[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Proposed Rules]
[Pages 2498-2524]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28172]



[[Page 2497]]

Vol. 83

Wednesday,

No. 11

January 17, 2018

Part II





Department of Agriculture





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Agricultural Marketing Service





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7 CFR Part 205





National Organic Program; Amendments to the National List of Allowed 
and Prohibited Substances (Crops, Livestock and Handling); Proposed 
Rule

  Federal Register / Vol. 83 , No. 11 / Wednesday, January 17, 2018 / 
Proposed Rules  

[[Page 2498]]


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DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 205

[Document Number AMS-NOP-14-0079; NOP-14-05]
RIN 0581-AD60


National Organic Program; Amendments to the National List of 
Allowed and Prohibited Substances (Crops, Livestock and Handling)

AGENCY: Agricultural Marketing Service, USDA.

ACTION: Proposed rule.

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SUMMARY: This proposed rule would amend the National List of Allowed 
and Prohibited Substances (National List) provisions of the U.S. 
Department of Agriculture's (USDA's) organic regulations to implement 
recommendations submitted to the Secretary of Agriculture (Secretary) 
by the National Organic Standards Board (NOSB). This rule proposes to 
change the use restrictions for seventeen substances allowed for 
organic production or handling on the National List: Micronutrients; 
chlorhexidine; parasiticides; fenbendazole; moxidectin; xylazine; 
lidocaine; procaine; methionine; excipients; alginic acid; flavors; 
carnauba wax; chlorine; cellulose; colors; and, glycerin. This rule 
also proposes to add sixteen new substances on the National List to be 
allowed in organic production or handling: Hypochlorous acid; magnesium 
oxide; squid byproducts; activated charcoal; calcium borogluconate; 
calcium propionate; injectable vitamins, minerals, and electrolytes; 
kaolin pectin; mineral oil; propylene glycol; acidified sodium 
chlorite; zinc sulfate; potassium lactate; and, sodium lactate. In 
addition, this proposed rule would list the botanical pesticide, 
rotenone, as a prohibited substance in organic crop production. 
Finally, this proposed rule would remove ivermectin as an allowed 
parasiticide for use in organic livestock production.

DATES: Comments must be received by March 19, 2018.

ADDRESSES: Interested persons may comment on the proposed rule using 
the following procedures:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.
     Mail: Robert Pooler, Standards Division, National Organic 
Program, USDA-AMS-NOP, 1400 Independence Ave. SW, Room 2642-S., Ag Stop 
0268, Washington, DC 20250-0268. Telephone: (202) 720-3252.
    Instructions: All submissions received must include the docket 
number AMS-NOP-14-0079; NOP-14-05, and/or Regulatory Information Number 
(RIN) 0581-AD60 for this rulemaking. When submitting a comment, clearly 
indicate the proposed rule topic and section number to which your 
comment refers. In addition, comments should clearly indicate whether 
you support or oppose the action being proposed and the reason(s) for 
your position. Your comments can also include information on 
alternative management practices, where applicable, that support 
alternatives to the proposed amendments. You should also offer any 
recommended language change(s) that would be appropriate to your 
position. Please include relevant information and data to support your 
position, such as scientific, environmental, manufacturing, industry, 
or impact information, or similar sources. Only relevant material 
supporting your position should be submitted. All comments received 
will be posted without change to http://www.regulations.gov.
    Document: For access to read background documents or comments 
received, go to http://www.regulations.gov. Comments submitted in 
response to this proposed rule will also be available for viewing in 
person at USDA-AMS, National Organic Program, Room 2642-South Building, 
1400 Independence Ave. SW, Washington, DC, from 9 a.m. to 12 noon and 
from 1 p.m. to 4 p.m., Monday through Friday (except official Federal 
holidays). Persons wanting to visit the USDA South Building to view 
comments received in response to this proposed rule are requested to 
make an appointment in advance by calling (202) 720-3252.

FOR FURTHER INFORMATION CONTACT: Robert Pooler, Standards Division, 
National Organic Program. Telephone: (202) 720-3252.

SUPPLEMENTARY INFORMATION: 

I. Background

    On December 21, 2000, the Secretary published the National List of 
Allowed and Prohibited Substances in Sec. Sec.  205.600 through 205.607 
of the USDA organic regulations (7 CFR 205.1-205.690). This National 
List identifies the synthetic substances that may be used and the 
nonsynthetic (natural) substances that may not be used in organic 
production. The National List also identifies synthetic, nonsynthetic 
nonagricultural, and nonorganic agricultural substances that may be 
used in organic handling. The Organic Foods Production Act of 1990, as 
amended (7 U.S.C. 6501-522) (OFPA), and Sec.  205.105 of the USDA 
organic regulations specifically prohibit the use of any synthetic 
substance in organic production and handling unless the synthetic 
substance is on the National List. Section 205.105 also requires that 
any nonorganic agricultural and any nonsynthetic nonagricultural 
substance used in organic handling be on the National List. Under the 
authority of OFPA, the National List can be amended by the Secretary 
based on recommendations presented by the NOSB. Since the final rule 
establishing the National Organic Program (NOP) became effective on 
October 21, 2002, AMS has published multiple rules amending the 
National List.
    This proposed rule would amend the National List to implement 29 
NOSB recommendations on 35 amendments to the National List that were 
submitted to the Secretary on November 17, 2000, September 19, 2002, 
May 6, 2009, November 5, 2009, October 28, 2010, December 2, 2011, 
March 20, 2012, October 16, 2012, May 2, 2014, April 30, 2015, October 
29, 2015, April 26, 2016, and November 18, 2016.
    Table 1 summarizes the NOSB recommendations on adding substances to 
the National List or amending currently listed substances that are 
included in this proposed rule.

             Table 1--Substances Being Added to the National List or Current Listings Being Amended
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           Substance                      National List section                    Proposed rule action
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Hypochlorous acid..............  205.601................................  Add to National List.
Magnesium oxide................  205.601................................  Add to National List.
Micronutrients.................  205.601(a).............................  Amend listing.
Squid byproducts...............  205.601................................  Add to National List.
Rotenone.......................  205.602................................  Add to National List.
Activated charcoal.............  205.603(a).............................  Add to National List.

[[Page 2499]]

 
Calcium borogluconate..........  205.603(a).............................  Add to National List.
Calcium propionate.............  205.603(a).............................  Add to National List.
Chlorhexidine..................  205.603(a).............................  Amend listing.
Hypochlorous acid..............  205.603(a).............................  Add to National List.
Kaolin pectin..................  205.603(a).............................  Add to National List.
Mineral oil....................  205.603(a).............................  Add to National List.
Nutritive supplements--          205.603(a).............................  Add to National List.
 Injectable vitamins, minerals,
 & electrolytes.
Parasiticides..................  205.603(a).............................  Amend listing.
Fenbendazole...................  205.603(a).............................  Amend listing.
Ivermectin.....................  205.603(a).............................  Remove from National List.
Moxidectin.....................  205.603(a).............................  Amend listing.
Propylene glycol...............  205.603(a).............................  Add to National List.
Sodium chlorite, acidified.....  205.603(a & b).........................  Add to National List.
Xylazine.......................  205.603(a).............................  Amend listing.
Zinc sulfate...................  205.603(a).............................  Add to National List.
Lidocaine......................  205.603(b).............................  Amend listing.
Procaine.......................  205.603(b).............................  Amend listing.
Methionine.....................  205.603(d).............................  Amend listing.
Excipients.....................  205.603(f).............................  Amend listing.
Alginic acid...................  205.605(a).............................  Reclassify listing.
Flavors........................  205.605(a).............................  Amend listing.
Carnauba wax...................  205.605(a).............................  Reclassify listing.
Cellulose......................  205.605(b).............................  Amend listing.
Chlorine.......................  205.605(b).............................  Amend listing.
Hypochlorous acid..............  205.605(b).............................  Add to National List.
Potassium lactate..............  205.605(b).............................  Add to National List.
Sodium lactate.................  205.605(b).............................  Add to National List.
Glycerin.......................  205.605(a) & 205.606...................  Reclassify listing.
Colors.........................  205.606................................  Amend listing.
----------------------------------------------------------------------------------------------------------------

    Each substance included in Table 1 is addressed in the Overview of 
Proposed Amendments. Substances recommended by the NOSB between 
November 2000 and April 2015 are described in more detail because less 
petition and technical information is available in NOP's petitioned 
substance database.\1\ Less technical and petition information is 
provided within the overview for substances recommended by the NOSB 
after its three public meetings between October, 2015, and November, 
2016, because such information is available in NOP's petitioned 
substance database.
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    \1\ NOP petitioned substance database, A-Z: https://www.ams.usda.gov/rules-regulations/organic/national-list/petitioned.
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II. Overview of Proposed Amendments

    The following provides an overview of the proposed amendments to 
designated sections of the National List regulations:

Sec.  205.601 Synthetic Substances Allowed for Use in Organic Crop 
Production

    This proposed rule would add three new substances, and amend one 
substance currently on the National List in Sec.  205.601, Synthetic 
substances allowed for use in organic crop production.
Hypochlorous Acid
    The proposed rule would amend the National List to add hypochlorous 
acid as a chlorine material for use as a disinfectant and sanitizer in 
Sec. Sec.  205.601, 205.603, and 205.605. Table 2 illustrates the 
proposed listing.

           Table 2--Proposed Rule Action for Hypochlorous Acid
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Current rule: N/A.
Proposed rule action: Sec.  Sec.   205.601(a), 205.603(a), 205.605(b),
 Hypochlorous acid--generated from electrolyzed water.
------------------------------------------------------------------------

    On May 29, 2015, AMS received a petition to add hypochlorous acid 
to the National List in Sec. Sec.  205.601 and 205.605, for use as an 
antimicrobial/sanitizer on equipment and raw agricultural products in 
organic crop production and handling.\2\ In water, chlorine materials 
such as calcium and sodium hypochlorite are in equilibrium with related 
chlorine species, including hypochlorous acid (HOCl) and hypochlorite 
(ClO-). These related chlorine species are formed in the 
generation of electrolyzed water. Chlorine materials (calcium 
hypochlorite, chlorine dioxide and sodium hypochlorite) are included on 
the National List in Sec. Sec.  205.601, 205.603 and 205.605.
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    \2\ The hypochlorous acid petition is available in the NOP 
Petitioned Substances Database: https://www.ams.usda.gov/rules-
regulations/organic/national-list/petitioned.
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    On September 11, 2015, AMS published NOP Policy Memorandum PM 15-4, 
Electrolyzed Water.\3\ This memo revised a prior NOP determination 
about the status of electrolyzed water by stating that hypochlorous 
acid, generated by electrolyzed water, is an allowable type of chlorine 
material. The petition review process continued after that memo was 
issued in order to codify the allowance for hypochlorous acid on the 
National List.
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    \3\ The policy memo is published in the NOP Handbook: http://www.ams.usda.gov/sites/default/files/NOP-PM-15-4-ElectrolyzedWater.pdf.

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    At its April 25-27, 2016, public meeting, the NOSB considered the 
petition to add hypochlorous acid to the National List for uses in 
organic production and organic handling and received public comment on 
these allowances. During its review, the NOSB also considered a 
technical evaluation report on hypochlorous acid \4\ that described its 
manufacture, industry uses, regulation, and chemical properties.
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    \4\ Hypochlorous acid technical report: https://www.ams.usda.gov/sites/default/files/media/
Hypochlorous%20Acid%20TR%2008%2013%2015.pdf.
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    In consideration of the petition, technical report, and public 
comments, the NOSB determined that the use of hypochlorous acid 
generated from electrolyzed water as a disinfectant and sanitizer 
satisfies OFPA evaluation criteria for National List substances and 
recommended adding hypochlorous acid to the existing listings for 
chlorine materials in Sec.  205.601(a) as an algicide, disinfectant, 
and sanitizer, including irrigation cleaning systems in organic crop 
production; Sec.  205.603(a) for use as a disinfectant, sanitizer, and 
medical treatment in organic livestock production; and Sec.  205.605(b) 
as a disinfectant and sanitizer in organic handling. The NOSB included 
the annotation ``generated from electrolyzed water'' to clarify that 
the source of hypochlorous acid allowed for use in organic production 
or handling must be production from electrolyzed water.
    AMS has reviewed and proposes to address this NOSB recommendation 
through this proposed rule. Consistent with the NOSB recommendation, 
this proposed rule would amend the listings for Chlorine materials in 
Sec.  205.601(a)(2), Sec.  205.603(a), and Sec.  205.605(b) to add 
hypochlorous acid--generated from electrolyzed water.
Magnesium Oxide
    This proposed rule would add magnesium oxide to Sec.  205.601(j) as 
an allowed substance to control the viscosity of a clay suspension 
agent for humates. In consideration of the petition, technical report, 
and public comments, the NOSB determined that this use of magnesium 
oxide satisfies the OFPA evaluation criteria for National List 
substances. Table 3 illustrates the proposed listing.

            Table 3--Proposed Rule Action for Magnesium Oxide
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Current rule: N/A.
Proposed rule action: Sec.   205.601(j) Magnesium oxide--for use only to
 control the viscosity of a clay suspension agent for humates.
------------------------------------------------------------------------

Applications
    Magnesium oxide (CAS Number 1309-48-4) is a white, free flowing, 
odorless powder. The technical report for magnesium hydroxide \5\ 
states that magnesium oxide is considered to be a relatively benign 
substance with a wide range of applications. There are several 
manufacturing processes used to produce magnesium oxide. The petition 
\6\ to add magnesium oxide to the National List describes an efficient 
and inexpensive process for producing magnesium oxide by combining sea 
water or salt brine with dolomitic limestone to precipitate magnesium 
hydroxide, which is then dehydrated by heating to form magnesium oxide. 
Since magnesium oxide is physically and chemically stable at high 
temperatures, it is widely used for agricultural and nonagricultural 
applications. For food use, magnesium oxide is listed in 21 CFR part 
184--Direct Food Additives Affirmed as Generally Recognized As Safe 
(GRAS), in Sec.  184.1431, for the following uses: anticaking and free-
flow agent, firming agent, lubricant and release agent, nutrient 
supplement, and a pH control agent.
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    \5\ 2007 magnesium hydroxide technical report, see: https://www.ams.usda.gov/rules-regulations/organic/national-list/petitioned.
    \6\ Petition for magnesium oxide, see: https://www.ams.usda.gov/
rules-regulations/organic/national-list/petitioned.
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Timeline
    On January 3, 2013, AMS received a petition to add magnesium oxide 
to the National List in Sec.  205.601. The petition states that the 
substance is ``intended to be used in combination with other organic 
inputs applied as a liquid foliar on a wide variety of different 
agricultural, vegetable, fruit and horticultural crops.'' According to 
the petition, small quantities of magnesium oxide would be used during 
the processing of attapulgite clay to control its viscosity when the 
clay is used as a suspension agent for finely ground humates. As stated 
in the petition, the rate of magnesium oxide use per the manufacturer's 
recommended rate would be 0.074 percent of the diluted humate product 
applied, or approximately 0.0007-0.0014 pounds of magnesium oxide per 
acre, which is a very low application rate.
    At its May 2, 2014, public meeting, the NOSB considered the 
petition to add magnesium oxide to the National List in Sec.  205.601. 
At this meeting, the NOSB considered magnesium oxide against the 
evaluation criteria stipulated in OFPA Sec.  2119(m). After review of 
the petition, technical report, and public comments, the NOSB 
determined that magnesium oxide satisfies the evaluation criteria and 
recommended magnesium oxide as a soil amendment for use in organic crop 
production.
    AMS has reviewed and proposes to address this NOSB recommendation 
through this proposed rule. Consistent with the NOSB recommendation, 
this proposed rule would amend Sec.  205.601(j) by adding: Magnesium 
oxide--for use only to control the viscosity of a clay suspension agent 
for humates.
Micronutrients
    This proposed rule would amend the current listing on 
micronutrients in Sec.  205.601(j) as an allowed plant or soil 
amendment material for use in organic crop production. This proposed 
rule would change the listing for micronutrients to remove soil testing 
as the required method for demonstrating a soil micronutrient 
deficiency. Table 4 illustrates the proposed listing.

            Table 4--Proposed Rule Action for Micronutrients
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Current rule: Sec.   205.601(j) Micronutrients--not to be used as a
 defoliant, herbicide, or desiccant. Those made from nitrates or
 chlorides are not allowed. Soil deficiency must be documented by
 testing.
Proposed rule action: Sec.   205.601(j) Micronutrients--not to be used
 as a defoliant, herbicide, or desiccant. Those made from nitrates or
 chlorides are not allowed. Micronutrient deficiency must be documented
 by soil or tissue testing, advice from certified crop advisors or
 professional agronomists, agricultural extension information, or other
 methods approved by the certifying agent.
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    In April 2015, the NOSB initiated a change to the existing listing 
for micronutrients in Sec.  205.601(j) based on public comments \7\ 
received during the NOSB 2017 sunset review for micronutrients. The 
USDA organic regulations permit micronutrients to be used as a soil 
amendment only when soil deficiency is documented by testing. 
Commenters suggested that alternative methods to document micronutrient 
deficiency, including, but not limited to, tissue testing, the 
incorporation of professional opinions and regional knowledge from 
agronomists, crop advisors, extension agents and publications, should 
be permitted in lieu of testing.
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    \7\ The public comments to the NOSB pertaining to the 2017 
sunset review are posted here: https://www.ams.usda.gov/event/
spring-nosb-meeting-2015-ca, and https://www.ams.usda.gov/event/
nosb-meeting-2015-vt.
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    During a public meeting on October 26-29, 2015, the NOSB considered 
an amendment to the micronutrients listing to remove the requirement 
for testing as the only method for documenting a soil micronutrient 
deficiency. In consideration of public comments, the NOSB determined 
that requiring soil testing for micronutrients was outdated and that 
other means of assessing micronutrient deficiencies in soil are 
acceptable.\8\
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    \8\ https://www.ams.usda.gov/rules-regulations/organic/nosb/
recommendations/fall2015.
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    AMS has reviewed and proposes to address this NOSB recommendation 
through this proposed rule. Consistent with the NOSB recommendation, 
this proposed rule would amend Sec.  205.601(j) Micronutrients, by 
removing soil testing as the only way to document a deficiency and 
stating that a deficiency must be documented.
Squid Byproducts
    This proposed rule would add squid byproducts to Sec.  205.601(j) 
as an allowed substance for use in organic crop production. Table 5 
illustrates the proposed listing.

           Table 5--Proposed Rule Action for Squid Byproducts
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Current rule: N/A.
Proposed rule action: Sec.   205.601(j) squid byproducts--from food
 waste processing only. Can be pH adjusted with sulfuric, citric or
 phosphoric acid. The amount of acid used shall not exceed the minimum
 needed to lower the pH to 3.5.
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    In April 2015, AMS received a petition to add ``squid and squid 
byproducts'' to the National List under the listing for liquid fish 
products allowed as plant or soil amendments in organic crop 
production, Sec.  205.601(j)(7). Squid byproducts are used as starting 
ingredients in the production of enzymatically produced hydrolysates 
which are used as foliar sprays and soil amendments for propagating 
crops such as cranberries, cherries and apples. Squid byproduct 
hydrolysates are similar in composition to fish emulsions and can be 
used as a fertilizer that provides organic matter to the soil.
    At the April 25-27, 2016 NOSB meeting, the Board reviewed the 
petition, public comments, and information in a technical report on 
squid and squid byproducts. The NOSB explained that squid byproducts 
are stabilized with acid to lower the pH, and that this practice is 
consistent with the existing listing for liquid fish products that are 
stabilized with synthetic sulfuric, citric, or phosphoric acid. The 
NOSB also stated that only squid byproducts from the food waste 
processing stream are acceptable; fertilizer from whole squid would not 
be acceptable.
    Based on the petition, technical report, and public comments, the 
NOSB determined that squid byproducts meet the OFPA evaluation criteria 
for National List substances. AMS has reviewed and proposes to address 
this NOSB recommendation through this proposed rule. Consistent with 
the NOSB recommendation, this proposed rule would add amend Sec.  
205.601(j)(7) of the National List to list squid byproducts as an 
allowed plant or soil amendment that can be pH adjusted with sulfuric, 
citric, or phosphoric acid. The amount of acid used shall not exceed 
the minimum needed to lower the pH to 3.5. AMS also accepts the source 
parameters specified by the NOSB, i.e., only squid byproducts from food 
waste processing are permitted.

