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

National Organic Standards Board (NOSB) New Member Onboarding Training Agenda

Wednesday - Thursday, February 4-5, 2015

Location: USDA South Building - Room 0727-S, Washington DC 

Wednesday

February 4, 2015

Content

9:00 - 9:30 AM AMS Welcome and Introductions 

Delivered by: Anne Alonzo, Miles McEvoy, and Team 

9:30 - 10:15 AM Organic Foods Production Act (OFPA) - Miles McEvoy

10:15 - 10:45 AM Federal Advisory Committee Act (FACA) Overview - Jenny Tucker

10:45 - 11:00 AM Break 

11:00 - Noon Overview of USDA Organic Regulations (Part 1) - Miles McEvoy

Noon - 1 PM Lunch - (USDA Cafeteria). Meet and greet with AMS/NOP over lunch

1:00 - 1:30 PM Overview of USDA Organic Regulations (Part 2) - Miles McEvoy 

1:30 - 2:30 PM NOP and NOSB Operational Guidelines (Charter, Nominations, Work agendas, 

Subcommittees, Public Meetings, FOIA Review). Emily Brown Rosen, Jenny 

Tucker (FOIA) 

2:30 - 2:45 PM Break 

2:45 - 4:30 PM Training: National List, and Sunset (Exercises/Hands-On Where Possible)

• Review National List petition process - Lisa Brines

• Review Sunset Process and Templates - Lisa Brines 

4:30 - 5:00 PM Q&A, Wrap-Up, day 2 Overview 
 

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

National Organic Standards Board (NOSB) New Member Onboarding Training Agenda

Wednesday - Thursday, February 4-5, 2015

Location: USDA South Building - Room 0727-S, Washington DC 

Thursday, 

February 5, 2015

Content

9:00 - 9:30 AM Review/follow up questions from previous day

9:30 - 11:00 AM 

Break in middle

National Organic Program Overview: Overview of NOP and an introduction to 

the three Divisions and their key activities and priorities. Miles McEvoy, Cheri 

Courtney, Matthew Michael, and Jenny Tucker. 

11:00 - 11:30 AM USDA Organic Working Group (OWG) and Secretary’s Organic Guidance - Betsy 

Rakola

11:30 - Noon Guided Tour: NOP/NOSB Website - Michelle Arsenault, Emily Brown Rosen 

Noon - 1 PM Lunch (USDA Cafeteria)

1:00 - 3:00 PM 

Break Midway 

Training: 

• Best practices for writing proposals and recommendations - Emily Brown 

Rosen/Standards

• Best practices for evaluating technical reports - Emily Brown Rosen 

• Best practices for analyzing public comments - Emily Brown Rosen

• Review key elements of rulemaking process; what information is needed 

to get a rule completed and through clearance (OGC and OBPA) -

Shannon Nally Yanessa or Emily Brown Rosen (Back-Up)

3:00 - 4:00 PM Ethics and Conflict of Interest (Teleconference/webcast with full NOSB) -

Jenny Tucker

4:00 - 4:30 PM Summary and Closing Discussion 
National Organic Standards Board 

Training: 

Organic Foods Production Act (OFPA) 

February 2015

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
National Organic Standards Board 

Training: 

Federal Advisory Committee Act (FACA)

February 2015

21
Goal: Review Key Elements of FACA

• FACA Overview 

• Agency Responsibilities 

• Board Responsibilities

• NOP Authority in Setting Board Policy 

• Shared Success Factors 

22
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.

24
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. 

26
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.

27
Subcommittees Versus Committees 

• Subcommittee’s meetings must be conducted in 

accordance with FACA’s openness requirements IF

– Recommendations are made directly to the Federal 

agency, or 

– The parent advisory committee will adopt 

subcommittee recommendations without further 

deliberations 

• NOSB subcommittee proposals do not come directly to 

USDA – they come through the NOSB Full Committee. 

• This is why subcommittee calls are not currently open 

to the public. This is also why we call subcommittee 

products proposals rather than recommendations. 

28
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. 

