[Federal Register Volume 83, Number 247 (Thursday, December 27, 2018)]
[Rules and Regulations]
[Pages 66559-66574]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27792]


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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: Final rule.

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SUMMARY: This final rule amends 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 changes the 
use restrictions for seventeen substances allowed for organic 
production or handling on the National List. This rule also adds 
sixteen new substances on the National List to be allowed in organic 
production or handling. In addition, this final rule lists the 
botanical pesticide, rotenone, as a prohibited substance in organic 
crop production. This final rule removes ivermectin as an allowed 
parasiticide for use in organic livestock production and amends our 
regulations to allow the use of parasiticides in fiber bearing animals. 
Finally, this rule inserts corrections of instructions and regulation 
text as listed in the proposed rule.

DATES: Effective date: This rule is effective January 28, 2019.
    Implementation Dates: This rule will be fully implemented January 
28, 2019, except that the amendments for the substances ivermectin, 
flavors, cellulose, and glycerin will be implemented December 27, 2019.

FOR FURTHER INFORMATION CONTACT: Robert Pooler, Standards Division, 
National Organic Program. Telephone: (202) 720-3252. Fax: (202) 205-
7808.

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. 6501-6522) (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 final rule amends the National List to implement 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.

II. Overview of Amendments

    The following provides an overview of the final rule additions and 
amendments to designated sections of the National List regulations. 
Application and timeline information on the amendments were addressed 
in the proposed rule (83 FR 2498) and have not been included in the 
final rule. In addition, the basis for the NOSB recommendations was 
presented in the proposed rule. In summary, the NOSB evaluated each 
substance by applying the OFPA substance evaluation criteria to 
determine if the substance is compatible with organic production or 
handling. AMS reviewed each NOSB recommendation and accepted each 
recommendation for rulemaking. Subsequently, AMS submitted the NOSB 
recommendations through rulemaking in the proposed rule and this final 
rule. After considering the received comments, AMS has determined that 
the additions and amendments described in the proposed rule will be 
included, with a few minor changes based on comments, in the final 
rule. Section E of this final rule provides an overview of the comments 
received and AMS's response on all additions and amendments.

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

    This final rule amends Sec.  205.601 by adding three new 
substances, hypochlorous acid, magnesium oxide, and squid byproducts, 
to this section and amends this section by changing the annotation of 
micronutrients as listed in Sec.  205.601 to include other agricultural 
practices that may be used in maintaining soil fertility.
Hypochlorous Acid
    This final rule adds hypochlorous acid to Sec.  205.601 as a 
chlorine material allowed for use as an algicide, disinfectant, and 
sanitizer. Paragraph (a)(2)(iii) reads as follows: Hypochlorous acid--
generated from electrolyzed water. Upon the effective date of this 
final rule hypochlorous acid is allowed as an algicide, disinfectant, 
and sanitizer, including irrigation cleaning systems in organic crop 
production. AMS has reviewed and agrees with the NOSB recommendation 
that hypochlorous acid be allowed for use in organic crop production. 
AMS received comments on the proposed rule for amending hypochlorous 
acid onto Sec.  205.601.
Magnesium Oxide
    This final rule adds magnesium oxide to the National List in Sec.  
205.601(j) for use in controlling the viscosity of a clay suspension 
agent for humates. Paragraph (j)(5) is added to this section to read as 
follows: Magnesium oxide (CAS # 1309-48-4)--for use only to control the 
viscosity of a clay suspension agent for humates. Upon the effective 
date of this rule, magnesium oxide is allowed in organic crop 
production as an agent for controlling the viscosity of clay suspension 
for humates. AMS has reviewed and agrees with the NOSB recommendation 
that magnesium oxide acid be allowed for use in organic crop 
production. AMS received comments on the proposed rule for amending 
magnesium oxide onto Sec.  205.601.

[[Page 66560]]

Micronutrients
    This final rule amends the annotation of micronutrients as listed 
in Sec.  205.601(j). Paragraph (j)(7) is modified to read as follows: 
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 or other 
documented and verifiable method as approved by the certifying agent. 
This change removes the restriction on documenting micronutrient 
deficiency that was imposed by allowing soil testing as the only method 
for demonstrating a soil micronutrient deficiency. This rule change 
allows alternative verifiable methods, such as tissue testing when 
approved by the certifying agent, to be used to document micronutrient 
deficiency. AMS has reviewed and agrees with the NOSB recommendation 
that the annotation for micronutrients be amended to clarify its use in 
organic crop production. AMS received comments on the proposed rule for 
amending the micronutrient annotation listed in Sec.  205.601.
Squid Byproducts
    This final rule adds squid byproducts to Sec.  205.601(j) as an 
allowed substance for use in organic crop production. Paragraph (j)(10) 
is added to Sec.  205.601 to read as follows: 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. Only squid byproducts from food waste 
processing are permitted for use as a soil amendment in organic crop 
production. AMS has reviewed and agrees with the NOSB recommendation 
that squid by-products be allowed for use in organic crop production. 
AMS received comments on the proposed rule for amending squid by-
products onto Sec.  205.601.

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

    This final rule amends Sec.  205.602 by adding rotenone to this 
section. Nonsynthetic substances are allowed in organic crop production 
except for those specifically listed as prohibited in Sec.  205.602.
Rotenone
    This final rule adds rotenone, a nonsynthetic substance, to Sec.  
205.602 which prohibits its use in organic crop production. Paragraph 
(f) is amended in this section to read as: Rotenone (CAS #83-79-4). 
After the effective date of this rule, rotenone will be a prohibited 
nonsynthetic substance in organic crop production. AMS has reviewed and 
agrees with the NOSB recommendation that rotenone be added to the 
National List as a prohibited non-synthetic and not allowed for use in 
organic crop production. AMS received comments on the proposed rule for 
amending rotenone onto Sec.  205.602.

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

    This final rule adds 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. This final rule also adds 
acidified sodium chlorite to Sec.  205.603(b). This final rule also 
amends the restrictive annotations 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 final 
rule removes ivermectin, Sec.  205.603(a).
Activated Charcoal
    This final rule adds activated charcoal to Sec.  205.603(a) for use 
in organic livestock production. Paragraph (a)(6) is amended in Sec.  
205.603 to read as follows: Activated charcoal (CAS # 7440-44-0)--must 
be from vegetative sources. After the effective date of this final 
rule, organic livestock producers may use activated charcoal as a 
therapeutic treatment on an as-needed basis with mammalian livestock in 
cases of suspected ingestion of toxic plants and control of diarrhea 
caused by moldy silage. Synthetic forms of activated charcoal derived 
from other non-vegetative sources continue to be prohibited in organic 
livestock production. AMS has reviewed and agrees with the NOSB 
recommendation that activated charcoal be allowed for use in organic 
livestock production. AMS received comments on the proposed rule for 
amending activated charcoal onto Sec.  205.603.
Calcium Borogluconate
    This final rule adds calcium borogluconate to Sec.  205.603(a) of 
the National List for use in organic livestock production. Paragraph 
(a)(7) is amended in Sec.  205.603 to read as follows: Calcium 
borogluconate (CAS # 5743-34-0)--for treatment of milk fever only. 
Organic livestock producers should know that calcium borogluconate 
cannot be used routinely, but only as an emergency treatment for milk 
fever. AMS has reviewed and agrees with the NOSB recommendation that 
calcium borogluconate be allowed for use in organic livestock 
production. AMS received comments on the proposed rule for amending 
calcium borogluconate onto Sec.  205.603.
Calcium Propionate
    This final rule adds calcium propionate to the National List at 
Sec.  205.603(a) for use in organic livestock production. Paragraph 
(a)(8) is amended in Sec.  205.603 to read as follows: Calcium 
Propionate (CAS #4075-81-4)--for treatment of milk fever only. 
Specifically, calcium propionate is allowed only as a treatment for 
milk fever. Organic livestock producers should know that calcium 
propionate is not to be used routinely, but only as an emergency 
treatment for milk fever. AMS has reviewed and agrees with the NOSB 
recommendation that calcium propionate be allowed for use in organic 
livestock production. AMS received comments on the proposed rule for 
amending calcium propionate onto Sec.  205.603.
Chlorhexidine
    This final rule amends the annotation for chlorhexidine in Sec.  
205.603(a). Paragraph (a)(9) is amended to read as follows: 
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. Including this amendment to the annotation of 
chlorhexidine in the final rule adds to organic livestock producers' 
ability to establish and maintain preventive livestock health care 
practices. AMS has reviewed and agrees with the NOSB recommendation 
that the annotation for chlorhexidine be amended to clarify its use in 
organic livestock production. AMS received comments on the proposed 
rule for amending the annotation for chlorhexidine as listed in Sec.  
205.603.
Hypochlorous Acid
    This final rule adds hypochlorous acid to Sec.  205.603 as a 
chlorine material allowed for use in disinfecting and sanitizing 
equipment and facilities in organic livestock production. Paragraph 
(a)(10)(iii) is modified to read as follows: Hypochlorous acid--
generated

