CONSULTANTS REPORT:
P Marc Schwartz
E/Mail: marc@Org Devas.com
Dated: 1999
Org Devas (ODC) has been commissioned by THE ANON.COMPANY Foods of
Canada to evaluate the compliance of several of their products to the Criteria
in the proposed USDA National Organic Program rule. More specifically ODC was
engaged to study THE ANON.COMPANY’s product compliance with the “National List”
of acceptable inputs.
I will begin by quoting statements from ‘prelude’ to the National Program for
your further study:
Section I
1) FDA and FSIS restrictions on use or combinations of food additives or
ingredients take precedence over the approved and prohibited uses specified in
this proposal. Any combinations of substances in food processing not already
addressed in FDA and FSIS regulations must be approved by FDA and FSIS prior to
use. Use-of-substance requirements are proposed by FDA and FSIS in rulemaking
actions and are frequently updated with revised use requirements.
2) Existing national and international organic certification standards clearly
and consistently prohibit GEO's. Accordingly, this proposal prohibits GEO's and
their derivatives and the products of GEO's and their derivatives in any product
or ingredient that is sold, labeled, or represented as organic. As a result of
the prohibition, the National List does not contain any materials derived from
GEO's..
3) Incidental Additives. The first proposal stated that a nonagricultural
synthetic substance occurring as an incidental additive, including a processing
aid, could be used in organic production and handling without having to be added
to the National List. This position was based on FDA and FSIS regulations which
require that active ingredients, but not incidental additives, appear on a
product label. Because incidental additives were not active ingredients in
organically processed food under these regulations, the first proposal
maintained that they were not prohibited by the OFPA and would not need to be
added to the National List. But….
4) Section 6510(a)(4) of the OFPA requires that any nonorganically produced
ingredient added to an organic product must be included on the National List. We
are proposing that to be used in or on a processed product labeled as "organic"
or "made with organic (specified ingredients)," a nonagricultural substance,
whether synthetic or nonsynthetic, must be included on the National List. This
position supports the NOSB recommendation that synthetic substances be allowed
in organic processed foods but incorporates the National List requirement
reflected in public comment. We have divided the materials on this list (section
205.605) in the current proposal to reflect the recommended distinction made by
the NOSB between synthetic and nonsynthetic substances. This distinction does
not affect how the substances may be used. We recognize that many commenters,
basing their argument on the OFPA, objected to allowing any synthetic substances
in processed organic products. However, we believe that the OFPA does allow
synthetic substances, when added to the National List, to be used in this
manner. The criteria utilized by the NOSB for evaluating processing aids and
adjuvants are very restrictive and, if applied to all incidental additives,
should minimize the number of substances added to the National List.
5) Removal of Substances from the National List. The first proposal outlined a
petition process for amending the National List and included an extensive list
of information to be provided for reviewing a substance. Some commenters
recommended that this section be amended to include procedures for deleting
substances from the National List. The OFPA and the first proposal indicated
that the NOSB would review substances added to the National List at least on a
5-year basis and recommend to the Secretary any substances that should be
removed. We concur with commenters that removal of a substance should not have
to wait for such a review cycle. Thus, a petition to remove a substance from the
National List may be filed at any time. The information contained in the
petition for removal of a substance will be provided by AMS upon request. The
NOSB will evaluate substance removal petitions and forward a recommendation to
the Secretary. Commenters suggested that any changes to the National List be
published in the Federal Register for public comment. All proposed changes to
the National List will be published in the Federal Register.
6) New Additions to the National List. During the October 1999 meeting, the NOSB
reviewed substances and made new recommendations to the Proposed National List.
The Secretary concurs with the recommendations from that meeting and this
proposal adds those substances with the applicable annotations to the National
List. These substances are: Potassium Bicarbonate (205.601(d)), Glycerin
(2005.603(a)), Phosphoric Acid (205.603(a) and 205.605(b) --
7) Petition Process to Amend the National List. We are modifying the contents of
the petition for amending the National List that was contained in the first
proposal. We are proposing that any person requesting a change in the National
List should request a copy of the petition procedures from the NOP Program
Manager. The procedures will include a list of information that has to be
provided for consideration of a change in the National List. Under the
provisions in the first proposal, the NOP would be required to go through
rulemaking every time it sought to update contents of the petition. Under this
proposal, the NOP will amend the requirements of the petition process and
publish the changes in the Federal Register. This revised process will help to
expedite amending the National List and keep the National List more current. We
anticipate that amendments to the National List will be made on an annual basis,
depending upon the number of substance petitions filed. Substances petitioned
for inclusion onto the National List will be reviewed by the NOSB, which will
forward a recommendation to the Secretary. All amendments to the National List
will be published for comment in the Federal Register.
