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By Paula Dinerstein

There have been many misunderstandings as well as intentional
misrepresentations about what the current USDA regulations provide,
what the Harvey decision actually did, and what the OTA rider did. The
following is an attempt to get the facts straight. The final judgment
in the Harvey case is attached to demonstrate what it actually did and
did not do. Organic farmers and consumers are already discussing an
effort to repeal the rider in Congress , as well as other
responsive actions. Therefore, these issues are far from closed. Also,
as discussed below, the rider did not invalidate all aspects of the
court decision, and thus there must still be rulemaking and
implementation of some aspects of the decision even if the rider
remains law.

Harvey prevailed on three counts of his complaint. Two of these
deal with the 5% non-organic ingredients which are permitted in
organically-labeled foods by the Organic Foods Production Act (OFPA)
and the regulations.11 The third concerns organic feed requirements
for dairy animals. The court ruled:

1) Non-organic agricultural products for use in organic products must
be individually listed on the National List.22 There are currently
only five such products on the National List. However, this is a small
fraction of such products actually used. Current practice is for
individual certifiers33 to decide which agricultural ingredients are
"not commercially available" in organic form, and therefore can be
used in non-organic form in organic foods which they certify. There is
currently no National List of such products allowed by individual
certifiers, no NOSB review, no clear standards for determining
commercial availability, and no consistency among the commercial
availability decisions of different certifiers.

2) Synthetic ingredients and processing aids are prohibited in the 5%
non-organic component of organically-labeled foods. The current
regulations contain standards for approving synthetics for inclusion
on the National List for use in post-harvest handling, and there are
38 such synthetics listed.44

3) OFPA requires 100% organic feed for dairy animals for one year
prior to sale of milk products as organic. The court struck down the
USDA regulatory allowance for dairy animals to be fed 20% non-organic
feed during the first 9 months of the conversion year when a whole
herd is being converted to organic production.

The following describes in more detail the existing regulations,
how the Harvey decision did and did not impact them,
misrepresentations or misunderstandings, and how the OTA rider affects
the existing regulations and the Harvey decision.

I. Allowance of 5% non-organic ingredients in organically-labeled foods:

Existing regulations: • As described above, this allowance is
statutorily authorized and reflected in the regulations.55

Impact of Harvey decision: • Does not change the allowance of 5%
non-organic ingredients.

Misconception: • Some press reports have incorrectly stated that the
Harvey decision meant that no non-organic ingredients would be allowed
in organically-labeled food.

Impact of OTA Rider: • Does not change the allowance of 5%
non-organic ingredients.

II. Allowance of synthetic substances in the 5% non-organic component
of organically-labeled foods.

Existing regulation: • The current regulations list criteria for
evaluating whether particular synthetic substances should be listed
for use in processing organic foods,66 and list 38 synthetic
substances for use in post-harvest handling of organically-labeled
foods.77\

Impact of Harvey decision: • Invalidated the regulations described
above "to the extent that they permit the addition of synthetic
ingredients and processing aids in handling and processing of products
which contain a minimum of 95% organic content and which are eligible
to bear the USDA seal."88 The court ruling was based on the statutory
provisions at 7 U.S.C. § 6510(a)(a) and § 6517(c)(B)(iii). USDA was
directed to conduct notice and comment rulemaking and publish rules
implementing the court's decision by June, 2006. An additional period
of one year, until June 2007, was afforded before the new regulations
come into effect "so as to prevent consumer confusion, commercial
disruption and unnecessary litigation."99

Misconception:   • Much of the argument in favor of the OTA rider
incorrectly claimed that synthetics which are not in fact covered by
the Harvey judgment would now be prohibited, purportedly making
organic production unworkable. The court judgment applies only to
synthetic ingredients and processing aids, not to equipment cleansers,
packaging materials, storage, or substances required by other
regulatory schemes such as added vitamins and minerals and chlorine in
water in accordance with the Safe Drinking Water Act.1010 In fact,
many items on the current list of 38 synthetics allowed in
organically-labeled foods are either not covered by the judgment or
are available in non-synthetic (natural) form. Only a few items are in
legitimate contention. The effort to retain the ability to list
synthetics for use in "organic" foods may have as much to do with the
desire to list other synthetics in the future as it does with the
current list.

