United States Department of Agriculture

Agricultural Marketing Service

National Organic Program

Organic Integrity from Farm to Table

Consumers Trust the Organic Label

National Organic Standards Board

Madison, Wisconsin – October 25, 2010

Miles McEvoy, Deputy Administrator
United States Department of Agriculture

Agricultural Marketing Service

Priorities

• Uphold and enforce the 

standards

• Implement and enforce 

the Access to Pasture 

final rule

• Implement Strategic 

Plan

• Implement the NOSB 

recommendations

• Quality management 

system

• Increased oversight 

over foreign operations

• Training and 

accountability of 

certifiers
United States Department of Agriculture

Agricultural Marketing Service

Accomplishments

• Completed Quality Manual, Program Handbook and Strategic Plan

• Published draft guidance

• Increased oversight of domestic and foreign certifying agents – Ghana, 

China, Mississippi, Ohio, Maine

• Strengthened enforcement procedures

• Transparency and communication – NOP Report; publication of 

suspended, reinstated and revoked operations; NOP responses to NOSB 

recommendations.
United States Department of Agriculture

Agricultural Marketing Service
United States Department of Agriculture

Agricultural Marketing Service

Office of Inspector General

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 Department of Agriculture

Agricultural Marketing Service

Fourteen Recommendations

NOP Corrective Action Plan

• Recommendations 1-6 (complete)

– Enforcement actions pursued, eight civil penalties issued, improved complaint 

reporting and timeliness, procedures for monitoring continued compliance 

implemented, resolved all old complaints

• #7 - California State Organic Program (SOP) – (complete)

– Audit conducted in December 2009

– New California SOP program implemented in 2010

• #8 - Periodic residue testing (in process)

– Rulemaking to require testing under development. 
United States Department of Agriculture

Agricultural Marketing Service

Corrective Action Plan

– #9 Peer review panel, (in process)

• NIST is conducting assessment of NOP Quality Management 

System, new NOP procedure for annual review of NOP audits

– #10 Accreditation process (complete)

• Revised the NOP audit review criteria, implemented annual review 

of NOP audits

– #11 Clarify program requirements (complete)

• Program Handbook and draft guidance published.
United States Department of Agriculture

Agricultural Marketing Service

Corrective Action Plan

– #12 Organic certificates (complete)

• Published instructions on Organic Certificates, responded to NOSB 

recommendations, rule making to follow

– #13 Disseminate guidance in a standardized method 

(complete)

• Program handbook, draft guidance, policy memos

– #14 Improve oversight of foreign certifying agents 

(complete)

• All foreign audits complete and on schedule. Additional foreign 

audits conducted – Ghana, China
United States Department of Agriculture

Agricultural Marketing Service

New OIG audit – Organic Milk

• Evaluate whether milk marketed as organic 

meets NOP requirements.

• Assess the adequacy of the AMS oversight 

provided by certifying agents.
United States Department of Agriculture

Agricultural Marketing Service

National Organic 10

Strategic Plan: link from homepage

www.ams.usda.gov/NOPNationalOrganicProgramHome
United States Department of Agriculture

Agricultural Marketing Service

NOP Strategic Plan

Organic Integrity from Farm to Table

Consumers Trust the Organic Label

MISSION: 

The NOP facilitates trade and ensures integrity of 

organic agricultural products by consistently 

implementing organic standards and enforcing 

compliance with the regulations throughout the world.
United States Department of Agriculture

Agricultural Marketing Service

1. Quality management

• Develop, implement, and maintain a quality 

management system (QMS) for the efficient and 

effective operation of the NOP.

– Quality Manual

– ISO 17011

– Peer review by National Institute of Standards and 

Technology

– Effective, consistent, efficient, scalable
United States Department of Agriculture

Agricultural Marketing Service

2. Standards - consistency

• Develop and communicate clear and 

consistent NOP standards in a uniform 

manner.

– Program Handbook – Guidance and Instructions

– Policy Memorandums

– Training of certifying agents
United States Department of Agriculture

Agricultural Marketing Service

3. Accreditation - oversight

• Enhance compliance with and enforcement 

of organic regulations.

– Audits of certifying agents

– Continuous improvement, training, technical 

assistance

– Accountability, consistent application and 

implementation of the standards
United States Department of Agriculture

Agricultural Marketing Service

4. Compliance and enforcement

• Ensure consistent application of the NOP 

regulations by the ACAs, State Organic 

Programs, and via International Agreements.

