[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Rules and Regulations]
[Pages 33479-33485]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13323]
========================================================================
Rules and Regulations
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by the Superintendent of Documents.
========================================================================
Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Rules
and Regulations
[[Page 33479]]
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[Doc. No. AMS-NOP-19-0053; NOP-19-02]
RIN 0581-AD92
National Organic Program: Amendments to the National List of
Allowed and Prohibited Substances per April 2019 NOSB Recommendations
(Livestock and Handling)
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: This rule amends the National List of Allowed and Prohibited
Substances (National List) section of the U.S. Department of
Agriculture's (USDA) organic regulations to implement recommendations
submitted to the Secretary of Agriculture (Secretary) by the National
Organic Standards Board (NOSB). This rule adds the following allowed
substances to the National List: Oxalic acid dihydrate as a pesticide
for organic apiculture (beekeeping); pullulan for use in organic
handling in products labeled, ``Made with organic (specified
ingredients or food group(s));'' and collagen gel as a nonorganic
nonagricultural substance for use as a casing in organic handling when
organic forms of collagen gel are not commercially available.
DATES: This rule is effective on July 26, 2021.
FOR FURTHER INFORMATION CONTACT: Jared Clark, Standards Division,
National Organic Program. Telephone: (202) 720-3252.
SUPPLEMENTARY INFORMATION:
I. Background
On December 21, 2000, the Secretary established the Agricultural
Marketing Service's (AMS) National Organic Program 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 and the nonsynthetic (natural) substances that may not
be used in organic crop and livestock production. It also identifies
the nonorganic substances that may be used in or on processed organic
products.
AMS is finalizing three 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 USDA must follow
to amend the National List (sec. 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
(sec. 6518).
This final rule adds oxalic acid dihydrate, pullulan, and
nonorganic collagen gel to the National List. Once effective, producers
and handlers of organic products will be allowed to use these
substances in organic production and in organic products. The permitted
use of each substance is discussed in detail below.
To remain on the National List, these substances must be: (1)
Reviewed every 5 years by the NOSB, a 15-member federal advisory
committee; and (2) renewed by the Secretary (sec. 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 first sunset date for the substances in this final rule will
be 5 years from the effective date in the DATES section of this final
rule above.
II. Overview of Amendments
This rule adds oxalic acid, pullulan, and nonorganic collagen gel
to the National List for use in organic livestock production or
handling. Additional background on the petitions and the NOSB's review
of the substances may be found in the proposed rule (85 FR 35011; June
8, 2020).
During a 60-day comment period that closed on August 7, 2020, AMS
received 20 comments on the proposed rule. See below for a discussion
of the comments received and AMS' responses to comments. Comments can
be viewed through Regulations.gov. Use the search area on the homepage
at https://www.regulations.gov to enter a keyword, title, or docket ID
(the docket folder for this rule is AMS-NOP-19-0053).
Oxalic Acid Dihydrate (Sec. 205.603)
Final Action
The final rule amends the National List to add oxalic acid
dihydrate to 7 CFR 205.603 as a synthetic substance allowed for use in
organic apiculture (beekeeping) only. Oxalic acid dihydrate is a
pesticide used for Varroa mite control on bees. Oxalic acid is a
naturally occurring substance, but this rule allows for the use of the
synthetic form (i.e., synthesized via chemical process) of oxalic acid
dihydrate.
AMS is finalizing this amendment to the National List, as proposed
by NOSB, to provide beekeepers that manage organic bees with an
additional option to combat parasitic Varroa mites. Since arriving to
the United States in 1987, Varroa mites have caused the death of
massive numbers of honey bee colonies, and beekeepers have identified
Varroa mites as their single most serious problem causing colony
losses.\1\ The mites damage honey bees both directly (by attaching to
bees) and by serving as a vector for pathogenic viruses.
---------------------------------------------------------------------------
\1\ USDA Agricultural Research Service https://www.ars.usda.gov/oc/br/ccd/index/. Accessed February 1, 2021.
