Agricultural Marketing Service (AMS) | National Organic Program (NOP)

National Organic Standards Board (NOSB) New Member Training Agenda

Monday, February 29, 2016

Location: USDA South Building - Washington DC - Cafeteria Room # 3

Tentative agenda revised: 4/11/2016

Time Content Notes:

Slide presentation #/handout/weblinks

Online self-paced Organic 101 and 201 (Can review either online with 

voiceover, or in pdf)

http://www.ams.usda.gov/services/organiccertification/is-it-an-option

Online self-paced Sound & Sensible Organic Certification: 

• http://www.ams.usda.gov/reportpresentation/sound-sensible

The Road to Organic Certification

• Interactive Video: “The Road to Organic 

Certification”

8:30 AM Arrive at USDA South building - Cafeteria room #3.

See instructions for getting into the USDA building

9:00 - 9:30 AM AMS Welcome and Introductions Acting AMS Administrator Starmer

~4:00pm, AMS Deputy Administrator 

McEvoy ~5:00

9:30 - 10:00 AM National Organic Program Overview: Brief 

overview of NOP and its divisions, and where NOSB 

fits in.

Delivered by: Paul Lewis

PP_001 NOP Overview

Handouts: 

 001a_AMS Org Chart

 001b_NOP Org Chart

 001c_Program Handbook TOC

10:00 - 10:15 AM Brief Overview of Organic Foods Production Act 

(OFPA)

Delivered by: Mark Bradley

PP_002 OFPA

Handouts: 

 002_ OFPA (7 USC Ch 94 Organic)

10:15 - 10:45 AM Overview of USDA Organic Regulations 

Delivered by: Mark Bradley

PP_003 USDA OrganicRegs 

Handouts: 

 003_Organic Regulations TOC only

 (Printed upon request 71 pages) 

10:45 - 11:00 AM Break 

11:15 - 11:30 AM Brief Overview of Federal Advisory Committee Act 

(FACA):

Delivered by: Paul Lewis 

PP_004 FACA

 Link to FACA website

11:30 - 1:00 PM National List 

Delivered by: Lisa Brines

• Review National List petition process 

PP_005 NL Petition Process 

Handouts:

 005a_National List Petition 

 Guidelines - 2007

005b_NOP 3005-1 OFPA Exemption 

Checklist

005c_NOP 3005-2 Petition Guidelines 

Checklist
Agricultural Marketing Service (AMS) | National Organic Program (NOP)

National Organic Standards Board (NOSB) New Member Training Agenda

Monday, February 29, 2016

Location: USDA South Building - Washington DC - Cafeteria Room # 3

Tentative agenda revised: 4/11/2016

Time Content Notes:

Slide presentation #/handout/weblinks

Sunset Process

Delivered by: Lisa Brines

• Review Sunset Process and Templates

PP_006 Sunset Process

Handouts:

 006a_NOP 5611 SunsetDates - Pg. 1 

 only

 006b_Sunset Process - 2013

1:00 PM Lunch - (USDA Cafeteria). Meet and greet with 

AMS/NOP staff over lunch. USDA cafeteria has a 

good variety of food options. Credit cards accepted

2:00 – 2:30 PM Rulemaking

Delivered by: Shannon Nally Yanessa

• Key elements of rulemaking process (Getting a 

rule completed and through clearance (OGC and 

OBPA).

PP_007 Rulemaking Process

2:30 – 4:30 PM Proposals, Technical Reports, Public Comments 

Delivered by: Emily Brown Rosen

• Best practices for writing proposals and 

recommendations 

• Best practices for evaluating technical reports 

• Best practices for analyzing public comments 

PP_008 BestPractices - Props Recs TRs 

PubComm

Handouts:

 008a_TR Samples Handout

 008b_Crops Pet Mat Prop Template 2- 

 24-16

 008c_LS HS Pet Mat Prop Template 2- 

 24-16

4:30 – 5:30 PM NOP and NOSB Operational Guidelines (Charter, 

Nominations, Work agendas, Subcommittees, Public 

Meetings, FOIA Review, NOSB website). 

Delivered by: Emily Brown Rosen, Michelle Arsenault 

PP_009 NOP NOSB OperatingGuides

009a_NOSB Charter 2014

009b_ 2013 NOSB NewMmbrGuide

009c_Work Agenda example

009d_SC AssignCallSched Jan2016

009e_2016 Apr DRAFT Agenda_Internal

5:30 – 6:00 Summary and Closing Discussion

Webinar 

Date: March 4

Content

30 minutes

(Entire NOSB)

USDA Organic Working Group (OWG) and Secretary’s 

Organic Guidance - Betsy Rakola 

(1 hour)

(Entire NOSB)

Ethics and Conflict of Interest

Stuart Bender 
National Organic Standards Board 

Training: 

National Organic Program Overview 

Agricultural Marketing Service | National Organic Program 

February 2016

USDA Agricultural Marketing Service | National Organic Program 1
Topics 

• NOP: Overview, Cross-Cutting Activities 

• Accreditation and International Activities 

• Compliance and Enforcement

• Standards 

USDA Agricultural Marketing Service | National Organic Program 2
The National Organic Program (NOP)

• Mission: 

Ensure the integrity of USDA organic products in the 

United States and throughout the world

• Vision: 

Organic Integrity from Farm to Table,

Consumers Trust the Organic Label 

• Core Role: 

Implement the Organic Foods Production Act and 

the USDA organic regulations 

National Organic Program | Agricultural Marketing Service 
What Does the Program Do? 

• Develop and maintain organic standards

• Accredit and oversee third party organic certifying 

agents, who review, inspect, and approve organic 

producers and handlers 

• Implement international organic trade agreements

• Investigate complaints of violations (example: 

uncertified farmer selling food as organic, selling 

conventional food as organic) 

• Manage the National Organic Standards Board

• Oversight Responsibility: 

79 certifying agents worldwide

31,000 + certified organic operations

$49 billion in U.S. organic sales (2015)

National Organic Program | Agricultural Marketing Service 
Quick Facts About NOP 

• Staffing: 45 employees in three Divisions and the 

Office of the Deputy Administrator 

• Budget: 

FY 2012: $6.919 million

FY 2013: $6.369 million 

FY 2014 to 2016: $9.04 million

• NOP Leadership Team: 

Miles McEvoy – Deputy Administrator

Jennifer Tucker – Associate Deputy Administrator 

Paul Lewis – Standards Division Director 

Cheri Courtney – Accreditation and International Activities Div. Director 

Matthew Michael – Compliance and Enforcement Division Director 

• MRP Leadership – Betsy Rakola, USDA Organic Policy Advisor 

National Organic Program | Agricultural Marketing Service 5
NOP Organization and Activities

National Organic Program

Office of Deputy Administrator

Miles McEvoy

Standards Division

Accreditation

& International 

Activities Division

Compliance &

Enforcement Division

National Organic 

Standards Board

• Rules, Guidance, 

Instructions, 

• National List

• Accreditation process

• Technical outreach

• International 

agreements

• Complaints

• Investigations

• Initiate enforcement 

actions 

• Market surveillance

• Communication

• National List • Administration 

recommendations

USDA Agricultural Marketing Service | National Organic Program 6
The Organic Stakeholder Community

There are three primary levels to the organic integrity framework. USDA’s National Organic Program establishes and enforces regulations, and accredits certifying agents. Agent certify operations, 

which include farmers and ranchers as well as processors and handlers. These operations sell to retailers and consumers. Feedback comes to the USDA through public comment to the NOP 

and the National Organic Standards Board.

National Organic Program | Agricultural Marketing Service 7
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. Continuous improvement
Key Cross-Cutting Activities 

• Policy Development

• Training and Outreach

• Communication 

• Collaboration: Across USDA and with Other 

Agencies 
Policy Development: NOP Document Matrix 

• NOP publishes a range of different types of 

documents for policy and outreach purposes. 

• The NOP Document Matrix is an internal tool that 

describes our different policy and outreach 

communication documents. 

• A brief overview of these document types follows. 

Often, NOSB recommendations will be considered 

against these options to determine best fit for 

implementation. 

USDA Agricultural Marketing Service | National Organic Program 10
NOP Document Matrix 

1. Rules

– Amend the USDA organic regulations

– Allow enforcement actions

– If “significant” require additional clearance

– Example: pasture rule, origin of livestock

2. Interpretive Rules

– Explain NOP’s interpretation of statutes/rules or 

clarifies existing rules

– Have not been used by NOP, but could be in the 

future 

Home: USDA Organic Regulations
NOP Document Matrix 

3. Instructions

– Instruct certifying agents how to apply 

certification and accreditation requirements per 

205.501(a)(21)

– Aren’t announced via the Federal Register 

– Example: Conservation activity plan for organic 

system plans

4. Guidance Documents

– Provide options to satisfy regulatory requirements

– Support enforcement by referencing section of 

USDA organic regulations

– Example: substances in post-harvest handling

Home: Program Handbook

Home: Program Handbook
NOP Document Matrix

5. Policy Memos

– Formally communicate NOP policy decisions, but 

less formally than instructions/rules

– Are generally directed at certifying agents

– Aren’t announced via the Federal Register 

– Example: nanotechnology

6. Formal Letters

– Communicate non-policy information or requests

– Directed to certifying agents and NOSB

– Aren’t announced via the Federal Register

– Example: response to NOSB recommendations

Home: Program Handbook

Home: Public Correspondence page
NOP Document Matrix

7. Federal Register Notices

– Announce activities requiring legal notification 

– Example: NOSB meeting announcement, NOSB 

Call for Nominations

8. Newsletter Articles

– Highlight NOP announcements, provide status 

updates

– Aren’t announced via the Federal Register

– Example: Origin of livestock update

Home: Rules/Notices Page

Home: About Us Page
NOP Document Matrix

9. NOP Organic Insider

– Announces all NOP documents and activities

– Aren’t announced via the Federal Register

– Examples: Recruiting announcements, new fact 

sheets, equivalency arrangement information, 

new policy documents and memos 

– Subscribe to receive email updates:

http://bit.ly/NOPOrganicInsider

Home: Insider archive
Training and Outreach

• Annual classroom training for NOP certifiers.

• Comprehensive webinar series for NOP auditors. 

• Visits with certifiers across the country to launch 

and discuss the “sound and sensible” initiative.

• Conference Outreach: Expo East, MOSES, Others

• Publications: New fact sheets, talking points, 

questions and answers, blogs, and other 

educational resources to support candidate and 

existing certified operations. 

USDA Agricultural Marketing Service | National Organic Program 16
NOP Communications 

• Email notification service 

• Quarterly Newsletter “Organic 

Integrity” 

• “Hot Topics” Website Postings

• Fact Sheets, Questions and Answers

• Briefings, Talking Points 

• Teleconferences and Webinars with 

Organic Community 

• National Organic Standards Board 

Public Meetings 

• Conference Presentations and 

Listening Sessions 

National Organic Program | Agricultural Marketing Service 17
Collaboration Across USDA and 

With Other Agencies 

• AMS Livestock, Poultry, and Seed Program: Economic analyses, technical 

reports, appeals reviews, accreditation audits

• AMS Science and Technology Program: Residue Testing Program 

• AMS Fruit and Vegetable Programs and Compliance and Analysis: 

Collaboration on investigations and enforcement actions; audits

• Food Safety Inspection Service and Natural Resources Conservation 

Service: Labelling coordination; streamline/reduce redundancies 

• Economic Research Service, NASS/Census of Agriculture, and National 

Agricultural Library: New data usage agreements 

• USDA Office of Chief Economist: Early review of NOP rules

• USDA Biotechnology Coordinating Group: NOP is AMS representative 

• NOP works with OIG, Department of Justice, DHS Customs and Border 

Protection, the Food and Drug Administration, the Environmental 

Protection Agency, and the TTB on both enforcement and regulatory issues. 

• Federal Trade Commission: Joint project to collect data on consumer 

perceptions of personal care products and textiles sold as organic. 

USDA Agricultural Marketing Service | National Organic Program 18
Topics 

• NOP: Overview, Cross-Cutting Activities 

• Accreditation and International Activities 

• Compliance and Enforcement

• Standards 

USDA Agricultural Marketing Service | National Organic Program 19
Accreditation Activities

• NOP oversees the work of 79 certifiers, which certify 

over 31,000 certified organic operations. 

– Work includes audits, audit report reviews, notices of 

noncompliance, corrective action reviews, 

responding to questions, updating list of certified 

operations 

– This work is done by 5 Accreditation Managers, and a 

Lead Auditor 

– Supplemented by audit team in AMS Quality 

Assurance Divisions, Livestock and Seed Program 

• At the close of FY 2015, certifiers were in full compliance 

with 97% of the NOP’s accreditation criteria, and have 

implemented corrective actions for all deficiencies. 

USDA Agricultural Marketing Service | National Organic Program 20
Key Accreditation Activities 

• Three accreditation renewal audits, 24 accreditation 

midterm audits, 3 satellite audits, initial accreditation 

audits and one peer review. 

• Consider 41 reinstatement of certification requests 

• Consider 5 requests for temporary variances to the 

USDA organic regulations

• Support training, policy development, and outreach 

activities (meetings, presentations, materials)

• Implement “sound and sensible” initiative to make the 

organic certification process affordable and attainable 

for organic operations.

USDA Agricultural Marketing Service | National Organic Program 21
International Trade 

• The United States has trade arrangements with several 

nations to facilitate the exchange of organic products 

and provide market opportunities for organic producers. 

• Equivalency Agreements: 

– U.S.-Canada – Launched in 2009 

– U.S.-European Union – Launched in June 2012 

– Japan – Effective in January 2014

– Korea – Effective in July 2014

– Switzerland – Effective in July 2015

• Recognition Agreements: 

– India, Israel, Japan, New Zealand

• NOP works closely with the Foreign Agricultural Service 

(FAS) and the U.S. Trade Representative (USTR). National Organic Program | Agricultural Marketing Service 
High Priority Certification Issues to Address 

• Inconsistent certification process

• Recordkeeping focus and burden

• Expense of certification

• Burden of time that is involved in inspections 

and maintaining paperwork

• Some farms that comply with organic standards 

avoid certification.

The Sound and Sensible Initiative was established 

to start to address these issues. 
‘Sound + Sensible’ Principles

1. Efficient Processes: Eliminate bureaucratic processes 

that do not contribute to organic integrity. 

2. Streamlined Recordkeeping: Ensure that required 

records support organic integrity and are not a barrier 

to organic compliance.

3. Practical Plans: Support simple Organic System Plans 

that clearly capture organic practices. 

4. Fair, Focused Enforcement: Focus enforcement on 

willful, egregious violators; handle minor violations in a 

way that leads to compliance; and publicize how 

enforcement protects the market. 

5. Integrity First: Focus on factors that impact organic 

integrity the most, building consumer confidencet.
Goal: Make Organic Certification:

Affordable, Accessible and Attainable for all 

operations

• Affordable – reasonable fees, reasonable 

compliance costs

• Accessible – certifiers and technical assistance 

available locally

• Attainable – Clear and understandable 

standards, plain language, reasonable record 

keeping requirements
AIA: Key Priorities in 2016 

• Publish updated list of certified operations 

• ACA Certifier Training: Spring 2016

• New equivalency agreement activities

• Accreditation Audits and Follow-up 

• Maintain existing recognition and equivalency 

arrangements – peer reviews, working groups 

• Recruiting and onboarding new staff 
Topics 

• NOP: Overview, Cross-Cutting Activities 

• Accreditation and International Activities 

• Compliance and Enforcement

• Standards 

USDA Agricultural Marketing Service | National Organic Program 27
Purposes of Enforcement

Purpose: To protect the integrity of the organic 

standards so as to facilitate commerce

• Maintain consumer confidence

• Ensure a fair market for the great majority of 

organic operations that operate in compliance with 

the law 

USDA Agricultural Marketing Service | National Organic Program 28
Compliance and Enforcement Division 

Key Activities: 

• Investigate complaints, work with operations to 

achieve compliance where possible and take 

enforcement actions as appropriate 

• Represent the NOP in appeals of adverse actions

• Work with ACAs, State Programs and Federal 

partners on enforcement of the OFPA and the USDA 

organic regulations 

• Lead enforcement-related policy development and 

outreach efforts 

USDA Agricultural Marketing Service | National Organic Program 29
FY 2015 Successes 

• Issued 13 civil penalties, totaling $1.8 million, for willful 

violations of the USDA organic regulations

• Closed 390 complaint investigations, a new record, and 

important as we received a record high 550 complaints

• Issued 121 Notices of Warning, 36 Notices to Cease and 

Desist and 64 investigation referrals

• Published six fraudulent organic certificates on the NOP 

webpage 

• Prevailed in an administrative hearing against Stoney-M 

Farm, seeking suspension of land to which prohibited 

substances had been applied

• Issued six subpoenas under new Farm Bill authority

USDA Agricultural Marketing Service | National Organic Program 30
FY16 Incoming Complaint 

Distribution by Type
2016 Priorities 

• Maintain high closure rate of complaint reviews and 

investigations

• Work closely with OGC to pursue complaints for 

hearing against violators, as appropriate 

• Contribute to policy, training and outreach 

development to improve compliance

• Expand cooperation with Federal and State partners 

regarding civil and criminal enforcement 
Topics 

• NOP: Overview, Cross-Cutting Activities 

• Accreditation and International Activities 

• Compliance and Enforcement

• Standards 

USDA Agricultural Marketing Service | National Organic Program 33
Standards Division: Key Activities 

• Key Activities

– Develop new rules and coordinate clearance

– Develop and maintain Regulatory Priorities Agenda 

– Draft new and updated guidance and policy memos 

based on OIG feedback, certifier and community 

questions, and priority needs 

– Develop materials to support rollout of new 

standards, respond to letters and questions about 

standards 

– Maintain National List, including petition intake and 

response, and list management activities 

– Support the National Organic Standards Board

USDA Agricultural Marketing Service | National Organic Program 34
In Development

• Guidance

– Classification of Materials

– Treated Lumber

– Calculation of Organic Ingredients

– Crop and Livestock Materials 

– Pesticide spray drift

• Rulemaking

– Final Rule: Origin of Livestock

– Proposed Rule: Aquaculture

– Proposed Rule: Pet Food

– Proposed Rule: Animal Welfare

– Proposed Rule: Apiculture

USDA Agricultural Marketing Service | National Organic Program 35
Questions/Discussion 

Agricultural Marketing Service | National Organic Program 

February 2016

36
National Organic Standards Board 

Training: 

Organic Foods Production Act (OFPA) 

February 2016

1
Overview

• Main Provisions of the Organic Foods 

Production Act of 1990

• Establishment, Administration and 

Enforcement of the National Organic 

Program (NOP)