[[Page 66561]]

from electrolyzed water. As listed in Sec.  205.603, hypochlorous acid 
is allowed for use as a disinfectant, sanitizer, and medical treatment 
in organic livestock production. AMS has reviewed and agrees with the 
NOSB recommendation that hypochlorous acid be allowed for use in 
organic livestock production. AMS received comments on the proposed 
rule that supported or opposed amending hypochlorous acid onto Sec.  
205.603.
Kaolin Pectin
    This final rule adds kaolin pectin to Sec.  205.603(a) of the 
National List for use as an adsorbent, antidiarrheal, and gut 
protectant in organic livestock production. Paragraph (a)(17) is 
modified to read as follows: Kaolin pectin--for use as an adsorbent, 
antidiarrheal, and gut protectant. Organic livestock producers should 
know that kaolin pectin is not to be used routinely, but only when an 
adsorbent, antidiarrheal or gut protectant is needed. AMS has reviewed 
and agrees with the NOSB recommendation that kaolin pectin be allowed 
for use in organic livestock production. AMS received comments on the 
proposed rule for amending kaolin pectin acid onto Sec.  205.603.
Mineral Oil
    This final rule adds mineral oil to Sec.  205.603(a) for use in 
organic livestock production for relief of intestinal impaction. 
Mineral oil is also on the National List as a topical treatment, 
external parasiticide, or local anesthetic in Sec.  205.603(b). 
Paragraph (a)(20) is modified to read as follows: Mineral oil--for 
relief of intestinal compaction, prohibited for use as a dust 
suppressant. Organic livestock producers should know that under 
paragraph (a)(20) mineral oil is only allowed for use to relieve 
intestinal compaction in livestock. Mineral oil cannot be used as a 
dust suppressant. AMS has reviewed and agrees with the NOSB 
recommendation that mineral oil be allowed for use in organic livestock 
production. AMS received comments on the proposed rule for amending 
mineral oil onto Sec.  205.603.
Nutritive Supplements--Injectable Vitamins, Minerals, and Electrolytes
    This rule adds injectable vitamins, minerals, and electrolytes to 
Sec.  205.603(a) of the National List for use in organic livestock 
production. Prior to this rule these substances were allowed under the 
USDA organic regulations only as part of the total feed ration, either 
as feed additives (vitamins and minerals per Sec.  205.603(d)) or as 
medical treatments (electrolytes without antibiotics per Sec.  
205.603(a)). Paragraph (a)(21) is modified to read as follows: 
Nutritive supplements--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 
regulations and restricted to use by or on the order of a licensed 
veterinarian. Under this rule, an operation is allowed to use these 
substances individually or in combination. This rule requires that 
injectable vitamins, minerals, or electrolytes only be administered or 
ordered by a licensed veterinarian. Organic livestock producers will 
need to keep records that document the need for any use of these 
materials. Further, producers and certifying agents need to review the 
specific formulations intended for use on organic livestock to ensure 
they comply with the USDA organic regulations. AMS has reviewed and 
agrees with the NOSB recommendation that injectable vitamins, minerals, 
or electrolytes be allowed for use in organic livestock production. AMS 
received comments on the proposed rule for amending injectable 
minerals, vitamins, and electrolytes onto Sec.  205.603.
Parasiticides, Fenbendazole, and Moxidectin
    This rule amends the National List to revise the listing for 
parasiticides (Sec.  205.603(a)(23)) and the listings for fenbendazole 
(Sec.  205.603(a)(23)(i)) and moxidectin (Sec.  205.603(a)(23)(iii)). 
This rule also amends the livestock health care practice standard in 
Sec.  205.238(b) to allow the use of parasiticides in organic fiber-
bearing animals. Paragraph (a)(23) reads as follows: 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 36 days prior to harvesting of fleece or wool that is to be sold, 
labeled, or represented as organic. AMS has reviewed and agrees with 
the NOSB recommendation that the annotation for parasiticides be 
amended to clarify its use in organic livestock production.
    Paragraph (a)(23)(i) is revised to read as follows: 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. AMS has reviewed and agrees with the 
NOSB recommendation that the annotation for fenbendazole be amended to 
clarify its use in organic livestock production.
    Paragraph (a)(23)(ii) is also revised to read as follows: 
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. AMS has reviewed and agrees with 
the NOSB recommendation that the annotation for moxidectin be amended 
to clarify its use in organic livestock production.
    In addition, paragraph (b)(2) of Sec.  205.238(b) is revised and 
paragraph (b)(3) is added to Sec.  205.238(b) as follows: (b)(2) Dairy 
animals, as allowed under Sec.  205.603; and (b)(3) fiber bearing 
animals, as allowed under Sec.  205.603. AMS has reviewed and agrees 
with the NOSB recommendation that Sec.  205.238(b) be amended to 
clarify its use of parasiticides for dairy animals and for fiber 
bearing animals.
    The USDA organic regulations specify conditions under which 
parasiticides can be used in organic livestock production (Sec.  
205.238(b)) and identify which parasiticides are allowed (Sec.  
205.603(a)(23)). These conditions include: (1) Emergency treatment for 
dairy and breeder stock only when preventive measures have failed; (2) 
a parasiticide 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 that is included on the National List. 
However, animals in need of medical attention cannot be left untreated 
in order to preserve its organic status.
    AMS received comments on the proposed rule for amending the 
annotation for parasiticides and the annotation for the specific 
parasiticides fenbendazole and moxidectin listed in Sec.  205.603.
Ivermectin
    This rule removes ivermectin from Sec.  205.603(a) as an allowed 
parasiticide for use in organic livestock production. Ivermectin (CAS 
#70288-86-7), as listed prior to this final rule in paragraph 
(a)(17)(ii) has been removed from the National List. The removal of 
ivermectin from the National List leaves organic

[[Page 66562]]

livestock producers with two synthetic parasiticides permitted for 
emergency treatment, fenbendazole and moxidectin. This final rule 
removes the requirement for a veterinarian to administer fenbendazole 
and also reduces the withdrawal times following the use of fenbendazole 
or moxidectin. AMS has reviewed and agrees with the NOSB recommendation 
that ivermectin be removed from the National List and prohibited for 
use in organic livestock production. AMS received comments on the 
proposed rule for removing ivermectin from Sec.  205.603.
Propylene Glycol
    This final rule adds propylene glycol to Sec.  205.603(a) of the 
National List for use in organic livestock production only as a remedy 
for ketosis in ruminants. Paragraph (a)(27) reads as follows: Propylene 
glycol (CAS # 57-55-6)--only for treatment of ketosis in ruminants. 
Organic livestock producers are required to use preventive practices as 
described in Sec.  205.238 before using propylene glycol to treat 
ketosis. However, animals in need of medical attention cannot be left 
untreated in order to retain organic status. AMS has reviewed and 
agrees with the NOSB recommendation that propylene glycol be allowed 
for use in organic livestock production. AMS received comments that 
either supported or opposed adding propylene glycol to Sec.  
205.603(a).
Sodium Chlorite, Acidified
    This final rule adds two listings for acidified sodium chlorite for 
use as a teat dip in organic livestock (dairy) production in Sec.  
205.603(a) and in Sec.  205.603(b). Both paragraph (a)(28) and 
paragraph (b)(8) read as follows: Sodium chlorite, acidified--allowed 
for use on organic livestock as a teat dip treatment only. Preventive 
health care is essential for organic production. Preventive care 
through clean milking parlors and clean animals is essential for 
reducing mastitis in dairy animals and teat dips are used by dairy 
producers as an essential tool for preventing mastitis. This rule adds 
sodium chlorite, acidified to Sec.  205.603(a) as a teat dip when used 
as a disinfectant, sanitizer, or medical treatment. This rule also adds 
sodium chlorite, acidified to Sec.  205.603(b) as a teat dip when used 
as a topical treatment or external parasiticide. AMS has reviewed and 
agrees with the NOSB recommendation that calcium sodium chlorite, 
acidified be allowed for use in organic livestock production. AMS 
received comments on the proposed rule for amending sodium chlorite, 
acidified onto Sec.  205.603.
Xylazine
    This rule amends the annotation of the listing for xylazine in 
Sec.  205.603(a) by removing the limitation ``The existence of an 
emergency'' on use of this substance. Paragraph (a)(30) reads as 
follows: 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, paragraph (a)(30 also includes the following requirements:
    (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.
    This change allows xylazine to be used for sedation of animals when 
necessary to perform non-emergency health care procedures in organic 
livestock. This amendment allows organic livestock producers to improve 
their ability to establish and maintain preventive livestock health 
care practices because there are no alternatives to xylazine on the 
National List or nonsynthetic substances that provide sedative 
properties. This rule does 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 
and dairy animals. AMS has reviewed and agrees with the NOSB 
recommendation that the annotation for xylazine be amended to clarify 
its use in organic livestock production. AMS received comments on the 
proposed rule for amending the annotation for xylazine as listed in 
Sec.  205.603.
Zinc Sulfate
    This final rule adds zinc sulfate to Sec.  205.603(b) for use in 
organic livestock production. Paragraph (b)(10) is amended to read as 
follows: Zinc sulfate--for use in hoof and foot treatments only. This 
rule allows zinc sulfate to be used in a footbath for control of foot 
rot in livestock, primarily dairy cattle, sheep and goats. Adding zinc 
sulfate to the National List provides organic livestock producers with 
an additional tool to treat foot disease and aids the welfare of the 
animals. Based upon comments AMS received on amending zinc sulfate onto 
Sec.  205.603(a & b), zinc sulfate is added only to Sec.  205.603(b). 
AMS has reviewed and agrees with the NOSB recommendation that zinc 
sulfate be allowed for use in organic livestock production.
Lidocaine
    This final rule amends the annotation of lidocaine in Sec.  
205.603(b) to reduce the withholding periods for lidocaine from 90 days 
to 8 days for slaughter stock and from 7 days to 6 days for milk. 
Paragraph (b)(4) is modified to read as follows: 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. A reduction in the withholding time was 
needed to improve animal welfare because a lengthy withholding time for 
lidocaine could result in animals not being timely treated, or not 
treated at all. AMS has reviewed and agrees with the NOSB 
recommendation that the annotation for lidocaine be amended to clarify 
its use in organic livestock production. AMS received comments on the 
proposed rule for amending the annotation for lidocaine as listed in 
Sec.  205.603.
Procaine
    This final rule amends the annotation of procaine in Sec.  
205.603(b) to reduce the withholding periods for procaine from 90 days 
to 8 days for slaughter stock and from 7 days to 6 days for milk. 
Paragraph (b)(7) reads as follows: 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. 
A reduction in the withholding time was needed to improve animal 
welfare because a lengthy withholding time for procaine could result in 
animals not being timely treated, or not treated at all. AMS has 
reviewed and agrees with the NOSB recommendation that the annotation 
for procaine be amended to clarify its use in organic livestock 
production. AMS received comments on the proposed rule for amending the 
annotation for procaine as listed in Sec.  205.603.
Methionine
    This rule amends the annotation for methionine in Sec.  205.603(d) 
by requiring that maximum methionine levels in feed be calculated as 
averages over the lifespan of organic poultry rather than as a constant 
percentage of the feed. Paragraph (d)(1) reads as follows: 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

