Certification Policy Update
National Organic Program Update: National List Changes
On December 27th, 2018 the National Organic Program (NOP) published a final rule (or here, if you prefer a column version) amending the National List of Allowed and Prohibited Substances. The rule changes the use restrictions for 17 substances and adds 16 new substances. The rule also removes the parasiticide Ivermectin as an allowed parasiticide for use in organic livestock production and amends regulations to allow the emergency use of other parasiticides (fenbendazole and moxidectin) in fiber-bearing animals. The rule now lists the botanical pesticide rotenone as a prohibited substance in organic crop production.
The final rule will be effective January 28, 2019, except for amendments concerning Ivermectin (now prohibited), flavors (organic flavors required when commercially available), cellulose (revised annotation specifying types of cellulose permitted), glycerin (reclassified as agricultural), and carnauba wax (reclassified as agricultural)--which will be implemented on December 27, 2019.
Each update is explained below along with any actions you can expect will be necessary where applicable. In general, you can expect to update organic system plans and input inventories or ingredient monitoring spreadsheets to align with the new rules, and to provide additional information for review where applicable. We’re working on implementation details now but if changes impact you specifically, you will hear from us as your file is reviewed. Certification Specialists and Inspectors will be paying attention to these changes and we’ll do our best to address changes that impact you, but please be prepared with any new information that will be required. On our end, we are also being as proactive as we can in verifying products that were previously prohibited, but if you see a material below that used to be prohibited and is now allowed and you want to use it, contact us to add the information to your Input Inventory form, even if you’ve inquired about it before. Please contact us with any questions about these changes.
Summary of Final Rule Changes
Added to all categories - 205.601(a)(2), 205.603(a), and 205.605(b).
Hypochlorous acid - generated from electrolyzed water.
Added to 205.601(j), Plant or soil amendments
(5) Magnesium oxide (CAS # 1309-48-4)—for use only to control the viscosity of a clay suspension agent for humates.
(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.
Revisions to 205.601(j), Plant or soil amendments
(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.
Added to 205.602, nonsynthetic substances prohibited in crop production.
(f) Rotenone (CAS # 83-79-4).
Added to 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable.
(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.
(17) Kaolin pectin—for use as an adsorbent, antidiarrheal, and gut protectant.
(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.
Revisions to 205.603(a) As disinfectants, sanitizer, and medical treatments as applicable.
(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.
(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.
Which goes along with the practice standard change to Livestock Health Practice Standard §205.238(b)(2) which has been amended by replacing the 90-day withholding time for milk and milk products with a cross-reference to withholding times specified in § 205.603. In addition, the term “stock” is replaced with “animal.” (b) When preventive practices and veterinary biologics are inadequate to prevent sickness, a producer may administer synthetic medications: Provided, That, such medications are allowed under §205.603. Parasiticides allowed under §205.603 may be used on: (1) Breeder stock, when used prior to the last third of gestation but not during lactation for progeny that are to be sold, labeled, or represented as organically produced; and (2) Dairy stock animals, as allowed under §205.603. a minimum of 90 days prior to the production of milk or milk products that are to be sold, labeled, or represented as organic. (3) Fiber bearing animals, as allowed under §205.603.
Ivermectin has been removed, effective December 27, 2019 which gives clients almost a year to discontinue use. Ivermectin will maintain the 90-day withhold until then. During the 2019 season we will be verifying and re-approving the parasite prevention and control plans in place on your operation. All input inventories listing ivermectin as an emergency input will need to updated with replacement products. Any client listing moxidectin or fenbendazole will need to have MOSA approval for use.
(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.
(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.
Added to 205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable.
(8) Sodium chlorite, acidified—allowed for use on organic livestock as teat dip treatment only. (Yes, this is being added twice, but as a teat dip only!)
(10) Zinc sulfate—for use in hoof and foot treatments only.
We are actively re-reviewing zinc sulfate hoof-care products that were noted as prohibited in our materials database.
Revisions to 205.603(b) As topical treatment, external parasiticide or local anesthetic as applicable.
(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.
Revisions to 205.603(d) As feed additives
(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.
This revision allows for averaging per ton of feed over the life of the flock. MOSA is actively working on new tools for manufacturers and farmers to use for documentation.
Revisions to 205.603(f) Excipients.
(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.
Revisions to 205.605(a) Nonsynthetics allowed.
- Remove Alginic from Acid listing (moving to (.605(b))
- Remove Carnauba wax from Wax listing (moving to .606)
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.
The revision includes an important change to the annotation for natural flavors that will require organic forms when they are commercially available in the appropriate quality, quantity or form. MOSA clients will need to be in compliance by the effective date of December 27, 2019 with appropriate documentation on file for review and audit. MOSA’s new Organic Search-Handlers form should be used to document your annual searches for organic flavors.
Added to 205.605(b) Synthetics allowed.
Alginic acid (CAS #9005-32-7)
- Reclassified from (a) to (b).
Potassium lactate—for use as an antimicrobial agent and pH regulator only.
Sodium lactate—for use as an antimicrobial agent and pH regulator only.
