Non-Organic Agricultural Materials Added to the National List

38 Non-Organic Agricultural Materials have been added to the National List, 205.606, on an Interim Basis Only – Handlers and Processors Encouraged to Submit Comments.

Effective June 21, 2007, the U.S. Department of Agriculture published an interim final rule that amended the USDA's National List of Allowed and Prohibited Substances (National List) to include 38 minor ingredients recommended by the National Organic Standards Board (NOSB).

These minor ingredients may be used in products making an “Organic” claim. Only once the certified handler has attempted to obtain the minor ingredient in organic form and documented that it is currently not organically available in the appropriate form, quality and quantity. The sum total of non-organic ingredients in products making an “organic” claim must not exceed 5%. In addition, all processing aids that are/contain non-organic agricultural materials (e.g., pan release agents, equipment lubricants, defoamers) used to produce a product making an “organic” claim must either be certified organic or listed on 205.606 of the NOP’s National List and proven to be commercially unavailable in organic form.

This amendment to the National List is not final, however. On May 15, 2007, AMS published proposed rule AMS-TM-07-0062 to add 38 minor ingredients to § 205.606 of the National List with a 7-day comment period. AMS received approximately 1,250 comments on the proposed rule, including comments expressing concern about the abbreviated comment period. In light of these concerns, the AMS is accepting additional comments on the amendment for another 60 days from the effective date (June 21, 2007). While the AMS continues to accept and review further comments, certified handlers may produce organic products that comply with this interim final rule.

The AMS states in the latest Federal Register notice, AMS-TM-07-0062; TM-07-06IF, that “though a significant number of comments were received, very few comments submitted were from processors or handlers. Comments from this segment of the industry would be helpful in developing a final rule.” For the complete Federal Register Notice and further background on this issue, visit http://www.ams.usda.gov/nop/Newsroom/FedRegNoticeTM-07-06InterimFinalRule062207.pdf.

The interim final rule may be immediately accessed at the National Organic Program website www.ams.usda.gov/nop.

Interested persons may comment on the interim final rule:

• By mail to Robert Pooler, Agricultural Marketing Specialist, National Organic Program, USDA/AMS/TMP/NOP, 1400 Independence Ave., SW, Room 4008-So., Ag Stop 0268, Washington, DC 20250.
• By Internet:www.regulations.gov

Written comments on the interim final rule should be identified with the docket number AMS-TM-07-0062. Comments should identify the relevant topic and section number of the interim final rule.

All comments will be made available for viewing on the National Organic Program homepage at www.ams.usda.gov/nop or in person at USDA-AMS, Transportation and Marketing Programs, Room 4008-South Building, 1400 Independence Ave., SW, Washington, DC, from 9 a.m. to 12 noon and from 1 p.m. to 4 p.m., Monday through Friday (except Federal holidays). Persons wishing to visit the USDA South Building to view comments received in response to this proposed rule should make an appointment in advance by calling (202) 720-3252.

For further information, contact Robert Pooler, Agricultural Marketing Specialist; Telephone: 202-720-3252; or fax: (202) 205-7808.

Colors to be Removed from the National List

As most of you know, colors will be removed from the National List, section 205.605 (list of allowed non-organic, non-agricultural materials) on October 22, 2007. Currently, several colors are also listed on the interim National List, section 205.606 (list of allowed non-organic, agricultural materials when the equivalent material cannot be sourced organically). What does this mean for organic food manufacturers wishing to use colors right now?

From now until October 2007, food manufacturers can still use colors in products making an “organic” and “made with organic (specified ingredients and food groups)” without regard to the National List, 205.606 (non-organic, agricultural ingredients). Colors used now, however, must comply with the NOP’s restriction as stated on 205.605 of the National List, which states colors must be non-synthetic.

If you are adding new products that contain non-organic colors to your organic certification between inspections or have just been inspected, you will be asked to provide QAI with a plan to bring your product(s) into compliance with the NOP by October 22, 2007. Your choices for bringing products into compliance are as follows:

• “Organic” claim: Reformulating products to replace conventional, nonsynthetic colors with certified organic agricultural colors, or confirming that the colors in use have been added to the National List, 205.606, and are commercially unavailable in organic form.
• “Made with Organic (specified ingredients or food groups)” claim: Reformulating products to replace conventional, nonsynthetic colors with agricultural colors (conventional or organic). Please note if you are claiming that the colors in use are “agricultural,” you will need to provide detailed information on how the colors are produced/processed.