• The National Organic Standards Board—

Creation, Membership, and Role of the 

Board in the NOP

2
OFPA: The Big Picture

• Organic Foods Production Act of 1990 (OFPA) (7 

U.S.C. 6501 - 6522) 

• Purpose: 

• To establish national standards governing the 

marketing of certain agricultural products as 

organically produced products 

• To assure consumers that organically produced 

products meet a consistent standard 

• To facilitate interstate commerce in fresh and 

processed food that is organically produced 

3
OFPA

• Definitions

– Ag product

– Handle

– Handler

– Livestock – includes fish, wild or domesticated, 

and nonplant life (e.g. mushrooms)

– National List

– Person

– Synthetic

4
OFPA

• National organic production program

– State program

– Consultation with the NOSB

– USDA to implement through certifying agents

• National standards for organic production

– Produced and handled without synthetic 

chemicals, except as provided

– 3 years no prohibited substances prior to harvest

– Produced and handled in compliance with 

Organic Plan

5
OFPA

• Compliance requirements

– May sell or label organic only in accordance 

with OFPA

– No person may affix a label to, or provide 

other market information concerning, an ag 

product, if such label or information implies, 

directly or indirectly, that such product is 

produced and handled using organic 

methods, except in accordance with OFPA

6
OFPA

• Compliance requirements

– USDA seal

– Imports

– Exemptions for processed food (50% in OFPA)

– Small farmer exemption

7
OFPA

• General requirements

– Be produced only on certified organic farms and 

handled only through certified organic handling 

operations

– Organic Plan

– Annual certification

– On-site inspection

– Periodic residue testing

– Enforcement

– Public access to certificates and lab analysis

– Other terms determined to be necessary

8
OFPA

• General requirements

– Wild seafood

– State program

• State organic certification program

– May have additional requirements

• Prohibited crop production practices

• Animal production practices

– Organic feed

– No antibiotics or hormones

– Dairy cows – 12 month transition

9
OFPA

• Handling

– No synthetics unless on National List

– No sulfites except in wine

• Additional guidelines – testing and removal of 

organic label

• If production or handling not prohibited then 

shall be permitted (contrast with organic 

regulations)

• Organic Plan

• Accreditation

10
OFPA

• Requirements of certifying agents

• Peer review of certifying agents

11
National List

• Exemption for specific synthetics

– The Secretary determine in consultation with 

HHS and EPA – • Would be harmful to human health or environment

• Is necessary to production or handling because of unavailability of 

natural substitute

• Is consistent with organic farming and handling

– The substance contains active synthetic 

ingredients, or

– Is used in production and contains synthetic 

inerts that are not classified by EPA as inerts of 

toxicological concern

• Prohibition of specific natural substances

12
Procedures for establishing NL

• National List must be based on NOSB 

recommendations

• Secretary may not add substances without 

NOSB recommendation

• NL must be established with notice and 

comment rulemaking

• Sunset – no NL listing is valid unless the NOSB 

reviews and the Secretary renews substance 

every 5 years

13
7 USC 6518: 

National Organic Standards Board

OFPA, 7 U.S.C. 6518 (a) states that:

The Secretary shall establish a National Organic 

Standards Board: 

• In accordance with Federal Advisory Committee 

Act (5 U.S.C. App. 2 et seq.)

• To assist in the development of standards for 

substances to be used in organic production; and 

• To advise the Secretary on any other aspects of 

the implementation of this title

14
National Organic Standards Board

Membership

• Four who own or operate an organic farming operation

• Two who own or operate an organic handling operation

• One who owns or operates a retail establishment with 

significant trade in organic products

• Three with expertise in areas of environmental protection and 

resource conservation

• Three who represent public interest or consumer interest 

groups

• One with expertise in the fields of toxicology, ecology, or 

biochemistry

• One who is a certifying agent

15
National Organic Standards Board

Generally

• Secretary appoints Board members

• Five year terms; members cannot serve consecutive 

terms

• Secretary convenes meetings on a periodic basis

• Secretary shall authorize the Board to hire a staff 

director and shall detail staff of USDA or allow for the 

hiring of staff

• Secretary may, subject to appropriations, pay 

necessary expenses incurred by the Board in carrying 

out OFPA provisions

16
National Organic Standards Board

Generally

• Members serve without compensation but may be paid for 

expenses while conducting the business of the Board

• Board selects a Chairperson

• At Board meetings, a quorum constitutes a majority of the 

members

• Decisive votes: 2/3 of votes cast at the meeting when a 

quorum is present

• No confidential business information obtained by the 

Board shall be released to the public
National Organic Standards Board

Responsibilities 

• Provide recommendations to the Secretary 

regarding implementation of OFPA

• Develop the proposed National List or proposed 

amendments to the National List for submission to 

the Secretary

• Convene technical advisory panels to provide 

scientific evaluation of materials

• Review botanical pesticides

• Advise the Secretary on product residue testing and 

emergency spray programs
National Organic Standards Board

National List

• Requirements while establishing proposed 

amendments: 

• Review available information on potential adverse human and 

environmental effects

• Obtain complete list of ingredients of considered substances from 

manufacturers to determine if it includes synthetic inert materials

• Submit to the Secretary results of Board’s evaluation and any technical 

advisory panel evaluation

• Use seven specified evaluation criteria

• Establish procedures for receiving petitions to 

evaluate substances for inclusion on the List

• Conduct Sunset review of each substance on the List 

within five years of it being adopted or renewed
Records, Compliance, Administration

• Recordkeeping

– Records must be made available

– Records of all inputs

– confidentiality

• Investigations 

– Investigations, subpoena authority, take evidence

• Enforcement

– Civil penalties - $11,000 per violation

– False statement, ineligibility

• Expedited appeals process

20
Questions/Discussion 

Agricultural Marketing Service | National Organic Program 

February 2016

21
United States Department of Agriculture

Agricultural Marketing Service

USDA Organic Regulations: 

Overview 

1
United States Department of Agriculture

Agricultural Marketing Service

NOP Definition of “organic”:

A production system, managed in 

accordance with the Act and USDA 

Regulations, to respond to sitespecific conditions by integrating 

cultural, biological, and mechanical 

practices that foster cycling of 

resources, promote ecological 

balance, and conserve biodiversity.

2
United States Department of Agriculture

Agricultural Marketing Service

• Definitions

– Commercially available

– Excipients

– Excluded methods

– Handler

– Labeling

– Livestock – (excludes aquatic animals)

– Prohibited substance

– Unavoidable residual environmental 

contamination

3
United States Department of Agriculture

Agricultural Marketing Service

• Applicability

– What has to be certified

– Exemptions and Exclusions

– Recordkeeping

– Allowed and prohibited substances, methods, and 

ingredients

4
United States Department of Agriculture

Agricultural Marketing Service

Banned in Organic Production 

and Handling

• Use of genetic engineering 

(GMO)

• Use of ionizing radiation

• Sewage sludge

5
United States Department of Agriculture

Agricultural Marketing Service

• Organic production and handling

– Maintain or improve natural resources (soil and 

water quality)

– Organic System Plan

– Soil fertility

– Seeds and planting stock

– Crop rotation

– Pest management practice standard

6
United States Department of Agriculture

Agricultural Marketing Service

Natural Resources

NOP 205.200

Practices must improve or 

maintain the natural 

resources of the 

farming operation, 

including soil and water 

quality.

7

NOP Regulations: Crop Production
United States Department of Agriculture

Agricultural Marketing Service

Organic Systems Plan

• Practices and procedures

• Substances to be used

• Monitoring practices to 

ensure plan works

• Recordkeeping system

• Preventing contact with 

prohibited substances

• Other info deemed 

necessary by certifier.

8

CERTIFICATION AND THE OSP
United States Department of Agriculture

Agricultural Marketing Service

NOP Regulations: Crop Production

• No prohibited substances on land/fields for 3 years

• Establish buffer zones

• Maintain or improve soil condition

• Minimize soil erosion

• Rotations, cover crops, and application of plant and 

animal material

• No raw manure applications within 120/90 days before 

harvest.

9
United States Department of Agriculture

Agricultural Marketing Service

Organic Seeds

NOP 205.204

• Organic seeds/planting stock 

required unless organic 

seeds/planting stock is not 

commercially available.

• If organic seeds not commercially 

available then untreated seeds 

may be used.

• Treated seeds are prohibited.

10

NOP Regulations: Crop Production
United States Department of Agriculture

Agricultural Marketing Service

Pest Management

NOP 205.206

Bio-intensive pest management plans. • Prevention first: – Crop rotations; – Resistant varieties; – Maintaining beneficial species habitat; – Sanitary cultural practices; • Approved materials used only when crop 

rotation, biological control, and cultural 

practices are insufficient to control pests.

11

NOP Regulations: Crop Production
United States Department of Agriculture

Agricultural Marketing Service

Wild Crop Harvest

• Sustainable harvest of defined area

• No prohibited substance exposure

• Protect the environment during harvest

12
United States Department of Agriculture

Agricultural Marketing Service

NOP Organic Livestock

• Managed Organically from 

last 3rd of gestation

– Poultry from second day 

of life.

– Dairy animals may be 

converted in 1 year

13

NOP Regulations: Livestock
United States Department of Agriculture

Agricultural Marketing Service • 100% Organic Feed – Synthetic vitamins and 

trace minerals are 

Allowed

• Prohibited Substances – No Synthetic Hormones 

or Growth Promoters

– No Antibiotics

• Animal Welfare – living 

conditions – Pasture requirement for 

ruminants

– Outdoor access

14

NOP Regulations: Livestock
United States Department of Agriculture

Agricultural Marketing Service

NOP Regulations: Handling HANDLING:

• Processing must be by certified operations

• Mechanical or biological methods for processing organic 

agricultural products

• “Organic” products: non-organic ingredients or processing 

aids must be on the National List

• Maintain organic integrity

• Preventive facility pest management

15
United States Department of Agriculture

Agricultural Marketing Service

NOP Organic Handlingcontinued

• Avoid contact with prohibited substances

• Segregate from conventional product

• Label according to NOP regulations.

NOP Regulations: 

16

Handling
United States Department of Agriculture Understanding Organic Agricultural Marketing Service

Labeling

•100% Organic

All ingredients & processing aids must 

be 100% certified organic.

•Organic 

95% - 100% certified organic 

ingredients.

•Made with Organic ...(list up to three 

ingredients or food groups)

At least 70% organic ingredients.

•Less Than 70% Organic Ingredients 

Claims are limited to ingredient 

statement.

17
United States Department of Agriculture

Agricultural Marketing Service

Subpart E - Certification

1. General requirements

2. Application

3. Review of application

4. Inspection

5. Certification

6. Denial of certification

7. Continuation of certification

39

CERTIFICATION AND THE OSP
United States Department of Agriculture

Agricultural Marketing Service

Accreditation of Certifying Agents 

7 CFR Subpart F 205.500-510

• The USDA Administrator of the Agricultural Marketing 

Service shall accredit a qualified applicant in the areas 

of crops, livestock, wild crops or handling or 

combination thereof to certify production or handling 

as a certified operation
United States Department of Agriculture

Agricultural Marketing Service

General Requirements for 

Accreditation

• Have sufficient expertise 

to fully comply with and 

implement the terms and 

conditions of the organic 

certification program 

established under the Act 

and regulations

• Education

• Experience

• Training

• Administration

• Regulations

• Inspection/auditing

• Crops/livestock/process

ing/handling/wild crops
United States Department of Agriculture

Agricultural Marketing Service

General Requirements 

– Internal Audits

Have an annual program review of its 

certification activities conducted by the 

certifying agent’s staff, an outside 

auditor, or a consultant who has 

expertise to conduct such reviews and 

implement measures to correct any 

noncompliances identified in the 

evaluation

• Internal Audits

– Conducting by internal 

personnel or outside auditor

– Evaluation of certification 

system and procedures

– Continuous Improvement

– Identify areas of strength and 

areas needing improvement

– Better to find issues during an 

internal audit then during an 

external audit.
United States Department of Agriculture

Agricultural Marketing Service

General Requirements – conflicts 

of interest

• Prevent conflicts of interest by:

Not certifying a production or handling operation if the 

certifying agent or a responsible connected party of such 

certifying agent has or has held a commercial interest in 

production or handling operation, including an immediate 

family interest or consulting within the 12 month period 

prior to the application of certification
United States Department of Agriculture

Agricultural Marketing Service

General Requirements – accepting 

all certification decisions

• One rule to rule them all

• All certifiers must comply 

with the NOP regulations

• Certifiers cannot require any 

additional requirements 

beyond the NOP regulations

NOP accredited certifiers 

must accept certification 

decisions made by other 

NOP accredited certifiers.

Especially important for 

processed products 

utilizing ingredients 

certified by other 

certifiers.
United States Department of Agriculture

Agricultural Marketing Service

Evidence of expertise – 205.504

• Policies and procedures for 

training, evaluating and 

supervising personnel

• Qualifications of staff

• Procedures used to evaluate 

applicants for certification

• Investigative procedures

• Residue testing procedures

• Procedures for 

handling violations

• Recordkeeping 

procedures

• Fees charged for 

certification

• Sample collection 

procedures
United States Department of Agriculture

Agricultural Marketing Service

Public information

• Procedures for providing to the public the following 

information:

– Organic certificates issued during the current and previous 3 

years

– List of all certified operations and products produced

– Results of laboratory analyses for residues of pesticides and 

other prohibited substances.
United States Department of Agriculture

Agricultural Marketing Service

• 205.509 - Peer review panel 

26
United States Department of Agriculture

Agricultural Marketing Service

Subpart G – Administrative

• 205.600 evaluation criteria

• 205.601 – Crops – allowed synthetics

• 205.602 – Crops – prohibited naturals

• 205.603 – Livestock – allowed synthetics

• 205.604 – Livestock – prohibited naturals

• 205.605 – Handling – allowed non-agricultural 

substances (natural and synthetic)

• 205.606 – Handling – allowed agricultural 

(commerially unavailable in organic form)

27
United States Department of Agriculture

Agricultural Marketing Service

• 205.620-622 State organic programs

• 205.640-642 Fees

• 205.660-668 Compliance

• 205.670-672 Inspection and testing

• 205.680-681 Appeals

28
National Organic Standards Board 

Training: 

Federal Advisory Committee Act (FACA)

February 2016

1
Goal: Review Key Elements of FACA

• FACA Overview 

• Agency Responsibilities 

• Board Responsibilities

• NOP Authority in Setting Board Policy 

• Shared Success Factors 

2
Federal Advisory Committees 

• OFPA: Secretary has responsibility to establish the 

NOSB in accordance with the Federal Advisory 

Committee Act (FACA) 

• FACA Committees are established for the purpose of 

obtaining advice or recommendations on issues or 

policies within the scope of an agency official’s 

responsibilities 

• Like the NOSB, many FACA Boards are statutory: 

In 2012, 141 of the 169 USDA Boards were statutory

• Federal advisory committees exist to advise and 

recommend, NOT to decide. 
FACA Committees Must Have.... 

• A charter with established mission and duties: 

The USDA renews the NOSB Charter every two years.

• Fair and balanced membership: The Secretary 

appoints NOSB members based on OFPA categories.

• A Designated Federal Official (DFO) for advisory 

committee and its subcommittees. FACA assigns a 

number of activities to the DFO. 

• Opportunity for reasonable participation by the 

public in advisory committee activities, subject to 

agency guidelines.

4
FACA Meeting Rules

• Open meetings with opportunity for public comment

• Any member of the public is permitted to file a written 

statement with advisory committee.

• Any member of the public may speak to or address 

advisory committee within appropriate guidelines.

• Feedback from previous CMO: “Only a few Boards have 

high comment rates, and of those, NOSB is 2nd highest.”

• Examples of public comment periods offered by others: 

– 2015 Dietary Guidelines Advisory Committee - 2 day 

meeting; 4 hours of oral comment. 

– USFS Committee: Forest Planning Rule 

Implementation. 1 day meeting; 1 hour of comment. 
FACA Meeting Rules 

• Reasonable time and accessible to the public; 

with sufficient space to accommodate 

committee, agency staff, and a reasonable 

number of the interested members of the public.

• Meetings must be announced 15 days in 

advance in Federal Register; Meeting minutes 

are required and are publicly available. 

6
FACA Representatives

• FACA members may be regular government 

employees, special government employees, and/or 

representatives: NOSB members are Representatives

• NOSB members are classified as representatives.

– Appointed based on ability to articulate and 

represent group’s interests 

– In representing others, speak in “We” not “I” 

statements 

– Are not expected to provide independent expert 

advice.

7
Subcommittees Versus Committees 

• Subcommittees are considered part of the FACA, BUT, 

FACA’s openness requirements do not apply. 

• This is because: 

• NOSB subcommittee proposals do not come directly 

to USDA – they come through the NOSB Committee. 

• The full committee deliberates on Subcommittee 

work. 

• This is why subcommittee calls are not currently open 

to the public. This is also why we call subcommittee 

products proposals rather than recommendations. 

8
Agency Responsibilities

• Comply with FACA 

• Issue administrative guidelines and management controls 

that apply to advisory committees

• Designate a Committee Management Officer (CMO) and 

Designate a Designated Federal Officer (DFO) for each 

advisory committee and its subcommittees

• Provide a written determination stating the reasons for 

closing any advisory committee meeting to the public

• Review, at least annually, the need to continue each 

existing advisory committee, consistent with the public 

interest and the purpose of each advisory committee
Agency Responsibilities

• Determine that ...staff, experts and consultants to 

advisory committees are justified and levels of agency 

support are adequate

• Develop procedures to assure that the committee’s 

recommendations will not be inappropriately influenced 

by the appointing authority or by any special interest, but 

will instead be the result of the committee's independent 

judgment

• Assure that the interests and affiliations of advisory 

committee members are reviewed for conformance with 

applicable conflict of interest statutes, regulations issued 

by Office of Government Ethics including any supplemental 

agency requirements, and other Federal ethics rules
NOP Responsibilities

• NOP’s Designated Federal Officer (DFO):

– Calls, attends, and adjourns committee meetings 

– Develops and approves agendas

– Maintains required records and budgets

– Ensures efficient operations and adherence to 

FACA and other laws 

– Develops committee reports for the Committee 

Management Officer: We must submit an annual 

report on Board activities, meetings, and 

expenses. 
FACA: Board Responsibilities 

• How should agencies consider the roles of 

advisory committee members and staff?

• FACA does not assign any specific responsibilities to 

members of advisory committees and staff (other than 

DFO), although both perform critical roles

• Agency heads, Committee Management Officers 

(CMOs), and Designated Federal Officers (DFOs) 

should consider the distinctions between these roles 

and how they relate to each other in developing 

agency guidelines implementing FACA 
NOP Authority in Setting Board Policy 

• Agency Guidelines for implementing FACA 

should reflect: 

– Clear operating procedures should provide for the 

conduct of advisory committee meetings and other 

activities, and specify the relationship among the 

advisory committee members, the DFO, and staff;

– In addition to complying with the Act, advisory 

committee members ....may be required to adhere to 

additional agency operating policies; and

– Other agency-specific statutes and regulations may 

affect the agency's advisory committees directly or 

indirectly. 