Section II
II. The current National List:
§ 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or
on processed products labeled as "organic" or "made with organic (specified
ingredients)."
The following nonagricultural substances may be used only in accordance with any
restrictions specified in this section and § 205.102, § 205.270, and § 205.300
through § 205.310.
(a) Nonsynthetics allowed:
(1) Agar-agar
(2) Acids
(i) Alginic
(ii) Citric - produced by microbial fermentation of carbohydrate substances
(iii) Lactic
(3) Baking Powder - aluminum-free
(4) Bentonite
(5) Calcium Carbonate
(6) Calcium Chloride
(7) Carrageenan
(8) Cornstarch (Native)
(9) Dairy Cultures - non-EM
(10) Diatomaceous Earth - food filtering aid only
(11) Enzymes - must be derived from edible, nontoxic plants, nonpathogenic
fungi, or nonpathogenic bacteria
(12) Gums - Water extracted only (arabic, guar, locust bean, carob bean)
(13) Kaolin
(14) Kelp - for use only as a thickener and dietary supplement
(15) Lecithin - unbleached
(16) Nitrogen - Oil-free grades
(17) Oxygen - Oil-free grades
(18) Pectin (high-methoxy)
(19) Perlite - for use only as a filter aid in food processing
(20) Potassium Chloride
(21) Potassium Iodide
(22) Sodium Bicarbonate
(23) Sodium Carbonate
(24) Yeast - Nonsynthetic, non-EM
(i) Autolysate
(ii) Bakers
(iii) Brewers
(iv) Nutritional
(v) Smoked - growth on petrochemical substrate and sulfite waste liquor
prohibited. Nonsynthetic smoke flavoring process must be documented
(b) Synthetics allowed:
(1) Alginates
(2) Ammonium Bicarbonate - for use only as a leavening agent
(3) Ammonium Carbonate - for use only as a leavening agent
(4) Ascorbic Acid
(5) Calcium Citrate
(6) Calcium Hydroxide
(7) Calcium Phosphates (monobasic and dibasic)
(8) Carbon Dioxide
(9) Chlorine Materials - disinfecting and sanitizing food contact surfaces,
Except, That, residual chlorine levels in the water shall not exceed the maximum
residual disinfectant limit under the Safe Drinking Water Act.
(i) Calcium Hypochlorite
(ii) Chlorine Dioxide
(iii) Sodium Hypochlorite
(10) Ethylene - allowed for post harvest ripening of tropical fruit
(11) Ferrous Sulfate - for iron enrichment or fortification of foods when
required by regulation or recommended (independent organization)
(12) Glycerides (mono and di) - for use only in drum drying of food
(13) Glycerin - produced by hydrolysis of fats and oils
(14) Hydrogen peroxide
(15) Lecithin - bleached
(16) Magnesium Carbonate - for use only in agricultural products labeled "made
with organic (specified ingredients)," prohibited in agricultural products
labeled "organic"
(17) Magnesium Chloride - derived from sea water
(18) Magnesium Stearate - for use only in agricultural products labeled "made
with organic (specified ingredients)," prohibited in agricultural products
labeled "organic"
(19) Magnesium Sulfate
(20) Nutrient vitamins and minerals, in accordance with 21 CFR 104.20,
Nutritional Quality Guidelines For Foods
(21) Ozone
(22) Pectin (low-methoxy)
(23) Phosphoric Acid - cleaning of food-contact surfaces and equipment only
(24) Potassium Acid Tartrate
(25) Potassium Tartrate made from Tartaric acid
(26) Potassium Carbonate
(27) Potassium Citrate
(28) Potassium Hydroxide - prohibited for use in lye peeling of fruits and
vegetables
(29) Potassium Iodide - for use only in agricultural products labeled "made with
organic (specified ingredients)," prohibited in agricultural products labeled
"organic"
(30) Potassium Phosphate - for use only in agricultural products labeled "made
with organic (specific ingredients)," prohibited in agricultural products
labeled "organic"
(31) Silicon Dioxide
(32) Sodium Citrate
(33) Sodium Hydroxide - prohibited for use in lye peeling of fruits and
vegetables
(34) Sodium Phosphates - for use only in dairy foods
(35) Tocopherols - derived from vegetable oil when rosemary extracts are not a
suitable alternative
(36) Xanthum gum
Section III
Relevant issues from the National Organic Program
(c)-(z) [Reserved]
§ 205.606 Nonorganically produced agricultural products allowed as ingredients
in or on processed products labeled as organic or made with organic ingredients.