Sec.  205.602 Nonsynthetic Substances Prohibited for Use in Organic 
Crop Production

    This proposed rule would add rotenone to paragraph (j) of Sec.  
205.602 and prohibit its use in organic crop production. Nonsynthetic 
substances are allowed in organic crop production except for those 
specifically listed as prohibited in Sec.  205.602.
Rotenone
    This proposed rule would add rotenone to Sec.  205.602 and prohibit 
its use in organic crop production, as recommended by the NOSB in 2012. 
Table 6 illustrates the proposed changes to this section.

               Table 6--Proposed Rule Action for Rotenone
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Current rule: N/A.
Proposed rule action: Sec.   205.602(f) Rotenone (CAS # 83-79-4).
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Applications
    Rotenone (CAS Number 83-79-4) is a substance that is extracted from 
various plant species such as Hoary pea (Tephrosia spp.) or Jicama vine 
(Pachyrhizus erosus) and similar tropical and subtropical plants. 
Rotenone preparations made from plants are also known as barbasco, 
derris, and cube root. Naturally occurring rotenone is used as a 
pesticide, insecticide, and as a piscicide (fish toxin). Pesticide 
formulations containing rotenone are nonsynthetic (natural) when 
prepared without synthetic extractions. Nonsynthetic substances are 
allowed in organic crop production except for those specifically listed 
as prohibited in Sec.  205.602.
Timeline
    The U.S. Environmental Protection Agency (EPA) cancelled the 
registration of rotenone for use on food commodities within the U.S. on 
March 23, 2011. Aligning with EPA's regulation of rotenone, AMS is 
adding rotenone to the list of prohibited nonsynthetic materials in 
Sec.  205.602, and organic producers both within and outside of the 
U.S.

[[Page 2502]]

would be prohibited from using rotenone on crops grown in accordance 
with USDA organic regulations.
    The NOSB considered rotenone and other botanical pesticides at its 
meeting on October 14, 1994, and determined that rotenone should not be 
prohibited. The USDA agreed and did not prohibit rotenone or other 
botanical pesticides to control plant diseases, but did require 
producers to use management practices to prevent crop pests, weeds, and 
diseases before using botanical pesticides, as specified in the USDA 
organic regulations at Sec.  205.206.
    In August 2012, the NOSB revisited the allowance for rotenone in 
organic production. After reviewing technical documents and considering 
public comment, the NOSB recommended to prohibit rotenone, citing 
adverse environmental and health impacts, lack of essentiality, and 
incompatibility with organic principles. AMS has reviewed and proposes 
to address this NOSB recommendation through this proposed rule. 
Therefore, this proposed rule would amend Sec.  205.602 of the National 
List by adding rotenone as a prohibited nonsynthetic substance in 
organic crop production.

Sec.  205.603 Synthetic Substances Allowed for Use in Organic Livestock 
Production

    The proposed rule would add the following substances to the 
National List in paragraph Sec.  205.603(a) for use in organic 
livestock production: Activated charcoal, calcium borogluconate, 
calcium propionate, hypochlorous acid, kaolin pectin, mineral oil, 
nutritive supplements--injectable vitamins, trace minerals and 
electrolytes, propylene glycol, acidified sodium chlorite, and zinc 
sulfate. The proposed rule would also add acidified sodium chlorite to 
Sec.  205.603(b). This proposed rule would also amend the allowances 
for the following substances currently allowed in organic livestock 
production: Chlorhexidine, parasiticides, fenbendazole, moxidectin, and 
xylazine, Sec.  205.603(a); lidocaine and procaine, Sec.  205.603(b); 
methionine, Sec.  205.603(d); and excipients, Sec.  205.603(f). In 
addition, this proposed rule would remove ivermectin, Sec.  205.603(a).
Activated Charcoal
    This proposed rule would add activated charcoal to Sec.  205.603(a) 
for use in organic livestock production. In consideration of the 
petition and public comments from livestock producers and animal health 
experts, the NOSB determined that activated charcoal should be allowed 
for use in organic livestock production. Synthetic forms of activated 
charcoal would continue to be prohibited. Table 7 illustrates the 
proposed listing.

          Table 7--Proposed Rule Action for Activated Charcoal
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: N/A.
Proposed rule action: Sec.   205.603(a) Activated charcoal--must be from
 vegetative sources.
------------------------------------------------------------------------

Applications
    Activated charcoal is manufactured from a physical activation 
process using high temperature and hot gases on raw materials such as 
coconut shells, various hardwoods, or bone. It can also be derived from 
coal or petroleum. The resulting product is a carbon based substance 
with small pore size and large surface area for adsorption or chemical 
reaction.
    While this basic process provides sufficient activation capability, 
the use of a strong acid or strong base, such as phosphoric acid or 
potassium hydroxide, enhances the activation process and adsorption 
properties. Chemical activation with a strong chemical acid or base is 
the preferred activated charcoal manufacturing process since lower 
temperatures and less time are needed to create the final product. 
Activated charcoal is distinguished from elemental carbon by the 
removal of non-carbon impurities and oxidation of the carbon surface.
    Activated charcoal is considered to be an adsorbent. Administered 
orally, activated charcoal chemically interacts with toxins in the 
intestines and prevents systemic absorption of the toxin into the 
blood. These bound toxins pass through the intestine to be excreted in 
the animal's manure. Under 21 CFR 310.545(a)(8), activated charcoal is 
approved as an ingredient in digestive aid drug products for humans.
Timeline
    This proposed rule would implement a 2002 NOSB recommendation to 
add activated charcoal (CAS # 7440-44-0) with the annotation ``must be 
from vegetative sources'' to Sec.  205.603(a) of the National List.\9\ 
The NOSB recommended that activated charcoal be added to Sec.  
205.603(a) as a medical treatment in organic livestock production.
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    \9\ Recommendation for activated charcoal in livestock 
processing, see https://www.ams.usda.gov/sites/default/files/media/
Activated%20Charcoal%20Committee%20Rec.pdf.
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    The petition to add activated charcoal to the National List states 
that this material is a high-priority livestock medication and is 
commonly used as a therapeutic treatment on an as-needed basis with 
mammalian livestock, particularly in cases of suspected ingestion of 
toxic plants and control of diarrhea caused by moldy silage. This 
information was also supported in public comments to the NOSB from 
organic livestock producers and veterinarians. The petition also states 
that there are no comparable nonsynthetic substances that provide a 
comparable therapeutic benefit nor practices to prevent the occasional 
ingestion of toxins that warrant treatment.
    The NOSB recommendation to add activated charcoal specifies that 
only vegetative sources of this material would be permitted. The NOSB 
determined that activated charcoal derived from bone charcoal or 
lampblack (a by-product from incomplete burning of oil, tar, natural 
gas, or fat) is not consistent with organic farming and handing, as 
described in the OFPA substance evaluation criteria. The NOSB also 
noted that activated charcoal, when used as a toxin binder, is safe, 
effective, and difficult to overdose.
    AMS has reviewed and proposed to address the NOSB recommendation 
through this proposed rule. Therefore, AMS is proposing to add 
activated charcoal to the National List at Sec.  205.603(a) with the 
following annotation: must be from vegetative sources. Only activated 
charcoal from vegetative sources would be permitted.
Calcium Borogluconate
    This proposed rule would add calcium borogluconate to Sec.  
205.603(a) of the National List for use in organic livestock 
production. Specifically, calcium borogluconate would be allowed only 
for the treatment of milk fever. Table 8 illustrates the proposed 
listing.

[[Page 2503]]



         Table 8--Proposed Rule Action for Calcium Borogluconate
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: N/A.
Proposed rule action: Sec.   205.603(a), Calcium Borogluconate--for
 treatment of milk fever only.
------------------------------------------------------------------------

Applications
    Calcium borogluconate, a D-gluconic acid, cyclic 4,5-ester with 
boric acid, is a stable, nonhazardous white powder derived from the 
reaction of five parts calcium gluconate to one part boric acid in an 
aqueous solution. Calcium borogluconate has been used for treatment of 
hypocalcemia (milk fever or parturient paresis) in cattle, sheep, and 
goats. Hypocalcemia, or milk fever, is a disease--observed mostly in 
high producing dairy cows--that can be induced by low blood calcium 
levels occurring just before birth or in early lactation just after 
birth, when demand for calcium for milk production exceeds the animal's 
ability to mobilize calcium reserves. Low blood calcium levels can 
inhibit muscle function causing general weakness, loss of appetite, and 
eventually heart failure. The condition is more frequent in high 
producing dairy cows that are five or more years old in age. Mature 
animals may have reduced ability to mobilize calcium from bone. Certain 
breeds, such as Jersey cattle, may be more susceptible to milk fever.
    When used to treat milk fever, calcium borogluconate is 
administered intravenously, intramuscularly, or subcutaneously, and has 
no established required withdrawal time. The calcium borogluconate 
technical report \10\ developed for the NOSB states that calcium 
borogluconate is recognized as an electrolyte in the European Union. 
The NOSB has determined that the use of calcium borogluconate in 
organic livestock production for the treatment of this condition meets 
the requirements of the OFPA substance evaluation criteria for organic 
production.
---------------------------------------------------------------------------

    \10\ Technical report for calcium borogluconate, see https://www.ams.usda.gov/sites/default/files/media/
Calcium%20Borogluconate%20TR.pdf.
---------------------------------------------------------------------------

Timeline
    This proposed rule would implement a November 2000 NOSB 
recommendation to add calcium borogluconate (CAS # 5743-34-0) to Sec.  
205.603 of the National List. At its public meeting the NOSB determined 
that calcium borogluconate should be added to Sec.  205.603(a) as a 
medical treatment in organic livestock production for treatment of milk 
fever. Comments indicated that organic livestock producers use calcium 
borogluconate as directed by veterinarians. During the meeting, the 
NOSB discussed that calcium borogluconate would be used rarely, and 
only in emergency situations.
    In formulating its recommendation, the NOSB determined that calcium 
borogluconate should be allowed for use in organic ruminants when 
production practices fail to prevent milk fever. AMS has reviewed and 
proposes to address the NOSB recommendations through this proposed 
rule. Therefore, AMS is proposing to add calcium borogluconate to Sec.  
205.603(a) with the following annotation: for treatment of milk fever 
only.
Calcium Propionate
    This proposed rule would add calcium propionate to the National 
List at Sec.  205.603(a) for use in organic livestock production. 
Specifically, this substance would be allowed only as a treatment for 
milk fever. Table 9 provides the proposed listing.

          Table 9--Proposed Rule Action for Calcium Proprionate
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: N/A.
Proposed rule action: Sec.   205.603(a), Calcium Propionate--for
 treatment of milk fever only.
------------------------------------------------------------------------

Applications
    Calcium propionate, also known as calcium propanoate, is a white 
crystalline water soluble powder manufactured from combining calcium 
hydroxide and propionic acid. Calcium propionate is a direct food 
additive affirmed as generally recognized as safe (GRAS) (21 CFR 
184.1221) for human food and is primarily used as a preservative in 
bakery products. It is also allowed as a preservative for hay and 
silage in nonorganic livestock production agriculture (21 CFR 
582.3221).
    In 2002, AMS received a petition \11\ to add calcium propionate to 
the National List for use in organic livestock production as a 
treatment for milk fever and as a mold inhibitor in dry formulated 
herbal remedies. According to the petition, calcium propionate can be 
administered to prevent milk fever or when milk fever symptoms first 
appear.
---------------------------------------------------------------------------

    \11\ Petition for calcium propionate, see https://www.ams.usda.gov/sites/default/files/media/
Calcium%20Propionate%20Petition.pdf.
---------------------------------------------------------------------------

Timeline
    This proposed rule would implement a September 2002 NOSB 
recommendation to add calcium propionate (CAS # 4075-81-4) to Sec.  
205.603 of the National List. At this meeting, the NOSB recommended 
that calcium propionate be allowed only for the treatment of milk 
fever. The NOSB recognized that calcium propionate would not be used 
routinely, but only as an emergency treatment for milk fever. Public 
comments informed that organic livestock producers use this substance 
as directed by veterinarians.
    During its 2003 public meeting, the NOSB also considered allowing 
calcium propionate to also be used as a mold inhibitor for aloe 
pellets, but the NOSB did not include this use in its final 
recommendation. The technical report on calcium propionate indicates 
the substance has been used as a feed preservative in nonorganic hay 
crops. During deliberation, the NOSB crops subcommittee did not propose 
to allow the use of calcium propionate as a feed preservative, or 
propose allowing the general use of calcium propionate as a feed 
additive. As a result, the final NOSB recommendation included the use 
of calcium propionate for use in organic livestock for the treatment of 
milk fever only.
    The NOSB also determined that the limited use of calcium propionate 
in organic livestock production in this manner meets the OFPA substance 
evaluation criteria for organic production. In formulating its 
recommendation, the NOSB determined that calcium propionate can be used 
in organic livestock production when

[[Page 2504]]

organic practices fail to prevent milk fever. AMS has reviewed and 
proposes to address the NOSB recommendation through this proposed rule. 
Therefore, AMS is proposing to add calcium propionate to Sec.  
205.603(a) with the following annotation: for treatment of milk fever 
only.
Chlorhexidine
    This proposed rule would amend the allowance for chlorhexidine in 
Sec.  205.603(a). The amendment--as recommended by the NOSB and public 
comment--will improve organic livestock producers' ability to establish 
and maintain preventive livestock health care practices. Table 10 
illustrates the changes between the current rule and the proposed rule.

            Table 10--Proposed Rule Action for Chlorhexidine
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: Sec.   205.603(a)(6) Chlorhexidine--Allowed for surgical
 procedures conducted by a veterinarian. Allowed for use as a teat dip
 when alternative germicidal agents and/or physical barriers have lost
 their effectiveness.
Proposed rule action: Sec.   205.603(a) Chlorhexidine--for medical
 procedures conducted under the supervision of a licensed veterinarian.
 Allowed for use as a teat dip when alternative germicidal agents and/or
 physical barriers have lost their effectiveness.
------------------------------------------------------------------------

Applications
    Chlorhexidine is a white to pale yellow, odorless powder. It is 
only slightly soluble in water and in most organic solvents. 
Chlorhexidine is manufactured by a two-step process beginning with 
sodium dicyanamide reacting with hexamethylene diamine to form 
hexamethylene-biscyanoguanidine (HMBCG). Subsequently, HMBCG is reacted 
with p-chloroaniline to yield the chlorhexidine base used in 
applications. In animals, chlorhexidine is used as a topical 
disinfectant, for wound healing, and for managing skin infection in 
dogs. Chlorhexidine is also used as a germicidal compound in teat dips 
for dairy production and as an umbilical cord treatment, udder and eye 
wash, and surgical scrub and sterilization material. Chlorhexidine's 
bactericidal effect is due to its binding with the bacterial cell wall 
or, when chlorhexidine concentrations are higher, inducing bacterial 
cell membrane disruption.
Timeline
    This proposed rule would implement a 2009 NOSB recommendation to 
amend the allowance for chlorhexidine as listed in Sec.  205.603(a) of 
the National List. Chlorhexidine is allowed for use in two 
applications: (1) For surgical procedures in organic livestock as 
performed by a licensed veterinarian, and (2) as a teat dip when 
alternative germicidal agents and/or physical barriers have lost their 
effectiveness.\12\ At the 2009 meeting, the NOSB determined that the 
annotation should reflect the use of chlorhexidine by livestock 
producers and veterinarians for antiseptic purposes and for hygienic 
cleansing of wounds encountered during livestock production. The NOSB 
determined that the current annotation is overly restrictive and that 
the general use of chlorhexidine for antiseptic purposes and for 
hygienic cleansing of wounds is compatible with organic standards. This 
proposed change to broaden the allowance from surgical to medical 
procedures would improve organic livestock producers' ability to 
establish and maintain preventive livestock health care practices. The 
use of chlorhexidine may also minimize pain and stress. Such use could 
preclude the need to use antibiotics, which are prohibited for use in 
organic livestock production. This proposed rule to amend the 
chlorhexidine annotation would not alter the existing restriction on 
using chlorhexidine as a teat dip when alternative germicidal agents 
and/or physical barriers have lost their effectiveness.
---------------------------------------------------------------------------

    \12\ 2009 NOSB Recommendation to amend chlorhexidine, see 
https://www.ams.usda.gov/sites/default/files/media/
NOP%20Final%20Rec%20Chlorhexidine.pdf.
---------------------------------------------------------------------------

    In October 1999, the NOSB originally recommended chlorhexidine for 
addition to the National List for medical procedures conducted under 
the supervision of a licensed veterinarian. Chlorhexidine was added to 
the National List that was published in the final rule establishing the 
NOP (The allowance for chlorhexidine has been renewed via the sunset 
process in 2007 (October 21, 2007 (72 FR 58469)) and 2012 (June 21, 
2012 (77 FR 33290)).
    The 2009 NOSB chlorhexidine recommendation \13\ would allow broader 
use of chlorhexidine for treating injuries and allow use before and 
after medical procedures to prevent bacterial infections and 
potentially avoid the need for antibiotics. The NOSB has determined 
that the use of chlorhexidine in organic livestock production in this 
manner meets the evaluation criteria for National List substances. In 
formulating its recommendation, the NOSB concluded that chlorhexidine 
is an important substance for treating livestock to cleanse infected 
areas that need medical attention. AMS has reviewed and proposes to 
address the NOSB recommendation through this proposed rule. Therefore, 
AMS is proposing to amend the listing for chlorhexidine in Sec.  
205.603(a) to: Chlorhexidine--for medical procedures conducted under 
the supervision of a licensed veterinarian. Allowed for use as a teat 
dip when alternative germicidal agents and/or physical barriers have 
lost their effectiveness.
---------------------------------------------------------------------------

    \13\ NOSB Final recommendation on chlorhexidine, see: https://www.ams.usda.gov/sites/default/files/media/
NOP%20Final%20Rec%20Chlorhexidine.pdf.
---------------------------------------------------------------------------

Hypochlorous Acid
    See discussion above under Sec.  205.601 Synthetic substances 
allowed for use in organic crop production.
Kaolin Pectin
    This proposed rule would add kaolin pectin to Sec.  205.603(a) of 
the National List for use as an adsorbent, antidiarrheal, and gut 
protectant in organic livestock production. Table 11 provides the 
proposed listing.

            Table 11--Proposed Rule Action for Kaolin Pectin
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: N/A.
Proposed rule action: Sec.   205.603(a), Kaolin Pectin, for use as an
 adsorbent, antidiarrheal, and gut protectant.
------------------------------------------------------------------------


[[Page 2505]]

Applications
    Kaolin pectin is a combination of kaolin clay and pectin. Kaolin 
clay is geologically formed and can be either a white, light yellow, 
light gray, or light brown powder composed of silica, alumina, and 
water. Kaolin is listed under 21 CFR 186.1256 as an indirect food 
substance affirmed as GRAS for human food and is used mostly as a 
gelling or thickening agent or stabilizer. Pectin is present in plant 
cell walls and consists of a polymer of galacturonic acid often 
disrupted by short branches of neutral sugars. Pectin is produced 
commercially as a white to light brown powder, produced mostly from hot 
dilute acid extraction of fruit juice production byproducts. Pectin is 
used in foods as an emulsifier or as a stabilizer and is listed as GRAS 
under 21 CFR 184.1588 for human food. Pectin molecules vary in the 
degree of methoxylation, either high (above 50 percent) or low (less 
than 50 percent) where the degree of methoxylation determines the 
gelling properties of the pectin.
Timeline
    This proposed rule would implement a September 2002 NOSB 
recommendation to add kaolin pectin to Sec.  205.603 of the National 
List for use as an adsorbent, antidiarrheal, and gut protectant in 
organic livestock production. The NOSB indicated that kaolin pectin 
should not be used routinely as a preventive practice but only when 
organic practices fail to treat gastrointestinal irritants or diarrhea. 
The NOSB determined that synthetic forms of pectin were compatible with 
organic livestock production and could be used in formulations to 
produce kaolin pectin.
    The NOSB has determined that the use of kaolin pectin in organic 
livestock production in this manner meets the requirements of the OFPA 
material evaluation criteria for organic production. AMS has reviewed 
and proposes to address the NOSB recommendation through this proposed 
rule. Therefore, AMS is proposing to add kaolin pectin to section Sec.  
205.603(a) with the following annotation: For use as an adsorbent, 
antidiarrheal, and gut protectant.
Mineral Oil
    This proposed rule would add mineral oil to the National List for 
use in organic livestock production for relief of intestinal impaction. 
The NOSB recommended that this substance be included in paragraph (a) 
of Sec.  205.603 as a medical treatment in livestock production. Table 
12 provides the proposed listing.