13
FACA and OFPA together

• OFPA doesn’t direct the NOSB to decide. 

• OFPA asks NOSB to: 

– Assist in development of Standards

– Provide recommendations 

– Evaluate substances

– Develop proposed National List and proposed 

amendments to the List for submission to the 

Secretary

• Secretary (authority delegated to AMS) retains 

decision-making and rulemaking authority 
Criteria for Success Under FACA.... 

• Enhance accountability to public

• Control the undue influence of special 

interests by balancing committee 

membership

• Ensure that public access to committee 

deliberations is maximized.

• Monitor and reduce costs

• Eliminate unproductive and/or unnecessary 

committees

• Provide for an annual report of committee 

activities and accomplishments to Congress

15
NOP and NOSB Success Factors

• NOP’s success is measured in part by its success in 

managing the NOSB: 

– Are recommendations within the Committee’s 

scope? (OFPA statute and agency responsibilities)

– Are Board and program resources being used 

effectively and efficiently? 

– Is the NOP asking for advice that it can then act 

upon? (It wastes time and resources for the Board 

to work on items that the NOP cannot implement.)

– Are appropriate management structures and 

processes in place and functioning? 
Questions/Discussion 

Agricultural Marketing Service | National Organic Program 

February 2015

17
National List Petition Process

1

Lisa M. Brines, Ph.D.

Agricultural Marketing Service | National Organic Program 

February 2016

NOSB Training
Multiple inputs for NOSB Recommendations

NOSB 

Recommendation

Petition

Technical 

Report

Subcommittee

Proposal

Public 

Comment

USDA Agricultural Marketing Service | National Organic Program 2
Materials Review

NOSB has a Well-Developed Evaluation

Process and Structure for Materials Review

• Evaluation Forms with Criteria linked to Organic 

Foods Production Act and USDA organic 

regulations.

• Boundaries for communicating with petitioners.

• Projected Timeline for review steps.

USDA Agricultural Marketing Service | National Organic Program 3
Petition Process

The Organic Foods Production Act:

Sec. 2119. [7 U.S.C. 6518] National 

Organic Standards Board.

(n) Petitions.—The Board shall establish 

procedures under which persons may 

petition the Board for the purpose of 

evaluating substances for inclusion on the 

National List.

USDA Agricultural Marketing Service | National Organic Program 4
Petition Process

USDA Organic Regulations, 7 CFR Part 205

§205.607 Amending the National List.

(a) Any person may petition the National Organic 

Standards Board for the purpose of having a 

substance evaluated by the Board for 

recommendation to the Secretary for inclusion on 

or deletion from the National List in accordance 

with the Act. 

(b) A person petitioning for amendment of the 

National List should request a copy of the petition 

procedures from the USDA at the address in 

§205.607(c). 

USDA Agricultural Marketing Service | National Organic Program 5
Petition Process: Petition Guidelines

• Most recent version of petition guidelines 

were published in the Federal Register on 

January 18, 2007 [72 FR 2167]

• Guidelines explain what information must 

be included in a petition

• No specific template or form is required

• No fee or cost to petition

• Petitions may contain confidential business 

information (CBI). CBI is not available to 

NOSB or public.

USDA Agricultural Marketing Service | National Organic Program 6
NOP’s Internal Process

• NOP confirms receipt of petition

• NOP reviews incoming petition for 

eligibility and sufficiency (generally 

within 30 days of submission)

• NOP is the primary point of contact for 

any correspondence between NOSB and 

petitioner

USDA Agricultural Marketing Service | National Organic Program 7
NOP’s Internal Process

NOP’s goal is to make sure that petitions are eligible 

and complete when they are distributed to the 

Subcommittee, so that revisions and supplementary 

petition information are infrequent

Two NOP checklists:

• OFPA Checklist, NOP 3005-1

• Petition Checklist, NOP 3005-2

Checklists are completed by NOP staff and 

provided to the NOSB Subcommittee, but are 

not posted for the public

USDA Agricultural Marketing Service | National Organic Program 8
NOP’s Internal Process

• OFPA Checklist, NOP 3005-1

–Used to verify eligibility of the 

substance for addition to the National 

List

– Substances that are not eligible are 

not forwarded to the NOSB for review

USDA Agricultural Marketing Service | National Organic Program 9
Ineligible Petitions

• Formulated (brand name) products

• Food additive without FDA approval

• Pesticide without EPA tolerance or tolerance 

exemption

• Requests to add substances already allowed

• Synthetic NPK fertilizers

• Materials otherwise prohibited by the USDA 

organic regulations (e.g., sewage sludge, 

GMOs, etc.)

• Previously petitioned/rejected materials (if 

no new information is provided)

USDA Agricultural Marketing Service | National Organic Program 10
NOP’s Internal Review

Eligibility review of previously petitioned/rejected 

materials

– NOP reviews previous petition and technical report(s) for the 

substance

– NOP identifies why the substance was prohibited

– NOP reviews new petition for any information that was not submitted 

in an earlier petition or provided in the technical report

– No new information

• Petitioner is notified that substance was previously reviewed and 

rejected and that no new information was provided

– New information

• Petition proceeds to NOSB review. NOP does not determine 

whether the new information would be likely to warrant a change 

in decision

**Important that NOSB recommendations to reject petitions also 

contain sufficient justification**

USDA Agricultural Marketing Service | National Organic Program 11
NOP’s Internal Process

• Petition Checklist, NOP 3005-2

– Used to verify that the petition meets the 

submission guidelines

– NOP does not fact check all of the data 

provided

– NOP may identify areas where more 

information or references are needed for 

completeness

– NOP’s “sufficiency” determination does not

mean NOP believes the substance should be 

added to the National List; only that it meets 

the eligibility requirements for NOSB review

USDA Agricultural Marketing Service | National Organic Program 12
Petition Process

• Examples of incomplete petitions:

– Too much information identified as 

confidential business information

– No description of alternatives

– Labels not submitted

– No reference list provided

– Inadequate description of previous 

reviews (e.g., NOSB reviews)

– Inadequate description of physical 

properties and chemical mode of action

USDA Agricultural Marketing Service | National Organic Program 13
NOP’s Internal Review

• “...acceptance of the petition for NOSB 

review is an administrative matter and 

does not reflect a decision by NOP on the 

substantive merits of the petition.”

• “...the NOSB, during its evaluation of the 

petitioned substance, may have additional 

requests for information. A notice will be 

sent to you should the NOSB request 

additional information.”

USDA Agricultural Marketing Service | National Organic Program 14
NOP’s Process

• Updated Petition Information

– Petitioner may submit updated 

(unsolicited) information after 

petition has been sent to NOSB

– Petitioner may respond to additional 

information requested by NOSB

• Updates are posted alongside petition 

on NOP website

USDA Agricultural Marketing Service | National Organic Program 15
NOSB Subcommittee Process

Petition – NOSB subcommittee review

• Should be completed within 60 days of 

receipt of petition

The NOSB subcommittee may request:

a) Additional information from petitioner

b) Technical report

USDA Agricultural Marketing Service | National Organic Program 16

Adapted from NOSB Policy & Procedures Manual
Technical Reports

• Completed by third-party contractors

• Technical report templates include evaluation 

questions derived from OFPA criteria

• Minimum of 4 months for development

• Reports are posted on NOP website after 

acceptance by NOSB Subcommittee

USDA Agricultural Marketing Service | National Organic Program 17
NOSB Process: TR Requests

• Requests for technical reports (TRs) should 

be submitted within 60 days of receipt of 

petition

• TRs are always optional, but may be 

requested at the discretion of the 

Subcommittee

• Any additional information requested 

(beyond the scope of a standard technical 

report), must be aligned with the OFPA 

criteria

• If particular areas of focus are needed, 

please provide the details in the request.

USDA Agricultural Marketing Service | National Organic Program 18
NOSB Process: TR Requests

• For petitions to add new substances to the 

National List, we do not recommend limiting the 

scope of the technical report

• Limited scope / supplemental TRs may be 

appropriate in the following scenarios:

– Crop or livestock petitions where classification 

is unclear

– Petitions to amend an existing annotation

– Petitions to remove an existing substance

– Sunset substances

USDA Agricultural Marketing Service | National Organic Program 19
Technical Report Content

• Technical reports do not currently 

include:

– Proprietary information

– Economic impact information

• NOP accepts quality, accuracy and 

completeness of technical reports

USDA Agricultural Marketing Service | National Organic Program 20
Technical Reviews, cont.

• NOP reviews all TRs before they are distributed to 

the Subcommittee to ensure they meet the 

requirements of the contract

• NOP will ensure that TRs are sufficient and complete 

when they are distributed to the Subcommittee 

• Occasionally, NOP will request that a subject matter 

expert from the Agricultural Research Service review 

a draft copy of the report. When this occurs, it will 

be noted when NOP distributes the report to the 

Subcommittee

USDA Agricultural Marketing Service | National Organic Program 21
Petition Process: Substance Evaluation Criteria

1. The potential of such substance for 

detrimental chemical interactions with other 

materials used in organic farming systems;

2. The toxicity and mode of action of the 

substance and of its breakdown products of 

any contaminants, and their persistence and 

areas of concentration in the environment;

3. The probability of environmental 

contamination during manufacture, use, 

misuse, or disposal of such substance;

4. The effect of the substance on human health;

USDA Agricultural Marketing Service | National Organic Program 22

OFPA, Sec. 2119(m)
5. The effect of the substance on biological 

and chemical interactions in the 

agroecosystem, including the 

physiological effects of the substance on 

soil organisms (including the salt index 

and solubility of the soil), crops and 

livestock;

6. The alternatives to using the substance in 

terms of practices or other available 

materials; and

7. Its compatibility with a system of 

sustainable agriculture. 

USDA Agricultural Marketing Service | National Organic Program 23

Petition Process: Substance Evaluation Criteria

OFPA, Sec. 2119(m)
Technical Advisory Panels (TAPs)

• OFPA: The NOSB shall convene technical advisory 

panels to provide scientific evaluation of materials 

considered for the National List. 

• The NOSB has not convened independent Technical 

Advisory Panels since 2005. Currently the NOSB is 

relying on information within the Technical Reports 

provided by the NOP and public comment to make 

their final recommendations.

• TAPs previously included recommendations. 

Technical reports do not recommend actions to the 

NOSB.

USDA Agricultural Marketing Service | National Organic Program 24
Petition Process: 205.606 Evaluation Criteria

The NOSB shall determine whether agricultural substances 

petitioned for Section 205.606 are potentially commercially 

unavailable.

The NOSB will consider:

• Why the non-organic form of the substance is necessary 

for use in organic handling;

• The current and historical industry 

information/research/evidence that explains how or why 

the substance cannot be obtained organically in the 

appropriate form, quality, or quantity to fulfill an essential 

function in a system of organic handling.

USDA Agricultural Marketing Service | National Organic Program 25

Petition guidelines, 72 FR 2167
Industry information includes, but is not 

limited to the following:

1. Regions of production, including factors such as 

climate and number of regions;

2. Number of suppliers and amount produced;

3. Current and historical supplies related to weather 

events such as hurricanes, floods, and droughts 

that may temporarily halt production or destroy 

crops or supplies;

USDA Agricultural Marketing Service | National Organic Program 26

Petition guidelines, 72 FR 2167

Petition Process: 205.606 Evaluation Criteria
Industry information includes, but is not 

limited to the following:

4. Trade related issues such as evidence of 

hoarding, war, trade barriers or civil unrest 

that may temporarily restrict supplies; and

5. Other issues which may present a challenge to 

a consistent supply.

USDA Agricultural Marketing Service | National Organic Program 27

Petition guidelines, 72 FR 2167

Petition Process: 205.606 Evaluation Criteria
NOSB Process - Checklists

• The NOSB checklists are a tool to 

facilitate and document evaluation of 

the petitioned substance against the 

OFPA criteria

• OFPA does not require checklists, but 

requires that Board shall consider seven 

different criteria

• New forms with alternative format – in 

development

USDA Agricultural Marketing Service | National Organic Program 28
NOSB Review - Documentation

• In general, suggest limiting your answers to 

address the uses that are within the scope 

of the petition (although there may be 

exceptions, such as effects from misuse)

• Does recommendation demonstrate that 

NOSB met its obligation under OFPA to 

consider the criteria (e.g., effect of the 

substance on human health?)

• Comments should be used to document 

the review and to provide clarity for 

stakeholders

USDA Agricultural Marketing Service | National Organic Program 29
• For substances that have a broad 

spectrum of utility, the NOP 

recommends that, to the extent 

possible, the NOSB review materials 

with a lens limited to the manner and 

amount that the substance would be 

used in organic production and handling

USDA Agricultural Marketing Service | National Organic Program 30
• Questions?

USDA Agricultural Marketing Service | National Organic Program 31
Sunset Process

1

Lisa M. Brines, Ph.D.

Agricultural Marketing Service | National Organic Program 

February 2016

NOSB Training
Sunset Provision of OFPA

• No exemption or prohibition contained 

in the National List shall be valid unless 

the NOSB has reviewed such exemption 

or prohibition as provided in this section 

within 5 years of such exemption or 

prohibition being adopted or reviewed 

and the Secretary has renewed such 

exemption or prohibition

USDA Agricultural Marketing Service | National Organic Program 2

OFPA, Section 2118(e)
Sunset Dates

• Apply to National List substances

• Sunset dates are published in Program 

Handbook, NOP 5611

• 5 years is calculated from effective date 

of final rule or renewal

• For efficiency, sunset reviews are 

grouped by calendar year

USDA Agricultural Marketing Service | National Organic Program 3
Sunset Process

• Thorough and transparent review 

process for all substances - provides 

two public comment opportunities 

before the NOSB completes its review of 

each substance. 

• Ensures that any change to the National 

List (petitioned or sunset) is supported 

by a 2/3 majority of the NOSB.

• Streamlines the administration of the 

National List by simplifying rulemaking. 

USDA Agricultural Marketing Service | National Organic Program 4
What is the process?

• The Sunset Process is comprised of

two components: 

(1) The NOSB review (Steps 1-6) and 

(2) USDA action (Steps 7-8) on substances 

within 5 years of their addition to or renewal 

on the National List. 

• Key documents used for the review:

(1) Sunset List

(2) Preliminary Review

(3) NOSB Sunset Review

USDA Agricultural Marketing Service | National Organic Program 5
Process Mechanics

• Step 1 – Meeting announcement in Federal 

Register inviting comment on Sunset List 

(background may include requests for 

specific info from Subcommittees)

• Step 2 – Written public comments 

submitted and analyzed by Subcommittees

• Step 3 (Mtg #1) – Subcommittees 

summarize background and public 

comment & receive oral comment

USDA Agricultural Marketing Service | National Organic Program 6
Process Mechanics Cont’d

• Step 4 – Subcommittees analyze written 

and oral comments from Mtg #1 and 

prepare Preliminary Review. 

– Meeting announcement inviting 

comment on Preliminary Review

published in Federal Register

• Step 5 – Written public comments 

submitted and analyzed by 

Subcommittees

USDA Agricultural Marketing Service | National Organic Program 7
Process Mechanics Cont’d

• Step 6 (Mtg #2) – Subcommittees 

present Preliminary Review, receive 

oral comment, and discuss with the full 

Board.

– Motions for removal from the 

Preliminary Review are voted on by 

the full Board.

– After Mtg #2, NOSB completes Sunset 

Review. 

USDA Agricultural Marketing Service | National Organic Program 8
Process Mechanics Cont’d

• Step 7 – AMS reviews NOSB Sunset 

Review and considers rulemaking action 

for any recommended removals

• Step 8 – AMS issues Federal Register 

Notice announcing renewal of 

applicable substances 

USDA Agricultural Marketing Service | National Organic Program 9
Sunset 2018

July 2015

• Subcommittees submitted Technical Reports requests

Spring 2016 Meeting

• Sunset 2018 Summaries

• Public comment

Fall 2016 Meeting

• Sunset 2018 Reviews

• Public comment

• Decisions to remove made here

Before Sunset Dates in 2018 (May 29/Nov 3)

• AMS renewal and removals, as applicable.

USDA Agricultural Marketing Service | National Organic Program 10
Review New Documents

• Sunset list template

• Preliminary review template

• NOSB review template

USDA Agricultural Marketing Service | National Organic Program 11
• Questions?

USDA Agricultural Marketing Service | National Organic Program 12
Rulemaking

1

Shannon Nally Yanessa

Agricultural Marketing Service | National Organic Program 

February 2016

NOSB Training
Objectives 

• What happens when NOP receives an 

NOSB recommendation for rulemaking?

• How do we get from recommendation 

to a proposed or final rule?

USDA Agricultural Marketing Service | National Organic Program 2
Framework

Administrative Procedures Act

• Fosters transparency and public participation 

in the rulemaking process.

Basic requirements:

– Publish a proposed rule in the Federal Register.

– Invite and consider public comments.

– Issue final rule at least 30 days before effective 

date. 

USDA Agricultural Marketing Service | National Organic Program 3
Rulemaking oversight

• Office of Information and Regulatory Affairs 

(OIRA) in the Office of Management and 

Budget (OMB)

– Operates as an “information aggregator” 

across government

– Facilitates interagency coordination & 

communication

– Considers costs and benefits of regulations

– Ensures public engagement in process

– Ensures compliance with relevant statutes 

• Reginfo.gov dashboard

USDA Agricultural Marketing Service | National Organic Program 4
How does NOP initiate a rulemaking? 

• Submit a regulatory workplan

– Summarizes objectives, possible 

alternatives, and effects of action to 

policy officials (non-technical)

– Provides information needed for 

“designation” of significance 

• Priority rulemaking actions appear on the 

Unified Agenda

– Communicates to OMB and public 

about agencies regulatory plan

USDA Agricultural Marketing Service | National Organic Program 5
Significance designation

• OMB reviews rules that may: 

– Have an annual effect on the economy of 

over $100 million or more, or adversely 

affect the economy, a sector of the 

economy, jobs, or competition;

– Create serious inconsistency or interferes 

with an action of another agency;

– Materially alter the budgetary impact of 

existing programs; or

– Raise novel legal or policy issues.

USDA Agricultural Marketing Service | National Organic Program 6
Significant vs Non-significant

What does this distinction mean in practice?

• Significant rules require additional analyses: 

– Regulatory Impact Analysis (cost-benefit) – E.O. 12866 & 

13563

– Regulatory Flexibility Act 

– Paperwork Reduction Act

– Consultation & Coordination with Indian Tribal 

Governments

– Civil Rights Impact Analysis

USDA Agricultural Marketing Service | National Organic Program 7
How does NOP draft a rule?

