This USDA option paper, along with two others, were published in the
Federal Register October 28, 1998 and are found on the USDA National
Organic Program webpage at www.ams.usda.gov/nop. The deadline for
submission of public comment is December 14, 1998.
We hope that you find our comments helpful as you begin the burdensome task
of crafting your own individual and organizational responses. Good luck!
Kathleen Merrigan and Mark Keating
Comments on "Issue Paper 2"
The Use of Antibiotics and Parasiticides in Organic Livestock Production
The Wallace Institute appreciates this opportunity to analyze options for
implementation of the Organic Foods Production Act (OFPA). We support the
Department's goal of clear, consistent regulations that stimulate the
growth of organic markets, satisfy consumer expectations, and allow organic
producers flexibility in making site-specific, real-time management
decisions. Our response to the options presented in Issue Paper 2 is
consistent with, and an expansion upon, the comments on the Proposed Rules
for the National Organic Program submitted by the Wallace Institute on
April 30, 1998.
Our comments will not respond to individual options outlined in Issue
Paper 2. The multiple and conflicting interpretations of the options
discussed at the October, 1998 NOSB meeting confused participants and USDA
staff alike. Therefore, rather than qualify or condition our responses to
specific options, we will use the important substantive issues they address
as the focus for our recommendations.
While the options outlined in Option Paper 2 for antibiotic and
parasiticide use treat these two categories of animal medications
identically, we find substantial justification for evaluating them
separately. The significant differences which exist in purpose of
application, essentiality to organic systems, and consumer expectations
merit the consideration of antibiotics and parasiticides as distinct
categories of synthetic materials. While the NOSB had, in the past, made
parallel recommendations concerning the use of antibiotics and
parasiticides, the Board recognized clear distinctions between the two
categories at the Ontario, California meeting in March, 1998.
Recommendations
(1) The Wallace Institute supports a prohibition on the use of all
antibiotics in certified organic livestock operations, with two exceptions
and one caveat.
Exception: We endorse the recommendation of the NOSB to allow the
exceptions for breeder and conversion stock contained in Section 205.12 of
the Proposed Rules, except as allowed for in Section 205.12(a)(4)
(non-edible products).
Exception: An exception may be appropriate in apiculture operations for
materials added to the National List, subject to certifying agent approval.
Caveat: The Wallace Institute does not, at this time, have sufficient
expertise to comment on the use of antibiotics in aquaculture operations.
As a result, we will refrain from making recommendations in this area until
more information becomes available.
(2) The Wallace Institute recommends allowing the use of specific
parasiticides, provided they are approved by the NOSB, added to the
National List, and their use is detailed in an approved farm plan. The use
of an approved synthetic parasiticide should only be permitted when the
certifying agent determines that no alternative management option can
provide an acceptable measure of control.
(3) The Wallace Institute recommends that USDA initiate immediately an
intensive research effort on parasiticide use, including the resistance
characteristics of different breeds, the role of climatic variables on
efficacy of treatment, and alternative (non-synthetic) treatment practices.
(4) The Wallace Institute expects that certain synthetic and natural
medications are potentially suitable for organic livestock production.
Therefore, as a class, "animal medications" should not be banned outright.
DISCUSSION
Antibiotics
The role of antibiotics in animal production has long been controversial
and limiting their use in organic operations was a priority in the OFPA.
Section 6509(d)(1)(A) prohibits the use of subtherapeutic doses of
antibiotics. Subsequent language in Section 6509(d)(1)(C) prohibits the
administration of medicine, other than vaccinations, in the absence of
illness. The OFPA does identify "livestock parasiticides and medicines",
including antibiotics, as a category of material suitable for inclusion on
the National List of approved synthetics. Synthetic materials placed on
the National List can only be used for itemized, specified applications.
The NOSB is responsible for identifying which synthetic materials are
suitable for use in organic operations and the Secretary, before and after
public comment, develops the National List by choosing from these
recommendations.
Organic production must be an expression of, not an alternative to, the
humane treatment of livestock and provide at least as much protection to
animals as conventional systems do. It has always been the NOSB's
position, which the Wallace Institute strongly supports, that an ill animal
requiring antibiotics must receive the treatment to alleviate prolonged
suffering and potential mortality. Just as a field which has been left
fallow for years does not become "organic by neglect", an animal cannot
become certified because it is denied a conventional treatment it requires.
Certified livestock operations must adopt a pro-active approach to animal
welfare and divert to conventional operations (and markets) those animals
which are not sustained by organic care.
