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National Organic Program Update

Organic Integrity from Farm to Table, 

Consumers Trust the Organic Label

National Organic Standards Board Meeting

November 29 – December 2, 2011

Savannah, Georgia
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Thank You for Five Years of Public 

Service

• Steve DeMuri, Handling Committee Chair

• Tina Ellor, Prior Crops Committee Chair

• Katrina Heinze, Materials Committee Chair

• Tracy Miedema, NOSB Chair
USDA Organic Listening 

Session
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USDA Organic Listening Session

September 2011 | Washington, DC

• Goal: public feedback on USDA activities and 

priorities related to organic agriculture. 

• Hosted by:

– National Organic Program

– USDA Organic Working Group 

(a USDA internal communications network)
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Public comments and USDA response

• Coordination of research needs with the USDA research 

agencies. 

– USDA $475,000 grant to Oregon State University for nonantibiotic treatments for the control of fire blight in organic 

apple and pear crops.

– Continue to provide input to USDA research agencies regarding 

NOP research needs.
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Public comments and USDA response

• Training of USDA service providers (NRCS, FSA, RMA) to 

provide support to prospective/organic farmers

– Effort funded by NOP, coordinated by the USDA Organic Working 

Group and USDA National Food and Agricultural Councils

– “Organic literacy” training effort for all USDA staff nationwide.

Includes training and printed materials for field offices. 
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Public comments and USDA response

• Protection of confidential business information and 

due process

– NOP 2607—Instructions for the Disclosure of Information 

concerning USDA Certified Organic Operations—revised to 

incorporate comments received.
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Public comments and USDA response

• Consistency in the interpretation and implementation of 

the USDA organic regulations. 

– New training modules to be presented at January 2012 certifier 

training: labeling, accreditation criteria, adverse action 

procedures, and GMO policy

– Additional guidance under development

– Noncompliance notices: improper compliance procedures, 

inadequate review of Organic System Plans, and inconsistent 

application of the USDA organic regulations.
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Public comments and USDA response

• Consideration of regulatory burden and costs of new 

efforts to improve organic integrity.

– Recordkeeping requirements need to be adequate and 

reasonable. NOP training and audits will stress reasonable 

application of requirements. 

– Standardizing Organic System Plans, inspection reports and 

procedures will reduce redundancy 
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Public comments and USDA response

• Importance of the organic certification cost share 

program.

– USDA supports continued funding of the program. The 

certification cost share programs are very important to the 

continued success of small and beginning producers and 

handlers. 

– NOP has worked with states to expand utilization of cost share 

programs.

– 15% increase in cost share utilization in 2010. 
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Public comments and USDA response

• Consideration of compensation for damages from GE crops 

and greater efforts by USDA to protect organic farmers from 

GE contamination.

– Secretary Vilsack appointed the Advisory Committee on Biotechnology 

for 21st Century Agriculture (AC21) 

– Sec. Vilsack charged the AC21 committee with suggesting possible 

compensation mechanisms to mitigate impact of unintended GE 

presence in organic and non-GE crops.

– Next meeting (open public meeting) is Dec. 6-7 in Washington, DC
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Public comments and USDA response

• Support for USDA to provide access to foreign organic 

markets through trade agreements.

– The US/Canada Organic Equivalency Arrangement continues to 

work well, reduces costs and paperwork for organic producers 

and handlers. 

– USDA is optimistic about the prospect of an equivalency 

arrangement with the European Union and will pursue other 

arrangements that support market access and protect organic 

integrity.
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NOP Priorities

• Protect organic integrity 

each and every day

• Implement NOSB 

recommendations

• Develop real-time database 

of organic operations

• Implement Quality 

Management System

• Support consistent and fair 

implementation of the 

USDA organic regulations

• Streamline process for 

handling complaints and 

appeals
Overview of Audits and 

Related Activities
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Office of Inspector General Audit #1 

• Conducted: March 2010

• Scope: Multiple mission-critical functions of NOP, 

including:

– Compliance and enforcement

– Oversight of certifying agents and State Organic Program

– Statutory requirements (OFPA)
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OIG Findings

• Complaint processing and enforcement needs to be more 

timely and robust

– Strengthened enforcement procedures, utilization of civil penalties for 

willful violations

• Inadequate oversight of California’s state organic program

– California SOP audited and corrective actions implemented to ensure 

proper implementation of program.