You will be expected to comply with your approved plan and submit any additional Individual Product Profile forms and draft labels if changes are made to your color ingredients.

After October 22, 2007, colors will be removed from the National List, 205.602 and your products must be in compliance with the NOP regulation, which states:

• products making an “organic” claim must be produced with colors that are either certified organic or are colors that are approved for use under section 205.606 of the National List and are documented to be commercially unavailable in organic form; and
• products making a “made with organic” claim must be produced with colors that are considered “agricultural” under the NOP.

Please note that as of October 22, 2007, QAI will evaluate all specific ingredients, including carriers and preservatives, in colors used to determine NOP compliance.

Below is a list of colors that have been added to the Interim Final Rule, section 205.606. As discussed in an earlier article, this list may change following additional comments made by members of the industry and further assessment made by the NOP.

Colors derived from agricultural products:

(1) Annatto extract color (pigment CAS # 1393–63–1)—water and oil soluble

(2) Beet juice extract color (pigment CAS # 7659–95–2)

(3) Beta-carotene extract color, derived from carrots (CAS # 1393–63–1)

(4) Black currant juice color (pigment CAS #'s: 528–58–5, 528–53–0, 643–84–5, 134–01–0, 1429–30–7, and 134–04–3)

(5) Black/purple carrot juice color (pigment CAS #'s: 528–58–5, 528–53–0, 643–84–5, 134–01–0, 1429–30–7, and 134–04–3)

(6) Blueberry juice color (pigment CAS #'s: 528–58–5, 528–53–0, 643–84–5, 134–01–0, 1429–30–7, and 134–04–3)

(7) Carrot juice color (pigment CAS # 1393–63–1).

(8) Cherry juice color (pigment CAS #'s: 528–58–5, 528–53–0, 643–84–5, 134–01–0, 1429–30–7, and 134–04–3)

(9) Chokeberry—Aronia juice color (pigment CAS #'s: 528–58–5, 528–53–0, 643–84–5, 134–01–0, 1429–30–7, and 134–04–3)

(10) Elderberry juice color (pigment CAS #'s: 528–58–5, 528–53–0, 643–84–5, 134–01–0, 1429–30–7, and 134–04–3)

(11) Grape juice color (pigment CAS #'s: 528–58–5, 528–53–0, 643–84–5, 134–01–0, 1429–30–7, and 134–04–3)

(12) Grape skin extract color (pigment CAS #'s: 528–58–5, 528–53–0, 643–84–5, 134–01–0, 1429–30–7, and 134–04–3)

(13) Paprika color (CAS # 68917–78–2)—dried, and oil extracted.

(14) Pumpkin juice color (pigment CAS # 127–40–2)

(15) Purple potato juice (pigment CAS #'s: 528–58–5, 528–53–0, 643–84–5, 134–01–0, 1429–30–7, and 134–04–3)

(16) Red cabbage extract color (pigment CAS #'s: 528–58–5, 528–53–0, 643–84–5, 134–01–0, 1429–30–7, and 134–04–3)

(17) Red radish extract color (pigment CAS #'s: 528–58–5, 528–53–0, 643–84–5, 134–01–0, 1429–30–7, and 134–04–3)

(18) Saffron extract color (pigment CAS # 1393–63–1).

(19) Turmeric extract color (CAS # 458–37–7)

Canadian Organic Regime QMS Manual 2nd Draft Published

On June 22, 2007, the Canadian Federal Inspection Agency (CFIA) published the 2nd draft of its Quality System Manual (QMS Manual).

This document was made available to concerned parties for review, and the CFIA welcomed comments to be submitted by Monday, July 16. Once received from translation, the English and French versions of this document will be posted on the CFIA’s external website: www.inspection.gc.ca.

The QMS Manual is one of four main documents by which the Canadian Organic Regime will be guided. The other documents include: the Agricultural Products Act, The Organic Products Regulation, Organic Production Systems General Principals and Management Standards, and the Organic Production Systems Permitted Substances List.

QAI strives to keep all clients interested in marketing to or within Canada apprised of the latest developments with the Organic Regime.