• Review all NOSB recommendations; technical 

information (e.g., TRs, petitions), overlapping 

regulations. 

• Review and analyze public comments (final rule).

• Draft overview of the amendment(s), including 

justification for action and info on implementation; 

• Draft amendatory instructions for Federal Register; 

• Conduct necessary supplementary analyses.

• Facilitate NOP approval; engage other Divisions as 

needed. 

USDA Agricultural Marketing Service | National Organic Program 8
How can public comments 

affect the final rule?

• The notice-and-comment process enables anyone to 

submit a comment on any part of a proposed rule. 

• An agency is not permitted to base its final rule on the 

number of comments in support of the rule over those in 

opposition to it. 

• The agency must base its reasoning and conclusions on the 

rulemaking record, consisting of the comments, scientific 

data, expert opinions, and facts accumulated during the 

pre-rule and proposed rule stages.

• If the rulemaking record contains persuasive new data or 

sound policy arguments, the agency may decide to 

terminate the rulemaking. 

• Or, the agency may decide to continue the rulemaking but 

change aspects of the rule to reflect these new issues. 

USDA Agricultural Marketing Service | National Organic Program 9
Clearance - review pathway

– Office of General Counsel & USDA General Counsel

– NOP Deputy Administrator

– AMS Administrator

– Office of Budget and Program Analysis

– Office of Risk Assessment and Cost Benefit Analysis

– Assistant Secretary, Civil Rights

– Office of Chief Economist

– Office of Chief of Information

– Office of Tribal Relations

– Undersecretary 

– Secretary

– OMB – includes interagency review. 

• 90-day review; can be extended. 

– (Congressional Review Act)

USDA Agricultural Marketing Service | National Organic Program 10

Red = needed 

for significant 

rules 
Why does rulemaking take so long?

• Review of NOSB recommendation

• Draft Regulatory Workplan for OMB Designation

• Draft Proposed Rule 

• Clearance & Federal Register Publication

• Comment Period

• Comment Analysis

• Workplan Addendum for OMB Designation

• Revise Required Analyses

• Draft Final Rule

• Clearance & Federal Register Publication

• Effective Date of Final Rule 

USDA Agricultural Marketing Service | National Organic Program 11

Proposed 

Rule 

Stage

Final Rule 

Stage
Resources

• A Guide to the Rulemaking Process

– Office of Federal Register

• The Office of Information and 

Regulatory Affairs: Myths and Realities

– Commentary By Cass R. Sunstein

• The Regulatory Plan and Unified Agenda

– Office of Management & Budget

USDA Agricultural Marketing Service | National Organic Program 12
Best Practices:

Proposals & Recommendations

Emily Brown Rosen

Agricultural Marketing Service | National Organic Program 

February 2016

1

NOSB Training
Overview

• Review overall process and templates 

• Example of a non-materials proposal

• Critical pieces of proposals & 

recommendations

USDA Agricultural Marketing Service | National Organic Program 2
NOSB Process

USDA Agricultural Marketing Service | National Organic Program 3

SC work

Discussion 

Document

posted

Proposal

posted

NOSB 

Meeting 

NOSB 

Meeting 

Final 

Recommendation

Public

comment

Substantive 

Changes?
Proposals

• Proposal

– Come from Subcommittees

– Propose an action, include a SC vote 

– Examples: 

• Motion to List, Remove, or Change a 

substance 

• Motion that calls for policy 

clarification or guidance

• Motion to change the regulation 

elsewhere

USDA Agricultural Marketing Service | National Organic Program 4
Discussion document

• Provided by Subcommittee

–Used to collect information

– Posted for comment

• No vote taken at first meeting 

– Verbal update, discuss comments

• Returns to subcommittee for further 

development

• May be turned into a Proposal at next 

meeting

USDA Agricultural Marketing Service | National Organic Program 5
Recommendation

• Product of full board

• SC proposal is voted on at meeting

– Final product is considered the 

recommendation to NOP

• Cover sheet is added to the SC 

proposal to summarize final action

– If substantive changes are considered 

during a meeting, must get sent back 

to SC for revision and re-posting 

USDA Agricultural Marketing Service | National Organic Program 6
Other types of documents

• Reports or Updates 

– Subcommittee does not expect public 

comment, but wants to provide 

update to public

–No votes or action expected by NOP 

in response

USDA Agricultural Marketing Service | National Organic Program 7
Forms used 

• Materials Review Template for new 

petitions

– Crops and livestock version

– Handling version

• Other proposals - narrative

• Sunset templates 

– Initial Meeting 1 Summary

– Meeting 2 Subcommittee Prelim Review

– NOSB Final Sunset Review

USDA Agricultural Marketing Service | National Organic Program 8
Example of narrative format 

recommendation

Calculation of Organic Percent, April 2013

Compliance Certification and 

Accreditation Subcommittee

USDA Agricultural Marketing Service | National Organic Program 9
What are the critical pieces?

• Assessment of Existing Rule

– Did you check if other parts of the regulations 

may be impacted by your proposed action?

• E.g., sulfites in fortified wines, colors 

– If other parts are impacted, what is your 

advice?

• Accuracy

– Did you use the correct citations to OFPA and 

the USDA organic regulations?

• E.g., Tetracycline

USDA Agricultural Marketing Service | National Organic Program 10
What are the critical pieces?

• Clear Use of Technical Information

–Did you ensure that accurate citations for 

any technical information is included?

–Did you clearly articulate why the technical 

information is relevant and supports any 

justification?

• E.g., Carrageenan

USDA Agricultural Marketing Service | National Organic Program 11
What are the critical pieces?

• Clear Explanation of “Limits”

– If there is some quantitative limit proposed, 

did you articulate the basis for the limit?

• E.g., Methionine

• E.g., Stocking Density

USDA Agricultural Marketing Service | National Organic Program 12
What are the critical pieces?

• Use of Criteria

–Did you clearly explain your evaluation of 

the OFPA criteria and how it connects to 

your proposal?

• E.g., Why a natural material is not 

effective

– For 606 materials, did you discuss evidence 

of commercial availability? 

• E.g., hops

USDA Agricultural Marketing Service | National Organic Program 13
What are the critical pieces?

• Responsive

–Did you address the petitioner’s request? 

–Did you explain why you chose an 

alternative to or rejected the petitioned 

use?

• E.g., pet food amino acids

USDA Agricultural Marketing Service | National Organic Program 14
What are the critical pieces?

• Impacts on Organic Market

– To the extent that data or public comment 

is available, did you summarize information 

on expected impacts on...?

• Organic producers and handlers

• Organic consumers

• Certifying agents

USDA Agricultural Marketing Service | National Organic Program 15
Best Practices:

Evaluating Technical Reports

and Petitions, 

Developing Materials Proposals

Emily Brown Rosen

Agricultural Marketing Service | National Organic Program 

February 2016

16

NOSB Training
Overview

• Identifying key information

– In petition

– In Technical Review

• Filling out the Materials Review 

Template

• Providing a summary narrative

USDA Agricultural Marketing Service | National Organic Program 17
Finding the Key Information

• You have just received an email 

with a large TR linked, and 

request for review 

USDA Agricultural Marketing Service | National Organic Program 18

Where to start?

• Identity

• Classification 

• What is it used 

for
Finding the Key Information

1. Identity of the Substance

- Is it obvious?

- Are there various forms?

- What was the petitioned form?

Example: formic acid

USDA Agricultural Marketing Service | National Organic Program 19
Finding the Key Information

• Identity 

– Is there one CAS number?

– Are there variations in form?

– Are there discrepancies between 

petitioned name and TR name?

USDA Agricultural Marketing Service | National Organic Program 20
Example of Identity Problem

• Petition was for “cellulose fibers” 

– For use in hot dog casings, also anticaking 

and filtering

• TR says: Chemical name = Cellulose, ß-1-4-Dglucan

– Other names include: 

• powdered cellulose; alpha-cellulose, flour 

cellulose; cellulose fibers. 

• Microcrystalline cellulose, MCC, (derived 

from cellulose) is also called cellulose gel.

• Cellulose casing, regenerated cellulose

USDA Agricultural Marketing Service | National Organic Program 21
Example of Identity problem

From TAP

• Cellulose

– CAS Number: 9004-34-6- alpha cellulose

• Other Codes:

INS numbers:

• 460 cellulose

• 460(i) microcrystalline cellulose

• 460(ii) powdered cellulose 

USDA Agricultural Marketing Service | National Organic Program 22
Example of Identity problem

• Best to identify the exact identity in final 

recommendation: 

– CAS number, INS number or other

–Will help in future reviews

USDA Agricultural Marketing Service | National Organic Program 23
Finding the Key Information

2. How should the substance be classified?

- Synthetic

- Nonsynthetic

- Agricultural

• Find this in the TR

• Does the petition also support this finding?

– If not, explain reasoning for a different 

determination

– Cite support for decision on Petition Review

Template

– Use Decision Tree 

– Classification of Materials Guidance

USDA Agricultural Marketing Service | National Organic Program 24
Finding the Key Information

3. What is the petitioned use?

- Is it clear from petition?

- Are there other uses mentioned in 

TR?

- Review Example: formic acid 

USDA Agricultural Marketing Service | National Organic Program 25
Read the Documents !

• Once oriented – read carefully the entire 

TR

• Revisit petition for comparison

– Petition Justification statement- does 

it seem valid?

• Then go through Review Template and 

answer questions.

• Discuss: does anyone have a different 

way to approach this?

USDA Agricultural Marketing Service | National Organic Program 26
Materials Review Template

• Provide reasoning

–Overall use is to balance overall 

evaluation, one factor might offset 

another

–No one criterion is determining

• Sometimes there is no answer, can 

indicate that information is lacking

USDA Agricultural Marketing Service | National Organic Program 27
Review Exercise - break into 2 groups 

• Category 1 – Classification and Category 

3 – Alternatives / Compatibility

• Category 2 – Adverse Impacts

USDA Agricultural Marketing Service | National Organic Program 28
Summary 

• Once template complete fill out 

Summaries on page 1

• Summary of Proposed Action

– Plainly describe what the proposed 

action is 

–Give brief justification for action, cite 

criteria met or not met

USDA Agricultural Marketing Service | National Organic Program 29
Questions? 

USDA Agricultural Marketing Service | National Organic Program 30
Best Practices: 

Comment Evaluation

31

Emily Brown Rosen

Agricultural Marketing Service | National Organic Program 

February 2016

NOSB Training
Role of Public Comment

• Enables stakeholder feedback and 

participation 

• Provides input on current needs and uses

• Provides input on public concerns

• Improves the final NOSB recommendation

• Helps support the final NOP action

USDA Agricultural Marketing Service | National Organic Program 32
Challenges

• Large number of comments on some 

topics

• Limited time to review

• Not always specific or helpful

• Useful to have a system for review

– Start with a table

• Count numbers

• Summarize significant ideas

USDA Agricultural Marketing Service | National Organic Program 33
Weighing the comments

• NOSB should treat comments similarly as USDA 

does in rulemaking

– It is not a ballot initiative or an up-or-down vote 

– Total numbers for or against are not 

determinative alone

– NOSB recommendations should have 

justification based on comments, scientific data, 

expert opinions, and facts accumulated during 

the NOSB process.

– If the comments contains persuasive new data 

or sound policy arguments, the SC could defer a 

final recommendation, or re-propose with 

changes.

USDA Agricultural Marketing Service | National Organic Program 34
Examples 

Total comments: 25 - Bulk Handling Draft Guidance 

(Internal NOP review) 

USDA Agricultural Marketing Service | National Organic Program 35

Suggested changes Likes other

Certifiers Assoc. – 43 

signers

- Transporters optionally may be certified, thinks “handle” 

does not include transport

- provide definition of broker: does not physically handle? 

- Sealed containers – should mean tamper proof,& 

impermeable 

Supports in 

general

Supported by 

(mkt coop)

XYZ certifier handlers, not always reqd to be certified.

-Certifiers may not be able to inspect railroad cars and trucks

-have not been requiring hay brokers to be certified

organic farmer, MN -Undue burden on smaller growers using custom haulers

-will be a lack of transporters if all have to be certified

Also filed as 

assoc, 144 

members
Examples – NOSB meeting Oct 2012

Crops Subcommittee Presentation

Total in favor of adding Biodegradable Mulch Film: 163

– Farmers: 38

– Consumers: 114

– Organizations: 11 

(Including, among others: BPI; Beyond Pesticides; CCOF; Driscoll’s; NOFA; NatureWorks; Novamont; OTA; 

Oregon Tilth; Protema; USDA BioPreferred Program)

Total opposed to listing Biodegradable Mulch Film: 4

– Farmers: 0

– Consumers: 1

– Organizations: 3

(CFS; Organically Grown Company; PCO)

Total requesting clarification, annotation changes or further research: 3

– Organizations: 3 

(CROPP Cooperative; OMRI; QAI)
Examples – NOSB meeting Oct 2012

Crops Subcommittee Presentation

205.601(b)(2)

(A)(2) showing at least 90% biodegradation absolute or relative to microcrystalline 

cellulose in less than two years, in soil, tested according to ISO 17556 or ASTM 5988

• BPI: Although sometimes used as synonyms, the terms “biodegradation” and 

“mineralization” are different. The 90% threshold value required by the petition and 

ASTM test methods refer to mineralization. A complete biodegradation is inferred 

when a mineralization level of 90% is reached.

• CFS: Concerned whether the tests have been adequately field verified; the TR did not 

address these questions. 10% of the mulch is allowed to remain in the microbial 

biomass or as an undegraded or partially degraded residue in soil; concerns for 

persistence in farm environment.

• OMRI: This language can serve as an appropriate and adequate review without A(1). 

5988 is a testing method, rather than a standard to which certification can be 

obtained; concerned about certifier expertise to determine if materials meet the 

annotation. A(2) & (E) conflict over the 2 year &/or end of each growing season 

biodegradation timeframe.

• PCO: there are too many standards referenced in the annotation.
Examples - NOSB meeting Oct 2012

Crops Subcommittee Presentation 

Concern Response

Short and long-term impact of 

pigments on ecosystem

Only titanium dioxide and carbon black are 

being petitioned. Titanium dioxide is nonsynthetic and would be allowed anyway, and 

carbon black is pure carbon and in effect 

already allowed as the main component of the 

ink in newspaper mulch 

Can metal catalysts build up in 

the soil and with what impacts? 

An important part of meeting the ASTM 6400 

standard above is to verify that any substances 

such as catalysts break down completely along 

with the other ingredients. All additives will be 

tested for by the MRO or the manufacturer.

Are there other additives or 

processing aids that have 

potential negative impacts? 

Same comment as above. Additionally, one of 

the makers of PLA bioplastic stated that the TR 

was inaccurate about the solvents used to 

produce PLA. No solvents are used for PLA.
Example – included in final NOSB review

Since the original recommendation dated September 1, 2009 

was posted, the NOSB has received 9 comments related to the 

Handling Committees original recommendation. Comments 

were received from organic manufacturers, certifiers, trade 

associations, and consultants to the organic industry. All 

comments disagree with the September 1, 2009 

recommendation, stating that this substance is still a necessary 

additive to boiler feed water of some organic operations to 

minimize corrosion of boilers and steam lines, especially for 

manufacturers who run predominantly organic products, and 

whose facilities are located in areas where water quality is 

exceptionally poor. There were no comments posted that agreed 

with the Handling Committees original decision. 

USDA Agricultural Marketing Service | National Organic Program 39

Nov. 2009 Handling Committee

Sunset Review of Octadecylamine
Comments

• Importance of Acknowledging 

Comments

– There will always be disagreements

– Public can accept they will not always 

get their desired outcome

• If they are not ignored

• If the reasons are explained

– Results in more consensus, and 

stronger program in the long run

USDA Agricultural Marketing Service | National Organic Program 40
Evaluation of Comments

• Questions?

• Other ideas or tips? 

• What works for you?

USDA Agricultural Marketing Service | National Organic Program 41
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Sunset [Year] Review Summary 

Meeting 1 - Request for Public Comment

[Crops/Livestock/Handling] Substances

[Month Year]

Introduction

As part of the Sunset Process, the National Organic Program (NOP) announces substances on the 

National List of Allowed and Prohibited Substances (National List) that are coming up for sunset review 

by the National Organic Standard Board (NOSB). The following list announces substances that are on the 

National List for use in organic crop production that must be reviewed by the NOSB and renewed by the 

USDA before their sunset dates in 2017. This list provides the substance’s current status on the National 

List, use description, references to past technical reports, past NOSB actions, and regulatory history, as 

applicable. If a new technical report has been requested for a substance, this is noted in this list. To see 

if any new technical report is available, please check for updates under the substance name in the 

Petitioned Substances Database. 

Request for Comments

While the NOSB will not complete its review and any recommendations on these substances until the 

[spring/fall Year] public meeting, the NOP is requesting that the public provide comments about these 

substances to the NOSB as part of the [spring/fall Year] public meeting. These comments should be 

provided through www.regulations.gov by [Month, day, year] as explained in the meeting notice 

published in the Federal Register. 

These comments are necessary to guide the NOSB’s review of each substance against the criteria in the 

Organic Foods Production Act (7 U.S.C. 6518(m)) and the USDA organic regulations (7 CFR 205.600). The 

current substances on the National List were originally recommended by the NOSB based on evidence 

available to the NOSB at the time of their last review which demonstrated that the substances were 

found to be: (1) not harmful to human health or the environment, (2) necessary because of the 

unavailability of wholly nonsynthetic alternatives, and (3) consistent and compatible with organic 

practices. 

Public comments should focus on providing new information about a substance since its last NOSB 

review. Such information could include research or data that may support a change in the NOSB’s 

determination for a substance. Public comment should also address the continuing need for a substance 

or whether the substance is no longer needed or in demand.

Guidance on Submitting Your Comments

Comments should clearly indicate your position on the allowance or prohibition of substances on the list 

and explain the reasons for your position. You should include relevant information and data to support 

your position (e.g., scientific, environmental, manufacturing, industry impact information, etc.). 

For Comments That Support Substances Under Review:

If you provide comments in support of an allowance of a substance on the National List, you should 

provide information demonstrating that the substance is: 

(1) not harmful to human health or the environment;

(2) necessary to the production of the agricultural products because of the unavailability of wholly 

nonsynthetic substitute products; and 

(3) consistent with organic [crop production/livestock production/handling]. 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Page 2 of 4

For Comments That Do Not Support Substances Under Review: 

If you provide comments that do not support a substance on the National List, you should provide 

reasons why the use of the substance should no longer be allowed in organic production or handling. 

Specifically, comments that support the removal of a substance from the National List should provide 

new information since its last NOSB review to demonstrate that the substance is: 

(1) harmful to human health or the environment; 

(2) unnecessary because of the availability of alternatives; and 

(3) inconsistent with [crop production/livestock production/handling]. 