– Complaint handling

– Investigations

– Civil penalties, penalty matrix

– Appeals, hearings, due process
United States Department 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 Department of Agriculture

Agricultural Marketing Service

United States Department of 

Agriculture

Office of the Secretary

Secretary of Agriculture

Mission Area

Marketing and Regulatory Programs

Under Secretary

Agency Level

Agricultural Marketing Service

Administrator

Program Level

National Organic Program

Deputy Administrator
United States Department of Agriculture

Agricultural Marketing Service

AMS 

Administrator

NOP

Deputy Administrator

1 FTE

Director 

Standards Division

1 FTE

Staff

7 FTE

National Organic 

Standards Board

(NOSB)

Director 

Accreditation & Int’l Activities 

Division

1 FTE

Director 

Compliance & Enforcement

Division

1 FTE

Staff

6 FTE

Staff

6 FTE

Quality Manager

1 FTE

Advisory Board Specialist 

1FTE

Grants Contracts Specialist

1FTE

NOP 

Associate Deputy Administrator 

1 FTE

NOSB Executive Director

1 FTE Administrative Assistant

1 FTE

Livestock & Seed 

Program

ARC Branch

(Assessments)

Compliance and 

Analysis Program

(Appeals)

Training Manager

1 FTE

NOP Compliance 

Officer 

1 FTE
United States Department of Agriculture

Agricultural Marketing Service

Year Budget # staff

2002 $ 1.6 million 6

2003 $ 1.0 million 6

2004 $ 1.6 million 5

2005 $ 1.5 million 6

2006 $ 1.5 million 7

2007 $ 1.5 million 8

2008 $ 2.65 million 14

2009 $ 3.87 million 16

2010 $ 6.97 million 31

2011 (President’s budget) $10.1 million 32
United States Department of Agriculture

Agricultural Marketing Service

New staff

• Melissa Bailey, Standards Director

• Betsy Rakola, Cost Share Program Manager

• Patricia Atkins, Secretary

• Details – John Punzi, Lee Cliburn

• Public Affairs – Soo Kim

• AMS Compliance – Jeff Sotosky
United States Department of Agriculture

Agricultural Marketing Service

Organic Certification Cost Share Programs

Eligibility

- Certified organic producers and handlers 

Mechanism

- Cooperative agreements with state agencies

Total Funding

- $6 million for FY11 reimbursements

Total Reimbursement

- 75% of certification costs, maximum of $750 annually
United States Department of Agriculture

Agricultural Marketing Service

Authorization and Funding

Two programs: Ag. Management Assistance and 

National Cost Share

AMA: approx. $1.5 million annually from 2001 

Federal Crop Insurance Act

NCS: $22 million allocated in the 2008 Food, 

Energy and Conservation Act
United States Department of Agriculture

Agricultural Marketing Service

Goal: Increase Awareness and 

Participation

For the last two years, only 74% of budgeted 

funds have been spent by states.

Approximately 45% of certified organic 

operations in the US receive reimbursements

NOP seeks to increase participation significantly
United States Department of Agriculture

Agricultural Marketing Service

New projects

• ATTRA – Organic System Plans

• Pesticide residue testing project – 6 commodities, results 

available in early 2011

• Business Process Analysis – prelude to NOP database

• Development of a penalty matrix

• Technical reports

• Assistance with rule writing

• Cosmetics – collaborating with FDA, market study
United States Department of Agriculture

Agricultural Marketing Service

Standards Division – Melissa Bailey, Director 

• Rulemaking – Practice Standards, National List

• NOP Program Handbook – instructions and guidance

• National List 

– petition process

– Technical reports

– Sunset review by the NOSB

• Interpretations, provide consistency to certifiers and certified 

operations.
United States Department of Agriculture

Agricultural Marketing Service

NOP Program Handbook 

• Guidance

– Clarification of existing regulation

– Organic certificates

– Liquid fertilizer

• Instructions/Procedures

– Information to certifying agents concerning accreditation requirements

– Responsibilities of certified operations changing certifying agents

– Accreditation procedures

– Enforcement policy
United States Department of Agriculture

Agricultural Marketing Service

Draft guidance 

– Wild crop certification 

– Compost

– Chlorine

– Commingling

– Outdoor access for poultry

Under development

– Nutrient Vitamins and Minerals

– “Made with organic ingredients”
United States Department of Agriculture

Agricultural Marketing Service

Rulemaking

1. Pesticide residue testing

2. Origin of Livestock

3. Streamlining appeals process

4. Apiculture

5. Mushrooms

6. Pet food

7. Aquaculture

8. Greenhouses 
United States Department of Agriculture

Agricultural Marketing Service

Access to Pasture implementation 

• Notified certifiers that full assessments for compliance with 

new pasture rule needs to occur during the 2010 grazing 

season.

• NOP is conducting assessments during the implementation 

period.

Made with organic labeling

• Guidance for percentage claims and allowed ingredients out 

early next year.