33
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

35
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

37
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

Agricultural Marketing Service

 

Understanding Organic

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: 

Operating Guidelines 

Agricultural Marketing Service | National Organic Program 

February 2015

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 

having announcement open 2 months 

3. Review applications for completeness and basic 

qualifications, i.e., fit in 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 

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
National List Petition Process

1

Lisa M. Brines, Ph.D.

Agricultural Marketing Service | National Organic Program 

February 2015

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 determine 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

• TR 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

USDA Agricultural Marketing Service | National Organic Program 28
Example Substance:

• New Petition: Substance A for addition to 

National List, section 205.605(a)

• OFPA criteria:

– the effect of the substance on human 

health

• Checklist question:

– Are there any harmful effects on human 

health from the main substance or the 

ancillary substances that may be added to 

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

§6518(m)(4), 205.600(b)(3)] 

USDA Agricultural Marketing Service | National Organic Program 29
Checklist Exercise:

Summary from TR:

• Substance A is considered nontoxic to humans 

and is not a carcinogen

• When used as petitioned, no adverse effects to 

human health have been reported

• Prolonged exposure to skin is known to cause 

tissue damage

• Ingestion of excessive quantities can produce 

non-life threatening side effects such as 

electrolyte imbalances or vomiting

USDA Agricultural Marketing Service | National Organic Program 30
Checklist exercise:

Are there any harmful effects on human health 

from the main substance or the ancillary 

substances that may be added to it?

USDA Agricultural Marketing Service | National Organic Program 31
Checklist exercise:

• 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 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 32
• 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 33
• Questions?

USDA Agricultural Marketing Service | National Organic Program 34
Review: Sunset Process

1

Lisa M. Brines, Ph.D.

Agricultural Marketing Service | National Organic Program 

February 2015

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

• 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
Previous Sunset Process

Drawbacks to previous process:

• Each sunset year required 3 separate 

rulemaking documents (ANPR, PR, and FR)

• Substances were discussed in a single public 

meeting

• Removal could occur with 2/5 of votes cast 

(fewer than required of “decisive” actions)

• Annotation changes during sunset were 

problematic

USDA Agricultural Marketing Service | National Organic Program 4
Inconsistent decision making:

• Example #1: Substance A is petitioned for 

removal

– Requires 2/3 votes to be recommended 

for removal (10 votes)

• Example #2: Substance A is subject to 

sunset

– Previously needed 2/5 votes for non- renewal (6 votes)

• Even with identical data, same board 

members, and same public comments, 

could have conflicting recommendations!

USDA Agricultural Marketing Service | National Organic Program 5
Benefits to Updated Sunset Process

• Thorough and transparent review 

process for all substances - provides 2 

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 6
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 7
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 8
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 9
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 10
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 11
Review New Documents

• Sunset list template

• Preliminary review template

• NOSB review template

USDA Agricultural Marketing Service | National Organic Program 12
Sunset 2015 Examples

• Sulfurous acid (Crops)

• Marsala – fortified cooking wine (Handling)

Spring 2014 Meeting

Sunset 2015 Summaries

Fall 2014 Meeting

Sunset 2015 Reviews

USDA Agricultural Marketing Service | National Organic Program 13
• Questions?

USDA Agricultural Marketing Service | National Organic Program 14
National Organic Standards Board 

Training: 

National Organic Program Overview 

Agricultural Marketing Service | National Organic Program 

February 2015

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: 

82 certifying agents worldwide

25,000 certified organic operations

$35 billion in U.S. organic sales (2013)

National Organic Program | Agricultural Marketing Service 
Quick Facts About NOP 

• Staffing: 43 employees in three Divisions and the 

Office of the Deputy Administrator 

• Budget: 

FY 2012: $6.919 million

FY 2013: $6.369 million 

FY 2014: $9.04 million

• NOP Leadership Team: 

Miles McEvoy – Deputy Administrator

Jennifer Tucker – Associate Deputy Administrator 

VACANT (Recruiting) – Standards Division Director 

Cheri Courtney – Accreditation and International Activities Division 

Director 

Matthew Michael – Compliance and Enforcement Division Director 

• MRP Leadership – Betsy Rakola, USDA Organics Specialist

National Organic Program | Agricultural Marketing Service 5
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 8
NOP Document Matrix 