---------------------------------------------------------------------------
Oxalic acid dihydrate is one of a dozen substances currently
registered by the EPA for the control of Varroa mites,\2\ and only a
subset of these are allowed under USDA organic regulations. For
example, the National List includes formic acid (Sec. 205.603(b)(3))
as a pesticide to treat hives. The addition of oxalic acid dihydrate
will be important addition to the National List, as rotating products
to combat Varroa mites is an important tactic to prevent resistance
[[Page 33480]]
development and to maintain the usefulness of individual pesticides.\3\
---------------------------------------------------------------------------
\2\ U.S. Environmental Protection Agency, https://www.epa.gov/pollinator-protection/epa-registered-pesticide-products-approved-use-against-varroa-mites-bee-hives. Accessed February 1, 2021.
\3\ U.S. Environmental Protection Agency, https://www.epa.gov/pollinator-protection/epa-registered-pesticide-products-approved-use-against-varroa-mites-bee-hives. Accessed February 1, 2021.
---------------------------------------------------------------------------
AMS concluded that the addition of oxalic acid dihydrate to the
National List is consistent with the requirements of OFPA sec. 2118(c)
(7 U.S.C. 6517(c)). Namely, the substance is not harmful to human
health or the environment when used as labeled; is necessary to
production because of the unavailability of wholly natural substitute
products; and is consistent with organic farming and handling. The
amendment is made following the procedures established in section
2118(d) of the OFPA (7 U.S.C. 6517(d)).
NOSB Review and Recommendation (Oxalic Acid Dihydrate)
NOSB submitted a recommendation to AMS in April 2019 to add oxalic
acid dihydrate to the National List.\4\ NOSB recommendation followed
receipt of a petition to add the substance to the National List in
October 2017.\5\ In NOSB's evaluation of the petition, they considered
information from a third-party technical evaluation report \6\ and
comments from the public. NOSB discussed the petition to amend the
National List in subcommittee calls and at its public meetings in
October 2018 and April 2019.\7\
---------------------------------------------------------------------------
\4\ NOSB final recommendation for oxalic acid dihydrate, April
26, 2019: https://www.ams.usda.gov/sites/default/files/media/LSOxalicAcidApril2019FinalRec.pdf.
\5\ Oxalic acid petition: https://www.ams.usda.gov/sites/default/files/media/OxalicAcidPetition10032017.pdf.
\6\ Technical Evaluation Report for oxalic acid dihydrate,
November 26, 2018: https://www.ams.usda.gov/sites/default/files/media/OxalicAcidTR.pdf.
\7\ Written and oral public comments submitted for the October
2018 and April 2019 NOSB meetings are available at https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-st-paul-mn and https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-seattle-wa.
---------------------------------------------------------------------------
In its recommendation, NOSB concluded that adding oxalic acid
dihydrate to the National List was consistent with OFPA evaluation
criteria in section 2119(m) (7 U.S.C. 6518(m)). NOSB found that the use
of oxalic acid dihydrate as a mite pest control would be compatible
with and necessary for organic apiculture, providing additional use
benefits over formic acid. NOSB noted that oxalic acid occurs naturally
in the environment and noted no concerns about environmental or human
health impacts or oxalic acid residues in food products.
Comments Received and AMS' Response (Oxalic Acid Dihydrate)
Apiculture standards. Comments recommended that AMS act on NOSB
recommendations from September 2001 and October 2010 \8\ to further
develop organic apiculture standards. Some believed that AMS should
promulgate detailed standards for managing organic bees prior to adding
synthetic substances for organic apiculture to the National List.
---------------------------------------------------------------------------
\8\ NOSB Apiculture Task Force Report, September 2001: https://www.ams.usda.gov/sites/default/files/media/Rec%20Apiculture%20Standards.pdf; and NOSB's Apiculture
Recommendation, October 2010: https://www.ams.usda.gov/sites/default/files/media/NOP%20Livestock%20Final%20Rec%20Apiculture.pdf.
---------------------------------------------------------------------------
AMS notes that the USDA organic regulations include ``nonplant
life'' (e.g., bees) in the definition of livestock (Sec. 205.2). Given
that AMS permits USDA-accredited certifiers to certify organic
apicultural operations under the regulations for livestock production,
AMS will continue to consider recommendations from NOSB regarding
substances for organic apiculture operations. Additionally, the
National List includes other substances that may be used in organic
apiculture, including formic acid (Sec. 205.603(b)(3)), which is
permitted for the treatment of honeybee hives. Oxalic acid dihydrate
provides some advantages compared to formic acid, and AMS is adding the
substance to the National List to provide certified organic apiculture
operations with an additional option to treat for Varroa.
