[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]



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 Rules and Regulations
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  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.

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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.
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    \1\ USDA Agricultural Research Service https://www.ars.usda.gov/oc/br/ccd/index/. Accessed February 1, 2021.
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    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\
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    \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.
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    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\
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    \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.
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    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.
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    \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.
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    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\
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    \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.
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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\
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    \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.
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    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\
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    \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.
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    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 . . .''.
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    \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.
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    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.
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    \18\ See 7 CFR 205.606 and 7 CFR 205.2 for definition of 
``Commercially available.''
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    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\
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    \19\ Available at https://organic.ams.usda.gov/Integrity/Default.aspx. Accessed and searched for ``collagen gel'' on February 
1, 2021.
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    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.
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    \20\ Collagen gel technical evaluation report, January 28, 2019: 
https://www.ams.usda.gov/sites/default/files/media/CollagenGelGelatinCasingsTechnicalReport01282019.pdf.
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    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\
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    \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.
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    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.
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    \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.
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    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.
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    \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