Agricultural Marketing Service USDA National Organic Program

Oversight of 

Organic Products

Miles V. McEvoy

Deputy Administrator

USDA National Organic Program
Agricultural Marketing Service USDA National Organic Program

USDA National Organic Program

Implement Organic Foods Production Act:

• USDA Organic Regulations

Crops, livestock, handling, wild crops, labeling, 

certification, accreditation, National List

• Accreditation and Oversight

~90 authorized certifying agents worldwide

30,000 certified organic operations

• Compliance and Enforcement 

Complaints, investigations, civil penalties, appeals

• National Organic Standards Board
Agricultural Marketing Service USDA National Organic Program

10 Points of Organic Integrity

1. Clear/enforceable 

standards

2. Communication

3. Transparency

4. Certification 

5. Complaints

6. Penalties

7. Market 

surveillance

8. Unannounced 

inspections

9. Periodic residue 

testing

10. Continual 

improvement 
Agricultural Marketing Service USDA National Organic Program

1. Clear/Enforceable Standards

Accomplishments

• Implemented 

National List 

recommendations 

• Almost done with 

Sunset 2012

• Residue testing 

proposed rule.

• Pasture rule 

implementation 

Still Planned

• Sodium nitrate

• Vitamins + minerals

• Origin of livestock

• Aquaculture, 

mushrooms, pet 

food

• Guidance (bulk 

products, seeds)

NOSB 

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Agricultural Marketing Service USDA National Organic Program

Pasture Rule - 2 Year Pulse Check

• Pasture visits/witness audits conducted in

AZ, CA, CO, FL, IO, KY, LA, ME, MN, MT, NE, 

NV, NH, NM, NY, ND, OH, OR, SC, TX, PA, 

WA, WI

• Expanded pasture land 

• Increased recordkeeping and inspection 

time 

• Verifiable method to measure compliance 

with pasture based standard.

• General compliance with pasture rule
Agricultural Marketing Service USDA National Organic Program

2012 drought 

• Most severe drought since 1988

• Temporary variance approved – non-irrigated land only, 

reduced DMI from pasture from 30% to 15%
Agricultural Marketing Service USDA National Organic Program
Agricultural Marketing Service USDA National Organic Program

2. Communication

Accomplishments

• Organic Literacy 

Initiative

• Newsletter

• NOP Organic 

Insider / website

Still Planned

• Outreach to 

increase number of 

certified operations

• Improved web 

platform
Agricultural Marketing Service USDA National Organic Program
Agricultural Marketing Service USDA National Organic Program

Ever struggle to find info on a 

USDA program?

USDA’s Organic Literacy Initiative will:

• Help users find information on 

organic and organic-related USDA 

programs.

• Improve customer service.

• Help farmers and businesses 

determine, “Is organic an option for 

me?”
Agricultural Marketing Service USDA National Organic Program

3. Transparency

Accomplishments

• Posting improved 

list of certified 

operations

• Posting suspended 

+ revoked 

operations

• Posting fraudulent 

certificates 

Still Planned

• Posting certifiers’ 

corrective action 

reports 

• Posting cease + 

desist letters

• Increasing 

transparency of 

NOSB members 

interests 
Agricultural Marketing Service USDA National Organic Program

4. Certification

Accomplishments

• ~50 audits of 

certifiers in 2012

• NCAT publications: 

developing OSPs

• Instructions to 

certifiers (penalty 

matrix, 

unannounced 

inspections, etc.) 

