Organic Watch:Special Supplement to Food Bytes #6

Supplement to Food Bytes #6 (Jan. 20, 1998)
News & Analysis on Genetic Engineering & Factory Farming
Ronnie Cummins, Pure Food Campaign USA
alliance@mr.net
http://www.purefood.org

Note: The following document was prepared by attorneys for Organic Watch, a
coalition of public interest non-governmental organizations in the U.S.
____________________________________________________________________

Materials Provided for Use in Commenting on
USDA's Proposed Rules for the Implementation of
the Organic Foods Production Act

Organic Watch's 16 Issues of Major Concern

Introduction.

The following material was created as an aid to organizations and
individuals who are preparing comments concerning the United States
Department of Agriculture ("USDA"), Agricultural Marketing Service's,
"National Organic Program; Proposed Rule" found at 62 Federal Register
65850 (December 16, 1997). Organic Watch encourages duplication and
wide distribution of this material and no prior permission for such
activity is required.

All comments concerning the proposed rule should be submitted to: Docket
Number TMD-94-00-2, Eileen S. Stommes, Deputy Administrator,
USDA-AMS-TM-NOP, Room 4007-So., Ag Stop 0275, P.O. Box 96456,
Washington, DC 20090-6456, and, if possible, electronically at
http://www.ams.usda.gov/nop. The current deadline for comment submission
is March 16, 1998. Please note that all comments submitted to the docket
should be labeled by "comment topic heading" and include the specific
section number and/or Federal Register page citation where a particular
subject is discussed.

Procedural Considerations.

Issue Number 1. Commenters Should Seek Withdrawal of the Proposed Rule
and Preparartion of a New Rule Which Comports with the NOSB
Recommendations. (Comment Topic Heading: General). Request that the
USDA withdraw the current proposed rule for the establishment of a
national organic program with the intent of having the agency prepare a
revised proposed rule which comports with the requirements of the
Organic Foods Production Act ("OFPA"), 7 U.S.C. § 6501, et seq., and
accurately reflects the recommendations of the National Organic
Standards Board ("NOSB"). See, Appendix I, "USDA's National Organic
Program: Procedural Issues."

Issue Number 2. Commenters Should Request that the Rule Be Reframed
Strictly as a Process Standard. (Comment Topic Heading: General). The
NOSB focus, and that of other organic standards, has been to establish
acceptable processes by which organic foods can be grown, handled,
marketed, etc. In this regard, the NOSB recommendations were designed
to create a national system outlining how to farm, process and handle
organically. However, the USDA has attempted to alter this approach to
the organic rule through the introduction of "performance" standards.
In describing these standards USDA states, "Performance standards are
generally written in terms of the results expected." 62 Federal
Register 65869 (emphasis added). As a result, USDA has attempted to
change the overarching philosophy of the rule from one of "processes"
(process standards) to one of "end results" (performance standards or
product standards). This philosophical shift informs the entire
proposed rule and provides USDA with its basis for creating a number of
large, vague exemptions from the organic processes recommended by the
NOSB.

In addition, the USDA has made numerous changes in definitions that
serve as the basis of the proposed national organic program. USDA has
altered a number of definitions (e.g., organic, unavoidable residual
environmental contamination) and added new, previously undiscussed
definitions (e.g., non-active synthetic, cytotoxic mode of action).
These definitional changes inform USDA's attempt to change the National
Organic Program ("NOP") into a performance-based program allowing for
new exemptions from required organic processes and standards. See
generally, § 205.1 & 205.2; 62 Federal Register 65865-65867.

Major NOSB Recommendations Reversed or Altered in the USDA's Proposed
Rule.

Organic Watch believes that the successful implementation of the Organic
Foods Production Act ("OFPA") is dependent upon maintaining the
statutory authority and independent integrity of the National Organic
Standards Board ("NOSB"). It is therefore essential that the USDA's
proposed rule comports with the original NOSB recommendations. The
following list of issues is based upon USDA proposals that alter
consensus definitions, processes, and recommendations established by the
NOSB. In many instances, Organic Watch believes that the USDA's action
may be violative of the OFPA. See, Appendix II, "Brief Legal Analysis
of the NOSB."