• Note: OFPA does contain provisions on packaging and storage. 7
U.S.C. § 6510(a)(5) prohibits the use in organically-labeled products
of "any packaging materials, storage containers or bins that contain
synthetic fungicides, preservatives or fumigants," and § 6510(a)(6)
prohibits the "use of any bag or container that had previously been in
contact with any substance in such manner as to compromise the organic
quality of such product." These provisions are not affected by the
Harvey decision or by the OTA rider. So far, USDA has not developed
regulatory standards for packaging and storage consistent with OFPA.

Misconception: • Phase-in period. Some have stated that the two year
phase-in period was adopted by the court for the purpose of giving
Congress time to act. The language of the final judgment -- which OTA
played a role in negotiating and agreed to in open court -- clearly
indicates that one year was provided to develop regulations to
implement the court's ruling and an additional year to allow the
industry time to achieve compliance with the court's ruling.

Impact of OTA Rider: • Amends OFPA1111 to remove prohibitions on
synthetic ingredients in post-harvest handling, provided they are
listed on the National List. Reverses the Harvey decision's holding of
no synthetic ingredients in handling.

Misconception: • Some have claimed that the rider retains stringent
review by the NOSB and comment by the public concerning all synthetics
permitted in organically-labeled foods. In fact, this was neither the
status quo pre-Harvey nor what the rider provides.

• The rider actually permits synthetic processing aids and food
contact substances (as opposed to ingredients) without being on the
National List, i.e., without restriction or review. The National
Organic Program's (NOP) pre-Harvey position was that synthetic food
contact substances listed by the FDA as allowable in conventional food
production (without being identified on the label) may also be used in
organic foods without being on the National List or the label. This is
the action referred to in anti-OTA rider publicity as sweeping over
500 synthetics into organic foods. "Food contact substances" is not a
category used in OFPA, and some of the FDA-listed substances are in
fact equipment cleansers or packaging materials that would not be
covered by the Harvey decision or other provisions of OFPA. However,
some are in fact ingredients or processing aids covered by the Harvey
decision or packaging materials forbidden by the provisions of OFPA
referred to above. The OTA rider apparently seeks not only to permit
synthetic processing aids and food contact substances, but also to
eliminate the need for their review and listing. The National List
provisions of the law apply to "substances," an all-inclusive term,
rather than being limited to ingredients. The rider removes all
reference to synthetics in handling from the National List provision
of the law, and addresses synthetics in a provision that refers only
to "ingredients." It also possible to interpret the OTA rider to
prohibit any synthetics except ingredients, since it affirmatively
allows only ingredients, but it is doubtful that this was the intent.

Impact of the OTA rider: • No criteria for inclusion of synthetics:
Because the court found that no synthetics could be allowed in
post-harvest handling of organic foods, it struck down the existing
regulatory criteria for judging whether particular synthetics should
be listed on the National List for such use.1212 The OTA rider did not
add the criteria back into the law. Whether the change in the law
resurrects the regulatory criteria that were struck down by the court
is unclear. If not, synthetics could be added to the National List
without any criteria at all, or new, weakened criteria could be adopted.

III. Individual listing of non-organic agricultural products for use
in the 5% non-organic component of organically-labeled foods

Impact of Harvey decision: • The court held that non-organic
agricultural products for use in the 5% non-organic component of
organically-labeled foods must be individually listed in accordance
with National List procedures. USDA claimed that this is what its
regulation had always required, and five such agricultural products
were listed. However, the practice has been for individual certifiers
to make determinations that a broad universe of agricultural
ingredients are "not commercially available" in organic form, and
therefore can be used in non-organic form in organic foods which they
certify. The court judgment states that the regulation must be
interpreted so that non-organic agricultural ingredients must be
individually listed on the National List and determined by the
certifier to be "not commercially available." The court allowed a two
year period, until June, 2007, for the industry to adjust to
compliance with its judgment.