General opposition. Some comments opposed the addition of oxalic
acid dihydrate to the National List because they opposed any use of
synthetic substances in organic production. AMS notes that OFPA permits
the use of specific synthetic substances (i.e., those on the National
List) in organic production. OFPA describes the procedures for amending
the National List and provides AMS and the NOSB with criteria and
guidelines to consider in evaluating changes to the National List. NOSB
and AMS followed these procedures, and this rule adds oxalic acid
dihydrate to the National List.
Health effects. Finally, AMS received a comment opposing the
addition of oxalic acid dihydrate that cites a source that suggests
that the consumption of oxalic acid dihydrate inhibits calcium
availability in the human body. AMS does not find merit in the comment.
AMS notes that EPA's Final Registration Decision for oxalic acid states
this compound is only used in beehives when honey supers are not
present and that dietary exposures to oxalic acid from in-hive
applications is indistinguishable from naturally occurring levels.\9\
---------------------------------------------------------------------------
\9\ U.S. Environmental Protection Agency, Registration Decision
for the New Active Ingredient Oxalic Acid, March 2015, https://www.regulations.gov/document?D=EPA-HQ-OPP-2015-0043-0119. Accessed
February 1, 2021.
---------------------------------------------------------------------------
Pullulan (Sec. 205.605)
Final Action
This final rule amends the National List to add pullulan to Sec.
205.605(a) as an ingredient allowed only in products labeled, ``Made
with organic (specified ingredients or food group(s))'' (or ``made
with''). The ``made with'' labeling category is distinct from the
``organic'' and ``100% organic'' labeling categories under USDA organic
regulations (7 CFR 205.301). Products labeled ``organic'' or ``100%
organic'' cannot contain nonorganic pullulan as an ingredient under
this final rule. Additionally, the final rule only permits nonorganic
pullulan in tablets and capsules for dietary supplements.
AMS is finalizing this amendment to the National List, as proposed
by NOSB, to add pullulan to the National List for use in ``made with''
products to provide manufacturers of organic dietary supplements with
an option to label products with additional dietary claims (e.g.,
vegan, vegetarian). Nonorganic forms of pullulan are necessary because
organic forms of pullulan are not readily available. By adding
nonorganic pullulan to Sec. 205.605 of the National List with a
limitation on use for ``made with'' products, AMS is providing a
limited exception for use of nonorganic pullulan.
Pullulan is a natural extracellular polysaccharide excretion
resulting from carbohydrate fermentation by the yeast-like fungus
Aureobasidium pullulans and other non-toxic fungi strains.\10\ The
fungus A. pullulans is ubiquitous in nature and is most common in
temperate zones in locations such as forest soil, freshwater, on plant
leaves, and on seeds. Pullulan has been self-affirmed as GRAS
(Generally Recognized as Safe) for multiple uses, including as a
multifunctional food ingredient, a film, and an excipient (GRN No. 99,
pp. 26-30).\11\
---------------------------------------------------------------------------
\10\ Pullulan technical evaluation report, September 7, 2018:
https://www.ams.usda.gov/sites/default/files/media/PullulanTechnicalReportFinal09072018.pdf. Accessed February 1, 2021.
\11\ GRAS Notice (GRN) No. 99 and FDA's response to the Notice,
are available at: https://www.fda.gov/food/generally-recognized-safe-gras/gras-notice-inventory. Accessed February 1, 2021.
---------------------------------------------------------------------------
AMS concluded that the addition of pullulan to the National List is
consistent with the requirements of OFPA sec. 6517(c). Namely, the
substance is not harmful to human
[[Page 33481]]
health or the environment; is necessary to production because of the
unavailability of wholly natural substitute products; and is consistent
with organic farming and handling. The amendment is made following the
procedures established in OFPA (sec. 6517(d)).