1. Rules

– Amend the USDA organic regulations

– Allow enforcement actions

– If “significant” require additional clearance

– Example: pasture rule, aquaculture 

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: Organic System Plans, Reinstatements, 

4. Guidance Documents

– Provide options to satisfy regulatory requirements

– Support enforcement by referencing section of 

USDA organic regulations

– Example: Unpackaged Commodities Guidance 

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: GMO policy

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 14
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 15
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 16
Topics 

• NOP: Overview, Cross-Cutting Activities

• Accreditation and International Activities

• Compliance and Enforcement

• Standards

USDA Agricultural Marketing Service | National Organic Program 17
Accreditation Activities

• NOP oversees the work of 82 certifiers, which certify

over 25,000 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 3 Accreditation Managers,

Lead Auditor, Program Analyst, and Program

Specialist

– Supplemented by audit team in AMS Quality

Assurance Divisions, Livestock and Seed Program

• At the close of FY 2014, certifiers were in full compliance

with 96% of the NOP’s accreditation criteria, and have

implemented corrective actions for all deficiencies.

USDA Agricultural Marketing Service | National Organic Program 18
Key Accreditation Activities 

• Seven accreditation renewal audits, 42 accreditation

midterm audits, and initial accreditation audit.

• Consider 34 reinstatement of certification requests

• Consider 7 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 19
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

• Recognition Agreements:

– India, Israel, 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 confidence.
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 2015 

• Publish updated list of certified operations

• ACA Certifier Training: February 2015

• 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 25
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 26
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 27
FY 2014 Successes 

• Issued nine civil penalties, totaling $81,500, for 

willful violations of the USDA organic regulations

• Closed 285 complaints, exceeding the record high 

number closed in FY12

• Initiated 162 initial enforcement actions, including 

66 Notices of Warning, 29 Notices to Cease and 

Desist and 54 investigation referrals

• Published 13 fraudulent organic certificates on the 

NOP webpage 

• Prevailed in an administrative hearing seeking 

revocation of a Pennsylvania operation.

• Issued first subpoena under new Farm Bill authority

USDA Agricultural Marketing Service | National Organic Program 28
FY14 Complaint Distribution by Type
2015 Priorities 

• Complaint investigations and closures - Reduce 

backlog and time to case closure 

• Work closely with OGC to pursue complaints for 

hearing against violators, as appropriate 

• Contribute to policy and training development to 

improve compliance

• Continue to implement Farm Bill provisions related 

to enforcement 
Topics 

• NOP: Overview, Cross-Cutting Activities 

• Accreditation and International Activities 

• Compliance and Enforcement

• Standards 

USDA Agricultural Marketing Service | National Organic Program 31
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 32
2015 Priorities 

• Origin of Livestock Draft Rule 

• Aquaculture Draft Rule 

• Pet Food Draft Rule 

• Animal Welfare Rule

• Guidance: Substances in Post-Harvesting Handling, 

Drift Policy

• Material Clarifications for Certifiers 

• National List Management, including Technical 

Report contract management 

• Provide support for National Organic Standards 

Board subcommittees 

USDA Agricultural Marketing Service | National Organic Program 33
Questions/Discussion 

Agricultural Marketing Service | National Organic Program 

February 2015

34
Organic Working Group and 

Secretary Vilsack’s Guidance on Organic

Betsy Rakola, Organic Policy Advisor

NOSB Training 2015

1
Overview

• USDA Organic Policy Advisor & the Organic 

Working Group

• Training and Outreach 

• Growing the Organic Sector

• Regulatory Reciprocity

• Data and Research

• Stakeholder engagement

2
USDA Organic Policy Advisor

& Organic Working Group

3
Organic Policy Advisor role

The Organic Policy Advisor:

• Is a permanent staff position advising the Office of the 

Secretary

• Coordinates USDA Organic Working Group and develops 

annual action plan

• Implements Secretary Vilsack’s 2013 Departmental Guidance 

on Organic Agriculture 

• Works across USDA to ensure that programs work for organic

• Participates on other inter-agency USDA initiatives

4
USDA Departmental Guidance on Organic

Secretary Vilsack’s May 2013 departmental guidance on organic 

agriculture outlined 5 priorities:

• Training and outreach

• Growing the sector

• Regulatory reciprocity (reducing paperwork)

• Research

• Data 

The USDA’s Organic Working Group defines annual projects for 

each of these priority areas. 