Any nonorganically produced agricultural product may be used in accordance with
any restrictions specified in this section and § 205.102, § 205.270, and §
205.300 through § 205.310. – {Whey Powder, Fructose} ?
III. (a) The producer or handler of a production or handling operation,
except as exempt or excluded under § 205.101, wishing to sell, label, or
represent agricultural products as "100 percent organic," "organic," or "made
with organic (specified ingredients)" must develop an organic production or
handling system plan that is agreed to by the producer or handler and an
accredited certifying agent. An organic system plan must meet the requirements
set forth in this section to establish a system of organic production or
handling. An organic production or handling system plan must include:
(1) A description of practices and procedures to be performed and maintained,
including the frequency with which they will be performed;
(2) A list of each substance to be used as a production or handling input,
indicating its composition, source, and location(s) where it will be used;
(3) A description of the monitoring practices and procedures to be performed and
maintained, including the frequency with which they will be performed, to verify
that the plan is effectively implemented;
(4) A description of the recordkeeping system implemented to comply with the
requirements established in § 205.103;
(5) A description of practices and procedures to prevent commingling of organic
and nonorganic products and to prevent contact of organic production and
handling operations and products with prohibited substances; and
(6) Additional information deemed necessary by the certifying agent to evaluate
compliance with the regulations.
(b) A producer may substitute a plan prepared to meet the requirements of
another Federal, State, or local government regulatory program for the organic
system plan: Provided, That, the submitted plan meets all the requirements of
this subpart.
IV. § 205.270 Organic handling requirements.
(a) Mechanical or biological methods, including, but not limited to, cooking,
baking, heating, drying, mixing, grinding, churning, separating, extracting,
slaughtering, cutting, fermenting, eviscerating, preserving, dehydrating,
freezing, chilling, or otherwise manufacturing, and the packaging, canning,
jarring, or otherwise enclosing food in a container may be used to process an
agricultural product intended to be sold, labeled, or represented as "100
percent organic," "organic," or "made with organic (specified ingredients)" for
the purpose of retarding spoilage or otherwise preparing the agricultural
product for market.
(b) Nonagricultural substances allowed under § 205.605 and nonorganically
produced agricultural products allowed under § 205.606 may be used in or on a
processed agricultural product intended to be sold, labeled, or represented as
"organic" or "made with organic (specified ingredients)."
(c) The handler of an organic handling operation must not use in or on an
agricultural product intended to be sold, labeled, or represented as "100
percent organic," "organic," or "made with organic (specified ingredients)":
(1) Ionizing radiation for any purpose;
(2) An ingredient produced with excluded methods; or
(3) A volatile synthetic solvent or any other synthetic processing aid not
allowed under § 205.605 as ingredients in or on processed products labeled as
organic or made with organic ingredients.
V. We have amended the term, "audit trail," by replacing the category,
"organic" or "made with certain organic ingredients," with "100 percent
organic," "organic," or "made with organic (specified ingredients)," or
agricultural product containing less than 50 percent organic ingredients
identified as organic in an ingredients statement. We have taken this action to
clarify the definition as requested by several commenters.. We have amended the
term, "audit trail," by replacing the category, "organic" or "made with certain
organic ingredients," with "100 percent organic," "organic," or "made with
organic (specified ingredients)," or agricultural product containing less than
50 percent organic ingredients identified as organic in an ingredients
statement. We have taken this action to clarify the definition as requested by
several commenters.
Please see Item #2 from the prelude about GEO’s (GMO’s). Please see Item #3 and
#4 from the prelude about incidentals and processing aids.
Section IV
- Areas of continuing potential concern:
1) Fructose
2) Whey Powder & Milk Powder (RBGH)
3) GEO’ s [in OG & NOG ingredients]
4) Processing aids
5) See the Highlighted statements
Section V GMO LIST:
Company Product Supplied Date Contacted Response Response Date
Some Cheese Whey Powder 8/14/2000 Non_GMO letter 8/22
Pasome Canada Skim Milk Powder 8/14/2000 Not Available ?
