Federal Register / Vol. 83, No. 247 / Thursday, December 27, 2018 / Rules and Regulations 66559 

complete records, or its failure to otherwise 

comply with an individual’s right to access 

or amend records. 

Philip S. Kaplan, 

Chief Privacy Officer, Department of 

Homeland Security. 

[FR Doc. 2018–27944 Filed 12–26–18; 8:45 am] 

BILLING CODE 9111–14–P 

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. 

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 §§ 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 § 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. 

§ 205.601 Synthetic Substances 

Allowed for Use in Organic Crop 

Production 

This final rule amends § 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 

§ 205.601 to include other agricultural 

practices that may be used in 

maintaining soil fertility. 

Hypochlorous Acid 

This final rule adds hypochlorous 

acid to § 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 § 205.601. 

Magnesium Oxide 

This final rule adds magnesium oxide 

to the National List in § 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 § 205.601. 


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Micronutrients 

This final rule amends the annotation 

of micronutrients as listed in 

§ 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 § 205.601. 

Squid Byproducts 

This final rule adds squid byproducts 

to § 205.601(j) as an allowed substance 

for use in organic crop production. 

Paragraph (j)(10) is added to § 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 byproducts be allowed for use in organic 

crop production. AMS received 

comments on the proposed rule for 

amending squid by-products onto 

§ 205.601. 

§ 205.602 Nonsynthetic Substances 

Prohibited for Use in Organic Crop 

Production 

This final rule amends § 205.602 by 

adding rotenone to this section. 

Nonsynthetic substances are allowed in 

organic crop production except for those 

specifically listed as prohibited in 

§ 205.602. 

Rotenone 

This final rule adds rotenone, a 

nonsynthetic substance, to § 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 § 205.602. 

§ 205.603 Synthetic Substances 

Allowed for Use in Organic Livestock 

Production 

This final rule adds the following 

substances to the National List in 

paragraph § 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 

§ 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, 

§ 205.603(a); lidocaine and procaine, 

§ 205.603(b); methionine, § 205.603(d); 

and excipients, § 205.603(f). In addition, 

this final rule removes ivermectin, 

§ 205.603(a). 

Activated Charcoal 

This final rule adds activated charcoal 

to § 205.603(a) for use in organic 

livestock production. Paragraph (a)(6) is 

amended in § 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 nonvegetative 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 § 205.603. 

Calcium Borogluconate 

This final rule adds calcium 

borogluconate to § 205.603(a) of the 

National List for use in organic livestock 

production. Paragraph (a)(7) is amended 

in § 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 § 205.603. 

Calcium Propionate 

This final rule adds calcium 

propionate to the National List at 

§ 205.603(a) for use in organic livestock 

production. Paragraph (a)(8) is amended 

in § 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 

§ 205.603. 

Chlorhexidine 

This final rule amends the annotation 

for chlorhexidine in § 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 § 205.603. 

Hypochlorous Acid 

This final rule adds hypochlorous 

acid to § 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 


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from electrolyzed water. As listed in 

§ 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 § 205.603. 

Kaolin Pectin 

This final rule adds kaolin pectin to 

§ 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 § 205.603. 

Mineral Oil 

This final rule adds mineral oil to 

§ 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 § 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 § 205.603. 

Nutritive Supplements—Injectable 

Vitamins, Minerals, and Electrolytes 

This rule adds injectable vitamins, 

minerals, and electrolytes to 

§ 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 § 205.603(d)) or as medical 

treatments (electrolytes without 

antibiotics per § 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 § 205.603. 

Parasiticides, Fenbendazole, and 

Moxidectin 

This rule amends the National List to 

revise the listing for parasiticides 

(§ 205.603(a)(23)) and the listings for 

fenbendazole (§ 205.603(a)(23)(i)) and 

moxidectin (§ 205.603(a)(23)(iii)). This 

rule also amends the livestock health 

care practice standard in § 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 

§ 205.238(b) is revised and paragraph 

(b)(3) is added to § 205.238(b) as 

follows: (b)(2) Dairy animals, as allowed 

under § 205.603; and (b)(3) fiber bearing 

animals, as allowed under § 205.603. 