Impact of OTA rider: • USDA has already publicly noticed the fact
that, after the phase-in period, i.e. by June, 2007, non-organic
agricultural ingredients cannot be used in organic products unless
they have been individually listed in accordance with National List
procedures as well as determined by the certifier to be not
commercially available in organic form. The OTA rider does not change
this. What the rider does is amend the portion of OFPA which limits
the National List to substances proposed by the NOSB, to permit the
USDA Secretary to develop emergency procedures to designate for the
National List agricultural products not commercially available in
organic form for a maximum one year period. This would be the first
time that the duty to evaluate and recommend substances for the
National List would be removed from the NOSB. Presumably these
emergency procedures would have to be developed through notice and
comment rulemaking.

Misconception: • Some press reports have indicated or implied that
the OTA rider completely reverses the Harvey decision. In the case of
non-organic agricultural ingredients, in fact the court decision
requiring individual listing of these products on the National List
has already been implemented by USDA (with the two year phase-in
period provided in the judgment). The rider authorizes a potential
change in the way non-organic agricultural ingredients could be placed
on the National List in the future.

Misconception: • Some press reports have indicated that the rider
allows synthetic ingredients to be listed in accordance with emergency
procedures. As explained above, the portion of the rider which
addresses synthetics appears to permit the use of synthetic processing
aids and food contact substances without any review. However, the
portion of the rider addressing emergency procedures applies only to
agricultural products.

• Some press reports have indicated that the expedited review
provision could result in permitting more than 5% non-organic
ingredients in organically-labeled foods, e.g., if a major ingredient
is found to be not commercially available in organic form. In fact,
the rider language applies to products "constituting less than 5
percent of an organic processed product."

IV. Organic Feed Requirements for Dairy Animals

Existing regulation: • In general, organic livestock are to be
handled organically from the last third of gestation.1313 However, an
exception is provided in the statute and the regulations for dairy
animals, which are to be organically raised and handled for not less
than 12 months before sale of dairy products as organic.1414 In order
to be "organically raised and handled," livestock must be fed 100%
organically produced and handled feed.1515 However, the regulations
provide an additional exception, which the court found not to be
authorized by the law, for when a whole herd is converted to organic
production. In that case, the animals may be fed up to 20% non-organic
feed for the first 9 months of the conversion year.1616

Impact of Harvey decision: • The "whole herd" exemption from the
otherwise applicable organic feed requirements was found to be
invalid. USDA was directed to conduct rulemaking and publish new rules
in conformance with the court's opinion by June, 2006. The final
judgment also provided that: "So as to prevent consumer confusion,
commercial disruption and unnecessary litigation, dairy farmers who,
at the time that the new rule becomes effective, [i.e. by June, 2006]
are in the process of converting their herds to organic production in
conformance with the invalidated conversion rule, may complete
conversion in conformance with the invalidated conversion rule. No
milk produced under the invalidated rules shall enter the stream of
commerce after 2 years from the date of this Judgment and Order,"
i.e., June, 2007.

Impact of OTA rider: • The rider allows organic dairy animals (not
only when a whole herd is being converted) to be fed "transitional"
organic feed during all of the 12 months of the conversion year.
Because organic dairy animals must have access to pasture, at least a
portion of their feed must be grown on the land on which they are
raised. It takes 3 years of organic management for such forage and
crops to be deemed "organic." The rider allows feeding from a dairy
farm's land in its third year of organic transition. This way, the
farm and its dairy animals can complete transition at the same time.
(Once the farm becomes organic, this provision becomes irrelevant,
since that farm will not have any transitional feed, and the rider
does not permit purchase of transitional feed from other operations).
The rider does not allow 20% conventional feed as did the prior
regulation. The use of third year "transitional feed" was not opposed
by Harvey or by groups who opposed the rider, but they did not believe
that legislation was necessary to so provide. In fact prior to the
rider, a proposal by the NOSB, as well as a rulemaking petition by
several NGO's, had similar provisions.