             Table 12--Proposed Rule Action for Mineral Oil
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: N/A.
Proposed rule action: Sec.   205.603(a) Mineral oil, for relief of
 intestinal impaction, prohibited for use as a dust suppressant.
------------------------------------------------------------------------

Applications
    Mineral oil, also known as white oil, liquid paraffin, pariffinum 
liquidum, and liquid petroleum, is colorless, insoluble in water, and 
odorless. It is a complex mixture of straight and branched chain 
aromatic hydrocarbons, such as paraffinic, and naphthenic oils, and is 
derived mostly from petroleum distillate.
    Applications for mineral oil include use as a lubricant (both 
mechanical and biological), in veterinary treatments, cosmetic 
products, pharmaceutical preparation (processing aids, intestinal 
lubricants), food preparation (release agents, binders, defoamers, 
protective coatings), and as an ingredient in animal feed products.
    Mineral oil is permitted as described at 21 CFR 172.878 for direct 
addition to food for human consumption. When administered orally, 
mineral oil absorption from the intestine is limited.\14\ Mineral oil 
is currently on the National List and is allowed in organic production 
for topical use and as a lubricant (Sec.  205.603(b)(6)). This proposed 
action does not affect this current allowance.
---------------------------------------------------------------------------

    \14\ Mineral Oil technical report: https://www.ams.usda.gov/
rules-regulations/organic/national-list/petitioned.
---------------------------------------------------------------------------

Timeline
    This proposed rule would implement a September 2002 NOSB 
recommendation to add mineral oil to section Sec.  205.603 of the 
National List for use in organic livestock production. During the 
September 2002 meeting, the NOSB considered allowing mineral oil to be 
used as a medical treatment for bloat (rumen-reticulum overdistention) 
and as a medical treatment of omasal impaction.\15\ The NOSB indicated 
that ruminal bloat or omasal impaction would occur infrequently. The 
2002 NOSB recommendation intended to allow mineral oil as an internal 
treatment for impaction.
---------------------------------------------------------------------------

    \15\ The NOSB also considered allowing mineral oil as a dust 
suppressant in livestock feed, but deferred consideration of this 
use to a subsequent meeting and did not include this use in its 
final 2002 recommendation.
---------------------------------------------------------------------------

    The NOSB has determined that the use of mineral oil in organic 
livestock production for the proposed use meets the requirements of the 
OFPA material evaluation criteria for organic production. AMS has 
reviewed and proposes to address the NOSB recommendation through this 
proposed rule. Therefore, AMS is proposing to add mineral oil to Sec.  
205.603(a) with the following annotation: For treatment of intestinal 
impaction, prohibited for use as a dust suppressant.
Nutritive Supplements--Injectable Vitamins, Minerals, and Electrolytes
    This proposed rule would also add injectable vitamins, minerals, 
and electrolytes to Sec.  205.603(a) of the National List for use in 
organic livestock production. Currently, these substances are allowed 
to be provided only orally as feed additives (vitamins and minerals per 
Sec.  205.603(d)) or medical treatments (electrolytes without 
antibiotics per Sec.  205.603(a)). Table 13 illustrates the proposed 
listings.

  Table 13--Proposed Rule Action for Nutritive Supplements--Injectable
                  Minerals, Vitamins, and Electrolytes
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: N/A.
Proposed rule action: Sec.   205.603(a) Nutritive supplements--
 Injectable minerals, vitamins, and electrolytes--formulated injectable
 supplements of trace minerals per 205.603(d)(2), vitamins per
 205.603(d)(3), and electrolytes per 205.603(a)(8), with excipients per
 205.603(f), in accordance with FDA and restricted to use by or on the
 order of a licensed veterinarian.
------------------------------------------------------------------------


[[Page 2506]]

Application
    Vitamins and trace minerals were added to the National List as feed 
additives, and electrolytes were added to the National List as a 
medical treatment when the NOP final rule became effective on October 
21, 2002.\16\ Organic livestock producers are required to provide 
livestock with a total feed ration, including pasture and forage, that 
is sufficient to meet the nutritional requirements of the animal. To 
provide a total feed ration, livestock producers may use nonsynthetic 
feed additives, and synthetic feed additives included on the National 
List in Sec.  205.603. As currently allowed under the regulations, 
vitamins, trace minerals, and electrolytes may be consumed only as part 
of the total feed ration. On occasion animals go off feed when their 
appetites are suppressed. If suppressed for an extended period, feeding 
a total ration with the required nutrients may not provide adequate 
amounts of vitamins, minerals, or electrolytes to alleviate any 
existing nutrient deficiencies. During its deliberation on their 
recommendation at the 2009 meeting, the NOSB received comments 
indicating that in livestock production it is common practice to 
provide off feed (low appetite) animals with injectable nutrients to 
help restore animal health. The NOSB concurred with this practice and 
argued in its justification that injectable formulations of vitamins 
and minerals (including electrolytes) can deliver increased amounts of 
these nutrients and can be used to quickly alleviate symptoms and 
reverse declines in livestock health resulting from nutrient 
deficiency.
---------------------------------------------------------------------------

    \16\ This final rule established the National Organic Program. 
It became effective on October 21, 2002. Sunset reviews for the 
listings for vitamins, minerals, and electrolytes were completed in 
2007 (72 FR 58469, October 21, 2007) and 2012 (77 FR 33290, June 21, 
2012).
---------------------------------------------------------------------------

    This proposed rule would implement a 2009 NOSB recommendation to 
add formulated (i.e., multiple ingredient products) injectable 
vitamins, trace minerals, and electrolytes, with or without excipients, 
to the National List under Sec.  205.603(a).\17\ The NOSB determined 
that an allowance for injectable vitamins, trace minerals, and 
electrolytes was necessary to rapidly deliver higher amounts of 
vitamins and minerals to targeted tissues in situations where an animal 
has higher vitamin and mineral demands. The NOSB also determined that 
use of these products would be occasional and as-needed. AMS is 
requesting comments on whether including electrolytes in the proposed 
listing for injectable vitamins and minerals is needed since 
electrolytes are currently listed as an allowed medical treatment in 
Sec.  205.603(a)(8). AMS would interpret the proposed listing to mean 
that an operation would be allowed to use these substances individually 
or in combination.
---------------------------------------------------------------------------

    \17\ NOSB Recommendation on injectable vitamins and minerals, 
see https://www.ams.usda.gov/sites/default/files/media/
Injectable%20Vitamins%20and%20Minerals%20Formal%20Rec.pdf.
---------------------------------------------------------------------------

Timeline
    Both vitamins and trace minerals were included in Sec.  205.603(d) 
in the USDA organic regulations (65 FR 13512, December 21, 2000), which 
became effective on October 21, 2002. Since this original listing, both 
vitamins and trace minerals were renewed under the 2007 and 2012 sunset 
review processes as recommended by the NOSB. These recommendations were 
accepted by the Secretary and processed through final rulemaking 
effective October 21, 2007 (72 FR 58469) and June 21, 2012 (77 FR 
33290).
    Electrolytes were included in Sec.  205.603(a) in the original 
National List in the final rule (65 FR 13512, December 21, 2000), which 
became effective on October 21, 2002. Since this original listing, 
electrolytes have been renewed under the 2007 and 2012 sunset review 
process as recommended by the NOSB. These recommendations were accepted 
by the Secretary and processed through final rulemaking effective 
October 21, 2007 (72 FR 58469) and June 21, 2012 (77 FR 33290).
    At its May 6, 2009, meeting, the NOSB issued a recommendation to 
the Secretary to add injectable vitamins, trace minerals and 
electrolytes to the National. In formulating this recommendation, the 
NOSB determined that allowing injectable forms of these substances 
would provide organic livestock producers with the use of injectable 
vitamins, trace minerals, and electrolytes as nutritive supplements, on 
an as-needed basis.
    This proposed rule would require that injectable vitamins, minerals 
or electrolytes only be administered or ordered by a licensed 
veterinarian. Livestock producers would need to keep records that 
document the need for any use of these materials. Further, producers 
and certifying agents would need to review the specific formulations 
intended for use on organic livestock to ensure they comply with the 
USDA organic regulations.
    The NOSB stated in its recommendation that this allowance would 
provide organic producers with more opportunity to enhance the overall 
welfare of certified organic livestock. AMS has reviewed and proposes 
to address this NOSB recommendation through this proposed rule. AMS is 
proposing to add injectable vitamins, minerals and electrolytes to 
Sec.  205.603(a) of the National List with the following annotation: 
formulated injectable supplements of trace minerals per 205.603(d)(2), 
vitamins per 205.603(d)(3), and electrolytes per 205.603(a)(8), with 
excipients per 205.603(f), in accordance with FDA and restricted to use 
by or on the order of a licensed veterinarian.
Parasiticides, Fenbendazole, and Moxidectin
    This proposed rule would amend the National List to revise the 
listing for parasiticides (Sec.  205.603(a)(17)) and the listings for 
fenbandazole (Sec.  205.603(a)(17)(i)) and moxidectin (Sec.  
205.603(a)(17)(iii)). This rule also proposes to amend the livestock 
health care practice standard in Sec.  205.238(b) to allow the use of 
parasiticides in organic fiber-bearing animals. Table 14 illustrates 
the proposed listings.

            Table 14--Proposed Rule Action for Parasiticides
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: Sec.   205.603(a)(17) Parasiticides--Prohibited in
 slaughter stock, allowed in emergency treatment for dairy and breeder
 stock when organic system plan-approved preventive management does not
 prevent infestation. Milk or milk products from a treated animal cannot
 be labeled as provided for in subpart D of this part for 90 days
 following treatment. In breeder stock, treatment cannot occur during
 the last third of gestation if the progeny will be sold as organic and
 must not be used during the lactation period for breeding stock.
Sec.   205.603(a)(17)(i) Fenbendazole (CAS #43210-67-9)--only for use by
 or on the lawful written order of a licensed veterinarian.
Sec.   205.603(a)(17)(iii) Moxidectin (CAS #113507-06-5)--for control of
 internal parasites only.

[[Page 2507]]

 
Proposed rule action: Sec.   205.603(a)(23) Parasiticides--Prohibited in
 slaughter stock, allowed in emergency treatment for dairy and breeder
 stock when organic system plan-approved preventive management does not
 prevent infestation. In breeder stock, treatment cannot occur during
 the last third of gestation if the progeny will be sold as organic and
 must not be used during the lactation period for breeding stock.
 Allowed for fiber-bearing animals when used a minimum of 90 days prior
 to harvesting of fleece or wool that is to be sold, labeled, or
 represented as organic.
Sec.   205.603(a)(23)(i) Fenbendazole (CAS #43210-67-9) Milk or milk
 products from a treated animal cannot be labeled as provided for in
 subpart D of this part for: 2 days following treatment of cattle; 36
 days following treatment of goats, sheep and other dairy species.
Sec.   205.603(a)(17)(ii). Moxidectin (CAS #113507-06-5) Milk or milk
 products from a treated animal cannot be labeled as provided for in
 subpart D of this part for: 2 days following treatment of cattle; 36
 days following treatment of goats, sheep and other dairy species.
------------------------------------------------------------------------

    The USDA organic regulations specify conditions under which 
parasiticides may be used in organic livestock production (Sec.  
205.238(b)) and identify which parasiticides are allowed (Sec.  
205.603(a)(17)). These conditions include: (1) Emergency treatment for 
dairy and breeder stock only when preventive measures have failed; (2) 
a 90-day withdrawal period before milk or milk products from treated 
animals can be sold as organic; and (3) a prohibition on use in breeder 
stock during the last third of gestation or during lactation if progeny 
will be sold as organic. Organic livestock producers are required to 
use preventive practices as described in Sec.  205.238 before using any 
parasiticide included on the National List. However, animals in need of 
medical attention cannot be left untreated in order to retain organic 
status (Sec.  205.238(c)(7)).
    In April 2016, the NOSB considered amendments to the use 
restrictions for parasiticides allowed in organic production based on 
updated information. The NOSB recommended: (1) Removing the 90-day 
withholding time for milk and milk products and specifying withholding 
times in the listings for specific parasiticides; and (2) permitting 
fiber-bearing organic animals to be treated with allowed parasiticides, 
provided there is a 90-day interval from treatment to harvest of fleece 
or wool to be sold as organic.\18\ The NOSB recommended that the 
provision for the use of parasiticides in the livestock health care 
practice standard, Sec.  205.238(b)(2), also be amended to reflect 
these changes.
---------------------------------------------------------------------------

    \18\ The April 2016 NOSB recommendation is available here: 
https://www.ams.usda.gov/sites/default/files/media/
LS%20Parasiticides%20NOP.pdf.
---------------------------------------------------------------------------

    The NOSB determined that these modifications would benefit sick 
animals in emergency situations without impacting the organic integrity 
of the products. Public comment received by the NOSB requested that the 
USDA organic regulations allow for animal skin and fleece treated with 
parasiticides to be sold as organic. The NOSB determined that 
parasiticide use in fiber-bearing animals should be allowed in organic 
production if necessary.
    In April 2016, the NOSB also considered modifications to the use 
restrictions for two allowed parasiticides, fenbendazole, and 
moxidectin. The USDA organic regulations permit the use of fenbendazole 
only when there is a written order of a licensed veterinarian. The NOSB 
recommended removing the requirement for the written order of a 
licensed veterinarian and reducing the 90-day withdrawal period for 
milk or milk products that will be sold as organic to 2 days for cattle 
and 36 days for goats, sheep and other dairy species.
    The USDA organic regulations permit the use of moxidectin only to 
control internal parasites and require a 90-day withdrawal period for 
milk and milk products after use. The NOSB recommended removing that 
restriction and reducing the 90-day withdrawal time for milk or milk 
products that will be sold as organic to 2 days for cattle and 36 days 
for goats, sheep and other dairy species.
    In addition, the NOSB recommended allowing the use of parasiticides 
in organic fiber-bearing animals.
    At its April 25-27, 2016 meeting, the NOSB received public comment 
on the proposals to amend the allowances for parasiticides generally in 
addition to the allowances for fenbendazole and moxidectin. Based on 
updated technical reports on parasiticides and public comments, the 
NOSB recommended the above amendments to the use parameters for 
parasiticides in organic livestock production.\19\
---------------------------------------------------------------------------

    \19\ The 2015 technical evaluation report on parasiticides is 
available here: https://www.ams.usda.gov/sites/default/files/media/
Para%20Technical%20Evaluation%20Report%20%282015%29.pdf.
---------------------------------------------------------------------------

    AMS has reviewed and proposes to address these NOSB recommendations 
on parasiticides as a category, fenbendazole, and moxidectin through 
this proposed rule. Consistent with the NOSB recommendations, this 
proposed rule would amend Sec.  205.238(b) and Sec.  205.603(a)(17) as 
follows:
     Sec.  205.238(b)(2) will be amended by replacing the 90-
day withholding time for milk and milk products with a cross-reference 
to withholding times specified in Sec.  205.603. In addition, the term 
``stock'' will be replaced with ``animal.''
     Sec.  205.238(b) will be amended to add an allowance for 
parasiticide use in fiber-bearing animals.
     The 90-day withholding time described in Sec.  
205.603(a)(17) for milk and milk products following treatment with 
allowed parasiticides will be deleted.
     The listing for parasiticides in Sec.  205.603(a)(17) will 
be amended to allow for use in fiber bearing animals with a 90-day 
withdrawal time from treatment to harvest of wool or fleece.
     The annotation for fenbendazole in Sec.  205.603(a)(17)(i) 
will be amended to delete the requirement for use by or on the lawful 
written order of a licensed veterinarian, and modified withholding 
times for milk and milk products will be added.
     The annotation for moxidectin in Sec.  205.603(a)(17)(iii) 
will be amended to delete the requirement for use by or on the lawful 
written order of a licensed veterinarian, and modified withholding 
times for milk and milk products will be added.
Ivermectin
    This proposed rule would remove ivermectin from Sec.  205.603(a) as 
an allowed parasiticide for use in organic livestock production. Table 
15 illustrates the proposed listing.

[[Page 2508]]



              Table 15--Proposed Rule Action for Ivermectin
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: Sec.   205.603(a)(17) (ii) Ivermectin (CAS #70288-86-7).
Proposed rule action: Remove Sec.   205.603(a)(17) (ii) Ivermectin (CAS
 #70288-86-7).
------------------------------------------------------------------------

    Ivermectin has been on the National List since October 21, 2002. On 
June 26, 2016, AMS received a petition to remove ivermectin \20\ from 
the National List. The petition explained that ivermectin does not meet 
the OFPA criteria for the National List because: (1) The availability 
of two other synthetic parasiticides which are allowed in organic 
production as emergency treatment when preventive measures have failed; 
(2) environmental toxicity, more specifically, that ivermectin residues 
adversely affect soil organisms and dung beetles that support healthy 
pastures and rangelands. Further, the petition stated that the NOSB 
received new information during the 2017 sunset review of ivermectin 
indicating that this substance is not always effective.
---------------------------------------------------------------------------

    \20\ Access to Ivermentin petition: https://www.ams.usda.gov/
rules-regulations/organic/national-list/petitioned.
---------------------------------------------------------------------------

    At its November 16-18, 2016, meeting in St. Louis, Missouri, the 
NOSB reviewed the petition information, parasiticide technical report, 
and public comments. The NOSB recommended removing ivermectin from 
Sec.  205.603(a) of the National List.
    AMS has reviewed and proposes to address this NOSB recommendation 
through this proposed rule. The removal of ivermectin would leave 
organic livestock producers with two parasiticides for emergency 
treatment, fenbendazole and moxidectin. Based on public comments during 
the NOSB deliberations on parasiticides, AMS understands that there is 
support among organic livestock producers to remove ivermectin if AMS 
concurrently removes the requirement for a veterinarian's order to 
administer fenbendazole. As discussed above, this action proposes to 
remove that requirement and to reduce the withdrawal times following 
the use of fenbendazole or moxidectin. Consistent with the NOSB 
recommendation, this proposed rule would amend Sec.  205.603(a)(17) by 
removing Ivermectin (CAS #70288-86-7).
Propylene Glycol
    This proposed rule would add propylene glycol to Sec.  205.603(a) 
of the National List for use in organic livestock production. The NOSB 
originally recommended that this substance be included in paragraph (a) 
of Sec.  205.603 as a medical treatment in livestock production. Table 
16 provides the proposed listing.

