National Organic Program; Amendments to the National List of Allowed and Prohibited Substances (2022 Sunset), 10930-10938 [2022-03851]
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Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations
Responsibilities of Department
Employees
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
§ 1.223 What must I, as an employee, do
upon receiving a demand?
7 CFR Part 205
(a)(1) If you receive a demand, you
must immediately notify your
supervisor, who must in turn notify the
appropriate Department official. Either
your supervisor or the appropriate
Department official must notify the
Office of the General Counsel contact for
your region or division for assistance
with issuing the proper response.
(2) Demands for Office of Inspector
General official information or
testimony should be forwarded
immediately to the Counsel to the
Inspector General.
(b)(1) The appropriate Department
official will decide whether to grant or
deny the demand. Before a decision
granting or denying a demand is made,
the Office of the General Counsel
contact for your region or division must
be consulted for advice. All decisions
granting or denying a demand must be
in writing and must receive Office of the
General Counsel concurrence prior to
issuance. Absent Office of the General
Counsel concurrence, a demand
decision cannot be issued.
(2) The Counsel to the Inspector
General will decide whether to grant or
deny a demand for Office of Inspector
General information and testimony.
(c) In the event that the appropriate
Department official decides to deny the
demand, the decision shall state that
you are not authorized to provide
official information or testimony and, if
applicable, that you will not personally
appear in response to the demand.
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§ 1.224 What must I, as an employee, do
upon becoming aware that a court or other
authority has ordered compliance with a
demand?
(a) If you become aware that a court
or other authority has ordered
compliance with a demand, you must
promptly notify your supervisor, who
must in turn notify the Office of the
General Counsel for your region or
division.
(b) In the case of compliance orders
involving a demand for Office of
Inspector General information and
testimony, promptly forward them to
your supervisor and the Counsel to the
Inspector General.
Dated: September 2, 2021.
David Grahn,
Principal Deputy General Counsel, United
States Department of Agriculture.
[FR Doc. 2022–03880 Filed 2–25–22; 8:45 am]
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RIN 0581–AD98
National Organic Program;
Amendments to the National List of
Allowed and Prohibited Substances
(2022 Sunset)
Agricultural Marketing Service,
USDA.
ACTION: Final rule.
AGENCY:
This final rule amends the
United States Department of
Agriculture’s (USDA) organic
regulations to implement
recommendations from the National
Organic Standards Board (NOSB). The
rule prohibits fourteen nonorganic
ingredients, which are currently
allowed in the manufacture of organic
processed products. The rule also
prohibits two substances (vitamin B1
and procaine), which are currently
allowed in organic crop and livestock
production. Finally, the rule renews an
allowance for two substances (oxytocin
and sucrose octanoate esters) in organic
production.
DATES:
Effective Date: This rule is effective
on March 30, 2022.
Compliance Dates: The compliance
date for the amendments that remove
vitamin B1 and procaine from the
National List is March 15, 2023. The
compliance date for all other
amendments that remove substances
from the National List is March 15,
2024. Products in the stream of
commerce after the compliance date that
are labeled as ‘‘organic’’ or ‘‘made with
organic (specified ingredients or food
group(s))’’ may contain substances
removed in this final rule if
manufactured prior to the compliance
date. The final rule renews an allowance
for two substances (oxytocin and
sucrose octanoate esters) in organic
production. This rule maintains the
current regulatory structure with regard
to these two substances upon
publication for up to five years.
FOR FURTHER INFORMATION CONTACT:
Jared Clark, Standards Division,
National Organic Program. Telephone:
(202) 720–3252 or Email: Jared.Clark@
usda.gov.
SUMMARY:
SUPPLEMENTARY INFORMATION:
BILLING CODE 3410–90–P
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I. Background
On December 21, 2000, the Secretary
of Agriculture (‘‘Secretary’’) established
the Agricultural Marketing Service’s
(AMS) National Organic Program (NOP)
and the USDA organic regulations (65
FR 80547). Within the USDA organic
regulations (7 CFR part 205) is the
National List of Allowed and Prohibited
Substances (or ‘‘National List’’). The
National List identifies the synthetic
substances that may be used in organic
crop and livestock production as well as
the nonsynthetic (natural) substances
that may not be used. It also identifies
the nonorganic substances that may be
used in or on processed organic
products.
AMS is finalizing 16 amendments to
the National List in accordance with the
procedures detailed in the Organic
Foods Production Act of 1990 (OFPA) (7
U.S.C. 6501–6524). OFPA establishes
what may be included on the National
List and the procedures that the USDA
must follow to amend the National List
(7 U.S.C. 6517). OFPA also describes the
NOSB’s responsibilities in proposing
amendments to the National List,
including the criteria for evaluating
amendments to the National List (7
U.S.C. 6518).
To remain on the National List,
substances must be: (1) Reviewed every
five years by the NOSB, a 15-member
federal advisory committee; and (2)
renewed by the Secretary (7 U.S.C.
6517(e)). This action of NOSB review
and USDA renewal is commonly
referred to as the ‘‘sunset review’’ or
‘‘sunset process.’’ AMS published
information about this process in the
Federal Register on September 16, 2013
(78 FR 56811). The sunset date (i.e., the
date by which the Secretary must renew
a substance for the listing to remain
valid on the National List) for each
substance is included in the NOP
Program Handbook (document NOP
5611).
The removal of substances from the
National List addresses National
Organic Standards Board (NOSB)
recommendations submitted to the
Secretary after the conclusion of the
NOSB’s public meetings on October 29,
2015; November 2, 2017; October 26,
2018; and October 30, 2020.
During a 60-day comment period that
closed on October 25, 2021, AMS
received 60 comments on the proposed
rule. See below for a discussion of the
comments received and AMS’s
responses to comments. Comments on
the proposed rule can also be viewed
through Regulations.gov. Use the search
area on the homepage at https://
www.regulations.gov to enter a keyword,
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title, or docket ID (the docket number
for this rule is AMS–NOP–19–0106).
II. Overview of Amendments
This rule removes fourteen
ingredients and two substances from the
National List and retains (or ‘‘renews’’)
two substances on the National List.
Additional background on the NOSB’s
review of the substances may be found
in the proposed rule (86 FR 47242;
August 24, 2021).
This final rule removes the following
synthetic substances, which are
currently allowed in organic crop and
livestock production (7 CFR 205.601
and 205.603):
• Vitamin B1 (crop production); and
• Procaine (livestock production).
As noted in the DATES section, AMS
is providing a one-year implementation
period for these changes to provide time
for certifying agents to communicate the
changes to organic operations and for
organic producers to cease use.
Additionally, AMS is removing the
following nonorganic ingredients,
which are currently allowed in organic
handling (§§ 205.605 and 205.606):
• Alginic acid;
• Colors (black currant juice color,
blueberry juice color, carrot juice color,
cherry juice color, grape juice color,
paprika color, pumpkin juice color,
turmeric extract color);
• Kelp;
• Konjac flour;
• Sweet potato starch;
• Turkish bay leaves; and
• Whey protein concentrate.
Finally, this rule renews sucrose
octanoate esters for organic crop and
livestock production and oxytocin for
organic livestock production. The new
sunset date for the two substances (three
listings on the National List) is March
15, 2027.
Below, AMS describes each substance
in alphabetical order, sorted by use (i.e.,
crop production, livestock production,
handling). Sucrose octanoate esters is
discussed first because it is used in both
crop and livestock production. For each
substance, AMS outlines the NOSB’s
sunset review, discusses comments
received, and describes the final action
by this rule.
Implementation Period. As noted in
the DATES section, AMS is providing a
one-year implementation period for
producers to cease use of vitamin B1 and
procaine. For all other substances
removed by this final rule, AMS is
providing a two-year implementation
period. A shorter implementation
period for vitamin B1 and procaine is
appropriate because there is no
evidence these substances are currently
used in organic production. A 2-year
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implementation period is provided for
organic handling operations to cease use
of the nonorganic ingredients (including
alginic acid) above. AMS believes that a
two-year implementation period
provides certifying agents with the
necessary time to communicate the
changes to organic operations and for
operations to source organic forms of
the ingredients (if necessary), revise
labels, and/or adjust recipes. Public
comment indicated a two-year
implementation period would be
adequate. AMS notes that while the
final rule provides a two-year
implementation period, organic
handlers may not use nonorganic forms
of ingredients when organic forms of the
ingredients are commercially available
(see 7 CFR 205.301(f)(6)).
Sucrose Octanoate Esters (§ 205.601 and
§ 205.603)
This final rule renews the allowances
for sucrose octanoate esters at 7 CFR
205.601(e)(10) and 205.603(b)(11).1
Sucrose octanoate esters is a pesticide
that targets mites (e.g., Varroa mites, a
pest that attacks honeybees) and certain
soft-bodied insects (e.g., aphids).
NOSB Review and Recommendation
Following the sunset review of
sucrose octanoate esters, the NOSB
recommended removing sucrose
octanoate esters from the National List.
As described in the Background section,
the sunset process is a system of regular
evaluation of National List substances
against criteria in the OFPA. If a
substance is found to no longer satisfy
these criteria, the NOSB may
recommend removal of the substance.
Prior to the NOSB’s 2018 Fall
meeting, the NOSB received information
indicating there were no current U.S.
Environmental Protection Agency (EPA)
registrations for sucrose octanoate esters
at the time and therefore no approved
pesticide applications. Based on this
information, the NOSB reasoned that no
argument could be made that this
substance remains an essential tool for
organic production if there was no
current legal use consistent with the
National List restrictions. The Board
then voted to remove both the crop use
listing (at § 205.601(e)) and the livestock
use listing (at § 205.603(b)).2 3 In both
1 Sucrose octanoate esters is cited in NOSB
recommendation(s) at 7 CFR 205.603(b)(10). The
current citation for sucrose octanoate esters is 7
CFR 205.603(b)(11).
2 National Organic Standards Board, Sunset
Review of Substances Listed at §§ 205.601 and
205.602, https://www.ams.usda.gov/sites/default/
files/media/CS2020SunsetFinalRecOct2018.pdf.
3 National Organic Standards Board, Sunset
Review of Substances Listed at § 205.603, https://
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organic crop and livestock production,
sucrose octanoate esters are allowed as
an insecticide and parasiticide, with the
latter including treatment of Varroa
mites in honeybees. Honeybees are
regulated as livestock under the USDA
organic regulations (see definition of
‘‘livestock’’ at § 205.2), allowing
substances on the National List for
livestock production to be used in
organic apiculture (beekeeping).
Comments Received
Most comments on the proposed rule
related to the proposed removal of
sucrose octanoate esters from the
National List.
Lack of approved alternatives. Most
comments supported keeping sucrose
octanoate esters on the National List.
Commenters stated that removing this
substance would have a negative impact
on organic farmers and beekeepers, as it
is a primary ingredient in
OrganiShield—a common product used
in Integrated Pest Management (IPM)
systems. Commenters stressed that there
is no comparable product on the market
that is safe, effective, and approved for
use in organic crop and livestock
production.
Environmentally friendly pesticide.
Commenters noted that the use of
sucrose octanoate esters benefits cropfriendly insects such as pollinators,
biodegrades rapidly after use, and does
not negatively impact the environment.
Multiple commenters highlighted that
sucrose octanoate esters play a key role
as an organic pesticide, specifically in
controlling Varroa mites.
Change in market situation.
Commenters highlighted that the NOSB
voted to remove both the crop use
listing at § 205.601(e) and the livestock
use at § 205.603(b) during the Fall 2018
meeting. The NOSB’s rationale was that
sucrose octanoate esters could not be
considered an essential tool for organic
production if there were no legally
approved uses (i.e., there were no active
EPA pesticide registrations at the time).
Commenters noted that the market
situation has changed since the NOSB’s
2018 decision, as there have since been
new EPA registrations for sucrose
octanoate esters.
AMS Response
AMS had tentatively suggested
removal of sucrose octanoate esters in
the proposed rule based on the lack of
EPA-approved uses for this substance
back when the NOSB recommended its
removal in 2018 (86 FR 47242, August
24, 2021). Following the 2018 NOSB
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meeting, the EPA received product
registrations for sucrose octanoate esters
in December 2020. Subsequent
comments demonstrated that the market
situation had changed since the 2018
NOSB recommendation, with recent
product registrations and increased use
of sucrose octanoate esters.