For Comments Addressing the Availability of Alternatives: 

Comments may present information about the viability of alternatives for a substance under sunset 

review. Viable alternatives include, but are not limited to:

o Alternative management practices that would eliminate the need for the specific 

substance; 

o Other currently exempted substances that are on the National List, which could 

eliminate the need for this specific substance; and

o Other organic or nonorganic agricultural substances. 

Your comments should address whether any alternatives have a function and effect equivalent to or 

better than the allowed substance, and whether you want the substance to be allowed or removed from 

the National List. Assertions about alternative substances, except for those alternatives that already 

appear on the National List, should, if possible, include the name and address of the manufacturer of the 

alternative. Further, your comments should include a copy or the specific source of any supportive 

literature, which could include product or practice descriptions; performance and test data; reference 

standards; names and addresses of producers or handlers who have used the alternative under similar 

conditions and the date of use; and an itemized comparison of the function and effect of the proposed 

alternative(s) with substance under review. The following table can help you describe recommended 

alternatives in place of a current substance that you do not want to be continued.

[NOTE – ONLY include this paragraph on handling list] For Comments on Nonorganic Agricultural 

Substances at Section 205.606.

For nonorganic agricultural substances on section 205.606, the NOSB Handling Subcommittee requests 

current industry information regarding availability of and history of unavailability of an organic form of 

the substance in the appropriate form, quality, or quantity of the substance. The NOSB Handling 

Subcommittee would like to know if there is a change in supply of organic forms of the substance or 

demand for the substance (i.e. is an allowance for the nonorganic form still needed), as well as any new 

information about alternative substances that the NOSB did not previously consider.

Written public comments will be accepted through [Month, day Year] via www.regulations.gov. 

Comments received after that date may not be reviewed by the NOSB before the meeting. 

Reference: 7 CFR §205.601 Synthetic substances allowed for use in organic crop production.

Reference: 7 CFR 205.603 Synthetic substances allowed for use in organic livestock production
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Page 3 of 4

Reference: 7 CFR 205.605 Nonagricultural (Nonorganic) substances allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food 

group(s)).’’

§205.605(a) Nonsynthetics allowed:

§205.605(b) Synthetics allowed:

Reference: 7 CFR §205.606 Nonorganically produced agricultural products allowed as ingredients in or 

on processed products labeled as “organic.”

LIST of MATERIALS LINKED TO SUMMARY BELOW

EXAMPLES:

Substance 1

Substance 2

NAME OF SUBSTANCE 1

Reference: 205.60X1(X)(X)

Technical Report(s): 19XX TAP; XX/20XX TR; XX/20XX TR

Petition(s): 199X, 200X

Past NOSB Actions: XX/1995 NOSB minutes and vote; XX/20XX NOSB sunset recommendation; 

XX/20XX NOSB sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 0X/0X/200XX (XX FR XXXXX)

Sunset Date: XX/XX/20XX

Background from Subcommittee:

INSERT BACKGROUND TEXT/PRELIMINARY REVIEW

Supplemental Review Information

(LINK TO OPTIONAL CHECKLIST IF COMPLETED)

Additional information requested by NOSB

INSERT QUESTIONS FROM SUBCOMMITTEE OR “NONE”

NAME OF SUBSTANCE 2
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Page 5 of 4

Reference: 205.60X1(X)(X)

Technical Report(s): 19XX TAP; XX/20XX TR; XX/20XX TR

Petition(s): 199X, 200X

Past NOSB Actions: XX/1995 NOSB minutes and vote; XX/20XX NOSB sunset recommendation; 

XX/20XX NOSB sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 0X/0X/200XX (XX FR XXXXX) 

Sunset Date: XX/XX/20XX 

Background from Subcommittee:

INSERT BACKGROUND TEXT/PRELIMINARY REVIEW

Supplemental Review Information

(LINK TO OPTIONAL CHECKLIST IF COMPLETED)

Additional information requested by NOSB

INSERT QUESTIONS FROM SUBCOMMITTEE OR “NONE”
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Sunset [Year] Review Summary

Meeting 2 - Subcommittee Review

[Crops/Livestock/Handling] Substances

[Month Year]

As part of the National List Sunset Review process, the NOSB [Crops, Livestock, or Handling]

Subcommittee has evaluated the need for the continued allowance for or prohibition of the following 

substances for use in organic [crop production, livestock production, or handling].

If the Subcommittee has obtained new information since its last review that supports a motion to 

remove a substance from the National List, the Subcommittee will provide justification that 

demonstrates that the substance is: 

(1) harmful to human health or the environment; 

(2) unnecessary because of the availability of alternatives; and 

(3) inconsistent with organic production or handling. 

Regarding the Availability of Alternatives: 

Justification will include information about the viability of alternatives for a substance under sunset 

review. Viable alternatives include, but are not limited to: 

• Alternative management practices that would eliminate the need for the specific substance; 

• Other currently exempted substances that are on the National List, which could eliminate the 

need for this specific substance; and 

• Other organic or nonorganic agricultural substances. 

Justification should include reference to Technical Reports, petitions, public comments, or other 

relevant literature.

[LIST OF MATERIALS WITH LINKS TO MATERIAL BELOW]

EXAMPLES:

Substance 1

Substance 2

Links to additional references and supporting materials for each substance can be found on the 

NOP website: http://www.ams.usda.gov/rules-regulations/organic/national-list/petitioned

Commented [AM-A1]: Instructions for NOSB. Delete for 

posting
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

 

NAME OF SUBSTANCE 1

Reference: 205.60X1(X)(X)

Technical Report(s): 19XX TAP; XX/20XX TR; XX/20XX TR

Petition(s): 199X, 200X

Past NOSB Actions: XX/1995 NOSB minutes and vote; XX/20XX NOSB sunset recommendation; 

XX/20XX NOSB sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 0X/0X/200XX (XX FR XXXXX) 

Sunset Date: XX/XX/20XX 

Subcommittee Review

[INSERT REVIEW]

Motion to Remove: 

This proposal to remove will be considered by the NOSB at its public meeting. 

The Subcommittee proposes removal of this substance from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): [INSERT CRITERIA]

Motion to remove [SUBSTANCE 1] (CAS # XX-XX-X) from 205.60X(X)

Motion by: 

Seconded by: 

Yes: 0 No: 0 Abstain: 0 Absent: 0 Recuse: 0

Approved by XXX XXX, Subcommittee Chair, to transmit to NOSB MONTH DATE, YEAR
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Sunset [Year] 

NOSB Final Review

[Crops/Livestock/Handling] Substances

[Month Year]

As part of the National List Sunset Review process, the NOSB has evaluated the need for the continued 

allowance for or prohibition of the following substances for use in organic crop production.

[LIST OF MATERIALS WITH LINKS TO MATERIAL BELOW]

EXAMPLES:

Substance 1

Substance 2

Links to additional references and supporting materials for each substance can be found on the 

NOP website: http://www.ams.usda.gov/rules-regulations/organic/national-list/petitioned
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

 

NAME OF SUBSTANCE 1

Reference: 205.60X1(X)(X)

Technical Report(s): 19XX TAP; XX/20XX TR; XX/20XX TR

Petition(s): 199X, 200X

Past NOSB Actions: XX/1995 NOSB minutes and vote; XX/20XX NOSB sunset recommendation; 

XX/20XX NOSB sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 0X/0X/200XX (XX FR XXXXX) 

Sunset Date: XX/XX/20XX 

Subcommittee Review [INSERT LINK TO PROPOSAL/REVIEW]

NOSB Review

Vote

Motion to remove [SUBSTANCE 1] (CAS # XX-XX-X) from 205.60X(X)

Motion by: 

Seconded by: 

Yes: 0 No: 0 Abstain: 0 Recuse: 0 Absent: 0

Outcome: Motion failed. NOSB completed its sunset review. OR

Outcome: Motion passed. NOSB completed its sunset review and recommended removal of [substance 

X]
Formal Recommendation 

From: National Organic Standards Board (NOSB) 

To: the National Organic Program (NOP)

Date: 

Subject: 

Chair: 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: 

Guidance Statement: 

Other: 

Statement of Recommendation: (Motion # 1) 

 

Rationale Supporting Recommendation (including consistency with OFPA and NOP):

 

Committee Vote:

 

Moved: 

SecondĞĚ: 

Yes:EŽ͗ďƐƚĂŝŶ͗ďƐĞŶƚ͗ZĞĐƵƐĞ͗

 

 

 3DJHUHYLVHGPD

April 11, 2013

Calculating Percentage Organic in Multi-Ingredient Products

Mac Stone

Motion to accept the Calculating Percentage Organic in Multi-Ingredient Products, as amended April 11, 

2013.

 

 

✔

✔

✔

Passed

 1. Proposed Regulatory Change at 205.302(a) brings language into line with actual practice to make 

calculations based on "all ingredients", not "finished product", which is consistent with OFPA and NOP 

 

2. Recommendations for development of self-calculating forms, exclusion of salt, processed single 

ingredients with specification sheets, multi-ingredient ingredients calculations, and organic labeling 

versus organic content, provide guidance language for clarification of the Rule consistent with OFPA and 

NOP. 

 

3. The organic community requires easily accessible, web based, detailed Guidance, with examples from 

the NOP, on the items listed above, and especially in calculation of excluded water. 

 

Jean Richardson

Tracy Favre

15 0 0 0 0

04/2013 1 of 8 NOSB Recommendation
National Organic Standards Board

Compliance, Accreditation and Certification

Proposal

Calculating Percentage of Organic Ingredients in Multi-ingredient Products

Amended April 11, 2013

I. INTRODUCTION:

 

The purpose of this document is to propose recommendations on determination of percentage 

organic ingredients in multi-ingredient products in order to assist the NOP in development of 

guidance for handlers and certifiers.

Consumers expect that labels on multi-ingredient products sold as “100% organic” or “organic” 

or “made with organic” reflect an accurate determination of percentage organic ingredients, and 

that all certifiers have uniformly calculated such percentages.

The integrity of USDA organic products in the USA and throughout the world depends on 

assurances of consistency and uniformity in interpretation and application of the Rule and 

associated Regulations, especially when calculating percentage organic ingredients.

 

II. BACKGROUND:

The Regulation at 205.302(c), under “Calculating the percentage of organically produced 

ingredients” states: 

“ The percentage must be determined by the handler who affixes the label on the 

consumer package and verified by the certifying agent of the handler. The handler may use 

information provided by the certified operation in determining the percentage”.

Thus, when an ingredient has been certified to the “organic” category, the supplier of that 

ingredient must provide information to the handler making the finished product regarding the 

actual percentage of organic content of that ingredient.

Over the years this has resulted in a wide variety of mechanisms for determining percentage of 

organic ingredients, and a wide variety of ways of establishing systems which allow verification

by auditors and inspectors. 

For example, if the supplier does not provide positive information, verified by the certifier, that 

the organic ingredient contains more than 95% organic content, then many, BUT NOT ALL

certifiers will only allow that ingredient to be calculated at 95% organic content.

With limited guidance, a lack of uniformity in procedures has developed. For example some 

certifiers may permit handlers to include 100% of the weight/volume of certified ingredients as 

organic, even if the ingredient is a formulated product and includes other permitted substances 

and may be in fact be anywhere from 95-100% organic. Chocolate chips for example may be 

certified organic, and contain 96% organic ingredients, plus 4% permitted substances on 

205.605/606. A cookie manufacturer may be considering that the entire weight of the chips 

counts as organic in the final cookie product. 

Many certificates list raw agricultural ingredients as “organic” when in fact they should be listed 

as “100% organic.” This can have a serious impact in calculating percentage organic in a multi04/2013 2 of 8 NOSB Recommendation
ingredient product if the handler must, by default, list those raw agricultural ingredients as 95%.

Further, some handlers and certifiers may not be accurately examining the water and salt 

content for exclusion from the percentage calculation. 

There is also a wide array of mechanisms in place amongst handlers as to how processing aids 

as opposed to additives are recorded or, if necessary calculated as part of the ingredient list.

Sub-ingredients are often added to multi-ingredient products, such as spice, oil, sugar, flavor or 

sauce mixes. Such sub-ingredients may be entirely or partially organic in ingredient make up, 

and the producer of such sub-ingredient mix may provide a Specification sheet listing 

ingredients and their organic percentages. In other instances no details are provided on subingredients.

When the percentage of organic ingredients as a percentage of all ingredients is calculated to 

be close to 95% or close to 70% then the issue of correct labeling of that product becomes 

difficult for the handler and those who must approve or verify. Standard practice is to calculate

ingredients as a percentage of all ingredients, although the relevant area of the Rule, as cited 

below, still states the calculation should be as a percentage of finished product. 

In October, 2001 the NOSB, recommended1 to change the regulations at § 205.302(a), to 

replace the phrase “finished product” with “of all ingredients”. The rationale was: Most products 

lose weight during processing. Dividing the total weight of all combined organic ingredients by 

the weight of the finished products could easily show that a product contains over 100% organic 

ingredients. Current practice is to divide the total weight of all combined organic ingredients by 

the total weight of all ingredients (excluding salt and water). This calculation establishes the total 

percentage of organic ingredients. The Rule should be changed to correctly calculate the 

percentage of organic ingredients”.

This regulation change has not yet taken place.

III. RELEVANT AREAS OF THE RULE:

 

NOP Regulation and Policy statements:

§ 205.302 Calculating the percentage of organically produced ingredients.

(a) The percentage of all organically produced ingredients in an agricultural product 

sold, labeled, or represented as “100 percent organic,” “organic,” or “made with 

organic (specified ingredients or food group(s)),” or that include organic ingredients 

must be calculated by:

(1) Dividing the total net weight (excluding water and salt) of combined organic 

ingredients at formulation by the total weight (excluding water and salt) of the finished 

product.

(2) Dividing the fluid volume of all organic ingredients (excluding water and salt) by the 

fluid volume of the finished product (excluding water and salt) if the product and 

ingredients are liquid. If the liquid product is identified on the principal display panel or 

information panel as being reconstituted from concentrates, the calculation should be 

made on the basis of single-strength concentrations of the ingredients and finished 

product.

(3) For products containing organically produced ingredients in both solid and liquid 

form, dividing the combined weight of the solid ingredients and the weight of the liquid 

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04/2013 3 of 8 NOSB Recommendation
ingredients (excluding water and salt) by the total weight (excluding water and salt) of 

the finished product.

(b) The percentage of all organically produced ingredients in an agricultural product 

must be rounded down to the nearest whole number.

(c) The percentage must be determined by the handler who affixes the label on the 

consumer package and verified by the certifying agent of the handler. The handler 

may use information provided by the certified operation in determining the percentage.

§ 205.2, Terms Defined:

Ingredient: any substance used in the preparation of an agricultural product that is still present 

in the final commercial product that is consumed

Processing Aid (NOP definition, based on FDA regulation at 21 CFR 100 (a)(3)(ii) Foods 

Exempt from Labeling): 

1. A substance that is added to a food during the processing of such food but is removed in 

some manner from the food before it is packaged in its final form.

2. A substance that is added during processing, is converted into constituents normally 

present in the food, and does not significantly increase the amount of the constituents 

naturally found in the food; and

3. A substance that is added to a food for its technical or functional effect in the processing 

but is present in the finished food in insignificant levels and does not have any technical 

or functional effect on that food.

IV. DISCUSSION: 

In 2012 the CAC subcommittee discussed this issue in detail and issued a discussion document 

with a request for public comment prior to the Public Meeting in October 2012. The NOSB 

received a substantial body of public comment with detailed recommendations for change. 

These comments came from Accredited Certifying Agencies, non-profit organizations, research

groups and trade associations, and they are included in the brief discussion below.

1. Regulatory change: 

There is broad consensus that the standard practice is to divide the total net weight (excluding 

water and salt) of combined organic ingredients at formulation by the total net weight (excluding 

water and salt) of all ingredients. Thus a simple change to the Regulation at 205.302 is needed to 

clarify that the calculation of percentage organic ingredients should be made based on “all 

ingredients” not “finished product” because most products lose weight during processing.

2. Self-calculating Forms:

Formulated multi-ingredient NOP-certified products contain organic ingredients that are either 

single or multiple-ingredient ingredients. Certified handlers adding an organic ingredient to a 

formulated product need to understand that the ingredient may contain anywhere between 95% 

and 100% organic ingredients. For a multi-ingredient certified product used as an ingredient in a 

multi-ingredient product, the actual organic content must be obtained. Otherwise the ingredient 

should be calculated at either 95% organic or 70% organic depending on how the product is 

classified on the certificate.

Thus, to ensure uniformity in making these calculations a number of certifiers use selfcalculating forms, samples of which were sent to the NOSB. Certifiers provide these forms to 

handlers, and there is broad consensus that self-calculating tools are very useful, but one 

standard NOP generated form is not required. 

04/2013 4 of 8 NOSB Recommendation
One certifier noted that being able to provide useful and coherent tools for clients was a point of 

differentiation for a certifier. 

A sample template of a self-calculating form could be included on the NOP website to 

demonstrate inclusion of all ingredients; show how to exclude water and salt, list supplier of 

ingredient, percentage organic content of each ingredient, percentage in formulation, and the

self-calculating column showing actual organic percentage of each ingredient. Such a sample

form should show how to list processing aids separately.

3. Salt Excluded:

Commenters all agree that the only salt which may be excluded is sodium chloride. Potassium 

chloride is on the National List as an allowed non-synthetic and should be calculated as a nonorganic ingredient.

Standard practice is to require any additives, such as anti-caking agents, added to the salt to be 

on the National List at 205.605 or 205.606. If salt containing an additive on the National List is 

added to a certified product the additive cannot be excluded. Therefore the product may not be 

labeled as 100% organic.

4. Water Excluded:

Commenters provided considerable discussion, and raised numerous questions on this complex 

issue.

In August 2002 the NOP issued a policy memo addressing the exclusion of water when 

calculating percentage organic ingredients in multi-ingredient food products. This information is 

incorporated in the NOP Handbook as Policy Memo 11-9.2 This memo includes reference to 

21CFR 131-169 for food and 21CFR 101.30 for vegetable and fruit juices. Several major 

certifiers find that the FDA is out of date in addressing water content in standardized foods. 

Several commenters noted that the lack of a standard of identity for many standardized foods is

an impediment to consistency and accuracy in calculating water to be excluded. There is a need 

for clarification and detailed guidance from the NOP on this topic. 

5. Processed single ingredients:

A specification sheet for a product such as “organic” olive oil could be of great assistance to the 

organic baker making a multi-ingredient product, but this is often not available.

6. Multi-ingredient ingredients:

Several commenters expressed frustration at how to calculate percentage organic when adding 

a purchased multi-ingredient ingredient, such as chocolate chips to a product and suggested 

that a specification sheet be provided if requested by handler.