NOSB Review and Recommendation (Pullulan)
NOSB submitted a recommendation to AMS in April 2019 to add
pullulan to the National List.\12\ NOSB recommendation followed receipt
of a petition to add the substance to the National List in January
2018.\13\ In NOSB's evaluation of the petition, they considered
information from a third-party technical evaluation report \14\ and
comments from the public. NOSB discussed the petition to amend the
National List in subcommittee calls and at its public meetings in
October 2018 and April 2019.\15\
---------------------------------------------------------------------------
\12\ NOSB final recommendation for pullulan, April 26, 2019:
https://www.ams.usda.gov/sites/default/files/media/HSPullullanApr2019FinalRec.pdf.
\13\ Pullulan petition: https://www.ams.usda.gov/sites/default/files/media/PullulanPetition18131.pdf.
\14\ Pullulan technical evaluation report, September 7, 2018:
https://www.ams.usda.gov/sites/default/files/media/PullulanTechnicalReportFinal09072018.pdf.
\15\ Written and oral public comments submitted for the October
2018 and April 2019 NOSB meetings are available at https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-st-paul-mn and https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-seattle-wa.
---------------------------------------------------------------------------
In its recommendation, NOSB concluded that adding pullulan to the
National List was consistent with OFPA criteria (sec. 6518(m)). In its
recommendation, NOSB noted that there are few, if any, other
encapsulation options available compliant with organic composition
requirements at Sec. 205.301 for consumers seeking a suitable
alternative to gelatin for religious and dietary requirements (e.g.,
vegan, halal, kosher).
Comments Received and AMS' Response (Pullulan)
Classification. In the proposed rule, AMS requested comments on
whether pullulan should be classified as a nonsynthetic,
nonagricultural substance, as proposed, or whether it should be
considered as an agricultural substance that may be certifiable as
organic.
An opposing comment argued that production of pullulan should be
considered a form of agricultural production and compared production of
A. pullulans to other types of fungi production. The comment suggested
that pullulan is better described as an agricultural product than a
nonagricultural product.
AMS also received comments that agreed with the classification of
pullulan as nonagricultural. Comments that argued that pullulan is a
nonsynthetic state that other products of microbial fermentation at
Sec. 205.605(a) (e.g., citric acid, enzymes, microorganisms) are
classified as nonsynthetic.
AMS received several comments that AMS' classification of pullulan
as nonagricultural does not mean that pullulan cannot also be certified
organic (i.e., that pullulan could be certified organic if manufactured
by alternative processes). Commenters pointed to published AMS guidance
and to examples of other substances on the National List at Sec.
205.605 that can be found in certified organic form (e.g., yeast,
flavors, citric acid).
AMS agrees with the classification of pullulan as nonsynthetic. The
referenced guidance \16\ provides examples and clarity on the
definitions of ``agricultural,'' ``synthetic,'' and ``nonsynthetic
(natural)'' as presented in Sec. 205.2. Nonsynthetic substances are
defined as ``A substance that is derived from mineral, plant, or animal
matter and does not undergo a synthetic process . . .''. Given that
pullulan is manufactured by the isolation of a byproduct of fungal
fermentation of a carbohydrate substrate,\17\ it fits the definition of
``nonsynthetic'' and will be classified as such rather than
``agricultural,'' defined as ``[a]ny agricultural commodity or product,
whether raw or processed, including any commodity or product derived
from livestock . . .''.
---------------------------------------------------------------------------
\16\ NOP 5033--Classification of Materials: https://www.ams.usda.gov/sites/default/files/media/NOP-5033.pdf.
\17\ Pullulan Technical Report, September 7, 2018: https://www.ams.usda.gov/sites/default/files/media/PullulanTechnicalReportFinal09072018.pdf.
---------------------------------------------------------------------------
Comments were received which argued both that pullulan could and
could not be certified under the USDA organic regulations. These
comments offer differing interpretations of whether any of the
manufacturing processes would result in a product which would be
certifiable. AMS will maintain the requirement that nonorganic pullulan
be used only in ``made with'' products, as we are aware there are
certified organic pullulan products on the international market.