           Table 16--Proposed Rule Action for Propylene Glycol
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: N/A.
Proposed rule action: Sec.   205.603(a). Propylene Glycol--only for
 treatment of ketosis in ruminants.
------------------------------------------------------------------------

Applications
    Propylene glycol is a viscous, colorless, nearly odorless, 
substance with a slightly sweet taste, and when mixed with water, it 
lowers the freezing point of water. Propylene glycol is chemically 
categorized as a diol (a compound containing two hydroxyl groups) and 
is miscible with many solvents, including water. It is stable substance 
under most conditions of use and storage, and it decomposes in water 
and soil within seven days.
    Propylene glycol is noncorrosive, and has a low volatility and low 
toxicity level, although toxicity varies with animal species as cats 
show more toxic susceptibility to propylene glycol compared to other 
animals.
    Propylene glycol can be manufactured from a variety of sources and 
procedures. Food-grade propylene glycol is produced from propylene 
oxide using either a non-catalytic high temperature process or a lower 
temperature catalytic process. Propylene glycol can also be 
manufactured from heating glycerol (biodiesel byproduct) with sodium 
hydroxide and distillation.
    Propylene glycol is considered to be GRAS and is a direct food 
substance for human food listed at 21 CFR 184.1666. As a food additive, 
it is used as a humectant (moisture retention), solvent, and 
preservative. Propylene glycol is also used as a solvent in many 
pharmaceuticals in oral, topical, or injectable formulations, including 
those where the active ingredient is insoluble in water.
    When present in surface water, propylene glycol can exert a high 
level of biochemical oxygen demand during degradation. This high demand 
could adversely affect aquatic species by consuming oxygen needed by 
aquatic organisms. Similarly, when microbial organisms decompose 
propylene glycol in surface water, significant amounts of dissolved 
oxygen are consumed. Low dissolved oxygen levels in surface water may 
reduce the amount of suitable aquatic habitat.
Timeline
    This proposed rule would implement a September 2002 NOSB 
recommendation to add propylene glycol (CAS # 57-55-6) to section 
205.603(a) of the National List. At this public meeting the NOSB 
determined that propylene glycol should be added to Sec.  205.603(a) as 
a medical treatment in organic livestock production. Propylene glycol 
was petitioned to the NOSB for addition onto the National List as a 
medical treatment for ketosis (elevated blood ketones) in ruminants. 
Primary ketosis (or acetonaemia) of dairy cows is a metabolic disorder. 
Ketosis or pregnancy toxaemia has been observed in beef cows near 
parturition. The NOSB recommended restricting the use of propylene 
glycol to treatment of acute ketosis in ruminants.
    During early lactation, the energy intake from feed may be 
insufficient to meet the energy output in milk, causing the animal to 
go into negative energy balance. To satisfy the nutrient requirements 
of milk production, dairy cows may draw on two sources of nutrients, 
food intake and body reserves. When in negative energy balance, the cow 
will metabolize fat reserves for energy, producing ketones. When ketone 
production exceeds ketone use by muscle and other animal tissue, 
ketosis can occur. Ketosis is an important clinical and sub-clinical 
disease, as several metabolic disorders

[[Page 2509]]

and diseases that are common in the periparturient (near calving) and 
early lactation periods have been linked to ketosis, including milk 
fever, retained foetal membranes, and displaced abomasums.
    The NOSB has determined that the proposed use of propylene glycol 
in organic livestock production fulfills the OFPA material evaluation 
criteria. AMS has reviewed and proposes to address the NOSB 
recommendation through this proposed rule. Therefore, AMS is proposing 
to add propylene glycol to Sec.  205.603(a).
Sodium Chlorite, Acidified
    This proposed rule would add two listings for acidified sodium 
chlorite for use as a teat dip in organic livestock (dairy) production 
(Sec.  205.603(a) and Sec.  205.603(b)). In 2015, the NOSB recommended 
an allowance for this substance as a pre- and post-milking teat dip 
treatment and cited supportive public comments from livestock producers 
and a lower environmental impact than other substances allowed for this 
use. Table 17 illustrates the proposed changes to this section.

      Table 17--Proposed Rule Action for Acidified Sodium Chlorite
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: N/A.
Proposed rule action: Sec.   205.603(a) and Sec.   205.603(b) Sodium
 Chlorite, Acidified--allowed for use on organic livestock as a teat dip
 treatment.
------------------------------------------------------------------------

Applications
    Acidified sodium chlorite is produced from mixing an aqueous 
solution of sodium chlorite with a food grade acid, such as citric 
acid. Acidified sodium chlorite can also be produced by mixing any FDA 
GRAS acid with an aqueous solution of sodium chlorite. The FDA has 
approved acidified sodium chlorite solutions as antimicrobial agents 
with proscribed sodium chlorite concentrations and pH values for 
several food product applications.
    Acidified sodium chloride is commonly used during livestock 
production as a standard practice for teat dips in order to prevent 
mastitis in dairy livestock. Mastitis is the inflammation of udder 
tissue resulting from bacterial infection. Teat dips are substances 
used in dairy livestock to control mastitis and reduce contamination of 
mastitis causing bacteria.
    Mastitis can be controlled by practices such as ensuring adequate 
nutrition, practicing good hygiene pre- and post-milking, and culling 
chronically mastitis-infected cows. Livestock producers can also use 
mastitis prevention practices to decrease the incidence of 
transmission, such as ensuring that cows have clean, dry bedding and 
carrying out routine sanitation of milking machines between milkings. A 
mastitis prevention program usually includes applying a pre-milking and 
a post-milking teat dip. After milking, the teat canal may remain open 
for several minutes. A post-milking dip is used as a disinfectant and a 
barrier between the open teat and the bacteria in the air.
Timeline
    This proposed rule would implement an April 2015 NOSB 
recommendation to add acidified sodium chlorite to sections 205.603(a) 
and (b) of the National List \21\ for use as a pre- and post-milking 
teat dip treatment. The NOSB received a petition \22\ in April 2012 to 
add acidified sodium chlorite to section 205.603(a) and (b) for use as 
a teat dip in organic livestock production. At its April 2014 meeting, 
the NOSB tabled a recommendation not to approve acidified sodium 
chlorite for use as a teat dip because several substances on the 
National List were already approved as teat dips. One factor in 
delaying a recommendation was a lack of public comments from organic 
livestock producers supporting a need for acidified sodium chlorite for 
this use.
---------------------------------------------------------------------------

    \21\ Acidified sodium chlorite was originally recommended for 
addition onto the National List as a microbial control substance for 
organic handing at the NOSB's May 2009 meeting. On March 15, 2012, 
acidified sodium chlorite was added onto the National List in Sec.  
205.605(b) when final rule 77 FR 8089, published on February 14, 
2012, became effective.
    \22\ Petition for acidified sodium chlorite, see https://www.ams.usda.gov/sites/default/files/media/
S%20Chlorite%20Acidified.pdf.
---------------------------------------------------------------------------

    During the April 2015 public meeting, the NOSB reviewed the 2013 
technical report \23\ on acidified sodium chlorite that included an 
assessment on the effectiveness of acidified sodium chlorite as a teat 
dip indicating that it may be as effective as iodine solution teat 
dips. The NOSB considered information indicating that alternative 
practices to teat dipping or udder washing did not prevent mastitis, 
and may actually increase udder infection. The NOSB also received 
comments from livestock producers supporting the use of acidified 
sodium chlorite as a teat dip in organic livestock production. Further, 
the NOSB determined that acidified sodium chlorite has comparatively 
lower environmental impacts than other teat dip substances that are 
currently on the National List. In its recommendation, the NOSB stated 
that preventive health care is an essential component of organic 
production and that clean animals and clean milking parlors are 
paramount for dairy livestock production. Therefore, the NOSB 
determined that acidified sodium chlorite for pre- and post-milking 
teat dipping is an important tool in preventing mastitis.
---------------------------------------------------------------------------

    \23\ Technical report on acidified sodium chlorite, see https://www.ams.usda.gov/sites/default/files/media/
S%20Chlorite%20A2%20report.pdf.
---------------------------------------------------------------------------

    In summary, based on alignment with OFPA evaluation criteria for 
National List substances, supportive comments from livestock producers 
on the need for acidified sodium chlorite, and information regarding 
low environmental impacts, the NOSB recommended allowing acidified 
sodium chlorite for use as a teat dip. AMS has reviewed and proposes to 
address the NOSB recommendation through this proposed rule. Therefore, 
AMS is proposing to add acidified sodium chlorite to sections 
205.603(a) and (b) of the National List with the following annotation: 
Allowed for use on organic livestock as a pre and post teat dip 
treatment.
Xylazine
    This proposed rule would amend the current listing for xylazine in 
Sec.  205.603(a) by removing the limitation on use of this substances 
to ``The existence of an emergency.'' Xylazine is used by veterinarians 
as a means for sedation of animals in both emergency and non-emergency 
procedures. Therefore, the NOSB recommended omitting the emergency 
condition restriction because it is overly restrictive for a substance 
that meets all OFPA evaluation criteria for National List substances. 
This proposed rule would not affect the provisions for the use of 
xylazine in the USDA organic regulations that require the written order 
of a licensed veterinarian and withdrawal periods for slaughter stock

[[Page 2510]]

and dairy animals. Table 18 illustrates the proposed changes to this 
section.

               Table 18--Proposed Rule Action for Xylazine
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: Sec.   205.603(a)(23) Xylazine--federal law restricts this
 drug to use by or on the lawful written or oral order of a licensed
 veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of
 the Food and Drug Administration regulations. Also, for use under 7 CFR
 part 205, the NOP requires:
(i) Use by or on the lawful written order of a licensed veterinarian;
(ii) The existence of an emergency; and
(iii) A meat withdrawal period of at least 8 days after administering to
 livestock intended for slaughter; and a milk discard period of at least
 4 days after administering to dairy animals.
Proposed rule action: Sec.   205.603(a) Xylazine--federal law restricts
 this drug to use by or on the lawful written or oral order of a
 licensed veterinarian, in full compliance with the AMDUCA and 21 CFR
 part 530 of the Food and Drug Administration regulations. Also, for use
 under 7 CFR part 205, the NOP requires:
(i) Use by or on the lawful written order of a licensed veterinarian;
(ii) A meat withdrawal period of at least 8 days after administering to
 livestock intended for slaughter; and a milk discard period of at least
 4 days after administering to dairy animals.
------------------------------------------------------------------------

Applications
    Xylazine is synthesized by reacting 2,6-
dimethylphenylisothiocyanate with 3-amino-1-propanol in a polar solvent 
(ether) to form a thiourea. Concentrated hydrochloric acid is added 
after the solvent is removed. Water is added to the cooled mixture 
which is then filtered, and the filtrate is made basic to form a 
precipitate that is recrystallized as xylazine.
    Xylazine is used as a sedative, analgesic, and muscle relaxant in 
veterinary medicine. As a medical treatment, it can be administered 
intravenously, intramuscularly, subcutaneously, or orally, usually as a 
water based injectable solution. Xylazine can also be found as a white 
crystalline powder. Xylazine sedative properties are due to its 
depressiant mode of action on nervous system synaptic receptors. 
Sedation of animals is necessary for both planned medical procedures 
and emergency procedures to prevent the pain and suffering of animals 
as well as injury to the veterinarians performing the procedures.
Timeline
    This proposed rule would implement a November 2009 NOSB 
recommendation to amend the allowance for xylazine as listed in Sec.  
205.603(a) of the National List.\24\ At this meeting, the NOSB 
determined that the restriction limiting xylazine only to emergency use 
should be lifted to allow use for sedation of animals when necessary to 
perform non-emergency health care procedures in organic livestock. The 
NOSB determined that the proposed change in the xylazine annotation 
would allow organic livestock producers to improve their ability to 
establish and maintain preventive livestock health care practices since 
there are no alternatives to xylazine on the National List or 
nonsynthetic substances that provide sedative properties.
---------------------------------------------------------------------------

    \24\ 2009 NOSB Final Recommendation on xylazine, see https://www.ams.usda.gov/sites/default/files/media/
NOP%20Final%20Rec%20;Xylazine%20Technical%20Correction.pdf.
---------------------------------------------------------------------------

    The NOSB recommended adding xylazine to the National List in 
September 2002. Xylazine was petitioned for use as a sedative and 
analgesic during short surgical procedures. Xylazine was added to the 
National List in 2007, with the use conditions stated in Table 6.\25\ 
The allowance for xylazine was renewed via sunset review in 2012 (77 FR 
33290, June 6, 2012).
---------------------------------------------------------------------------

    \25\ 2002 Technical Advisory Report on xylazine, see https://www.ams.usda.gov/sites/default/files/media/Xylazine%20TR.pdf.
---------------------------------------------------------------------------

    During its initial xylazine deliberation, the NOSB considered 
limiting xylazine use to ``once in a lifetime'' applications. The 
NOSB's decision to recommend an allowance upon ``the existence of an 
emergency'' was the result of a compromise between two objectives, 
avoiding significant interference with a veterinarian's judgment and 
preventing routine use of xylazine. The NOSB described an emergency as 
an unplanned event requiring immediate medical attention. During its 
2009 deliberation, the NOSB received information indicating that 
xylazine is used more frequently as a sedative for non-emergencies and 
less often for actual emergencies.
    The NOSB has determined that the use of xylazine in organic 
livestock production for non-emergency medical procedures meets the 
requirements of the OFPA evaluation criteria for National List 
substances. AMS has reviewed and proposes to address the NOSB 
recommendation through this proposed rule. Therefore, AMS is proposing 
to amend the current listing of xylazine in Sec.  205.603 with the 
following annotation: Federal law restricts this drug to use by or on 
the lawful written or oral order of a licensed veterinarian, in full 
compliance with the AMDUCA and 21 CFR part 530 of the Food and Drug 
Administration regulations. Also, for use under 7 CFR part 205, the NOP 
requires: (i) Use by or on the lawful written order of a licensed 
veterinarian; and (ii) A meat withdrawal period of at least 8 days 
after administering to livestock intended for slaughter; and a milk 
discard period of at least four days after administering to dairy 
animals.
Zinc Sulfate
    This proposed rule would add zinc sulfate to the National List for 
use in organic livestock production. Table 19 illustrates the changes 
between the current rule and the proposed rule.

             Table 19--Proposed Rule Action for Zinc Sulfate
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: N/A.
Proposed rule action: Sec.   205.603(a). Zinc Sulfate--for use in hoof
 and foot treatments only.
------------------------------------------------------------------------


[[Page 2511]]

Applications
Zinc sulfate is a white, odorless powder that is soluble in water and 
alcohol (nonhydrates). The hydrates of zinc sulfate are the primary 
forms used for commercial applications. Agricultural applications of 
zinc sulfate include as a zinc supplement in animal feeds since zinc is 
an essential element in several biological processes. It is also used 
in fertilizers and agricultural sprays (mold or bacterial inhibitors).
    Zinc sulfate is manufactured from mined zinc ore that is crushed 
and ground. The ground ore is heated to produce a zinc ash that is 
subsequently mixed with sulfuric acid. The zinc dissolves in the 
sulfuric acid to yield a zinc sulfate solution that is further 
processed to yield a zinc sulfate powder.
    The 2015 zinc sulfate technical report \26\ developed for the NOSB 
states that zinc sulfate can stimulate an immune response to microbes 
that may cause foot rot to develop. The technical report also indicates 
that elevated zinc levels are toxic to some bacteria. Research cited in 
the technical report indicates that zinc sulfate, used alone or in 
combination with excipients, is effective in controlling foot rot. Zinc 
sulfate is not currently FDA approved as a treatment for controlling 
foot rot or digital dermatitis as described in the zinc sulfate 
petition submitted to the NOSB.\27\
---------------------------------------------------------------------------

    \26\ https://www.ams.;usda.gov/rules-regulations/organic/national-list/petitioned.
    \27\ https://www.ams.usda.gov/rules-regulations/organic/
national-list/petitioned.
---------------------------------------------------------------------------

    Zinc sulfate is allowed as a GRAS food additive for human food 
under FDA regulation 21 CFR 182.8997. Under the USDA organic 
regulations, zinc sulfate is on the National List as a synthetic trace 
mineral in organic livestock feed under Sec.  205.603(d)(2).
    As proposed, zinc sulfate would be used in a footbath for control 
of foot rot in livestock, primarily dairy cattle, sheep and goats. Foot 
rot, as the name indicates, is a disease that rots away the foot of the 
animal, specifically the area between the two toes of the affected 
animal. Foot rot is an infection of anaerobic bacteria that are common 
in the environments where cattle, sheep, and goats live. Temperature 
and moisture are factors in the transmission and invasion of these 
bacteria. More foot rot infections are likely with above average 
rainfall, elevated temperatures, and lush pasture growth. Infection may 
occur directly from the soil to the animals, usually though a lesion in 
the skin. If left untreated, foot rot can cause lameness in sheep, 
goats, and cattle and an infected animal can infect a whole herd.
    Once foot rot is detected, the animal is usually isolated from the 
herd and treated with antibiotics, or antibacterial treatments such as 
iodine or zinc sulfate. Foot-bathing solutions with ethanol, copper 
sulfate, formalin, or zinc sulfate are used when a large number of 
animals requires treatment. Ethanol, copper sulfate, and iodine are on 
the National List in Sec.  205.603, each with varying degrees of 
efficacy (therapeutic effect).
Timeline
    This proposed rule would implement an April 2015 NOSB 
recommendation to add zinc sulfate (CAS # 7733-02-0) to Sec.  205.603 
of the National List. At its public meeting, the NOSB determined that 
zinc sulfate should be allowed as a medical treatment (Sec.  
205.603(a)) and as a topical treatment, local parasiticide, or local 
anesthetic (Sec.  205.603(b)) in organic livestock production, 
specifically for use in hoof and foot treatments only. As proposed, 
zinc sulfate would be used in a footbath for control of foot rot in 
livestock, primarily dairy cattle, sheep and goats.
    In its recommendation, the NOSB indicated that copper sulfate and 
zinc sulfate are the two most accepted foot rot treatments, with 
similar efficacy. The NOSB considered that there are alternatives to 
zinc sulfate for foot rot treatment, but noted concerns about the 
efficacy of other materials and that some are not permitted for use in 
organic livestock. The NOSB determined that zinc sulfate provides 
organic livestock producers with an additional tool to treat foot 
disease, aids the welfare of the animals, and is preferable to the use 
of copper sulfate because of the buildup of potentially toxic 
persistent copper in the soil. The NOSB also noted that zinc has the 
potential to accumulate in soils, but persistence depends on several 
factors, and excess zinc can be reduced in soil by planting crops such 
as sunflower or canola.
    At its April 2015 public meeting, the NOSB voted to expand the 
allowed use of zinc sulfate as a treatment for foot disease in 
livestock for the purpose of ensuring the welfare of animals. The NOSB 
determined that the availability of zinc sulfate as a foot treatment 
would reduce the use of copper sulfate for treatment of foot disease, 
which may contribute to lower copper build up in soils. The NOSB 
considers zinc sulfate to be a more benign substance when compared to 
copper sulfate. The NOSB has determined that the use of zinc sulfate in 
organic livestock production as a foot treatment meets the requirements 
of the OFPA material evaluation criteria for organic production. In 
formulating its recommendation, the NOSB determined that use of zinc 
sulfate in organic livestock production promotes animal welfare and is 
preferable to the use of copper sulfate.
    AMS has reviewed and proposes to address the NOSB recommendation 
through this proposed rule. Therefore, AMS is proposing to add zinc 
sulfate to Sec.  205.603(a) with the following annotation: for use in 
hoof and foot treatments only.
Lidocaine and Procaine
    This proposed rule would amend the current listing of lidocaine in 
Sec.  205.603(b), Synthetic substances allowed for use in organic 
livestock production. Table 20 illustrates the proposed listing.