Additionally, comments noted this
substance is not harmful to the
environment and cited the lack of
alternatives approved for organic use. In
response to comments identifying the
recent registration, increased use, and a
lack of alternatives, AMS is not
removing sucrose octanoate esters from
the National List at §§ 205.601(e)(10)
and 205.603(b)(11). The substance will
undergo another sunset review prior to
the new March 15, 2027 sunset date. At
that time, the Board will have another
opportunity to evaluate the substance
against OFPA criteria considering this
recent registration and increase in use.
Vitamin B1 (§ 205.601)
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This final rule amends the National
List to prohibit use of synthetic vitamin
B1 in organic crop production by
removing vitamin B1 from 7 CFR
205.601(j)(9).
NOSB Review and Recommendation
Following the sunset review of
vitamin B1, the NOSB recommended
removing vitamin B1 from the National
List. As described in the Background
section, the sunset process is a system
of regular evaluation of National List
substances against criteria in the OFPA.
If a substance is found to no longer
satisfy these criteria, the NOSB may
recommend removal of the substance.
In support of their sunset review,4 the
NOSB requested a third-party technical
report on the use of vitamins B1, C, and
E in crop production.5 The technical
report stated these vitamins are
generally used for stimulation of crop
growth and plant protection but found
that previous claims about root growth
and reduction of transplant shock
associated with vitamin B1 were largely
unsubstantiated outside of a laboratory
environment. Due to this, and the lack
of support voiced during the public
comment process regarding efficacy or
necessity, the NOSB recommended
removal.
4 National Organic Standards Board, Crops 2019
Sunset Substances, https://www.ams.usda.gov/
sites/default/files/media/CS2019SunsetsFinal
Rec.pdf.
5 Pesticide Research Institute, Technical
Evaluation Report: Vitamins B1, C and E, https://
www.ams.usda.gov/sites/default/files/media/
Vitamins%20B1-C-E%20TR%202015.pdf.
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Comments Received
AMS received no comments in
support of keeping synthetic vitamin B1
on the National List for organic crop
production. One commenter requested
the NOP allow for a 12-month
implementation timeline.
AMS Response
As commenters noted, the NOSB
voted to remove vitamin B1 from the
National List at the Fall 2017 meeting
on the basis that it is not essential for
organic crop production and because its
primary use for root growth and
reduction of transplant shock was not
substantiated by technical information.
Given this information regarding use
and efficacy, AMS is removing vitamin
B1 from the National List for organic
crop production. Further, the 2015
technical report on vitamins for crop
production identified several natural
(nonsynthetic) alternatives to vitamin
B1, including yeast, various meals (e.g.,
soybean meal, cottonseed meal), and
other crop waste or residues. After
considering public comments, technical
reports, and the NOSB review, AMS is
finalizing the removal of vitamin B1
from the National List at § 205.601(j)(9).
As specified in the DATES section,
organic crop producers will have until
March 15, 2023, to comply with this
change.
Oxytocin (§ 205.603)
This final rule renews the allowance
for oxytocin (an animal drug) for use in
post-parturition (birth) therapeutic
applications at 7 CFR 205.603(a)(22).
Oxytocin will not be prohibited, as
proposed, in organic livestock
production. A discussion of the
compliant uses under the annotation,
‘‘postparturition therapeutic
applications,’’ is included below in
AMS’s response.
NOSB Review and Recommendation
Following its sunset review of
oxytocin, the NOSB recommended
removing oxytocin from the National
List.6 As described in the Background
section, the sunset process is a system
of regular evaluation of National List
substances against criteria in the OFPA.
If a substance is found to no longer
satisfy these criteria, the NOSB may
recommend removal of the substance.
The NOSB requested public comment
on whether the substance was essential
for organic production and whether
there were natural alternative materials
6 National Organic Standards Board, Livestock
2019 Sunset Substances, https://
www.ams.usda.gov/sites/default/files/media/
LS2019SunsetsFinalRec.pdf.
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and methods that render it unnecessary.
In response, the NOSB received public
comments indicating the substance was
no longer necessary and generally
supporting its removal. The NOSB
concluded there are numerous
alternative methods and materials to
oxytocin and that the use of oxytocin no
longer meets the criteria at 7 U.S.C.
6518(m)(6). Additionally, the NOSB
noted that oxytocin is a synthetic
hormone and that hormones are not
otherwise permitted in organic
production (§§ 205.237(b)(1) and
205.238(c)(3)).
Comments Received
AMS received several comments in
response to the proposed sunset
removal of oxytocin from the National
List.
General opposition. A certifying agent
(‘‘certifier’’) noted that 35 of the organic
dairies they certify include the
substance in their Organic System Plans
for use in post-parturition therapeutic
applications. The commenter stated that
those operations use oxytocin for
various uses, including uterine care,
milk letdown for first-time heifers or as
a mastitis treatment, retained placenta,
and strained labor treatment. The
commenter noted they do not allow
routine or repeated use of oxytocin nor
permit operations to use oxytocin to
promote milk production. The
commenter requested that any
prohibition of the substance occur
following the 2022 spring birthing
season.
A dairy manufacturer requested
retention for oxytocin on the National
List due to a lack of alternatives. The
commenter also stated oxytocin is a
veterinary control drug that should only
be administered or prescribed under
veterinary instruction. The commenter
recognized alternatives can assist with
topical inflammation; however, for uses
to assist with inflammation caused by
animals withholding milk or to assist
with uterine cleaning, the commenter
stated there were no compliant
alternatives. Another commenter also
requested oxytocin to remain an
allowed substance on account of its
effectiveness as a post-parturition
therapeutic to transition a dry cow to a
lactating cow.
General agreement. A comment stated
that natural alternatives are available to
address certain post-parturition
complications that can arise in organic
dairy cattle and that use of oxytocin
would prevent organic producers from
claiming their products are ‘‘hormonefree.’’ The commenter requested an
implementation period of 12 months to
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allow for industry time to comply with
the final rule.
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AMS Response
After reviewing public comments,
AMS is renewing the listing for oxytocin
in this final rule. The substance will
remain on the National List, with a new
sunset date of March 15, 2027. AMS
agrees with commenters that synthetic
oxytocin remains essential to organic
livestock production in the absence of
alternative nonsynthetic (natural)
medical treatments for post-parturition
emergency treatments (i.e., treatment for
severe complications resulting from
labor). AMS notes that under current
FDA regulations, ‘‘Federal law restricts
[oxytocin] to use by or on the order of
a licensed veterinarian.’’ (21 CFR
522.1680(c)(3)). Although some
annotations on the National List for
animal drugs specify that they may be
used only by or on the order of a
veterinarian, the absence of this
phrasing in the annotation for oxytocin
would not alter a producer’s obligations
to comply with other federal laws.
By retaining oxytocin on the National
List, organic livestock producers will
continue to be permitted to use the drug
to treat specific conditions within a
limited timeframe following parturition
without forfeiting the animal’s organic
status. Additional discussion of the
permitted uses of the substance in
organic production follows.
Annotation Discussion
AMS is aware there is some confusion
around what uses comply with the
annotation for oxytocin that reads, ‘‘use
in postparturition therapeutic
treatments’’ (§ 205.603(a)(22)). This
discussion is meant to inform certifying
agents and organic operations of AMS’s
current thinking on uses that comply
with the annotation.
The current annotation allows
producers to use oxytocin to treat
conditions related to labor and to an
animal’s postpartum survival. Its use is
not permitted on a routine basis (i.e., as
protocol). Instead, it is available for
emergency situations and severe
complications in the immediate
postpartum (following birth of young)
period. It may not be administered to
increase an animal’s milk production
(volume) or for milk letdown. As
previously noted in this document,
Federal law restricts this drug to use by
or on the order of a licensed
veterinarian (21 CFR 522.1680(c)(3)).
AMS’s interpretation of the
annotation for oxytocin at § 205.603,
‘‘for postparturition therapeutic
applications,’’ is informed and
supported by its prior discussion of
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oxytocin in its March 13, 2000 proposed
rule (65 FR 13511). AMS believes that
discussion is relevant to the meaning of
the current annotation in the USDA
organic regulations. In the discussion in
the proposed rule, AMS noted that
oxytocin, ‘‘has some uses that do not
involve lactation but are instead related
to an animal’s postpartum survival’’ and
that oxytocin was permitted by some
certifiers for ‘‘animals that experience
severe complications resulting from
labor,’’ and described those as
‘‘emergency situations’’ (65 FR 13511,
13588).
AMS’s expectation is that certifiers
will always review an organic
operation’s use of oxytocin to ensure it
is used only in postparturition
therapeutic applications.
Procaine (§ 205.603)
This final rule amends the National
List to remove procaine at 7 CFR
205.603(b)(9) and prohibit its use in
organic livestock production.
NOSB Review and Recommendation
Following the sunset review of
procaine, the NOSB recommended
removing procaine from the National
List. As described in the Background
section, the sunset process is a system
of regular evaluation of National List
substances against criteria in the OFPA.
If a substance is found to no longer
satisfy these criteria, the NOSB may
recommend removal of the substance.
In support of their sunset review, the
NOSB solicited public comment over
two meetings on use of procaine and
whether procaine can be sourced
without prohibited antibiotics. The
comments stated procaine is rarely
used, is only available in drug
formulations that are combined with
prohibited antibiotics, and is not as
effective as lidocaine (allowed for
organic livestock use at § 205.603(b)(5)).
After their review, the NOSB
recommended removal of procaine from
the National List.
Comments Received
AMS received no comments opposed
to removing procaine from the National
List. A certifying agent noted the
importance of pain relievers but stated
that procaine was not an active
ingredient in any product currently
used by organic operations that it
certifies. Another comment highlighted
that procaine products are already
prohibited for use because they are
always formulated with antibiotics that
are prohibited in organic livestock
production. One commenter requested
an implementation timeline of 12
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months to allow industry time to
comply with the final rule.
AMS Response
As the NOSB referenced in their
recommendation, procaine is not
available on its own (i.e., not
compounded with an antibiotic). A
search of the FDA’s animal drug
database (https://animaldrugs
atfda.fda.gov/) indicates that all 16 of
the FDA approved drugs that contain
procaine also contain an antibiotic (e.g.,
Penicillin G Procaine). Furthermore,
another National List material,
lidocaine, could be used to perform the
same function (as a local anesthetic).
This information supports that procaine
is not currently used in organic
production and no longer meets the
exemption requirement (7 U.S.C.
6517(c)(1)(A)(ii)). AMS agrees with
commenters and the NOSB that
procaine is not essential to organic
livestock production. AMS is finalizing
the removal of synthetic procaine from
the National List at § 205.603(b)(9) to
prohibit its use in organic livestock
production. As specified in the DATES
section, organic livestock producers will
have until March 15, 2023, to comply
with this change.
Alginic Acid (§ 205.605)
This final rule amends the National
List to remove alginic acid at 7 CFR
205.605(b) and prohibit its use in
organic processed products.
NOSB Review and Recommendation
Following the sunset review of alginic
acid, the NOSB recommended removing
alginic acid from the National List. As
described in the Background section,
the sunset process is a system of regular
evaluation of National List substances
against criteria in the OFPA. If a
substance is found to no longer satisfy
these criteria, the NOSB may
recommend removal of the substance.
In support of their sunset review of
alginic acid, the NOSB received a thirdparty technical report in 2015 and
solicited public comment at their Spring
2019 meeting.7 The NOSB received no
comments in support of continuing the
allowance of, or stating use of, alginic
acid. In addition, no certifying agents
(‘‘certifiers’’) reported this material in
use by their certified operations.
Further, the 2015 technical report cited
other National List materials (including
agar-agar, carrageenan, gellan gum, and
xanthan gum) as possible alternatives to
alginic acid. Based on this, the NOSB
7 OMRI, Technical Evaluation Report: Alginic
Acid, https://www.ams.usda.gov/sites/default/files/
media/Alginic%20Acid%20TR.pdf.
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determined that there are readily
available alternatives and recommended
removal.
Comments Received
AMS received no comments in favor
of retaining alginic acid on the National
List. One comment agreed with the
NOSB’s rationale for removing alginic
acid from the National List and
requested a 24-month implementation
period to comply with the final rule.
