obtaining
information and submitting comments,
see ‘‘Obtaining Information and
Submitting Comments’’ in the
SUPPLEMENTARY INFORMATION section of
this document.
FOR FURTHER INFORMATION CONTACT: Ian
Irvin, Office of the General Counsel,
U.S. Nuclear Regulatory Commission,
Washington DC 20555–0001; telephone:
301–287–9193; email: 2020_Part_2_
Rulemaking@usnrc.onmicrosoft.com.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Obtaining Information and Submitting
Comments
II. Rulemaking Procedure
III. Background
IV. Discussion
V. Plain Writing
VI. National Environmental Policy Act
VII. Paperwork Reduction Act Act
VIII. Congressional Review Act
I. Obtaining Information and
Submitting Comments
A. Obtaining Information
Please refer to Docket ID NRC–2020–
0033 when contacting the NRC about
the availability of information for this
action. You may obtain publicly
available information related to this
action by any of the following methods:
E:\FR\FM\05NOR1.SGM
05NOR1
Agencies
[Federal Register Volume 85, Number 215 (Thursday, November 5, 2020)]
[Rules and Regulations]
[Pages 70431-70435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-22784]
========================================================================
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. 85, No. 215 / Thursday, November 5, 2020 /
Rules and Regulations
[[Page 70431]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS-NOP-19-0023; NOP-19-01]
RIN 0581 AD83
National Organic Program; Amendments to the National List of
Allowed and Prohibited Substances per October 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. This rule
adds non-organic tamarind seed gum as an allowed ingredient in organic
products when certified organic tamarind seed gum is not commercially
available.
DATES: This final rule is effective December 7, 2020.
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 allowed
in organic farming and the nonsynthetic substances prohibited in
organic farming. The National List also identifies nonagricultural and
nonorganic agricultural substances (ingredients) that may be used in
organic handling.
The Organic Foods Production Act of 1990 (OFPA), as amended (7
U.S.C. 6501-6524), and the USDA organic regulations (7 CFR part 205)
specifically prohibit the use of any synthetic substance in organic
production and handling unless the synthetic substance is on the
National List (7 CFR 205.601-205.606). Section 205.105 also requires
that any nonorganic agricultural substance 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 addresses one NOSB recommendation to amend the
National List that was submitted to the Secretary on October 26, 2018.
The amendment in this final rule is discussed in the section on
Overview of Amendments below.
II. Overview of Amendments
The following provides an overview of the amendment to a designated
section of the National List regulations. This rule adds tamarind seed
gum to the National List. This rule does not add blood meal made with
sodium citrate or natamycin to the National List, as proposed by AMS
(84 FR 55866, October 18, 2019).
The background information on each substance and the basis for each
NOSB recommendation was addressed in the proposed rule. The NOSB
evaluated each substance by applying the OFPA substance evaluation
criteria to determine if the substance was compatible with organic
production and handling. For each substance, AMS reviewed the
recommendation submitted by the NOSB 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.
AMS received 45 comments on the proposed rule. After considering
the comments, AMS determined that the addition of nonorganic tamarind
seed gum to the National List for use in organic handling will be
finalized as proposed. The proposed amendments to add blood meal made
with sodium citrate and to prohibit the use of natamycin in organic
production have not been finalized for the reasons discussed below.
Section F of this final rule provides an overview of the comments
received and AMS's response to these comments.
Tamarind Seed Gum
This rule amends the National List to allow nonorganic tamarind
seed gum (by addition to Sec. 205.606) in organic products when
organic tamarind seed gum is not commercially available. Tamarind seed
gum is used as a thickener, stabilizer, emulsifier or gelling agent in
processed foods. The U.S. Food and Drug Administration (FDA) has been
informed that tamarind seed is Generally Recognized as Safe (GRAS) for
the above uses.\1\ During its October 24-26, 2018, public meeting, the
NOSB recommended adding tamarind seed gum as an allowed nonorganic
agricultural ingredient to Sec. 205.606 of the National List. As
required by the USDA organic regulations (Sec. 205.606), the
nonorganic form of the ingredient will only be permitted when organic
tamarind seed gum is not commercially available.\2\ To use nonorganic
forms of ingredients listed at Sec. 205.606, organic handling
operations must demonstrate and document that organic forms of the
ingredient(s) are not commercially available. Certifying agents
(``certifiers'') review the operation's use of nonorganic ingredients
for compliance with the regulations in the course of reviewing an
organic operation's organic system plan.
