USDA Agricultural 	 1400 Independence Avenue, SW. 

Marketing Room 2646-S, STOP 0268 

Service Washington, DC 20250-0201 

April 23 , 2010 

MEMORANDUM FOR THE CHAIRMAN OF THE NATIONAL ORGANIC 

STANDARDS BOARD 

FROM: 	 Miles McEvoy 

Deputy Administrator 

National Organic Progra 

SUBJECT: 	 National Organic Standards Board Recommendations (November 2009) 

ISSUE: 

The National Organic Standards Board (NOSB) made recommendations in November 2009 that 

addressed the following: renewal and rejection of materials on the National List used in crop 

production and handling; annotation changes for materials used in livestock production; 

vaccination allowances; standards for aquaculture; regulations for heightened animal welfare 

practices; classification of materials according to a defined, predictable standard; changes to the 

NOSB Policy Manual; and retail certification. 

SUMMARY: 

The National Organic Program (NOP) generally supports the recommendations made by the 

NOSB and plans to pursue actions accordingly, as specified in the discussion below. 

DISCUSSION: 

1. Sunset 2011 - Crop production 

The NOSB reviewed the following material on the National List for use in organic crop 

production, due to sunset in 2011 , and recommended continued listing on the basis that no new 

information was presented to support removal. The NOP concurs with the November 2009 

NOSB recommendations to renew the following listing for crop production substances, and any 

restrictive annotations, that are due to sunset in 2011: 

§ 205.601 

Seed preparations. Hydrogen chloride (CAS #7647-01-0)-for delinting colton seed for 

planting 
MEMORANDUM FOR THE CHAIRMAN OF THE NOSB 

Page 2 

2. Sunset 2011 - Handling 

The NOSB reviewed the following materials on the National List for use in organic handling, 

due to sunset in 2011 , and recommended continued listing on the basis that no new information 

was presented to support removal. The NOP concurs with the November 2009 NOSB 

recommendations to renew the following listings for handling substances, and any restrictive 

annotations, that are due to sunset in 2011 : 

§ 205.605(a) 


Egg White Lysozyme (CAS # 9001-63-2) 


L-Malic acid (CAS # 97-67-6) 


Microorganisms 


§ 205.605(b) 


Activated charcoal (CAS # 7440-44-0; 64365-11-3)-only from vegetative sources; for 


use only as a filtering aid. 


Cyclohexylamine (CAS # 1 08-91-8)- for use only as a boiler water additive for 


packaging sterilization. 


Diethylaminoethanol (CAS # 100-37-8)- for use only as a boiler water additive for 


packaging sterilization. 


Octadecylamine (CAS # 124-30-1)- for use only as a boiler water additive for 


packaging sterilization. 


Peracetic acidlPeroxyacetic acid (CAS #79-21-0)-for use in wash and/or rinse water 


according to FDA limitations. For use as a sanitizer on food contact surfaces. 


Sodiwn acid pyrophosphate (CAS # 7758-16-9)-for use only as a leavening agent. 


Tetrasodium pyrophosphate (CAS # 7722-88-5)-for use only in meat analog products. 


3. Crop Production Substances - Peracetic acid 

The NOSB rejected the petition to expand the use of peracetic acid for plant disease control. The 

NOSB made an alternative recommendation to amend the annotation for peractic acid to read­

§ 205.601(a)(6) Peracetic acid- for use in disinfecting equipment, seed, and asexually 

propogated planting material. Permitted in hydrogen peroxide formulations at 

concentration of no more than 5%. 

§ 205.601(i)(7) Peracetic acid- for use to control fireblight bacteria. Permitted in 

hydrogen peroxide formulations at concentration of no more than 5%. 

The NOP concurs and will propose changes to the annotation as recommended by the NOSB. 