• Periodic residue testing not implemented

– Proposed rule published and the final rule expected out next year.
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OIG Findings

• Peer review of NOP accreditation not performed

– NIST assessment completed, corrective actions are in process.

• Inconsistent program requirements

– Publications: Quality Manual, Program Handbook, Strategic 

Plan, Pasture rule, nine new draft guidance documents, seven 

new final guidance documents

• Audits of foreign certifiers not conducted

– Increased oversight of domestic and foreign certifying agents
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Office of Inspector General Audit #2

• Timing: Ongoing

• Scope: Organic milk

– Evaluate whether milk 

marketed as organic meets 

NOP requirements.
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Office of Inspector General Audit #3

• Timing: Ongoing

• Scope: National List and NOSB

– National List

Evaluate process for adding substances to National List 

of Allowed and Prohibited Substances
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National Institute of Standards and 

Technology (NIST) Assessment

• Peer review is required by OFPA and the NOP regulations.

• The March 2010 Office of Inspector General audit found 

that peer review had never been conducted.

• First phase completed in July 2011: 28 findings, 4 

observations

• NOP Corrective actions in process.
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NIST Findings

• Overall, NOP is designed to fulfill the requirements of 

USDA organic regulations. NOP documentation is 

organized in accordance with these requirements.

• The ISO/IEC 17011 elements not required in the USDA 

organic regulations are not always thoroughly presented 

in the documentation. 

• Additional work is necessary to align with 17011.

• NOP’s cooperation and timeliness allowed for an efficient 

and thorough document review.
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NIST Audit: NOP Actions

• Revised work agreement with NOP auditors

• Updated website to better communicate information 

on certification, accreditation, and related activities

• Drafting proposed regulation to remove FACA 

requirement related to accreditation

• Improving document and record control procedures
NOP Update

Activities & Priorities
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NOP Accreditation Program

• Improved the accreditation process from implementation 

of QMS aligned with ISO 17011

• Revised audit checklist based on certification and 

accreditation sections of NOP regulations.

• 2012 audits will focus on pasture rule implementation, 

grower group certification, materials review and approval 

process, conflict of interest, certifier compliance 

procedures 
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Standards Update

• Accomplishments since October 2010 (FY 2011)

• 2012 Preview: What’s next?
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Practice Standard Accomplishments

• Proposed Rule – Periodic Residue Testing

• Final Rule/comment discussion – Access to Pasture 

for Ruminant Slaughter Stock 
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National List Accomplishments

• Final Rule for crops/processing (aqueous potassium silicate; sodium carbonate 

peroxyhydrate; gellan gum; tragacanth gum, fortified cooking wines) 

• Final Rule livestock (methionine)

• Proposed Rule for crops/processing (lecithin, cheesewax, acidified sodium 

chlorite, dried orange pulp, Pacific kombu seaweed)

• Proposed rule for livestock (fenbendazole, moxidectin) 

• Proposed Rule for crops/livestock/processing (tetracycline, formic acid and 

attapulgite)

• Proposed and Final Rules - Sunset 2011

• Advanced Notice of Proposed Rulemaking – Sunset 2013
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Guidance Accomplishments

• Draft and Final Guidance for Wild Crops, Commingling, Compost 

and Chlorine 

• Draft Guidance for Made with Organic products ingredients and 

labeling 

• Draft Guidance on Seed/Annuals/Planting Stock (including 

commercial availability), Livestock Feed Additives, Kelp, and 

Responding to Positive Residue Testing Results;

• Program Handbook 2nd ed.(Jan 2011) and updates - residue 

testing instructions, policy memos on use of GMOs and textile 

labeling 
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Practice Standards: 2012 Preview

• Final Rule – Residue testing

• Proposed Rule - Organic pet food standards

• Proposed Rule – Remove FACA requirement from 

205.509

• Proposed Rule – origin of livestock
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National List: 2012 Preview

• Final Rule for livestock (fenbendazole, moxidectin)

• Final Rule for crops/processing (lecithin, cheesewax, 

acidified sodium chlorite, dried orange pulp, Pacific 

kombu seaweed)

• Final Rule for crops/livestock/processing (tetracycline, 

formic acid, attapulgite)

• Proposed Rule – Methionine 

• Proposed and Final Rule – Sunset 2012
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Guidance: 2012 Preview