---------------------------------------------------------------------------
\1\ Agency Response Letter GRAS Notice No. GRN 000503, August
12, 2014; https://wayback.archive-it.org/7993/20171031004449/https://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm413748.htm.
\2\ The USDA organic regulations (7 CFR 205.2) define
``commercially available'' as, ``The ability to obtain a production
input in an appropriate form, quality, or quantity to fulfill an
essential function in a system of organic production or handling, as
determined by the certifying agent in the course of reviewing the
organic plan.''
---------------------------------------------------------------------------
Amendments Not Finalized in This Rule
Based upon public comments received on the proposed rule, AMS is
not finalizing the proposed amendments to (1) list blood meal made with
sodium citrate as an allowed synthetic substance for organic crop
production or (2) prohibit natamycin use in crop
[[Page 70432]]
production. A summary of the comments received on the proposed rule and
AMS's responses to these comments are included in Section F of this
final rule.
III. Related Documents
On October 18, 2019, AMS published in the Federal Register (84 FR
55866) a proposed rule to amend the National List to include blood meal
made with sodium citrate; natamycin; and nonorganic tamarind seed gum.
On August 9, 2018, AMS published a Notice in the Federal Register (83
FR 39376) announcing the fall 2018 NOSB meeting. One purpose of that
meeting was to deliberate recommendations for the substances addressed
in this rule.
IV. Statutory and Regulatory Authority
The OFPA authorizes the Secretary to make amendments to the
National List based on recommendations developed by the NOSB (7 U.S.C.
6517(d)). 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 and directs petitioners to obtain the petition
procedures from USDA. The current petition procedures published in the
Federal Register (81 FR 12680, March 10, 2016) for amending the
National List 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 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) \3\ 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 $1,00,000. 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 $16.5 million.
---------------------------------------------------------------------------
\3\ North American Industry Classification System: https://www.census.gov/eos/www/naics/.
---------------------------------------------------------------------------
AMS has considered the economic impact of this proposed rulemaking
on small agricultural entities. Data collected by the USDA National
Agricultural Statistics Service and the NOP indicate most of the
certified organic production operations in the United States would be
considered small entities. According to the 2017 Census of Agriculture,
18,166 organic farms in the United States reported sales of organic
products and total farmgate 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 $1,000,000 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/Full_Report/Volume_1,_Chapter_1_US/. The number of organic farms includes both
certified and exempt farms.
---------------------------------------------------------------------------
According to the NOP's Organic Integrity Database, there are 19,764
organic handlers that are certified under the USDA organic regulations
(10,492 of these handlers are based 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 June 15, 2020.
---------------------------------------------------------------------------
The USDA has 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 $16.5 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 one substance in organic handling. Adding this
substance to the National List would increase regulatory flexibility
and would give small entities more tools to use in day-to-day
operations. 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 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
[[Page 70433]]
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 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 (U.S. 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 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 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
During a 60-day comment period that closed on December 17, 2019,
AMS received 45 comments on the proposed rule (84 FR 55866). These
comments were submitted by organic farmers and handlers, certifying
agents, researchers, trade associations, nonprofit organizations, and
consumers. The comments can be viewed at https://www.regulations.gov by
searching for docket ID ``AMS-NOP-19-0023.''
