United States Dept. of Agriculture | Agricultural Marketing Service

4/27/2011 1

National Organic Program

Organic Integrity from Farm to Table

Consumers Trust the Organic Label

National Organic Standards Board | April 26, 2011
United States Dept. of Agriculture | Agricultural Marketing Service

Overview

• Program update

• Materials

• Nutrient vitamins and minerals
United States Dept. of Agriculture | Agricultural Marketing Service

Protecting organic integrity

• Clear, enforceable standards

• Rigorous certification process

• Enforcement
United States Dept. of Agriculture | Agricultural Marketing Service

Program Update

• FY 2010 Budget = $6.9 million

• FY 2011 Budget = requested $3.1 

million increase 

• Final FY 2011 Budget reflects 

2010 numbers - $6.9 million

• FY 2012 request is for $9.8 million

• Arthur Neal is now Deputy 

Administrator of the AMS 

Transportation and Marketing 

Program

• Ruihong Guo is Acting Associate 

Deputy Administrator

• New hires include 

Communications Director, more 

Ag Marketing Specialists
United States Dept. of Agriculture | Agricultural Marketing Service

Office of Inspector General (OIG)

Audit of NOP – March 2010

Findings

1. NOP needs to improve enforcement

2. Processing of complaints needs to be more timely

3. Oversight of California’s state organic program inadequate

4. Periodic residue testing not implemented

5. Peer review of NOP accreditation not performed

6. Inconsistent program requirements

7. Audits of foreign certifiers not conducted
United States Dept. of Agriculture | Agricultural Marketing Service

OIG Recommendations

NOP Corrective Action Plan

• The OIG made 14 recommendations for program 

improvements.

• The NOP has completed corrective action on 13 out of 14 

recommendations.

• Recommendation #9 Peer review panel, (in process)

• National Institute of Standards and Technology (NIST) is 

conducting assessment of NOP Quality Management System, 

• New NOP procedure for annual review of NOP audits
United States Dept. of Agriculture | Agricultural Marketing Service

National Organic 7

Strategic Plan: link from homepage

www.ams.usda.gov/NOPNationalOrganicProgramHome
United States Dept. of Agriculture | Agricultural Marketing Service

1. Quality management

• Objectives

– Develop and publish Quality Manual

– Analyze existing processes and develop QMS aligned with ISO 17011

– Implement and train NOP staff on the QMS

– Conduct internal audits, management reviews and continuous 

improvement efforts
United States Dept. of Agriculture | Agricultural Marketing Service

1. Quality management

• Performance

– Quality Manual published in August 2010

– ARC and NOP collaborated to analyzed and improve accreditation and 

audit procedures to align with ISO 17011. Training conducted on 

new system in March-April 2011.

– Implementation and training of NOP staff on the QMS is ongoing. 

Each division has an Assistant Quality Manager to assist in training 

and implementation.

– Mid-year assessment of strategic plan. NOP integration team is 

making improvements. Internal audit and management review to 

occur later this year.
United States Dept. of Agriculture | Agricultural Marketing Service

2. Standards - consistency

• Objectives

– Publish Program Handbook

– Develop and publish additional organic practice 

standards

– Implement NOSB recommendations

– Develop system to respond to questions and 

interpretations of NOP regulations
United States Dept. of Agriculture | Agricultural Marketing Service

2. Standards

• Performance

– Published Program Handbook, 1st and 2nd edition.

– Residue testing rule in clearance, other practice 

standards and National List rules under development or 

in clearance.

– Provided training to NOP auditors on Program 

Handbook. 

– New internal public inquiries tracking and 

documentation system under development.
United States Dept. of Agriculture | Agricultural Marketing Service

2. Standards

• Since October 2010, published rules, guidance and notices including:

– Proposed Rule –National List for crops/processing (lecithin, cheesewax, acidified 

sodium chlorite, orange pulp, Pacific kombu seaweed); 

– Final Rule – National List for crops/processing (aqueous potassium silicate; sodium 

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

– Proposed Rule - Sunset 2011; 

– Notice – Draft Guidance for Made with Organic ingredients and labeling; 

– Notice – Draft Guidance for Wild Crop, Poultry, Commingling, Compost and Chlorine; 

– Second edition of Program Handbook (Jan 2011) – including residue testing 

instructions; 