4. Livestock Substance - Eprinomectin 

The NOSB rejected the petition to add eprinomectin to the National List. The NOP will not 

pursue rulemaking to add eprinomectin to the National List. 
MEMORANDUM FOR THE CHAIRMAN OF THE NOSB 

Page 3 

5. Livestock Substance - Xylazine 

The NOSB recommended that the annotation be amended to remove the words "the existence of 

an emergency" thereby allowing xylazine to be used during both non-emergencies and 

emergencies. The livestock committee presented this recommendation to align with the usage 

practices by veterinarians for sedation during non-emergency procedures. The NOP concurs and 

will propose changes to the annotation as recommended by the NOSB. 

6. Livestock Substance - Excipients 

a. The NOSB approved a recommendation to amend the current listing for excipients to 

include a reference to drugs approved by APHIS. The current listing, which was 

intended to include excipients in all animal drugs used to treat organic livestock only 

referenced those approved by FDA, but omitted APHIS approved drugs. The NOP 

concurs with the NOSB recommended correction and will propose the addition of "or 

approved by APHIS" to the current listing. 

b. The NOSB also recommended expanding the allowance for excipients to "animal 

health care products." The livestock committee has a recommendation pending for 

review at the April 2010 NOSB meeting. The NOP finds "animal health care 

products" to be a vague term and awaits the recommendation for a definition before 

proceeding with rulemaking. 

7. Livestock Substance - Chlorhexidine 

The NOSB has recommended that the annotation be amended to not limit the use of this 

substance to veterinarians, as follows -

Chlorhexidine - Allowed as a germicide for medical and surgical procedures. Allowed 

for use as a teat dip when alternative germicidal agents and/or physical barriers have lost 

their effectiveness. 

The NOP concurs and will propose changes to the annotation as recommended by the NOSB. 

8. Vaccines 

On November 5, 2009, the NOSB made a recommendation to clarify that vaccines produced 

through excluded methods (i.e., genetically engineered) are allowed under § 205 .603 and do not 

need to be individually petitioned for allowance on the National List. Further, the NOSB 

recommends that vaccines produced from non-excluded methods be located and used before 

those produced by excluded methods. 

The NOSB recommendation to the rule with regards to vaccines reads as follows: 

§ 205.1 05 Allowed and prohibited substances, methods, and ingredients in organic 

production and handling. 
MEMORANDUM FOR THE CHAIRMAN OF THE NOSB 

Page 4 

To be sold or labeled as" 1 00 percent organic," "organic," or "made with organic 

(specified ingredients or food group(s))," the product must be produced and handled 

without the use of: 

(e) Excluded methods, except for vaccines: Provided, That, the vaccines are approved in 

accordance with §205.600(a) vaccines made from non-excluded methods are used if 

commercially available; 

Vaccines are listed as allowed under § 205.603­

(a) As disinfectants, sanitizer, and medical treatments as applicable. 

(4) Biologics-Vaccines 

The NOP is seeking legal review from USDA's Office of General Council to determine whether 

vaccines produced through excluded methods (i.e. , genetically engineered) are currently allowed 

under § 205.603(a)(4). The NOP will also conduct a technical review to report on the status of 

genetically modified vaccines and the economic impact of using commercial availability criteria 

for vaccines. 

9. Molluscan Shellfish (bivalves) 

In November 2009, the NOSB completed a recommendation on Molluscan Shellfish (bivalves). 

This is the third and final recommendation in the series for aquaculture standards. The NOP 

accepts the recommendation and will begin rulemaking for aquaculture standards as resources 

allow. 

10. Animal Welfare 

On November 5, 2009, the NOSB approved a rulemaking action recommendation to create more 

explicit rules for the care and handling of livestock that would heighten animal welfare practices 

of organic livestock production. The NOSB recommended revised regulatory language for 

sections § 205.238 (Livestock health care practice standard) and § 205 .239 (Livestock living 

conditions). 

The NOP appreciates NOSB's focus on animal welfare and agrees that rulemaking action on this 

matter is warranted to foster the natural behavior of organic livestock. 