5
2014 Farm Bill update

Farm Bill program implementation update

• Organic Research and Extension Initiative - $19 million 

• Cost share increased - $11 million available through states

• Organic data initiative restored - $5 million for data collection

• Organic crop insurance expanding

• Research and promotion “checkoff” exemption

• Option for proposal of organic checkoff program

6
Training and Outreach

7
Training and Outreach Goals 

USDA Organic Working Group Training & Outreach Goals:

1. Update the Organic Literacy Initiative in early 2015

2. Work with external partners to distribute organic resources 

beyond the USDA

8
Organic Literacy Initiative

9
Organic Literacy Toolkit

10

Where to find USDA resources on organic:

www.ams.usda.gov/OrganicInfo 

 

usda.gov/organic
Growing the Sector

11
Supporting transition to organic goals

USDA Organic Working Group 

“Growing the Sector” Goals: 

1. Identify Tools for Transition: how can existing USDA technical 

and financial assistance help producers transition to organic?

– Conservation Reserve Program

– Agroforestry technical assistance

2. Create web and print resources to help producers with 

financing, buffer zones, cover crops, etc. 

12
Certified Operations Worldwide 

USDA Agricultural Marketing Service | National Organic Program 13

 -

 2,000

 4,000

 6,000

 8,000

 10,000

 12,000

 14,000

 16,000

 18,000

 20,000

2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

USDA Certified Organic Operations, Domestic, 2002-2013

Note: Foreign operations may also be certified to the USDA organic standards.
Bridges to Opportunity

Bridges to Opportunity: 

Partnership with the USDA Farm Service Agency

• FSA working to improve customer service, build knowledge of 

all USDA programs and sectors of agriculture

• Organic “pilot” launched in Minnesota in fiscal year 2015

• Connecting producers and handlers with the economic 

opportunities in the organic sector

14
Regulatory Reciprocity

15
OWG Themes: Reciprocity

Reciprocity team goals

1. Conservation - ongoing: Natural Resources Conservation 

Service and National Organic Program (NOP) are coordinating 

conservation program requirements and organic system 

plans.

2. Non-GE label claims – complete: Food Safety and Inspection 

Service streamlined procedures for certified organic meat 

and poultry processors

3. Crop insurance - new: Risk Management Agency and NOP 

will conduct a needs assessment for crop insurance 

documentation.

16
Conservation Activity Plans

NRCS Conservation Activity Plans 

for Organic Producers

• USDA Natural Resources Conservation Service created a 

conservation activity plan that mirrors an OSP

• Important tool for transitioning producers: helps with 

paperwork and conservation implementation

• First step for EQIP: financial assistance up to $20,000 per year

17
– Land Use History

– Affirmations

– Production practices

– Recordkeeping

– Commingling/contamination

– Maps

– Natural resource assessment

– Planned practices

– Pest management

– Soil Fertility Management

– Crop rotation

– Inputs

Organic System Plan

Conservation 

Activity Plan 

Linking Conservation Activity Plans with OSPs The “plug

-

in” plan
Getting involved with NRCS

We need more organic Technical Service Providers to 

implement the new organic conservation plans. 

TSPs are individuals or businesses that have technical 

expertise in conservation planning and design. 

Please help us recruit experts in organic agriculture!

Visit www.nrcs.usda.gov/wps/portal/nrcs/

main/national/programs/technical/tsp/

19
Data

20
Crop Insurance

Crop insurance: USDA has new risk management tools 

for organic, small, and diversified producers

• Whole Farm insurance now available: certified farms may use 

organic prices, cover up to 85% of value

• Contract price elections available since spring 2014: insurance 

based on existing contract

• Price elections for organic crops: 26 organic crops now have 

insurance options

• Expansion continues through the Organic Data Initiative 

21
Non-Insured Assistance Program

Non-Insured Crop Disaster Assistance Program (NAP)

• 2015 interim rule: allows NAP to use organic and direct-toconsumer prices

• Coverage may vary by state, requires availability of good price 

data

• See your local Farm Service Agency office for more 

information: www.fsa.usda.gov

22
Organic Producer Survey: Data

USDA mailed a new Organic Producer Survey in 

mid-January 2015

• Third USDA organic producer survey since 2008. 