Issue Number 3. Commenters Should Request that the Statutory Authority
of the NOSB Be Maintained. (Comment Topic Heading: General/National
List). The NOSB has two distinct roles: (1) to provide the Secretary of
Agriculture with recommendations regarding the implementation of the
OFPA; and (2) to develop the Proposed National List or amendments to the
National List for submission to the Secretary. The NOSB has fulfilled
this statutory role by providing the USDA with extensive, consensus
recommendations on the acceptable practices governing virtually all
aspects of organic farming, processing, handling and labeling. As
directed by the OFPA, the NOSB compiled the final, initial National List
of Allowed and Prohibited Substances. Despite these efforts, the USDA
has significantly altered the majority of the NOSB's recommended
practices, directly altered the NOSB's National List, removed the NOSB's
annotations and restrictions on use that accompanied the National List,
and attempted to change the NOSB's future governance of the National
List process. Such an explicit challenge to the NOSB's statutory
authority is contrary to the OFPA and violative of the public/private
partnership that supported Congressional passage of the OFPA. See,
Appendix II.

Issue Number 4. Commenters Should Oppose All USDA Changes To The
National List. (Comment Topic Heading: National List). The USDA's
proposed rule explicitly challenges and takes away the NOSB's statutory
power to establish the National List of Allowed and Prohibited
Substances. See, Appendix II. At a minimum, commenters should oppose
these specific examples of USDA's alteration of NOSB findings.

A. National Organic Standards Board.
(1). "Killed B.t.". On November 1, 1995, the NOSB listed genetically
engineered Pseudomonas florescens with a B.t. gene ("Killed B.t.") as
synthetic and non-approved.

(2). Piperonyl Butoxide. On October 14, 1994, the NOSB rejected a
motion to add Piperonyl Butoxide to the National List as an approved
synthetic. NOSB, Final Recommendation, Addendum 2, "Botanical
Pesticides Policy."

(3). Chymosin. On September 20, 1996, the NOSB determined genetically
engineered chymosin to be an unacceptable synthetic. "Summary of NOSB
Recommendation for Materials Considered at Indianapolis, IN."

B. USDA Proposed Rule.
(1). "Killed B.t.". USDA ignored the NOSB and proposes that toxins
derived from genetically engineered bacteria be placed on the National
List of Active Synthetic Substances Allowed "so that [the agency] can
receive comments on the proper classification of these substances, and
whether they should be allowed, prohibited or allowed on a case-by-case
basis" (Proposed § 205.20; 62 Federal Register 65889) and specifically
lists "Killed B.t." as an allowed active synthetic (Proposed §
205.22(d); 62 Federal Register 65891).

(2). Piperonyl Butoxide. USDA ignored the NOSB finding and proposes that
Piperonyl Butoxide be included on the National List of Active Synthetic
Substances Allowed. (Proposed § 205.22(c)(9); 62 Federal Register
65891).

(3). Chymosin. USDA ignored the NOSB finding and proposes that
genetically engineered chymosin be placed on the National List of
Non-agricultural Substances Allowed "so as to solicit public comment."
(Proposed § 205.26; 62 Federal Register 65895).

Issue Number 5. Commenters Should Support the NOSB's Prohibition on the
Use of Genetic Engineering. (Comment Topic Heading:
General/Crops/Handling/National List).

A. National Organic Standards Board Action.
The National Organic Standards Board recommended that the use of genetic
engineering be prohibited in organic foods.