P Milling Oat Bran 8/14/2000 Non-GMO Letter 8/17
The Somedian Salt Co Salt 8/14/2000 Not Applicable - Exempt N/A
Organic International Sugar, Palm Short & Sunflower 8/14/2000 Non-GMO Statement
8/24
Some Wheat Pool/H All Purpose Flour & Bran 8/14/2000 See Ex #1 9/26
Some Sugar Sugar 8/14/2000 Non-GMO Letter 8/21
InfraSome 7 Grain Mix & Barley 8/14/2000 OG/Non-GMO Statements 8/17
Some Oil Co Palm, Soybean, Canola & Sterin 8/14/2000 Non-GMO Affidavit 8/16
Some Mills Flour, Grain & Brans 8/14/2000 Personal Statement 8/17
Some Specialties Nutmeg 8/14/2000 Non-GMO Letter 8/30
Someco Xanthum Gum, Fructose 8/14/2000 Non_GMO statement 8/23
Someone & Sons Cinnamon 8/14/2000 Non-GMO Letter 9/27
THE ANON.COMPANY Baking Powder (Aluminum Free) 8/14/2000 Not Applicable - Exempt
* N/A
JM Someone Silicon Dioxide 8/14/2000 Not Applicable - Exempt * N/A
Under Current USDA/NOP List
Date Contacted Response Response Date
GMO List:
I would accept the GMO statements as given in good faith. They are enclosed
as received. The concern for Milk product from Parmalt stands. I am less
confident that it is possible to isolate the RBGH or “bovine growth factor” in
non-organic milk. The Fructose may prove to be a problem in the future. Many of
the discussions centering around some forms of fructose suggest that there may
be an attempt to prohibit some forms it in the future.
I have received no information about any processing aids from THE ANON.COMPANY
to date. I can only assume that there are none used in the production of the
products that I have reviewed (see below).
Section VI (The percentages have been removed to protect confidentiality)
Bran Muffin Made with Organic Ingredients:
Organic Cake Flour
Organic Edible Bran
Sugar
Organic All Purpose Flour
Golden Yellow Sugar
Barley Meal
Fructose
Baking Powder
Whey Powder
Skim Milk Powder
Salt
Cinnamon
Organic Palmoil Shortening
Xanthan Gum
Note sum of * results in 50+% mix and sum of * and ** results in 70+% mix
Oat Bran Muffin Made with Organic Ingredients:
Organic Cake Flour
Organic All Purpose Flour
Golden Yellow Sugar or Oat bran
Sugar
Oat Bran or Golden Yellow Sugar
Organic Sunflower Oil
Organic Palmoil Shortening
Fructose
Skim Milk Powder
Baking Powder
Salt
Silicon Dioxide
Cinnamon
Nutmeg
Note sum of * results in 50+% mix and sum of * and ** results in 70+% mix
Organic White Bread Mix :
Organic All Purpose Flour
Organic Palmoil Shortening
Sugar
Salt
Skim Milk Powder
Note * results in 95+% of mix when the exemption of salt is taken into
account
Organic Multigrain Bread :
Organic All Purpose Flour
Organic Ancient 7 Grain Blend
(rye, oats, kamut, soya, spelt, golden flax, quinoa)
Organic Palmoil Shortening
Sugar
Salt
Skim Milk Powder
Note sum of * results in 95% of mix when the exemption of salt is taken
into account
Section VII
Summary Statement
Based on the information received and the current inputs list of the Organic
Growers and Buyers Association, the Organic Materials Review Institute and the
National Organic Program Input list, the formulae as submitted should be
acceptable for sale in the United States. These products would not be acceptable
if labeled as 100% Organic, or with the prefix organic as part of the main
product label. Under current revision they may* be labeled with the prefix
“organic” in the ingredient listing where applicable and may* contain the
statement “Contains Organic Ingredients”. This is the qualified opinion of
Org Devas LLC.
Section 6510(a)(4) of the OFPA requires that any nonorganically produced
ingredient added to an organic product must be included on the National List. We
are proposing that to be used in or on a processed product labeled as "organic"
or "made with organic (specified ingredients)," a nonagricultural substance,
whether synthetic or nonsynthetic, must be included on the National List. This
quote from above: “the prelude” to the NOP rules does give one a concern, but I
do not see any implications to THE Some. Company's current products as described.
In closing, it appears that (with the exception of the milk product from
Someone) under the current rules THE Some. Company's submitted products will
pass, if labeled properly.
* The National Organic Program is under rewrite with the USDA. Some of the
regulations may change. The National List may be amended at any time and may
effect the acceptance of any of the non-organic ingredients contained in these
formulae. The safest approach would be to replace the non-organic components
with organic analogs.
All received support documents are enclosed in the attached folder