• Data is vital – helps USDA to create new and better programs 

for organic producers and handlers.

23
Data highlights

Organic data: Who are organic producers?

• Organic special tabulation, 2012 agricultural census

– Includes state-by-state data on organic producers

– Shows that organic producers are more likely to have direct-toconsumer sales and participate in non-traditional markets, like CSAs

– Organic farms were more likely to invest in on-farm renewable energy

– Organic farmers are younger, on average, and more likely to be 

beginning farmers 

www.agcensus.usda.gov/Publications/2012/ 

Online_Resources/Special_Organics_Tabulation/organictab.txt

24
Research

25
OWG Themes: Research

Research team goals

1. Review and respond to NOSB research priorities.

2. Conduct a stakeholder needs assessment of organic research 

priorities and develop a white paper on critical research 

needs.

3. Possible new goal: collaborate with climate change team to 

identify organic practices which mitigate greenhouse gases

26
Research

Research Activities

• Organic-specific grant funding: $25 million annually through 

organic set-aside programs

• Grants research solutions to common challenges: high-quality 

seed, nutrient management, controlling animal diseases with 

natural materials, cover cropping strategies

• Long-term organic studies at USDA research facilities examine 

performance, yields, climate change impacts, and more

27
Stakeholder engagement

Focus on stakeholder engagement through 

outreach and education

• 2015 webinar series will cover a broad range of topics, with 

time for discussion, questions and answers.

– To receive email invitations, sign up at the USDA National Organic 

Program website: www.ams.usda.gov/nop

• USDA & NOP will participate in several conferences and 

annual meetings this fall/winter.

28
Questions

Betsy Rakola

USDA Organic Policy Advisor

www.usda.gov/organic

Betsy.Rakola@osec.usda.gov

29
Best Practices:

Proposals & Recommendations

Emily Brown Rosen

Agricultural Marketing Service | National Organic Program 

February 2015

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 

–Discussion of 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

– 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 Checklists for new petitions

– Crops and livestock version

–Handling version

• Narrative format for other proposals

• 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

Emily Brown Rosen

Agricultural Marketing Service | National Organic Program 

February 2015

1

NOSB Training
Overview

• Identifying key information

– In petition

– In Technical Review

• Filling out the Checklist

• Providing a summary narrative

USDA Agricultural Marketing Service | National Organic Program 2
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 3

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 4
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 5
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 6
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 7
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 8
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 Checklist , Category 2

USDA Agricultural Marketing Service | National Organic Program 9
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 10
Read the Documents !

• Once oriented – read carefully the entire 

TR

• Revisit petition for comparison

– Petition Justification statement- does 

it seem valid?

• Then go through checklist and answer 

questions.

• Discuss: does anyone have a different 

way to approach this?

USDA Agricultural Marketing Service | National Organic Program 11
Checklist use

• Yes vs No – sometimes could be both

– Provide reasoning in comments 

section

–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 12
Checklist Exercise - break into 3 groups 

• Category 1 – Adverse Impacts on 

humans and environment

–Questions 2, 3, 10

• Category 2 – Is the substance Essential?

–Questions 7, 8, 9

• Category 3- Is the substance 

Compatible?

–Questions 1, 2 

USDA Agricultural Marketing Service | National Organic Program 13
Summary 

• Once checklist complete fill out first 

page , based on SC discussion 

• List motions and votes

• 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 14
 

Questions? 

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

Comment Evaluation

1

Emily Brown Rosen

Agricultural Marketing Service | National Organic Program 

February 2014

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 2
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 3
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 4
Examples 

Total comments: 25  Bulk Handling Draft Guidance

(Internal NOP review) 

USDA Agricultural Marketing Service | National Organic Program 5

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 truck

-have not been requiring hay brokers to be certifie

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

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

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 9

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 10
Evaluation of Comments

• Questions?

• Other ideas or tips? 