[[Page 66563]]

synthetic 100 percent methionine per ton of feed in the diet, maximum 
rates as averaged per ton of feed over the life of the flock: Laying 
chickens--2 pounds; broiler chickens--2.5 pounds; turkeys and all other 
poultry--3 pounds. Alternatives to synthetic methionine have yet to be 
developed for commercial use. This rule change provides organic poultry 
producers with the ability to adjust methionine supplementation based 
on the nutritional needs of the birds at specific stages of production 
that would have positive impacts on animal welfare. In addition, this 
rule change maintains limits on the use of synthetic methionine, which 
preserves the incentive to develop viable nonsynthetic methionine 
alternatives. AMS has reviewed and agrees with the NOSB recommendation 
that the annotation for methionine be amended to clarify its use in 
organic livestock production. AMS received several comments on the 
amending the methionine annotation.
Excipients
    This final rule amends the Sec.  205.603 annotation for excipients 
that are used in animal drugs to treat organic livestock. The rule adds 
a provision that the excipient must be approved by the USDA Animal and 
Plant Health Inspection Service (APHIS) for use in veterinary 
biologics. Paragraph (f) of Sec.  205.603 reads as follows: 
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. This change should minimize the variation 
in certifying agents' interpretations of excipients and enhance 
consistency of enforcement. AMS has reviewed and agrees with the NOSB 
recommendation that the annotation for excipients be amended to clarify 
its use in organic livestock production. AMS received comments on the 
proposed rule for amending the annotation for excipients as listed in 
Sec.  205.603.

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)).''

    This final rule adds 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 rule also amends 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 rule 
removes glycerin from Sec.  205.605(b) and adds it to Sec.  205.606 as 
an agricultural product.
Alginic Acid
    This final rule amends the National List to reclassify alginic acid 
from a non-synthetic substance included in Sec.  205.605(a) to a 
synthetic substance included in Sec.  205.605(b), for use in organic 
handling. The listing for alginic acid in paragraph (b) reads as 
follows: Alginic acid (CAS # 9005-32-7). This rule change is based upon 
updated information on the sourcing of alginic acid and the definition 
of ``synthetic'' in Sec.  205.2 of the USDA organic regulations. AMS 
has reviewed and agrees with the NOSB recommendation that the listing 
of alginic acid be reclassified to clarify its use in organic handling. 
AMS received comments on the proposed rule for reclassifying alginic 
acid from Sec.  205.605(a) to Sec.  205.605(b).
Flavors
    The final rule amends the National List to revise the annotation of 
flavors in Sec.  205.605(a) to change the allowance for nonorganic 
flavors to require the use of organic flavors when they are 
commercially available. The listing of flavors in paragraph (a) reads 
as follows: 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. This rule retains 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. This rule applies to products in the ``organic'' and 
``made with organic (specified ingredients or food group(s))'' 
categories. This rule change does not apply to nonorganic ingredients 
that may be used in up to 30 percent of ``made with organic'' products. 
Due to the number of distinctly different natural flavors and the pace 
of new product development in flavors, AMS has determined it would be 
impractical to list individual flavors on the National List to indicate 
which are commercially available in organic form. AMS has reviewed and 
agrees with the NOSB recommendation that the annotation for flavors be 
amended to clarify its use in organic handling. AMS received comments 
on the proposed rule for amending the annotation for flavors as listed 
in Sec.  205.605.
Carnauba Wax
    This final rule reclassifies carnauba wax from a nonagricultural 
substance on Sec.  205.605(a) to an agricultural product on Sec.  
205.606 that may be used in organic handling when organic carnauba wax 
is not commercially available. Paragraph (a) under Sec.  205.606 reads 
as follows: Carnauba wax. The basis for this reclassification is new 
information on how carnauba wax is extracted from the leaves and buds 
of palm trees. This information shows that carnauba wax extracted from 
this process meets the definition of an agricultural product in Sec.  
205.2 of the USDA organic regulations. AMS has reviewed and agrees with 
the NOSB recommendation that the listing of carnauba wax be 
reclassified to clarify its use in organic handling. AMS received 
comments on the proposed rule for reclassifying carnauba wax from a 
nonsynthetic listed under Sec.  205.605 to an agricultural product 
listed under Sec.  205.606.
Cellulose
    This final rule amends the current allowance for the use of 
cellulose in organic processing in Sec.  205.605 of the National List. 
The listing of cellulose in paragraph (b) in Sec.  205.605 reads as 
follows: 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. The change 
specifies the type of cellulose allowed for certain uses. This rule 
adds language to prohibit the use of microcrystalline cellulose to 
avoid ambiguity about its status. In the proposed rule AMS specifically 
asked for comments on the need for this additional language concerning 
microcrystalline cellulose. This rule change prohibits some forms of 
cellulose, such as microcrystalline cellulose, which may have the same 
functions as powdered cellulose. AMS has reviewed and agrees with the 
NOSB recommendation that the annotation for cellulose be amended to 
clarify its use in organic handling. AMS received comments on the 
proposed rule for amending the annotation for cellulose as listed in 
Sec.  205.605.
Chlorine Materials
    This final rule amends the listing of chlorine materials in Sec.  
205.605(b). This

[[Page 66564]]

rule change clarifies what chlorine levels are permitted for use in 
water in direct contact with food versus in water used as an ingredient 
in food. The listing of chlorine materials in paragraph (b) in Sec.  
205.605 reads as follows: 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 (Calcium hypochlorite; Chlorine dioxide; and 
Sodium hypochlorite). AMS has reviewed and agrees with the NOSB 
recommendation that the annotation for chlorine materials be amended to 
clarify its use in organic handling. AMS received comments on the 
proposed rule for amending the annotation for chlorine materials as 
listed in Sec.  205.605.
Hypochlorous Acid
    This final rule adds hypochlorous acid to Sec.  205.605 as a 
chlorine material allowed for use in disinfecting and sanitizing 
equipment and facilities in organic handling and processing. The 
listing of hypochlorous acid in paragraph (b)(iii) in Sec.  205.605 
reads as follows: Hypochlorous acid--generated from electrolyzed water. 
As listed under Sec.  205.605, hypochlorous acid is allowed for use as 
a disinfectant and sanitizer in organic handling. AMS has reviewed and 
agrees with the NOSB recommendation that hypochlorous acid be allowed 
for use in organic handling. AMS received comments on the proposed rule 
for amending hypochlorous acid onto Sec.  205.605.
Potassium Lactate
    This final rule adds potassium lactate to Sec.  205.605(b) as an 
allowed substance for use in organic handling. The listing of potassium 
lactate in paragraph (b) in Sec.  205.605 reads as follows: Potassium 
lactate--for use as an antimicrobial agent and pH regulator only. 
Including the annotation with this listing limits the use applications 
of potassium lactate to those uses included in the petition to add 
potassium lactate to the National List. AMS has reviewed and agrees 
with the NOSB recommendation that potassium lactate be allowed for use 
in organic handling. AMS received comments on the proposed rule for 
amending potassium lactate onto Sec.  205.605.
Sodium Lactate
    This final rule adds sodium lactate to Sec.  205.605(b) as an 
allowed substance for use in organic handling. The listing of sodium 
lactate in paragraph (b) in Sec.  205.605 reads as follows: Sodium 
lactate--for use as an antimicrobial agent and pH regulator only. 
Including the annotation with this listing limits the use applications 
of sodium lactate to those uses included in the petition to add sodium 
lactate to the National List. AMS has reviewed and agrees with the NOSB 
recommendation that sodium lactate be allowed for use in organic 
handling. AMS received comments on the proposed rule for amending 
sodium lactate onto Sec.  205.605.
Glycerin
    This final rule removes glycerin from Sec.  205.605(b) and amends 
Sec.  205.606 to include this substance with an annotation. Paragraph 
(h) in Sec.  205.606 reads as follows: 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). For organic handling and processing, this action changes 
the classification of glycerin under the USDA organic regulations from 
an allowed synthetic substance to an agricultural product that must be 
an organic product unless such organic products are not commercially 
available. After preventive measures have been exhausted, synthetic 
glycerin may still be used for organic livestock practices as described 
in Sec.  205.603. AMS has reviewed and agrees with the NOSB 
recommendation that the listing of glycerin be reclassified to clarify 
its use in organic handling. AMS received comments on the proposed rule 
for reclassifying glycerin from a synthetic substance listed under 
Sec.  205.605 to an agricultural product listed under Sec.  205.606.

Sec.  205.606 Nonorganically Produced Agricultural Products Allowed as 
Ingredients in or on Processed Products Labeled as ``Organic.''