        Table 20--Proposed Rule Action for Lidocaine and Procaine
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule:
    Sec.   205.603(b)(4) Lidocaine--as a local anesthetic. Use requires
     a withdrawal period of 90 days after administering to livestock
     intended for slaughter and 7 days after administering to dairy
     animals.
    Sec.   205.603(b)(7) Procaine--as a local anesthetic. Use requires a
     withdrawal period of 90 days after administering to livestock
     intended for slaughter and 7 days after administering to dairy
     animals.
Proposed rule action:
    Sec.   205.603(b)(4) Lidocaine--as a local anesthetic. Use requires
     a withdrawal period of 8 days after administering to livestock
     intended for slaughter and 6 days after administering to dairy
     animals.
    Sec.   205.603(b)(7) Procaine--as a local anesthetic. Use requires a
     withdrawal period of 8 days after administering to livestock
     intended for slaughter and 6 days after administering to dairy
     animals.
------------------------------------------------------------------------


[[Page 2512]]

This proposed rule would amend the allowances for lidocaine and 
procaine in Sec.  205.603(b).
    Lidocaine \28\ and procaine \29\ have been on the National List 
since October, 2002, as local anesthetics to reduce pain after de-
budding horns or minor livestock surgery.\30\ The allowance requires 
withholding periods for livestock treated with either substance: 90 
days for livestock intended for slaughter and 7 days for dairy animals.
---------------------------------------------------------------------------

    \28\ https://www.ams.usda.gov/rules-regulations/organic/
national-list/l.
    \29\ https://www.ams.usda.gov/rules-regulations/organic/
national-list/p.
    \30\ https://www.ams.usda.gov/sites/default/files/media/
LS%20Lidocaine_Procaine%20NOP.pdf.
---------------------------------------------------------------------------

    Based on new information and public comments received during the 
2015 sunset review, the NOSB determined that the withholding times 
should be reduced. The NOSB explained that lengthy withholding times 
could result in animals not being timely treated, or not treated at 
all. The NOSB also noted that in 2007 it agreed that withholding times 
should be double the U.S. Food and Drug Administration (FDA) 
withholding times.\31\ For lidocaine, FDA recommended withdrawal 
intervals for cattle are 1 day for meat and 24 hours for milk following 
an epidural administration, or 4 days for meat and 72 hours for milk 
following subcutaneous administration. FDA provides information on 
procaine only as it relates to procaine with an antibiotic as part of 
delivery and thus it would not be used in organic production. The NOSB 
determined that withholding periods following the use of lidocaine or 
procaine should be revised from 90 days to 8 days for slaughter stock 
and from 7 days to 6 days for dairy animals.
---------------------------------------------------------------------------

    \31\ https://www.ams.usda.gov/sites/default/files/media/
LS%20Lidocaine_Procaine%20NOP.pdf.
---------------------------------------------------------------------------

    During a public meeting on October 26-29, 2015, the NOSB reviewed 
public comments on the proposal to amend lidocaine and procaine on the 
National List.\32\ Based on new information received in technical 
reports and public comments, the NOSB determined that reducing the 
withdrawal times for lidocaine and procaine supports animal health and 
is consistent with prior NOSB decisions regarding withdrawal times.
---------------------------------------------------------------------------

    \32\ https://www.ams.usda.gov/rules-regulations/organic/nosb/
recommendations/fall2015.
---------------------------------------------------------------------------

    AMS has reviewed and proposes to address the NOSB recommendation on 
lidocaine and procaine through this proposed rule. Consistent with the 
NOSB recommendation, AMS proposes to amend section 205.603(b) of the 
National List to reduce the withholding periods for lidocaine and 
procaine from 90 days to 8 days for slaughter stock and from 7 days to 
6 days for milk.
Methionine
    This proposed rule would amend the allowance for methionine in 
Sec.  205.603(d) by requiring that maximum methionine levels in feed be 
calculated as averages over the lifespan of the birds rather than a 
constant percentage of the feed. The NOSB considered reports of 
methionine deficiency in some organic poultry flocks. Alternatives to 
synthetic methionine have yet to be developed for commercial use. In 
consideration of public comments, NOSB input, and technical reports, 
AMS proposes to continue to allow methionine in restricted amounts. The 
proposed amendment to the methionine annotation includes limits on the 
amount that may be used over the life of the flock, as well as breed-
specific limits. Table 21 illustrates the changes proposed change for 
this substance.

              Table 21--Proposed Rule Action for Methionine
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: Sec.   205.603(d)(1) DL-Methionine, DL-Methionine--hydroxy
 analog, and DL-Methionine--hydroxy analog calcium (CAS Numbers 59-51-8,
 583-91-5, 4857-44-7, and 922-50-9)--for use only in organic poultry
 production at the following maximum levels of synthetic methionine per
 ton of feed: Laying and broiler chickens--2 pounds; turkeys and all
 other poultry--3 pounds.
Proposed rule action: Sec.   205.603(d) DL-Methionine, DL-Methionine--
 hydroxy analog, and DL-Methionine--hydroxy analog calcium (CAS Numbers
 59-51-8, 583-91-5, 4857-44-7, and 922-50-9)--for use only in organic
 poultry production at the following pounds of synthetic 100 percent
 methionine per ton of feed in the diet, averaged over the life of the
 flock: Laying chickens--2 pounds; Broiler chickens--2.5 pounds; Turkeys
 and all other poultry--3 pounds.
------------------------------------------------------------------------

Applications
    Methionine is a sulfur containing amino acid that is a white solid 
or white crystalline powder, or may be in liquid form when produced as 
a hydroxyl analog. The 2011 methionine technical report developed for 
the NOSB states that methionine is soluble in water, methanol, alkali 
solutions, and mineral acids. Methionine is stable under normal 
temperature and pressure but is susceptible to strong oxidizing agents. 
Methionine can be produced or extracted from nonsynthetic sources or 
manufactured through a synthetic process. Nonsynthetic methionine is 
produced from microbial fermentation and extraction or by hydrolyzing 
protein. Amino acids can also be produced by bacterial fermentation. 
However, the technical report prepared for the NOSB in 2011 states that 
methionine yields from bacterial fermentation are low and not cost 
effective. According to a 2011 petition submitted to AMS, the most 
economical chemical method involves combining reagents acrolein, methyl 
mercaptan, hydrogen cyanide, and ammonia carbonate to yield an 
intermediary substance that is saponified with potassium carbonate, 
which results in high yields of methionine.
    Methionine can be provided either as part of an intact protein or 
as an amino acid that is added to a poultry diet. As a single 
ingredient animal feed supplement, it is regulated by the Food and Drug 
Administration (21 CFR 582.5475). In the 2011 technical report, 
methionine is described as the first limiting amino acid for the 
synthesis of protein in poultry. It is considered to be an essential 
amino acid for poultry production because it is required for cell 
tissue growth and metabolism, but it cannot be synthesized by poultry 
and must be supplied in the diet.
    To meet requirements for cell growth and function, poultry must 
obtain adequate methionine from agricultural feed ingredients or 
receive methionine to the ration through supplementation (addition). In 
the 2011 NOSB methionine technical report, poultry rations composed of 
corn and soybean meal may not provide adequate non-synthetic methionine 
to prevent deficiency symptoms.
    To compensate for low methionine content in corn-soybean meal 
diets, poultry producers may use various production practices to meet 
methionine requirements. Such production practices include increasing 
intake of the existing diet (ration); increasing the protein content of 
a ration by either increasing soybean meal content or by adding other 
protein feed ingredients that contain higher

[[Page 2513]]

concentrations of methionine; or by adding synthetic methionine to the 
ration. Each of these practices presents challenges in ensuring that 
sufficient methionine is available to meet requirements for the various 
stages of poultry production.
    Young birds, especially those less than three weeks in age, may be 
physically unable to ingest the additional ration needed to meet 
minimum methionine levels required at that production stage. These few 
weeks can represent a significant portion of the production cycle where 
bird growth may be restricted, resulting in lower production or even 
increased bird death. When implemented, this practice may not provide 
adequate methionine to the birds during the early phase of the 
production cycle. For example, young broilers physically that are 
unable to increase feed intake for the initial three weeks out of seven 
weeks of production may not obtain adequate methionine during their 
production cycle and will have less growth. This practice may also 
result in reduced feed efficiency and an increase in feed costs. 
Conversely, increasing feed intake to meet methionine needs could also 
result in overfeeding of other nutrients and lead to subsequent 
livestock health problems.
    An alternative to increasing feed intake is to increase the protein 
content of the diet by adding more soybean meal to the corn-soybean 
meal ration. Since animals consume feed to meet their energy 
requirements, adding additional protein may be more effective in 
meeting poultry methionine requirements when compared to only 
increasing feed intake. However, increasing protein content in a feed 
may result in excessive amino acids--the amino acids remaining after 
methionine is no longer available for protein synthesis--to be used in 
energy metabolism. When used as an energy source, amino acids are 
deaminated and the resulting nitrogen is excreted as uric acid. 
Continued feeding of a higher protein, low methionine ration may result 
in excessive nitrogen being excreted as uric acid and, subsequently, 
higher ammonia levels within the bird house.
    Increasing methionine content in the diet can be achieved through 
the use of alternative protein feed sources that can be added to the 
standard soybean-corn poultry diet. Protein feed sources known to have 
a high methionine content include blood meal, meat meal, fish meal, 
crab meal, and corn gluten meal. Organic producers, however, have 
limited options to use these because of: (1) A lack of commercially 
available nonsynthetic or organic sources of methionine, such as 
organic corn gluten meal, and (2) the prohibition on feeding slaughter 
by-products derived from mammalian or avian sources (Sec.  
205.237(b)(5)), which prohibits feeding blood meal or meat meal to 
organic poultry. Further, the use of fish meal and crab meal in poultry 
diets may be limited by the potential for off flavors in the poultry 
products, especially eggs. For this and other reasons, organic 
producers have petitioned the NOSB to allow the use synthetic sources 
of methionine for supplementation.
    The NOSB has acknowledged that certain production practices support 
the need for synthetic methionine supplementation, but stated that 
methionine obtained from outdoor access or pasturing alone may not be 
adequate to offset the need for methionine supplementation. The NOSB 
also considered that the breed of bird can affect methionine needs.
Timeline
    This proposed rule would implement an April 2015 NOSB 
recommendation to amend the allowance for methionine as listed in Sec.  
205.603(d)(1) of the National List.\33\ At this meeting, the NOSB 
determined that the annotation should be amended to allow organic 
poultry producers to adjust the concentration of synthetic methionine 
in poultry feed rations to meet the nutritional requirements of the 
birds at different life stages, while simultaneously limiting the total 
amount of synthetic methionine used in a poultry ration that is fed 
during the lifetime of the flock. Table 21 shows the comparison of the 
current and proposed allowances for synthetic methionine. At this 
meeting the NOSB considered information that the current restriction on 
methionine could result in methionine deficiency in poultry flocks. In 
its recommendation, the NOSB noted that a methionine deficiency may 
suppress immune system development and cause poor feathering, feather 
pecking, cannibalism, and increased bird death.
---------------------------------------------------------------------------

    \33\ https://www.ams.usda.gov/sites/default/files/media/
LS%20MET%20Final%20Rec.pdf.
---------------------------------------------------------------------------

    The NOSB also received comments from poultry producers indicating 
that the use of synthetic methionine is necessary because alternatives 
to synthetic methionine are not commercially available or are 
prohibited by Sec.  205.237(b)(5), which states that the producer of an 
organic operation must not feed mammalian or poultry slaughter by-
products to organic mammalian livestock or poultry.
    In 2001, the NOSB recommended adding methionine to the National 
List as a feed supplement for use in organic poultry production. 
Methionine was added to Sec.  205.603 of the National List on October 
31, 2003, with the annotation ``for use in organic poultry production 
until October 21, 2005 (68 FR 61987).'' When the NOSB approved its 2001 
recommendation to allow methionine, an expiration date was inserted 
into the annotation to indicate that synthetic methionine would be 
phased out when non-synthetic alternatives to synthetic methionine were 
developed and were commercially available. Based on multiple NOSB 
recommendations, AMS has amended section 205.603 of the National List 
to allow methionine as a synthetic substance for use in organic poultry 
production several times. A full description of the NOSB 
recommendations and rulemaking related to synthetic methionine for 
organic poultry through 2012 is available in a Final Rule, September 
19, 2012 (77 FR 57985).
    Between 2010 and 2012, AMS completed two rules that revised the 
allowance for synthetic methionine by specifying maximum levels as 
recommended by the NOSB.\34\ The NOSB conveyed that the intent of this 
recommendation was to balance various interests including: (1) 
Providing for the basic maintenance requirements of organic poultry; 
(2) satisfying consumer preference to reduce the use of synthetic 
methionine in organic poultry production; and (3) motivating the 
organic poultry industry to continue the pursuit of commercially 
sufficient sources of allowable natural sources of methionine. The two-
part April 2010 NOSB recommendation specified:
---------------------------------------------------------------------------

    \34\ A detailed discussion of this part of the NOSB 
recommendation is available in the proposed rule that was published 
in the Federal Register on February 6, 2012 (77 FR 5717).
---------------------------------------------------------------------------

     Allow synthetic methionine in organic poultry production 
until October 1, 2012, at the following maximum levels per ton of feed: 
Laying chickens--4 pounds; broiler chickens--5 pounds; and turkey and 
all other poultry--6 pounds. This recommendation was implemented 
through a final rule published on March 14, 2011 (76 FR 13501).
     After October 1, 2012, reduce the maximum levels of 
synthetic methionine allowed in organic poultry feed to: laying and 
broiler chickens--2 pounds; turkeys and all other poultry--3 pounds. 
This recommendation was implemented through a final rule

[[Page 2514]]

published on September 19, 2012 (77 FR 57985).
    In 2011, a group of organic poultry producers resubmitted a 
petition to revise the maximum rates of synthetic methionine as 
averages per ton of feed over the life of the bird, rather than as a 
maximum quantity (pounds) per ton of feed.
    At the April 2015 meeting, the NOSB considered how the current 
restriction on methionine, a constant maximum per ton of feed, was 
impacting organic poultry and described this in its recommendation. The 
recommendation explained that organic poultry producers have been 
feeding additional levels of protein to provide sufficient methionine 
because the maximum allowance is inadequate for certain growth stages. 
The excess amino acids from the protein are excreted in urine, which 
causes ammonia levels to rise indoors during winter. The elevated 
ammonia levels may cause blisters on birds' feet. The recommendation 
noted reports from producers of increased feather pecking, which is a 
symptom of a methionine deficiency. Feather pecking may lead to 
cannibalism, agitation, nervousness, and other harmful behaviors.
    The NOSB reasoned that providing flexibility for producers to 
adjust methionine supplementation based on the nutritional needs of the 
birds at specific stages of production could have positive impacts on 
animal welfare. In effect, the NOSB predicted that overall methionine 
rates could be lower as supplementation levels would be matched with an 
average rate and not added at a maximum rate. Further, the NOSB 
explained that maintaining limitations on the use of synthetic 
methionine would preserve the incentive to develop viable nonsynthetic 
alternatives.
    Therefore, AMS is proposing to amend the current listing of 
methionine in Sec.  205.603 with the following annotation: DL- 
Methionine, DL- Methionine--hydroxy analog, and DL- Methionine--hydroxy 
analog calcium (CAS Numbers 59-51-8, 583-91-5, 4857-44-7, and 922-50-
9)--for use only in organic poultry production at the following pounds 
of synthetic 100 percent methionine per ton of feed in the diet, 
averaged over the life of the flock: Laying chickens--2 pounds; Broiler 
chickens--2.5 pounds; Turkeys and all other poultry--3 pounds.
Excipients
    This proposed rule would further clarify the allowance for 
excipients in animal drugs to treat organic livestock by adding a 
provision that the excipient must be approved by the USDA Animal and 
Plant Health Inspection Service (APHIS) for use in veterinary 
biologics. The proposed amendment, based on a 2009 NOSB recommendation, 
would minimize the variation in certifying agents' interpretation of 
excipients and ensure consistent enforcement. Table 22 illustrates the 
changes between the current and proposed rule.

              Table 22--Proposed Rule Action for Excipients
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: Sec.   205.603(f) Excipients--only for use in the
 manufacture of drugs used to treat organic livestock when the excipient
 is: Identified by the FDA as Generally Recognized As Safe; Approved by
 the FDA as a food additive; or Included in the FDA review and approval
 of a New Animal Drug Application or New Drug Application.
Proposed rule action: Sec.   205.603(f) Excipients--only for use in the
 manufacture of drugs and biologics used to treat organic livestock when
 the excipient is:
    (1) Identified by the FDA as Generally Recognized As Safe;
    (2) Approved by the FDA as a food additive;
    (3) Included in the FDA review and approval of a New Animal Drug
     Application or New Drug Application; or
    (4) Approved by APHIS for use in veterinary biologics.
------------------------------------------------------------------------

Applications
    Under the USDA organic regulations, excipients are defined at Sec.  
205.2 as ``any ingredients that are intentionally added to livestock 
medications but do not exert therapeutic or diagnostic effects at the 
intended dosage, although they may act to improve product delivery 
(e.g., enhancing absorption or controlling release of the drug 
substance). Examples of such ingredients include fillers, extenders, 
diluents, wetting agents, solvents, emulsifiers, preservatives, 
flavors, absorption enhancers, sustained-release matrices, and coloring 
agents.''
    Most animal medications are regulated under the Federal Food Drug 
and Cosmetic Act, as implemented by FDA. Biologics (e.g., vaccines, 
bacterins, antisera, diagnostic kits and other products of biological 
origin) are regulated by APHIS under the Virus-Serum-Toxin Act (21 
U.S.C. 151-159).
Timeline
    This proposed rule would implement a recommendation approved by the 
NOSB at its November 5, 2009 meeting to amend the allowance for 
excipients as listed in Sec.  205.603(f) of the National List.\35\ At 
its November 2009 meeting, the NOSB determined that the annotation 
required amending to clarify the use of excipients in formulated 
livestock products and to minimize variation in certifying agent 
interpretation of excipient use.
---------------------------------------------------------------------------

    \35\ NOSB Technical Report on excipients, see https://www.ams.usda.gov/sites/default/files/media/
NOP%20Final%20Rec%20Excipients%20Technical%20Correction.pdf.
---------------------------------------------------------------------------

    The allowance for excipients was added to the National List on 
December 12, 2007 (72 FR 70479). The NOSB renewed excipients under the 
2012 Sunset review process (77 FR 33290, June 6, 2012). This listing 
specified criteria for excipients for use in organic livestock 
production. These criteria pertained to the regulatory status of the 
substances under FDA authority, but the existing listing for excipients 
does not include an allowance for excipients approved by APHIS for use 
in veterinary biologics.
    Based on the consideration of National List petitions to allow the 
use of certain active ingredients in animal drugs, the NOSB observed 
that verifying the compliance status of excipients in therapeutic and 
diagnostic products and other formulated livestock products is 
burdensome and unclear for organic farmers and certifying agents. For 
example, federal regulations do not require excipients used in 
therapeutic and diagnostic products to appear on product ingredient 
labels. In addition, the identity of excipients may not be disclosed 
when product formulations are held as confidential business 
information.
    Therefore, AMS is proposing to amend the current listing of 
excipients in Sec.  205.603 with the following annotation: Only for use 
in the manufacture of drugs and biologics used to treat organic 
livestock when the excipient is: (1) Identified by the FDA as Generally 
Recognized As Safe; (2) Approved by the FDA as a food additive; (3) 
Included in the FDA review and approval of a New Animal Drug

[[Page 2515]]

Application or New Drug Application; or (4) Approved by APHIS for use 
in veterinary biologics.

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))''

    The proposed rule would add the following substances to the 
National List in paragraph Sec.  205.605 for use in organic handling: 
Hypochlorous acid, potassium lactate, and sodium lactate. This proposed 
rule would also amend the allowances for the following substances 
currently allowed in organic handling: Alginic acid, flavors, carnauba 
wax (Sec.  205.605(a)), and cellulose and chlorine (Sec.  205.605(b)). 
In addition, this proposed rule removes glycerin from Sec.  205.605(b) 
and adds it to Sec.  205.606 as an agricultural product.
Alginic Acid
    The proposed rule would amend the National List to reclassify 
alginic acid from a non-synthetic substance included in Sec.  
205.605(a) to a synthetic substance listed included in Sec.  
205.605(b), for use in organic handling. Table 23 illustrates the 
proposed listing.