If you have any questions regarding the Canadian Organic Regime, please contact your Account Coordinator or Kasey Moctezuma (kasey@qai-inc.com), International Account Coordinator-Canada Specialist.

Updates Made to JAS Law

The Japanese Agricultural Standards for Organic Agricultural Products and Organic Processed Foods (JAS) were partially revised in October 2006.

The JAS Law was originally established in 1950 to address food quality. In 2000, organic production standards were introduced to the JAS system. The organic JAS standards are reviewed and revised every five years, with the latest revisions occurring in 2006. They were also revised in 2005.

In the 2006 revision, mushrooms were added as a certifiable product under the organic Japanese Agricultural Standards. The 2006 revision also updated the list of allowed inputs for producers and allowed food additives for processors.

To obtain an electronic copy of the revised Japanese Agricultural Standards, please refer to the Japanese Ministry of Agriculture, Forestry and Fisheries website, and click on “organic” under “Specific JAS” on the left side of the page:

http://www.maff.go.jp/soshiki/syokuhin/hinshitu/e_label/index.htm    

Livestock Inputs 101

Not all aspects of the National Organic Program Final Rule are black and white. To help clarify the regulations and recent NOP clarifications, we have put together a synopsis of the requirements for livestock feed additives, medical treatments that are administered internally and veterinary biologics.

Type of Input: Feed additives, which include:

• Vitamins and minerals, used for enrichment or fortification when FDA (AAFCO) approved.
• DL-Methionine, DL-Methionine-hydroxyl analog, and DL-Methionine-hydroxyl analog calcium (CAS #—59–51–8; 63–68–3; 348–67–4)—for use in organic poultry production until October 1, 2008.

Use: These materials are fed on a routine basis as part of the feed ration.

Specific conditions:

1. All organic agricultural ingredients, including carriers, must be certified organic. For mineral/vitamin mixes, the final product does not have to be certified as long as the individual agricultural ingredients are certified organic and are accompanied by an organic certificate. 
2. Non-agricultural components must be on the National List, 205.603 (e.g., included under 205.603(d) or they must be non-synthetic (e.g., microorganisms).
3. The product as a whole must comply with the Big 3 (i.e., must be produced and processed without the use of excluded methods (genetically modified organisms, irradiation, and, where applicable, sewage sludge).

Type of Input: Medical Treatments – Includes aspirin, vaccines, chlorhexidine (allowed for surgical procedures conducted by a veterinarian. Allowed for use as a teat dip when alternative germicidal agents and/or physical barriers have lost their effectiveness), electrolytes (without antibiotics), glucose, glycerine (allowed as a livestock teat dip, must be produced through the hydrolysis of fats or oils), hydrogen peroxide, iodine, oxytocin (use in postparturition therapeutic applications), magnesium sulfate, ivermectin (prohibited in slaughter stock, allowed in emergency treatment for dairy and breeder stock when organic system plan-approved preventive management does not prevent infestation. Milk or milk products from a treated animal cannot be labeled as provided for (in subpart D of this part) for 90 days following treatment. In breeder stock, treatment cannot occur during the last third of gestation if the progeny will be sold as organic and must not be used during the lactation period of breeding stock).

Use: These are materials administered to treat an acute condition. They are not fed as a part of the feed ration on a routine basis.

Specific conditions:

1. Treatments must be used on a short-term basis for acute and specific purposes.
2. Active synthetic ingredients must be on the National List or else they must be non-synthetic.  In medical treatments agricultural carriers/excipients do not need to be certified organic.
3. Certain non-active ingredients or excipients used in manufacturing or found in the finished product of drugs used in livestock treatments are allowed, unless specifically prohibited. That is, excipients, are allowed when the excipient is identified by the FDA as Generally Recognized as Safe; approved by the FDA as a food additive, or included in the FDA review and approval of New Animal Drug Applications or New Drug Application. Examples of excipients include (but are not limited to) colors, preservatives, stabilizers, thickeners, flavors, binders, coatings, disintegrants, fillers, diluents, lubricants, sweeteners.
4. The product as a whole must comply with the Big 3 (i.e., must be produced and processed without the use of excluded methods (genetically modified organisms, Irradiation, and, where applicable, sewage sludge).