• What works for you?

USDA Agricultural Marketing Service | National Organic Program 11
Rulemaking

1

Shannon Nally Yanessa

Agricultural Marketing Service | National Organic Program 

February 2014

NOSB Training
What is a Rule?

• A rule is a “an agency statement of 

general applicability and future effect 

designed to implement, interpret or 

prescribe law or policy or describing the 

organization, procedure or practice 

requirements of an agency...”

• Must be issued in accordance with the 

Administrative Procedure Act.

USDA Agricultural Marketing Service | National Organic Program 2
The Simplified Rulemaking Process

• Publish Proposed Rule in the Federal 

Register. 

• Provide interested parties an opportunity 

to submit written data, views, or opinions 

about the proposed rule. 

• Publish a Final Rule in the Federal Register. 

USDA Agricultural Marketing Service | National Organic Program 3
How does NOP initiate a rulemaking? 

• We are required to prepare, submit and 

receive approval on a regulatory 

workplan for every stage of rulemaking.

– Summarizes objectives, possible 

alternatives, and effects of action to 

policy officials (non-technical)

– Provides information needed for 

“designation” of significance 

– Communicates to OMB and public 

about agencies regulatory plan

USDA Agricultural Marketing Service | National Organic Program 4
Office of Management & Budget

• Office of Information and Regulatory Affairs 

(OIRA) 

– 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 

• Career staff: ~45. 

USDA Agricultural Marketing Service | National Organic Program 5
Significance

• OMB reviews rules that are: 

– Likely to 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;

– Creates serious inconsistency or interferes with an 

action of another agency;

– Materially alter the budgetary impact of existing 

programs; or

– Raises novel legal or policy issues.

*Rules that have an effect of $100M or more on the 

economy are Economically Significant rules, often 

considered “major” and triggers Congressional Review 

Act. 

USDA Agricultural Marketing Service | National Organic Program 6
How do stakeholders know what rules 

agencies are working on?

• Once OMB approves a workplan, this 

information is published:

– In the fall in a “Regulatory Plan”; and 

– Every spring and fall an “Agenda of 

Regulatory and Deregulatory Actions”. 

• This “Unified Agenda” is how agencies 

announce future rulemaking activities update 

the public on pending and completed 

regulatory actions.

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

• Review and summarize all NOSB recommendations; 

• Summarize technical information (e.g. CAS, 

use/availability/function, production system details); 

• Review overlapping regulations and coordinate with 

those agencies (e.g., FDA, EPA);

• Draft overview of the amendment(s), including 

justification for action and info on implementation; 

• Draft amendatory instructions for Federal Register; 

and

• Conduct necessary supplementary analyses.

• Facilitate NOP approval; engage other Divisions as 

needed. 

USDA Agricultural Marketing Service | National Organic Program 8
How are rules structured? 

• Required front sections!

– Summary

– Dates 

– Addresses

– Agency Contact

– Comment Instructions

• Supplementary Information

– Background, Overview of Amendment, 

Impact Analyses, EOs

• Must have legal authority and instructions for 

Federal Register

USDA Agricultural Marketing Service | National Organic Program 9
Executive Orders 12866 & 13563

Regulatory Planning & Review

• Agencies must assess both costs and 

benefits of regulation.

• Agencies should propose or adopt a 

regulation only upon a reasoned 

determination that the benefits of the 

intended regulation justify its costs. 

• Agencies should consider alternatives and 

select an approach that maximizes net 

benefits.

USDA Agricultural Marketing Service | National Organic Program 10
Cost/Benefit Estimates

USDA Agricultural Marketing Service | National Organic Program 11

Costs (range) Benefits

$500 million - $4.2 billion

The upper limit is the upper limit for 

sales of product categories that would 

be impacted by this action. The lower 

bound is based on industry data 

summarizing annual commodity 

ingredient sales and retail sales of 

organic products. 

Establishes a clear, finite list of essential 

and required vitamins and mineral for 

use in organic food, including infant 

formula.

Facilitates the use of essential or 

required vitamins and minerals in 

organic food, including infant formula.

Fosters certainty in determining 

whether a specific ingredient can be 

used in an organic product.