Comments Received on the Proposed Addition to Sec. 205.601
AMS received several comments on the proposed amendment to add
blood meal made with sodium citrate to the National List for use in
organic crop production. Most of these comments opposed the proposed
listing. These comments argued that classifying blood meal made with
sodium citrate as a synthetic substance contradicts guidance in NOP
5033 Classification of Materials and NOP 5034-1 Materials for Organic
Crop Production, which lists blood meal as a nonsynthetic substance.\6\
Some comments noted that the use of anticoagulants, such as sodium
citrate, is part of the ``standard of identity'' of blood meal, and,
therefore, blood meal made with anticoagulants should be considered a
nonsynthetic substance. Some comments stated that the use of sodium
citrate in the making of blood meal has no technical effect, does not
transform the blood into a different substance through a chemical
change, and is not present in the final product. A few comments stated
that sodium citrate binds with calcium in blood, making blood meal
processed with sodium citrate the same as blood meal derived from
processed animal blood where no anticoagulant was used. These comments
suggested that the blood meal processed with sodium citrate is not
altered into a form that does not occur in nature and should be
classified as nonsynthetic.
---------------------------------------------------------------------------
\6\ NOP 5033 and NOP 5034-1 are available in the NOP Program
Handbook: https://www.ams.usda.gov/rules-regulations/organic/handbook.
---------------------------------------------------------------------------
A few comments expressed concern about the potential impact of
adding processing aids used to manufacture crop inputs to the National
List. These comments postulate that adding blood meal made with sodium
citrate to the National List sets a precedent for reviewing and
approving processing aids that may be used in other currently approved
inputs that are considered to be nonsynthetic, such as bone meal or
feather meal, but which in turn, could become prohibited.
Several comments opposed or questioned the allowance of blood meal
in organic production generally. A comment indicated that blood meal
can be made without the use of sodium citrate and several comments were
concerned that there are no restrictions on or required information
about the source of the blood meal used in organic production, for
example, to prohibit blood meal from nonorganic animals. One comment
was concerned about disease transmission resulting from the use of
blood meal and proposed that blood meal should be added to Sec.
205.602 as a prohibited nonsynthetic substance.
AMS also received comments supporting the addition of blood meal
made with sodium citrate to the National List. However, supporting
comments noted concerns with potential impacts of the proposed action
beyond blood meal and one suggested revising guidance as an alternative
to rulemaking. One comment supported the listing with the caveat that
there was public support for such action and acknowledged the potential
broader implications of that action and regulatory uncertainty about
reviewing substances used in the processing of inputs.
Comments Received on the Proposed Addition to Sec. 205.602
Many of the public comments addressed the proposal to list
natamycin as a prohibited substance in organic crop production. Many
comments opposed natamycin's listing in Sec. 205.602 as a prohibited
nonsynthetic substance. These comments argued that the NOSB's
determination that natamycin use could increase fungal resistance is
flawed and is not supported by research. Several comments also included
citations to specific research findings which conclude that natamycin
use does not contribute to fungal resistance. Comments also stated that
natamycin has been used for many years with no documented evidence of
increased fungal resistance.
In addition to disputing fungal resistance, comments cited other
concerns with prohibiting the use of natamycin, including reduced
product shelf-life, economic loss, and fewer options for controlling
diseases where options are already very limited. The comments also
stated that natamycin is generally not used for treatment of human
fungal infections.
AMS received several comments claiming that the proposed listing to
[[Page 70434]]
prohibit natamycin, and the deliberations on the natamycin petition,
did not meet requirements for prohibiting nonsynthetic substances
stipulated in OFPA (7 U.S.C. 6517). To prohibit a nonsynthetic
substance in organic crop or livestock production, OFPA requires that
the USDA, in consultation with the U.S. Department of Health and Human
Services and the U.S. Environmental Protection Agency, determine that
the substance is harmful to human health or the environment, or is
inconsistent with organic farming. Comments stated that natamycin is
not harmful to and has negligible impact on human health. In addition,
comments argued that the NOSB did not conclude that the use of
natamycin was inconsistent with organic farming. Some comments stated
that the NOSB's recommendation to prohibit natamycin because it is
``non-essential for organic production'' is not valid because
essentiality is not an evaluation criterion included in 7 U.S.C.