Type of Input: Biologics - Veterinary biologics may be administered to livestock to prevent disease. Vaccines are synthetic biologics and may be used according to 205.603(a). Non-synthetic biologics include viruses, serums, toxins, and analogous products of natural origin, such as diagnostics, antitoxins, live microorganisms, killed microorganisms, and the antigenic or immunizing components of microorganisms intended for use in the diagnosis, treatment, or prevention of diseases of animals. Probiotics would be considered a biologic if administered to animals to treat or prevent a specific condition.

Use: Materials that fall under the definition of biologics may be used for preventative treatment or as components of the feed ration (e.g., probiotics). Therefore, how we assess compliance of the biologic depends on the purpose of use.

Specific conditions:

1. The active ingredients must either be a vaccine or a non-synthetic biologic.
2. If administered to livestock on a short-term basis to treat or prevent a specific medical condition, the non-active ingredients are allowed unless specifically prohibited. In this case, the agricultural carriers/excipients do not need to be certified organic.
3. If fed to livestock on a routine basis as a component of a feed additive or feed ration, the non-active ingredients must be non-synthetic non-agricultural, on the National List 205.603, or must be organic agricultural.

Attention Organic Producers: The NOP Issues Guidance on Processed Manures

Background

The NOP regulations currently do not address heat processed animal manure products and their proper use in organic production. In the past, the NOP had determined that processed manures, would fall in the category of uncomposted manure products, (for the purpose of determining any restrictions) since they have not been composted according to the NOP regulations.

At its September 2006 meeting, the National Organic Standards Board (NOSB) made a recommendation regarding the use of processed animal manures in organic farming operations. In its recommendation, the NOSB said that when animal manures are treated to a certain temperature over a given period of time and then subsequently dried to a very low moisture level, the resulting product should fulfill the pathogen reduction requirements imposed on compost in the NOP regulations. Therefore, the NOSB recommended that the NOP issue guidance to the effect that processed manure products that meet prescribed minimum time, temperature, and moisture requirements, or processed manure products that have the same level of pathogen reduction as the prescribed process, should be allowed for use without pre-harvest time restrictions.

Policy

Processed manure may be used as a supplement to a soil-building program without a specific interval between application and harvest. As always, producers are expected to comply with all applicable requirements of the NOP regulations with respect to soil quality, including ensuring the soil is enhanced and maintained through proper stewardship.

Processed manure products must be treated so that all portions of the product, without causing combustion, reach a minimum temperature of either 150° F (66° C) for at least one hour or 165° F (74° C), and are dried to a maximum moisture level of 12%; or an equivalent heating and drying process could be used. In determining the acceptability of an equivalent process, processed manure products should not contain more than 1x10³ (1,000) MPN (Most Probable Number) fecal coliform per gram of processed manure sampled and not contain more than 3 MPN Salmonella per 4 gram sample of processed manure.

For processed manure used in your fertility management program, QAI and QAI inspectors will look for justification that it meets this NOP policy. Where an equivalent heating and drying process is used to the one specified in the policy, QAI will ask for a detailed description of the process.

For the complete policy, please go to http://www.ams.usda.gov/nop/NoticesPolicies/NOP5006ProcessedManure7-16-07.pdf

Sept 27 - 29th Natural Products Expo East, Baltimore, MD

Nov 11 - 13th PLMA's 2007 Private Label Trade Show, Chicago, IL

This time we turn the spotlight on QAI Account Coordinators Andrea Castellanos and John Joseph!

Andrea Castellanos

BACK STORY:

I am a true California girl who grew up on the beach.  My parents are both Colombian, and I am a first generation American.  I was born in Orange County, California, but I moved to Ventura, California when I was in the 4th grade. 

Ventura is a beach town located right in between Los Angeles and Santa Barbara.  It is not a small town by any means, but it is small compared to Los Angeles.  After high school I got tired of small town living (at least that’s what it seemed like to me), and I decided to move to Santa Monica, California where I attended community college.  After two years in Santa Monica, I was disenchanted with living in L.A. mainly because it was a bit too fast-paced for me and because of the horrendous traffic that my life seemed to revolve around.  I had visited friends in San Diego a few times while living in Santa Monica and fell in love with it.  It seemed to be the perfect middle ground for me -- not as boring as Ventura, but more laid back and less congested than Santa Monica.   I moved to San Diego and transferred to the University of California – San Diego where I majored in economics and double minored in chemistry and biology.   I do not plan on leaving San Diego anytime soon, as I have lived in Southern California all of my life and will probably live here for the rest of my life if I can help it!