Facilitates enforcement of organic 

product composition standards. 
The Regulatory Flexibility Act (RFA)

• Requires agencies to assess the 

potential economic effects of rules on 

small U.S. businesses, non-profit 

organizations, and small 

governmental jurisdictions.

• “Small” using Small Business 

Administration criteria.

• For purposes of NOP rules, most 

affected entities are considered 

“small” by SBA. 

USDA Agricultural Marketing Service | National Organic Program 12
RFA – In Practice

• The agency must consider following:

– Does the RFA apply to this rule?

– Will this rule have a significant economic 

impact on a substantial number of small 

entities?

– What is the potential economic impact 

of the rule on small entities?

– What has been/can be done to minimize 

the adverse economic impact of the rule 

on small entities? Are there 

alternatives?

USDA Agricultural Marketing Service | National Organic Program 13
Paperwork Reduction Act

• Goal is to minimize federal paperwork 

for individuals, small businesses, and 

State and local governments.

• The agency must show that:

– Paperwork is least burdensome;

–Not duplicative of other federal 

collections; and

– Information has practical use.

USDA Agricultural Marketing Service | National Organic Program 14
Additional Analyses

• EO 13175 - Consultation & Coordination with 

Indian Tribal Governments

– Requires agencies to consider the compliance 

costs imposed on tribal governments by 

regulations. 

– Requires agencies to consult with tribal 

governments if the regulation would have 

tribal implications and preempt tribal law. 

• Civil Rights Impact Analysis - Requires agencies 

to assess any disproportionate impact on 

protected groups.

USDA Agricultural Marketing Service | National Organic Program 15
Great! Whew. We finished a draft. 

How do we clear rules for publication?

• Not Significant

–Office of General Counsel

–Deputy Administrator

– Administrator

–Undersecretary 

– Secretary

USDA Agricultural Marketing Service | National Organic Program 16
Clearance for significant actions?

– Office of General Counsel & USDA General Counsel

– Deputy Administrator

– 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 17
Why does rulemaking take so long?

• Review of NOSB recommendation

• Draft Regulatory Workplan for OMB Designation

• Conduct and Draft Required Analyses

• 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 18

Proposed 

Rule 

Stage

Final Rule 

Stage
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 19
Ex Parte Communication

• A private communication between agency 

decision makers and other persons regarding 

substance of the rule.

• It is USDA policy to avoid ex parte 

communications during rulemaking.

• Once proposed rule is published, we can: 

– Answer factual questions

– Accept written comment 

– Accept oral comment during public hearing

• If it does occur, we draft memo about the 

communication and post as part of rulemaking 

record. 

USDA Agricultural Marketing Service | National Organic Program 20
How are rules incorporated into the 

regulations?

• The Code of Federal Regulations (CFR) contains all 

of the generally applicable rules of the Federal 

government with current or future effect.

• On the day a final rule is published in the Federal 

Register, Federal Register staff process the material 

for codification into the CFR. 

– Rules that are immediately effective are 

integrated into the “Electronic Code of Federal 

Regulations” (e-CFR) database 

(ecfr.gpoaccess.gov). 

– Rules with delayed effective dates are placed in 

amendment files and linked from the main e-CFR 

database. 

USDA Agricultural Marketing Service | National Organic Program 21
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 22
National Organic Standards Board 

Refresher Training: 

Ethics and Conflict of Interest Training 

February 2015

1
Overview 

• Ethics: Challenges and Strategies

• Managing Interests and Conflicts of Interest

2
Challenges 

• NOSB-Developed Mission Statement: Provide effective 

and constructive advice, clarification and guidance to the 

Secretary of Agriculture concerning the National Organic 

Program and the consensus of the organic community.

• Realistic challenges in making this mission real: 

– Making recommendations that are defensible and hold 

up under legal and public scrutiny.

– Getting sufficient and pertinent information and facts.

– Consistent and transparent analysis of facts.

– Interacting with the public, receiving and evaluating 

input.

– Balancing stakeholder interests.

3
As a Board member representing an 

interested and engaged community, 

and making recommendations that will 

have wide-reaching regulatory impacts, 

your decisions and actions 

are carefully scrutinized.