– Notice – Section 610 Review per requirements of Regulatory Flexibility Act; 

– Notice – Information Collection per requirements of OMB; and 

– Final Rule – National List for livestock (methionine).
United States Dept. of Agriculture | Agricultural Marketing Service

2. Standards

• Forthcoming rules, guidance and policies (anticipated Spring-Summer 

2011):

– Advanced Notice of Proposed Rulemaking – Sunset 2013;

– Proposed Rule – Periodic Residue Testing;

– Proposed Rule –National List for livestock (fenbendazole, moxidectin);

– Notice – Final Guidance for Wild Crop, Poultry, Commingling, Compost and Chlorine; 

– Notice – Ruminant Slaughter Stock under Access to Pasture; 

– Final Rule –National List for crops/processing (lecithin, cheesewax, acidified sodium 

chlorite, orange pulp, Pacific kombu seaweed); 

– Final Rule - Sunset 2011; 

– Notice – Draft Guidance on Seed/Annuals/Planting Stock (including commercial 

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

Testing Results;

– Third edition of Program Handbook (July 2011). 
United States Dept. of Agriculture | Agricultural Marketing Service

3. Accreditation - oversight

• Objectives

– Conduct thorough and timely audits of 

certifiers, state organic programs and foreign 

governments.

– Develop real-time database for certified 

operations.
United States Dept. of Agriculture | Agricultural Marketing Service

3. Accreditation - oversight

• Performance

– All foreign audits completed and on schedule.

– Implemented requirement for pre-decisional 

audits prior to granting accreditation, 3 predecisional audits conducted in 2010.

– Completed assessment of Canadian Organic 

Regime and California State Organic Program.
United States Dept. of Agriculture | Agricultural Marketing Service

3. Accreditation - oversight

• Performance

– Developed new audit review checklist that will be implemented in 

2011. New checklist will score certifiers for % compliance with 

accreditation requirements.

– Established designated accreditation specialists to provide technical 

support to certifying agents.

– Removed accreditation from two accreditation agents through 

settlement agreements.
United States Dept. of Agriculture | Agricultural Marketing Service

International Activities

• U.S. – Canada Organic Equivalency Arrangement

– Technical working group, steering committee, mutual 

peer assessment, request to remove stocking rates critical 

variance for ruminants

• EU equivalency

– EU mission in October 2010, US assessment of EU 

program later this year. 

• Other priorities – China, Korea, Japan

17
United States Dept. of Agriculture | Agricultural Marketing Service

4. Compliance and 

Enforcement

• Objectives

– Handle complaints and enforcement actions in a 

timely manner.

– Classify and prioritize complaints

– Develop on-site investigative procedures and 

penalty matrix.
United States Dept. of Agriculture | Agricultural Marketing Service

4. Compliance and Enforcement

• Performance

– Closed 71 complaints in first 6 months of fiscal year 

2011, improving the closure rate by 15% over 2010. 

• 36 complaints alleged the representation of products as organic 

without certification.

• 11 complaints alleged labeling violations of certified products.

• 2 complaints alleged the use of a fraudulent NOP certificate .

– Streamlined complaint intake procedures by establishing 

internal investigative priority policy.
United States Dept. of Agriculture | Agricultural Marketing Service

4. Compliance and 

Enforcement

• Performance

– Collected 8 civil penalties for willful violations of the 

NOP regulations in first 6 months of fiscal year 2011, 

compared to 10 civil penalties collected in FY2010. 

– Implemented enforcement action procedure of 

publishing notices of NOP fraudulent certificates. 

• Two notices have been published to date. Both involved an 

international operator’s mispresentation of agricultural products as 

certified organic through falsification of an approved Accredited 

Certifying Agent’s certificate. 
United States Dept. of Agriculture | Agricultural Marketing Service

5. Management strategy

• Effectively manage the human resources, 

communication, and administrative activities of 

the NOP.

– National Organic Standards Board

– Cost Share Programs

– Human resources, civil rights

– FOIA, Transparency, Communication
United States Dept. of Agriculture | Agricultural Marketing Service

5. Management strategy

• Performance

– Developed employee handbook for NOP staff.

– NOP Organic Insider developed to disseminate information.

– Certifier trainings, numerous presentations

– New technical report contractor; should expedite response time to 

TR requests from NOSB. 