Colors Derived From Agricultural Products
    This final rule amends the USDA organic regulations to replace the 
Chemical Abstract Services (CAS) numbers included in the annotation of 
each color listed under National List at Sec.  205.606(d)(1) through 
(18) with the binomial nomenclature of the agricultural source of the 
color. Paragraph (d)(1) through (18) in Sec.  205.606 reads as follows:
    1. Beet juice extract color--derived from Beta vulgaris L., except 
must not be produced from sugarbeets.
    2. Beta-carotene extract color--derived from carrots (Daucus carota 
L.) or algae (Dunaliella salina).
    3. Black currant juice color--derived from Ribes nigrum L.
    4. Black/purple carrot juice color--derived from Daucus carota L.
    5. Blueberry juice color--derived from blueberries (Vaccinium 
spp.).
    6. Carrot juice color--derived from Daucus carota L.
    7. Cherry juice color--derived from Prunus avium (L.) L. or Prunus 
cerasus L.
    8. Chokeberry, aronia juice color--derived from Aronia arbutifolia 
(L.) Pers. or Aronia melanocarpa (Michx.) Elliott.
    9. Elderberry juice color--derived from Sambucus nigra L.
    10. Grape juice color--derived from Vitis vinifera L.
    11. Grape skin extract color--derived from Vitis vinifera L.
    12. Paprika color--derived from dried powder or vegetable oil 
extract of Capsicum annuum L.
    13. Pumpkin juice color--derived from Cucurbita pepo L. or 
Cucurbita maxima Duchesne.
    14. Purple sweet potato juice color--derived from Ipomoea batatas 
L. or Solanum tuberosum L.
    15. Red cabbage extract color--derived from Brassica oleracea L.
    16. Red radish extract color--derived from Raphanus sativus L.
    17. Saffron extract color--derived from Crocus sativus L.
    18. Turmeric extract color--derived from Curcuma longa L.
    The use of binomial nomenclature in Sec.  205.606(d) clarifies 
which agricultural sources may be used to derive the color extract. 
Varieties or cultivars of the same species may be used as sources for a 
color extract unless otherwise excluded in the annotation. 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(d). 
For agricultural products, the application of binomial nomenclature for 
colors derived from agricultural products is appropriate when 
classifying colors because it better indicates the agricultural source 
of the color. The NOSB requested AMS review the use of CAS numbers in 
annotations of colors derived from agricultural products to determine 
if there is a better classification for defining colors derived

[[Page 66565]]

from agricultural products. The NOSB recommended that the use of CAS 
numbers is not accurate and that the annotations for colors derived 
from agricultural products be amended to clarify their use in organic 
handling. AMS has reviewed and agrees with the NOSB recommendation that 
the annotations of colors derived from agricultural products be 
amended. AMS received comments on the proposed rule for amending the 
annotations of colors derived from agricultural products listed in 
Sec.  205.606.

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.
    The proposal to allow the use of 16 substances, to amend the 
allowed use of 17 National List substances, and to remove one 
substance, along with allowing the use of parasiticides in fiber 
bearing animals, was published on January 18, 2018. Additional 
information on or about the substances in this final rule, including 
petitions, technical reports, and NOSB recommendations, is available on 
the AMS website at https://www.ams.usda.gov/rules-regulations/organic/national-list.

IV. Statutory and Regulatory Authority

    The OFPA (7 U.S.C. 6501 et seq.) authorizes the Secretary to make 
amendments to the National List based on recommendations developed by 
the NOSB. The OFPA at 7 U.S.C 6518(k) and 6518(n) authorizes 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 rulemaking falls within a category of regulatory actions that 
the Office of Management and Budget (OMB) has exempted from Executive 
Order (E.O.) 12866. Additionally, because this final rule does not meet 
the definition of a significant regulatory action, it does not trigger 
the requirements contained in E.O. 13771. 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 to evaluate alternatives that would accomplish the objectives of 
the rule without unduly burdening small entities or erecting barriers 
that would restrict their ability to compete in the market. The purpose 
of the RFA is to fit regulatory actions to the scale of businesses 
subject to the action. Section 605 of the RFA allows an agency to 
certify a rule, in lieu of preparing an analysis, if the rulemaking is 
not expected to have a significant economic impact on a substantial 
number of small entities.
    The Small Business Administration (SBA) sets size criteria for each 
industry described in the North American Industry Classification System 
(NAICS), to delineate which operations qualify as small businesses. The 
SBA has classified small agricultural producers that engage in crop and 
animal production as those with average annual receipts of less than 
$750,000. Handlers are involved in a broad spectrum of food production 
activities and fall into various categories in the NAICS Food 
Manufacturing sector. The small business thresholds for food 
manufacturing operations are based on the number of employees and range 
from 500 to 1,250 employees, depending on the specific type of 
manufacturing. Certifying agents fall under the NAICS subsector, ``All 
other professional, scientific and technical services.'' For this 
category, the small business threshold is average annual receipts of 
less than $15 million.
    AMS has considered the economic impact of this rulemaking on small 
agricultural entities. Data collected by the USDA National Agricultural 
Statistics Service (NASS) and the NOP indicate most of the certified 
organic production operations in the U.S. would be considered small 
entities. According to the 2016 Certified Organic NASS Survey, 13,954 
certified organic farms in the U.S. reported sales of organic products 
and total farm gate sales in excess of $7.5 billion. Based on that 
data, organic sales average $541,000 per farm. Assuming a normal 
distribution of producers, we expect that most of these producers would 
fall under the $700,000 sales threshold to qualify as a small business.
    According to the NOP's Organic Integrity Database there are 9,633 
certified handlers in the U.S. The Organic Trade Association's 2017 
Organic Industry Survey has information about employment trends among 
organic manufacturers. The reported data are stratified into three 
groups by the number of employees per company: Less than 5; 5 to 49; 
and 50 plus. These data are representative of the organic manufacturing 
sector, and the lower bound (50) of the range for the larger 
manufacturers is significantly smaller than the SBA's small business 
thresholds (500 to 1,250). Therefore, AMS expects that most organic 
handlers would qualify as small businesses.
    The USDA has 79 accredited certifying agents who provide organic 
certification services to producers and handlers. The certifying agent 
that reports the most certified operations, nearly 3,500, would need to 
charge approximately $4,200 in certification fees in order to exceed 
the SBA's small business threshold of $15 million. The costs for 
certification generally range from $500 to $3,500, depending on the 
complexity of the operation. Therefore, AMS expects that most of the 
accredited certifying agents would qualify as small entities under the 
SBA criteria. The economic impact on entities affected by this rule 
would not be significant. The effect of this rule is to allow the use 
of additional substances in organic crop or livestock production and 
organic handling. This action increases regulatory flexibility and 
gives small entities more tools to use in day-to-day operations. AMS 
concludes that the economic impact of this rule, if any, would be 
minimal and beneficial to small agricultural service firms. 
Accordingly, USDA certifies that this rule would not have a significant 
economic impact on a substantial number of small entities.

B. Executive Order 12988

    E.O. 12988 instructs each executive agency to adhere to certain 
requirements in the development of new and revised regulations in order 
to avoid unduly

[[Page 66566]]

burdening the court system. This final rule is not intended to have a 
retroactive effect. To prevent duplicative regulation, 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 Sec. Sec.  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 Sec.  6507(b)(2) of the OFPA, a state organic 
certification program that has been approved by the Secretary may, 
under certain circumstances, contain additional requirements for the 
production and handling of agricultural products organically produced 
in the state and for the certification of organic farm and handling 
operations located within the state. Such additional requirements must 
(a) further the purposes of 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.
    In addition, pursuant to Sec.  6519(c)(6) of the OFPA, this final 
rule does not supersede or alter the authority of the Secretary under 
the Federal Meat Inspection Act (21 U.S.C. 601-624), the Poultry 
Products Inspection Act (21 U.S.C. 451-471), or the Egg Products 
Inspection Act (21 U.S.C. 1031-1056), concerning meat, poultry, and egg 
products, respectively, nor any of the authorities of the Secretary of 
Health and Human Services under the Federal Food, Drug and Cosmetic Act 
(21 U.S.C. 301 et seq.), nor the authority of the Administrator of the 
Environmental Protection Agency under the Federal Insecticide, 
Fungicide and Rodenticide Act (7 U.S.C. 136 et seq.).

C. Paperwork Reduction Act

    No additional collection or recordkeeping requirements are imposed 
on the public by this final rule. Accordingly, OMB clearance is not 
required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501, 
Chapter 35.