Still Planned

• NCAT pubs on crops, 

livestock, handling, 

certification 

• Inspector 

qualifications, grower 

groups

• Classification, 

permitted substances 

list, MROs

NOSB 

NOSB 

NOSB 

93% compliance 

with accreditation 

requirements, 

increased focus on 

biodiversity.
Agricultural Marketing Service USDA National Organic Program

5. Complaints

Accomplishments

• Opened 279 

complaints (54% 

increase from FY 

2011) 

• Closed 279 

complaints (121% 

increase from FY 

2011) 

Still Planned

• Continue rigorous 

investigations and 

improved case 

closures

• Outreach to avoid 

compliance issues
Agricultural Marketing Service USDA National Organic Program

In FY 2012, NOP

• Average days to closure for open 

cases – 

– FY 2010 – 269 

– FY 2011 – 204 

– FY 2012 - 80 
Agricultural Marketing Service USDA National Organic Program

6. Penalties

Accomplishments

• 9 civil penalties for 

willful violations 

totaling $120k

• Suspended / 

revoked over 263 

operations

Still Planned

• Explore alternate 

ways to enforce 

USDA organic 

standards to the 

fullest extent of the 

law 
Agricultural Marketing Service USDA National Organic Program

7. Market Surveillance

Accomplishments

• Compliance visits 

to small number of 

markets 

Still Planned

• Implement market 

surveillance 

program
Agricultural Marketing Service USDA National Organic Program

8. Unannounced Inspections

Accomplishments

• Published 

instruction: 

certifying agents 

should conduct 

unannounced 

inspections on 5 

percent of the 

operations they 

certify 

Still Planned

• Address at annual 

certifying agent 

training

• Evaluate during 

certifying agent 

compliance audits

NOSB 
Agricultural Marketing Service USDA National Organic Program

9. Periodic Residue Testing

Accomplishments

• Published 

proposed rule.

• Published 

instructions on 

responding to 

positive residues, 

selecting labs, 

target prohibited 

pesticides list.

Still Planned

• Publish final rule 

(soon).

• Publish updated 

instructions.

• Assess compliance 

during certifying 

agent audits.
Agricultural Marketing Service USDA National Organic Program

10. Continual Improvement

Accomplishments

• Training webinars + 

modules

• Audits with 

increased rigor

• Outreach materials

• National List 

“Sunset” dates

Still Planned

• Modernizing list of 

certified operations

• Annual training for 

certifiers 

• Oversight of 

international 

agreements 
Agricultural Marketing Service USDA National Organic Program

Peer review

• Required by Organic Food Production Act

• National Institute of Standards and 

Technology (NIST) review 

• Corrective Actions completed

• 2013 – American National Standards 

Institute (ANSI) will conduct peer review
Agricultural Marketing Service USDA National Organic Program

Office of Inspector General

• 2010 audit – all 14 recommendations 

have been addressed and closed.

• OIG Milk Audit – Phase 1

– 4 findings

– Corrective actions in progress

• OIG National List/NOSB audit

– No findings 
Agricultural Marketing Service USDA National Organic Program

Clear 

Standards

Market 

Access

Consumer 

Protection

Information 

Technology

How Does This Fit Into NOP’s 

Strategic Plan?
Agricultural Marketing Service USDA National Organic Program

2012 Focus Areas

Sunset 2012

To avoid expiration, renewals/changes to over 

200 substances (example: baking soda)

Pending: sodium nitrate + vitamins/minerals

Amendments to allowed/prohibited substances

Address expiration dates in allowances for 

methionine and tetracycline

Certifying agent compliance audits

Must be audited every 2.5 years
Agricultural Marketing Service USDA National Organic Program

2012 Focus Areas (cont.)

• Periodic residue testing

• Pasture rule compliance 

• Penalty matrix 

• FDA food safety rules + organic 

standards

• European Union trade partnership

• Organic Literacy Initiative

• Better communication of 

actions/requirements 
Agricultural Marketing Service USDA National Organic Program

2013 Focus Areas

Sunset 2013 (many less substances than 2012)

• Origin of livestock

• Pet food standards

• Aquaculture standards

• Implementation of residue testing requirements

• Guidance documents, including: 

– Organic seeds, grower groups

– “Made with” organic, organic in the brand name

– Inspector qualifications

– Handling bulk organic products

• Classification of materials / permitted substances
Agricultural Marketing Service USDA National Organic Program

Organic Pet Food: Lifecycle of a “Rule”

Working group 

recommendation

NOSB 

recommendation

Final Rule

Public Comments

Proposed Rule

What takes 

so long?
Agricultural Marketing Service USDA National Organic Program

Organic Pet Food: Lifecycle of a “Rule”

Vitamins + 

minerals 

unique to 

pets

Economically 

significant! 