AMS Response
Given that there were no reports of
operations using alginic acid and the
availability of possible alternatives on
the National List (as referenced in the
technical report), this substance no
longer appears to meet the requirements
for inclusion on the National List at 7
U.S.C. 6517(c)(1)(A)(ii). AMS is
finalizing the removal of alginic acid
from the National List at § 205.605(b) to
prohibit its use in organic processed
products. As identified in the DATES
section, organic processors will have
until March 15, 2024, to comply with
this change.
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Colors (§ 205.606)
This final rule amends the National
List to remove eight nonorganic colors
from the National List at § 205.606(d):
• Black currant juice color—derived
from Ribes nigrum L.;
• Blueberry juice color—derived from
blueberries (Vaccinium spp.);
• Carrot juice color—derived from
Daucus carota L.;
• Cherry juice color—derived from
Prunus avium (L.) L. or Prunus cerasus
L.;
• Grape juice color—derived from
Vitis vinifera L.;
• Paprika color—derived from dried
powder or vegetable oil extract of
Capsicum annuum L.;
• Pumpkin juice color—derived from
Cucurbita pepo L. or Cucurbita maxima
Duchesne;
• Turmeric extract color—derived
from Curcuma longa L.
NOSB Review and Recommendation
The NOSB recommended the removal
of these colors at their Fall 2020
meeting.8 The effect of these removals
means that only organic forms of these
colors will be allowed in organic
handling. The NOSB solicited public
comments in support of their sunset
review of these colors at the Spring and
Fall 2020 meetings. The NOSB noted
these public comments were mixed
8 National Organic Standards Board, 2022 Sunset
Reviews—Handling (§§ 205.605, 205.606), https://
www.ams.usda.gov/sites/default/files/media/
HS2022SunsetRecs_webpost.pdf.
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regarding the availability and necessity
of these colors. Additionally, in the case
of carrot juice color and grape juice
color, the NOSB noted that the
availability of these crops in organic
forms should provide an adequate
supply of organic carrot juice and
organic grape juice for color production
and cited that as a reason for their
recommended removal.
these colors, given sufficient time. As
such, AMS is finalizing the removal of
these non-organic colors from the
National List at § 205.606(d). To support
the development of an adequate supply
of organic colors, as requested by
commentors, organic processors will
have until March 15, 2024 (a 24-month
implementation period) to comply with
these changes.
Comments Received
AMS received few comments in
response to the proposed removal of
eight nonorganic colors from the
National List.
General opposition. A comment
requested retaining turmeric extract
color on the National List because there
is no readily available organic
alternative in the marketplace. Another
comment requested retaining paprika
color on the National List as there are
no commercially-available, organic
alternatives for the color; however, the
commenter stated there are readilyavailable, organic raw materials that
may allow an organic version of the
color to be developed. The commenter
estimated a two-year implementation
period would provide enough time for
color development, shelf-life trials, and
commercialization.
General agreement. A certifier noted
limited use of the nonorganic colors in
this final rule among the organic
handlers they certify. The comment
noted there is limited use of nonorganic
paprika color, grape juice color, and
cherry juice powder. A certifying agent
was particularly concerned about an
insufficient supply of blueberry juice
color, carrot juice color, paprika color,
and turmeric extract color. The
commenter cited an internal survey (of
organic operations) that indicated the
supply of organic colors is fragile and
that removal from the National List may
be premature, especially without a
substantial implementation period. The
commenter requested an
implementation timeline of 24 months
to allow industry time to comply with
the final rule.
Kelp (§ 205.606)
This final rule amends the National
List to remove kelp at 7 CFR 205.606(k)
and prohibit its use. Wakame seaweed
and Pacific kombu remain allowed in
§ 205.606 in organic processed products.
AMS Response
In the rule proposing removal of these
colors, AMS requested comments
regarding whether any of these colors
are necessary and whether there are
enough organic versions available to
meet demand. Comments received
suggested there may not be sufficient
supplies of certain organic colors but
that supply would likely develop over
the course of the 24-month
implementation period. None of these
comments suggested an inability to
produce or develop organic versions of
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NOSB Review and Recommendation
Following the sunset review of kelp at
their Fall 2020 meeting, the NOSB
recommended removing kelp from the
National List. Only organic forms of
kelp (other than wakame seaweed and
Pacific kombu, which remain allowed in
§ 205.606), would be allowed in organic
handling. As described in the
Background section, the sunset process
is a system of regular evaluation of
National List substances against criteria
in the OFPA. If a substance is found to
no longer satisfy these criteria, the
NOSB may recommend removal of the
substance.
During its sunset review, the NOSB
received comments in support of
removing, as well as relisting, kelp. The
NOSB determined that there were
alternatives to kelp on the National List
(namely Pacific kombu and wakame)
and therefore recommended removing
kelp from the National List in § 205.606.
Comments Received
AMS received no comments in favor
of retaining nonorganic kelp on the
National List for organic handling. A
comment requested an implementation
period of 24 months to allow industry
time to comply with the final rule.
AMS Response
According to the Organic Integrity
Database, there are currently 104
certified crop, wild crop, and handling
operations that list ‘‘kelp’’ as a certified
organic product.9 Organic kelp appears
to be commercially available; therefore,
this substance is no longer necessary
and no longer meets the requirements
for inclusion on the National List at 7
U.S.C. 6517(c)(1)(A)(ii). AMS did not
receive any comments challenging this
conclusion and is finalizing the removal
of non-organic kelp from the National
List at § 205.606(k). As identified in the
9 Organic Integrity Database, accessed January 5,
2022: https://organic.ams.usda.gov/integrity/
Search.aspx.
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DATES section, organic processors will
have until March 15, 2024, to comply
with this change.
identified in the DATES section, organic
processors will have until March 15,
2024, to comply with this change.
Konjac Flour (§ 205.606)
This final rule amends the National
List to remove konjac flour at 7 CFR
205.606(l) and prohibit its use in
organic processed products.
Sweet Potato Starch (§ 205.606)
This final rule amends the National
List to remove sweet potato starch at 7
CFR 205.606(s)(2) and prohibit the use
of non-organic sweet potato starch in
organic products.
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NOSB Review and Recommendation
Following the sunset review of konjac
flour at their Fall 2017 meeting, the
NOSB recommended removing konjac
flour from the National List. As
described in the Background section,
the sunset process is a system of regular
evaluation of National List substances
against criteria in the OFPA. If a
substance is found to no longer satisfy
these criteria, the NOSB may
recommend removal of the substance.
In support of their recommendation,
the NOSB solicited public comment
regarding the use and necessity of
konjac flour in organic handling as well
as the availability of organic konjac
flour. The NOSB received little feedback
from industry in response. One trade
organization reported one organic
producer using konjac flour but was
unsure if it was for products sold as
‘‘organic.’’ Several certifiers stated they
had not received any feedback from
their clients regarding the need for, or
use of, nonorganic konjac flour in their
products. Ultimately, the NOSB voted to
recommend removal of konjac flour
from the National List at § 205.606(l)
due to available alternatives.
NOSB Review and Recommendation
Following the sunset review of sweet
potato starch at their Fall 2020 meeting,
the NOSB recommended removing
sweet potato starch from the National
List. As described in the Background
section, the sunset process is a system
of regular evaluation of National List
substances against criteria in the OFPA.
If a substance is found to no longer
satisfy these criteria, the NOSB may
recommend removal of the substance.
During its sunset review, the NOSB
solicited public comment on the use
and necessity of sweet potato starch but
received little feedback. The comments
suggested there is scant use of
nonorganic sweet potato starch, that
alternatives are readily available, and
that organic sweet potato starch is
available. Further, comments noted that
the continued listing of nonorganic
sweet potato starch is inhibiting
production of organic forms of sweet
potato starch. Based on this information,
the NOSB recommended the removal of
this substance due to available
alternatives.
Comments Received
AMS received no comments in favor
of retaining nonorganic konjac flour on
the National List for organic handling. A
comment requested an implementation
period of 24 months to allow industry
time to comply with the final rule.
Comments Received
AMS received no comments in favor
of retaining nonorganic sweet potato
starch on the National List for organic
handling. A comment requested an
implementation period of 24 months to
allow industry time to comply with the
final rule.
AMS Response
A search in the Organic Integrity
Database for ‘‘konjac’’ shows 30
operations with some form of certified
organic konjac products (e.g., powder,
starch, konjac tubers).10 Given the lack
of reported use of, or need for,
nonorganic konjac flour, and the
availability of organic konjac flour and
konjac tubers, nonorganic konjac flour
no longer meets the requirements for
inclusion on the National List at 7
U.S.C. 6517(c)(1)(A)(ii). AMS did not
receive any comments challenging this
conclusion and, as such, is finalizing
the removal of non-organic konjac flour
from the National List at § 205.606(l). As
AMS Response
A search in the Organic Integrity
Database for ‘‘potato starch’’ shows 60
operations with some form of certified
organic potato starch and another 27
operations with some form of certified
organic pea starch, a cited alternative to
sweet potato starch.11 Given the low
reported use of nonorganic sweet potato
starch and the availability of organic
sweet potato starch and organic pea
starch, nonorganic sweet potato starch
no longer meets the requirements for
inclusion on the National List at 7
U.S.C. 6517(c)(1)(A)(ii). AMS did not
receive any comments challenging this
conclusion and, as such, is finalizing
10 Organic
Integrity Database, accessed January 5,
2022: https://organic.ams.usda.gov/integrity/
Search.aspx.
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11 Organic
Integrity Database, accessed January 5,
2022: https://organic.ams.usda.gov/integrity/
Search.aspx.
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10935
the removal of non-organic sweet potato
starch from the National List at
§ 205.606(s)(2). As identified in the
DATES section, organic processors will
have until March 15, 2024, to comply
with this change.
Turkish Bay Leaves (§ 205.606)
This final rule amends the National
List to remove Turkish bay leaves at 7
CFR 205.606(v) to prohibit its use in
organic products.
NOSB Review and Recommendation
Following the sunset review of
Turkish bay leaves at their Fall 2020
meeting, the NOSB recommended
removing Turkish bay leaves from the
National List. As described in the
Background section, the sunset process
is a system of regular evaluation of
National List substances against criteria
in the OFPA. If a substance is found to
no longer satisfy these criteria, the
NOSB may recommend removal of the
substance.
During its sunset review, the NOSB
received many comments supporting
the removal of Turkish bay leaves due
to the availability of organic versions.
The NOSB called attention to one
comment received at its Fall 2020
meeting from an organic producer who
uses Turkish bay leaves in a wide range
of organic canned soups. This food
manufacturer noted that organic forms
of Turkish bay leaves are readily
available. Further comments from
certifiers indicated that few, if any, of
their operations use nonorganic Turkish
bay leaves. Based on this information,
the NOSB recommended the removal of
this substance due to available
alternatives.12
Comments Received
AMS received no comments in favor
of retaining nonorganic Turkish bay
leaves on the National List for organic
handling. A commenter noted that the
NOSB received multiple comments
supporting the removal of Turkish bay
leaves from the National List during the
2020 sunset review. The commenter
stated that Turkish bay leaves only
remained on the National List after the
NOSB’s Fall 2015 meeting due to the
lack of available, organic alternatives.
AMS Response
Previously, AMS proposed removing
Turkish bay leaves from § 205.606
following a Fall 2015 NOSB
12 National Organic Standards Board, 2022 Sunset
Reviews—Handling (§§ 205.605, 205.606), https://
www.ams.usda.gov/sites/default/files/media/
HS2022SunsetRecs_webpost.pdf.
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recommendation.13 At the time, AMS
received comments stating organic
whole Turkish bay leaves were not
available in the quantity or quality to
meet organic handling needs. As a
result, AMS did not finalize removing
Turkish bay leaves (82 FR 31241, July 6,
2017), and its sunset date was extended
five years.
A search in the Organic Integrity
Database for ‘‘bay leaves’’ shows 143
crop and handling operations with some
form of certified organic bay leaves. A
search using the term ‘‘Turkish bay
leaves’’ shows six operations, as it
appears that only one certifying agent
identifies bay leaves with that level of
specificity in the Organic Integrity
Database.14 Given that comments to the
NOSB indicated organic Turkish bay
leaves are readily available in all forms
and the high number of operations
reported in the Organic Integrity
Database with organic bay leaves (of
which a subset are Turkish bay leaves),
nonorganic Turkish bay leaves no longer
meet the requirements for inclusion on
the National List at 7 U.S.C.