7. Organic label versus organic content:

There were a number of comments related to the fact that the issue of organic content

contribution versus organic labeling claim creates confusion and leads to a lack of consistency 

in interpretation when formulating multi-ingredient products. 

Organic operations want their crops and ingredients to be in the 100% organic category on 

certificates so that buyers calculate their content at 100% in finished products. If certifiers had 

clear permission to assume 100% organic content for single-ingredient ingredients and crop 

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04/2013 5 of 8 NOSB Recommendation
ingredients in the “organic” category this would remove some of the inconsistencies.

Very few products actually make the 100% organic claim on the retail label.

As noted by the range of comments received by the NOSB there is a lack of consistency in 

determining organic percentages for ingredients treated with processing aids. Often single 

ingredients such as flour, oil or sugar or crop ingredients such as apples do not meet the 100% 

organic category due to permitted, but non-organic processing aids (filtration materials in the 

case of oil, wash water in the case of apples) They will be listed on an organic certificate by the 

certifier as “organic”. However common sense tells you that they may contribute more than 95% 

organic content to the finished product formula. 

The organic content of a product is based on the percentage of organic ingredients. The use of 

non-organic processing aids prevents a product being labeled as 100% organic but the product 

contains 100% organic ingredients and can be calculated as such when determining an 

organic percentage. For Example: Pear Juice Concentrate may be formulated using 100% 

organic pears, NOP-compliant non-organic enzymes as processing aid, and NOP-compliant 

non-organic Diatomaceous Earth as a filter aid. For calculation purposes however the pear juice 

should be calculated at 100% organic in the formulation because all of the ingredients are 100% 

organic.

8. Raw Agricultural Ingredients:

The lack of a statement of specific percentage of organic content on either the organic 

certificate or product specification sheet, if one is available, requires additional work for both the 

certifier and handler. The inclusion of such information on the certificate would be helpful.

Single raw crop ingredients such as carrots or pears, can be listed as “100% organic” on the 

Certificate (or attached addendum list) issued by the certifier to the Handler. In many cases 

however the Certificate and attached list simply states “organic”. Thus, when making a multiingredient product, those ingredients listed as “organic” on their certificates must be calculated 

at the default 95% organic calculation. While there may be some instances where a raw crop 

has been changed, such as adding a wax coating to a cucumber, all commenters agreed that it 

is reasonable to assume that a single raw crop ingredient should be considered 100%organic 

for content.

The recommendations following reflect the public comments received prior to the Public Meeting 

and presented at the Public Meeting.

V. RECOMMENDATIONS: 

1. Proposed Regulatory Change 

The CACS proposes a change to the regulations at 205.302(a) as follows with proposed 

deletions with strike through and additions in bold italics:

§ 205.302 Calculating the percentage of organically produced ingredients.

(a) The percentage of all organically produced ingredients in an agricultural product 

sold, labeled, or represented as “100 percent organic,” “organic,” or “made with organic 

(specified ingredients or food group(s)),” or that include organic ingredients must be 

calculated by:

(1) Dividing the total net weight (excluding water and salt) of combined organic 

04/2013 6 of 8 NOSB Recommendation
ingredients at formulation by the total weight (excluding water and salt) of the finished 

product all ingredients.

(2) Dividing the fluid volume of all organic ingredients (excluding water and salt) by 

the fluid volume of all ingredients the finished product (excluding water and salt) if the 

product and ingredients are liquid. If the liquid product is identified on the principal display 

panel or information panel as being reconstituted from concentrates, the calculation should 

be made on the basis of single-strength concentrations of all the ingredients. (3) For 

products containing organically produced ingredients in both solid and liquid form, dividing 

the combined weight of the solid ingredients and the weight of the liquid ingredients 

(excluding water and salt) by the total weight (excluding water and salt) of all ingredients 

(b) The percentage of all organically produced ingredients in an agricultural product 

must be rounded down to the nearest whole number.

2. Self-Calculating forms

Section 205.302 (c) states:

(c) The percentage must be determined by the handler who affixes the label on the 

consumer package and verified by the certifying agent of the handler. The handler 

may use information provided by the certified operation in determining the percentage.

The CACS proposes that handlers utilize a self-calculating form of their own, or utilize a form 

provided by their certifier so that a uniform method of calculation is clearly established. One 

standard NOP generated form is not required. 

3. Salt Excluded. 

The CACS proposes that the only salt excluded from the calculation is sodium chloride. 

Potassium chloride, listed on 205.605 and any item on the National List such as magnesium 

chloride or magnesium sulfate used as an ingredient shall be counted in the organic content

calculation.

Standard practice is to require any additives, such as anti-caking agents, added to the salt to be 

on the National List at 205.605 or 205.606. If salt containing an additive on the National List is 

added to a certified product the additive cannot be excluded. Therefore the product may not be 

labeled as 100% organic

4. Water Excluded

Water is excluded from the percentage calculation. 

The CACS proposes extensive, detailed and clear NOP guidance to drive consistency among 

handlers and certifiers to determine how much water should be excluded from certain multiingredient formulations that include such ingredients as chicken soup, soy “milk”, almond “milk”, 

fruit juice, vegetable juice, or ready to drink teas. 

5. Processed Single Ingredients.

Handlers or certifiers may request specification sheets from manufacturers of processed single 

ingredients if they desire more verification that the ingredient was not processed in a way that 

there would be remaining non-organic components in the single ingredient product. Examples of 

such ingredients include oil, flour, sugar, and syrup. 

04/2013 7 of 8 NOSB Recommendation
6. Multi-ingredient ingredients; 

Formulated multi-ingredient NOP-certified products contain organic ingredients that are either 

single ingredients or multi-ingredient ingredients. For multi-ingredient products added to the 

formula of another product, such as chocolate chips where as much as 5% of the ingredients 

may be non-organic, the actual organic content must be obtained if the contributing content is 

above 70% organic or 95% organic. Otherwise the ingredients should be calculated at either 

95% organic or 70% organic depending on how the product is classified on the certificate.

Handlers must provide certifiers with supporting documentation that substantiates the organic 

content claim of a multi-ingredient product used in a production formulation submitted for 

approval.

7. Organic Label versus Organic Content: 

As specified in 205.302, the organic content or percentage of a product is based on the 

percentage of organic ingredients. Sanitizers and processing aids are not ingredients; therefore 

they should not impact the organic percentage of a product. The use of a non-organic 

processing aid prevents the single ingredient product from being labeled as 100% organic, but 

the product continues to contain 100% organic ingredients and can be calculated as such when 

it is calculated into a multi-ingredient organic product

8. Raw agricultural and Single-ingredient ingredients can be assumed by handlers, 

manufacturers and certifiers to contribute 100% organic content in a multi-ingredient 

formulation, even if they are listed as “organic” on a certificate, except where it is clear that the 

ingredient is significantly different from the raw condition.

9. NOP Guidance

The NOSB recommends that the NOP establish and maintain an easily accessible website with 

examples of how to calculate percentage organic ingredients in multi-ingredient products, and 

related topics such as how to determine when a processing aid becomes an ingredient in 

calculation, and how to determine excluded water.

Motion to accept and forward to the full Board the proposal on Calculating % of organic 

ingredients in multi-ingredient products as amended 

Subcommittee Vote:

Moved: Jean Richardson Second: Joe Dickson

Yes: 7 No: 0 Absent: 1 Abstain: 0 Recusal: 0 

04/2013 8 of 8 NOSB Recommendation
Formal Recommendation 

From: National Organic Standards Board (NOSB) 

To: the National Organic Program (NOP)

Date: 

Subject: 

Chair: 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: 

Guidance Statement: 

Other: 

Statement of Recommendation:;DŽƚŝŽŶηϭͿ

 

Rationale Supporting Recommendation (including consistency with OFPA and NOP):

 

Committee Vote:

 

Moved: 

SecondĞĚ: 

Yes:EŽ͗ďƐƚĂŝŶ͗ďƐĞŶƚ͗ZĞĐƵƐĞ͗

 

 

 3DJHUHYLVHGPD

October 18, 2012

Petition to list Biodegradable biobased mulch films on §205.601(b)(2)

Barry Flamm

Petition Passed

Motion to classify Biodegradable biobased mulch film as synthetic.

 

 

✔

Passed

While the building blocks of the polymers that make the mulch films are often starches and other 

non-synthetic components, there are some synthetic additives to help the films hold together and 

add pigment. 

Carmela Beck

Jay Feldman

15 0 0 0 0
Rationale Supporting Recommendation (including consistency with OFPA and NOP):

Statement of Recommendation:;DŽƚŝŽŶηϮͿ

Committee Vote:

 

Moved: 

SecondĞĚ: 

Yes:EŽ͗ďƐƚĂŝŶ͗ďƐĞŶƚ͗ZĞĐƵƐĞ͗

 

 

 

 

3DJHUHYLVHGPD

Passed

Petition to list Biodegradable biobased mulch films on §205.601(b)(2) Mulches:

See attached Statement of Recommendation (Motion # 2) for further detail

 

The NOSB sees the approval of these materials as an opportunity to reduce pollution substantially 

without sacrificing organic farming principles. The first several criteria apply to those certifiers and 

Material Review Organizations (MROs) that will determine allowed products. The last clause is the 

only one that refers to a grower's responsibility and correspondingly what the certifier must 

evaluate. The annotation has been crafted to be as specific as possible to ensure that only acceptable 

products are reviewed and allowed for organic farming. 

Rationale behind the annotation and some accompanying issues are attached.

Zea Sonnabend

Harold Austin

12 3 0 0 0
Statement of Recommendation (Motion #2) 

Petition to list Biodegradable biobased mulch films on §205.601(b)(2) Mulches: 

(iii) Biodegradable biobased mulch films to be reviewed meet the following criteria: 

(A) Completely biodegradable as shown by: 

1) meeting the requirements of ASTM Standard D6400 or D6868 specifications, or of other 

international standard specifications with essentially identical criteria, i.e. EN 13432, EN 14995, 

ISO 17088; and 

2) Showing at least 90% biodegradation in soil absolute or relative to microcrystalline cellulose 

in less than two years, in soil, tested according to ISO 17556 or ASTM 5988; 

(B) Must be biobased with content determined using the ASTM D6866 method; 

(C) Must be produced without organisms or feedstock derived from excluded methods; and 

(D) Grower must take appropriate actions to ensure complete degradation. 

In addition, add the following definition to 205.2 

Biobased: organic material in which carbon is derived from a renewable resource via biological 

processes. Biobased materials include all plant and animal mass derived from carbon dioxide 

recently fixed via photosynthesis, per definition of a renewable resource (ASTM). 

Rationale Supporting Recommendation (including consistency with OFPA and NOP) 

The NOSB sees the approval of these materials as an opportunity to reduce pollution substantially 

without sacrificing organic farming principles. The first several criteria apply to those certifiers and 

Material Review Organizations (MROs) that will determine allowed products. The last clause is the 

only one that refers to a grower’s responsibility and correspondingly what the certifier must 

evaluate. The annotation has been crafted to be as specific as possible to ensure that only 

acceptable products are reviewed and allowed for organic farming. 

Rationale behind the annotation and some accompanying issues: 

Introductory Text 

The term “Biodegradable biobased mulch film” reflects the Board’s intention to define bio-based so 

that this category would not allow products, for example those made from aliphatic aromatic 

copolymers (AACs), which come from petroleum. The definition of biobased is provided in addition 

to the annotation to make this as clear as possible. 

The Board chose to not use the word “bioplastic” because OFPA and the NOP rule encourage 

biodegradable mulches and have clauses that prohibit plastic that is not removed at the end of the 

season. The NOSB adopts the interpretation that these mulches biodegrade and the process of 

biodegradation is equivalent to removal of the substance at the end of the growing season. 
“(A) Completely biodegradable as shown by..... “ 

The standards referred to here will cover the range of products in a range of temperatures and 

environments. The Board understands that the ASTM 6400 will involve testing for any residues and 

ecotoxic effects. 

“(B) Must be biobased with content.....“ 

The Board has also provided a good definition of ‘biobased material’ to ensure that this testing 

protocol is meaningful. 

“(C) Must be produced without organisms or feedstock derived from excluded methods.” 

While the NOSB has some concerns about consistency between this and excluded methods in other 

soil inputs, since this will be a brand new category of materials to the Board intends to shut the 

door to GMOs at the outset. The annotation regarding GMO feedstock is not to be construed as 

carrying over to other soil applied materials. 

“(D) Grower must take appropriate actions to ensure complete degradation.” 

It is expected that NOP, in conjunction with the NOSB, will develop guidance that explains proper 

practices for utilizing the biodegradable mulch film. In addition, it is expected that the inspection 

process and certification review will determine that biodegradation of the mulch film is occurring so 

that it does not accumulate in the fields where it is used. 

It is the Board’s belief, in submitting this recommendation, that biodegradable mulch film made 

with nanomaterials is prohibited under the listing on the National List. While the NOSB established 

a working definition of nanomaterials in 2010, the clause in the Crops Subcommittee proposal 

prohibiting nanomaterials was removed due to the current lack of an officially-recognized definition 

of nanomaterials. 

The Board continues to support the prohibition of nanomaterials as defined in 2010: 

Engineered nanomaterials: substances deliberately designed, engineered and produced by 

human activity to be in the nanoscale range (approx. 1-300 nm) because of very specific 

properties or compositions (e.g., shape, surface properties, or chemistry) that result only in that 

nanoscale. Incidental particles in the nanoscale range created during traditional food processing 

such as homogenization, milling, churning, and freezing, and naturally occurring particles in the 

nanoscale range are not intended to be included in this definition. All nanomaterials (without 

exception) containing capping reagents or other synthetic components are intended to be 

included in this definition. 

In a December 17, 2010 Memorandum to the NOSB, the NOP responded as follows: 

The NOP understands that the NOSB considers nanomaterials to be synthetic and prohibited 

under the National Organic Program..... The NOP accepts the NOSB recommendation and 

intends to gather additional information about how nanomaterials are regulated and used in 

agricultural production and handling. 
The Board would like the proposed guidance regarding appropriate grower actions to be added to 

the Crops Subcommittee workplan. Additionally, the Board would like unanswered questions, 

especially those concerning possible long-term impacts of biodegradable mulch film on soil 

health, to be added to the Materials Subcommittee research priorities for the coming year as a high 

priority topic, in order to provide more complete data for the sunset decision. 

Some members of the Board who did not support the final annotation noted a concern that 

explicit language requiring removal (or in this case complete degradation) of plastic or synthetic 

mulch at the end of each harvest or growing season was removed from the Crops 

Subcommittee proposal. Additionally, some Board members felt that the Board should retain 

the listing as originally petitioned, “Biodegradable Mulch Film Made from Bioplastics”, due to 

the nature of the material under review and the testimony of the petitioner and others on the 

definition of plastic (albeit biodegradable). 

Committee Vote: 

Moved: Zea Sonnabend 

Seconded: Harold Austin 

Yes: 12 No: 3 Abstain: 0 Absent: 0 Recuse: 0 
National Organic Standards Board

Crops Subcommittee

Petitioned Material Proposal

Biodegradable Mulch Film Made from Bioplastics

August 15, 2012

Introduction

A petition was submitted requesting the addition of biodegradable biobased bioplastic 

mulch to section 205.601(h) of the National List. This petition involves definitions of new 

substances, which the subcommittee recommends be incorporated into the listing. The 

subcommittee explicitly seeks public comment on the definitions and possible 

restrictions on use.

Background

Biodegradable mulch film made from bioplastics is petitioned to section 205.601 of the 

National List for use in organic crop production. This is an alternative to petroleumbased plastic mulches that do not completely biodegrade. Over the past 50 years much

research and development has gone into developing biodegradable mulches which are 

the subject of this petition. As product development has been underway, removal and 

disposal of polyethylene plastic mulches has become increasingly difficult because its 

removal is time-consuming, delays cover cropping and must largely be sent to landfills. 

The OFPA requires the removal of plastic mulches at the end of the growing or harvest 

season (7 U.S.C. 6508).

The petitioner argues that OFPA’s mention of plastic was not intended to refer to 

biodegradable mulch film. Biodegradable mulch is intended to biodegrade by the end of 

the season or prior to the beginning of the following season. This distinction leads us to 

question whether the approval of the petition would require a rule change to allow the 

mulch to biodegrade in the field or whether the two substances should be treated as 

separate and distinct. However, bioplastics are defined in terms of “plastics,” according 

to the petitioner, “Biodegradable Plastic Mulch is defined as plastic mulching material 

that meets both of the following requirements.” Furthermore, bioplastics fit the definition 

of plastic, “Any of various organic compounds produced by polymerization, capable of 

being molded, extruded, cast into various shapes and films, or drawn into filaments 

used as textile fibers.” (American Heritage Dictionary) The petition defines 

biodegradable mulch film as mulching materials that:

1) meet the requirements of ASTM International (formerly American Society for 

Texting and Materials) Standard D6400 or D6868 specifications, or of other 

international standard specifications with essentially identical criteria, i.e. EN 

13432, EN 14995, ISO 17088; and

2) show at least 90% biodegradation absolute or relative to microcrystalline 

cellulose2 in less than two years, in soil, tested according to ISO 17556 or 

ASTM 5988.
Additionally, the petitioner suggests that the reference to “fully biodegradable” in section 

205.206(c)(1) be defined when referencing bioplastic degradation in soil. Full 

biodegradation is covered under several standards which discuss the compostability of 

the petitioned product. These include, American Society for Testing and Materials 

(ASTM) Standard D5988 (biodegradability of bioplastic in soil), ASTM Standard D6400 

(biodegradability of bioplastic in compost), and ASTM Standard D6868 (biodegradability 

of bioplastic specifications). The ASTM definition of “biodegradable plastic” is, “a 

degradable plastic in which the degradation results from the action of naturally occurring 

microorganisms such as bacteria, fungi, and algae.”

The petition further clarifies, that according to the European Bioplastics’ definition, 

bioplastics are biobased, biodegradable, or both. The ASTM definition of “biobased 

material” is “organic material in which carbon is derived from a renewable resource via 

biological processes. Biobased materials include all plant and animal mass derived from 

carbon dioxide recently fixed via photosynthesis, per definition of a renewable 

resource.” Biobased materials are certified using the ASTM D6866 method, which 

certifies the biologically derived content of bioplastics. 

The petition provides the following description: biodegradable films are produced from 

bioplastics that meet standards for aerobic biodegradation in soil. These bioplastics are 

comprised of structural units which may be easily broken down into carbon substrates 

by soil microorganisms. Under aerobic conditions, these microorganisms are able to 

utilize the carbon substrates as a food source. This metabolism of the carbon substrates 

ultimately results in two simple compounds – carbon dioxide and water.