AMS has reviewed and agrees with the 

NOSB recommendation that 

§ 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 (§ 205.238(b)) and identify 

which parasiticides are allowed 

(§ 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 § 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 

§ 205.603. 

Ivermectin 

This rule removes ivermectin from 

§ 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 


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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 § 205.603. 

Propylene Glycol 

This final rule adds propylene glycol 

to § 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 § 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 § 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 § 205.603(a) and in 

§ 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 § 205.603(a) as a teat dip 

when used as a disinfectant, sanitizer, 

or medical treatment. This rule also 

adds sodium chlorite, acidified to 

§ 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 § 205.603. 

Xylazine 

This rule amends the annotation of 

the listing for xylazine in § 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 § 205.603. 

Zinc Sulfate 

This final rule adds zinc sulfate to 

§ 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 § 205.603(a 

& b), zinc sulfate is added only to 

§ 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 § 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 § 205.603. 

Procaine 

This final rule amends the annotation 

of procaine in § 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 

§ 205.603. 

Methionine 

This rule amends the annotation for 

methionine in § 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: DLMethionine, 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 


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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 § 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 

§ 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 

§ 205.603. 

§ 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 § 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 (§ 205.605(a)), 

and cellulose and chlorine 

(§ 205.605(b)). In addition, this rule 

removes glycerin from § 205.605(b) and 

adds it to § 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 

§ 205.605(a) to a synthetic substance 

included in § 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 

§ 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 

§ 205.605(a) to § 205.605(b). 

Flavors 

The final rule amends the National 

List to revise the annotation of flavors 

in § 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 § 205.605. 

Carnauba Wax 

This final rule reclassifies carnauba 

wax from a nonagricultural substance 

on § 205.605(a) to an agricultural 

product on § 205.606 that may be used 

in organic handling when organic 

carnauba wax is not commercially 

available. Paragraph (a) under § 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 § 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 § 205.605 to 

an agricultural product listed under 

§ 205.606. 

Cellulose 

This final rule amends the current 

allowance for the use of cellulose in 

organic processing in § 205.605 of the 

National List. The listing of cellulose in 

paragraph (b) in § 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 § 205.605. 

Chlorine Materials 

This final rule amends the listing of 

chlorine materials in § 205.605(b). This 


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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 § 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 § 205.605. 

Hypochlorous Acid 

This final rule adds hypochlorous 

acid to § 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 § 205.605 reads as 

follows: Hypochlorous acid—generated 

from electrolyzed water. As listed under 

§ 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 § 205.605. 

Potassium Lactate 

This final rule adds potassium lactate 

to § 205.605(b) as an allowed substance 

for use in organic handling. The listing 

of potassium lactate in paragraph (b) in 

§ 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 

§ 205.605. 

Sodium Lactate 

This final rule adds sodium lactate to 

§ 205.605(b) as an allowed substance for 

use in organic handling. The listing of 

sodium lactate in paragraph (b) in 

§ 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 § 205.605. 

Glycerin 

This final rule removes glycerin from 

§ 205.605(b) and amends § 205.606 to 

include this substance with an 

annotation. Paragraph (h) in § 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 

§ 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 § 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 § 205.605 to an 

agricultural product listed under 

§ 205.606. 

§ 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 

§ 205.606(d)(1) through (18) with the 

binomial nomenclature of the 

agricultural source of the color. 

Paragraph (d)(1) through (18) in 

§ 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 

§ 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 

§ 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 


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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 § 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 § 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/rulesregulations/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’ ’’ (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 


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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 §§ 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 § 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 § 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 twelvemonth 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 § 205.601 

AMS received comments on the three 

substance additions to § 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 

§ 205.601 from farmers, certifying 

agents, handlers, and commodity 

associations. Comments opposing the 

addition of hypochlorous acid § 205.601 

were generally opposed to any National 

List additions. Many comments on 

squid byproducts supported the 

addition to the National List in 

§ 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 § 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 § 205.602 

AMS did not receive any comments 

that opposed the addition of rotenone to 

§ 205.602. All of the comments received 

on rotenone supported its addition to 

§ 205.602. 