6517(c)(2) for prohibiting nonsynthetic substances.
AMS did receive some comments in support of adding natamycin to
Sec. 205.602 as a prohibited nonsynthetic substance. These comments
agreed with the NOSB's recommendation to list natamycin as a prohibited
nonsynthetic because of hazards to human health and the environment,
and issues with essentiality for and compatibility with organic
agriculture. Some comments argued that natamycin should be categorized
as a synthetic substance because of the potential for synthetic
substrates to be used in the fermentation process to produce natamycin.
One comment requested guidance on determining whether the use of
synthetic fermentation substrates in natamycin production would result
in a nonsynthetic product. Another comment supporting the listing
speculated on the possible impact natamycin use could have on soil
fungi.
Comments Received on the Proposed Addition to Sec. 205.606
AMS received five comments opposed to the addition of nonorganic
tamarind seed gum to Sec. 205.606 for use in organic handling.
Comments argued that nonorganic ingredients should never be allowed in
the processing and handling of organic products. Other comments
indicated that tamarind seed gum is not essential for organic handling.
Some comments argued for a focus on improved traceability of tamarind
seed supply chains (as cited by the tamarind seed gum petitioner),
noting that organic tamarind seed is available, but poor traceability
makes confirmation of the organic status of tamarind seed gum
difficult. Other comments argued that the tamarind seed gum petition
review process did not adequately determine whether tamarind seed gum
is commercially available in organic form. One comment more broadly
noted that the petition process for listing materials on Sec. 205.606
should include a review of all barriers to the organic production and
commercial availability of a substance, and that a substance should be
listed only if those barriers are clearly shown to be insurmountable.
This comment also challenged the NOSB review of tamarind seed gum,
stating that the petition review was not robust enough.
AMS Response to Comments on Blood Meal Made With Sodium Citrate and
Comments on Natamycin
Sodium citrate was the petitioned substance for use as a processing
aid (anticoagulant) in spray-dried blood products, such as blood meal.
The NOSB recommended adding sodium citrate to the National List as an
allowed synthetic substance for that use and requested that AMS review
sodium citrate to determine whether sodium citrate used to process
blood meal must be on the National List in order for the resulting
blood meal to be allowed in organic crop production. As such, AMS
proposed adding blood meal made with sodium citrate as a synthetic
substance to the National List for use in organic crop production.
Natamycin was petitioned to be classified as an allowed
nonsynthetic substance for use as a post-harvest treatment to control
fungal diseases on certain commodities. The NOSB determined that
natamycin is nonsynthetic and that it should be prohibited in organic
crop production because it is not essential, is inconsistent with
sustainable agriculture, and has the potential to contribute to fungal
resistance and the associated negative effects on human health.
Therefore, AMS proposed listing natamycin as a nonsynthetic substance
that is prohibited in organic crop production.
AMS is not adopting two amendments in the proposed rule. These
amendments would have listed (1) blood meal made with sodium citrate as
an allowed synthetic substance in organic crop production and (2)
natamycin as a prohibited nonsynthetic in organic crop production.
Commenters raised significant concerns about each of these proposals.
Specifically, many comments opposed AMS's classification of blood
meal made with sodium citrate as a synthetic substance and explained
that there may be potential impacts of that action which had not been
considered in the proposed rule. AMS does not agree that information
presented in these comments conclusively shows that blood meal made
with sodium citrate is a nonsynthetic substance. However, AMS does
agree that classifying blood meal made with sodium citrate as synthetic
may have negative implications for some other materials used in organic
production and that such impacts were not anticipated or considered in
the proposed rule.