• The rider does not provide, as did the previous regulation, that
once a herd is converted to organic production, "all dairy animals
shall be under organic management from the last third of
gestation."1717 The NOSB proposal for implementing the Harvey decision
and the NGO rulemaking petition included regulatory provisions similar
to the old regulation. This still could be done through rulemaking,
and rulemaking to implement this part of the Harvey decision will
still be required, since the rider did not completely overrule it.
However, the rider as it stands allows dairy farmers, even after they
have converted their farms and herds, to treat animals conventionally
- i.e., with conventional feed, antibiotics, growth hormones, etc. -
until one year before their milk products are to be sold as organic.

Misconception: • Some media reports have stated or implied that the
OTA rider completely reverses the Harvey decision. As shown above,
this is not the case with regard to the court's invalidation of the
allowance of 20% non-organic feed.

By Paula Dinerstein, Arthur Harvey's lawyer

1 1 See, 7 U.S.C. § 6510(a)(4); 7 CFR § 205.301(b); § 205.303. The
Harvey decision on these counts pertains only to this "organic," i.e.,
at least 95% organic, labeling category. It has no bearing on the
other labeling categories: 100% organic, 7 CFR § 205.301(a); §
205.303, "made with organic" ingredients or food groups, 7 CFR §
205.301(c); § 205.304, and less than 70% organic. 7 CFR § 205.301(d);
§ 205.305. Foods labeled 100% organic cannot contain non-organic
ingredients or processing aids in any event, and the requirements of
the Harvey decision do not apply to the non-organic ingredients in
"made with organic" or less than 70% organic foods.

2 2 The National List of approved and prohibited substances was
created by OFPA (7 U.S.C. § 6517) to list otherwise prohibited
substances which could be used in organic production and otherwise
permitted substances (such as natural arsenic) that cannot be used.
These substances must be individually subjected to a rigorous review,
recommended by the National Organic Standards Board (NOSB), and
adopted by the Secretary of Agriculture after a public notice and
comment period.

3 3 The National Organic Program is implemented by private and state
certifying organizations accredited by USDA.

4 4 OFPA authorizes the listing of certain limited categories of
synthetics for use in organic production, i.e. the growing of food or
raising of livestock, a matter not addressed in the Harvey case. The
challenge was to the use of synthetics in post-harvest handling,
specifically the addition of synthetic ingredients and processing aids
in the course of processing organic foods. Also, the court decision
concerning non-organic agricultural products and synthetics in the 5%
non-organic component of organic foods impacts only the "organic"
labeling category, covering products containing at least 95% organic
ingredients.

5 5 7 U.S.C. § 6510(a)(4); 7 CFR § 205.301(b); § 205.303.

6 6 7 CFR §205.601(b).

7 7 7 CFR 205.605(b). Actually some of the 38 synthetics on the list
are limited to use in "made with organic" foods and are therefore not
affected by the Harvey ruling. The final judgment made the synthetics
ruling applicable only to "products which contain a minimum of 95%
organic content and which are eligible to bear the USDA seal."

8 8 Quoting from the final judgment. (Emphasis supplied).

9 9 Quoting from the final judgment.

10 10 The regulations define "ingredient" as "any substance used in
the preparation of an agricultural product that is still present in
the final commercial product as consumed." 7 CFR 205.2. A "processing
aid" is basically defined as a substance that is added to a food
during processing and either is removed or is present in the finished
food in insignificant amounts and has no technical or functional
effect in that food. Id.

11 11 7 U.S.C. § 6510(a)(a) and § 6517(c)(B)(iii).

12 12 7 CFR §205.601(b).

13 13 7 U.S.C. § 6509(a) and (b); 7 CFR 205.36(a).

14 14 7 U.S.C. § 6509(e)(2); 7 CFR 205.236(a)(2).

15 15 7 CFR § 205.237.

16 16 7 CFR 205.237(a)(2)(i).

17 17 7 CFR 205.236(a)(2)(iii).