Organic Regulatory Recap

Across the value chain, organic producers, processors, retailers, consumers, and other stakeholders are actively engaging to advance organic standards and federal oversight to maintain a strong, trusted, and verified Organic seal.

The first half of 2019 is a story of the organic industry getting fraud under control.Multi-year federal investigations into fraud allegations have paid off, resulting in sweeping enforcement actions against bad actors in the Black Sea region. The U.S. Department of Agriculture’s (USDA’s) National Organic Program’s (NOP) special initiatives to detect and deter fraud across global supply chains are ongoing. The forthcoming rulemaking on Strengthening Organic Enforcement will institutionalize regulatory requirements to bolster these anti-fraud efforts and ensure the integrity of organic production. The Organic Trade Association’s private sector fraud prevention program also launched early this year. All of these efforts work together to give consumer increased confidence in the integrity of organic products across the globe.

We may also see payoff from our persistent efforts to advocate for final rulemaking on origin of livestock. This rule, in conjunction with outcomes of the NOP Dairy Compliance Project’s unannounced inspections, will make huge strides in leveling the playing field for organic dairy operations.

Other topics of particular interest to the work of the Organic Trade Association and its members include NOP’s recent record of advancing National List rulemaking in a timely fashion, the legalization of hemp and hemp products per the 2018 Farm Bill, best labeling practices for the non-food sector, the increasing focus on seaweed-based crop inputs and NOP’s prompt clarification on the prohibited use of glyphosate in container-based crop production.

Here’s a closer look at these highlights and other important regulatory actions that have occurred this year organized by crops, livestock, food and non-food processing and topics that apply to all organic businesses. 


ORGANIC CROPS

Clarification on Container-based Production

The National Organic Program (NOP) issued a statement to certifiers in June clarifying that all certified organic production systems, including container systems built and maintained on land, must comply with the three-year transition period as an eligibility requirement for certification.

This statement was issued in direct response to reports that NOP’s policy was not clear enough and that some certifiers may be allowing operations to bypass the three-year transition process following the use of glyphosate in field-based container systems. In response to such reports, the Organic Trade Association sent a letter to USDA in April asking for immediate and strong clarification that these systems much comply with the three-year transition requirement. 

Container systems must meet all aspects of the organic regulations including the strict prohibition of glyphosate and other prohibited substances, and natural resources and biodiversity requirements on an ongoing basis. Although the NOP policy statement clarifies specific issues around transition requirements for container systems built and maintained on land, the industry still needs clear instructions to certifiers for applying the organic regulations to production systems maintained in greenhouses and other enclosures. The Organic Trade Association supports the National Organic Standards Board (NOSB) recommendation from 2010 that would allow container production of organic crops under specific provisions that support natural and diverse soil ecology within the container.

Proposed allowances for new pest and disease controls in organic crop production

NOP published a proposed rule in February that would allow elemental sulfur as a molluscicide bait to control slugs and snails and polyoxin D zinc salt to control fungal diseases. Both of these substances were reviewed and recommended for approval by NOSB in Spring 2018 and were determined to meet the requirements for not harming the environment or human health and being essential for production due to a lack of natural alternatives, all while aligning with organic farming principles. NOP will consider public comments and may issue a final rule in the future which will codify the allowance of these substances in the organic regulations.

Guidance for Strengthening Organic Seed usage

The current regulations require the use of organic seed and planting stock unless organic forms are not commercially available. At the spring 2019 meeting, after almost four years, NOSB finally passed a recommendation to revise NOP’s “Guidance on Seeds, Annual Seedlings, and Planting Stock” that will strengthen the requirement for using organic seed. This improved guidance is recommended in combination with last year’s NOSB recommendation to revise to the regulations at §205.204 to read, “Improvement in searching, sourcing and use of organic seed must be demonstrated every year with the goal of using only organic seed and planting stock.” The guidance and regulatory revision must be implemented by NOP to be enforced, and will then make a huge impact on increasing the use of organic seed.

Guidance for EPA oversight of plant growth regulators and biostimulants

Biostimulants are a class of crop inputs products that contain naturally occurring substances and microbes that stimulate a plant’s natural processes to improve growth and resistance to pests and diseases. In May, the Environmental Protection Agency (EPA) issued a draft guidance intended to clarify whether products with label claims that are considered to be plant regulator claims are subject to regulation as a pesticide. The guidance raises questions about whether specific ingredients (e.g. seaweeds and humic acids) typically contained in EPA-registered plant growth regulators would automatically be subject to pesticide registration requirements. The Organic Trade Association submitted comments in response to the draft guidance to communicate the impact the guidance may have for non-synthetic fertilizers commonly used in organic production, and warn against unintended consequences.

What’s new in NOSB’s Proposed Organic Seed Guidance?