Further, AMS is not finalizing the proposed amendment based in part
on the fact that the NOSB did not specifically recommend adding blood
meal made with sodium citrate as a synthetic to the National List. The
NOSB recommended adding sodium citrate for use as an anticoagulant in
the processing of blood meal, but did not determine that blood meal
made with sodium citrate is a synthetic substance. Based on new
information received in public comments about sodium citrate's action
in blood meal, AMS determined that further discussion and deliberation
by the NOSB are needed to determine whether or not the use of sodium
citrate makes blood meal a synthetic substance. Therefore, in the
absence of an NOSB recommendation that blood meal made with sodium
citrate should be added to the National List as a synthetic substance
and because information submitted in public comment raised new
questions about the proposed classification of blood meal made with
sodium citrate as a synthetic substance, AMS is not adopting the
proposed listing.
In regards to natamycin, several public comments also presented
research findings to challenge the conclusions that natamycin use in
organic crop production would increase fungal resistance to
antimicrobials, have negative environmental or human health impacts,
and that a prohibition meets the OFPA criteria for prohibiting natural
substances. AMS agrees that these research findings should be
considered as part of the totality of the information considered on
natamycin, and that the merits of those findings should be discussed as
part of any regulatory action. AMS has not assessed the validity of the
research findings presented in public comment, and AMS believes that
the availability of this information warrants consideration before
finalizing a prohibition on natamycin in organic production. As a
result, AMS is not finalizing the proposed amendment to add natamycin
[[Page 70435]]
as a nonsynthetic substance prohibited for use in organic crop
production.
AMS is not finalizing the proposed amendments for blood meal with
sodium citrate and natamycin for reasons discussed above. The
information presented in public comments opposing the proposed actions
should be assessed before any new proposal for regulatory action. AMS
may invite additional input from the NOSB on these topics; the NOSB's
work may include conducting further study of the information and
potential impacts and risks presented in public comments. AMS will not
continue rulemaking on these two substances unless the NOSB forwards a
new recommendation(s) on these topics to AMS.
AMS Response to Comments on Tamarind Seed Gum
This rule will add tamarind seed gum to the National List. AMS
received few comments on tamarind seed gum. These comments expressed
concern about the traceability of organic tamarind seed gum, and one
comment argued that the NOSB did not conduct a robust review of the
tamarind seed gum petition when determining organic tamarind seed gum
availability. AMS disagrees with these comments. The NOSB
comprehensively reviewed information on the potential sources of
tamarind seed gum to determine if there were adequate sources of
organic tamarind seed gum available to organic handlers in form,
quantity, and quality. Based on the Organic INTEGRITY Database, which
identifies no organic producers or handlers of tamarind seed gum, the
NOSB determined there were insufficient sources of organic tamarind
seed gum and recommended that tamarind seed gum be added to the
National List in Sec. 205.606. AMS agrees that the absence of organic
tamarind seed gum handlers in the Organic INTEGRITY Database
demonstrates that this ingredient is not currently commercially
available in organic form. The USDA organic regulations require organic
handlers to use organic agricultural ingredients when available before
using any nonorganic agricultural ingredients that are included under
Sec. 205.606. Tamarind seed gum that is sold, labeled or represented
as organic must be verified as organically produced and handled.
G. 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.
List of Subjects in 7 CFR Part 205
Administrative practice and procedure, Agriculture, Animals,
Archives and records, Imports, Labeling, Organically produced products,
Plants, Reporting and recordkeeping requirements, Seals and insignia,
Soil conservation.
For the reasons set forth in the preamble, 7 CFR part 205 is
amended as follows:
PART 205--NATIONAL ORGANIC PROGRAM
0
1. The authority citation for part 205 is revised to read as follows:
Authority: 7 U.S.C. 6501-6522.
0
2. Amend Sec. 205.606 by redesignating paragraphs (t) through (w) as
paragraphs (u) through (x) and adding new paragraph (t) to read as
follows:
Sec. 205.606 Nonorganically produced agricultural products allowed
as ingredients in or on processed products labeled as ``organic.''
* * * * *
(t) Tamarind seed gum.
* * * * *
Bruce Summers,
Administrator,Agricultural Marketing Service.
[FR Doc. 2020-22784 Filed 11-4-20; 8:45 am]
BILLING CODE P