B. USDA Proposed Rule.
Under the preamble discussing proposed § 205.8, the USDA specifically
set aside the NOSB's prohibition of genetic engineering and opened up
the question for comment. Additionally, in requesting comments on
genetically engineered organisms ("GEOs") the USDA fails to seek comment
on whether GEO's and their resulting products should be considered
"synthetic." 62 Federal Register 65875. As discussed in Appendix II,
such an action could result in a de facto allowance of genetic
engineering. Other proposed sections that could be affected by this
USDA proposal include § 205.9 (Prevention and Control of Crop Pests,
Weeds, and Diseases), § 205.22 (National List) and § 205.26 (National
List).

Issue Number 6. Commenters Should Support NOSB's Broad Definition of
Genetic Engineering. (Comment Topic Heading: General/Crops/
Handling/National List).

A. National Organic Standards Board Action.
As noted above, the NOSB recommended a prohibition on the use of genetic
engineering because genetically engineered organisms and the products of
such organisms are "synthetic." The NOSB also recommended a
comprehensive definition of genetic engineering. This was done to
ensure that the recommended prohibition on genetically engineered foods,
processes, and inputs encompasses all potential genetic engineering
techniques. NOSB, Final Recommendation Addendum 25, "Definitions and
Interpretations" (November 1, 1995).

B. USDA Proposed Rule.
Under proposed § 205.2(56), the USDA's rejects the NOSB's broad
definition of genetic engineering and replaces it with an extremely
narrow one. Should the USDA's definition be in the final rule, it
would seriously undermine any prohibition on genetic engineering.

Issue Number 7. Commenters Should Support the NOSB's Prohibition on the
Use of Municipal Sewer Sludge. (Comment Topic Heading:
Crops/Handling/National List).

A. National Organic Standards Board Action.
Concerned with residue levels of heavy metals, pesticides and
contaminants such as PCBs, the NOSB specifically found that "sewage
sludge" was "synthetic" and "unacceptable for use in organic crop
production." "Summary of NOSB Recommendations for Materials Considered
at Indianapolis, IN" (September 1996).

B. USDA Proposed Rule.
Under discussion of proposed § 205.22, USDA put aside the NOSB
determination and asks for comments on whether sewer sludge should be
permitted or prohibited in organic production and whether it should be
defined as a "synthetic" or "non-synthetic." 62 Federal Register
65892-65893. As discussed in Appendix II, such an action could result
in a de facto allowance of municipal sewer sludge.

Issue Number 8. Commenters Should Support the NOSB's Prohibition on the
Use of Ionizing Radiation (Irradiation). (Comment Topic Heading:
Handling/National List).

A. National Organic Standards Board Action.
NOSB's Final Recommendation, Addendum Number 7, "Organic Good
Manufacturing Practices" (April 25, 1995) stated that ionizing radiation
(irradiation) may not be used in the handling of organic food.

B. USDA Proposed Rule.
Under proposed § 205.17, the USDA ignored the NOSB's recommendation and
asks for comments on whether irradiation is compatible with organic
farming and handling and whether it is an "essential standard industry
practice" or "good manufacturing practice." 62 Federal Register 65884.
As discussed in Appendix II, such an action could result in a de facto
allowance of irradiation.

Issue Number 9. Commenters Should Support the NOSB's Recommendation
Requiring Outdoor Access for Livestock. (Comment Topic Heading:
Livestock).

A. National Organic Standards Board Action.
The NOSB, Final Recommendation, Addendum 8, "Organic Livestock
Healthcare Practices" (April 25, 1995) found that "Certified organic
livestock shall be based on a system that incorporates access to the
outdoors and direct sunlight." (Emphasis added).

B. USDA Proposed Rule.
Under the Livestock Living Conditions and Manure Management provision of
proposed § 205.15(a), USDA states that producers must provide space for
movement and outdoor access. However, USDA's proposed § 205.15(b) makes
the requirement for space for movement and outdoor access meaningless by
providing a loophole allowing for the restriction of available space for
movement and access to the outdoors "if necessary." Further guidance on
the "if necessary" qualifier is not given by USDA, thereby allowing each
livestock producer the discretion as to when it is "necessary" to
restrict space for movement and prevent outdoor access. As written, a
livestock producer could find it is always "necessary" to restrict an
animal's space for movement and prevent an animal's access to the
outdoors.