D. Executive Order 13175

    This final rule has been reviewed in accordance with the 
requirements of E.O. 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. Comments Received on Proposed Rule AMS-NOP-14-0079; NOP-14-05

    During two separate comment periods totaling 90 days, AMS received 
approximately 130 public comments on proposed rule AMS-NOP-14-0079 from 
farmers, handlers, ingredient manufactures, universities, consumers, 
trade associations, certifying agents, and non-governmental 
organizations. AMS received two requests to extend the comment period 
near the close of the initial 60-day comment period. Because the 
request to extend the comment was received late in the comment period, 
AMS published a notice to reopen the comment period for an additional 
30 days after the initial comment period closed. The received comments 
can be viewed at http://www.regulations.gov by searching for the 
document AMS-NOP-14-0079.
    A majority of comments on the proposed rule indicated support for 
the new substance additions and amendments to the current listings. 
Several comments stated opposition to adding any of the proposed new 
substances to the National List. Such comments argued that the addition 
of any substances would devalue the organic label and weaken the 
organic standards. There were comments that only addressed a portion of 
the new additions or amendments, including a few comments that 
mentioned a specific addition or amendment but did not indicate support 
or opposition to the proposed addition or amendment. Some comments 
proposed changes to the proposed rule, including three comments that 
requested a twelve-month implementation period before the effective 
date of the final rule. AMS' response to the received comments on the 
additions or amendments per National List section is described below.
Comments Received on Additions or Amendments to Sec.  205.601
    AMS received comments on the three substance additions to Sec.  
205.601. Comments on magnesium oxide indicated either support or 
opposition to its addition to the National List. Almost all comments 
opposing the addition of magnesium oxide were generally opposed to the 
addition of any substance to the National List. AMS received comments 
supporting the addition of hypochlorous acid to Sec.  205.601 from 
farmers, certifying agents, handlers, and commodity associations. 
Comments opposing the addition of hypochlorous acid Sec.  205.601 were 
generally opposed to any National List additions. Many comments on 
squid byproducts supported the addition to the National List in Sec.  
205.601. Comments opposing the addition of squid byproducts to the 
National List were generally opposed to the addition of any new 
substance to the National List.
    AMS also received comments on the amendment of the annotation for 
micronutrients included in Sec.  205.601. Comments on this amendment 
either supported the amendment or were opposed to the change. Some 
comments supported the amendment, but requested that the proposed 
annotation be changed, stating that it was too long and confusing and 
needed to be shortened. AMS' response to these comments is included in 
the section on Changes Based Upon Comments described below.
Comments Received on Additions or Amendments to Sec.  205.602
    AMS did not receive any comments that opposed the addition of 
rotenone to Sec.  205.602. All of the comments received on rotenone 
supported its addition to Sec.  205.602.
Comments Received on Additions or Amendments to Sec.  205.603
    AMS received the most comments on the section of the proposed rule 
dealing with the eight substance additions and nine substance 
annotation amendments for Sec.  205.603. AMS received several comments, 
either in support of or opposition to the additions of activated 
charcoal, calcium borogluconate, calcium propionate, kaolin pectin, 
mineral oil and propylene glycol to Sec.  205.603. Several comments 
questioned whether these substances are still needed in organic 
livestock production, as these additions are based upon NOSB 
recommendations that were submitted for rulemaking several years ago. A 
few comments stated that the additions of calcium borogluconate and 
calcium propionate are not needed, as these substances are already 
included on the National List. Other comments on these substances 
argued that the addition of these substances to Sec.  205.603 violated 
FDA regulations. Our response to these comments is included in the 
section on AMS' response to comments.
    AMS received comments from livestock farmers, certifying agents, 
handlers, and livestock associations in support of the addition of 
hypochlorous acid to Sec.  205.603. AMS also received comments opposing 
the addition of hypochlorous acid Sec.  205.603. Most of

[[Page 66567]]

these latter comments were generally opposed to any National List 
substance additions. The proposed addition of nutritive supplements--
injectable vitamins, minerals, and electrolytes--generated several 
comments from certifying agents, organic advocacy groups, livestock 
associations, and producers. Many comments supported adding nutritive 
substances to Sec.  205.603. One comment supporting the addition 
requested altering the annotation to remove the requirement for a 
licensed veterinarian. Some comments opposing the addition of nutritive 
substances stated that injectable forms of vitamins, minerals, and 
electrolytes are already on the National List. Our response to these 
comments is included under the section AMS' Response to Comments.
    AMS received several comments on the proposed amendments of 
substance annotations listed under Sec.  205.603. Although fewer 
comments on chlorhexidine were received, most of the received comments 
supported this amendment. One comment opposing the amendment argued 
that ``. . . under the supervision of a licensed veterinarian'' is not 
defined, and there are toxicity concerns when used as a teat dip pre-
milking. Many comments on the proposed rule supported amending the 
category of parasiticides and each individual parasiticide, 
fenbendazole and moxidectin. A few comments opposed the reduction in 
withdrawal time or opposed allowing parasiticides in fiber bearing 
animals. However, comments received from livestock producers, 
certifying agents and trade associations supported adding paragraph 
(b)(3) to Sec.  205.238, to allow parasiticide use in fiber bearing 
animals. Our response to these comments is included under the section 
on AMS' Response to Comments.
    Most comments received on ivermectin supported the removal of 
ivermectin from Sec.  205.603. Comments submitted by consumers, 
certifying agents, public health advocacy and organic advocacy groups 
(non-government organizations) supported the removal of ivermectin, 
stating that it is nonessential and has negative impacts on pasture 
ecosystems. Some comments supporting the removal of ivermectin stated 
that the use of preventative management practices in organic production 
should preclude the need for parasiticides. Comments from a few 
producers, a parasiticide manufacturer and a dairy producers' 
association opposed the removal of ivermectin. Some of the producer 
comments stated that ivermectin was needed as a rotation with other 
parasiticides to prevent the development of pesticide resistance. One 
comment opposing ivermectin's removal stated that ivermectin is 
effective against parasites that are not controlled by remaining 
parasiticides on the National List. Our response to these comments is 
included under the section on AMS' Response to Comments.
    AMS received many comments from livestock producers that supported 
the addition of sodium chlorite, acidified onto Sec.  205.603(a) and 
Sec.  205.603(b). A certifying agent, a dairy producers' association, 
and a trade association also indicated support for this amendment in 
their comments. Comments from a second certifying agent and an organic 
consulting organization supported listing sodium chlorite, acidified in 
Sec.  205.603(a), but were opposed to its listing in Sec.  205.603(b). 
Several consumers submitted comments that opposed the addition of 
sodium chlorite, acidified. These commenters were generally opposed to 
the addition of any substance to the National List. In the sodium 
chlorite, acidified recommendation forwarded to the Secretary, the NOSB 
did not fully clarify its reason for adding sodium chlorite, acidified 
to both Sec.  205.603(a) and Sec.  205.603(b). However, each of these 
regulation paragraphs contains substances that are used as teat dips or 
may be ingredients in teat dip products.
    Although AMS received fewer comments on the annotation changes for 
lidocaine, procaine, and excipients listed in Sec.  205.603, and most 
of these comments supported the amendments, including comments from 
certifying agents. Comments opposing these amendments were opposed to 
any synthetic substance being used in organic production. AMS received 
many comments from trade association groups, certifying agents, 
livestock producers and researcher supporting the annotation amendment 
for methionine. Other comments on methionine opposed the amendment and 
requested that the use of methionine be phased out of organic 
production. Our response to comments on methionine is discussed in the 
section on AMS' Response to Comments.
Comments Received on Additions or Amendments to Sec.  205.605
    AMS received few comments on the reclassification of alginic acid, 
and the received comments supported the change. AMS received comments 
from industry groups and certifying agents indicating support for the 
reclassification of carnauba wax, although some received comments 
expressed opposition to all additions and amendments. Several comments 
received on the amendment of the allowance for the use of cellulose 
expressed support for this amendment. A few comments received stated 
opposition to the prohibition of microcrystalline cellulose. AMS 
received few comments regarding the proposed amendments to the listing 
of chlorine in Sec.  205.605(b), and most comments received supported 
the changes. Most of the comments received regarding the proposed 
addition of hypochlorous acid to Sec.  205.605 of the National List 
supported this addition. AMS received one comment from a certifying 
agent supporting the addition of potassium lactate and sodium lactate 
to Sec.  205.605(b), while opposing comments were submitted by groups 
and individuals that are opposed to any synthetic substance being added 
to the National List. AMS received several comments that supported the 
removal of glycerin from Sec.  205.605(b) and its addition to Sec.  
205.606 as an agricultural product. Comments from manufacturers or 
industry representatives expressed concern with limits on the 
manufacturing process or in sourcing glycerin. AMS received several 
comments on or about the amendment of the annotation for flavors listed 
in Sec.  205.605, both in support of and in opposition to this rule 
change. Comments opposed to the change argued that requiring organic 
flavors to be used when commercially available may adversely impact 
product formulations. Our response to these comments is discussed in 
AMS' Response to Comments section.
Comments Received on Additions or Amendments to Sec.  205.606
Colors Derived From Agricultural Products
    Nearly all received comments on the use of binomial nomenclature 
for colors derived from agricultural products supported this change. 
Some comments proposed adding additional agricultural product sources 
from the same genus but different species. Other comments offered 
technical corrections to the nomenclature cited in the proposed rule. 
These and other comments are discussed in our response to comments in 
section E.