Reliance upon synthetic antibiotics in organic agriculture has evolved as
producers acquire expertise in preventative management and alternative
treatments. Innovators in organic livestock management have consistently
found ways to reduce, even eliminate, their dependence on synthetic
antibiotics. Driven by consumer demand which favors unqualified label
claims ("no ... used", "never treated with..."), the organic livestock
industry has been quick to adapt innovative techniques. The USDA has
facilitated this trend by approving label claims such as "antibiotic and
hormone free" which have become successful marketing devices. The pace of
change has been so swift that the NOSB fundamentally re-wrote its
recommendations for the use of antibiotics before the original position was
four years old. By re-writing its recommendations on use of antibiotics,
the NOSB demonstrated that meaningful standards need to respond to industry
practice and consumer preference. In re-evaluating its position on
antibiotics and parasiticides, the USDA should incorporate proven
innovations in organic practice while leaving some flexibility for
production areas where change has not been as conclusive.
In its initial recommendations from 1994 and 1995, the NOSB supported
using the flexibility within OFPA to allow use of antibiotics in dairy and
breeder stock under certain conditions and with extended withdrawal
periods. In 1998, however, the Board eliminated these exceptions by
recommending that "No animal product or animal by-product may be labeled as
organic once an antibiotic has been given to the animal, except as provided
for production stock under the Origin of Livestock Section 205.12." This
recommendation means that once a certified animal is treated with
antibiotics for any reason, none of its products can again be sold as
organic. This position is far more stringent than the standard found in the
USDA's Proposed Rules. The Section 205.12 exception pertains solely to the
treatment of animals prior to their introduction to organic systems. While
we support the NOSB's position, we do not favor extending the exemption to
the category "Livestock used for the production of non-edible livestock
products" created in Section 205.12(a)(4). In our comments of April 30, we
stated that there is no statutory provision within OFPA to support
differential treatment of animals based upon the nature of the products
derived from them. The Wallace Institute continues to believe that
creating this category and applying weaker standards will mean that
affected animals will be inadequately integrated into the certified
operation. The exception for antibiotic use prior to an animal's
introduction to an organic operation should be determined by its species,
not its market niche.
The NOSB was able to strengthen its standards on antibiotics because
producers developed innovative ways to avoid using them. These innovations
came through considerable effort; most producers agree that avoiding
antibiotics requires highly sophisticated management techniques. Advances
in understanding animal health care and the improved availability of
replacement stock contributed to the NOSB's decision to revise its
antibiotic use recommendation. Organic livestock producers have
consistently demonstrated their ability to raise animals without using
antibiotics. In instances when antibiotic use is deemed essential for
survival, the treated animal can be diverted to the conventional market.
Because certified replacement stock have become more widely available, a
producer who loses capacity due to required treatments can efficiently
rebuild his organic operation. Consumers are paying a price premium for
animals products raised without antibiotics and the USDA should support
this trend by adopting the NOSB's 1998 recommendation.
Apiculture is one important production system in which we suspect that
alternatives to antibiotics are not yet fully developed. Use of
antibiotics may be necessary and justifiable for the control of documented
occurrences of American foulbrood in apiculture operations. We do not
support prophylactic applications of antibiotics in instances where
disease is not established. While apiaries should be regulated as
livestock operations, beekeepers cannot exercise the same measure of
control over their operations that other producers do. For example,
beekeepers cannot monitor the source of their animals' food as producers of
pastured animals can. Neither can beekeepers protect the hive by culling
individual sick bees. We believe that organic operations which otherwise
comply with their farm plan should be allowed an exception for the use of
specific approved antibiotics in cases where foulbrood becomes established
in the hive.
The Wallace Institute supports the initiative the organic industry and the
NOSB have taken to restrict and, in cases, eliminate the approved uses of
antibiotics in certified operations. We hope that the limited and
conditional uses we support for production stock and in hives diagnosed
with foulbrood are the exceptions that prove the rule. We endorse these
exceptions because we do not believe that natural alternatives are viable
and that the antibiotic treatments satisfy OFPA's requirements for
allowable synthetics.
At this time, the Wallace Institute does not have sufficient information
or expertise to determine whether the prohibition on the use of antibiotics
should apply to aquaculture operations. It is possible that aquaculture
operations may operate without antibiotics, just as organic livestock
producers have refined their practices to eliminate them. It is also
possible that specific applications of antibiotics will be as justifiable
and unavoidable in aquaculture operations as we believe they are for the
control of foulbrood. The NOSB has received minimal public input on this
subject and there are few existing operations from which to learn. We
need additional insight into current practice and the potential for
innovation before reaching a conclusion on the use of antibiotics in these
operations. We urge the USDA and the NOSB to solicit input from affected
producers and consumer interests on this topic.
Parasiticides
Our analysis of organic livestock production indicates that producers have
not been able to develop practices and treatments to replace parasiticides
as they have for antibiotics. Without parasiticides, poultry and young
sheep seem to be especially vulnerable to parasites. For the control of
parasites, environmental conditions, including temperature and
precipitation, may exist for which no level of management expertise can
substitute for parasiticide use. In the absence of parasiticides, many
organic pasture-based grazing systems may be impossible to maintain without
excessive animal culling and mortality. Organic standards which have
allowed conditional use of parasiticides essentially trade off use of a
synthetic material for the multiple benefits (for the land as well as the
animal) associated with grazing. The ability to pasture raise animals,
especially poultry and sheep, is a significant potential benefit to weigh
when considering the suitability of parasiticides in organic production
systems.