This final rule adds pullulan to the National List as a
nonagricultural ingredient. AMS notes that similar National List
substances produced by microbial fermentation are classified as
nonagricultural (e.g., citric acid, xanthan gum, and gellan gum). AMS
agrees with NOSB determination that pullulan is a nonagricultural
substance, as described in our response to comments regarding
classification. The classification of pullulan as nonagricultural does
not preclude the production of certified organic pullulan, as long as
the process meets the requirements of Sec. 205.105 and Sec. 205.301.
Genetically modified organisms. A comment was opposed to the
addition of pullulan to the National List because of the potential that
genetically modified organisms (GMOs) might be used in the production
of pullulan (e.g., substrates as nutrient sources for the fermentation
process).
AMS understands concerns regarding the use of genetically modified
organisms in the production of National List materials. The USDA
organic regulations (Sec. 205.105) include a prohibition on
ingredients produced or handled with the use of excluded methods
(including genetic engineering) as defined in Sec. 205.2.
Digestibility concern. A comment cited a study comparing human
digestion of pullulan to digestion of maltodextrin. AMS understands
that NOSB considered the effects of slow digestion (including increased
flatulence, as cited in the comment) and did not conclude these effects
to be sufficiently detrimental to human health to disqualify the
substance from addition to the National List per OFPA (7 U.S.C.
6518(m)).
General opposition. Two comments generally opposed changes to the
National List and were opposed to the addition of pullulan. AMS notes
that OFPA permits the use of specific synthetic substances (i.e., those
on the National List) in organic production. OFPA describes the
procedures for amending the National List and provides AMS and NOSB
with criteria and guidelines to consider in evaluating changes to the
National List. These procedures were followed by NOSB and AMS, and this
rule adds pullulan to the National List.
General support. Comments supporting the addition of pullulan cited
its potential to be used as a vegetarian alternative for capsules used
for oral supplements. These comments argued that while gelatin is on
the National List and is used for capsules, it is an animal byproduct,
which vegan and vegetarian consumers choose not to use. Another comment
stated that gelatin-based capsules are not appropriate for many vegan
and
[[Page 33482]]
vegetarian supplement products and may cause issues among kosher and
halal consumers.
AMS appreciates public engagement in the rulemaking process and
agrees with the general support above which mirrors the recommendation
by NOSB. AMS is moving forward with adding this substance to the
National List as proposed.
Collagen Gel Casing (Sec. 205.605)
Final Action
This final rule amends the National List to add collagen gel as a
casing to 7 CFR 205.605(b) as a nonorganic nonagricultural ingredient
allowed in organic handling. The amendment will permit the use of
nonorganic forms of collagen gel when organic collagen gel is not
commercially available (i.e., not available in an appropriate form,
quality, or quantity, as determined by the certifying agent in the
course of reviewing the organic plan).\18\ The final rule only permits
nonorganic collagen gel as a casing. This final rule adds collagen gel
casing to Sec. 205.605(b) rather than to Sec. 205.606, as proposed.
The change in AMS' classification of collagen gel (and, therefore, its
location on the National List) is discussed in the ``Comments Received
and AMS' Response'' section below.
---------------------------------------------------------------------------
\18\ See 7 CFR 205.606 and 7 CFR 205.2 for definition of
``Commercially available.''
---------------------------------------------------------------------------
AMS is finalizing the addition of collagen gel casing to the
National List, as proposed by NOSB, as organic collagen gel is not
commercially available as of the issuance of this final rule. This
conclusion is based on AMS' review of comments made to NOSB and
comments received in response to the proposed rule. Additionally, AMS
searched the Organic Integrity Database and found no certified organic
operations with certified organic collagen gel.\19\
---------------------------------------------------------------------------
\19\ Available at https://organic.ams.usda.gov/Integrity/Default.aspx. Accessed and searched for ``collagen gel'' on February
1, 2021.
---------------------------------------------------------------------------
AMS expects that the allowance for nonorganic forms of collagen gel
when organic forms are not available will encourage organic
certification of products that have not been previously eligible for
organic certification. This will encourage food manufacturers to
develop new organic products, which could, in turn, create new demand
for organic production (livestock production). There are no
alternatives on the National List which are suitable for use in a co-
extrusion system as a non-removable edible film.