6517(c)(1)(A)(ii). During this current
rulemaking, AMS received no
comments challenging this conclusion
and is removing non-organic Turkish
bay leaves from the National List at
§ 205.606(v). As identified in the DATES
section, organic processors will have
until March 15, 2024, to comply with
this change.
Whey Protein Concentrate (§ 205.606)
This final rule amends the National
List to remove whey protein concentrate
at 7 CFR 205.606(x) and prohibit its use
in organic processed products.
Comments Received
AMS received no comments in favor
of retaining nonorganic whey protein
concentrate on the National List for
organic handling. A certifier noted that
an organic operation they certify
previously used non-organic whey
protein concentrate but no longer does.
Another commenter noted that the
NOSB received many comments
supporting the removal of whey protein
from the National List during the 2020
sunset review, including from several
manufacturers who demonstrated they
produce a robust supply of organic
whey protein concentrate. The
commenter noted that removing the
allowance of a nonorganic form will
help support organic cheese
manufacturers. A comment requested an
implementation period of 24 months to
allow industry time to comply with the
final rule.
substantial supply of all forms of
organic whey protein concentrate and
cited the diversion of some quantity to
the conventional market as evidence
that there is enough supply to meet the
demand for organic whey protein
concentrate. Given the comments
submitted to the NOSB outlining the
lack of use and stated abundance of
supply, nonorganic whey protein
concentrate no longer meets the
requirement for inclusion on the
National List at 7 U.S.C.
6517(c)(1)(A)(ii). During this current
rulemaking, AMS received no
comments challenging this conclusion
and is removing non-organic whey
protein concentrate from the National
List at § 205.606(x). As identified in the
DATES section, organic processors will
have until March 15, 2024, to comply
with this change.
III. Related Documents
AMS published notices in the Federal
Register to announce the NOSB
meetings where the Board discussed
these substances. The notices invited
public comments on the NOSB
recommendations addressed in this
final rule. Transcripts of the meetings,
along with the NOSB recommendations,
can be found on the AMS website at:
https://www.ams.usda.gov/rulesregulations/organic/nosb/meetings. The
AMS proposed rule that preceded this
final rule was published on August 24,
2021 (86 FR 47242).
AMS Response
IV. Statutory and Regulatory Authority
Following the sunset review of whey
protein concentrate at their Fall 2020
meeting, the NOSB recommended
removing whey protein concentrate
from the National List. As described in
the Background section, the sunset
process is a system of regular evaluation
of National List substances against
criteria in the OFPA. If a substance is
found to no longer satisfy these criteria,
the NOSB may recommend removal of
the substance.
During this sunset review, the NOSB
received many comments supporting
the removal of whey protein concentrate
Previously, AMS proposed removing
whey protein concentrate from
§ 205.606, following a Fall 2015 NOSB
recommendation.16 At that time, AMS
received comments stating organic whey
protein concentrate was essential for
organic processed products and that
there were no commercially available,
organic products. As a result, AMS did
not finalize the removal of whey protein
concentrate from the National List (82
FR 31241, July 6, 2017).
A search in the Organic Integrity
Database for ‘‘whey protein
concentrate’’ shows 23 operations with
some form of certified organic whey
protein concentrate. The NOSB also
received comments suggesting a
13 National Organic Standards Board, Sunset 2017
NOSB Final Review Handling Substances, https://
www.ams.usda.gov/sites/default/files/media/
HS%202017%20Sunset%20Final%20
Rvw%20605%28a%29_%28b%29_606_
final%20rec.pdf.
14 Organic Integrity Database, accessed January 5,
2022: https://organic.ams.usda.gov/integrity/
Search.aspx.
15 National Organic Standards Board, 2022 Sunset
Reviews—Handling (§§ 205.605, 205.606),https://
www.ams.usda.gov/sites/default/files/media/
HS2022SunsetRecs_webpost.pdf.
16 National Organic Standards Board, Sunset 2017
NOSB Final Review Handling Substances, https://
www.ams.usda.gov/sites/default/files/media/
HS%202017%20Sunset%20Final%20Rvw%20605
%28a%29_%28b%29_606_final%20rec.pdf.
The OFPA authorizes the Secretary to
make amendments to the National List
based on recommendations developed
by the NOSB. The OFPA authorizes 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 (7 U.S.C.
6518(k) and (n)). 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 (7 CFR 205.607).
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 Handbook on
the NOP website as document NOP
3011 at https://www.ams.usda.gov/
rules-regulations/organic/handbook.
NOSB Review and Recommendation
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due to the availability of organic
versions. The NOSB highlighted several
commenters, who demonstrated that
they produce a robust supply of organic
whey protein concentrate in several
forms and sell excess to the
conventional market. A comment noted
that the international supply chain of
organic whey-based products is also
robust. Further comments from at least
one certifier indicated that none of their
operations are using nonorganic whey
protein concentrate. Based on this
information, the NOSB recommended
the removal of this substance based on
available alternatives.15
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A. Executive Order 12866 and
Regulatory Flexibility Act
This final rule does not meet the
criteria of a significant regulatory action
under Executive Order 12866 as
supplemented by Executive Order
13563. Therefore, the Office of
Management and Budget (OMB) has not
reviewed this rule under those Orders.
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.17 The SBA classifies
small agricultural producers that engage
in crop and animal production as those
with average annual receipts of less than
$1,000,000 (13 CFR 121.201). 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.
Producers. 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 United States would
be considered small entities. According
to the 2017 Census of Agriculture,
16,585 organic farms in the United
17 ‘‘Table of Small Business Size Standards
Matched to North American Industry Classification
System Codes,’’ U.S. Small Business
Administration, August 19, 2019, https://
www.naics.com/wp-content/uploads/2017/10/SBA_
Size_Standards_Table.pdf.
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16:12 Feb 25, 2022
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States reported sales of organic products
and total farmgate sales more than $9.9
billion.18 Based on that data, organic
sales average just under $600,000 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.
Handlers. According to the NOP’s
Organic Integrity Database (OID), there
are 10,971 U.S.-based organic handlers
that are certified under the USDA
organic regulations.19 The Organic
Trade Association’s 2020 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:
Fewer 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.
Certifying agents. The SBA defines
‘‘all other professional, scientific, and
technical services,’’ which include
certifying agents, as those having annual
receipts of less than $16,500,000 (13
CFR 121.201). There are currently 76
USDA-accredited certifying agents,
based on a query of the OID database,
who provide organic certification
services to producers and handlers.
While many certifying agents are small
entities that would be affected by this
final rule, we do not expect that these
certifying agents would incur significant
costs as a result of this action as
certifying agents already must comply
with the current regulations (e.g.,
maintaining certification records for
organic operations).
AMS does not expect this rule to have
a significant economic impact on
entities affected by this rule.
Alternatives exist to the substances that
this rule prohibits, as determined by the
NOSB and AMS. Additionally, AMS is
providing a 12- to 24-month
implementation period, depending on
the substance or ingredient, to allow
affected entities time to modify
practices.
B. Executive Order 12988
18 ‘‘2019 Organic Survey,’’ 2017 Census of
Agriculture, U.S. Department of Agriculture
National Agricultural Statistics Service, table 1,
https://www.nass.usda.gov/Publications/AgCensus/
2017/Online_Resources/Organics/ORGANICS.pdf.
19 Organic Integrity Database, U.S. Department of
Agriculture, accessed October 27, 2021, https://
organic.ams.usda.gov/Integrity.
C. Paperwork Reduction Act
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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 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 the USDA to be
accredited as a certifying agent, as
described in the OFPA (7 U.S.C.
6514(b)). States are also preempted 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 (7 U.S.C. 6503–6507).
Pursuant to the OFPA (7 U.S.C.
6507(b)(2)), 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 OFPA,
(b) not be inconsistent with 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 7 U.S.C.
6519(c)(6), this final rule does 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 EPA under the
Federal Insecticide, Fungicide and
Rodenticide Act (7 U.S.C. 136 et seq.).
No additional collection or
recordkeeping requirements are
imposed on the public by this final rule.
Accordingly, Office of Management and
Budget (OMB) clearance is not required
E:\FR\FM\28FER1.SGM
28FER1
10938
Federal Register / Vol. 87, No. 39 / Monday, February 28, 2022 / Rules and Regulations
by the Paperwork Reduction Act (PRA)
of 1995, 44 U.S.C. 3501, Chapter 35.
D. Executive Order 13175
This final rule has been reviewed
under Executive Order 13175—
Consultation and Coordination with
Indian Tribal Governments. Executive
Order 13175 requires Federal agencies
to consult and coordinate with tribes on
a government-to-government basis on:
(1) Policies that have tribal implication,
including regulation, legislative
comments, or proposed legislation; and
(2) other policy statements or actions
that have substantial direct effects on
one or more Indian tribes, on the
relationship between the Federal
Government and Indian tribes, or on the
distribution of power and
responsibilities between the federal
government and Indian tribes.
AMS has assessed the impact of this
final rule on Indian tribes and
determined that this rule would not
have tribal implications that require
consultation under Executive Order
13175. AMS hosts a quarterly
teleconference with tribal leaders where
matters of mutual interest regarding the
marketing of agricultural products are
discussed. Information about the
proposed changes to the regulations are
shared during quarterly calls with Tribal
leaders, who have the opportunity to
submit comments. AMS works with the
USDA Office of Tribal Relations to
ensure meaningful consultation is
provided as needed with regards to the
NOP regulations.
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).
khammond on DSKJM1Z7X2PROD with RULES
F. General Notice of Public Rulemaking
This final rule reflects
recommendations submitted by the
NOSB to the Secretary to remove
fourteen nonorganic ingredients and
two substances from the National List.
This final rule retains (or ‘‘renews’’) two
substances on the National List.
List of Subjects in 7 CFR Part 205
Administrative practice and
procedure, Agricultural commodities,
Agriculture, Animals, Archives and
records, Fees, 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:
VerDate Sep<11>2014
16:12 Feb 25, 2022
Jkt 256001
PART 205—NATIONAL ORGANIC
PROGRAM
1. The authority citation for 7 CFR
part 205 continues to read as follows:
■
Authority: 7 U.S.C. 6501–6524.
2. Amend § 205.601 by revising
paragraph (j)(9) to read as follows:
■
§ 205.601 Synthetic substances allowed
for use in organic crop production.
*
*
*
*
*
(j) * * *
(9) Vitamins, C and E.
*
*
*
*
*
§ 205.603
[Amended]
3. Amend § 205.603 by removing
paragraph (b)(9) and redesignating
paragraphs (b)(10) through 12 as
paragraphs (b)(9) through (11).
■
§ 205.605
[Amended]
4. Amend § 205.605(b) by removing
the words ‘‘Alginic acid (CAS #9005–
32–7)’’.
■ 5. Amend § 205.606 by revising
paragraphs (d) through (t) and removing
paragraphs (u) through (w).
The revisions read as follows:
■
§ 205.606 Nonorganically produced
agricultural products allowed as ingredients
in or on processed products labeled as
‘‘organic.’’
*
*
*
*
*
(d) Colors derived from agricultural
products—Must not be produced using
synthetic solvents and carrier systems or
any artificial preservative.
(1) Beet juice extract color—derived
from Beta vulgaris L., except must not
be produced from sugarbeets.
(2) Beta-carotene extract color—
derived from carrots (Daucus carota L.)
or algae (Dunaliella salina).
(3) Black/purple carrot juice color—
derived from Daucus carota L.
(4) Chokeberry, aronia juice color—
derived from Aronia arbutifolia (L.)
Pers. or Aronia melanocarpa (Michx.)
Elliott.
(5) Elderberry juice color—derived
from Sambucus nigra L.
(6) Grape skin extract color—derived
from Vitis vinifera L.
(7) Purple sweet potato juice color—
derived from Ipomoea batatas L. or
Solanum tuberosum L.
(8) Red cabbage extract color—derived
from Brassica oleracea L.
(9) Red radish extract color—derived
from Raphanus sativus L.
(10) Saffron extract color—derived
from Crocus sativus L.
(e) Cornstarch (native).
(f) Fish oil (Fatty acid CAS #’s:
10417–94–4, and 25167–62–8)—
stabilized with organic ingredients or
PO 00000
Frm 00014
Fmt 4700
Sfmt 4700
only with ingredients on the National
List, §§ 205.605 and 205.606.
(g) Fructooligosaccharides (CAS #
308066–66–2).