REAL TIME:

I have been an account coordinator at QAI for almost one year.  Working for the growing organic industry has proved to be a constant learning experience.  I love the fact that I learn something new everyday at work, and that I am able to utilize my Spanish as one of the bilingual account coordinators.  It is great to work for a company that possesses such a positive work environment and that encourages personal growth.  

When I am away from the “Q” I enjoy spending time with family and friends, traveling, yoga, kickboxing, scuba diving (see picture diving in Hawaii), snowboarding, going to concerts, reading, movies, and the beach of course.

FUN FACTS:

Favorite places I have visited:  Fiji, Barcelona, The French Riviera, Amsterdam

Travel Wish List: Thailand, Rome, New Zealand

What I listen to at work: 80’s and Classic Rock

Favorite Bands: Pink Floyd, The Cure, The Police

Guilty Pleasure: American Idol

Favorite TV Show: Grey’s Anatomy

Favorite Film Director: Akira Kurosawa

Favorite Ice Cream: Cherry Garcia

Pets: two kitties named Elvis and Dojah

John Jospeh

I may ask myself, "How did I get here?" but I'm back from where I started.  I was born in Van Nuys, California and moved to San Diego in the mid-70s, or what I call BCE (before condo era).  My parents live up the road from QAI, and I can still remember when the area was just a bunch of fields.

After high school in San Diego, I fled to California's central coast and attended college at California Polytechnic State University, San Luis Obispo.  I obtained a B.S. in natural resources management with a specific emphasis in forest and woodland resources.  I also began working with Charan Springs Farm, a small, organic farm in Cambria, CA.  This was before the USDA's National Organic Program, although the farm was certified at the time by another certifier.  Along with avocados, we had a diverse offering for farmers markets, including a washed and bagged salad, kiwifruit, and a variety of mixed produce.  This began my love of farmers markets that continues today.

Farming is difficult in many ways, especially economically.  While continuing to work a couple days a week at the farm, I worked at Calzyme Laboratories, Inc., an enzyme and biochemical extraction and purification business.  We supplied highly purified enzymes to the medical, diagnostic industry for test kits and clinical, blood testing equipment.  Basically you start off with about three tons of animal or vegetable parts and end up with a 2L jar of product.  While we were not required to comply with FDA rules, the customers were, and vendor compliance audits were common. 

This was the early 1990s and the allure of the Internet drew me in.  After some missteps with our first partnership, a good friend and I formed studio G, an Internet services and design studio.  I went back to school and received an masters of business administration in 1999.  Explaining the value of the Internet at that time felt like I was touting the virtues of washed lettuce in a bag all over again.  I rode the dot.com market up and saw it coming back down.

I left San Luis Obispo after 15 years and came back to San Diego as a dot.com refugee.  It was like coming back to my hometown in a strange city.  I worked in supply chain software and data management, but I knew I really wanted to get back into food and consumer products.  Through a friend’s referral, I ended up at QAI and have been an account coordinator for the past two years.  One of the newest events in my life was my marriage last New Year's Eve!

To my clients, I empathize with you.  I have been in the compliance hot seat.  I've been at the market stand when the inspector arrives clipboard in hand.  I've watched business deals implode.  I have produced, processed, repackaged, distributed, and traded products for the past 20 years.  I feel your pain, so that’s why I’m here now to assist you through the process the best that I can!

Fun Facts
Favorite Publications: Acres USA, Wall Street Journal, Motley Fool
Favorite Radio Programs: Prairie Home Companion, On The Media, This American Life
Favorite Addictions: Farmers Markets and the VitaMix
Favorite Guilty Pleasures: Quality time in the kitchen processing and preparing food, attending theatre especially Shakespeare, free market capitalism.
What you don't know about me: I've been a vegetarian and natural food nut for about 20 years.
What I listen to on the radio: National Public Radio.
What’s in my CD player now: Doesn't everybody just use iPods now?

To contact QAI:

If you have questions, concerns, or need general information, go to the QAI web site to learn how to contact us or to send us an email. For questions pertaining to QAI’s Quality News contact Joshua Rollins, Sales Coordinator.

QAI, Inc. is an NSF International Company. Visit the NSF web site to learn more about NSF International, The Public Health and Safety Company™.