Comments Received on Additions or 

Amendments to § 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 § 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 

§ 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 § 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 § 205.603. AMS also received 

comments opposing the addition of 

hypochlorous acid § 205.603. Most of 


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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 

§ 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 § 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 premilking. 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 § 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 § 205.603. Comments 

submitted by consumers, certifying 

agents, public health advocacy and 

organic advocacy groups (nongovernment 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 § 205.603(a) and § 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 

§ 205.603(a), but were opposed to its 

listing in § 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 § 205.603(a) and 

§ 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 § 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 § 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 § 205.605(b), and most 

comments received supported the 

changes. Most of the comments received 

regarding the proposed addition of 

hypochlorous acid to § 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 § 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 § 205.605(b) and its 

addition to § 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 

§ 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 § 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 


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4U.S. Integrated Taxonomic Information System: 

https://www.itis.gov/. Accessed August 2, 2018. 

5U.S. Department of Agriculture, Natural 

Resources Conservation Service Plants Database: 

https://plants.usda.gov/java/. Accessed August 2, 

2018. 

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 § 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 § 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 (§§ 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 § 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 § 205.603. A few 

of these comments stated that the NOSB 

recommended that zinc sulfate should 

be added only to § 205.603(b) and not 

added to § 205.603(a). Based upon a 

review of the NOSB recommendation, 

AMS determined that zinc sulfate was 

only recommended for addition to 

§ 205.603(b), and, therefore, that adding 

zinc sulfate to § 205.603(a) would not 

comply with OFPA requirements. Based 

upon this finding, zinc sulfate is added 

only to § 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

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 § 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 


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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 § 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 § 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 § 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 § 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 § 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 


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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 § 205.603(a) of 

the National List. Comments seeking to 

limit the addition of sodium chlorite, 

acidified to only § 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 § 205.603(a) and 

§ 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 § 205.603(a), and as a topical 

treatment, a use application provided 

udder § 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 §§ 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 

§§ 205.603(a) and 205.603(b). Therefore, 

this rule adds sodium chlorite, acidified 

to the National List in §§ 205.603(a) and 

205.603(b). 

Methionine 

AMS received many comments 

supporting the amendment of the 

annotation of methionine under 

§ 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 § 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 

§ 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 

§ 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 

§ 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 

§ 205.603. Copies of all of the proposed 

§ 205.603 additions and amendments 

were transmitted to CVM staff before the 

proposed rule was published. AMS and 

CVM discussed the proposed changes to 

§ 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 § 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 § 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 

§ 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 


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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 (§ 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 

§ 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 § 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 nonorganic 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: 

• 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 

§ 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. 

• 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 

§ 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). 

• 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 

■ 1. The authority citation for part 205 

continues to read as follows: 

Authority: 7 U.S.C. 6501–6522. 

■ 2. Amend § 205.238 by revising 

paragraph (b)(2) and adding paragraph 

(b)(3) to read as follows: 

§ 205.238 Livestock health care practice 

standard. 

* * * * * 

(b) * * * 

(2) Dairy animals, as allowed under 

§ 205.603. 

(3) Fiber bearing animals, as allowed 

under § 205.603. 

* * * * * 

■ 3. Amend § 205.601 as follows: 

■ a. Redesignate paragraph (a)(2)(iii), as 

(a)(2)(iv) and add new paragraph 

(a)(2)(iii); and, 

■ 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: 

§ 205.601 Synthetic substances allowed 

for use in organic crop production. 

* * * * * 

(a) * * * 

(2) * * * 

(iii) Hypochlorous acid—generated 

from electrolyzed water. 

* * * * * 


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(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. 