 • More clarification for producer methods of trialing or searching for an “equivalent” organic variety or cultivar

 • Lists of options for certifiers and operators to judge if seed searches were done in an effective manner, and provides the option to require more activities if the certifier feels the quality of the search could be improved.

 • Information to address situations where seed or planting stock is sourced or mandated by the buyer of a contracted organic crops. In these cases, the producer must obtain sourcing information and documentation from the contracted buyer.

 • Encouragement for certifiers to ask for corrective actions for producers that aren’t making sufficient progress towards greater use of organic seeds and planting stock, and provides some examples of scenarios that could result in a noncompliance.

 • Encouragement for certifiers to review operator’s prevention measures for avoiding GMO contamination for seeds from at-risk crops grown by the operator.


The Organic Trade Association will be in Pittsburgh, PA (October 23–25) for the National Organic Standards Board Meeting. This meeting is open to the public. Our team can help guide you through the public comment process. Contact info@ota.com to get engaged.

 ORGANIC LIVESTOCK

Origin of Livestock Rulemaking expected this fall

The Organic Trade Association has been strongly advocating to USDA to immediately publish a final rule on origin of livestock. As described on Page 40, we are advocating for Congress to include language in their yearly appropriations legislation that funds USDA requiring the agency to issue a final rule. USDA staff indicated at a congressional hearing in July that it expects to move forward with rulemaking this fall. At the time of writing this article, it is unclear whether the published rule will be a final rule or a proposed rule open for public comment. A proposed rule on this issue was released in 2015 and received overwhelming support from the organic industry.

Elemental sulfur now allowed for external pest control in organic livestock production

NOP published a final rule adding elemental sulfur to §205.603(b) of the National List for use as an external parasiticide to treat organic livestock and livestock housing for the control of mites, fleas, and ticks when preventive practices are ineffective. The new allowance became effective on May 30, 2019.

NOSB recommends new pest control for organic honeybee producers

Oxalic acid is used for varroa mite control in apiculture (honeybee) production. At the spring 2019 meeting, NOSB passed a recommendation to allow its use as a pesticide solely for apiculture production. Oxalic acid is considered to be a less harmful alternative to allowed formic acid (already allowed in organic honeybee production), has a unique application for use in package bees, and is approved in other international organic standards. The allowance is not effective until NOP implements the recommendation through rulemaking.


ORGANIC PROCESSORS AND HANDLERS

Potassium acid tartrate is now required in organic form when available

NOP published a final rule that reclassifies potassium acid tartrate (also known as cream of tartar) from “non-agricultural” to “agricultural.” Potassium acid tartrate is used in food processing as a leavening agent, a pH control agent, and an antimicrobial agent. As a result of this change, organic processors and handlers will be required to source an organic form of the ingredient. Only when organic potassium acid tartrate is not commercially available can non-organic form of potassium acid tartrate be used. This new requirement became effective on May 30, 2019.

Magnesium chloride to be reclassified as non-synthetic

In February, NOP published a proposed rule that would reclassify magnesium chloride from an allowed synthetic to an allowed non-synthetic, thereby allowing only non-synthetic forms to be used in processed organic products. This proposal would implement a unanimous recommendation from NOSB in spring 2018 to more accurately reflect that non-synthetic forms of this material are widely available. The primary uses of magnesium chloride in organic food processing are as a firming agent in tofu processing and as a source of the essential mineral magnesium in organic infant formula.

NOSB unanimously approves our petition for pullulan

NOSB unanimously passed the Organic Trade Association’s petition to add pullulan to the National List at §205.605(a) as an allowed non-agricultural, non-synthetic ingredient used in tablets and capsules for dietary supplements labeled “made with organic” at its spring 2019 meeting. This decision will protect the ongoing production and availability of USDA-NOP certified encapsulated dietary supplements. A recommendation for adding the substance to the National List will be referred to USDA for approval and rulemaking. Our petition intentionally limits the petitioned allowance of non-organic pullulan to dietary supplements certified to the “made with” category. Any encapsulated dietary supplement sold or labeled as “certified organic (95% +)” would still need to use certified organic pullulan.

Collagen gel recommended to be allowed in organic processing

At the 2019 spring meeting, NOSB passed a recommendation to allow non-organic collagen gel in sausage production when organic collagen gel is not commercially available. In co-extrusion systems, collagen gel enrobes the sausage meat like a casing as the meat is extruded, and holds the form of the meat product. The allowance will need to be implement through rulemaking.


OVERSIGHT & ENFORCEMENT

NOP takes sweeping enforcement actions in Black Sea region

On May 9, NOP suspended accreditation of Control Union Certification’s satellite office in Turkey. The almost 200 operations that were certified by this office had to either surrender their organic certification or apply to a new certifier within 60 days to retain their USDA organic certification. NOP sent a notice to all USDA- accredited certification agencies providing an alert about organic certification activities in the Black Sea region, along with new additional reporting requirements for certifiers. The notice also include a new directive to certification staff and inspectors listing mandatory compliance verification points for grain and oilseed producers in the Black Sea region, as well as any affiliated grain and oilseed handlers.