(h) Gelatin (CAS # 9000–70–8).
(i) Glycerin (CAS # 56–81–5)—
produced from agricultural source
materials and processed using biological
or mechanical/physical methods as
described under § 205.270(a).
(j) Gums—water extracted only
(Arabic; Guar; Locust bean; and Carob
bean).
(k) Inulin—oligofructose enriched
(CAS # 9005–80–5).
(l) Lecithin—de-oiled.
(m) Orange pulp, dried.
(n) Orange shellac—unbleached (CAS
# 9000–59–3).
(o) Pectin (non-amidated forms only).
(p) Potassium acid tartrate.
(q) Seaweed, Pacific kombu.
(r) Tamarind seed gum.
(s) Tragacanth gum (CAS # 9000–65–
1).
(t) Wakame seaweed (Undaria
pinnatifida).
*
*
*
*
*
Erin Morris,
Associate Administrator, Agricultural
Marketing Service.
[FR Doc. 2022–03851 Filed 2–25–22; 8:45 am]
BILLING CODE P
DEPARTMENT OF AGRICULTURE
Rural Business-Cooperative Service
7 CFR Part 4280
[Docket No. RBS–20–BUSINESS–0027]
RIN 0570–AA98
Rural Energy for America Program
Rural Business-Cooperative
Service, USDA.
ACTION: Final rule; confirmation and
response to comments.
AGENCY:
The Rural BusinessCooperative Service (RBCS or the
Agency), a Rural Development agency of
the United States Department of
Agriculture (USDA), is confirming the
final rule published in the Federal
Register on April 27, 2021, to remove
the provisions relating to guaranteed
loans and to make other revisions to
enhance program delivery and customer
service for the Rural Energy for America
Program (REAP). This notice presents
the opportunity for the Agency to
provide its responses to the public
comments received on the final rule and
to confirm the final rule as published.
DATES: As of February 28, 2022, the
effective date of the final rule published
SUMMARY:
E:\FR\FM\28FER1.SGM
28FER1
]]>Agencies
[Federal Register Volume 87, Number 39 (Monday, February 28, 2022)]
[Rules and Regulations]
[Pages 10930-10938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03851]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Document Number AMS-NOP-19-0106; NOP-19-03]
RIN 0581-AD98
National Organic Program; Amendments to the National List of
Allowed and Prohibited Substances (2022 Sunset)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This final rule amends the United States Department of
Agriculture's (USDA) organic regulations to implement recommendations
from the National Organic Standards Board (NOSB). The rule prohibits
fourteen nonorganic ingredients, which are currently allowed in the
manufacture of organic processed products. The rule also prohibits two
substances (vitamin B1 and procaine), which are currently
allowed in organic crop and livestock production. Finally, the rule
renews an allowance for two substances (oxytocin and sucrose octanoate
esters) in organic production.
DATES:
Effective Date: This rule is effective on March 30, 2022.
Compliance Dates: The compliance date for the amendments that
remove vitamin B1 and procaine from the National List is
March 15, 2023. The compliance date for all other amendments that
remove substances from the National List is March 15, 2024. Products in
the stream of commerce after the compliance date that are labeled as
``organic'' or ``made with organic (specified ingredients or food
group(s))'' may contain substances removed in this final rule if
manufactured prior to the compliance date. The final rule renews an
allowance for two substances (oxytocin and sucrose octanoate esters) in
organic production. This rule maintains the current regulatory
structure with regard to these two substances upon publication for up
to five years.
FOR FURTHER INFORMATION CONTACT: Jared Clark, Standards Division,
National Organic Program. Telephone: (202) 720-3252 or Email:
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Secretary of Agriculture (``Secretary'')
established the Agricultural Marketing Service's (AMS) National Organic
Program (NOP) and the USDA organic regulations (65 FR 80547). Within
the USDA organic regulations (7 CFR part 205) is the National List of
Allowed and Prohibited Substances (or ``National List''). The National
List identifies the synthetic substances that may be used in organic
crop and livestock production as well as the nonsynthetic (natural)
substances that may not be used. It also identifies the nonorganic
substances that may be used in or on processed organic products.
AMS is finalizing 16 amendments to the National List in accordance
with the procedures detailed in the Organic Foods Production Act of
1990 (OFPA) (7 U.S.C. 6501-6524). OFPA establishes what may be included
on the National List and the procedures that the USDA must follow to
amend the National List (7 U.S.C. 6517). OFPA also describes the NOSB's
responsibilities in proposing amendments to the National List,
including the criteria for evaluating amendments to the National List
(7 U.S.C. 6518).
To remain on the National List, substances must be: (1) Reviewed
every five years by the NOSB, a 15-member federal advisory committee;
and (2) renewed by the Secretary (7 U.S.C. 6517(e)). This action of
NOSB review and USDA renewal is commonly referred to as the ``sunset
review'' or ``sunset process.'' AMS published information about this
process in the Federal Register on September 16, 2013 (78 FR 56811).
The sunset date (i.e., the date by which the Secretary must renew a
substance for the listing to remain valid on the National List) for
each substance is included in the NOP Program Handbook (document NOP
5611).
The removal of substances from the National List addresses National
Organic Standards Board (NOSB) recommendations submitted to the
Secretary after the conclusion of the NOSB's public meetings on October
29, 2015; November 2, 2017; October 26, 2018; and October 30, 2020.
During a 60-day comment period that closed on October 25, 2021, AMS
received 60 comments on the proposed rule. See below for a discussion
of the comments received and AMS's responses to comments. Comments on
the proposed rule can also be viewed through Regulations.gov. Use the
search area on the homepage at https://www.regulations.gov to enter a
keyword,
[[Page 10931]]
title, or docket ID (the docket number for this rule is AMS-NOP-19-
0106).
II. Overview of Amendments
This rule removes fourteen ingredients and two substances from the
National List and retains (or ``renews'') two substances on the
National List. Additional background on the NOSB's review of the
substances may be found in the proposed rule (86 FR 47242; August 24,
2021).
This final rule removes the following synthetic substances, which
are currently allowed in organic crop and livestock production (7 CFR
205.601 and 205.603):
Vitamin B1 (crop production); and
Procaine (livestock production).
As noted in the DATES section, AMS is providing a one-year
implementation period for these changes to provide time for certifying
agents to communicate the changes to organic operations and for organic
producers to cease use.
Additionally, AMS is removing the following nonorganic ingredients,
which are currently allowed in organic handling (Sec. Sec. 205.605 and
205.606):
Alginic acid;
Colors (black currant juice color, blueberry juice color,
carrot juice color, cherry juice color, grape juice color, paprika
color, pumpkin juice color, turmeric extract color);
Kelp;
Konjac flour;
Sweet potato starch;
Turkish bay leaves; and
Whey protein concentrate.
Finally, this rule renews sucrose octanoate esters for organic crop
and livestock production and oxytocin for organic livestock production.
The new sunset date for the two substances (three listings on the
National List) is March 15, 2027.
Below, AMS describes each substance in alphabetical order, sorted
by use (i.e., crop production, livestock production, handling). Sucrose
octanoate esters is discussed first because it is used in both crop and
livestock production. For each substance, AMS outlines the NOSB's
sunset review, discusses comments received, and describes the final
action by this rule.
Implementation Period. As noted in the DATES section, AMS is
providing a one-year implementation period for producers to cease use
of vitamin B1 and procaine. For all other substances removed
by this final rule, AMS is providing a two-year implementation period.
A shorter implementation period for vitamin B1 and procaine
is appropriate because there is no evidence these substances are
currently used in organic production. A 2-year implementation period is
provided for organic handling operations to cease use of the nonorganic
ingredients (including alginic acid) above. AMS believes that a two-
year implementation period provides certifying agents with the
necessary time to communicate the changes to organic operations and for
operations to source organic forms of the ingredients (if necessary),
revise labels, and/or adjust recipes. Public comment indicated a two-
year implementation period would be adequate. AMS notes that while the
final rule provides a two-year implementation period, organic handlers
may not use nonorganic forms of ingredients when organic forms of the
ingredients are commercially available (see 7 CFR 205.301(f)(6)).
Sucrose Octanoate Esters (Sec. 205.601 and Sec. 205.603)
This final rule renews the allowances for sucrose octanoate esters
at 7 CFR 205.601(e)(10) and 205.603(b)(11).\1\ Sucrose octanoate esters
is a pesticide that targets mites (e.g., Varroa mites, a pest that
attacks honeybees) and certain soft-bodied insects (e.g., aphids).
---------------------------------------------------------------------------
\1\ Sucrose octanoate esters is cited in NOSB recommendation(s)
at 7 CFR 205.603(b)(10). The current citation for sucrose octanoate
esters is 7 CFR 205.603(b)(11).
---------------------------------------------------------------------------
NOSB Review and Recommendation
Following the sunset review of sucrose octanoate esters, the NOSB
recommended removing sucrose octanoate esters from the National List.
As described in the Background section, the sunset process is a system
of regular evaluation of National List substances against criteria in
the OFPA. If a substance is found to no longer satisfy these criteria,
the NOSB may recommend removal of the substance.
Prior to the NOSB's 2018 Fall meeting, the NOSB received
information indicating there were no current U.S. Environmental
Protection Agency (EPA) registrations for sucrose octanoate esters at
the time and therefore no approved pesticide applications. Based on
this information, the NOSB reasoned that no argument could be made that
this substance remains an essential tool for organic production if
there was no current legal use consistent with the National List
restrictions. The Board then voted to remove both the crop use listing
(at Sec. 205.601(e)) and the livestock use listing (at Sec.
205.603(b)).2 3 In both organic crop and livestock
production, sucrose octanoate esters are allowed as an insecticide and
parasiticide, with the latter including treatment of Varroa mites in
honeybees. Honeybees are regulated as livestock under the USDA organic
regulations (see definition of ``livestock'' at Sec. 205.2), allowing
substances on the National List for livestock production to be used in
organic apiculture (beekeeping).
---------------------------------------------------------------------------
\2\ National Organic Standards Board, Sunset Review of
Substances Listed at Sec. Sec. 205.601 and 205.602, https://www.ams.usda.gov/sites/default/files/media/CS2020SunsetFinalRecOct2018.pdf.
\3\ National Organic Standards Board, Sunset Review of
Substances Listed at Sec. 205.603, https://www.ams.usda.gov/sites/default/files/media/LS2020SunsetFinalRecOct2018.pdf.
---------------------------------------------------------------------------
Comments Received
Most comments on the proposed rule related to the proposed removal
of sucrose octanoate esters from the National List.
Lack of approved alternatives. Most comments supported keeping
sucrose octanoate esters on the National List. Commenters stated that
removing this substance would have a negative impact on organic farmers
and beekeepers, as it is a primary ingredient in OrganiShield--a common
product used in Integrated Pest Management (IPM) systems. Commenters
stressed that there is no comparable product on the market that is
safe, effective, and approved for use in organic crop and livestock
production.
Environmentally friendly pesticide. Commenters noted that the use
of sucrose octanoate esters benefits crop-friendly insects such as
pollinators, biodegrades rapidly after use, and does not negatively
impact the environment. Multiple commenters highlighted that sucrose
octanoate esters play a key role as an organic pesticide, specifically
in controlling Varroa mites.
Change in market situation. Commenters highlighted that the NOSB
voted to remove both the crop use listing at Sec. 205.601(e) and the
livestock use at Sec. 205.603(b) during the Fall 2018 meeting. The
NOSB's rationale was that sucrose octanoate esters could not be
considered an essential tool for organic production if there were no
legally approved uses (i.e., there were no active EPA pesticide
registrations at the time). Commenters noted that the market situation
has changed since the NOSB's 2018 decision, as there have since been
new EPA registrations for sucrose octanoate esters.
AMS Response
AMS had tentatively suggested removal of sucrose octanoate esters
in the proposed rule based on the lack of EPA-approved uses for this
substance back when the NOSB recommended its removal in 2018 (86 FR
47242, August 24, 2021). Following the 2018 NOSB
[[Page 10932]]
meeting, the EPA received product registrations for sucrose octanoate
esters in December 2020. Subsequent comments demonstrated that the
market situation had changed since the 2018 NOSB recommendation, with
recent product registrations and increased use of sucrose octanoate
esters. Additionally, comments noted this substance is not harmful to
the environment and cited the lack of alternatives approved for organic
use. In response to comments identifying the recent registration,
increased use, and a lack of alternatives, AMS is not removing sucrose
octanoate esters from the National List at Sec. Sec. 205.601(e)(10)
and 205.603(b)(11). The substance will undergo another sunset review
prior to the new March 15, 2027 sunset date. At that time, the Board
will have another opportunity to evaluate the substance against OFPA
criteria considering this recent registration and increase in use.