             Table 23--Proposed Rule Action for Alginic Acid
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: Sec.   205.605(a) Nonsynthetics allowed: Acids (Alginic;
 Citric--produced by microbial fermentation of carbohydrate substances;
 and Lactic).
Proposed rule action: Remove alginic acid from Sec.   205.605(a) and
 reinsert alginic acid under Sec.   205.605(b) synthetics allowed.
------------------------------------------------------------------------

    Alginic acid is allowed as a nonorganic ingredient in or on 
processed products labeled as ``organic'' or ``made with organic 
(specified ingredients or food group(s)).'' During the 2017 sunset 
review, the NOSB considered new information in an updated technical 
report \36\ on alginic acid. This technical report described how 
alginic acid is extracted from brown seaweed using alkali treatment and 
acid precipitation. To isolate alginic acid from its salt forms, 
several pH adjustments are made during the extraction.
---------------------------------------------------------------------------

    \36\ Petitioned substance database: https://www.ams.usda.gov/
rules-regulations/organic/national-list/petitioned. See alginic 
acid, under the ``A'' sublink.
---------------------------------------------------------------------------

    Based upon guidance document NOP 5033, Classification of 
Materials,\37\ and the definition of ``synthetic' in Sec.  205.2 of the 
USDA organic regulations, the NOSB determined that alginic acid should 
be reclassified as synthetic because of the pH adjustments used to 
extract alginic acid. In conjunction with a recommendation to renew 
alginic acid for the 2017 sunset review, the NOSB also forwarded a 
separate recommendation to reclassify alginic acid as a synthetic 
substance on the National List.\38\
---------------------------------------------------------------------------

    \37\ NOP 5033, Classification of Materials: https://www.ams.usda.gov/sites/default/files/media/Program%20Handbk_TOC.pdf.
    \38\ The NOSB recommendation to reclassify alginic acid is 
available here: https://www.ams.usda.gov/sites/default/files/media/
HS%20Reclassification%20Alginic%20Acid_final%20rec.pdf.
---------------------------------------------------------------------------

    At its October 26-29, 2015, public meeting, the NOSB received 
public comment and reviewed information in an updated technical report. 
In order to be consistent with NOP 5033, the NOSB recommended 
reclassifying alginic acid from a non-synthetic substance under Sec.  
205.605(a) to a synthetic substance under Sec.  205.605(b). AMS has 
reviewed and proposes to address this NOSB recommendation through this 
proposed rule. Consistent with the NOSB recommendation, this proposed 
rule would amend Sec.  205.605 by removing alginic acid from Sec.  
205.605(a) and inserting alginic acid in Sec.  205.605(b).
Flavors
    The proposed rule would amend the National List to revise the 
annotation of flavors in Sec.  205.605(a), nonsynthetic, 
nonagricultural substances allowed in organic handling. Table 24 
illustrates the proposed listing.

               Table 24--Proposed Rule Action for Flavors
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: Sec.   205.605(a) Flavors, nonsynthetic sources only and
 must not be produced using synthetic solvents and carrier systems or
 any artificial preservative.
Proposed rule action: Sec.   205.605(a) Flavors, non-synthetic flavors
 may be used when organic flavors are not commercially available. All
 flavors must be derived from organic or nonsynthetic sources only, and
 must not be produced using synthetic solvents and carrier systems or
 any artificial preservative.
------------------------------------------------------------------------

    On November 6, 2014, AMS received a petition to change the 
allowance for nonorganic flavors to require the use of organic flavors 
when they are commercially available.\39\ \40\ Flavors are allowed in 
organic products if they are derived from nonsynthetic sources and are 
not produced using synthetic solvents and carrier systems or any 
artificial preservative (Sec.  205.605(a)). Flavors have been on the 
National List since October 2002. The allowance for flavors is a broad 
category that includes many substances derived from different methods.
---------------------------------------------------------------------------

    \39\ The petition for flavors is available here: https://www.ams.usda.gov/sites/default/files/ media/
Flavors%20nonsynthetic%201%20Petition.pdf.
    \40\ The USDA organic regulations define ``commercial 
availability'' as: ``The ability to obtain a production input in an 
appropriate form, quality, or quantity to fulfill an essential 
function in a system of organic production or handling, as 
determined the certifying agent in the course of reviewing the 
organic plan.'' (Sec.  205.2 Terms Defined).
---------------------------------------------------------------------------

    At its October 26-29, 2015, public meeting, the NOSB received 
public comment on the proposal to require organic flavors when 
commercially available. During its petition review the NOSB determined 
that organic flavors have become more available, but acknowledged the 
continued need for nonorganic forms in organic handling because of 
limited organic availability across the category. Due to the number of 
distinctly different natural flavors and the pace of new product 
development in flavors, the NOSB determined it would be impractical to 
list individual flavors on the National List to indicate which are 
commercially available in organic form. Based on the petition and 
public comments, the NOSB recommended revising the allowance for 
flavors to require the use

[[Page 2516]]

of organic flavors when commercially available.
    The NOSB recommended retaining the existing requirements that all 
flavors must be derived from organic or nonsynthetic sources only, and 
must not be produced using synthetic solvents and carrier systems, or 
any artificial preservative. In addition, the NOSB recommended a 
revision to convey that the listing for flavors applies to products in 
the ``organic'' and ``made with organic (specified ingredients or food 
group(s))'' categories.
    AMS has reviewed and proposes to address this NOSB recommendation 
through this proposed rule. Consistent with the NOSB recommendation, 
this proposed rule would amend Sec.  205.605(a) by revising the listing 
of flavors to read: Flavors, non-synthetic flavors may be used when 
organic flavors are not commercially available. All flavors must be 
derived from organic or non-synthetic sources only, and must not be 
produced using synthetic solvents and carrier systems, or any 
artificial preservative.
Carnauba Wax
    This proposed rule would reclassify carnauba wax from a 
nonagricultural substance on Sec.  205.605(a), to an agricultural 
substance on Sec.  205.606, that may be used in organic handling when 
organic carnauba wax is not commercially available. Table 25 
illustrates the proposed listing.

             Table 25--Proposed Rule Action for Carnauba Wax
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: Sec.   205.605(a), Waxes--nonsynthetic (Carnauba wax; and
 Wood resin).
Proposed rule action: Remove carnauba wax from Sec.   205.605(a) and
 insert carnauba wax under Sec.   205.606.
------------------------------------------------------------------------

    Carnauba wax is allowed as a nonsynthetic substance for use in 
organic handling. Carnauba wax has been on the National List since 
October 2002. During the 2017 sunset review, the NOSB reviewed an 
updated technical report \41\ on carnauba wax. This report described 
how carnauba wax is extracted from the leaves and buds of palm trees. 
Based upon NOP 5033,\42\ the NOSB determined that carnauba wax meets 
the definition of an agricultural product in Sec.  205.2 of the USDA 
organic regulations.\43\ While the NOSB recommended renewing carnauba 
wax as part of the 2017 sunset review, it also forwarded a separate 
recommendation to reclassify carnauba wax as an agricultural 
substance.\44\
---------------------------------------------------------------------------

    \41\ 2014 carnauba technical report: https://www.ams.usda.gov/
rules-regulations/organic/national-list/petitioned. Under ``C.''
    \42\ NOP 5033, Classification of Materials: https://www.ams.usda.gov/sites/default/files/media/Program%20Handbk_TOC.pdf.
    \43\ The USDA organic regulations define ``agricultural 
product'' as: ``Any agricultural commodity or product, whether raw 
or processed, including any commodity or product derived from 
livestock, that is marketing in the United States for human or 
livestock consumption.''
    \44\ The NOSB recommendation for the reclassification of 
carnauba wax is available here: https://www.ams.usda.gov/sites/
default/files/ media/
HS%20Reclassification%20Carnauba_final%20rec.pdf.
---------------------------------------------------------------------------

    At its October 26-29, 2015, public meeting, the NOSB reviewed 
public comment and reviewed information in an updated technical report. 
To be consistent with NOP 5033, the NOSB recommended reclassifying 
carnauba wax as an agricultural substance under Sec.  205.606.
    AMS has reviewed and proposes to address this NOSB recommendation 
through this proposed rule. Consistent with the NOSB recommendation, 
this proposed rule would amend Sec.  205.605 by removing carnauba wax 
from Sec.  205.605(a) and inserting carnauba wax in Sec.  205.606.
Cellulose
    This proposed rule would amend the current allowance for the use of 
cellulose in organic processing in section 205.605 of the National 
List. The revision specifies the type of cellulose allowed for certain 
uses. Table 26 illustrates the changes between the current rule and the 
proposed rule.

              Table 26--Proposed Rule Action for Cellulose
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: Sec.   205.605(b) Cellulose--for use in regenerative
 casings, as an anti-caking agent (non-chlorine bleached) and filtering
 aid.
Proposed rule action: Sec.   205.605(b) Cellulose--for use in
 regenerative casings, powdered cellulose as an anti-caking agent (non-
 chlorine bleached) and filtering aid. Microcrystalline cellulose is
 prohibited.
------------------------------------------------------------------------

Applications
    Cellulose is a major component of plant cell walls and is one of 
the most abundant compounds in nature. It can be derived from several 
sources and is available in many forms that provide different 
functional properties in food products. In addition to the petitioned 
uses as a processing aid for juice filtration, anti-caking agent, or 
peelable meat casings, cellulose is also used as a fat substitute, 
bulking agent, texturizer, emulsifier, and an extender. In 2001, the 
NOSB considered a petition for the use of three forms of cellulose, 
powdered cellulose, regenerative casing cellulose, and microcrystalline 
cellulose.
    Powdered cellulose is a purified white, odorless polysaccharide 
consisting of a linear polymer of D-glucose units joined together by 
glycosidic linkages. When forming, cellulose molecules develop as long 
chain fibrous bundles with crystalline and amorphous regions. Cellulose 
is isolated from several biological sources, but most commercial 
cellulose is derived from cotton linters and wood pulp. Mechanical and 
chemical extraction procedures are used to isolate the cellulose. 
Varying these manufacturing procedures can result in a range of 
cellulose products differing in molecular weight and fiber length, 
which yields a range of food or drug processing properties.
    The NOSB considered two cellulose derivatives in 2001, 
microcrystalline cellulose and regenerative casing cellulose. 
Microcrystalline cellulose, also known as nanocrystalline cellulose, is 
manufactured from the acid hydrolysis of powdered cellulose. This 
process reduces the degree of molecular polymerization (number of 
glucose units that make up the polymer molecule) where the amorphous 
region of the cellulose molecule is extracted, leaving the shorted 
fiber crystalline region. Altering cellulose to its microcrystalline 
form provides different ingredient and processing aid uses in addition 
to the uses provided by powdered cellulose. Comments submitted by 
organic food processors during the 2013 sunset review stated that they 
do not use microcrystalline cellulose and they were

[[Page 2517]]

not aware of any organic food processor using microcrystalline 
cellulose.
    Powdered cellulose is also used to manufacture regenerative casing 
cellulose where the cellulose fibers are dissolved into smaller 
polymers, regenerated into tubular forms, and used as a casing to pack 
skinless meat products such as hot dogs and sausage. The regenerative 
casing cellulose is then removed from the packed meat product since 
this form of cellulose is considered to be inedible.
Timeline
    Cellulose was added to Sec.  205.605(b) of the National List in 
November 2003 (68 FR 62215) for limited uses: In regenerative casings, 
as an anti-caking agent (non-chlorine bleached) and filtering aid. For 
the 2013 sunset review, the NOSB provided two recommendations in May 
2012.\45\ AMS addressed one recommendation by renewing the current 
listing for cellulose in a final rule (78 FR 61154, October 3, 2013). 
This renewal action established October 3, 2018, as the next sunset 
date for cellulose. For the second 2013 sunset recommendation issued in 
May 2012, the NOSB recommended revising the cellulose listing to 
specify that only powdered cellulose is allowed as an anticaking agent 
and filtering aid, and specifically prohibiting the use of 
microcrystalline cellulose. This proposed rule addresses the latter 
recommendation.
---------------------------------------------------------------------------

    \45\ https://www.ams.usda.gov/sites/default/files/media/
Cellulose%20Rec.pdf.
---------------------------------------------------------------------------

    During the 2013 sunset review, the NOSB reviewed its 2001 cellulose 
recommendation, Technical Advisory Panel reports on this substance from 
2001 and 2016, NOSB records from the 2008 cellulose sunset review, 
other technical documents, and received public comments prior to and 
during the May 2012 NOSB meeting. Some of the public comments requested 
that the NOSB specifically prohibit microcrystalline cellulose for use 
in organic handling, asserting that this was the intent of the NOSB's 
2001 cellulose recommendation. However, other comments stated that the 
2001 cellulose recommendation did not clearly convey the intent to 
prohibit microcrystalline cellulose as an ingredient or processing aid 
in organic handling. During the 2013 sunset review, the NOSB determined 
that the intent of the current annotation was to allow only powdered 
cellulose and regenerative casing cellulose. In formulating its 
recommendation, the NOSB received information indicating that 
certifying agents were already implementing a prohibition of 
microcrystalline cellulose, so that a specific prohibition in the 
annotation was not needed. In preparation of this proposed rule, AMS 
learned that microcrystalline cellulose is also marketed in powdered 
form. Consequently, AMS revised the NOSB's recommended annotation for 
cellulose to specifically prohibit microcrystalline cellulose. The 
revised annotation is consistent with the NOSB recommendation to allow 
powdered cellulose as defined by the NOSB. Therefore, we have proposed 
adding language to prohibit the use of microcrystalline cellulose to 
avoid ambiguity about its status. AMS specifically seeks comments on 
the need for this additional language concerning microcrystalline 
cellulose.
    Consistent with the NOSB recommendation, this action would clarify 
the allowed forms of cellulose and corresponding uses. In effect, it 
would prohibit other forms of cellulose, such as microcrystalline 
cellulose, that might be used for the same functions as powdered 
cellulose. Therefore, AMS is proposing to amend the current listing of 
cellulose in Sec.  205.605 with the following annotation: For use in 
regenerative casings, powdered cellulose as an anti-caking agent (non-
chlorine bleached) and filtering aid. Microcrystalline cellulose is 
prohibited.
Chlorine
    This proposed rule would implement a December 2011 NOSB 
recommendation \46\ to amend the current allowance for chlorine in 
organic processing. The proposed change would be consistent with the 
NOP guidance, ``The Use of Chlorine Materials in Organic Production and 
Handling,'' NOP 5026, which clarifies the use of chlorine materials in 
organic production and handling. Table 27 illustrates the changes 
between the current rule and the proposed rule.
---------------------------------------------------------------------------

    \46\ NOSB Final Recommendation on Chlorine, see: https://www.ams.usda.gov/sites/default/files/media/
NOP%20Handling%20Final%20Rec%20Chlorine%20Materials%20Annotation.pdf.


 Table 27--Proposed Rule Action for Chlorine Materials in Sec.   205.605
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: Sec.   205.605(b) Chlorine materials--for disinfecting and
 sanitizing food contact surfaces, Except, That, residual chlorine
 levels in the water shall not exceed the maximum residual disinfectant
 limit under the Safe Drinking Water Act (Calcium hypochlorite; Chlorine
 dioxide; and Sodium hypochlorite).
Proposed rule action: Sec.   205.605(b) Chlorine materials--for
 disinfecting and sanitizing food contact surfaces, equipment and
 facilities may be used up to maximum labeled rates. Chlorine materials
 in water used in direct crop or food contact are permitted at levels
 approved by the FDA or EPA for such purpose, provided the use is
 followed by a rinse with potable water at or below the maximum residual
 disinfectant limit for the chlorine material under the Safe Drinking
 Water Act. Chlorine in water used as an ingredient in organic food
 handling must not exceed the maximum residual disinfectant limit for
 the chlorine material under the Safe Drinking Water Act.'' (Calcium
 hypochlorite; Chlorine dioxide; and Sodium hypochlorite).
------------------------------------------------------------------------

Applications
    Chlorine is a highly reactive element that rarely exists in free 
form in the environment. It readily combines with many other elements, 
including metals, from which metal salts, or chlorides are formed. The 
most common chloride is sodium chloride (table salt). This substance 
and other chloride ions are essential for cellular metabolism of all 
known species of life. Chlorine can be extracted from chlorides through 
oxidation induced by electrolysis. In free form, chlorine's high 
oxidizing property is utilized in bleaching and disinfectant chlorine 
compound products. These products are the most utilized equipment and 
food contact sanitizers in food processing and handling.
Timeline
    Chlorine materials were added to the National List that was 
published in the final rule establishing the National Organic Program 
(65 FR 13512, December 21, 2000). The chlorine materials listings were 
renewed through the 2007 (72 FR 58469) and 2012 sunset reviews (77 FR 
33290).
    When the NOSB initially considered chlorine materials in November 
1995, the annotation included in the resulting recommendation 
acknowledged that levels of chlorine permitted in municipal drinking 
water were acceptable for organic production and handling. The 1995 
recommendation stated that chlorine materials should be

[[Page 2518]]

allowed for use in organic crop production, organic food processing, 
and organic livestock production with the following annotation: 
``Allowed for disinfecting and sanitizing food contact surfaces. 
Residual chlorine levels for wash water in direct crop or food contact 
and in flush water from cleaning irrigation systems that is applied to 
crops or fields cannot exceed the maximum residual disinfectant limit 
under the Safe Drinking Water Act.'' In 2010, the NOP issued guidance 
on the use of chlorine materials in organic production and handling in 
order to provide clarity on chlorine materials.
    At its December 2011 public meeting, the NOSB recommended modifying 
the chlorine materials annotation listed in Sec.  205.605(b) to improve 
consistency between the USDA organic regulations and the NOP guidance, 
``The Use of Chlorine Materials in Organic Production and Handling,'' 
NOP 5026. The proposed amendment would clarify what levels of chlorine 
are permitted for use in water in direct contact with food versus in 
water used as an ingredient in food. This aligns with the NOP guidance 
on this subject, provides clarity on the allowed uses of chlorine, and 
reflects current industry practice. Therefore, AMS is proposing to 
amend the current listing of chlorine materials in Sec.  205.605(b) 
with the following annotation:
    For disinfecting and sanitizing food contact surfaces, equipment 
and facilities may be used up to maximum labeled rates. Chlorine 
materials in water used in direct crop or food contact are permitted at 
levels approved by the FDA or EPA for such purpose, provided the use is 
followed by a rinse with potable water at or below the maximum residual 
disinfectant limit for the chlorine material under the Safe Drinking 
Water Act. Chlorine in water used as an ingredient in organic food 
handling must not exceed the maximum residual disinfectant limit for 
the chlorine material under the Safe Drinking Water Act.'' (Calcium 
hypochlorite; Chlorine dioxide; and Sodium hypochlorite).
Hypochlorous Acid
    See discussion above under Sec.  205.601, Synthetic substances 
allowed for use in organic crop production.
Potassium Lactate and Sodium Lactate
    This proposed rule would add potassium lactate and sodium lactate 
to Sec.  205.605(b) as an allowed synthetic substance for use in 
organic handling. Table 28 illustrates the proposed listing.