Relevant areas in the Rule

OFPA §6508 (c) says

For a farm to be certified under this chapter, producers on such farm shall not - 

...(2) use plastic mulches, unless such mulches are removed at the end of each growing 

or harvest season; 

The regulations provide at §205.206(c) that 

Weed problems may be controlled through: 

... (6) Plastic or other synthetic mulches: Provided, That, they are removed from the field 

at the end of the growing or harvest season. 

And the National List includes at §205.601(b)(2) 

Mulches. 

...(ii) Plastic mulch and covers (petroleum-based other than polyvinyl chloride (PVC)). 

Discussion 

Neither conventional plastic mulch nor biodegradable bioplastic mulch can perform all of 

the functions—particularly, feeding the soil—that organic mulches perform. However, 

there are times—such as when cold soil is a problem—when the qualities of plastic or 

bioplastic have been viewed as necessary. As always, it is our understanding that the 
use of synthetic mulch products will be limited to those circumstances when natural 

organic mulches are inappropriate or impossible to use. When this is the case, it makes 

sense to use a material that degrades in place rather than one that is removed and 

taken to a landfill. On the other hand, the subcommittee believes that it may be difficult 

to separate claims from truth concerning biodegradability and the source of the material. 

In addition, the subcommittee would like to make a robust recommendation that 

correctly describes biodegradable biobased bioplastic mulches that meet the three 

criteria above. According to the European Bioplastics definition, bioplastics are 

biobased, biodegradable, or both. The committee intends this recommendation to cover 

those bioplastics that are both biobased and biodegradable.

The subcommittee understands the importance of a definition, which it is proposing, and 

is particularly interested in public comment on the biobased classification and the ASTM 

standard. Meeting this standard, however, does not automatically ensure that the mulch 

will be “removed from the field at the end of each growing or harvest season.” This 

removal may require steps like tilling the film into the ground. The subcommittee 

therefore proposes the annotation that growers take appropriate actions to guarantee

that the mulch decomposes within the appropriate time frame.

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria Satisfied? 

(see “B” below)

1. Impact on Humans and Environment ܈ Yes ܆ No 

܆ N/A 

2. Essential & Availability Criteria ܈ Yes ܆ No 

܆ N/A

3. Compatibility & Consistency ܈ Yes ܆ No 

܆ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ܆ Yes ܆ No 

܈ N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: [ ] Comments:

Proposed Annotation:

List on §205.601(b)(2) Mulches: (iii) Biodegradable biobased bioplastic mulch meeting 

the following criteria: (A) Completely biodegradable as shown by: 1) meeting the 

requirements of ASTM Standard D6400 or D6868 specifications, or of other 

international standard specifications with essentially identical criteria, i.e. EN 13432, EN 

14995, ISO 17088; and 2) showing at least 90% biodegradation absolute or relative to 

microcrystalline cellulose in less than two years, in soil, tested according to ISO 17556 

or ASTM 5988; (B) Biobased certified using the ASTM D6866 method; (C) Must be 

produced without excluded methods; (D) Must be produced without engineered 

nanomaterials; and (E) Grower must take appropriate actions to ensure complete 

degradation at the end of each growing or harvest season.
Basis for annotation: ܈ To meet criteria above ܈ Other regulatory criteria ܆

Citation 

Notes: Annotation is necessary to meet the requirements of OFPA §6508(c).

Recommended Subcommittee Action & Vote, including classification 

recommendation (state actual motion):

Classification Motion:

Biodegradable Mulch Film Made from Bioplastics is synthetic.

Motion by: Colehour Bondera Seconded by: Jay Feldman

Yes__8___ No__0__ Abstain__0__ Recuse__0__ Absent__0__ 

Listing Motion: 

To list on §205.601(b)(2) Mulches: (iii) Biodegradable biobased bioplastic mulch 

meeting the following criteria: (A) Completely biodegradable as shown by: 1) 

meeting the requirements of ASTM Standard D6400 or D6868 specifications, or of 

other international standard specifications with essentially identical criteria, i.e. EN 

13432, EN 14995, ISO 17088; and 2) showing at least 90% biodegradation absolute 

or relative to microcrystalline cellulose in less than two years, in soil, tested 

according to ISO 17556 or ASTM 5988; (B) Biobased certified using the ASTM 

D6866 method; (C) Must be produced without excluded methods; (D) Must be 

produced without engineered nanomaterials; and (E) Grower must take appropriate 

actions to ensure complete degradation at the end of each growing or harvest 

season.

Motion by: Colehour Bondera Seconded by: Barry Flamm

Yes__7___ No__0__ Abstain__1__ Recuse__0__ Absent__0__

܆ 1Allowed ܆ Agricultural ܈ Crops

Livestock ܆ Non-synthetic ܆ Prohibited2 ܆

܆ 3Rejected ܈ Synthetic ܆ Handling

No restriction ܆ Commercial unavailable as 

organic

܆ 4Deferred ܆

1

Substance voted to be added as “allowed” on National List to § 20 with Annotation 

(if any): 

2

Substance to be added as “prohibited” on National List to § 205 with Annotation (if 

any): 

Describe why a prohibited substance: 
3

Substance was rejected by vote for amending National List to § 205. Describe why 

material was rejected: 

4

Substance was recommended to be deferred because 

If follow-up needed, who will follow up: 

Approved by Subcommittee Chair to Transmit to NOSB

Jay Feldman, Subcommittee Chair August 15, 2012

NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment? Substance: Biodegradable

 Mulch Film Made from Bioplastics 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Are there adverse effects on environment 

from manufacture, use, or disposal?

[§205.600 b.2]

x TER 525-531: The production of PLA & 

PHA involves fermentation processes & 

feedstocks derived from natural sources 

(with the exception of geneticallymodified organisms). The potential for 

environmental contamination from these 

products is limited, with the exception of 

the metal salt catalysts used to 

polymerize PLA (Bastioli, 2005). No 

reports of tin contamination from 

production of bioplastics were found.

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

x TER 533-537: Many of the feedstocks 

used in the production of AAC could be 

hazardous if they were spilled or 

discharged into the environment during 

manufacture & processing. No specific 

reports of environmental contamination 

from these compounds as a result of 

manufacturing bioplastics were found. 

Systematic reviews of the environmental 

impact from manufacturing of bioplastics 

were not found. TER 547-550:

Erucamide, glycerol, and stearic acid 

amide could be released to the 

environment through multiple 

manufacturing processes, including 

bioplastics production. No research 

reports were found that described 

environmental releases of these 
chemicals from bioplastics 

manufacturing.

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

x TER 614-621: The researchers 

concluded that using PE mulch may have 

a harmful effect on the environment due 

to increased runoff & is less sustainable 

than vegetative mulch (Rice et al., 2001). 

Based on their similarities in construction 

& intended use, bioplastic mulches would 

likely have similar environmental impacts 

to PE mulch, though their greater 

tendency to degrade sooner than PE 

mulch may decrease some of the 

adverse environmental impacts. TER 

623-627: Anaerobic degradation of 

bioplastics may produce methane 

(greenhouse gas). Research was not 

found that quantified methane emissions 

from bioplastic mulch use. Degradation of 

bioplastic mulches must take place in an 

aerobic environment in the soil to prevent 

methane emissions. TER 629-630:

Adverse environmental impacts from the 

use of bioplastic mulches are only likely 

to occur if the material does not 

completely biodegrade in soil. TER 652-

657: Some reports have shown that 

bioplastics containing terephthalic acid at 

concentrations over 50% do not 

completely biodegrade in soil (Bastioli, 

2005). 

4. Does the substance contain List 1, 2 or 3 

inerts? [§6517 c (1)(B)(ii); 205.601(m)2]

x

5. Is there potential for detrimental chemical 

interaction with other materials used?

[§6518 m.1]

x TER 566-567: The plastics are inert in 

the soil when they are intact, and are 

biodegraded by soil microorganisms.

6. Are there adverse biological and 

chemical interactions in agro-ecosystem? 

[§6518 m.5]

x TER 582-587: Given the complete 

aerobic biodegradation of bioplastic 

mulches, the by-products are carbon 

dioxide, water, & soil biomass. Soil 

biomass refers to the total amount of 

microorganisms in the soil, excluding 

plant roots & macrofauna (NRCS, 2012). 

The increase in biomass may cause a 

concomitant increase in the populations 

of microorganisms that degrade the 

mulches on a local basis. This could lead 

to changes in the population dynamics of 

microorganisms in the soil. TER 593-595:

Complete degradation of the bioplastics 
depends on blending the polymers to 

maximize degradability & depends on the 

composition of soil microorganisms. 

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

x TER 352-354 ASTM standard D5988 is 

designed to be applicable to bioplastic 

materials that are “not inhibitory to the 

bacteria & fungi present in the soil”...it 

could be assumed that the bioplastic 

does not inhibit soil bacteria or fungi by 

its breakdown processes. TER 357-358:

Many bacteria & fungi in the soil can use 

bioplastics derived from starch as a 

carbon source (Shah et al., 2008). TER 

409-410: Biochar, a method of generating 

carbon black for soil amendment, may 

help promote nutrient use efficiency in 

treated soils (Chan, 2008; Hunt, 2010).

8. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518 m.2]

x TER 446-447: Studies were not found 

that specifically assessed the ecotoxicity 

of bioplastics following degradation in the 

soil, & a better understanding of 

bioplastic degradation & soil 

environmental effects is needed. TER 

462-466: It seems unlikely that the 

source material (the bioplastic film) would 

interact with other organisms & cause

toxicity. The material is manufactured to 

remain intact & inert during its intended 

use, then (ideally) break down at the end 

of the season.

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in environment? 

[§6518 m.2]

x x TER 330-333: The petitioner states that 

biodegradable mulch film is defined in 

two ways...Second, by “show[ing] at least 

90% biodegradation absolute or relative 

to microcrystalline cellulose in less than 

two years, in soil, tested according to ISO 

17556 or ASTM 5988.” TER 347-350:

ISO 17556 & ASTM 5988 are equivalent 

standards. They “describe the standard 

test method for determining aerobic 

biodegradation of plastic materials in 

soil.” This standard is most applicable to 

the proposed use of the bioplastic mulch 

because the mulches will be left in the 

field at the end of the season to 

biodegrade according to their petitioned 

use. TER 356-357: Biodegradability is 

quantified by measuring the amount of 

carbon dioxide released from the soil 

over time. TER 362-370: degradation 

occurs quicker when chiseled or tilled into 
the soil during times of warm 

temperatures & moisture in soils with 

high organic matter. TER 374-375:

Hydrolysis breaks PLA into lactic acid & 

water-soluble compounds. Once this 

breakdown occurs, PLA is completely 

mineralized to CO2, water, & biomass. 

TER 384-386: Degradation of PHA 

occurs by enzymatic hydrolysis at the 

surface of the film, which is carried out by 

soil microbial populations. Hydrolysis 

breaks the PHA polymers into oligomers 

& monomers which are subsequently 

consumed & assimilated by microbes in 

the soil as nutrients. TER 395-399: All of 

the commercially available AAC polymer 

materials contain terephthalic acid, which 

is most responsible for determining the 

degradation rates in AAC plastics. As the 

fraction of terephthalic acid increases, the 

degradation rate decreases. No 

significant biological degradation was 

found when the molar fraction of AAC 

was increased to more than 60%, which 

is thought to be due to the relatively low 

melting point of terephthalic acid (Bastioli, 

2005). TER 405-410: Carbon black is 

elemental carbon in the form of a 

particulate that is manufactured from 

burning or partial combustion of 

hydrocarbons (NLM, 2011)...it is resistant

to breakdown in the soil environment. 

TER 412-419: Titanium dioxide is found 

as the minerals rutile, octahedrite, 

brookite, ilmenite, & perovskite. Titanium 

dioxide may persist in soil as the byproduct of titanium tetrachloride 

hydrolysis (ATSDR, 1997), so it may 

persist from use in bioplastic mulch as 

well. Titanium dioxide may settle out into 

sediments & persist for long periods of 

time (ATSDR, 1997). The compound is 

characterized by ATSDR as “ a very inert 

compound” (ATSDR, 1997). TER 421-

425: Erucamide (plasticizer) binds 

strongly to soil & sediments in water & is 

likely to bioconcentrate in aquatic 

organisms, meaning it will occur at higher 

levels up the food chain (NLM, 2011). 

The physical properties of erucamide 

suggest that the material will persist in 
the environment, and would be found in 

the water, soil & air if released (NLM, 

2011). TER 427-431: Glycerol 

(plasticizer) released to the environment 

will be present as both a vapor & a 

particle in the atmosphere, but will be 

degraded within hours (NLM, 2011). The 

potential for bioconcentration in aquatic 

organisms is low for glycerol in aquatic 

environments (NLM, 2011).

10. Is there any harmful effect on human 

health? [§6517 c (1)(A)(i); 6517 c(2)(A)i; 

§6518 m.4]

x TER 663-673: Pesticide runoff may be 

increased if plastic mulches are used in 

agricultural production due to the creation 

of impervious surfaces (Rice et al., 2001). 

The increase in pesticide loads may lead 

to an overall increase in the pesticide 

load in waterways which could potentially

impact human health by causing 

increases in pesticide loads in 

downstream drinking water sources. No 

other reports of impacts on human health 

from the use of bioplastic mulches were 

found in the published literature.

11. Is there an adverse effect on human 

health as defined by applicable Federal 

regulations? [205.600 b.3]

x

12. Is the substance GRAS when used 

according to FDA’s good manufacturing 

practices? [§205.600 b.5]

x

13. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 

b.5]

x

1

If the substance under review is for crops or livestock production, all of the questions from 

205.600 (b) are N/A—not applicable.
NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production? Substance: 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance formulated or 

manufactured by a chemical process? 

[6502 (21)]

x TER 294-296: Bioplastic mulches are 

manufactured with the addition of 

synthetic plasticizers and colorants which 

are added using a synthetic process. 

2. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral, sources? 

[6502 (21)]

x TER 301-302: To develop PLA the lactic 

acid monomers must be polymerized. 

This is accomplished through the use of a 

chemical catalyst. TER 302-305:

Fermentation is a naturally occurring 

process, but under laboratory conditions, 

the feedstocks and environmental 

conditions are manipulated in order to 

provide an environment that is most 

conducive to production of PLA, a 

process which would be unlikely to occur 

in nature. TER 309-310: Researchers 

have developed genetically-engineered 

bacterial strains that produce PHA more 

efficiently & in differing polymer amounts. 

TER 313-315: PHA production by 

fermentation is a natural process, but the 

conditions used in laboratories to 

maximize yields and polymer amounts 

are not naturally occurring. TER 317-319:

Some feedstocks used to produce AAC 

are naturally occurring, but the chemical 

processes used to refine them for use do 

not occur in nature, nor do the synthetic 

processes that are used to create the 

ester linkages.

3. Is the substance created by naturally 

occurring biological processes? [6502 

(21)]

x x

4. Is there a natural source of the 

substance? [§205.600 b.1]

x

5. Is there an organic substitute? [§205.600 

b.1]

x

6. Is the substance essential for handling of 

organically produced agricultural 

products? [§205.600 b.6]

x

7. Is there a wholly natural substitute 

product?

[§6517 c (1)(A)(ii)] 

x TER 679-682: The petitioned substance 

would be an alternative to synthetic, nondegradable substance, polyethylene 

plastic mulch. Bioplastic mulch is 
produced through synthetic processes as 

previously described, but is created to be 

biodegradable, a reason for its petitioned 

use in organic agriculture. TER 684-690:

Mulches made from biomass include 

bark, cocoa-bean hulls, corncobs, grass 

clippings, leaves, pine needles, sawdust, 

straw, & wood chips. Biomass mulch 

availability may depend on what types of 

plants or crops are available in the area & 

the type of crop they are used in.

8. Is the substance used in handling, not 

synthetic, but not organically produced?

[§6517 c (1)(B)(iii)]

x

9. Is there any alternative substances? 

[§6518 m.6]

x TER 717-721: Living mulch involves 

planting a low-growing cover crop that is 

effective at competing with weed species. 

The drawback is that living mulches 

compete for nutrients & water & reduce 

yields. Reports discuss the need to strike 

a balance between environmental impact, 

cost, ease of use, & crop yields to 

determine which alternative is most 

beneficial for individual farms & crops.

10. Is there another practice that would make 

the substance unnecessary? [§6518 m.6]

x

1

If the substance under review is for crops or livestock production, all of the questions from 

205.600 (b) are N/A—not applicable.
NOSB Evaluation Criteria for Substances Added To the National List

Category 3. Is the substance compatible with organic production practices? Substance: 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance compatible with organic 

handling? [§205.600 b.2]

x

2. Is the substance consistent with organic 

farming and handling? [§6517 c 

(1)(A)(iii); 6517 c (2)(A)(ii)]

x x The substance is of synthetic origin but 

appears to completely biodegrade in a 

two-year timeframe. This serves as an 

alternative to the current practice of using 

synthetic, non-degradable, polyethylene 

plastic mulch.

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7]

x

4. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600 b.3]

x

5. Is the primary use as a preservative? 

[§205.600 b.4]

x

6. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive 

values lost in processing (except when 

required by law, e.g., vitamin D in milk)? 

[205.600 b.4]

x

7. Is the substance used in production, and

does it contain an active synthetic 

ingredient in the following categories:

a. copper and sulfur compounds;

x

b. toxins derived from bacteria; x

c. pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals?

x

d. livestock parasiticides and 

medicines?

x

e. production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleaners?

x TER 218- 221: Bioplastic mulch is used 

as a production aid, but is not technically 

considered a row cover because they 

increase soil temperature, reduce weed 

pressure, maintain soil moisture levels, 

and may help extend the growing season.