Revisions to 205.605(b) Synthetics allowed.
- Remove Glycerin (moving to .606)
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.
MOSA clients will need to be in compliance by the effective date of December 27, 2019 with appropriate documentation on file. Only powdered cellulose is allowed as an anti-caking agent and filtering aid and microcrystalline cellulose is now 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.
Added to 205.606
(a) Carnauba wax
This materials was reclassified from 205.605(a). Effective December 27, 2019, MOSA clients using carnauba wax will need to use organic carnauba wax unless commercially unavailable. MOSA’s new Organic Search-Handlers form should be used to document your annual searches for organic carnauba wax.
(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).
This material was reclassified from 605(b). Effective December 27, 2019, MOSA clients using glycerin will need to use organic glycerin unless commercially unavailable and sourced from agricultural materials and processed using biological or mechanical or physical methods. MOSA’s new Organic Search-Handlers form should be used to document your annual searches for organic glycerin.
Revisions to 205.606
(d) Colors - all entries have been revised to remove specific CAS numbers and to add the binomial nomenclature of the agricultural source of the color. The two noted below have additional annotation changes to take note of.
(1) Beet juice extract color—derived from Beta vulgaris L., except must not be produced from sugarbeets.
(12) Paprika color—derived from dried powder or vegetable oil extract of Capsicum annuum 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).
Other Policy News
Paper Pots Update
We’ve been talking about paper pots for several months now and are still in limbo waiting for the National Organic Standards Board (NOSB) to make a recommendation. To recap, though certifiers have historically allowed the use of paper pots on organic operations, the National Organic Program (NOP) clarified that paper pots were actually not an approved application of paper, and sent a notice to all certifiers requiring operations to discontinue the use of paper pots after the 2018 season. They further clarified that in order for paper pots to continue to be allowed in the future, a petition to the NOSB would be necessary, and so a petition was submitted and is in the process of being considered. The petition covers all paper pots including those manufactured with additives which are standardly included in the manufacture of paper. At the last NOSB meeting, paper pots were a focus and many comments that were submitted requested withdrawal of the phase-out period--to allow for the continued use of pots while the NOSB work unfolds. As a result, the NOSB passed a resolution to allow for this strongly supported continued use, which the NOP considered and on November 5th sent an update to certifiers allowing for the unrestricted continued use of paper pots. “The NOP is extending the allowance of paper pots until further notice. Any additional changes to the allowance for the use of paper pots will be communicated to certifiers to provide adequate time to make any adjustments. For fairness and consistency in certification across operations, all certifiers may allow paper pots during this extension period.”
The NOSB will likely have a recommendation at the next NOSB meeting in April and we anticipate that paper pots will be recommended for allowance. We hope to see a business as usual decision in the end.
Organic Livestock and Poultry Practices (OLPP) Rule Update - Certifiers have been working tirelessly to determine which new rules and clarifications are easily interpreted within the current regulation, and which would seem to go beyond the current regulation or would be more difficult to implement. In many areas, the new rule simply outlined policies and practices already certifiers already have in place so agreement is not difficult to achieve. Our collective goal is to consistently follow the same interpretation of the standards and the group is nearing completion on a “best practices” document which will aid certifier policy development and consistency in interpretation of the NOS. At MOSA we’re beginning to make updates to our internal policies and will be communicating any clarifications applying to your operation during review and inspection this season.
Origin of Livestock (OOL) Rule Clarification Support
MOSA recently signed onto a letter sent to Secretary Perdue by the Accredited Certifiers Association (ACA) to emphasize the importance of consistent enforcement of the organic regulations by certifiers. Quite notable is the inconsistent interpretation certifiers have related to origin of livestock standards. The ACA is requesting clarification related to 205.236 Origin of Livestock. The letter states, “Accredited certifiers would really like to get on the same page as one another about this. The topic is discussed frequently in various forums, but lack of regulatory clarity coupled with diverging past precedents make it extremely challenging for certifiers to switch course from where they are currently. Although our members do not all agree on the interpretation of this regulation as it is currently written, we are in strong agreement that once regulatory clarification is provided, we can stand together to enforce the rule consistently to the benefit of the organic dairy industry.”
The NOSB also passed a resolution at the recent 2018 Fall meeting. The resolution stated: “It has come to the attention of the National Organic Standards Board (NOSB) that the continued state of varying interpretations and practices around the Origin of Livestock standards is creating market instability for organic producers.”
The resolution went on to state, “Rulemaking is necessary to ensure consistent interpretation and enforcement of the standards for origin of livestock and provide industry with additional clarity of application of the organic dairy standards.”
The resolution concluded with a request to the Secretary. “Therefore, be it resolved by unanimous vote, the National Organic Standards Board - as USDA’s Federal Advisory Board on organic issues and representing organic farmers, ranchers, processors, retailers, and consumers- urges the Secretary to directly issue a final rule for Origin of Livestock that incorporates public comments submitted in response to the Proposed Rule (Docket Number AMS-NOP-11-0009).”
MOSA strongly supports certifiers working toward a cohesive interpretation of the regulation. Consistent and fair enforcement of the standards is required.