These enforcement actions are a result of strengthening ongoing enforcement initiatives by NOP and certifiers. With increased unannounced inspections and residue testing, 180 operations (60 percent of the certified population) in the Black Sea region have lost their organic certification. The impact of reduced organic grain and oilseed imports from the Black Sea region represents 49% (dollar value of these imports) in 2016, and 21% (dollar value of these imports) in 2018.

Ongoing efforts to detect and prevent fraudulent imports

In collaboration with the Office of Inspector General, NOP is actively conducting risk-based oversight of organic supply chains through five key initiatives. Some have been ongoing since 2016 and are continuing to support robust oversight and enforcement of organic certification systems.

 • Farm-level yield analysis: NOP is using (and training certifiers to use) new analytical tools for evaluating farm-level records against a range of open-source regional dataset on crop yields. This type of analysis can reveal patterns of organic farms reporting yields that far exceed regional averages which can then be further investigated.

 • Supply chain research: NOP is completing a project to illuminate the business relationships between high-impact farms, consolidators, handlers and exporters in the Black Sea region. The research will be modeled for and deployed in other regions of the world to better target resources to and investigations.

 • Ship-specific surveillance: When credible information has demonstrated cause for concern, NOP has conducted investigations, in collaboration with Customs and Border Protection, of specific shipments for fraud. These types of ship-specific investigations in and of themselves have not revealed fraud but often revealed other areas where certifiers need improved oversight of farms or the supply chain.

 • Country-commodity studies: In collaboration with the International Organic Accreditation Service (IOAS), NOP had conducted two country-commodity studies (grain in the Black Sea region and a specialty crop in Central America). These studies will inform the development of standard approaches for examining risks, or emerging risks, at the commodity level across an entire country.

 • Fumigation investigations: NOP has been working with the USDA Animal and Plant Health Inspection Service (APHIS) to investigate the possible fumigation of products label as organic and to ensure such products are not represented following fumigations by a prohibited substance.

NOP Dairy Compliance Project

Last year, NOP initiated the Dairy Compliance Project with the goal to better assess industry compliance with USDA organic regulations, particularly with respect to the pasture standard.  Working with Agricultural Marketing Service auditors, NOP compliance specialists, Animal and Plant Health Inspection Service staff and certifiers, NOP has been conducting unannounced inspections of organic dairy operations nationwide to verify compliance with dairy livestock standards. Operations were selected for inspection based on risk factors such as herd size and previous compliance history. NOP is also conducting targeted audits of certifiers based on their oversight of specific livestock operations, and non-compliances were issued to certifiers and operations. The project will continue in 2019 with additional unannounced inspections. So far, the Dairy Compliance Project has revealed key areas where certifier and inspector training and consistent enforcement are needed (e.g. defining the regional grazing season, reviewing justifications for allowed breaks in the grazing season, and ensuring sufficient qualifications for inspectors of large complex dairy operations).

NOP Enforcement Rulemaking expected to address growing list of topics

Expected to be published in fall 2019, the NOP Proposed Rule on Strengthening Organic Enforcement and Oversight will address the following topics (as reported by NOP at the spring 2019 NOSB Meeting):

 • Imports to U.S. (Import Certificates)

 • Labeling of Non-retail Containers

 • On-Site Inspections (Unannounced)

 • Certificates of Organic Operations

 • Continuation of Certification (Certificate Expirations)

 • Paperwork Submissions to the Administrator

 • Personnel Training and Qualifications

 • Oversight of Certification Activities (Certified Office Oversight)

 • Accepting Foreign Conformity Assessment Systems (International Oversight)

 • Compliance—General

 • Non-compliance Procedure for Certified Operations

 Mediation

 Adverse Actions—General, Appeals

 • Producer Group Operations

 • Calculating the Percentage of Organically Produced Ingredients

 • Supply Chain Traceability and Organic Fraud Prevention

The proposed rule is expected to be largest single piece of rulemaking since the implementation of NOP regulations.

Organic stakeholders are attacking fraud from various other angles. NOSB maintains a work agenda item for oversight improvement to deter fraud. At the spring 2019 meeting, NOSB members discussed issues that NOSB could address in tandem with NOP’s efforts on enforcement rulemaking. Furthermore, the Organic Trade Association’s Organic Fraud Prevention Solutions Program launched earlier this year is quickly gaining participation among OTA members. Since the launch of the program, the number of pre-enrolled participants has grown from the initial leading 10 companies to 40.