AMS Response To Comments

Changes Based Upon Comments
Micronutrients
    Few comments addressed the amendment of the annotation for 
micronutrients. Three comments recommended that the annotation be 
shortened to ``micronutrient deficiency

[[Page 66568]]

must be documented'' or that the annotation also require site specific 
data. These comments recommended shortening the annotation to reduce 
confusion. Upon considering the totality of comments received, AMS 
determined that shortening the annotation would reduce the potential 
for confusion and has modified the amendment accordingly. Paragraph 
Sec.  205.601(j)(7) reads as follows: (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 or other documented and verifiable 
method as approved by the certifying agent. AMS has determined that the 
modified amendment includes information sources that producers can use 
to support their need to use micronutrients to maintain soil fertility 
while providing more tools to the organic producer. The requirement 
that certifying agents must approve the method for documenting 
micronutrient deficiency is retained in the final rule.
Parasiticides for Fiber Bearing Animals
    AMS received many comments supporting the use of parasiticides in 
fiber bearing animals and the proposed changes to Sec.  205.603(a)(23). 
Many comments indicated the changes would benefit domestic producers by 
aligning with international organic production standards for fiber 
bearing animals. Some of these comments, however, argued for a 
reduction in the parasiticide withdrawal period required prior to 
harvesting fleece or wool of treated animals, and stated that a 90-day 
withdrawal period for fiber bearing animals is not based upon 
withholding times established by the FDA or the Food Animal Residue 
Avoidance Databank (FARAD), a university-based national program. 
Comments received from a trade association, a consulting firm, and a 
sheep producer stated that a 90-day withdrawal period for fiber bearing 
animals is excessive and problematic for sheep production cycles and 
requested a 36-day withdrawal period instead. Upon review of the 2016 
NOSB recommendation on parasiticides and the FARAD withdrawal interval 
recommendations, AMS determined that the FARAD-recommended withholding 
time for milk when goats are treated orally with moxidectin is up to 18 
days. No recommendations for withholding times for sheep following 
treatment with parasiticides were available. The recommendation that 
was forwarded to the Secretary indicated that for organic production, 
animal withholding periods following treatment with parasiticides 
should double those recommended by FARAD. AMS has determined that the 
36-day withdrawal period for milk or milk products from goats, sheep 
and other dairy species treated with fenbendazole or moxidectin 
(Sec. Sec.  205.603(a)(23)(i)--(ii)) is consistent with a doubling of 
FARAD recommendations and aligns with the production criteria 
established by the OFPA. AMS has considered the totality of comments 
received, the NOSB recommendations and the withholding periods 
established by FARAD, and determined that a 36-day withdrawal period 
for fiber-bearing animals treated with parasiticides aligns with the 
production criteria established by the OFPA. Therefore, this final rule 
reduces from 90 days to 36 days the withholding period required before 
harvesting fleece or wool form fiber-bearing animals treated with 
parasiticides. Producers are reminded that the use of any individual 
substance in Sec.  205.603 in a formulated product that is intended or 
used as a medical treatment is under the authority of FDA and must 
comply with all FDA regulations.
Methionine
    A few of the many comments on methionine that AMS received 
requested that the term ``maximum'' be added to the amended annotation 
to illustrate that the intent of the recommendation submitted to the 
Secretary is to have maximum rates of synthetic methionine 
supplementation as averages per ton of feed over the life of the bird, 
rather than as a maximum quantity per ton of feed. Upon review of both 
the NOSB recommendation, the comments received, and the technical 
report on methionine, AMS determined that adding the term ``maximum'' 
is appropriate. Thus, AMS amended the methionine annotation in the 
final rule to read, ``maximum rates as averaged per ton of feed over 
the life of the flock.'' This change in the methionine annotation 
recognizes that methionine requirements change over a bird's life. This 
change also ensures that a bird's changing nutritional requirements are 
met which, in turn, should reduce the overfeeding of dietary crude 
protein.
Zinc Sulfate
    AMS received several comments supporting the addition of zinc 
sulfate to the national List in Sec.  205.603. A few of these comments 
stated that the NOSB recommended that zinc sulfate should be added only 
to Sec.  205.603(b) and not added to Sec.  205.603(a). Based upon a 
review of the NOSB recommendation, AMS determined that zinc sulfate was 
only recommended for addition to Sec.  205.603(b), and, therefore, that 
adding zinc sulfate to Sec.  205.603(a) would not comply with OFPA 
requirements. Based upon this finding, zinc sulfate is added only to 
Sec.  205.603(b) in this final rule.
Colors Derived From Agricultural Products
    Nearly all comments received supported the change to remove 
chemical abstract (CAS) numbers and replace them with binomial 
nomenclature to identify colors that are derived from agricultural 
sources. A few comments stated that using binomial nomenclature to 
identify colors derived from agricultural products is more accurate 
than using CAS numbers. Based upon analysis developed for this 
rulemaking, AMS agrees with these comments. AMS reviewed comments on 
colors submitted during the 2012 Sunset review. Some of the comments 
stated that the CAS numbers included in the annotations actually refer 
to pigments in the color and not the color itself. AMS has determined 
that CAS numbers are applied to chemical substances and not to 
agricultural products. As a result, AMS agrees with these comments and 
has replaced all CAS numbers included within each color product 
annotation with the appropriate binomial or other taxonomic 
nomenclature to identify the color derived from agricultural product. 
Other comments on colors offered technical corrections to some of the 
binomial nomenclatures cited in the proposed rule. AMS agrees with 
these comments and has corrected the binomial nomenclatures of all 
color listings in this final rule using binomial nomenclatures 
currently listed as accepted by both the Integrated Taxonomic 
Information System \1\ and the USDA Natural Resources Conservation 
Service Plants Database.\2\
---------------------------------------------------------------------------

    \4\ U.S. Integrated Taxonomic Information System: https://www.itis.gov/. Accessed August 2, 2018.
    \5\ U.S. Department of Agriculture, Natural Resources 
Conservation Service Plants Database: https://plants.usda.gov/java/. 
Accessed August 2, 2018.
---------------------------------------------------------------------------

    Two comments received from food coloring manufacturers noted that 
some colors are derived from more than one agricultural source and 
requested that these additional color sources be added to the National 
List at Sec.  205.606. AMS considered these comments and determined 
that adding these additional agricultural sources complies with OFPA. 
Thus, in this final rule, additional agricultural sources have been 
added to the color listings for blueberry juice color, cherry juice 
color, chokeberry-- aronia juice color, pumpkin juice color, and purple 
potato juice color. Three comments received by

[[Page 66569]]

AMS noted a technical correction to the beet juice extract color listed 
in the proposed rule. These comments stated that sugarbeet is not the 
appropriate cultivar of Beta vulgaris for use as a source of food 
coloring, because it is not used by the organic industry. The comments 
further indicated it would be difficult for the organic industry to 
source sugarbeet that is not genetically modified. These comments 
suggested listing as beet root or redbeet instead of sugarbeet. AMS 
agrees and has modified this listing to indicate any variety of Beta 
vulgaris may be used except for sugarbeet. AMS has received information 
which indicates sugarbeet varieties are mostly derived from excluded 
methods as listed in Sec.  205.2 and use of any of these varieties in 
organic production or handling is prohibited.
Twelve-Month Implementation Period
    AMS received a few comments supporting the inclusion of an 
implementation period for this final rule. These comments argued that 
an implementation period would allow organic producers and handlers 
time to comply with the changes in the USDA organic regulations. One 
comment recommended a twelve-month implementation period. AMS only 
partially agrees with these comments. Based upon other comments that 
supported the additions of new substances or amendments to substance 
annotations, many organic producers and handlers want to use these 
additional substances as soon as allowed. As such, AMS determined that 
a twelve-month implementation period would not benefit operations 
seeking to include any of the new National List substances in their 
organic system plan. Therefore, AMS has determined that all of the 
additions to the National List and most of the amendments to the List 
will be effective 30 days after publication of the final rule, per the 
Federal Register requirements.
    AMS does agree that some of the amendments in the final rule will 
require an implementation period. AMS has determined that changes to 
the following substances will require a twelve-month implementation 
before taking effect: Ivermectin, Flavors, Carnauba Wax, Glycerin, and 
Cellulose. AMS determined a twelve-month implementation period is 
warranted to permit organic livestock producers to use existing stocks 
of ivermectin and for organic handlers using flavors, glycerin, or 
carnauba wax to adjust to the requirement to use organic sources of 
these substances when organic sources are commercially available. AMS 
determined that a twelve-month implementation period is also 
appropriate for the prohibition of microcrystalline cellulose, in order 
to provide time for industry to modify production practices.
Changes Requested But Not Made
Additions to the National List
    AMS received several comments requesting that all of the synthetic 
substance additions to the National List cited in the proposed rule not 
be added to the list in the final rule. Because the commenters did not 
provide any justification for their view, AMS did not have a basis for 
evaluating their objections. The OFPA at 7 U.S.C. 6517 authorizes the 
Secretary to add synthetic substances to the National List provided the 
Secretary determines that the substance meets the criteria in 7 U.S.C. 
6517 (c)(1). Section 6517(d)(1) further authorizes the Secretary to 
propose amendments to the National List based upon recommendations 
developed by the NOSB. The NOSB recommended adding these 16 synthetic 
substances to the National List, based upon their review against the 
OFPA substance evaluation criteria (7 U.S.C 6518(m)). AMS reviewed the 
recommendations and agrees the substances meet the OFPA criteria for 
addition to the National List. Therefore, this rule adds the 16 
synthetic substances to the National List.
Activated Charcoal, Calcium Borogluconate, Calcium Propionate, Kaolin 
Pectin, Mineral Oil, and Propylene Glycol
    AMS received fewer comments on these substances, however a few 
comments questioned whether these substances are still needed. These 
comments recommended that the substances be sent back to the NOSB for 
the purpose of reviewing new information, because the original NOSB 
recommendations are now considered dated. A few comments opposing the 
addition of these substances stated that the associated annotations do 
not comply with U.S. Food and Drug Administration (FDA) regulations. 
AMS stated in previous rulemaking (proposed rule, July 17, 2006, 71 FR 
40624) that these six substances could not be added to Sec.  205.603(a) 
as medical treatments because they were not FDA-approved and did not 
qualify for extra-label use by veterinarians under the Animal Medical 
Drug Use Clarification Act (AMDUCA) provisions. This proposed rule 
indicated that AMS would continue consultation with the FDA regarding 
the use of these six substances in organic livestock production. 
Subsequently, prior to publication of the proposed rule, AMS conferred 
with the FDA on the proposed additions and amendments to Sec.  205.603. 
During this conference, the FDA indicated that their process involves 
reviewing formulated products for medical treatment approval. FDA 
indicated they do not review for medical treatment approval of generic 
materials, as included in this rule. Therefore, individual substances 
cited in this rule would not be reviewed as medical treatments under 
the FDA process. Based upon this consultation, AMS believes these 
substances are not in conflict with FDA regulations. Thus, this final 
rule adds these six substances to Sec.  205.603.
Ivermectin
    A majority of comments on ivermectin received by AMS supported its 
removal from the National List. A few producers submitting comments on 
ivermectin opposed its removal, arguing that ivermectin is needed for 
parasiticide rotation to prevent the development of parasite 
resistance. A comment from a dairy association opposed the ivermectin 
removal, arguing that ivermectin is used to control a different set of 
parasites that are not controlled by either moxidectin or fenbendazole. 
AMS does not agree with these comments. The USDA regulations stipulate 
that producers must establish and maintain preventive livestock health 
care practices before using available healthcare treatments that are on 
the National List. Only when preventive practices and veterinary 
biologics are inadequate to prevent sickness can synthetic treatments 
be administered to livestock, and then only when such treatments are on 
the National List in Sec.  205.603. AMS review has determined that 
ivermectin and moxidectin are part of the same chemical class 
(macrocyclic lactones) with broad spectrum efficacy against both 
internal parasites and external parasites (e.g., cattle lice). 
Fenbendazole is a broad spectrum external parasiticide in a different 
chemical class (i.e., benzimidazoles). Ivermectin and moxidectin appear 
to have a similar mode of action and may be less effective when used in 
a two parasiticide rotation to manage the prevention of parasiticide 
resistance. AMS review of the 2015 Technical Report on Ivermectin 
developed for the National List petition process identified several 
livestock management practices that can control parasite infestation 
and the report also cited multiple alternative non-synthetic substances 
that are effective as parasiticides. The technical report also