Collagen gel is described as a multi-ingredient product made from
collagen (3.0-4.5%), cellulose (<3.0%), and water (95.5-97.0%) in the
commissioned third-party technical evaluation report.\20\ Collagen is
isolated from animal materials (e.g., skin, bones) through thermal,
acid, base, or enzymatic hydrolysis. Once isolated, the extract is
decalcified and swollen with acid (generally hydrochloric or sulfuric)
prior to use in a co-extrusion process.
---------------------------------------------------------------------------
\20\ Collagen gel technical evaluation report, January 28, 2019:
https://www.ams.usda.gov/sites/default/files/media/CollagenGelGelatinCasingsTechnicalReport01282019.pdf.
---------------------------------------------------------------------------
When used in sausage production, collagen gel is used to enrobe the
extruded product. The collagen gel forms an edible film that holds the
form of the product and acts as a protective barrier. The collagen
casing is an ingredient in the final product (i.e., it is disclosed on
the ingredients list). AMS understands that collagen gel may be
formulated with additional substances to improve the appearance (e.g.,
colors) or flavor of the final product. AMS expects these additional
substances, when used, will be evaluated by USDA-accredited certifying
agents for compliance with the National List and the USDA organic
regulations.
AMS concluded that the addition of collagen gel to the National
List is consistent with the requirements of OFPA sec. 6517(c). Namely,
the substance is not harmful to human health or the environment; is
necessary to production because of the unavailability of wholly natural
substitute products; and is consistent with organic farming and
handling. The amendment is made following the procedures established in
OFPA (sec. 6517(d)).
NOSB Review and Recommendation (Collagen Gel)
NOSB submitted a recommendation to AMS in April 2019 to add
collagen gel to the National List.\21\ NOSB recommendation followed
receipt of a petition to add the substance to the National List in
February 2018.\22\ In NOSB's evaluation of the petition, they
considered information from a third-party technical evaluation report
and comments from the public. NOSB discussed the petition to amend the
National List in subcommittee calls and at its public meetings in
October 2018 and April 2019.\23\
---------------------------------------------------------------------------
\21\ NOSB final recommendation for collagen gel, April 26, 2019:
https://www.ams.usda.gov/sites/default/files/media/HSCollagenGelApr2019FinalRec.pdf.
\22\ Collagen gel petition: https://www.ams.usda.gov/sites/default/files/media/CollagenGelPetition.pdf.
\23\ Written and oral public comments submitted for the October
2018 and April 2019 NOSB meetings are available at https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-st-paul-mn and https://www.ams.usda.gov/event/national-organic-standards-board-nosb-meeting-seattle-wa.
---------------------------------------------------------------------------
In its recommendation, NOSB concluded that adding collagen gel to
the National List was consistent with OFPA criteria (sec. 6518(m)). In
its recommendation, NOSB noted that adding collagen gel to the National
List would increase opportunity for production of organic products that
are not possible with current ingredients on the National List, such as
single-species sausage and meat products.
Comments Received and AMS' Response (Collagen Gel Casing)
Classification. In the proposed rule, AMS requested additional
information on whether the use of acid induces chemical change(s) in
the collagen gel which should cause the substance to be classified as a
nonagricultural, synthetic substance. In response, AMS received a
comment stating that AMS guidance \24\ indicates that synthetic acids
used in a hydrolysis process would result in a synthetic product. The
comment also stated that under this interpretation of program guidance,
the use of synthetic acids as described in the technical evaluation
report \25\ would not be allowed in the production of nonsynthetic
collagen gel.
---------------------------------------------------------------------------
\24\ AMS National Organic Program Handbook, Guidance NOP 5033-1
Decision Tree for Classification of Materials as Synthetic or
Nonsynthetic, December 2, 2016. https://www.ams.usda.gov/sites/default/files/media/NOP-Synthetic-NonSynthetic-DecisionTree.pdf.
\25\ Collagen gel technical evaluation report, January 28, 2019:
https://www.ams.usda.gov/sites/default/files/media/CollagenGelGelatinCasingsTechnicalReport01282019.pdf.