Vitamin B1 (Sec. 205.601)
This final rule amends the National List to prohibit use of
synthetic vitamin B1 in organic crop production by removing
vitamin B1 from 7 CFR 205.601(j)(9).
NOSB Review and Recommendation
Following the sunset review of vitamin B1, the NOSB
recommended removing vitamin B1 from the National List. As
described in the Background section, the sunset process is a system of
regular evaluation of National List substances against criteria in the
OFPA. If a substance is found to no longer satisfy these criteria, the
NOSB may recommend removal of the substance.
In support of their sunset review,\4\ the NOSB requested a third-
party technical report on the use of vitamins B1, C, and E
in crop production.\5\ The technical report stated these vitamins are
generally used for stimulation of crop growth and plant protection but
found that previous claims about root growth and reduction of
transplant shock associated with vitamin B1 were largely
unsubstantiated outside of a laboratory environment. Due to this, and
the lack of support voiced during the public comment process regarding
efficacy or necessity, the NOSB recommended removal.
---------------------------------------------------------------------------
\4\ National Organic Standards Board, Crops 2019 Sunset
Substances, https://www.ams.usda.gov/sites/default/files/media/CS2019SunsetsFinalRec.pdf.
\5\ Pesticide Research Institute, Technical Evaluation Report:
Vitamins B1, C and E, https://www.ams.usda.gov/sites/default/files/media/Vitamins%20B1-C-E%20TR%202015.pdf.
---------------------------------------------------------------------------
Comments Received
AMS received no comments in support of keeping synthetic vitamin
B1 on the National List for organic crop production. One
commenter requested the NOP allow for a 12-month implementation
timeline.
AMS Response
As commenters noted, the NOSB voted to remove vitamin B1
from the National List at the Fall 2017 meeting on the basis that it is
not essential for organic crop production and because its primary use
for root growth and reduction of transplant shock was not substantiated
by technical information. Given this information regarding use and
efficacy, AMS is removing vitamin B1 from the National List
for organic crop production. Further, the 2015 technical report on
vitamins for crop production identified several natural (nonsynthetic)
alternatives to vitamin B1, including yeast, various meals
(e.g., soybean meal, cottonseed meal), and other crop waste or
residues. After considering public comments, technical reports, and the
NOSB review, AMS is finalizing the removal of vitamin B1
from the National List at Sec. 205.601(j)(9). As specified in the
DATES section, organic crop producers will have until March 15, 2023,
to comply with this change.
Oxytocin (Sec. 205.603)
This final rule renews the allowance for oxytocin (an animal drug)
for use in post-parturition (birth) therapeutic applications at 7 CFR
205.603(a)(22). Oxytocin will not be prohibited, as proposed, in
organic livestock production. A discussion of the compliant uses under
the annotation, ``postparturition therapeutic applications,'' is
included below in AMS's response.
NOSB Review and Recommendation
Following its sunset review of oxytocin, the NOSB recommended
removing oxytocin from the National List.\6\ As described in the
Background section, the sunset process is a system of regular
evaluation of National List substances against criteria in the OFPA. If
a substance is found to no longer satisfy these criteria, the NOSB may
recommend removal of the substance.
---------------------------------------------------------------------------
\6\ National Organic Standards Board, Livestock 2019 Sunset
Substances, https://www.ams.usda.gov/sites/default/files/media/LS2019SunsetsFinalRec.pdf.
---------------------------------------------------------------------------
The NOSB requested public comment on whether the substance was
essential for organic production and whether there were natural
alternative materials and methods that render it unnecessary. In
response, the NOSB received public comments indicating the substance
was no longer necessary and generally supporting its removal. The NOSB
concluded there are numerous alternative methods and materials to
oxytocin and that the use of oxytocin no longer meets the criteria at 7
U.S.C. 6518(m)(6). Additionally, the NOSB noted that oxytocin is a
synthetic hormone and that hormones are not otherwise permitted in
organic production (Sec. Sec. 205.237(b)(1) and 205.238(c)(3)).
Comments Received
AMS received several comments in response to the proposed sunset
removal of oxytocin from the National List.
General opposition. A certifying agent (``certifier'') noted that
35 of the organic dairies they certify include the substance in their
Organic System Plans for use in post-parturition therapeutic
applications. The commenter stated that those operations use oxytocin
for various uses, including uterine care, milk letdown for first-time
heifers or as a mastitis treatment, retained placenta, and strained
labor treatment. The commenter noted they do not allow routine or
repeated use of oxytocin nor permit operations to use oxytocin to
promote milk production. The commenter requested that any prohibition
of the substance occur following the 2022 spring birthing season.
A dairy manufacturer requested retention for oxytocin on the
National List due to a lack of alternatives. The commenter also stated
oxytocin is a veterinary control drug that should only be administered
or prescribed under veterinary instruction. The commenter recognized
alternatives can assist with topical inflammation; however, for uses to
assist with inflammation caused by animals withholding milk or to
assist with uterine cleaning, the commenter stated there were no
compliant alternatives. Another commenter also requested oxytocin to
remain an allowed substance on account of its effectiveness as a post-
parturition therapeutic to transition a dry cow to a lactating cow.
General agreement. A comment stated that natural alternatives are
available to address certain post-parturition complications that can
arise in organic dairy cattle and that use of oxytocin would prevent
organic producers from claiming their products are ``hormone-free.''
The commenter requested an implementation period of 12 months to
[[Page 10933]]
allow for industry time to comply with the final rule.
AMS Response
After reviewing public comments, AMS is renewing the listing for
oxytocin in this final rule. The substance will remain on the National
List, with a new sunset date of March 15, 2027. AMS agrees with
commenters that synthetic oxytocin remains essential to organic
livestock production in the absence of alternative nonsynthetic
(natural) medical treatments for post-parturition emergency treatments
(i.e., treatment for severe complications resulting from labor). AMS
notes that under current FDA regulations, ``Federal law restricts
[oxytocin] to use by or on the order of a licensed veterinarian.'' (21
CFR 522.1680(c)(3)). Although some annotations on the National List for
animal drugs specify that they may be used only by or on the order of a
veterinarian, the absence of this phrasing in the annotation for
oxytocin would not alter a producer's obligations to comply with other
federal laws.
By retaining oxytocin on the National List, organic livestock
producers will continue to be permitted to use the drug to treat
specific conditions within a limited timeframe following parturition
without forfeiting the animal's organic status. Additional discussion
of the permitted uses of the substance in organic production follows.
Annotation Discussion
AMS is aware there is some confusion around what uses comply with
the annotation for oxytocin that reads, ``use in postparturition
therapeutic treatments'' (Sec. 205.603(a)(22)). This discussion is
meant to inform certifying agents and organic operations of AMS's
current thinking on uses that comply with the annotation.
The current annotation allows producers to use oxytocin to treat
conditions related to labor and to an animal's postpartum survival. Its
use is not permitted on a routine basis (i.e., as protocol). Instead,
it is available for emergency situations and severe complications in
the immediate postpartum (following birth of young) period. It may not
be administered to increase an animal's milk production (volume) or for
milk letdown. As previously noted in this document, Federal law
restricts this drug to use by or on the order of a licensed
veterinarian (21 CFR 522.1680(c)(3)).
AMS's interpretation of the annotation for oxytocin at Sec.
205.603, ``for postparturition therapeutic applications,'' is informed
and supported by its prior discussion of oxytocin in its March 13, 2000
proposed rule (65 FR 13511). AMS believes that discussion is relevant
to the meaning of the current annotation in the USDA organic
regulations. In the discussion in the proposed rule, AMS noted that
oxytocin, ``has some uses that do not involve lactation but are instead
related to an animal's postpartum survival'' and that oxytocin was
permitted by some certifiers for ``animals that experience severe
complications resulting from labor,'' and described those as
``emergency situations'' (65 FR 13511, 13588).
AMS's expectation is that certifiers will always review an organic
operation's use of oxytocin to ensure it is used only in
postparturition therapeutic applications.
Procaine (Sec. 205.603)
This final rule amends the National List to remove procaine at 7
CFR 205.603(b)(9) and prohibit its use in organic livestock production.
NOSB Review and Recommendation
Following the sunset review of procaine, the NOSB recommended
removing procaine from the National List. As described in the
Background section, the sunset process is a system of regular
evaluation of National List substances against criteria in the OFPA. If
a substance is found to no longer satisfy these criteria, the NOSB may
recommend removal of the substance.
In support of their sunset review, the NOSB solicited public
comment over two meetings on use of procaine and whether procaine can
be sourced without prohibited antibiotics. The comments stated procaine
is rarely used, is only available in drug formulations that are
combined with prohibited antibiotics, and is not as effective as
lidocaine (allowed for organic livestock use at Sec. 205.603(b)(5)).
After their review, the NOSB recommended removal of procaine from the
National List.
Comments Received
AMS received no comments opposed to removing procaine from the
National List. A certifying agent noted the importance of pain
relievers but stated that procaine was not an active ingredient in any
product currently used by organic operations that it certifies. Another
comment highlighted that procaine products are already prohibited for
use because they are always formulated with antibiotics that are
prohibited in organic livestock production. One commenter requested an
implementation timeline of 12 months to allow industry time to comply
with the final rule.
AMS Response
As the NOSB referenced in their recommendation, procaine is not
available on its own (i.e., not compounded with an antibiotic). A
search of the FDA's animal drug database (https://animaldrugsatfda.fda.gov/) indicates that all 16 of the FDA approved
drugs that contain procaine also contain an antibiotic (e.g.,
Penicillin G Procaine). Furthermore, another National List material,
lidocaine, could be used to perform the same function (as a local
anesthetic). This information supports that procaine is not currently
used in organic production and no longer meets the exemption
requirement (7 U.S.C. 6517(c)(1)(A)(ii)). AMS agrees with commenters
and the NOSB that procaine is not essential to organic livestock
production. AMS is finalizing the removal of synthetic procaine from
the National List at Sec. 205.603(b)(9) to prohibit its use in organic
livestock production. As specified in the DATES section, organic
livestock producers will have until March 15, 2023, to comply with this
change.
Alginic Acid (Sec. 205.605)
This final rule amends the National List to remove alginic acid at
7 CFR 205.605(b) and prohibit its use in organic processed products.
NOSB Review and Recommendation
Following the sunset review of alginic acid, the NOSB recommended
removing alginic acid from the National List. As described in the
Background section, the sunset process is a system of regular
evaluation of National List substances against criteria in the OFPA. If
a substance is found to no longer satisfy these criteria, the NOSB may
recommend removal of the substance.
In support of their sunset review of alginic acid, the NOSB
received a third-party technical report in 2015 and solicited public
comment at their Spring 2019 meeting.\7\ The NOSB received no comments
in support of continuing the allowance of, or stating use of, alginic
acid. In addition, no certifying agents (``certifiers'') reported this
material in use by their certified operations. Further, the 2015
technical report cited other National List materials (including agar-
agar, carrageenan, gellan gum, and xanthan gum) as possible
alternatives to alginic acid. Based on this, the NOSB
[[Page 10934]]
determined that there are readily available alternatives and
recommended removal.
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\7\ OMRI, Technical Evaluation Report: Alginic Acid, https://www.ams.usda.gov/sites/default/files/media/Alginic%20Acid%20TR.pdf.
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Comments Received
AMS received no comments in favor of retaining alginic acid on the
National List. One comment agreed with the NOSB's rationale for
removing alginic acid from the National List and requested a 24-month
implementation period to comply with the final rule.
AMS Response
Given that there were no reports of operations using alginic acid
and the availability of possible alternatives on the National List (as
referenced in the technical report), this substance no longer appears
to meet the requirements for inclusion on the National List at 7 U.S.C.
6517(c)(1)(A)(ii). AMS is finalizing the removal of alginic acid from
the National List at Sec. 205.605(b) to prohibit its use in organic
processed products. As identified in the DATES section, organic
processors will have until March 15, 2024, to comply with this change.