 Table 28--Proposed Rule Action for Potassium Lactate and Sodium Lactate
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: N/A.
Proposed rule action:
    Sec.   205.605(b) potassium lactate, for use as an antimicrobial
     agent and pH regulator only.
    Sec.   205.605(b) sodium lactate, for use as an antimicrobial agent
     and pH regulator only.
------------------------------------------------------------------------

    Potassium lactate and sodium lactate were originally petitioned 
\47\ for addition to the National List on January 5, 2005, for use in 
organic handling as antimicrobial ingredients. On January 27, 2005, the 
NOP notified the petitioner that their petition was not necessary 
because the precursors, lactic acid and potassium hydroxide or sodium 
hydroxide, which are used to manufacture potassium lactate or sodium 
lactate, were on the National List. This decision caused confusion in 
the industry on the use of potassium lactate and sodium lactate, as 
well as other lactate salts.
---------------------------------------------------------------------------

    \47\ Potassium lactate and sodium lactate petition: https://www.ams.usda.gov/rules-regulations/organic/national-list/s.
---------------------------------------------------------------------------

    To resolve this confusion, the NOP issued a memorandum to the NOSB 
on June 25, 2014, requesting that the NOSB review the petition to add 
potassium lactate and sodium lactate to the National List in Sec.  
205.605(b).\48\
---------------------------------------------------------------------------

    \48\ The June 25, 2014 memorandum is available at: https://www.ams.usda.gov/sites/default/files/media;/
S%20Lactate%20national%20list%20petitions_0.pdf.
---------------------------------------------------------------------------

    At its April 25--27, 2016, public meeting, the NOSB received public 
comment and reviewed the petition and technical report.\49\ During this 
review, the NOSB determined that uses for potassium lactate and sodium 
lactate had expanded from the original petitioned use as an 
antimicrobial. As a result, the NOSB determined that adding potassium 
lactate and sodium lactate to the National List would need the 
annotation, ``for use as an antimicrobial agent and pH regulator only'' 
to maintain use applications in organic handling. Based on the 
petition, technical report, and public comments, the NOSB determined 
that potassium lactate and sodium lactate, as petitioned, meet the OFPA 
criteria for National List substances.
---------------------------------------------------------------------------

    \49\ Potassium lactate/Sodium lactate technical report: https://www.ams.usda.gov/sites/default/files/media/
Lactic%20Acid%20and%20Lactates%20TR%2002-17-15%20Final.pdf.
---------------------------------------------------------------------------

    AMS has reviewed and proposes to address this NOSB recommendation 
through this proposed rule. Consistent with the NOSB recommendation, 
this proposed rule would amend Sec.  205.605(b) by adding potassium 
lactate and sodium lactate with the same restrictive annotation: for 
use as an antimicrobial agent and pH regulator only.
Glycerin
    This proposed rule would remove glycerin from section 205.605(b) 
and amend section 205.606 to include this substance with annotation. In 
effect, for organic processing activities, this proposed action would 
change the classification of glycerin under the USDA organic 
regulations from an allowed synthetic to an agricultural product which 
must be in organic form unless an organic version is not commercially 
available. Table 29 illustrates the changes between the current rule 
and the proposed rule.

               Table 29--Proposed Rule Action for Glycerin
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Current rule: Remove from Sec.   205.605(b). Glycerin--produced by the
 hydrolysis of fats and oils.
Proposed rule action: Add to Sec.   205.606. Glycerin--produced from
 agricultural source materials and processed using biological or
 mechanical/physical methods as described under Sec.   205.270(a).
------------------------------------------------------------------------


[[Page 2519]]

Applications
    Glycerin, whether made by fermentation of carbohydrate substrates 
or by hydrolysis of fats and oils, is listed as GRAS by the FDA and has 
a long history of safe use in a wide variety of food, cosmetic, and 
medical applications, including but not limited to use as a solvent, 
emollient, bodying agent, plasticizer, pharmaceutical agent, and 
sweetening agent in a wide range of processed food and cosmetic 
products. Glycerin is metabolized as a carbohydrate in the body.
    Commercial glycerin can be produced in several ways: Common methods 
include hydrogenolysis of carbohydrates or by synthesis from propylene; 
as a waste byproduct of biodiesel production; and by saponification of 
natural fats and oils. Glycerin produced from saponification was 
recommended by the NOSB in 1995 for inclusion on the National List with 
the annotation ``produced by hydrolysis of fats and oils.'' It is 
currently included on the National List as a synthetic nonagricultural 
substance at Sec.  205.605(b) and also for livestock use as a teat dip 
at Sec.  205.603(a)(12).
    Saponification of natural fats and oils is a process of hydrolyzing 
agricultural product fat or oil with water (steam) under pressure (or 
chemically with sodium carbonate, sodium hydroxide, or potassium 
hydroxide) to produce synthetic glycerin and fatty acids. The steam 
process is described in the 1995 Technical Advisory Panel Report on 
glycerin. The alkali process is the traditional process used to 
saponify fats and oils. The three sources of alkali used in this 
process, identified above, are included in the National List.
    According to a 2013 Technical Report,\50\ glycerin can be produced 
organically by microbial fermentation using only mechanical and 
biological processes and without the use of allowed synthetics listed 
in section 205.605(b). Those are acceptable methods for processing 
organically produced products as provided in section 205.270(a). 
Glycerin produced organically by fermentation is an agricultural 
product as defined in Sec.  205.2 since it is a processed product 
produced from an agricultural commodity, e.g. cornstarch. In addition, 
certified organic glycerin can be produced by hydrolysis of organic 
fats and oils using either steam splitting or traditional 
saponification with a catalytic amount of an alkali (sodium carbonate, 
sodium hydroxide, or potassium hydroxide) on the National List.
---------------------------------------------------------------------------

    \50\ Petition to remove glycerin from Sec.  205.605 to add to 
Sec.  205.606 and the Glycerin Technical Report, see https://www.ams.usda.gov/sites/default/files/media/
Glycerin%20Petition%20to%20remove%20TR%202013.pdf.
---------------------------------------------------------------------------

    The NOSB determined that glycerin produced by hydrolysis of fats 
and oils using a chemical process is considered to yield synthetic 
glycerin, which may be used only when certified organic glycerin is not 
commercially available. In summary, glycerin produced through 
saponification of fats and oils using steam, and glycerin produced by 
microbial fermentation of carbohydrate substances, would be 
agricultural products that may be certified organic. The technical 
report for glycerin indicates that there are currently 21 USDA 
certified organic operations supplying glycerin.\51\
---------------------------------------------------------------------------

    \51\ The April 2015 NOSB recommendation for Glycerin is 
available at the following link: https://www.ams.usda.gov/sites/
default/files/media/HS%20Glycerin%20Final%20Rec.pdf.
---------------------------------------------------------------------------

Timeline
    This proposed rule would amend paragraph (b) of Sec.  205.605 of 
the National List regulations by removing the exemption for the 
following substance: Glycerin--produced by the hydrolysis of fats and 
oils. This proposed rule would also amend Sec.  205.606 of the National 
List regulations by adding Glycerin--produced from agricultural source 
materials and processed using biological or mechanical/physical methods 
as described under Sec.  205.270(a), and would require organic glycerin 
to be used unless not commercially available. Glycerin was included in 
Sec.  205.605(b) of the National List as originally published on 
December 21, 2000 (FR 65 80548), as an allowed synthetic ingredient in 
or on processed products labeled as ``organic'' or ``made with organic 
(specified ingredients or food group(s)).''
    In December 2012, a petition was submitted to the NOSB for the 
removal of glycerin from Sec.  205.605(b). The petition stated that 
certified organic glycerin had become available and could replace 
nonorganic glycerin. Specifically, the petition cited that certified 
organic glycerin is currently available, but there is no ``commercial 
availability'' requirement to incentivize processors to use it or 
certifiers to require it. The petition described how the process of 
microbial fermentation used to produce organic glycerin is consistent 
with USDA organic regulation requirements because it relies on 
mechanical and biological processes as required in Sec.  205.270(a) 
without the use of allowed synthetics, and stated that the removal of 
glycerin from Sec.  205.605(b) will encourage organic agricultural 
production.
    Based upon NOP guidance, ``Classification of Materials Draft 
Guidance,'' NOP 5033 \52\ published in the Federal Register on April 2, 
2013 (78 FR 19637), the NOSB determined that some forms of glycerin 
could be listed as an agricultural product at Sec.  205.606 rather than 
a nonagricultural product as currently listed at Sec.  205.605. The 
NOSB determined that agricultural forms of glycerin would include 
glycerin produced by microbial fermentation of carbohydrate substances 
as well as glycerin produced from hydrolysis of fats and oils using 
mechanical/physical methods, as long as the original source material 
was agricultural.
---------------------------------------------------------------------------

    \52\ NOP 5033 Classification of Materials Draft Guidance, see 
https://www.ams.usda.gov/sites/default/files/media/NOP-5033.pdf.
---------------------------------------------------------------------------

    The petition to remove glycerin from Sec.  205.605(b) was first 
considered at the 2014 Spring NOSB meeting. At its spring 2015 meeting, 
the NOSB evaluated glycerin against the evaluation criteria of 7 U.S.C. 
6517 and 6518 of the OFPA and NOP criteria on commercial availability, 
received public comment, and concluded that agricultural forms of 
glycerin are consistent with the OFPA evaluation criteria. The NOSB 
determined that the manufacturing processes used to produce glycerin 
differentiate how the types of glycerin are classified, e.g., as 
synthetic or agricultural, and that because of the concerns regarding 
the commercial availability of organically produced glycerin in 
appropriate quality and quantity, agricultural glycerin should be 
listed at Sec.  205.606.
    This proposed rule would prohibit the use of nonorganic synthetic 
glycerin and allow the use of nonorganic agricultural glycerin--
produced from agricultural source materials and processed using 
biological or mechanical/physical methods as described under Sec.  
205.270(a)--when an organic version is not commercially available.
    Consistent with this NOSB recommendation, AMS proposes to: (1) 
Remove the exemption for synthetic Glycerin--produced by the hydrolysis 
of fats and oils in paragraph (b) of Sec.  206.605 and (2) amend Sec.  
205.606 of the USDA organic regulations to allow the use of 
agricultural forms of glycerin as a nonorganically produced 
agricultural substance allowed as an ingredient in or on processed 
products labeled as ``organic'' as follows: Glycerin--produced from 
agricultural source materials and processed using biological or 
mechanical/physical

[[Page 2520]]

methods as described under Sec.  205.270(a).


Sec.  205.606  Nonorganically produced agricultural products allowed as 
ingredients in or on processed products labeled as ``organic.''

    This proposed rule would amend the allowance for colors currently 
allowed in organic handling by replacing color Chemical Abstract 
Services (CAS) numbers with the binomial name of the agricultural 
source of the color.
Colors Derived From Agricultural Products
    This proposed rule would amend USDA organic regulations to replace 
Chemical Abstract Services (CAS) numbers included in the annotation of 
each color listed under National List Sec.  205.606(c) with the 
binomial name of the agricultural source of the color. The NOSB 
requested that AMS conduct a review on the accuracy of these CAS 
numbers and propose any necessary changes.\53\ During its 2012 sunset 
review, the NOSB received comments stating that the CAS numbers within 
annotations for several colors were incorrect. After completing its 
2012 sunset review, the NOSB recommended retaining the current color 
listings without change until either CAS numbers could be verified or 
until corrections to the USDA organic regulations could be added. 
Subsequently, the final rule (77 FR 33290) on the 2012 sunset review 
retained CAS numbers in the annotations for each color derived from 
agricultural product.
---------------------------------------------------------------------------

    \53\ On October 28, 2010, the NOSB requested the review of CAS 
numbers in its recommendation on amending the National List to 
prohibit the use of synthetic solvents and carrier systems or any 
artificial preservatives in manufacturing colors derived from 
agricultural product.
---------------------------------------------------------------------------

    Colors--nonsynthetic sources only, was included in Sec.  
205.605(a), in the original National List incorporated into the USDA 
organic final rule (65 FR 80548) published on December 21, 2000, and 
became effective on October 21, 2002. Based upon comments received 
during the 2007 sunset review process, the NOSB recommended not to 
renew this category of substances in National List Sec.  205.605(a). 
Comments on listing of colors in Sec.  205.605(a) that were provided 
during the 2007 sunset review informed the NOSB that the listing of 
colors in Sec.  205.605(a) never received a formal NOSB recommendation 
to be added to the National List. Since OFPA states that the National 
List shall be based upon recommendations developed by the NOSB, it was 
determined that colors, as listed in Sec.  205.605(a), were erroneously 
included in the final rule. Several comments also requested the NOSB to 
recommend the removal of colors from the National List in Sec.  
205.605(a), and to have nonsynthetic colors be evaluated by the NOSB 
through the National List petition process. Additional comments 
indicated that the broad category of ``nonsynthetic colors'' as listed 
in Sec.  205.605(a) hindered certifying agents in determining and 
verifying nonsynthetic colors and that this ambiguity could give rise 
to the use of inappropriate substances in organically handled products.
    During the 2007 sunset review, the NOSB deliberated on the fact 
that colors, as listed under Sec.  205.605(a), had been allowed for use 
by organic handlers for more than five years. Some commenters expressed 
concern that removing colors from Sec.  205.605(a) would cause 
disruption in the manufacture of organic products in the organic 
handling sector. While considering these comments the NOSB determined 
that, since there was no formal recommendation from the NOSB to allow 
nonsynthetic colors as a broad category for use in organic handling, 
the listing of colors in Sec.  205.605(a) could not continue.
    At the completion of the 2007 sunset review, the NOSB voted not to 
renew the listing of colors on Sec.  205.605(a). Prior to this 
decision, the NOSB decided that there is a need to provide the organic 
industry with the opportunity to petition to add nonsynthetic colors to 
the National List before finalizing its vote. In April 2006 the NOSB 
announced it would defer its vote not to renew the colors from 
nonsynthetic sources listing in Sec.  205.605(a) and proposed that 
organic handling operations using nonsynthetic colors in organic 
handling submit petitions to add specific nonsynthetic colors to the 
National List. Prior to its March 2007 NOSB meeting, the NOSB received 
several National List petitions to add individual nonsynthetic colors 
to the National List. At the March 2007 meeting, the NOSB voted to add 
19 nonsynthetic colors to National List Sec.  205.606. These 
nonsynthetic colors, with CAS numbers listed in their annotations, were 
added to the National List in June 2007 (72 FR 35137).
    In May 2013 (78 FR 31815), the listing of annatto extract color in 
Sec.  205.606 was removed from the National List as recommended by NOSB 
after considering a petition to remove this color from the National 
List. The petition to remove annatto extract color was submitted by the 
same petitioner that submitted the 2007 petition to add annatto extract 
color to the National List. This petitioner indicated that annatto 
extract color is no longer needed on the National List in Sec.  205.606 
since certified organic annatto extract is available in adequate 
quantities and in the forms needed to meet demand for organic annatto 
extract color.
    Each color listed under Sec.  205.606(c) includes CAS numbers cited 
in the annotation. Some listed colors have several CAS numbers within 
the annotation. The listed CAS numbers actually apply to the pigments 
contained in the color extract. CAS numbers are unique numerical 
identifiers assigned by CAS to every known chemical substance. Such 
numbers are not assigned to chemical compounds or formulations. As 
requested by the NOSB, AMS reviewed the CAS numbers contained in the 
color annotations in Sec.  205.606(c). The AMS review determined that 
CAS numbers are not assigned to the fruit and vegetable raw materials 
used to make colors. Consequently, CAS numbers may not be appropriate 
for use when classifying agricultural colors as the use of CAS numbers 
would not indicate an agricultural source. The AMS review also 
determined that the petitions to add nonsynthetic colors to the 
National List may have cited incorrect CAS numbers or applied multiple 
CAS numbers to the same material. Some of the written comments received 
during the 2012 sunset review provided more than one CAS number for the 
same substance. Other comments stated that CAS numbers are not 
appropriate for nonorganic agricultural substances listed in Sec.  
205.606 and some operations may consider a substance represented by a 
certain CAS number obtained from any source to be compliant with the 
USDA organic regulations. Some comments received during the 2012 sunset 
review suggested that binomial nomenclature (genus and species 
classifications) is more appropriate for identifying nonorganic 
agricultural products listed in Sec.  205.606. For colors that are 
derived from agricultural product, use of binomial name may better 
define these color extracts. Since CAS numbers may not be appropriate 
for use with agricultural products, and there is variation in what CAS 
numbers should be applied to some of the color extracts, AMS agrees 
with the comments that use of binomial nomenclature may provide better 
clarification on source of colors that are listed in Sec.  205.606.
    This rule proposes to make a amendments to the color listings in 
Sec.  205.606(c) by removing the CAS numbers assigned to the color 
extracts and substituting in the binomial name

[[Page 2521]]

of the agricultural source that was identified in the color petitions 
submitted to the NOSB. AMS has inserted this information into Table 30 
below describing each binomial name for each color derived from 
agricultural product listed in Sec.  205.606(c).

       Table 30--Colors With CAS Numbers Changed to Binomial Names
------------------------------------------------------------------------
                                            Proposed 205.606 listing:
    Current 205.606 listing: Color--       Color--agricultural  source/
      agricultural source/CAS Nos.            Binomial nomenclature
------------------------------------------------------------------------
Beet juice extract color (pigment CAS    Beet juice extract color,
 #7659-95-2).                             derived from sugarbeet (Beta
                                          vulgaris).
Beta-carotene extract color--derived     Beta-carotene extract color
 from carrots and algae (pigment CAS      derived from carrots (Daucus
 #1393-63-1).                             carota), or algae (Dunaliella
                                          salina).
Black currant juice color (pigment CAS   Black currant juice color,
 #'s: 528-58-5, 528-53-0, 643-84-5, 134-  derived from Ribes nigrum.
 01-0, 1429-30-7, and 134-04-3).
Black/purple carrot juice color          Black/purple carrot juice
 (pigment CAS #'s: 528-58-5, 528-53-0,    color, derived from Apiaceae
 643-84-5, 134-01-0, 1429-30-7, and 134-  daucus carota.
 04-3).
Blueberry juice color (pigment CAS #'s:  Blueberry juice color, derived
 528-58-5, 528-53-0, 643-84-5, 134-01-    from Vaccinium cyanococcus.
 0, 1429-30-7, and 134-04-3).
Carrot juice color (pigment CAS #1393-   Carrot juice color, derived
 63-1).                                   from Daucus carota.
Cherry juice color (pigment CAS #'s:     Cherry juice color, derived
 528-58-5, 528-53-0, 643-84-5, 134-01-    from Prunus avium.
 0, 1429-30-7, and 134-04-3).
Chokeberry--Aronia juice color (pigment  Chokeberry--Aronia juice color,
 CAS #'s: 528-58-5, 528-53-0, 643-84-5,   derived from Aronia
 134-01-0, 1429-30-7, and 134-04-3).      prunifolia.
Elderberry juice color (pigment CAS      Elderberry juice color, derived
 #'s: 528-58-5, 528-53-0, 643-84-5, 134-  from Sambucus nigra.
 01-0, 1429-30-7, and 134-04-3).
Grape juice color (pigment CAS #'s: 528- Grape juice color, derived from
 58-5, 528-53-0, 643-84-5, 134-01-0,      Vitis vinifera.
 1429-30-7, and 134-04-3).
Grape skin extract color (pigment CAS    Grape skin extract color,
 #'s: 528-58-5, 528-53-0, 643-84-5, 134-  derived from Vitis vinifera.
 01-0, 1429-30-7, and 134-04-3).
Paprika color--dried, and oil extracted  Paprika color--dried powder and
 (CAS #68917-78-2).                       vegetable oil extract, derived
                                          from Capsicum annuum.
Pumpkin juice color (pigment CAS #127-   Pumpkin juice color, derived
 40-2).                                   from Cucurbita pepo.
Purple potato juice (pigment CAS #'s:    Purple potato juice color,
 528-58-5, 528-53-0, 643-84-5, 134-01-    derived from Solanum
 0, 1429-30-7, and 134-04-3).             andigenum.
Red cabbage extract color (pigment CAS   Red cabbage extract color,
 #'s: 528-58-5, 528-53-0, 643-84-5, 134-  derived from Brassica
 01-0, 1429-30-7, and 134-04-3).          oleracea.
Red radish extract color (pigment CAS    Red radish extract color,
 #'s 528-58-5, 528-53-0, 643-84-5, 134-   derived from Raphanus sativus.
 01-0, 1429-30-7, and 134-04-3),.
Saffron extract color (pigment CAS       Saffron extract color, derived
 #1393-63-1).                             from Crocus sativus.
Turmeric extract color (CAS #458-37-7).  Turmeric extract color, derived
                                          from Curcuma longa.
------------------------------------------------------------------------

    The use of binomial nomenclature in Sec.  205.606 will clarify 
which agricultural sources may be used to derive the color extract. 
Varieties or subspecies of the same agricultural product may be used as 
sources for a particular color extract. Agricultural sources with the 
same genus but not the same species will not be eligible for use as a 
source for a color listed in Sec.  205.606(c). For agricultural 
products, the application of binomial nomenclature for colors derived 
from agricultural product is appropriate when classifying colors since 
it better indicates the agricultural source of the color. Therefore, 
AMS is proposing to amend the current listing of colors in Sec.  
205.606 by inserting the binomial nomenclature of the color described 
in Table 30 into each respective annotation.

