[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.
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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.
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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.
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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
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Current rule: N/A.
Proposed rule action: Sec. 205.603(a) Activated charcoal--must be from
vegetative sources.
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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
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Current rule: N/A.
Proposed rule action: Sec. 205.603(a), Calcium Borogluconate--for
treatment of milk fever only.
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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\
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\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.
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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