Colors (Sec. 205.606)
This final rule amends the National List to remove eight nonorganic
colors from the National List at Sec. 205.606(d):
Black currant juice color--derived from Ribes nigrum L.;
Blueberry juice color--derived from blueberries (Vaccinium
spp.);
Carrot juice color--derived from Daucus carota L.;
Cherry juice color--derived from Prunus avium (L.) L. or
Prunus cerasus L.;
Grape juice color--derived from Vitis vinifera L.;
Paprika color--derived from dried powder or vegetable oil
extract of Capsicum annuum L.;
Pumpkin juice color--derived from Cucurbita pepo L. or
Cucurbita maxima Duchesne;
Turmeric extract color--derived from Curcuma longa L.
NOSB Review and Recommendation
The NOSB recommended the removal of these colors at their Fall 2020
meeting.\8\ The effect of these removals means that only organic forms
of these colors will be allowed in organic handling. The NOSB solicited
public comments in support of their sunset review of these colors at
the Spring and Fall 2020 meetings. The NOSB noted these public comments
were mixed regarding the availability and necessity of these colors.
Additionally, in the case of carrot juice color and grape juice color,
the NOSB noted that the availability of these crops in organic forms
should provide an adequate supply of organic carrot juice and organic
grape juice for color production and cited that as a reason for their
recommended removal.
---------------------------------------------------------------------------
\8\ National Organic Standards Board, 2022 Sunset Reviews--
Handling (Sec. Sec. 205.605, 205.606), https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf.
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Comments Received
AMS received few comments in response to the proposed removal of
eight nonorganic colors from the National List.
General opposition. A comment requested retaining turmeric extract
color on the National List because there is no readily available
organic alternative in the marketplace. Another comment requested
retaining paprika color on the National List as there are no
commercially-available, organic alternatives for the color; however,
the commenter stated there are readily-available, organic raw materials
that may allow an organic version of the color to be developed. The
commenter estimated a two-year implementation period would provide
enough time for color development, shelf-life trials, and
commercialization.
General agreement. A certifier noted limited use of the nonorganic
colors in this final rule among the organic handlers they certify. The
comment noted there is limited use of nonorganic paprika color, grape
juice color, and cherry juice powder. A certifying agent was
particularly concerned about an insufficient supply of blueberry juice
color, carrot juice color, paprika color, and turmeric extract color.
The commenter cited an internal survey (of organic operations) that
indicated the supply of organic colors is fragile and that removal from
the National List may be premature, especially without a substantial
implementation period. The commenter requested an implementation
timeline of 24 months to allow industry time to comply with the final
rule.
AMS Response
In the rule proposing removal of these colors, AMS requested
comments regarding whether any of these colors are necessary and
whether there are enough organic versions available to meet demand.
Comments received suggested there may not be sufficient supplies of
certain organic colors but that supply would likely develop over the
course of the 24-month implementation period. None of these comments
suggested an inability to produce or develop organic versions of these
colors, given sufficient time. As such, AMS is finalizing the removal
of these non-organic colors from the National List at Sec. 205.606(d).
To support the development of an adequate supply of organic colors, as
requested by commentors, organic processors will have until March 15,
2024 (a 24-month implementation period) to comply with these changes.
Kelp (Sec. 205.606)
This final rule amends the National List to remove kelp at 7 CFR
205.606(k) and prohibit its use. Wakame seaweed and Pacific kombu
remain allowed in Sec. 205.606 in organic processed products.
NOSB Review and Recommendation
Following the sunset review of kelp at their Fall 2020 meeting, the
NOSB recommended removing kelp from the National List. Only organic
forms of kelp (other than wakame seaweed and Pacific kombu, which
remain allowed in Sec. 205.606), would be allowed in organic handling.
As described in the Background section, the sunset process is a system
of regular evaluation of National List substances against criteria in
the OFPA. If a substance is found to no longer satisfy these criteria,
the NOSB may recommend removal of the substance.
During its sunset review, the NOSB received comments in support of
removing, as well as relisting, kelp. The NOSB determined that there
were alternatives to kelp on the National List (namely Pacific kombu
and wakame) and therefore recommended removing kelp from the National
List in Sec. 205.606.
Comments Received
AMS received no comments in favor of retaining nonorganic kelp on
the National List for organic handling. A comment requested an
implementation period of 24 months to allow industry time to comply
with the final rule.
AMS Response
According to the Organic Integrity Database, there are currently
104 certified crop, wild crop, and handling operations that list
``kelp'' as a certified organic product.\9\ Organic kelp appears to be
commercially available; therefore, this substance is no longer
necessary and no longer meets the requirements for inclusion on the
National List at 7 U.S.C. 6517(c)(1)(A)(ii). AMS did not receive any
comments challenging this conclusion and is finalizing the removal of
non-organic kelp from the National List at Sec. 205.606(k). As
identified in the
[[Page 10935]]
DATES section, organic processors will have until March 15, 2024, to
comply with this change.
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\9\ Organic Integrity Database, accessed January 5, 2022:
https://organic.ams.usda.gov/integrity/Search.aspx.
---------------------------------------------------------------------------
Konjac Flour (Sec. 205.606)
This final rule amends the National List to remove konjac flour at
7 CFR 205.606(l) and prohibit its use in organic processed products.
NOSB Review and Recommendation
Following the sunset review of konjac flour at their Fall 2017
meeting, the NOSB recommended removing konjac flour from the National
List. As described in the Background section, the sunset process is a
system of regular evaluation of National List substances against
criteria in the OFPA. If a substance is found to no longer satisfy
these criteria, the NOSB may recommend removal of the substance.
In support of their recommendation, the NOSB solicited public
comment regarding the use and necessity of konjac flour in organic
handling as well as the availability of organic konjac flour. The NOSB
received little feedback from industry in response. One trade
organization reported one organic producer using konjac flour but was
unsure if it was for products sold as ``organic.'' Several certifiers
stated they had not received any feedback from their clients regarding
the need for, or use of, nonorganic konjac flour in their products.
Ultimately, the NOSB voted to recommend removal of konjac flour from
the National List at Sec. 205.606(l) due to available alternatives.
Comments Received
AMS received no comments in favor of retaining nonorganic konjac
flour on the National List for organic handling. A comment requested an
implementation period of 24 months to allow industry time to comply
with the final rule.
AMS Response
A search in the Organic Integrity Database for ``konjac'' shows 30
operations with some form of certified organic konjac products (e.g.,
powder, starch, konjac tubers).\10\ Given the lack of reported use of,
or need for, nonorganic konjac flour, and the availability of organic
konjac flour and konjac tubers, nonorganic konjac flour no longer meets
the requirements for inclusion on the National List at 7 U.S.C.
6517(c)(1)(A)(ii). AMS did not receive any comments challenging this
conclusion and, as such, is finalizing the removal of non-organic
konjac flour from the National List at Sec. 205.606(l). As identified
in the DATES section, organic processors will have until March 15,
2024, to comply with this change.
---------------------------------------------------------------------------
\10\ Organic Integrity Database, accessed January 5, 2022:
https://organic.ams.usda.gov/integrity/Search.aspx.
---------------------------------------------------------------------------
Sweet Potato Starch (Sec. 205.606)
This final rule amends the National List to remove sweet potato
starch at 7 CFR 205.606(s)(2) and prohibit the use of non-organic sweet
potato starch in organic products.
NOSB Review and Recommendation
Following the sunset review of sweet potato starch at their Fall
2020 meeting, the NOSB recommended removing sweet potato starch from
the National List. As described in the Background section, the sunset
process is a system of regular evaluation of National List substances
against criteria in the OFPA. If a substance is found to no longer
satisfy these criteria, the NOSB may recommend removal of the
substance.
During its sunset review, the NOSB solicited public comment on the
use and necessity of sweet potato starch but received little feedback.
The comments suggested there is scant use of nonorganic sweet potato
starch, that alternatives are readily available, and that organic sweet
potato starch is available. Further, comments noted that the continued
listing of nonorganic sweet potato starch is inhibiting production of
organic forms of sweet potato starch. Based on this information, the
NOSB recommended the removal of this substance due to available
alternatives.
Comments Received
AMS received no comments in favor of retaining nonorganic sweet
potato starch on the National List for organic handling. A comment
requested an implementation period of 24 months to allow industry time
to comply with the final rule.
AMS Response
A search in the Organic Integrity Database for ``potato starch''
shows 60 operations with some form of certified organic potato starch
and another 27 operations with some form of certified organic pea
starch, a cited alternative to sweet potato starch.\11\ Given the low
reported use of nonorganic sweet potato starch and the availability of
organic sweet potato starch and organic pea starch, nonorganic sweet
potato starch no longer meets the requirements for inclusion on the
National List at 7 U.S.C. 6517(c)(1)(A)(ii). AMS did not receive any
comments challenging this conclusion and, as such, is finalizing the
removal of non-organic sweet potato starch from the National List at
Sec. 205.606(s)(2). As identified in the DATES section, organic
processors will have until March 15, 2024, to comply with this change.
---------------------------------------------------------------------------
\11\ Organic Integrity Database, accessed January 5, 2022:
https://organic.ams.usda.gov/integrity/Search.aspx.
---------------------------------------------------------------------------
Turkish Bay Leaves (Sec. 205.606)
This final rule amends the National List to remove Turkish bay
leaves at 7 CFR 205.606(v) to prohibit its use in organic products.
NOSB Review and Recommendation
Following the sunset review of Turkish bay leaves at their Fall
2020 meeting, the NOSB recommended removing Turkish bay leaves from the
National List. As described in the Background section, the sunset
process is a system of regular evaluation of National List substances
against criteria in the OFPA. If a substance is found to no longer
satisfy these criteria, the NOSB may recommend removal of the
substance.
During its sunset review, the NOSB received many comments
supporting the removal of Turkish bay leaves due to the availability of
organic versions. The NOSB called attention to one comment received at
its Fall 2020 meeting from an organic producer who uses Turkish bay
leaves in a wide range of organic canned soups. This food manufacturer
noted that organic forms of Turkish bay leaves are readily available.
Further comments from certifiers indicated that few, if any, of their
operations use nonorganic Turkish bay leaves. Based on this
information, the NOSB recommended the removal of this substance due to
available alternatives.\12\
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\12\ National Organic Standards Board, 2022 Sunset Reviews--
Handling (Sec. Sec. 205.605, 205.606), https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf.
---------------------------------------------------------------------------
Comments Received
AMS received no comments in favor of retaining nonorganic Turkish
bay leaves on the National List for organic handling. A commenter noted
that the NOSB received multiple comments supporting the removal of
Turkish bay leaves from the National List during the 2020 sunset
review. The commenter stated that Turkish bay leaves only remained on
the National List after the NOSB's Fall 2015 meeting due to the lack of
available, organic alternatives.
AMS Response
Previously, AMS proposed removing Turkish bay leaves from Sec.
205.606 following a Fall 2015 NOSB
[[Page 10936]]
recommendation.\13\ At the time, AMS received comments stating organic
whole Turkish bay leaves were not available in the quantity or quality
to meet organic handling needs. As a result, AMS did not finalize
removing Turkish bay leaves (82 FR 31241, July 6, 2017), and its sunset
date was extended five years.
---------------------------------------------------------------------------
\13\ National Organic Standards Board, Sunset 2017 NOSB Final
Review Handling Substances, https://www.ams.usda.gov/sites/default/files/media/HS%202017%20Sunset%20Final%20Rvw%20605%28a%29_%28b%29_606_final%20rec.pdf.
---------------------------------------------------------------------------
A search in the Organic Integrity Database for ``bay leaves'' shows
143 crop and handling operations with some form of certified organic
bay leaves. A search using the term ``Turkish bay leaves'' shows six
operations, as it appears that only one certifying agent identifies bay
leaves with that level of specificity in the Organic Integrity
Database.\14\ Given that comments to the NOSB indicated organic Turkish
bay leaves are readily available in all forms and the high number of
operations reported in the Organic Integrity Database with organic bay
leaves (of which a subset are Turkish bay leaves), nonorganic Turkish
bay leaves no longer meet the requirements for inclusion on the
National List at 7 U.S.C. 6517(c)(1)(A)(ii). During this current
rulemaking, AMS received no comments challenging this conclusion and is
removing non-organic Turkish bay leaves from the National List at Sec.
205.606(v). As identified in the DATES section, organic processors will
have until March 15, 2024, to comply with this change.