• Final Guidance – “Made with Organic” products composition and labeling 

• Final Guidance - Seed/Annuals/Planting Stock (including commercial 

availability), Livestock Feed Additives, Kelp, and Responding to Positive 

Residue Testing Results

• Draft Guidance – Certification of handlers of bulk organic products

• Draft Guidance – Post-harvest materials

• Draft Guidance – Classification of materials

• Draft Guidance – Organic Seafood/Aquaculture Labeling
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Pending Actions: NOSB National List 

Recommendations

• Injectable trace minerals, vitamins and electrolytes (L)

• Chlorhexidine (L)

• Xylazine (L)

• Excipients (L)
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Pending Actions: NOSB Practice 

Standard Recommendations

• Mushrooms

• Greenhouses

• Apiculture

• Aquatic animals 

• Outdoor access for poultry
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Appeals

• OFPA sec. 2121 – Secretary shall establish expedited administrative 

appeals process.

• In 2009 the average timeline for appeal decisions was 2 years.

• New initiative to reduce appeals time. 

• More resources directed to appeals (Appeals staff, Office of General 

Counsel)

• Appeals staff conduct early analysis to determine potential settlement 

options.

• Currently almost all 2010 appeals closed, goal is to close appeals within 

90-180 days of appeal filing date in 2012.
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Complaint Management Update

Since October 2010:

• Received and commenced investigative activities on 181 

complaints, representing a 15% increase from Fiscal Year 

2010.

• Closed 128 complaints, representing a 20% increase from 

Fiscal Year 2010. 

• Achieved a 177-day average time period for complaint 

closures.
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Enforcement Update

Since October 2010:

• Issued 10 civil penalties through settlement agreements 

for willful violations of the USDA organic regulations.

• Implemented enforcement action procedure of 

publishing notices of NOP fraudulent certificates.

– Three notices have been published to date. Each involved an 

international operator’s misrepresentation of agricultural 

products as certified organic through falsification of an NOP 

certificate.
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Key Priorities for FY2012

• Develop formal scoring matrix and publish guidance to ensure consistency 

and fairness in civil penalties and other enforcement actions

• Work with other AMS and USDA stakeholders to improve the timeliness 

and tracking of post-decision activities (such as civil penalty collections).

• Continue to refine case management procedures to reduce time to closure 

while maintaining investigative rigor. 

• Develop tools to point non-certified violators of the organic regulations 

towards a path of certification, to enable them to become compliant 

community members. 
National Organic Standards 

Board
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NOP Response to Seattle NOSB 

Meeting – April 2011

• Sunset 2012 including annotation changes

– First time NOP is changing annotations during sunset. 

– NOP will propose to amend the nutrient vitamins and minerals annotation .

– NOP will propose annotations for hops, sodium nitrate and chlorine

• No decisive vote to classify corn steep liquor (CSL)

– NOSB did not decide whether CSL is natural or synthetic

– CSL retains status as natural substance
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“Other Ingredients”

• Overview: Request for Clarification of “Other 

Ingredients” in Processed Organic Products
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National List Setup

• Organic Foods Production Act grants NOSB authority to 

recommend substances for inclusion on the National List.

• All synthetics used in organic crop and livestock production 

must be on National List.

• All nonagricultural substances used in processed organic food 

must be on National List.
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What Are “Other Ingredients?”

• Formulated products often include “other ingredients.” 

• For example:

– Pesticides include inert ingredients

– Medications include excipients

– Feed supplements include minor ingredients

– Enzymes include carriers, stabilizers and preservatives.
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Crop and Livestock: What’s Allowed

Crop input materials (fertilizers, soil 

amendments, pesticides) may 

contain ingredients that are:

• Natural (nonsynthetic)

• Listed under 205.601

• EPA List 4 (pesticide formulations 

only); EPA List 3 (passive 

pheromone dispensers only)

Livestock input materials (feed 

supplements, medications) may contain 

ingredients that are:

• Feed, feed additives, supplements: All 

agricultural ingredients in ingredients 

list must be organic

• Natural (nonsynthetic) substances 

allowed.

• Synthetics listed on 205.603.

• Excipients (allowed in FDA-approved 

medications only).