Perceptions matter. 

4
Optics and Ethics: Common Concerns 

• Absence of Transparency: When relevant facts are hidden 

from one or more parties involved in making a decision.

• Unwarranted Gain: Seeking an improper or unearned 

benefit for yourself or others (“disproportionate gain”)

• Lack of Impartiality: Allowing friendships, family 

relationships, personal, financial, or other biases to 

influence you improperly. You must represent collective 

interests. 

• Nonperformance of Obligation: Failing to meet the 

obligations of your position: NOT voting, NOT contributing 

your input, or NOT gathering and weighing facts from all 

stakeholders to the best of your ability.

Optics – How things appear to others - is important! 

5
Strategies for Ethical Decision Making

• Gathering Information: Information about alternatives may 

come from multiple sources. Failing to gather sufficient 

information can lead to poor decision making. 

• Identifying Stakeholders: All of the people who have an 

interest in the outcome of a decision are the stakeholders. To 

choose the most ethical alternative, identify all the parties 

who will be affected. Is it appropriate or even possible to 

assess which stakeholders are significantly more affected 

than others? What is your criteria for assessing impact?

• Analysis: Find the Right Balance between: Utility, Rights, 

Fairness, and Relationships – Personal, organizational, and 

cultural values underlie most decisions 

6
Overview 

• Ethics: Challenges and Strategies

• Managing Interests and Conflicts of Interest

7
USDA Policy for Board Representatives

• “Representatives” are appointed based on ability to share the viewpoints 

and perspectives of the community or sector you represent. 

• Even if there is no financial conflict of interest, your outside relationships 

may raise questions in the public’s mind about how fair you can be while 

working on a particular committee matter. 

• You should avoid participating in those particular matters in which you could 

reasonably be viewed by others as engaging in “self-dealing” to benefit 

yourself or someone close to you. 

• Be alert for situations when one of the following persons or entities will be 

specifically affected by your committee’s activities:

– a member of your household; 

– a former employer or a prospective employer;

– a client of yours or your spouse; 

– a person or organization with which you have some kind of business or 

contract relationship; or your spouse’s employer. 

8
Key: Disproportionate Impact 

• Board members are appointed in part because of their 

interests. As such, finding the line between an acceptable 

interest and a conflict of interest is important. 

• Definition of Conflict of Interest: A situation in which there 

is an actual or potential direct financial interest of a Board 

member, or a person or entity associated with a Board 

member, which could impair the individual’s objectivity or 

which has the potential to create an unfair competitive 

advantage. 

• Acceptable Interest: An interest carried by an NOSB 

member in the interest of a represented group. 

• Conflict of Interest: Interest that directly and 

disproportionally benefits the NOSB member (or a person 

associated with that member). 

9
Disclosure of Interests 

• Conflict of Interest is as much about the appearance of a 

personal conflict and loss of impartiality as it is about actual 

direct interest.

• Board members need to review proposals and research any 

actual and potential conflicts of interest. 

• If a Board member discloses having a conflict of interest and 

offers to recuse him or herself, NOP will accept that, with no 

questions asked. You do not need to give the details of the 

conflict – just state that a conflict exists.

• If the Board member discloses a potential Conflict of Interest and 

is uncertain as to whether he or she should recuse him or herself, 

then the NOP will make the determination about whether a 

conflict exists, and will instruct the member accordingly as to 

whether to vote or not. 

10
Process Used at the NOSB Meetings 

• The Designated Federal Officer (DFO ) will provide a matrix in advance of 

the meeting that lists proposals being voted on at the meeting. Review 

the list and: 

• Decide on your own to recuse yourself and notify the DFO which 

proposals you will not be voting on OR 

• If you are unsure, contact the NOP Associate Deputy Administrator to 

discuss your possible conflict to determine whether you should recuse 

or not.

• NOP will compile a list of all recusals for the meeting. 

• At the beginning of each Subcommittee session, DFO will identify NOSB 

members that have a COI and will not be voting. 

• When it is time to vote, the Board member recusing will simply state 

“Recuse” when it is his or her time to vote. 

11
Questions/Discussion 

Agricultural Marketing Service | National Organic Program 

February 2015

12