FDA and 

AAFCO 

standards
Agricultural Marketing Service USDA National Organic Program

2013 Focus Areas (cont.)

• Market surveillance

• OIG milk audit part II

• Verification of international trade 

partnerships 

• Additional international market access.

• Posting additional audits/compliance info

• List of certified operations

• Stakeholder engagement

• NOSB support/coordination 
Agricultural Marketing Service

Criteria for Handling Ingredients

• OFPA permits exceptions if the use of such substance:

– Would not be harmful to human health of the environment

– Is necessary to the production or handling of agricultural 

product because of the unavailability of wholly natural 

substitute products; and

– Is consistent with organic farming and handling

• National List is based on proposals from the National 

Organic Standards Board

• NOP cannot add a substance to the National List that has 

not been recommended by the NOSB
Agricultural Marketing Service

NOSB Evaluation Criteria

• The potential for detrimental chemical interactions with 

other materials 

• The toxicity and mode of action of the substance and of 

its breakdown products or any contaminants, and their 

persistence and areas of concentration in the 

environment 

• The probability of environmental contamination during 

manufacture, use, misuse or disposal of such substance 

OFPA, Sec 2119(m)
Agricultural Marketing Service

NOSB Evaluation Criteria (cont.)

• The effect of the substance on human health

• The alternatives to using the substance in terms of 

practices or other available materials

• Its compatibility with a system of sustainable agriculture

OFPA, Sec 2119(m)
Agricultural Marketing Service

Additional Criteria for Processing Substances

• The substance cannot be produced from a natural source 

and there are no organic substitutes 

• The substance's manufacture, use, and disposal do not 

have adverse effects on the environment and are done in 

a manner compatible with organic handling 

• The nutritional quality of the food is maintained when the 

substance is used, and the substance, itself, or its 

breakdown products do not have an adverse effect on 

human health as defined by applicable Federal regulations 

§205.600(b) 
Agricultural Marketing Service

Additional Criteria for Processing Substances (cont.)

• The substance's primary use is not as a preservative or to 

recreate or improve flavors, colors, textures, or nutritive 

value lost during processing, except where the 

replacement of nutrients is required by law; 

• The substance is listed as GRAS by FDA when used in 

accordance with FDA's good manufacturing practices 

(GMP) and contains no residues of heavy metals or other 

contaminants in excess of tolerances set by FDA; and 

• The substance is essential for the handling of organically 

produced agricultural products.

§205.600(b) 
Agricultural Marketing Service

Overlap with Other Regulations

• National List substances must meet certain 

eligibility requirements

• FDA or EPA must have authorized the 

substance for the petitioned use in 

conventional (i.e., non-organic) production or 

handling, if applicable
Agricultural Marketing Service

Additional Requirements for Handling

In addition to FDA requirements, non-organic 

ingredients and processing aids must not be produced 

using:

– Excluded methods (genetic engineering)

– Ionizing radiation, as described in Food and Drug 

Administration regulation, 21 CFR 179.26

– Sewage sludge (biosolids) as a fertilizer

§205.105
Agricultural Marketing Service USDA National Organic Program
Agricultural Marketing Service USDA National Organic Program

Thank you Barry Flamm
Agricultural Marketing Service USDA National Organic Program
Agricultural Marketing Service USDA National Organic Program

Thank You

Organic Integrity from 

Farm to Table, 

Consumers Trust the 

Organic Label