– New internal petitioned substances database. 

– Met federal requirements for disclosing information and redacting 

non-disclosable info under the Freedom Of Information Act.
United States Dept. of Agriculture | Agricultural Marketing Service

4/27/2011 23

Positive trends

• Certifiers effective in 

protecting organic 

integrity 

• Vast majority of organic 

operations comply with 

organic standards

• Organic products have 

minimal pesticide residues
United States Dept. of Agriculture | Agricultural Marketing Service

Materials used in organic 

agriculture

• Long history of use

• Consistent with organic principles

• The Organic Food Production Act (OFPA) 

does not state that the list of allowed 

materials should be minimized.
United States Dept. of Agriculture | Agricultural Marketing Service

Crop materials – over 500 natural 

substances and 88 synthetics

• Greenhouse, potting soils

• Compost, manure, rock minerals, soil amendments, 

liquid fertilizers, micronutrients

• Pest Control – botanicals, dormant oils, Bt, sulfur, 

pheromones

• Inert ingredients

• Crop production aids – gibberellic acid, cytokinins, 
United States Dept. of Agriculture | Agricultural Marketing Service

Livestock materials – over 400 

naturals and 38 synthetics

• Livestock feed

– Feed additives – vitamins, minerals, methionine

– Feed supplements – molasses (must be organic) 

• Health care 

– Vaccines

– Health care – medications, probiotics, excipients
United States Dept. of Agriculture | Agricultural Marketing Service

Handling – Post-harvest substances, 

processing aids & ingredients

Both naturals and synthetic must be listed. 

• 28 Naturals –§205.605(a)

• 44 Synthetics –§205.605(b)

• Agricultural – must be organic or 

– 43 agricultural substances on §205.606, must be organic 

or not commercially available as organic
United States Dept. of Agriculture | Agricultural Marketing Service

Handling – Post-harvest substances, 

processing aids & ingredients

• Natural - citric acid, bentonite, dairy cultures, 

enzymes, flavors, microorganisms, waxes

• Synthetic – Ascorbic acid, baking soda, baking 

powder, chlorine, ethylene, glycerin, vitamins and 

minerals, xanthan gum

• Agricultural – 19 colors, casings, celery powder, fish oil, 

gelatin, gums, kelp, cornstarch, wakame seaweed, 
United States Dept. of Agriculture | Agricultural Marketing Service

Organic Foods Production Act

• Designed to respect the authority of the organic community 

through the National Organic Standards Board (NOSB)

• Natural substances (non-synthetics) allowed unless 

prohibited.

• Synthetic substances prohibited unless allowed (NOSB 

recommendation and rulemaking to add substance to 

National List)

• OFPA has no restrictions regarding length of materials list

29
United States Dept. of Agriculture | Agricultural Marketing Service

NOSB

• NOSB has statutory authority to review and recommend 

approval of the following classes of materials:

– Synthetics in crop production

– Synthetics in livestock production

– Non-synthetics and synthetics in organic handling - Ingredients and 

processing aids 

• NOSB recommends prohibitions on natural substances.

• NOSB advises the Secretary on any other aspect of the 

implementation of the NOP.

30
United States Dept. of Agriculture | Agricultural Marketing Service

National Organic Program

• Supports the work of the NOSB

– Liaison between NOSB and National List petitioners

– Coordinates development of technical reports by 3rd party 

contractors

– Takes notes for NOSB committee work

– Facilitates logistics of the NOSB meetings

– Ensures a public and transparent process

• The NOP respects the work of the NOSB

and strives to implement their recommendations.

31
United States Dept. of Agriculture | Agricultural Marketing Service

NOP responsibility

• Clear, enforceable standards including a clear list of 

allowed substances.

• Cannot add substances to the National List unless 

the NOSB has reviewed and recommended adding 

materials to the National List.

• Ensure NOSB recommendations are clearly defined and 

follow the process outlined in OFPA, the NOP regulations, 

and the NOSB Policy Handbook.

32
United States Dept. of Agriculture | Agricultural Marketing Service

Respect

• Reasonable and well-intentioned people have 

different opinions and perspectives.

• Spirited debate and public input

• We are all part of the same organic 

community, we will not always agree, and we 

should respect the process and the decisions 

made by the NOSB.