.
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Processing Substances: What’s Allowed

• Processed organic foods may contain nonagricultural minor 

ingredients or processing aids that are listed on 205.605:

– Examples: natural flavors, microbial products, vitamins, and enzymes.

• When used as a formulated product, 205.605 substances used in 

commercial food preparation often contain “other ingredients:” 

– Examples: carriers, stabilizers and preservatives. 

– In most cases, FDA considers these “other ingredients” as incidental and 

they are not required to be listed on the ingredients list.

– Are “other ingredients” that are not specifically listed on the National List 

allowed?
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Which “Other Ingredients” Are Allowed?

• OFPA requires that each non-agricultural ingredient be 

specifically allowed. Many of these “other ingredients” in 605 

substances aren’t on the National List.

• The NOP, certifiers and the organic trade have allowed “other 

ingredients” (unless annotations limit “other ingredients”) 

(e.g. natural flavors and solvents)

• Additional clarity is needed: request for NOSB to specify 

which “other ingredients” are allowed.
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Request to NOSB

• NOP is requesting that NOSB clarify what “other ingredients” are allowed in 

non-agricultural substances listed under 205.605.

• NOSB needs to develop a comprehensive recommendation on “other 

ingredients” in 205.605 substances.

• In the meantime, the NOSB should include reference to “other ingredients” in 

the background of their recommendation. Any recommended restrictions 

should be part of the recommended annotation.

• Clarification from the NOSB regarding the allowance or restriction of “other 

ingredients” will provide consistency to the organic trade, consumers and 

certifiers as the NOP codifies these recommendations into regulations.
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Comments on NOSB Proposals

• Inspector qualifications. The USDA Fruit and Vegetable Program licenses hundreds 

of state inspectors. NOP could develop a similar process for licensing organic 

inspectors.

• Organic research needs. NOP is collaborating with the Agricultural Research 

Service on technical report review and priority research needs of organic 

community.

• Conflict of interest. NOSB members are appointed because they have interests. 

They represent a specific interest or group (e.g. producers, handlers, scientists, 

consumers, etc.). Representatives articulate the interests of their particular group 

and are not appointed to provide independent expert advice. They represent a 

particular bias. It is important for all perspectives of the organic community to 

have a voice in the process. 
2012 NOSB Members
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Welcome to the NOSB!

• Member, Producer

• Member, Scientist

• Member, Environmentalist

• Member, Handler

• Member, Consumer / Public Interest
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Thank you for 

your input while 

we continue 

improving NOP!

www.ams.usda.gov/nop | 202-720-3252
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Classification of Materials

• Under the Organic Foods Production Act, classification is 

necessary for determining eligibility and placement on the 

National List

• Crop and Livestock Production:

– Natural or Synthetic

– Non-Agricultural or Agricultural (Livestock)

• Handling

– Agricultural or Non-Agricultural

– Non-Agricultural: Synthetic or Natural
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Previous Work: Classification of Materials

NOSB Formal Recommendations

• April 20, 2011

• May 24, 2010

• November 5, 2009

• August 17, 2005
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Previous Work: Classification of Materials

• Joint Materials and Handling Committee

• Draft Guidance: March 1, 2010

• Discussion Document: October 19, 2007

• Recommendation: September 9, 2009

• Materials Working Group
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Determining Classification

• Most substances are straightforward to classify; some substances are 

more challenging

• Classification is currently done by NOSB, certifying agents, and material 

review organizations

• For production, NOSB generally only receives petitions for substances 

petitioned for use as synthetic; natural substances are not typically 

reviewed by NOSB

• For handling, only agricultural substances are subject to commercial 

availability

• NOP regulations need to be clear and applied consistently
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Guidance on Classification of Materials

• NOP is developing draft guidance based upon the 

November 2009 NOSB Recommendation for 

Classification of Materials

• NOP will engage NOSB Materials Committee for initial 

feedback

• Draft guidance will be available for public comment 

before the NOP issues final guidance
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Key Elements

• Separate decision trees for production and handling

• Example materials

• Clarification of the distinction between extraction, 

manufacture, and formulation

• Draft guidance will be available for public comment 

before the NOP issues final guidance
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Related Guidance:

List of Permitted Substances

• NOP plans to publish draft guidance on a generic list 

of substances allowed for use in organic crop 

production

• List will include allowed natural and synthetic 

substances

• Will ensure consistency in decision making