Issue Number 10. Commenters Should Support the NOSB's Prohibitions and
Restrictions on the Use of Antibiotics in Livestock. (Comment Topic
Heading: Livestock).

A. National Organic Standards Board Action.
(1). For livestock, NOSB recommended an absolute prohibition on
antibiotic use in slaughter stock. The NOSB also recommended a
restriction on antibiotic use in breeding stock to "healthcare
emergencies." However, in no case can the offspring of breeding stock be
sold as organic if antibiotics are used during the breeder's last third
of gestation or nursing period. NOSB, Final Recommendation, "The Use
of Antibiotics in Organic Livestock Production" (June 4, 1994).

(2). For laying hens, NOSB recommended restricting antibiotic use to
only "healthcare emergencies," and further recommended that eggs or egg
products may not be sold or labeled organic until 90 days following
antibiotic use. NOSB, Final Recommendation, Addendum 22, "The Use of
Antibiotics In Organic Livestock Production" (October 31, 1995).

(3). For dairy cows, NOSB recommended restricting antibiotic use to
only "healthcare emergencies," and further recommended that milk or
dairy products may not be sold or labeled organic until 90 days
following antibiotic use. NOSB, Final Recommendation, "The Use of
Antibiotics in Organic Livestock Production" (June 4, 1994).

B. USDA Proposed Rule.
(1). Under proposed § 205.14(b)(1) & (2), contrary to the NOSB
recommendation on slaughter stock, USDA allows the use of antibiotics in
the first twenty-one days of life in mammals. 62 Federal Register
65880. The USDA proposal fails to specifically address antibiotic use
in breeder stock, laying hens and dairy cows.

(2). For non-mammal slaughter stock (i.e., poultry) the USDA allows the
use of antibiotics within the first seven days after arrival at a
certified facility. 62 Federal Register 65880. Once again, this is
contrary to the NOSB recommendation and creates a potentially
significant loophole that would allow antibiotic treated animals to be
slaughtered and labeled organic.

(3). For non-slaughter stock (e.g. breeder stock, egg laying chickens
and dairy cows), the USDA also goes against the NOSB recommendations.
Under proposed § 205.14(d), the agency allows the use of the "organic"
label on the product of antibiotic treated animals when the producer
determines that the "animal has fully recovered." 62 Federal Register
65880. USDA specifically rejects the NOSB 90-day waiting period
requirement for laying hens, dairy stock, and breeding stock. USDA only
specifies that FDA drug withdrawal times be observed and the animal is
determined to be fully recovered from the condition being treated. No
definition or concrete guidance is offered regarding how this would be
defined or such a judgment assessed. This loophole gives the producer
significant discretion in determining the length of the waiting period
necessary after antibiotic use.

Other notes. In the proposed rule's preamble the USDA appears to be
open to additional comments on the use of antibiotics in slaughter
stock. 62 Federal Register 65880. This may allow USDA to create
additional loopholes in the final rule.

Issue Number 11. Commenters Should Support NOSB's Recommendations on
Animal Feed. (Comment Topic Heading: Livestock).

A. National Organic Standards Board Action.
In order to preserve consumer confidence and ensure growth in the demand
for organic meats, the NOSB found that all certified organically
produced livestock shall be fed certified organically produced feeds and
feed supplements. This included allowance for emergency non-organic
feeding only for established time periods and after a certifying agent
is notified. NOSB, Final Board Recommendation, "Livestock Feed Standard"
(June 2, 1994).

B. USDA Proposed Rule.
Under proposed § 205.13(a)(1)(I), USDA will allow organic animals to
receive up to twenty (20) percent non-organic feed as part of its total
feed per year. 62 Federal Register 65878. In addition, the proposed
rule allows for a greater percentage of feed to be non-organic "if
necessary." Similar to the USDA's proposed provisions on outdoor
access, this represents a significant loophole in the enforcement of
organic feeding practices. See supra, Issue Number 9.