33
United States Dept. of Agriculture | Agricultural Marketing Service

Nutrient Vitamins and 

Minerals
United States Dept. of Agriculture | Agricultural Marketing Service

1995 NOSB Recommendations

• Vitamins and minerals required by law

• Accessory nutrients allowed or supported by independent 

professional organizations

• Nutrients not specifically classified as vitamins and 

minerals.

• Omega-3 fatty acids

• Inositol, Choline, Carnitine, Taurine

• Open ended list to support continued development of 

nutritionally rich foods
United States Dept. of Agriculture | Agricultural Marketing Service

Nutrient Vitamins and Minerals

National List, 7 CFR 205.605 (b) Synthetics allowed: 

Nutrient vitamins and minerals, in accordance 

with 21 CFR 104.20, Nutritional Quality 

Guidelines For Foods.

The reference states that only vitamins and minerals are 

allowed, nutrients that are not vitamins or minerals are not 

referenced in the National List – 205.605(b).
United States Dept. of Agriculture | Agricultural Marketing Service

Background

• In 2006, NOP received a complaint alleging violation to the 

National Organic Standards for certified organic products 

that contained accessory nutrients

• NOP determined that accessory nutrients were allowed 

based on an interpretation of 7 CFR 205.605(b), 21 CFR 

104.20, and past NOSB recommendations

• In 2008, the NOP determined that lutein ester did not fall 

under the FDA fortification policy and was not allowed in 

organic foods. The letter also stated that only nutrients 

listed in 21 CFR 104.20(d)(3) were allowed.
United States Dept. of Agriculture | Agricultural Marketing Service

Food and Drug Administration – Center 

for Food Safety and Applied Nutrition

• Limited scope of the regulatory citation, Nutritional Quality Guidelines for 

Food, 21 CFR 104.20

• 21 CFR 104.20 does not cover the use of nutrients such as taurine, DHA, 

ARA, lycopene, lutein, 

• Does not include nutrients used in infant formula or pet food

• FDA does not define “accessory nutrients”

• FDA suggested that 21 CFR 101.9, 107.100 and 107.10 are the 

appropriate regulatory references to include essential and approved 

vitamins, minerals and other nutrients for infant formula and the 

fortification of foods. 
United States Dept. of Agriculture | Agricultural Marketing Service

NOP Action Plan

• The NOP lacks a clear list of nutrients, vitamins and minerals allowed 

in organic food products. 

• Previous NOP interpretation of nutrient vitamins and minerals allowed 

under 205.605(b) was incorrect. 

• The NOP recognizes that many certified operations made business 

decisions based on the 1995 NOSB recommendations and statements 

provided previously by the program.

• The NOP plans to publish draft guidance that will clarify the FDA 

interpretation of 21 CFR 104.20 – only nutrient vitamins and minerals 

listed in 104.20(d)(3) and those identified as essential nutrients in 21 

CFR 101.9 are allowed under the NOP standards.
United States Dept. of Agriculture | Agricultural Marketing Service

NOP Action Plan

• The NOP plans to provide a transition time for businesses to 

reformulate products to comply with the regulations as per 

the FDA interpretation

• The draft guidance will be published in the Federal Register 

with a 60 day comment period for the draft guidance

• The NOP will publish final guidance after considering the 

comments received.
United States Dept. of Agriculture | Agricultural Marketing Service

NOP Action Plan

• Nutrients, vitamins and minerals required for pet food will 

be covered by separate rulemaking.

• DHA, ARA, choline and taurine have been petitioned and 

are awaiting board action.

• The NOP advises companies that they may petition to add 

substances to the National List including nutrients, 

vitamins and minerals not allowed under 21 CFR 104.20.
United States Dept. of Agriculture | Agricultural Marketing Service

Summary

• NOSB needs to review and approve all substances on 

National List

• Clear list of allowed and prohibited substances is needed

• Open and transparent public process is essential.

• Adequate time is needed for organic trade to petition 

substances not included under 21 CFR 104.20, for NOSB to 

review, and for any rulemaking to be completed.
United States Dept. of Agriculture | Agricultural Marketing Service

4/27/2011 43

We are all in this together!
Thank You
United States Dept. of Agriculture | Agricultural Marketing Service

4/27/2011 45

www.ams.usda.gov/nop

202 720 3252