---------------------------------------------------------------------------
Some comments received were neutral, neither in support of nor in
opposition to the addition of collagen gel casing. One comment
supported classifying collagen gel casing as an agricultural substance
should it be added to the National List. This same comment also
acknowledged that collagen gel casing's classification as an
agricultural substance could be challenged during future NOSB meetings.
However, the comment also stated that since the source material for
collagen gel casing source is agricultural, its inclusion on Sec.
205.606 would be appropriate.
Upon further review of the manufacturing process of collagen, as
described in the petition and technical evaluation report, AMS agrees
with the comment that the acid hydrolysis step typical in the
manufacturing process of collagen is a non-biological chemical change
that results in its classification
[[Page 33483]]
as a nonagricultural, synthetic substance. In order to preserve the
intent of NOSB to encourage future availability of certified organic
collagen gel, AMS is listing collagen gel casing as a synthetic
nonagricultural substance at Sec. 205.605(b) with the annotation ``may
be used only when organic collagen gel is not commercially available.''
AMS understands that there are many different manufacturing
processes for the production of collagen gel.\26\ It is our
understanding that while there are many different processes for
manufacturing collagen gel, the current predominant manufacturing
process renders the final collagen gel as synthetic. While the main
manufacturing process results in a synthetic product, there are
manufacturing processes described which would result in a nonsynthetic
product and are consistent with Sec. 205.270 (i.e., could be a
certifiable process). Aware of the fact that the addition of collagen
gel to the National List would allow for the production of additional
organic products, we classified collagen gel as synthetic due to the
predominant manufacturing process to provide access to organic
producers. Given that there are processing methods which could be
certified, we are maintaining the commercial availability requirement
to encourage the development of nonsynthetic, certified organic
products.
---------------------------------------------------------------------------
\26\ Collagen Gel Technical Report, January 28, 2019: https://www.ams.usda.gov/sites/default/files/media/CollagenGelGelatinCasingsTechnicalReport01282019.pdf.
---------------------------------------------------------------------------
General Opposition. AMS received comments opposed to adding
collagen gel casing to the National List. Some of the opposing comments
want organic products to be composed only of organic ingredients. AMS
notes that OFPA permits the use of specific nonorganic substances
(i.e., those on the National List) in organic production and handling.
OFPA describes the procedures for amending the National List and
provides AMS and NOSB with criteria and guidelines to consider in
evaluating changes to the National List. These procedures were followed
by NOSB and AMS, and this rule adds collagen gel to the National List.
Misleading to Consumers. A comment argued AMS will confuse
consumers, especially vegan consumers, should collagen gel casings be
allowed for use in organic plant-based sausage products. AMS
understands that labeling requirements implemented by other agencies
would require disclosure of collagen casings in a product's ingredient
list. AMS believes that disclosure of the collagen casing as an
ingredient provides sufficient transparency for consumers.
III. Related Documents
AMS published notices in the Federal Register on August 9, 2018,
announcing the Fall 2018 NOSB Meeting (83 FR 39376) and on November 26,
2018, announcing the Spring 2019 NOSB meeting (83 FR 60373). These
notices invited public comments on NOSB recommendations addressed in
this final rule. The AMS proposed rule that preceded this final rule
was published on June 8, 2020 (85 FR 35011).
IV. Statutory and Regulatory Authority
OFPA authorizes the Secretary to make amendments to the National
List based on recommendations developed by NOSB. Sections 6518(k) and
6518(n) of OFPA authorize NOSB to develop recommendations for
submission to the Secretary to amend the National List and establish a
process by which persons may petition NOSB for the purpose of having
substances evaluated for inclusion on or deletion from the National
List. Section 205.607 of the USDA organic regulations permits any
person to petition to add or remove a substance from the National List
and directs petitioners to obtain the petition procedures from USDA.
The current petition procedures published in the Federal Register (81
FR 12680; March 10, 2016) for amending the National List can be
accessed through the NOP Program Handbook on the NOP website at https://www.ams.usda.gov/rules-regulations/organic/handbook.
A. Executive Order 12866 and Regulatory Flexibility Act
This final rule has been determined to be not significant for
purposes of Executive Order 12866, and, therefore, has not been
reviewed by the Office of Management and Budget (OMB).