* * * * * 

■ 4. Amend § 205.602 as follows: 

■ a. Remove reserved paragraphs (j)–(z); 

and 

■ b. Redesignate paragraphs (f) through 

(i) as (g) through (j), and add new 

paragraph (f) to read as follows: 

§ 205.602 Nonsynthetic substances 

prohibited for use in organic crop 

production. 

* * * * * 

(f) Rotenone (CAS # 83–79–4). 

* * * * * 

■ 5. Amend § 205.603 as follows: 

■ a. Revise paragraph (a); 

■ b. Revise paragraphs (b)(4) and (7); 

■ c. Redesignate paragraph (b)(8) as 

(b)(9) and add new paragraph (b)(8); 

■ d. Add paragraph (b)(10); 

■ e. Revise paragraph (d)(1); and 

■ f. Revise paragraph (f). 

The revisions and addition read as 

follows: 

§ 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. 


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(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. 

* * * * * 

■ 6. Amend § 205.605 as follows: 

■ a. Remove ‘‘Alginic:’’ from the listing 

for ‘‘Acids’’ and remove ‘‘Carnauba wax; 

and’’ from the listing for ‘‘Waxes’’ in 

paragraph (a); 

■ b. Revise the listing for ‘‘Flavors’’ in 

paragraph (a); 

■ c. Add a listing for ‘‘Alginic acid’’ to 

paragraph (b) in alphabetical order; 

■ d. Revise the listings for ‘‘Cellulose’’ 

and ‘‘Chlorine materials’’ in paragraph 

(b); 

■ e. Remove the listing for ‘‘Glycerin’’ 

from paragraph (b); and 

■ f. Add listings for ‘‘Potassium lactate’’ 

and ‘‘Sodium lactate’’ to paragraph (b) 

in alphabetical order. 

The revisions and additions read as 

follows: 

§ 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 (nonchlorine 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. 

* * * * * 

■ 7. Amend § 205.606 as follows: 

■ a. Redesignate paragraphs ((g) through 

(t) as paragraphs (i) through (v); and, 

■ b. Redesignate paragraphs (d) through 

(f) as paragraphs (e) through (g); 

■ c. Redesignate paragraphs (a) through 

(c) as paragraphs (b) through (d). 

■ d. Add new paragraph (a). 

■ e. Revise newly redesignated 

paragraphs (d)(1) through (d)(18); and 

■ f. Add new paragraph (h). 

The additions and revisions read as 

follows: 

§ 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. 


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(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 § 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 

DEPARTMENT OF AGRICULTURE 

Federal Crop Insurance Corporation 

7 CFR Part 400 

[Docket No. FCIC–14–0001] 

RIN 0563–AC45 

General Administrative Regulations; 

Interpretations of Statutory Provisions, 

Policy Provisions, and Procedures 

AGENCY: Federal Crop Insurance 

Corporation, USDA. 

ACTION: Final rule. 

SUMMARY: The Federal Crop Insurance 

Corporation (FCIC) finalizes the General 

and Administrative Regulation Subpart 

X- Interpretations of Statutory and 

Regulatory Provisions (Subpart X) to 

incorporate interpretations of 

procedures previously issued and 

administered in accordance with 

Manager’s Bulletin MGR–05–018, and to 

provide a mechanism for interpretations 

of policy provisions that are not 

codified in the Code of Federal 

Regulations. The effect of this action is 

to provide requestors with information 

on how to request a final agency 

determination or an interpretation of 

FCIC procedures within one 

administrative regulation, and bring 

consistency and clarity to the processes 

used and existing provisions. 

DATES: This rule is effective January 28, 

2019. 

ADDRESSES: Anyone can to search the 

electronic form of all comments 

received for any dockets by the name of 

the person submitting the comment (or 

signing the comment, if submitted on 

behalf of an association, business, labor 

union, etc.). You may review the 

complete User Notice and Privacy 

Notice for Regulations.gov at http://

www.regulations.gov/#!privacyNotice. 