---------------------------------------------------------------------------
\14\ Organic Integrity Database, accessed January 5, 2022:
https://organic.ams.usda.gov/integrity/Search.aspx.
---------------------------------------------------------------------------
Whey Protein Concentrate (Sec. 205.606)
This final rule amends the National List to remove whey protein
concentrate at 7 CFR 205.606(x) and prohibit its use in organic
processed products.
NOSB Review and Recommendation
Following the sunset review of whey protein concentrate at their
Fall 2020 meeting, the NOSB recommended removing whey protein
concentrate from the National List. As described in the Background
section, the sunset process is a system of regular evaluation of
National List substances against criteria in the OFPA. If a substance
is found to no longer satisfy these criteria, the NOSB may recommend
removal of the substance.
During this sunset review, the NOSB received many comments
supporting the removal of whey protein concentrate due to the
availability of organic versions. The NOSB highlighted several
commenters, who demonstrated that they produce a robust supply of
organic whey protein concentrate in several forms and sell excess to
the conventional market. A comment noted that the international supply
chain of organic whey-based products is also robust. Further comments
from at least one certifier indicated that none of their operations are
using nonorganic whey protein concentrate. Based on this information,
the NOSB recommended the removal of this substance based on available
alternatives.\15\
---------------------------------------------------------------------------
\15\ National Organic Standards Board, 2022 Sunset Reviews--
Handling (Sec. Sec. 205.605, 205.606),https://www.ams.usda.gov/sites/default/files/media/HS2022SunsetRecs_webpost.pdf.
---------------------------------------------------------------------------
Comments Received
AMS received no comments in favor of retaining nonorganic whey
protein concentrate on the National List for organic handling. A
certifier noted that an organic operation they certify previously used
non-organic whey protein concentrate but no longer does. Another
commenter noted that the NOSB received many comments supporting the
removal of whey protein from the National List during the 2020 sunset
review, including from several manufacturers who demonstrated they
produce a robust supply of organic whey protein concentrate. The
commenter noted that removing the allowance of a nonorganic form will
help support organic cheese manufacturers. A comment requested an
implementation period of 24 months to allow industry time to comply
with the final rule.
AMS Response
Previously, AMS proposed removing whey protein concentrate from
Sec. 205.606, following a Fall 2015 NOSB recommendation.\16\ At that
time, AMS received comments stating organic whey protein concentrate
was essential for organic processed products and that there were no
commercially available, organic products. As a result, AMS did not
finalize the removal of whey protein concentrate from the National List
(82 FR 31241, July 6, 2017).
---------------------------------------------------------------------------
\16\ National Organic Standards Board, Sunset 2017 NOSB Final
Review Handling Substances, https://www.ams.usda.gov/sites/default/files/media/HS%202017%20Sunset%20Final%20Rvw%20605%28a%29_%28b%29_606_final%20rec.pdf.
---------------------------------------------------------------------------
A search in the Organic Integrity Database for ``whey protein
concentrate'' shows 23 operations with some form of certified organic
whey protein concentrate. The NOSB also received comments suggesting a
substantial supply of all forms of organic whey protein concentrate and
cited the diversion of some quantity to the conventional market as
evidence that there is enough supply to meet the demand for organic
whey protein concentrate. Given the comments submitted to the NOSB
outlining the lack of use and stated abundance of supply, nonorganic
whey protein concentrate no longer meets the requirement for inclusion
on the National List at 7 U.S.C. 6517(c)(1)(A)(ii). During this current
rulemaking, AMS received no comments challenging this conclusion and is
removing non-organic whey protein concentrate from the National List at
Sec. 205.606(x). As identified in the DATES section, organic
processors will have until March 15, 2024, to comply with this change.
III. Related Documents
AMS published notices in the Federal Register to announce the NOSB
meetings where the Board discussed these substances. The notices
invited public comments on the NOSB recommendations addressed in this
final rule. Transcripts of the meetings, along with the NOSB
recommendations, can be found on the AMS website at: https://www.ams.usda.gov/rules-regulations/organic/nosb/meetings. The AMS
proposed rule that preceded this final rule was published on August 24,
2021 (86 FR 47242).
IV. Statutory and Regulatory Authority
The OFPA authorizes the Secretary to make amendments to the
National List based on recommendations developed by the NOSB. The OFPA
authorizes 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 (7 U.S.C.
6518(k) and (n)). 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 (7 CFR 205.607). 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 Handbook on the NOP
website as document NOP 3011 at https://www.ams.usda.gov/rules-regulations/organic/handbook.
[[Page 10937]]
A. Executive Order 12866 and Regulatory Flexibility Act
This final rule does not meet the criteria of a significant
regulatory action under Executive Order 12866 as supplemented by
Executive Order 13563. Therefore, the Office of Management and Budget
(OMB) has not reviewed this rule under those Orders.
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.\17\
The SBA classifies small agricultural producers that engage in crop and
animal production as those with average annual receipts of less than
$1,000,000 (13 CFR 121.201). 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.
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\17\ ``Table of Small Business Size Standards Matched to North
American Industry Classification System Codes,'' U.S. Small Business
Administration, August 19, 2019, https://www.naics.com/wp-content/uploads/2017/10/SBA_Size_Standards_Table.pdf.
---------------------------------------------------------------------------
Producers. 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 United
States would be considered small entities. According to the 2017 Census
of Agriculture, 16,585 organic farms in the United States reported
sales of organic products and total farmgate sales more than $9.9
billion.\18\ Based on that data, organic sales average just under
$600,000 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.
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\18\ ``2019 Organic Survey,'' 2017 Census of Agriculture, U.S.
Department of Agriculture National Agricultural Statistics Service,
table 1, https://www.nass.usda.gov/Publications/AgCensus/2017/Online_Resources/Organics/ORGANICS.pdf.
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Handlers. According to the NOP's Organic Integrity Database (OID),
there are 10,971 U.S.-based organic handlers that are certified under
the USDA organic regulations.\19\ The Organic Trade Association's 2020
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: Fewer 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.
---------------------------------------------------------------------------
\19\ Organic Integrity Database, U.S. Department of Agriculture,
accessed October 27, 2021, https://organic.ams.usda.gov/Integrity.
---------------------------------------------------------------------------
Certifying agents. The SBA defines ``all other professional,
scientific, and technical services,'' which include certifying agents,
as those having annual receipts of less than $16,500,000 (13 CFR
121.201). There are currently 76 USDA-accredited certifying agents,
based on a query of the OID database, who provide organic certification
services to producers and handlers. While many certifying agents are
small entities that would be affected by this final rule, we do not
expect that these certifying agents would incur significant costs as a
result of this action as certifying agents already must comply with the
current regulations (e.g., maintaining certification records for
organic operations).
AMS does not expect this rule to have a significant economic impact
on entities affected by this rule. Alternatives exist to the substances
that this rule prohibits, as determined by the NOSB and AMS.
Additionally, AMS is providing a 12- to 24-month implementation period,
depending on the substance or ingredient, to allow affected entities
time to modify practices.
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 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 the USDA to be accredited as a certifying agent, as described
in the OFPA (7 U.S.C. 6514(b)). States are also preempted 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 (7 U.S.C. 6503-6507).
Pursuant to the OFPA (7 U.S.C. 6507(b)(2)), 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 OFPA, (b) not be inconsistent with 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 7 U.S.C. 6519(c)(6), this final rule does
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 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. Accordingly, Office of Management and
Budget (OMB) clearance is not required
[[Page 10938]]
by the Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501, Chapter
35.
D. Executive Order 13175
This final rule has been reviewed under Executive Order 13175--
Consultation and Coordination with Indian Tribal Governments. Executive
Order 13175 requires Federal agencies to consult and coordinate with
tribes on a government-to-government basis on: (1) Policies that have
tribal implication, including regulation, legislative comments, or
proposed legislation; and (2) other policy statements or actions that
have substantial direct effects on one or more Indian tribes, on the
relationship between the Federal Government and Indian tribes, or on
the distribution of power and responsibilities between the federal
government and Indian tribes.
AMS has assessed the impact of this final rule on Indian tribes and
determined that this rule would not have tribal implications that
require consultation under Executive Order 13175. AMS hosts a quarterly
teleconference with tribal leaders where matters of mutual interest
regarding the marketing of agricultural products are discussed.
Information about the proposed changes to the regulations are shared
during quarterly calls with Tribal leaders, who have the opportunity to
submit comments. AMS works with the USDA Office of Tribal Relations to
ensure meaningful consultation is provided as needed with regards to
the NOP regulations.
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. General Notice of Public Rulemaking
This final rule reflects recommendations submitted by the NOSB to
the Secretary to remove fourteen nonorganic ingredients and two
substances from the National List. This final rule retains (or
``renews'') two substances on the National List.
List of Subjects in 7 CFR Part 205
Administrative practice and procedure, Agricultural commodities,
Agriculture, Animals, Archives and records, Fees, Imports, Labeling,
Organically produced products, Plants, Reporting and recordkeeping
requirements, Seals and insignia, Soil conservation.
For the reasons set forth in the preamble, 7 CFR part 205 is
amended as follows:
PART 205--NATIONAL ORGANIC PROGRAM
0
1. The authority citation for 7 CFR part 205 continues to read as
follows:
Authority: 7 U.S.C. 6501-6524.
0
2. Amend Sec. 205.601 by revising paragraph (j)(9) to read as follows:
Sec. 205.601 Synthetic substances allowed for use in organic crop
production.
* * * * *
(j) * * *
(9) Vitamins, C and E.
* * * * *
Sec. 205.603 [Amended]
0
3. Amend Sec. 205.603 by removing paragraph (b)(9) and redesignating
paragraphs (b)(10) through 12 as paragraphs (b)(9) through (11).
Sec. 205.605 [Amended]
0
4. Amend Sec. 205.605(b) by removing the words ``Alginic acid (CAS
#9005-32-7)''.
0
5. Amend Sec. 205.606 by revising paragraphs (d) through (t) and
removing paragraphs (u) through (w).
The revisions read as follows:
Sec. 205.606 Nonorganically produced agricultural products allowed
as ingredients in or on processed products labeled as ``organic.''
* * * * *
(d) Colors derived from agricultural products--Must not be produced
using synthetic solvents and carrier systems or any artificial
preservative.
(1) Beet juice extract color--derived from Beta vulgaris L., except
must not be produced from sugarbeets.
(2) Beta-carotene extract color--derived from carrots (Daucus
carota L.) or algae (Dunaliella salina).
(3) Black/purple carrot juice color--derived from Daucus carota L.
(4) Chokeberry, aronia juice color--derived from Aronia arbutifolia
(L.) Pers. or Aronia melanocarpa (Michx.) Elliott.
(5) Elderberry juice color--derived from Sambucus nigra L.
(6) Grape skin extract color--derived from Vitis vinifera L.
(7) Purple sweet potato juice color--derived from Ipomoea batatas
L. or Solanum tuberosum L.
(8) Red cabbage extract color--derived from Brassica oleracea L.
(9) Red radish extract color--derived from Raphanus sativus L.
(10) Saffron extract color--derived from Crocus sativus L.
(e) Cornstarch (native).
(f) Fish oil (Fatty acid CAS #'s: 10417-94-4, and 25167-62-8)--
stabilized with organic ingredients or only with ingredients on the
National List, Sec. Sec. 205.605 and 205.606.
(g) Fructooligosaccharides (CAS # 308066-66-2).
(h) Gelatin (CAS # 9000-70-8).
(i) Glycerin (CAS # 56-81-5)--produced from agricultural source
materials and processed using biological or mechanical/physical methods
as described under Sec. 205.270(a).
(j) Gums--water extracted only (Arabic; Guar; Locust bean; and
Carob bean).
(k) Inulin--oligofructose enriched (CAS # 9005-80-5).
(l) Lecithin--de-oiled.
(m) Orange pulp, dried.
(n) Orange shellac--unbleached (CAS # 9000-59-3).
(o) Pectin (non-amidated forms only).
(p) Potassium acid tartrate.
(q) Seaweed, Pacific kombu.
(r) Tamarind seed gum.
(s) Tragacanth gum (CAS # 9000-65-1).
(t) Wakame seaweed (Undaria pinnatifida).
* * * * *
Erin Morris,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2022-03851 Filed 2-25-22; 8:45 am]
BILLING CODE P