OTHER REGULATORY ISSUES

Hemp Regulatory Outlook

The 2018 Farm Bill includes statutory changes that legalize the domestic cultivation, production and commercial development of hemp and hemp products at the federal level for the first time in over 50 years. By removing hemp from the Controlled Substances Act (CSA) and categorizing it as an agricultural commodity under the purview of USDA, this crop should be eligible for federal programs such as crop insurance, agricultural research grants, and certification of organic production practices under the National Organic Program. USDA is in the process of developing and implementing regulations for the production (growing) of hemp while the Food and Drug Administration (FDA) maintains its responsibility over cannabis and cannabis-derived substances, including Cannabidiol (CBD), that are added to food products. It is currently illegal to put into interstate commerce a food to which CBD has been added, or to market CBD as or in a dietary supplement. FDA is exploring potential pathways for various types of CBD products to be lawfully marketed.

With respect to organic certification, USDA’s current policy is, “For hemp produced in the United States, only industrial hemp produced in accordance with the 2014 Farm Bill may be certified as organic, if produced in accordance with USDA organic regulations.” We expect this instruction will be updated to align with the provisions of the 2018 Farm Bill once USDA completes its rulemaking on the general production of hemp. The Organic Trade Association will continue to track hemp developments and keep its members informed.

Best Practices for Labeling Non-Food

Many consumers have come to trust and understand that organic products are third-party certified to strict standards and regulated and enforced by the federal government. However, organic claims made on products such as processed fiber and textiles and personal care products are outside of NOP’s scope of enforcement and therefore go unregulated and enforced. To promote and optimize compliant and truthful labeling, the Organic Trade Association’s Board of Directors in February formally adopted a guidance document titled “Best Labeling Practices for Textiles.” The adopted guidance sets the stage for a more comprehensive document that will be created for the larger non-food sector (personal care, dietary supplements and farm inputs). A diverse task force will be convened in the winter to help shape its development.

Global Organic Textiles Standard (GOTS)

The Global Organic Textile Standards is undergoing a periodic scheduled revision during 2019 with the goal of a revised standard—GOTS Version 6.0—in place in March 2020. This is a transparent process where multiple stakeholders are encouraged to participate. The Organic Trade Association, as a founding member of GOTS, is engaged in the comment and revision process. The first stakeholder input period closed  May 31. The next opportunity for comments will be in September in response to a second draft of the revised standard.

GMOs and Excluded Methods

On June 6, USDA published a proposed rule that would revise the regulatory framework that oversees the importation, interstate movement, and environmental release of genetically engineered organisms. This rule, considered a “deregulatory action,” would reduce the regulatory burden for developers of organisms that are unlikely to pose plant pest risks. This is the third time that USDA has attempted to implement such a revision, the past two times being unsuccessful due to the significance of concerns raised during past public comments. The proposed rule was published in tandem with an Executive Order on modernizing the regulatory framework for agricultural biotechnology products.

Under organic regulations, GMOs have always and continue to be prohibited. NOSB has also been publishing recommendations for the past few years that address the new emerging technologies that may not be explicitly addressed in NOP regulatory definitions. For instance, NOSB has passed recommendations to classify the following technologies under the NOP definition of “Excluded Methods” and thereby prohibit in organic: targeted genetic medication (including CRISPR), gene silencing, accelerated plant breeding techniques, synthetic biology, cisgenesis, intragenesis, and agro-infiltration.


LOOKING AHEAD

The Organic Trade Association’s regulatory staff will continue to focus on actions that inform USDA in its rulemaking activities and provide its members with opportunities to develop and adopt best practices that will advance organic standards and help ensure consumer trust.

Priority topic areas for the remainder of the year for organic producers, processors, retailers, and others:

Crop Producers:

  • Proposed rule to prohibit Vitamin B1 and Natamycin for crop production
  • Allowance of paper-based planting aids and fatty alcohols for tobacco sucker control
  • Sustainability requirements for seaweed-based crop input materials (crops) — Join the Organic Trade Association’s Task Force!

Livestock Producers:

  • Origin of Livestock rulemaking
  • Restrictions on livestock vaccines produced using excluded methods
  • Proposed Rule to prohibit the use of Procaine in livestock production

Food and Non-Food Processors and Handlers:

  • Proposed Rule to prohibited Konjac Flour and allow Tamarind Seed Gum
  • Draft 2 of revised GOTS Standards for public comment – Join the Organic Trade Association’s Task Force!

All organic operations:

  • Proposed Rule to strengthen organic enforcement and oversight — Join the Organic Trade Association’s Task Force!
  • NOSB 2021 Sunset Reviews (reviewed in 2019)
  • 2019 Organic Survey to be administered by National Agricultural Statistics Survey this winter. //

This recap was prepared by Gwendolyn Wyard, Vice President of Regulatory & Technical Affairs, and Johanna Mirenda, Farm Policy Director.