FOR FURTHER INFORMATION CONTACT: 

Francie Tolle, Director, Product 

Management, Product Administration 

and Standards Division, Risk 

Management Agency, United States 

Department of Agriculture, Beacon 

Facility, Stop 0812, Room 421, PO Box 

419205, Kansas City, MO 64141–6205, 

telephone (816) 926– 7730. 

SUPPLEMENTARY INFORMATION: 

Background 

This rule finalizes changes to Subpart 

X that were published by FCIC on 

March 18, 2015, as a notice of proposed 

rulemaking in the Federal Register at 80 

FR 14030–14033. The public was 

afforded 30 days to submit comments 

after the regulation was published in the 

Federal Register. 

A total of 18 comments were received 

from 5 commenters. The commenters 

included persons or entities from the 

following categories: Financial, 

insurance provider, legal, trade 

association, and other. The public 

comments received regarding the 

proposed rule and FCIC’s responses to 

the comments are as follows: 

Comment: A commenter stated 

Subpart X—Interpretations of statutory 

provisions could provide asset 

management improvements. Driving 

these types of assets would be a 

dynamic and unprecedented 

improvement in the field of asset 

management. 

Response: FCIC does not understand 

the comment and does not see a 

connection between asset management 

and interpretations of policy and 

procedures. Subpart X intended to 

ensure that the Federal crop insurance 

program policy provisions and 

procedures are interpreted in a 

consistent manner for all participants. 

No change has been made. 

Comment: A commenter questioned 

the use of ‘‘calendar year(s)’’ in 

§ 400.766(a)(1) when § 400.766(a)(2) 

refers to ‘‘crop years’’. For the calendar 

years 2011–2014 used in the example, 

these could include policies for crop 

years from 2010–2016, depending on 

the time of the calendar year the request 

was submitted. The commenter 

suggested only referencing crop years in 

these two sections. 

Response: FCIC agrees that the use of 

the term calendar year can be confusing 

since all crop insurance, except for 

Whole-Farm Revenue Protection, is 

conducted on a crop year basis. Further, 

although crop years may differ, since 

the opinion is about a specific provision 

in a policy and effects producers with 

that policy, crop years is more 

appropriate. FCIC has revised the 

provisions accordingly. 

Comment: A commenter stated in 

proposed rule § 400.766(a)(2), FCIC 

states that it will reject requests for 

interpretations of crop year policy 

provisions that are older than four years 

prior to the calendar year in which the 

request was submitted. The commenter 

did not understand the purpose of this 

time limit. It is not unusual for litigation 

or arbitration to drag on for quite some 

time due to continuances, changes in 

attorneys, changes in arbitrators, etc. 

There may be situations in which it 

does not become clear that an 

interpretation of a policy provision or 

procedure is necessary until the time 

limit set forth in this section has already 

passed, particularly if the dispute 

involves a claim overpayment 

discovered in a subsequent crop year. 

As a result, the commenter believed this 

time limit should be stricken or revised 

to include any crop year(s) of policies 

subject to current litigation or 

arbitration. 

Response: As stated above, FCIC is 

moving to a crop year basis instead of 

a calendar year basis. However, FCIC 

does not agree the time limit should be 

stricken or revised to include any crop 

years of policies subject to current 

litigation or arbitration. The policy 

provisions require filing of a request for 

mediation, arbitration or litigation 

within one year of the determination by 

the insurance provider in the event of a 

dispute. The current time limit is set to 

allow an additional two years to pass 

before an interpretation must be 

requested to permit time for the appeals 

process to proceed. FCIC believes that 

most proceedings initiated within oneyear of a determination that is in 

dispute would be readily able to request 

an interpretation within the timeframes 

established by this regulation. Further, 

the published interpretations state that 

to the extent the language in the 

provisions interpreted is identical to the 

language applicable for any other crop 

year, including previous crop years, the 

same interpretation can be applied to 

such other crop year provided the 

person seeking to use the published 

interpretation for a different crop year 

provided that the language of the 


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