• Rule making needed to address the use of “organic” in the 

brand name on the principal display panel
United States Department of Agriculture

Agricultural Marketing Service

Accreditation and International Activities 

Division – Ruihong Guo, Director

• ~ 95 Accredited Certifying Agents (ACAs)

• NOP audits of certifying agents – pre-decisional, mid-term, 

renewal, compliance assessments

• State Organic Programs

• Reinstatements and Temporary Variances

• Recognition agreements

• Equivalency arrangements
United States Department of Agriculture

Agricultural Marketing Service

Accreditation and International Activities 

Division – new initiatives

• Audits prior to new accreditations

• Additional audits conducted – Ghana, China, 

Mississippi conducted in 2010

• Increased accountability – Annual Updates, adverse 

action notices, lists of certified operations

• Organic Harmonized Trade Codes 
United States Department of Agriculture

Agricultural Marketing Service

6 Recognition Agreements and One 

Equivalency Agreement
United States Department of Agriculture

Agricultural Marketing Service

Compliance & Enforcement Division – Mark 

Bradley, Director 

New and revised procedures

• Complaint Handling Procedures –goal to close cases within 180 days

• Enforcement Policy

• Enforcement Actions Follow-up Monitoring 

• Civil Penalty procedures – evaluating NOP authority, rule change

• Publication of Suspensions, revocations, reinstatements, civil penalties

• Penalty matrix development
United States Department of Agriculture

Agricultural Marketing Service

Age of enforcement

• Civil penalties

• Three additional compliance officers

• Revised enforcement procedures –

• Proposed streamlining of appeals process
United States Department of Agriculture

Agricultural Marketing Service

Civil penalties

• § 205.100 (c) Any operation that: 

• Knowingly sells or labels a product as organic, 

except in accordance with the Act, shall be 

subject to a civil penalty of not more than 

$11,000 per violation. 
United States Department of Agriculture

Agricultural Marketing Service

Civil penalties

“Per Violation” may be defined as (but not limited to):

• Per regulatory citation violated, Per purchase order, invoice, or bill of 

lading

• Per shipment, Per box, Per product label, Per package 

The determination of what unit to use to count violations will be based on 

what is reasonable and what is supported by the evidence obtained 

through investigation (i.e. packages obtained, inspections, photographs, 

testimonials, purchase orders acquired, website printouts). 
United States Department of Agriculture

Agricultural Marketing Service

Civil penalties

• Minor Noncompliance is defined as a violation that is correctable, does 

not affect the integrity of the organic system or the organic product, and 

does not preclude the certification or continued certification of an 

otherwise qualified organic producer or handler. Examples of a “minor 

noncompliance” include failure to submit information on time, failure to 

update the organic system plan, and inadequate record-keeping.
United States Department of Agriculture

Agricultural Marketing Service

Civil penalties

• Major Noncompliance is defined as a violation of organic standards that 

affects the integrity of the organic system or the organic product and 

precludes the certification or continued certification of a producer or 

handler. Examples of a "major noncompliance" include the application of 

a prohibited substance, the commingling of organic with nonorganic 

products, the contamination of organic products with prohibited 

substances, and the failure to correct a minor noncompliance. 

• Willful violation refers to an intentional violation of the Act or plain 

indifference to its requirements.
United States Department of Agriculture

Agricultural Marketing Service

Civil penalties

• 8 civil penalties issued in 2010

• 6 civil penalties issued to non-certified operations for 

making organic claims

• 2 civil penalties to certified operations, one for using 

non-organic seeds in organic sprout production, the 

other for using organic ingredients from a falsified 

certificate.
United States Department of Agriculture

Agricultural Marketing Service

Enforcement policy

• NOP noted that problems with investigations 

and enforcement actions

– Inadequate investigations

– Errors in adverse action notices

• NOP decided to monitor/supervise certifiers 

investigations – collaborate for training and 

effectiveness.
United States Department of Agriculture

Agricultural Marketing Service

New enforcement policy

• Collaborate with certifiers and other 

authorities (e.g. EPA, FDA, state authorities)

• Review reports of investigations to determine 

next steps

– If minor violations let certifiers handle

– If willful violations then NOP issues adverse action
United States Department of Agriculture

Agricultural Marketing Service

Positive trends

• Certifiers are effective in protecting organic 

integrity in the majority of situations

• Vast majority of organic operations comply 

with the organic standards

• Samples are generally free of pesticide 

residues
United States Department of Agriculture

Agricultural Marketing Service

• Over the last 16 years, the AMS Pesticide Data 

Program has tested 1,351 organic samples of 

mostly fruits and vegetables, representing 

1.3% of the total number of samples tested 

(107,503). 