On balance, the Wallace Institute supports the conditional use of
parasiticides in organic livestock operations. We encourage the Department
to incorporate into the next Proposed Rules the 1994 New Mexico NOSB
recommendations for allowing the use of synthetic parasiticides. These
recommendations are based on prevention of illness, biological controls,
and culling of infected animals, and permit the use of parasiticides as a
last recourse. Producers are allowed the discretion to use approved
parasiticides, but their decision would be subject to certifier review of
the farm plan. We expect that these procedures will result in a
collaborative relationship where producers incrementally refine their
management practices to reduce their dependence on synthetic materials.
The Wallace Institute also supports the NOSB recommendations on the
handling of products from animals which have been treated with synthetic
parasiticides. The NOSB proposed that animals which receive necessary
treatment could not be sold as certified slaughter stock, but could be
allowed as breeder and dairy stock after appropriate withdrawal periods.
These provisions allow producers to provide humane treatment without
preventing their animals from eventually returning to organic care.
Allowing the conditional use of parasiticides rewards producers for
maintaining organic systems without removing their final safety net during
emergencies.
Producers should assess the need for parasiticides in their farm plan by
providing a detailed analysis of their efforts to minimize exposure to
parasites and what synthetic treatments they believe will be required.
Given their understanding of regional conditions and the producer's past
performance and compliance record, certifying agents can best determine if
the suggested treatment regime is allowable. Dialogue during the
certification process can insure that the quantity and duration of
treatment are appropriate to the operation under prevailing regional
conditions. Requiring producers to document their parasite management
practices in a certifier-approved farm plan and establishing handling
restrictions on treated animals will insure that synthetic treatments are
the option of last resort. We find it relevant that the NOSB's 1994
recommendations on conditional use and post-treatment withdrawal periods
were applicable to antibiotics as well as parasiticides. Producer
innovation in organic livestock management has enabled the NOSB to amend
its antibiotic recommendations in favor of more restrictive standards. We
believe that the evolution of production practices, augmented by
significant federally-supported research, could similarly achieve a
pronounced reduction in the dependence on parasiticides in organic
livestock operations.
OFPA's provisions for developing a National List of approved synthetics
allows the NOSB and the Secretary to identify which parasiticides are
allowable in organic systems. We strongly encourage the USDA to begin the
necessary TAP review process to determine suitability of specific synthetic
parasiticides. In addition, the ARS should dedicate resources to
evaluating current organic production practices related to parasiticides
and evaluate the conditions which most directly contribute to their use.
We suspect that a better understanding of the susceptibility of particular
species to disease (especially older breeds relative to modern hybrids
developed for intensive production) as well as the climatic conditions
which contribute to regional differences in the pressure from parasites
will significantly advance the ability of organic producers to handle the
problem appropriately.
Reflections on Public Comment and the Role of Animal Medications
The outpouring of negative public reaction to the livestock production
provisions in the Proposed Rules has clearly affected the options put
forward in this Issue Paper. Many comments adamantly rejected the
provisions which the USDA proposed for synthetic medications but did not
substantively address what role they thought they should have. The USDA
has had to interpret many thousands of comments which did little more than
denounce the proposed policy. This blanket criticism may have prompted the
Department to raise the option of prohibiting the use of any medication in
organic livestock production. Upon review of the statute, the historical
debate on this subject, and the comments themselves, the Wallace Institute
believes that a blanket prohibition on the use of medications is
unwarranted. With regard to food safety and animal welfare, antibiotics
and hormones have consistently been the medications of greatest concern to
the general public. The OFPA specifically prohibits the use of hormones
and growth promoters and sets very prescribed conditions on the use of
antibiotics. Taken together, the ban on hormones and the stringent NOSB
recommendations on antibiotics will go a long way towards allaying public
concern about synthetic materials in organic operations.
OFPA allows, and concern for the animals dictates, that the NOSB
evaluate every natural and synthetic medication on its own merits. Many
natural treatments, including pro-biotic and homeopathic remedies, have a
proven success record and are perfectly compatible with organic systems.
The Secretary should not seek to prohibit any natural medication unless the
NOSB has recommended that it be placed on the National List of prohibited
natural materials. Similarly, as mandated by OFPA, the Secretary may elect
to add synthetic medications to the National List of approved materials
upon the NOSB's recommendation.
Henry A Wallace Institute for Alternative Agriculture
9200 Edmonston Rd Ste 117
Greenbelt MD 20770-1551
Phone: 301-441-8777
Fax: 301-220-0164
Web site: www.hawiaa.org
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