[[Page 66570]]

highlighted new research that indicated that when excreted in cattle 
dung, ivermectin is toxic to dung beetle larvae and causes negative 
effects to pasture ecosystems. Based on the similar efficacies between 
ivermectin and moxidectin, and a review of information provided in the 
technical report, AMS has determined that ivermectin is not essential 
for organic production. Subsequently, this final rule removes 
ivermectin from the National List.
Sodium Chlorite, Acidified
    AMS received several comments, including a signed petition with 
several signatures, supporting the addition of sodium chlorite, 
acidified to the National List. Some of these comments cited its 
effectiveness in controlling mastitis in dairy animals and its 
environment compatibility. Other comments grouped sodium chlorite, 
acidified into opposition to any new additions to the National List. 
Comments opposing the listing of sodium chlorite, acidified did not 
provide any justification for their opposition. Consequently, AMS did 
not have for consideration a basis for their opposition to sodium 
chlorite, acidified.
    AMS also received comments supporting the addition of sodium 
chlorite, acidified only to Sec.  205.603(a) of the National List. 
Comments seeking to limit the addition of sodium chlorite, acidified to 
only Sec.  205.603(a) stated that the intent of the NOSB's 
recommendation was not for use as a topical treatment. Based upon a 
review of the NOSB recommendation on sodium chlorite, acidified 
forwarded to the Secretary, AMS determined that the original 
recommendation was to add the substance to both Sec.  205.603(a) and 
Sec.  205.603(b). The recommendation on sodium chlorite, acidified 
provided for pre-milking and post-milking teat dip treatment, which 
allows sodium chlorite, acidified to be used as a sanitizer, a use 
application provided under Sec.  205.603(a), and as a topical 
treatment, a use application provided udder Sec.  205.603(b). AMS 
determined that dairy producers use teat dips as a sanitizer and as a 
topical treatment. AMS also reviewed all substances listed in 
Sec. Sec.  205.603(a) and 205.603(b) and determined that substances 
that may be used in teat dips or as ingredients in teat dip products 
are listed in both Sec. Sec.  205.603(a) and 205.603(b). Therefore, 
this rule adds sodium chlorite, acidified to the National List in 
Sec. Sec.  205.603(a) and 205.603(b).
Methionine
    AMS received many comments supporting the amendment of the 
annotation of methionine under Sec.  205.603. A few comments in 
opposition to this change requested that AMS implement a phase-out of 
methionine. These comments argued the substance is no longer essential 
for organic poultry production. One opposing comment recommended that 
the final rule add an expiration date to the annotation. AMS has 
considered the totality of comments received and reviewed the 
historical use and effectiveness of expiration dates for this 
substance. In previous rulemaking, AMS amended section 205.603 of the 
National List to allow methionine in organic poultry production with 
established expiration dates included in the annotation for the 
substance (October 31, 2003, 68 FR 61987; October 21, 2005, 70 FR 
61217; August 24, 2010, 73 FR 54057; March 14, 2011, 75 FR 51919). 
Expiration dates were included in previous rulemaking in order to 
emphasize the need to develop alternatives to synthetic methionine that 
are more compatible with organic production practice standards. AMS 
subsequently published additional rulemaking that removed the 
previously established expiration dates from the methionine annotation 
on September 19, 2012 (77 FR 57985). AMS has determined that the use of 
expiration dates did not result in the development of effective 
alternatives to synthetic methionine for use by organic poultry 
producers. Furthermore, establishing a phase-out in the absence of an 
effective alternative to methionine would result in a significant 
reduction in organic poultry and egg production. AMS has determined 
that the use of synthetic methionine is still essential for organic 
poultry production. Consequently, this final rule does not include a 
phase-out of methionine.
Microcrystalline Cellulose
    Some comments opposed amending the cellulose annotation in Sec.  
205.605(b) that would prohibit microcrystalline cellulose. Upon review 
of the technical report on cellulose, AMS determined that 
microcrystalline cellulose is derived from cellulose through additional 
chemical processing that has not been subjected to the evaluation 
criteria stipulated in the OFPA Sec.  6581(m). Therefore, AMS has 
determined that microcrystalline cellulose is not the same substance as 
cellulose. Furthermore, based on a review of public comments provided 
during the 2012 National List sunset reviews, AMS determined that some 
public comments raised concern that microcrystalline cellulose was 
being interpreted as being an allowed form of cellulose when these 
commenters indicated microcrystalline cellulose is a prohibited 
substance. Subsequently, this final rule retains the prohibition of 
microcrystalline cellulose in Sec.  205.605(b).
Clarifications
U.S. Food and Drug Administration, AMS
    Comments from an animal feed association, a dairy association, and 
an animal health association opposed the additions of several 
substances to Sec.  205.603. These comments inferred that some of the 
proposed substance additions are not compliant with FDA regulations or 
other federal regulations. During the development of the proposed rule, 
AMS staff conferred with the FDA Center for Veterinary Medicine (CVM) 
staff regarding the additions and amendments that would be included in 
Sec.  205.603. Copies of all of the proposed Sec.  205.603 additions 
and amendments were transmitted to CVM staff before the proposed rule 
was published. AMS and CVM discussed the proposed changes to Sec.  
205.603. Based upon this conference, AMS believes adding these 
substances to the National List is not inconsistent with FDA or other 
federal regulations. CVM reviews and approves formulated products as 
medical treatments. The National List contains individual substances 
that may be used in organic production. The use of any individual 
substance in Sec.  205.603 in a formulated product that is intended or 
used as a medical treatment is under the authority of FDA and must 
comply with all FDA regulations. The OFPA Sec.  2120(c)(6) stipulates 
that no provision within the USDA organic regulations supersedes the 
authority of the FDA regulations.
Comments on Substances Considered To Be Already on the National List
    Some comments opposed adding substances such as calcium 
borogluconate, calcium propionate, and nutritive supplements--
injectable forms of vitamins, minerals, or electrolytes, to Sec.  
205.603 because they interpret these substances to be currently 
included on the National List. AMS has considered these comments and 
determined that calcium borogluconate, calcium propionate, and 
nutritive supplements--injectable forms of vitamins, minerals, or 
electrolytes, were individually petitioned for addition to the National 
List. AMS facilitated the NOSB's petition review process during which 
public comments were received on each of these substances. After 
deliberate consideration, the NOSB forwarded to the Secretary separate

[[Page 66571]]