While the NOSB presented the animal welfare recommendation as a tinal recommendation, the 

NOP finds that several significant topics have yet to be fully addressed. The recommendation 

did not include stocking density and spacing requirements, which are to be discussed at the April 

2010 NOSB Meetings. Also since then the NOSB has proposed clarifications and revisions to 

the recommendation. The final recommendation does not include animal welfare requirements 

for livestock transport to the slaughter facility or upon arrival at the slaughter facility. 

Additionally, the Access to Pasture Final Rule was published on February 17,2010, and the NOP 

anticipates that it will impact parts of the animal welfare recommendation. 
MEMORANDUM FOR THE CHAIRMAN OF THE NOSB 

Page 5 

Questions for the NOSB: 

Further NOSB guidance is needed before NOP can proceed with rulemaking on animal welfare. 

NOP asks that the NOSB consider the following questions while discussing the details of the 

animal welfare recommendation. Clarifications would facilitate and strengthen the rulemaking 

process: 

• 	 What impact will the recently published Access to Pasture rule have on the proposed 

animal welfare recommendations, specifically on stocking density? How will the 

adoption of intensive rotational grazing systems impact the NOSB recommendations on 

stocking density requirements? 

• 	 What are the economic and record keeping burdens on organic livestock producers to 

comply with the animal welfare requirements? 

• 	 Would the NOSB consider amending the rule to include broad principles of animal 

welfare and require each livestock operation to have routine animal welfare audits 

conducted by organizations recognized and deemed appropriate by the NOP and NOSB? 

• 	 What impact will the recommendations have on other livestock (e.g., bison, ratites, and 

other domesticated game)? Will there be stocking density and spacing requirements for 

all types of livestock (e.g., bison, ratites, and other domesticated game)? 

• 	 How will the animal welfare requirements be monitored and enforced? 

• 	 What resources were used during the decision making process for the recommendation? 

How were the recommendations derived? 

11. Classification of Materials 

The NOSB has done some excellent work on the issue of classifying materials. Developing a 

classification system that makes decision-making determinable and predictable is a challenging 

task. There is a wide range of materials from natural 'to synthetic and from raw agricultural 

ingredients to highly processed agricultural products. 

Definitions and classifications are important components of the National Organic Standards due 

to the way the Organic Foods Production Act (0FP A) is constructed. Nonsynthetic materials are 

allowed and synthetic materials are prohibited. The regulations do not provide a comprehensive 

list of allowed and prohibited materials. For many substances the classification as synthetic or 

nonsynthetic is clear; however, other materials are not straightforward resulting in 

inconsistencies. Some materials could be considered synthetic due to minor chemical changes 

which occur during manufacturing, others may be considered synthetic due to addition of small 

amounts of synthetic ingredients. Under OFPA, they are all treated the same: if the material is 

synthetic then the substance is prohibited unless it is added to the National List. 
MEMORANDUM FOR THE CHAIRMAN OF THE NOSB 

Page 6 

Because of the importance that OFPA places on the detennination of synthetic vs. nonsynthetic, 

the NOP supports the NOSB taking two votes on each material- the first vote to decide whether 

the substance is synthetic or natural, the second to decide whether to allow the substance. It is 

also especially important for the NOSB to clarify the use of the substance. Annotations may be 

necessary to clarify the specific substance that is allowed as well as what use is specifically 

allowed. 

The NOP does not intend to pursue rule changes based on the NOSB November 2009 

recommendations at this time. The recommendation needs further attention before it is ready for 

proposed rulemaking. 

The definitions in the NOSB's recommendation need to be further refined to be applicable to all 

of the various uses of materials in organic agriculture including crop production, post harvest 

handling, livestock feed and healthcare, and food processing. 

12. Policy Manual Changes 

The NOP recognizes the amendments to the NOSB Policy Manual. The changes to the manual 

will be incorporated into the official NOSB Policy Manual. 

13. Retail Certification 

The NOSB has done some excellent work on retail certification. The NOP is not plalIDing on 

doing any rulemaking or guidance development at this time on the NOSB retail certification 

recommendation. The NOP encourages the NOSB to continue to develop recommendations on 

retail certification.