III. Related Documents

    Thirteen notices were published regarding the meetings of the NOSB 
and deliberations on recommendations and substances petitioned for 
amending the National List. Substances and recommendations included in 
this proposed rule were announced for NOSB deliberation in the 
following Federal Register notices: 65 FR 64657, October 30, 2000; 67 
FR 54784, August 26, 2002; 74 FR 11904, March 20, 2009; 74 FR 46411, 
September 9, 2009; 75 FR 57194, September 20, 2010; 76 FR 62336, 
October 7, 2011; 77 FR 21067, April 9, 2012; 77 FR 2679, August 30, 
2012; 79 FR 13272, March 10, 2014; 80 FR 12975, March 12, 2015; 80 FR 
53759, September 8, 2015; 81 FR 14079, March 16. 2016; and 81 FR 50460, 
August 1, 2016.

IV. Statutory and Regulatory Authority

    The OFPA, as amended (7 U.S.C. 6501 et seq.), authorizes the 
Secretary to make amendments to the National List based on 
recommendations developed by the NOSB. Sections 6518(k) and 6518(n) of 
the OFPA authorize the NOSB to develop recommendations to amend the 
National List for submission to the Secretary and establish a petition 
process by which persons may petition the NOSB for the purpose of 
having substances evaluated for inclusion on or deletion from the 
National List. The National List petition process is implemented under 
Sec.  205.607 of the NOP regulations. The current petition process (81 
FR 12680, March 10, 2016) can be accessed through the NOP Program 
Handbook on the NOP website at https://www.ams.usda.gov/rules-
regulations/organic/handbook.

A. Executive Orders 12866 and 13771, and Regulatory Flexibility Act

    This proposed rule is not expected to be an E.O. 13771 regulatory 
action because this proposed rule is not significant under E.O. 12866. 
See OMB's Memorandum titled ``Interim Guidance Implementing Section 2 
of the Executive Order of January 30, 2017 titled `Reducing Regulation 
and Controlling Regulatory Costs'[thinsp]'' (February 2, 2017).
    The Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612) requires 
agencies to consider the economic impact of each rule on small entities 
and evaluate alternatives that would accomplish the objectives of the 
rule without unduly burdening small entities or erecting barriers that 
would restrict their ability to compete in the market. The purpose is 
to fit regulatory actions to the scale of businesses subject to the 
action. Section 605 of the RFA allows an agency to

[[Page 2522]]

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.
    Pursuant to the requirements set forth in the RFA, AMS performed an 
economic impact analysis on small entities in the final rule published 
in the Federal Register on December 21, 2000 (65 FR 80548). AMS has 
also considered the economic impact of this action on small entities. 
The impact on entities affected by this rule would not be significant. 
The effect of this rule, if implemented as final, would be to allow the 
use of additional substances in organic crop or livestock production 
and organic handling. This action would increase regulatory flexibility 
and would give small entities more tools to use in day-to-day 
operations. AMS concludes that the economic impact of this addition, if 
any, would be minimal and beneficial to small agricultural service 
firms. Accordingly, USDA certifies that this rule will not have a 
significant economic impact on a substantial number of small entities.
    Small agricultural service firms, which include producers, 
handlers, and accredited certifying agents, have been defined by the 
Small Business Administration (SBA) (13 CFR 121.201) as those having 
annual receipts of less than $7,000,000 and small agricultural 
producers are defined as those having annual receipts of less than 
$750,000.
    According to USDA, National Agricultural Statistics Service, 
certified organic acreage exceeded 5.0 million acres in 2016.\54\ 
According to NOP's Organic Integrity Database, there are 25,239 
certified organic operations in the U.S.\55\ AMS believes that most of 
these entities would be considered small entities under the criteria 
established by the SBA. U.S. sales of organic food products and non-
food products have grown from $1 billion in 1990 to more than $47 
billion in 2016.\56\ In addition, the USDA has 83 accredited certifying 
agents who provide certification services to producers and handlers. A 
complete list of names and addresses of accredited certifying agents 
may be found on the AMS NOP website, at https://www.ams.usda.gov/
services/organic-certification/certifying-agents. AMS believes that 
most of these accredited certifying agents would be considered small 
entities under the criteria established by the SBA. A complete list of 
NOP certified operations may be found on the AMS NOP website, at 
https://apps.ams.usda.gov/integrity/.
---------------------------------------------------------------------------

    \54\ U.S. Department of Agriculture, National Agricultural 
Statistics Service. September 2017. Certified Organic Survey, 2016 
Summary. http://usda01.library.cornell.edu/usda/current/OrganicProduction/OrganicProduction-10-04-2012.pdf.
    \55\ Organic Integrity Database: https://organic.ams.usda.gov/Integrity/. Accessed on October 13, 2017.
    \56\ Organic Trade Association, 2017 Organic Industry Survey.
---------------------------------------------------------------------------

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 proposed rule 
is not intended to have a retroactive effect.
    States and local jurisdictions are preempted under the OFPA from 
creating programs of accreditation for private persons or State 
officials who want to become certifying agents of organic farms or 
handling operations. A governing State official would have to apply to 
USDA to be accredited as a certifying agent, as described in section 
6514(b) of the OFPA. States are also preempted under sections 6503 
through 6507 of the OFPA from creating certification programs to 
certify organic farms or handling operations unless the State programs 
have been submitted to, and approved by, the Secretary as meeting the 
requirements of the OFPA.
    Pursuant to section 6507(b)(2) of the OFPA, a State organic 
certification program may contain additional requirements for the 
production and handling of organically produced agricultural products 
that are produced in the State and for the certification of organic 
farm and handling operations located within the State under certain 
circumstances. Such additional requirements must (a) further the 
purposes of the OFPA, (b) not be inconsistent with the OFPA, (c) not be 
discriminatory toward agricultural commodities organically produced in 
other States, and (d) not be effective until approved by the Secretary.
    Pursuant to section 6519(c)(6) of the OFPA, this proposed rule 
would not 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, 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 proposed 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 proposed rule has been reviewed in accordance with the 
requirements of Executive Order 13175, Consultation and Coordination 
with Indian Tribal Governments. The review reveals that this regulation 
will not have substantial and direct effects on Tribal governments and 
will not have significant Tribal implications.

E. General Notice of Public Rulemaking

    This proposed rule reflects 29 recommendations submitted by the 
NOSB to the Secretary to amend the annotation for 17 substances 
currently on the National List, add 17 substances to the National List, 
and remove one substance from the National List. A 60-day period for 
interested persons to comment on this rule is provided and is deemed 
appropriate.

List of Subjects in 7 CFR Part 205

    Administrative practice and procedure, Agriculture, Animals, 
Archives and records, Imports, Labeling, Organically produced products, 
Plants, Reporting and recordkeeping requirements, Seals and insignia, 
Soil conservation.

    For the reasons set forth in the preamble, 7 CFR part 205, subpart 
G is proposed to be amended as follows:

PART 205--NATIONAL ORGANIC PROGRAM

0
1. The authority citation for 7 CFR part 205 continues to read as 
follows:

    Authority:  7 U.S.C. 6501--6522.

0
2. Amend Sec.  205.238 by revising paragraph (b)(2) and adding 
paragraph (b)(3) to read as follows:


Sec.  205.238   Livestock health care practice standard.

* * * * *
    (b) * * *
    (2) Dairy animals, as allowed under Sec.  205.603.
    (3) Fiber bearing animals, as allowed under Sec.  205.603.
0
3. Amend Sec.  205.601 as follows:
0
a. Redesignate paragraph (a)(2)(iii) as (a)(2)(iv) and add new 
paragraph (a)(2)(iii),
0
b. Redesignate paragraphs (j)(5) through (j)(8) as (j)(6) through 
(j)(9), redesignate paragraph (j)(10) as (j)(11),

[[Page 2523]]

add new paragraphs (j)(5) and (j)(10), and revise newly redesignated 
paragraph (j)(7).
    The additions and revisions to read as follows:


Sec.  205.601   Synthetic substances allowed for use in organic crop 
production.

* * * * *
    (a) * * *
    (2)(iii) Hypochlorous acid--generated from electrolyzed water.
* * * * *
    (j) * * *
    (5) Magnesium oxide (CAS #1309-48-4)--for use only to control the 
viscosity of a clay suspension agent for humates.
* * * * *
    (7) Micronutrients--not to be used as a defoliant, herbicide, or 
desiccant. Those made from nitrates or chlorides are not allowed. 
Micronutrient deficiency must be documented by soil or tissue testing, 
advice from certified crop advisors or professional agronomists, 
agricultural extension information, or other methods approved by the 
certifying agent.
* * * * *
    (10) Squid byproducts--from food waste processing only. Can be pH 
adjusted with sulfuric, citric, or phosphoric acid. The amount of acid 
used shall not exceed the minimum needed to lower the pH to 3.5.
* * * * *
0
4. Amend Sec.  205.602 by redesignating paragraphs (f) through (i) as 
(g) through (j), and add new paragraph (f) to read as follows:


Sec.  205.602   Nonsynthetic substances prohibited for use in organic 
crop production.

* * * * *
    (f) Rotenone (CAS #83-79-4).
* * * * *
0
5. Amend Sec.  205.603 by revising paragraphs (a)(6) through (a)(31), 
paragraphs (b)(4) and (b)(7), redesignating paragraph (b)(8) as (b)(9) 
adding new paragraph (b)(8); and revising paragraphs (d)(1) and (f) to 
read as follows:


Sec.  205.603   Synthetic substances allowed for use in organic 
livestock production.

* * * * *
    (a) * * *
    (6) Activated charcoal (CAS #7440-44-0)--must be from vegetative 
sources.
    (7) Calcium borogluconate (CAS #5743-34-0)--for treatment of milk 
fever only.
    (8) Calcium propionate (CAS #4075-81-4)--for treatment of milk 
fever only.
    (9) Chlorhexidine (CAS #55-56-1)--for medical procedures conducted 
under the supervision of a licensed veterinarian. Allowed for use as a 
teat dip when alternative germicidal agents and/or physical barriers 
have lost their effectiveness.
    (10) Chlorine materials--disinfecting and sanitizing facilities and 
equipment. Residual chlorine levels in the water shall not exceed the 
maximum residual disinfectant limit under the Safe Drinking Water Act.
    (i) Calcium hypochlorite.
    (ii) Chlorine dioxide.
    (iii) Hypochlorous acid--generated from electrolyzed water.
    (iv) Sodium hypochlorite
    (11) Electrolytes--without antibiotics.
    (12) Flunixin (CAS #38677-85-9)--in accordance with approved 
labeling; except that for use under 7 CFR part 205, the NOP requires a 
withdrawal period of at least two-times that required by the FDA.
    (13) Glucose.
    (14) Glycerin--Allowed as a livestock teat dip, must be produced 
through the hydrolysis of fats or oils.
    (15) Hydrogen peroxide.
    (16) Iodine.
    (17) Kaolin pectin--for use as an adsorbent, antidiarrheal, and gut 
protectant.
    (18) Magnesium hydroxide (CAS #1309-42-8)--federal law restricts 
this drug to use by or on the lawful written or oral order of a 
licensed veterinarian, in full compliance with the AMDUCA and 21 CFR 
part 530 of the Food and Drug Administration regulations. Also, for use 
under 7 CFR part 205, the NOP requires use by or on the lawful written 
order of a licensed veterinarian.
    (19) Magnesium sulfate.
    (20) Mineral oil--for treatment of intestinal compaction, 
prohibited for use as a dust suppressant.
    (21) Nutritive supplements--injectable supplements of trace 
minerals per Sec.  205.603(d)(2), vitamins per Sec.  205.603(d)(3), and 
electrolytes per Sec.  205.603(a)(11), with excipients per Sec.  
205.603(f), in accordance with FDA and restricted to use by or on the 
order of a licensed veterinarian.
    (22) Oxytocin--use in postparturition therapeutic applications.
    (23) Parasiticides-- Prohibited in slaughter stock, allowed in 
emergency treatment for dairy and breeder stock when organic system 
plan-approved preventive management does not prevent infestation. In 
breeder stock, treatment cannot occur during the last third of 
gestation if the progeny will be sold as organic and must not be used 
during the lactation period for breeding stock. Allowed for fiber 
bearing animals when used a minimum of 90 days prior to harvesting of 
fleece or wool that is to be sold, labeled, or represented as organic.
    (i) Fenbendazole (CAS #43210-67-9)--milk or milk products from a 
treated animal cannot be labeled as provided for in subpart D of this 
part for: 2 days following treatment of cattle; 36 days following 
treatment of goats, sheep, and other dairy species.
    (ii) Moxidectin (CAS #113507-06-5)--milk or milk products from a 
treated animal cannot be labeled as provided for in subpart D of this 
part for: 2 days following treatment of cattle; 36 days following 
treatment of goats, sheep, and other dairy species.
    (24) Peroxyacetic/peracetic acid (CAS #79-21-0)--for sanitizing 
facility and processing equipment.
    (25) Phosphoric acid--allowed as an equipment cleaner, Provided, 
That, no direct contact with organically managed livestock or land 
occurs.
    (26) Poloxalene (CAS #9003-11-6)--for use under 7 CFR part 205, the 
NOP requires that poloxalene only be used for the emergency treatment 
of bloat.
    (27) Propylene glycol (CAS #57-55-6)--for treatment of ketosis in 
ruminants only.
    (28) Sodium chlorite, acidified, allowed for use on organic 
livestock as a teat dip treatment only.
    (29) Tolazoline (CAS #59-98-3)--federal law restricts this drug to 
use by or on the lawful written or oral order of a licensed 
veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of 
the Food and Drug Administration regulations. Also, for use under 7 CFR 
part 205, the NOP requires:
    (i) Use by or on the lawful written order of a licensed 
veterinarian;
    (ii) Use only to reverse the effects of sedation and analgesia 
caused by Xylazine; and,
    (iii) A meat withdrawal period of at least 8 days after 
administering to livestock intended for slaughter; and a milk discard 
period of at least 4 days after administering to dairy animals.
    (30) Xylazine (CAS #7361-61-7)--federal law restricts this drug to 
use by or on the lawful written or oral order of a licensed 
veterinarian, in full compliance with the AMDUCA and 21 CFR part 530 of 
the Food and Drug Administration regulations. Also, for use under 7 CFR 
part 205, the NOP requires:
    (i) Use by or on the lawful written order of a licensed 
veterinarian; and,
    (ii) A meat withdrawal period of at least 8 days after 
administering to livestock intended for slaughter; and a milk discard 
period of at least 4 days after administering to dairy animals.
    (31) Zinc sulfate--for use in hoof and foot treatments only.

[[Page 2524]]

    (b) * * *
* * * * *
    (4) Lidocaine--as a local anesthetic. Use requires a withdrawal 
period of 8 days after administering to livestock intended for 
slaughter and 6 days after administering to dairy animals.
* * * * *
    (7) Procaine--as a local anesthetic. Use requires a withdrawal 
period of 8 days after administering to livestock intended for 
slaughter and 6 days after administering to dairy animals.
    (8) Sodium chlorite, acidified--allowed for use on organic 
livestock as teat dip treatment only.
* * * * *
    (d) * * *
    (1) DL-Methionine, DL-Methionine--hydroxy analog, and DL-
Methionine--hydroxy analog calcium (CAS #'s 59-51-8, 583-91-5, 4857-44-
7, and 922-50-9)--for use only in organic poultry production at the 
following pounds of synthetic 100 percent methionine per ton of feed in 
the diet, averaged over the life of the flock: laying chickens--2 
pounds; broiler chickens--2.5 pounds; turkeys and all other poultry--3 
pounds.
* * * * *
    (f) Excipients, only for use in the manufacture of drugs and 
biologics used to treat organic livestock when the excipient is:
    (1) Identified by the FDA as Generally Recognized As Safe;
    (2) Approved by the FDA as a food additive;
    (3) Included in the FDA review and approval of a New Animal Drug 
Application or New Drug Application; or
    (4) Approved by APHIS for use in veterinary biologics.
* * * * *
0
6. Amend Sec.  205.605 as follows:
0
a. In paragraph (a), revise the entry for ``Acids,'' revise the entries 
for ``Flavors,'' and ``Waxes;''
0
b. In paragraph (b) add in alphabetical order an entry for ``alginic 
acid'', revise the entries for ``cellulose'' and ``chlorine materials'' 
and remove the entry for ``Glycerin--produced by hydrolysis of fats and 
oils.''
    The revisions and addition to 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) * * *
    Acids (Citric--produced by microbial fermentation of carbohydrate 
substances; Lactic).
* * * * *
    Flavors, non-synthetic flavors may be used when organic flavors are 
not commercially available. All flavors must be derived from organic or 
nonsynthetic sources only, and must not be produced using synthetic 
solvents and carrier systems or any artificial preservative.
* * * * *
    Waxes--nonsynthetic (Wood resin).
* * * * *
    (b) * * *
    Alginic acid (CAS #9005-32-7)
* * * * *
    Cellulose (CAS #9004-34-6)--for use in regenerative casings, 
powdered cellulose as an anti-caking agent (non-chlorine bleached) and 
filtering aid. Microcrystalline cellulose is prohibited.
    Chlorine materials--disinfecting and sanitizing food contact 
surfaces, equipment and facilities may be used up to maximum labeled 
rates. Chlorine materials in water used in direct crop or food contact 
are permitted at levels approved by the FDA or EPA for such purpose, 
provided the use is followed by a rinse with potable water at or below 
the maximum residual disinfectant limit for the chlorine material under 
the Safe Drinking Water Act. Chlorine in water used as an ingredient in 
organic food handling must not exceed the maximum residual disinfectant 
limit for the chlorine material under the Safe Drinking Water Act.
    (1) Calcium hypochlorite.
    (2) Chlorine dioxide.
    (3) Hypochlorous acid--generated from electrolyzed water.
    (4) Sodium hypochlorite.
* * * * *
0
7. Amend Sec.  205.606 by
0
a. Redesignating paragraphs (g) through (t) as paragraphs (i) through 
(v);
0
b. Redesignating paragraphs (a) through (f) as paragraphs (b) through 
(g);
0
c. Adding new paragraphs (a) and (h and revising newly redesignated 
paragraphs (d)(1) through (d)(18).
    The additions and revisions to read as follows:


Sec.  205.606   Nonorganically produced agricultural products allowed 
as ingredients in or on processed products labeled as ``organic.''

* * * * *
    (a) Carnauba wax
* * * * *
    (d) * * *
    (1) Beet juice extract color, derived from sugarbeet (Beta 
vulgaris).
    (2) Beta-carotene extract color derived from carrots (Daucus 
carota), or algae (Dunaliella salina).
    (3) Black currant juice color, derived from Ribes nigrum.
    (4) Black/purple carrot juice color, derived from Apiaceae daucus 
carota.
    (5) Blueberry juice color, derived from Vaccinium cyanococcus.
    (6) Carrot juice color, derived from Daucus carota.
    (7) Cherry juice color, derived from Prunus avium.
    (8) Chokeberry--Aronia juice color, derived from Aronia prunifolia.
    (9) Elderberry juice color, derived from Sambucus nigra.
    (10) Grape juice color, derived from Vitis vinifera.
    (11) Grape skin extract color, derived from Vitis vinifera.
    (12) Paprika color--dried powder and vegetable oil extract, derived 
from Capsicum annuum.
    (13) Pumpkin juice color, derived from Cucurbita pepo.
    (14) Purple potato juice color, derived from Solanum andigenum.
    (15) Red cabbage extract color, derived from Brassica oleracea.
    (16) Red radish extract color, derived from Raphanus sativus.
    (17) Saffron extract color, derived from Crocus sativus.
    (18) Turmeric extract color, derived from Curcuma longa.
* * * * *
    (h) Glycerin (CAS #56-81-5)--produced from agricultural source 
materials and processed using biological or mechanical/physical methods 
as described under Sec.  205.270(a).
* * * * *

    Dated: December 26, 2017.
Bruce Summers,
Acting Administrator, Agricultural Marketing Service.
[FR Doc. 2017-28172 Filed 1-16-18; 8:45 am]
 BILLING CODE 3410-02-P