Issue Number 12. Commenters Should Support NOSB's Fee Recommendations
Concerning the Impact on Small Farms. (Comment Topic Heading: Fees).

A. National Organic Standards Board Action.
The NOSB recommended that the USDA use appropriated funds to cover the
cost of the first round of accreditation. NOSB, Final Recommendation,
"Standards and Procedures Governing the Accreditation of Organic
Certification Organizations" (June 4, 1994). It was the NOSB's intention
that these costs then be analyzed so a fair and equitable fee structure
could be established for the next round of accreditation.

B. USDA Proposed Rule.
Under proposed §§ 205.421 - 205.425, USDA creates a regressive, flat fee
structure that will make participation in the National Organic Program
by small certifiers, farmers and handlers economically burdensome.

Issue Number 13. Commenters Should Support the NOSB's Prohibition on
the Use of Inert Ingredients. (Comment Topic Heading:
Crops/Handling/National List).

A. National Organic Standards Board Action.
On April 11, 1995, the NOSB voted to prohibit the use of synthetic
inerts contained in EPA List 1 - "Inerts of Toxicological Concern," EPA
List 2 - "Potentially Toxic Inerts," and EPA List 3 - "Potentially Toxic
Inerts."

B. USDA Proposed Rule.
Under proposed § 205.20(b)(3) the USDA ignored NOSB's recommendations on
synthetic inerts. The USDA proposes limiting the prohibition on use to
inerts on EPA List 1, and allows the use of formulated products
containing inerts included on EPA List 2, and EPA List 3. 62 Federal
Register 65890.

Other Major Issues.

Issue Number 14. Commenters Should Oppose USDA's Eco-Labeling
Prohibitions. (Comment Topic Heading: Labeling).

Under § 205.103, the USDA proposes to regulate "the labeling or market
information that directly or indirectly imply organic production and
handling practices." This includes a prohibition on the use of terms
that directly or indirectly imply organic production if the products
being labeled are not produced in accordance with OFPA. Some of
examples of the prohibited labeling include "produced without synthetic
pesticides," "pesticide-free farm," "no growth stimulants administered,"
"raised without antibiotics," "humanely raised" and "ecologically
produced." This broad prohibition would prevent new eco-labeled
products from entering the market and could force many U.S. companies
and grower associations who currently produce and label eco-products to
remove them from the market. See, Appendix III, "Brief Legal Analysis of
Labeling Issues."

Issue Number 15. Commenters Should Oppose USDA's Definition of
"Unavoidable Residual Environmental Contamination." (Comment Topic
Heading: General).

USDA has ignored NOSB recommendations and defined this term to give the
Secretary discretion in determining (on a case-by-case basis) whether
environmentally contaminated land may be used for organic food
production. 62 Federal Register 65866-65867 and 65932. This creates a
significant loophole that may allow many of the proposed rule's
requirements to be circumvented.

Issue Number 16. Commenters Should Seek Clarification on the Procedures
Addressing the Importation of Foreign Organic Products. (Comment Topic
Heading: Equivalency).

Under § 6505(b) of the OFPA and USDA's proposed §§ 205.480 - 205.483,
all determinations on the eligibility of agricultural products for
importation as organic shall be made by the Secretary of Agriculture.
Two notes on this: (1) the maintaining of eligibility for importation of
organic products will depend on "periodic reviews by the Secretary." It
is unclear as to how often the "periodic reviews" will be undertaken;
and (2) the USDA's proposed rules do not determine how to deal with
maintaining organic integrity during pre-shipment and quarantine
activities due to importation (e.g., will treatments of imports by
fumigants during quarantine be considered equivalent to the national
organic standards).


Organic Consumers Association
6101 Cliff Estate Rd., Little Marais, Minnesota 55614
Activist or Media Inquiries: (218) 226-4164,  Fax: (218) 226-4157
Ronnie Cummins E-mail: alliance@mr.net    http://www.purefood.org

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