Voglio sapere a riguardo di…

33482

Federal Register / Vol. 86, No. 120 / Friday, June 25, 2021 / Rules and Regulations
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.

lotter on DSK11XQN23PROD with RULES1

Collagen Gel Casing 205.605
Final Action This final rule amends the National List to add collagen gel as a casing to 7
CFR 205.605b 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 205.605b rather than to 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.
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
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 multiingredient product made from collagen 18 See 7 CFR 205.606 and 7 CFR 205.2 for definition of Commercially available.
19 Available at https organic.ams.usda.gov/
Integrity/Default.aspx. Accessed and searched for collagen gel on February 1, 2021.

VerDate Sep<11>2014

16:27 Jun 24, 2021

Jkt 253001

3.04.5%, cellulose <3.0%, and water 95.597.0% 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.
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 USDAaccredited 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. 6517c. 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.
6517d.
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 NOSBs evaluation of the petition, they considered information from a thirdparty 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
20 Collagen
gel technical evaluation report, January 28, 2019: https www.ams.usda.gov/sites/
default/files/media/CollagenGelGelatinCasings TechnicalReport01282019.pdf.
21 NOSB final recommendation for collagen gel, April 26, 2019: https www.ams.usda.gov/sites/
default/files/media/HSCollagenGelApr2019Final Rec.pdf.
22 Collagen gel petition: https www.ams.
usda.gov/sites/default/files/media/CollagenGel Petition.pdf.
23 Written and oral public comments submitted for the October 2018 and April 2019 NOSB

PO 00000

Frm 00004

Fmt 4700

Sfmt 4700

In its recommendation, NOSB
concluded that adding collagen gel to the National List was consistent with OFPA criteria sec. 6518m. 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 changes 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.
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 casings 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 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 meetings are available at https www.ams.
usda.gov/event/national-organic-standards-boardnosb-meeting-st-paul-mn and https www.ams.
usda.gov/event/national-organic-standards-boardnosb-meeting-seattle-wa.
24 AMS National Organic Program Handbook, Guidance NOP 50331 Decision Tree for Classification of Materials as Synthetic or Nonsynthetic, December 2, 2016. https www.ams.
usda.gov/sites/default/files/media/NOP-SyntheticNonSynthetic-DecisionTree.pdf.
25 Collagen gel technical evaluation report, January 28, 2019: https www.ams.usda.gov/sites/
default/files/media/CollagenGelGelatinCasings TechnicalReport01282019.pdf.

E:FRFM25JNR1.SGM

25JNR1