• The average risks associated with pesticide 

residues in organic food appear to be 

declining.
United States Department of Agriculture

Agricultural Marketing Service

• 43 out of 1,351 (3.2%) of organic samples 

contained residues above 5% of the EPA 

tolerance level

• 63 out of 1,351 (4.7%) of organic samples had 

residues from inadvertent sources – below 

tolerance

– Residues from residual soil contamination, spray 

drift
United States Department of Agriculture

Agricultural Marketing Service

Limitations

1. Subpoena authority lacking in OFPA. Certifiers/NOP 

does not have authority to subpoena records – e.g. 

Promiseland

2. Lengthy appeals process.

– For willful violations NOP is filing complaints to assess 

civil penalties and avoid mediation and appeals

– NOP is proposing to delete requirement that certifiers 

can appeal adverse actions to the AMS Administrator.

3. Input approval – No accreditation program for input 

approval programs.
United States Department of Agriculture

Agricultural Marketing Service

Protecting Organic Integrity

1. Clear, enforceable standards

2. Notification to certifiers, organic producers 

and handlers concerning 

changes/clarifications to the standards.

3. Transparency of suspensions, revocations 

adverse actions, and sanctions
United States Department of Agriculture

Agricultural Marketing Service

4. Quality verification process.

– Organic system plans – thorough and complete

– Quality review of plans

– Inspections by qualified and skilled auditors

– Sales and yield audits

– Feed audits

– Inspection of non-organic areas of operation

– Timely notices by certifier and continual 

monitoring.
United States Department of Agriculture

Agricultural Marketing Service

5. Complaint handling

– File complaints at NOPcompliance@usda.gov

– Effective, timely, thorough 

– Thorough investigations by qualified investigators

– Allegations can be confirmed or could be 

determined to have no basis in fact. 

6. Penalties for willful violations

7. Market surveillance inspections

8. Unannounced inspections – risk based
United States Department of Agriculture

Agricultural Marketing Service

9. Periodic pesticide residue testing

10.Monitor use of organic-like claims and take 

action as appropriate to protect organic label

11.Improve quality of inspections, certifiers

– Training, testing

– Conflict of interest (e.g. funding conflict)

– Certifier limited resources – reluctance to raise 

fees to improve services
United States Department of Agriculture

Agricultural Marketing Service

April NOSB recommendations

• Sunset 2011

• Sunset 2012

• Methionine Interim Rule –

– Comment period closes today, October 25, 2010

– Final rule by end of March, 2011

• Methionine step down – requesting more 

justification for the step down numbers 
United States Department of Agriculture

Agricultural Marketing Service

April NOSB recommendations

Clarification on livestock health care

– Organic calves fed organic milk treated with an 

allowed synthetic input – NOP accepts NOSB 

clarification

Inerts in pesticides

– NOP is collaborating with EPA

– NOP regulations more prescriptive than most 

foreign organic standards
United States Department of Agriculture

Agricultural Marketing Service

April NOSB recommendations

Greenhouse recommendation accepted

Inert Atmospheric gases – packaging aids?

– Gases are regulated by FDA as direct food 

substances, not as packaging or packaging aids.

– Nitrogen and carbon dioxide are allowed.

– Argon is not listed and not allowed.
United States Department of Agriculture

Agricultural Marketing Service

Classification of materials

– Classification of materials is related to the category of use 

(e.g. crop production, livestock, handling).

– Crops and livestock - is the substance synthetic or natural?

– Processing (ingredients, processing aids) - is the substance 

agricultural or nonagricultural – most critical , then 

synthetic or nonsynthetic

– Chemical change definition conflicts with common 

understanding of chemical change.
United States Department of Agriculture

Agricultural Marketing Service

Vaccines

– 205.105(e) prohibits excluded methods (genetically 

modified organisms) 

– Except vaccines produced through excluded methods may 

be allowed if approved according to 205.600(a)

– NOSB has not approved vaccines produced through 

excluded methods according to 205.600(a)

– NOSB may review vaccines produced under excluded 

methods as a class of substances.
United States Department of Agriculture

Agricultural Marketing Service

Sodium nitrate

Sodium nitrate – natural substance – prohibited except 

allowed for up to 20% of nitrogen needs of the crop.

U.S. organic standards only organic standard that allows 

sodium nitrate. 

High sodium content can negatively affect soil quality.

Affects ability to access foreign organic markets.

NOP requests that NOSB reviews allowance.
United States Department of Agriculture

Agricultural Marketing Service

Guidelines for removing substances 

(non-sunset) from allowed inputs list

Notification of all affected parties within 120 days

– NOP notifies certifiers, state organic programs, foreign 

governments within 60 days.

– Certifiers, foreign governments notify producers and 

handlers within 120 days.

Prohibited substance removed from input stream 24 

months after NOSB decision.
United States Department of Agriculture

Agricultural Marketing Service

Organic Integrity from Farm to Table

Consumers Trust the Organic Label
Thank you
United States Department of Agriculture

Agricultural Marketing Service