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
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.\27\
SBA has classified 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.
---------------------------------------------------------------------------
\27\ Table of Small Business Size Standards Matched to North
American Industrial Classification System Codes, 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 USDA's
National Agricultural Statistics Service (NASS) and NOP indicate most
of the certified organic production operations in the United States
would be considered small entities. According to the 2019 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.\28\ 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.
---------------------------------------------------------------------------
\28\ U.S. Department of Agriculture, National Agricultural
Statistics Service. 2019 Census of Agriculture. https://www.nass.usda.gov/Publications/AgCensus/2017/Online_Resources/Organics/ORGANICS.pdf.
---------------------------------------------------------------------------
Handlers. According to the NOP's Organic Integrity Database, there
are 19,059 organic handlers that are certified under the USDA organic
regulations.\29\ 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
[[Page 33484]]
larger manufacturers is significantly smaller than SBA's small business
thresholds (500 to 1,250). Therefore, AMS expects that most organic
handlers would qualify as small businesses.
---------------------------------------------------------------------------
\29\ Organic Integrity Database: https://organic.ams.usda.gov/Integrity/. Accessed February 1, 2021.
---------------------------------------------------------------------------
Certifying agents. 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 77 USDA-accredited certifying agents,
based on a query of NOP certified organic operations database, who
provide organic certification services to producers and handlers. While
many certifying agents are small entities that would be affected by
this proposed 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 the economic impact on entities affected by
this rule to be significant. The effect of this final rule will allow
the use of three additional substances in organic crop production and
organic handling. Adding three substances to the National List will
increase regulatory flexibility and provide small entities with more
options to use in day-to-day operations.
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 USDA to be accredited as a certifying agent, as described in
section 6514(b) of OFPA. States are also preempted under sections 6503
through 6507 of OFPA from creating certification programs to certify
organic farms or handling operations unless the State programs have
been submitted to, and approved by, the Secretary as meeting the
requirements of OFPA.
Pursuant to section 6507(b)(2) of OFPA, a State organic
certification program that has been approved by the Secretary may,
under certain circumstances, contain additional requirements for the
production and handling of agricultural products organically produced
in the State and for the certification of organic farm and handling
operations located within the State. Such additional requirements must
(a) further the purposes of 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 Sec. 6519(c)(6) of OFPA, 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 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, OMB clearance is not
required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501,
Chapter 35.
D. Executive Order 13175
This final rule has been reviewed 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 will be
shared during an upcoming quarterly call, and tribal leaders will be
informed about the proposed revisions to the regulation and the
opportunity to submit comments. AMS will work with USDA's 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).
G. General Notice of Public Rulemaking
This final rule reflects recommendations submitted by NOSB to the
Secretary to add three substances to 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 part 205 is revised to read as follows:
Authority: 7 U.S.C. 6501-6524.
0
2. Amend Sec. 205.603 by redesignating paragraphs (b)(8) through
(b)(11) as paragraphs (b)(9) through (b)(12) and adding paragraph
(b)(8) to read as follows:
Sec. 205.603 Synthetic substances allowed for use in organic
livestock production.
* * * * *
(b) * * *
(8) Oxalic acid dihydrate--for use as a pesticide solely for
apiculture.
* * * * *
0
3. Amend Sec. 205.605 by:
0
a. In paragraph (a), adding in alphabetical order the term
``Pullulan;'' and
0
b. In paragraph (b), adding in alphabetical order the term ``Collagen
gel.''
The additions read as follows:
Sec. 205.605 Nonagricultural (nonorganic) substances allowed as
ingredients in or on processed products labeled as ``organic'' or
``made with organic (specified ingredients or food group(s)).''
* * * * *
(a) * * *
[[Page 33485]]
Pullulan--for use only in tablets and capsules for dietary
supplements labeled ``made with organic (specified ingredients or food
group(s)).''
* * * * *
(b) * * *
Collagen gel--as casing, may be used only when organic collagen gel
is not commercially available.
* * * * *
Erin Morris,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2021-13323 Filed 6-24-21; 8:45 am]
BILLING CODE P