recommendations to add these substances to the National List. AMS 
reviewed these recommendations and determined that the NOSB reviewed 
each substance against the substance evaluation criteria delineated by 
the OFPA (Sec.  6518(m)). AMS agrees that these substances have met the 
criteria. Therefore, this final rule adds calcium borogluconate, 
calcium propionate, and nutritive supplements--injectable forms of 
vitamins, minerals, or electrolytes to Sec.  205.603 of the National 
List. Organic livestock producers and certifying agents should amend 
any prior interpretation on the allowance of these substances.
Requirement for Licensed Veterinarian and ``Off Label'' Use
    AMS received comments on the proposed rule that addressed the 
requirement for use by a ``licensed Veterinarian'' or for a substance 
to be administered under the ``supervision of a licensed 
Veterinarian.'' Some of these comments argued that inclusion of these 
requirements with use of the substances as listed under Sec.  205.603 
would be confusing or too restrictive. The requirement for use by a 
licensed veterinarian or the use of a substance under the supervision 
of a licensed veterinarian is a condition required by FDA regulations. 
The USDA organic regulations do not supersede FDA regulations. Other 
comments questioned the oversight of ``off label'' use of some of the 
substances being added or amended in this rule. As noted above, use of 
any animal drug in organic production must comply with both the USDA 
organic regulation requirements and the FDA regulation requirements. 
Certifying agents should ensure compliance with these regulation 
requirements during approval of an operation's organic system plan and 
verification during inspection.
Flavors and Commercial Availability
    AMS received a comment from the petitioner of the amendment to the 
flavors annotation which requires that non-synthetic flavors be used 
when organic flavors are not commercially available. The petitioner 
noted that this change should be applied to ``organic'' products and 
not be applied to non-organic ingredients that make up the 30 percent 
or less portion of a ``made with organic (specified ingredients)'' 
product. AMS concurs with the petitioner's comments and interprets the 
rule to not apply to non-organic ingredients that compose 30 percent or 
less of ``made with organic'' products. Also, in its comment, the 
petitioner requested that the National Organic Program develop guidance 
on commercial availability based upon the NOSB's November 2007 
recommendation on commercial availability. Prior to being revised in 
2013, the National List petition guidelines included guidance on 
commercial availability that was based upon a Fall 2006 NOSB 
recommendation.
Requested Changes Not Addressed in the Proposed Rule
    AMS received comments that requested changes to annotations that 
were not addressed in the proposed rule. These changes, as such, cannot 
be included in this final rule because they have not been available for 
comment.
Corrections to Proposed Rule 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)
    This document corrects the regulation text of the proposed rule 
published in the Federal Register of January 17, 2018, regarding 
National Organic Program; Amendments to the National List of Allowed 
and Prohibited Substances (Crops, Livestock, and Handling). These 
corrections clarify that the proposed rule applies prospectively to the 
plans submitted for approval from the effective date of this final 
rule. AMS has inserted the following corrections in this final rule:
    <bullet> In the proposed rule (83 FR 2498), beginning on page 2522 
in the issue of January 17, 2018, column C, make the following 
correction, under the List of Subjects in 7 CFR part 205, 3. Amend 
Sec.  205.601 as follows: b. Redesignate paragraphs (j)(5) through 
(j)(8) as (j)(6) through (j)(9), redesignate paragraph (j)(9) as 
(j)(11), add new paragraphs (j)(5) magnesium oxide and (j)(10) squid 
byproducts, and revise newly redesignated paragraph (j)(7) 
micronutrients.
    <bullet> In the proposed rule (83 FR 2498), beginning on page 2524 
in the issue of January 17, 2018, column A, make the following 
correction, under the List of Subjects in 7 CFR part 205, 6. Amend 
Sec.  205.605 as follows: Remove ``Alginic'' from the listing for 
``Acids'' and remove ``Carnauba wax'' from the listing for ``Waxes'' in 
paragraph (a). Revise the listing for ``Flavors'' in paragraph (a). Add 
``alginic acid'' to paragraph (b). Add ``potassium lactate'' and 
``sodium lactate'' to paragraph (b). Revise the substances 
``cellulose'' and ``chlorine materials'' in paragraph (b). Remove 
``Glycerin--produced by hydrolysis of fats and oils'' from paragraph 
(b).
    <bullet> In the proposed rule (83 FR 2498), beginning on page 2524 
in the issue of January 17, 2018, column B, make the following 
correction, under the List of Subjects in 7 CFR part 205, Amend (b), 
Add ``Potassium lactate--for use as an antimicrobial agent and pH 
regulator only,'' and ``Sodium lactate--for use as an antimicrobial 
agent and pH regulator only,'' to paragraph (b). Revise the substances 
``cellulose'' and ``chlorine materials'' in paragraph (b). Remove 
``Glycerin--produced by hydrolysis of fats and oils'' from paragraph 
(b).

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 is 
amended as follows:

PART 205--NATIONAL ORGANIC PROGRAM

0
1. The authority citation for 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); and,
0
b. Redesignate paragraph (j)(9) as (j)(11), redesignate paragraphs 
(j)(5) through (j)(8) as (j)(6) through (j)(9), add new paragraphs 
(j)(5) and (j)(10), and revise newly redesignated paragraph (j)(7).
    The additions and revision read as follows:


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

* * * * *
    (a) * * *
    (2) * * *
    (iii) Hypochlorous acid--generated from electrolyzed water.
* * * * *

[[Page 66572]]

    (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 
or other documented and verifiable method as approved by the certifying 
agent.
    (i) Soluble boron products.
    (ii) Sulfates, carbonates, oxides, or silicates of zinc, copper, 
iron, manganese, molybdenum, selenium, and cobalt.
* * * * *
    (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 as follows:
0
a. Remove reserved paragraphs (j)-(z); and
0
b. Redesignate 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 as follows:
0
a. Revise paragraph (a);
0
b. Revise paragraphs (b)(4) and (7);
0
c. Redesignate paragraph (b)(8) as (b)(9) and add new paragraph (b)(8);
0
d. Add paragraph (b)(10);
0
e. Revise paragraph (d)(1); and
0
f. Revise paragraph (f).
    The revisions and addition read as follows:


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

* * * * *
    (a) As disinfectants, sanitizer, and medical treatments as 
applicable.
    (1) Alcohols.
    (i) Ethanol--disinfectant and sanitizer only, prohibited as a feed 
additive.
    (ii) Isopropanol-disinfectant only.
    (2) Aspirin-approved for health care use to reduce inflammation.
    (3) Atropine (CAS #-51-55-8)--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:
    (i) Use by or on the lawful written order of a licensed 
veterinarian; and
    (ii) A meat withdrawal period of at least 56 days after 
administering to livestock intended for slaughter; and a milk discard 
period of at least 12 days after administering to dairy animals.
    (4) Biologics--Vaccines.
    (5) Butorphanol (CAS #-42408-82-2)--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 42 days after 
administering to livestock intended for slaughter; and a milk discard 
period of at least 8 days after administering to dairy animals.
    (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 paragraph (d)(2) of this section, vitamins per paragraph 
(d)(3), and electrolytes per paragraph (a)(11), with excipients per 
paragraph (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 36 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)--only for treatment of ketosis 
in ruminants.
    (28) Sodium chlorite, acidified--allowed for use on organic 
livestock as a teat dip treatment only.

[[Page 66573]]

    (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.
    (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.
* * * * *
    (10) Zinc sulfate--for use in hoof and foot treatments 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, maximum rates as averaged per ton of feed 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. Remove ``Alginic:'' from the listing for ``Acids'' and remove 
``Carnauba wax; and'' from the listing for ``Waxes'' in paragraph (a);
0
b. Revise the listing for ``Flavors'' in paragraph (a);
0
c. Add a listing for ``Alginic acid'' to paragraph (b) in alphabetical 
order;
0
d. Revise the listings for ``Cellulose'' and ``Chlorine materials'' in 
paragraph (b);
0
e. Remove the listing for ``Glycerin'' from paragraph (b); and
0
f. Add listings for ``Potassium lactate'' and ``Sodium lactate'' to 
paragraph (b) in alphabetical order.
    The revisions and additions read as follows:


Sec.  205.605  Nonagricultural (nonorganic) substances allowed as 
ingredients in or on processed products labeled as ``organic'' or 
``made with organic (specified ingredients or food group(s)).''

* * * * *
    (a) * * *
* * * * *
    Flavors--nonsynthetic 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.
* * * * *
    (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.
    i. Calcium hypochlorite.
    ii. Chlorine dioxide.
    iii. Hypochlorous acid--generated from electrolyzed water.
    iv. Sodium hypochlorite.
* * * * *
    Potassium lactate--for use as an antimicrobial agent and pH 
regulator only.
* * * * *
    Sodium lactate--for use as an antimicrobial agent and pH regulator 
only.
* * * * *

0
7. Amend Sec.  205.606 as follows:
0
a. Redesignate paragraphs ((g) through (t) as paragraphs (i) through 
(v); and,
0
b. Redesignate paragraphs (d) through (f) as paragraphs (e) through 
(g);
0
c. Redesignate paragraphs (a) through (c) as paragraphs (b) through 
(d).
0
d. Add new paragraph (a).
0
e. Revise newly redesignated paragraphs (d)(1) through (d)(18); and
0
f. Add new paragraph (h).
    The additions and revisions 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 Beta vulgaris L., except 
must not be produced from sugarbeets.
    (2) Beta-carotene extract color--derived from carrots (Daucus 
carota L.) or algae (Dunaliella salina).
    (3) Black currant juice color--derived from Ribes nigrum L.
    (4) Black/purple carrot juice color--derived from Daucus carota L.
    (5) Blueberry juice color--derived from blueberries (Vaccinium 
spp.).
    (6) Carrot juice color--derived from Daucus carota L.
    (7) Cherry juice color--derived from Prunus avium (L.) L. or Prunus 
cerasus L.
    (8) Chokeberry, aronia juice color--derived from Aronia arbutifolia 
(L.) Pers. or Aronia melanocarpa (Michx.) Elliott.
    (9) Elderberry juice color--derived from Sambucus nigra L.
    (10) Grape juice color--derived from Vitis vinifera L.
    (11) Grape skin extract color--derived from Vitis vinifera L.

[[Page 66574]]

    (12) Paprika color--derived from dried powder or vegetable oil 
extract of Capsicum annuum L.
    (13) Pumpkin juice color--derived from Cucurbita pepo L. or 
Cucurbita maxima Duchesne.
    (14) Purple sweet potato juice color--derived from Ipomoea batatas 
L. or Solanum tuberosum L.
    (15) Red cabbage extract color--derived from Brassica oleracea L.
    (16) Red radish extract color--derived from Raphanus sativus L.
    (17) Saffron extract color--derived from Crocus sativus L.
    (18) Turmeric extract color--derived from Curcuma longa L.
* * * * *
    (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 18, 2018.
Bruce Summers,
Administrator, Agricultural Marketing Service.
[FR Doc. 2018-27792 Filed 12-26-18; 8:45 am]
 BILLING CODE 3410-02-P