1

If the substance under review is for crops or livestock production, all of the questions from 

205.600 (b) are N/A—not applicable.
NOSB Evaluation Criteria for Substances Added To the National List

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or 

potentially unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 

(d), 205.600 (c)] Substance: Name

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the comparative description provided

as to why the non-organic form of the 

material /substance is necessary for use 

in organic handling? 

x

2. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance cannot be obtained 

organically in the appropriate form to

fulfill an essential function in a system of 

organic handling? 

x

3. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance cannot be obtained 

organically in the appropriate quality to

fulfill an essential function in a system of 

organic handling? 

x

4. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance cannot be obtained 

organically in the appropriate quantity to

fulfill an essential function in a system of 

organic handling?

x

5. Does the industry information provided 

on material / substance non-availability 

as organic, include ( but not limited to) 

the following:

a. Regions of production (including 

factors such as climate and number 

of regions);

x

b. Number of suppliers and amount 

produced;

x

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

x

d. Trade-related issues such as 

evidence of hoarding, war, trade 

x
barriers, or civil unrest that may 

temporarily restrict supplies; or

e. Are there other issues which may 

present a challenge to a consistent 

supply?

x

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—not applicable.
National Organic Standards Board 

Training: 

Operating Guidelines 

Agricultural Marketing Service | National Organic Program 

February 2016

USDA Agricultural Marketing Service | National Organic Program 1
Topics 

• Nominations Process Overview 

• Charter Renewal Overview 

• Work Agenda Development 

• Subcommittee Management 

• Public Meeting Agenda 

• Public Meeting Management 

• FOIA Review 

USDA Agricultural Marketing Service | National Organic Program 2
Nominations Process Overview

The Board nomination process takes about 1 year: 

1. Prepare Federal Register call for nominations 

and outreach plan; complete clearance process 

2. Announce call for nominations – we target a 2 

month long recruitment period 

3. Review applications for completeness and basic 

qualifications, i.e., fit with OFPA categories

4. Vet qualified candidates against exclusion 

criteria (examples: registered lobbyist; service 

on other Board)

USDA Agricultural Marketing Service | National Organic Program 3
Nominations Process Overview

The Board nomination process takes about 1 year:

6. Interview qualified and vetted candidates

7. Prepare slate and information summary about 

qualified and vetted candidates for Secretary’s 

consideration

8. Secretary selects appointee; appointee 

announced 

9. Term begins in January 

USDA Agricultural Marketing Service | National Organic Program 4
Nomination Process Criteria 

A range of factors are considered in evaluating applicants: 

– OFPA categories of seats to be filled – mandatory 

– NOSB Recommendation on Criteria for Board 

Membership (1999) – More on this next slide! 

– Ability to work collaboratively with other Board 

members and USDA

– Ability to represent all racial and ethnic groups, 

women and men, and persons with disabilities. 

USDA Agricultural Marketing Service | National Organic Program 5
NOSB Recommendations on Nominations 

Evaluation Criteria 

• In 1999, NOSB recommended criteria for Board 

membership – these criteria are on NOP’s nominations 

webpage, are in Federal Register announcements, and are 

used during candidate evaluation. 

• Criteria include: 

– Understanding of organic principles and practical 

experience in the organic community; 

– Experience in public policy; 

– Commitment to organic integrity; 

– Ability to evaluate technical information; 

– Willingness to commit time and energy needed;

– Demonstrated experience and interest in organic 

production and certification

USDA Agricultural Marketing Service | National Organic Program 6
Charter Renewal Overview 

• FACA requires that the NOSB charter be considered 

for renewal every two years.

• This involves review by USDA and the General 

Services Administration (GSA) (oversees FACA across 

agencies) in order to revalidate the need for the 

Board and its overarching governance. 

• USDA releases Federal Register Notice announcing 

its intent to renew the Board’s charter. 

• This is a process that occurs between USDA and the 

GSA – the Board and public are not involved. 

USDA Agricultural Marketing Service | National Organic Program 7
Work Agendas: Background

1. AMS establishes the work agenda with input from the 

NOSB.

2. Board may propose ideas, but should not start work on 

new topics without NOP approval 

3. The public has a voice in this process: 

– Public may petition additions or deletions from the 

National List.

– Public may also submit comments to the Board and 

write to the NOP. 

4. FACA requires that agencies effectively use resources: 

we shouldn’t ask for advice we can’t act on.

USDA Agricultural Marketing Service | National Organic Program 8
Work Agendas: Criteria for Adding Items

1. Within Scope: Item must be within the scope of 

OFPA and within agency authority.

2. USDA/NOP Priority: Item must be a priority for the 

USDA/NOP; and something that the NOP is able to 

implement in a reasonable timeframe. 

3. Clear Need: Item must reflect a clear need for the 

NOP and/or organic community, for which 

information or advice is needed. (If it is a need, but 

NOP has enough information, it doesn’t need to be 

on the work agenda.) 

4. Clear Scope: NOP must have a clear sense of the 

intent and scope of the work agenda item. 

USDA Agricultural Marketing Service | National Organic Program 9
Work Agenda Development

The Work Agenda establishes subcommittee scope for 

the upcoming semester or year. Process: 

1. NOP develops list based on substance evaluations 

(e.g., petitions, sunset) and formal requests (via 

memos) that NOP has provided NOSB. 

2. NOP and Executive subcommittee review work 

agenda.

3. NOP approves final work agenda. 

USDA Agricultural Marketing Service | National Organic Program 10
Subcommittee Management 

• Subcommittees hold conference calls between 

public meetings to work on work plan items. 

• Effective facilitation by the subcommittee chair 

elicits different questions and perspectives, while 

keeping the group focused and on task. 

• Helping keep each other on point may help reduce 

time needed – regularly ask “what is our goal, and 

how does this discussion support the outcome we 

are trying to achieve?”

• Subcommittee notes maintained by NOP and posted 

on-line.

USDA Agricultural Marketing Service | National Organic Program 11
Discussion Documents/Proposals:

Criteria for NOP Acceptance 

1. Within NOSB Scope: Item must have been within scope 

to be on work agenda; content of product must also be 

within scope of OFPA and agency authority.

2. Implementable: Item must have been an NOP priority to 

be on work agenda; content of completed product must 

be something that NOP can actually implement if a 

recommendation is accepted.

3. Requests for Public Comment: Public comment is vital in 

shaping advice; requests must be within NOP/OFPA 

authority and not conflict with current statute and rules.

4. Quality and Clarity: Document must be clearly written. If 

two opinions or a minority opinion are included, the 

motion being voted on must be very clear. 

USDA Agricultural Marketing Service | National Organic Program 12
Public Meeting Agenda 

• Public meeting agenda prepared by NOP, driven by 

several factors: 

– Inclusion of work agenda items that have yielded 

discussion documents or proposals 

– Reasonable time for public comments 

– Time for presentations and expert panels 

– Cost

USDA Agricultural Marketing Service | National Organic Program 13
Substantive Changes at Public Meetings

• Only minor adjustments to discussion documents and 

proposals will be allowed before voting. 

• Consider the extent to which: 

• A reasonable person affected by the recommendation 

would have understood that the published proposal 

affects his or her interests;

• The recommendation’s content is substantially different 

from the proposal’s content; and

• The effects of the recommendation differ from the effects 

of the proposal.

• The NOP Deputy Administrator or designee will determine if 

a proposed amendment is a substantive change. If public 

comments lead to substantive changes, the document goes 

back to subcommittee. 

USDA Agricultural Marketing Service | National Organic Program 14
NOSB Meeting Ground Rules

Board members request of the audience:

• We ask commenters to focus on issues, not people. 

• No questions or comments from the audience 

unless invited by the Board Chair.

• Commenters may not interrupt each other or step 

in for each other without the Chair’s permission. 

• Any sidebar conversations or commenter 

preparation activities must happen out in the 

hallway, to prevent disruption and the ability of 

others to hear what’s going on. 

USDA Agricultural Marketing Service | National Organic Program 15
FOIA/FACA Overview: 

Rules of the Road on Records Release 

February 4, 2015

USDA Agricultural Marketing Service | National Organic Program 16
FOIA/Government in the Sunshine 

• The Freedom of Information Act (FOIA) gives people 

the right to access information from the federal 

government. 

• FACA notes: “The records, reports, transcripts, 

minutes, appendixes, working papers, drafts, studies, 

agenda, or other documents which were made 

available to or prepared for or by each advisory 

committee shall be available for public inspection and 

copying at a single location in the offices of the 

advisory committee or the agency to which the 

advisory committee reports.“

USDA Agricultural Marketing Service | National Organic Program 17
Most of What You Write is OPEN 

• NOSB records (your emails and your work) are subject 

to public inspection, following agency review.

• AMS will redact confidential business information, 

private email accounts, private phone numbers, and 

cell phone numbers. Work phone numbers, fax 

numbers and email addresses, are releasable. 

• Board member’s opinions, exclamations, jokes, or 

other personal statements are likely to be released.

USDA Agricultural Marketing Service | National Organic Program 18
AMS Review Essential:

Do Not Share NOSB Documents/Email 

• NOSB communications (e.g., emails) and draft documents 

(e.g., draft proposals) must be available to the public: 

through the agency that oversees the FACA Board.

• NOP is the custodian of all Board records, so only AMS/NOP 

can make records available to requesting parties. AMS/NOP 

reviews all records before release, to determine whether 

any exemptions apply (e.g., personal information, 

confidential business information). 

• Board members may speak with community members 

about the work being done by the Board, and ask for input. 

• No Board communications or documents are to be 

forwarded or shared with any individuals or 

constituencies outside the Board members and AMS/NOP. 

USDA Agricultural Marketing Service | National Organic Program 19
Best Practices 

• Avoid sending full mail strings when responding or 

forwarding emails, unless relevant to discussion. 

• Send only the information that is necessary to 

convey your message. 

• Informality is natural, AND, watch what you state in 

your emails. Personal jokes and remarks usually 

cannot be redacted.

• Mark all drafts with watermarks or “DRAFT” in the 

header within the document.

• Do not circulate “drafts” outside of the NOSB.

USDA Agricultural Marketing Service | National Organic Program 20
Questions/Discussion 

Agricultural Marketing Service | National Organic Program 

February 2015

21
Federal Advisory Committees 

and the Ethics Rules:

An Overview for the:

National Organic Standards Board
Federal Advisory Committees 

and the Ethics Rules

Presenter:

Stuart Bender

Director, USDA Office of Ethics 

• Stuart.Bender@oe.usda.gov

• (202) 720-2251
WHAT IS AN ADVISORY COMMITTEE?

Committee, board, panel, or other similar group –

• Established by statute or established or utilized 

by either the President or an agency official 

• For the purpose of obtaining advice or 

recommendations on ”issues or policies within 

the scope of an agency official’s responsibilities” 
ADVISORY COMMITTEES

• Committee Charter established with mission and 

duties 

• Fair and balanced Committee Membership

• Designated Federal Official (DFO) 

• Open meetings, noticed in Federal Register 

• Charter expires after 2 years, unless provided 

otherwise
ADVISORY COMMITTEE

MEMBERS 

• Designation of members as 

either:

1. Regular Government 

Employees, 

2. Special Government 

Employees, 

or 

3. Representatives.
A REGULAR GOVERNMENT 

EMPLOYEE:

• Full-time or permanent part-time employee

• Paid a Federal salary

• Subject to Federal employee ethics laws and 

rules

• May submit an ethics Financial Disclosure 

Report (depending upon position)
A SPECIAL GOVERNMENT 

EMPLOYEE (“SGE”):

• Performs temporary duties

• On a full-time or part-time basis 

• With or without compensation

• Not to exceed 130 days for all Federal service 

during a 365-day period (part of a day counts 

as full day)

• Usually a Subject Matter Expert

– “I” Statements (“I believe, in my expert opinion”)

• Subject to Federal employee ethics laws and 

rules
A “REPRESENTATIVE” :

• Not a Federal employee

• Only represents specific interest or group 

(e.g. industry, consumers, labor)

• “We” statements (“We farmers believe...“)

• Represents a “particular bias” or a 

particular perspective.
A Representative 

• If you are appointed as a “Representative” 

– Your purpose is to represent the viewpoints of a non-Federal 

organization or group. 

•

– This means you are not serving as an employee of the Federal 

government.

• Since you are not a Federal employee, you are not subject to the 

specific ethical laws or rules governing the conduct of Federal 

employees.

• However, common sense ethical 

obligations still apply to you:
A “REPRESENTATIVE” :

– Required to maintain your integrity – by not seeking your own 

personal benefit. This means:

– Fully and immediately disclose to the DFO and Chairperson any 

conflicts of interest or any “appearance” issues.

– This may require you to prudentially disqualify (recuse) 

yourself if a particular matter involving specific parties (such as 

a specific contract, grant, loan or cooperative agreement) 

involves your own financial interests or those of your spouse, 

minor child or business partner, employer or future employer. 
A “REPRESENTATIVE” :

– Don’t accept improper gifts (from those seeking action from the 

Board).

– Don’t misuse internal non-public government information

– Use government property and time properly.

– Don’t engage in partisan political activities while performing your 

Board duties or while in a Federal building.

– Immediately disclose to the DFO and Chairperson if you or your 

employer enter into a lawsuit against USDA or its subagencies.
SGE ETHICS 

REQUIREMENTS 

• Must submit a Financial Disclosure Report 

to the Office of Ethics 

• Report is Reviewed for Conflicts of Interest

• SGE Should Promptly Notify DFO about 

Ethics Issues 

• Must Receive Annual Ethics Training
IF SGE, THEN 

CONFLICTS RESTRICTIONS APPLY (Part 1)

• Prohibited from accepting anything in 

return for being influenced in 

performing official duties. 

• This includes gifts, job offers, gifts offered to 

spouse or dependent children.
IF SGE, THEN 

CONFLICTS RESTRICTIONS APPLY (Part 2)

• Prohibited from participating personally 

and substantially in particular matters 

affecting their financial interests or 

interests of certain others (such as outside 

employers) or potential employers with 

whom they are negotiating for 

employment. (18 U.S.C. 208 

The Conflicts of Interest Ban)
IF SGE, THEN 

CONFLICTS RESTRICTIONS APPLY (Part 2)

• If you discover you have a potential 

conflict of interest, you must:

– Notify your DFO and Chair immediately

– Not work on matters in which you have a 

financial interest -- or an “imputed” interest –

until you discuss with the Office of Ethics

– Implement a recusal, if determined to be 

necessary 

Note: This is a Criminal Statute.
IF SGE, THEN 

CONFLICTS RESTRICTIONS APPLY (Part 3)

Post-Employment Restrictions (18 U.S.C. 207): 

• Prohibition on representations back to the 

Executive Branch on the SAME particular 

matters involving specific parties while serving 

the Government

• Prohibited for two years from representing on 

such matters under their supervision during last 

year of service

• Other restrictions may apply
STANDARDS OF CONDUCT RESTRICTIONS 

OF NOTE TO SGEs

• No gifts from prohibited sources for service.

• No participation in particular matters affecting 

“covered relationships.”

• No unauthorized disclosure of nonpublic 

information.

• No honorary degrees without prior ethics 

approval.

• No fundraising from persons whose interests 

they can substantially affect in official duties. 
STANDARDS OF CONDUCT RESTRICTIONS 

OF NOTE TO SGEs

• No unauthorized use of title or position for private 

personal use or endorsement of third party.

• No compensation for outside teaching, speaking or 

writing related to official duties – BUT, no restriction on 

teaching regular university courses.

• Cannot be an expert witness (except for US) before a 

Federal court or agency, if US is a party or has an 

interest in litigation.

• Restrictions on Political Activities (the Hatch Act) apply 

to SGEs on those days they are officially serving. 
Questions? 

Stuart Bender

Director, Office of Ethics

• Contact Info: (202) 720- 2251

• Stuart.Bender@oe.usda.gov
USDA Resources for Organic

Betsy Rakola, Organic Policy Advisor

1

NOSB Ethics Training

March 28, 2016
Topics

• USDA strategic goals for organic

• USDA programs supporting organic

• Research priorities & the Organic Working Group 

2
USDA Vision:

Departmental Goals & Strategies for Organic

3
Departmental Leadership: Priorities

USDA Goals and Vision for Organic

• USDA Strategic Plan

• Departmental Guidance

• Organic Working Group

4
USDA Strategic Plan & Organic Agriculture 

• Goal: increase the number of certified 

organic operations to 20,000 by 2018

• Strategy:

– Research and education

– Outreach to farmers through field offices

– Risk management tools (crop insurance)

– Reduce paperwork / eliminate 

duplication

– Make certification simpler – small & 

beginning farmers

5
USDA Departmental Guidance on Organic

USDA Secretary Tom Vilsack’s May 2013 departmental guidance 

on organic agriculture instructed all agencies to incorporate 

organic into their mission and outlined 5 priorities:

• Reducing barriers to small & beginning farmers

• Training and outreach

• Growing the sector

• Research

• Data 

6
USDA Organic Working Group

• The Organic Working Group (OWG) is led by the Agricultural 

Marketing Service’s Organic Policy Advisor

• It has members from all across USDA

• The OWG tracks progress against the Secretary’s annual goals for 

organic 

• External speakers present at OWG meetings and brown bag lunches

• Coordination with local & regional, sustainability, coexistence, 

beginning farmers, and veterans initiatives

7
USDA Organic Portal

8
Organic Literacy Initiative Snapshot

9
Training and Capacity Building

10
USDA Programs for 

Organic and Transitional Producers

11
USDA Programs Overview:

• Educational resources 

• Certification cost share

• Conservation technical assistance

• Crop insurance 

• Loans & price information

• Research & data

12
Tools for Transition – In Depth

eorganic.info/ToolsForTransition

13
Organic Certification Cost Share 

AMS Organic Certification Cost Share Programs

• Reimbursements for up to 75% of the cost of certification

• About $12 million available annually, through 2018

• Administered through State departments of agriculture 

www.ams.usda.gov/services/grants/occsp

14
Conservation Programs

• Conservation technical assistance

– Conservation planning for the transition to organic 

• Financial assistance

– Example: Environmental Quality Incentives Program - Organic Initiative 

www.nrcs.usda.gov/organic

15
Loan & Financial Assistance Programs

Loans & Financial Assistance

• Loans for 

– Storage facilities

– Farm ownership 

• Financial assistance for crop losses due to natural disasters

• Interim financing after harvest

16
Crop Insurance

Crop insurance tools for organic producers

• Options for specific organic crop prices

• Insurance based on organic or transitional contracts

• Revenue insurance for diversified farms

• More tools to come soon!

17
Data & Research

18
DRAFT
DRAFT
Economic Research 

21

Profit Potential of Certified 

Organic Field Crop Production

• Organic producers are less likely to 

work off-farm

• Different cultivation practices –

more mechanical weed control, 

more diverse crop rotations

• Despite higher per-acre costs, 

organic has greater returns

www.ers.usda.gov
Farming Systems Project

22

ARS long-term, side-by-side field trials
NOSB Research Priorities

• How do NOSB research priorities impact USDA?

– Organic Policy Advisor & AMS leadership share the NOSB’s annual 

priorities with USDA research leaders

– Some USDA grant programs reference the priorities in their Requests 

for Applications

• Organic Research and Extension Initiative

• Organic Transitions

• Sustainable Agriculture Research & Education program 

– Broader research programs may incorporate relevant priorities

• Example: Specialty Crops Research Initiative may fund citrus greening, fire 

blight research

23
NOSB Research Priorities

• What are some suggestions going forward?

– Refine research priorities to target specific goals

– Prioritize listed topics to aid grant-funding agencies

– Provide short (1-2 page, bulleted) executive summaries

• How can USDA help?

– Distribute organic research priorities and explain unique needs

– Provide information to the Board on funded research projects

– Facilitate conversations with research leaders 

24
Questions

Thank you

Betsy Rakola

USDA Organic Policy Advisor

www.usda.gov/organic

Betsy.Rakola@ams.usda.gov

25