[Federal Register Volume 63, Number 208 (Wednesday, October 28, 1998)]
[Proposed Rules]
[Pages 57624-57626]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-28880]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 63, No. 208 / Wednesday, October 28, 1998 /
Proposed Rules
[[Page 57624]]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 205
[TM-98-00-7]
RIN 0581-AA40
National Organic Program--Issue Papers
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed Rule; request for comments on Issue Papers.
-----------------------------------------------------------------------
SUMMARY: Agricultural Marketing Service (AMS) is seeking comments on
three papers that address certain issues raised in the comments
received on the National Organic Program proposed rule published in the
Federal Register on December 16, 1997. These issue papers which address
livestock confinement, livestock health care, and certification
termination, and comments received on them will be considered during
the development of a revised National Organic Program proposed rule.
DATES: Comments must be submitted on or before December 14, 1998.
ADDRESSES: Interested persons are invited to submit written comments on
these issues to: Eileen S. Stommes, Deputy Administrator, USDA-AMS-TM-
NOP, Room 4007-S, AG Stop 0275, P.O. Box 96456, Washington, D.C. 20090-
6456. Comments may also be sent by fax to (202) 690-4632 or via e-mail
to: NOPIssue P[email protected]. Additionally, USDA plans to accept
comments via the National Organic Program home page at a future date.
Notification of acceptance of comments by this form will occur through
an additional Federal Register notice.
FOR FURTHER INFORMATION CONTACT: T. Keith Jones, Program Manager, USDA-
AMS-TM-NOP, Room 2510-S, AG Stop 0275, P.O. Box 96456, Washington, D.C.
20090-6456. Phone (202) 720-3252.
SUPPLEMENTARY INFORMATION: AMS is seeking comments on three papers that
address certain issues raised during the National Organic Program's
proposed rule comment period. These issue papers which address
livestock confinement, livestock health care, and certification
termination, and comments received on them will be considered during
the development of a revised National Organic Program proposed rule.
The issue papers are: Issue Paper 1. Livestock Confinement in
Organic Production Systems; Issue Paper 2. The Use of Antibiotics and
Parasiticides in Organic Livestock Production; and Issue Paper 3.
Termination of Certification by Private Certifiers. These issue papers
are being published in an effort to provide the opportunity for public
input. USDA is committed to a process that is open to all interested
parties.
All comments, whether mailed, faxed, or submitted via the Internet,
will be available for viewing at the USDA-AMS, Transportation and
Marketing Programs, Room 2945-South Building, 1400 Independence Ave.,
S.W., Washington, D.C., from 9:00 a.m. to 1:00 p.m., and from 2:00 p.m.
to 4:30 p.m., Monday through Friday (except official Federal holidays).
Persons wanting to visit the USDA South Building to view comments
received in response to this proposal are requested to make an
appointment in advance by calling Gayle Patterson at (202) 720-3252.
The issue papers are published below.
Issue Paper 1. Livestock Confinement in Organic Production Systems
1. Goal
USDA's goal is to establish clear, consistent regulations that
stimulate the growth of the organic livestock sector, satisfy consumer
expectations and allow organic livestock producers flexibility in
making site-specific, real-time management decisions.
2. Issue
Commenters on USDA's proposed rule, published December 16, 1997 (62
FR 65850), assert that the language in the proposed rule,
if necessary, livestock may be maintained under conditions that
restrict the available space for movement or access to the outside,
section 205.15(b), creates a significant loophole for factory farming
of livestock despite the other requirements for access to outdoors and
space for movement. USDA believes that commenters are concerned that
the term if necessary, could be broadly interpreted by public and
private certifiers.
3. Background
The Organic Foods Production Act (7 U.S.C. 6501-6522) (OFPA) is
silent on livestock confinement. In its proposed rule, USDA
specifically requested public comment on the conditions under which
animals may be maintained, specifically with regard to the available
space for movement and access to the outdoors. Many commenters
advocated USDA's adoption of the National Organic Standards Board
(NOSB) recommendations on livestock production which recognize that
proper livestock management may provide for times when livestock are
confined. The NOSB said
temporary indoor housing may be justified for: 1. inclement weather
conditions; 2. health, care, safety and well-being of the livestock;
and 3. protection of soil and water quality.
Therefore, commenters who support the NOSB recommendations appear to
accept animal confinement as long as the criteria allowing confinement
are clearly delineated.
In writing the proposed rule, USDA, like the NOSB, sought to
balance animal health issues, such as prevention of exposure to disease
and predators, with the concepts that organic management is soil-based,
and that animals should be allowed access to the soil. USDA envisioned
that the language of section 205.15(b) would allow the flexibility
needed for producers to confine animals during critical periods such as
farrowing.
In keeping with this intent, USDA chose the term if necessary to
capture the spirit of the NOSB recommendation. The terms if necessary
or justified, used respectively in the proposed rule and the NOSB
recommendation, envisioned guidelines by which a producer or certifier
would benchmark the management decision. USDA believed that such
guidelines would be formulated during development of a program manual
for the National Organic Program. USDA also concluded that the proposed
livestock standards, when taken as a whole, serve as a delimiting
mechanism to large-scale confined animal feeding operations.
[[Page 57625]]
Many commenters indicated opposition to factory farming of
livestock. It is unclear how these commenters would define the term
factory farming and whether those who oppose factory farming are
concerned about animal space requirements, environmental issues, or a
particular business structure. Like NOSB and USDA, they believe that
routine, continuous confinement of livestock must be prohibited, but
some commenters stated that the proposed livestock requirements, which
required access to outdoors and space for movement, fall short of
consumer expectations for the production of organically grown
livestock. Therefore, a more detailed delineation of the criteria for
appropriate confinement may be necessary to satisfy the concerns of
these commenters.
4. Options
In response to these comments, USDA is considering the following
options:
Option 1--Retain the Current Language but Elaborate on Its Intent
Pros: Consistent with NOSB recommendations;
Allows for producer/certifier flexibility;
Allows for various animal space requirements.
Cons: May not meet expectations of some commenters;
Compliance verification could be difficult.
Option 2--Establish Animal Space Requirements in Animal Feeding
Operations
Pros: Addresses commenter concerns about animal space requirements.
Simplifies animal space verification.
Cons: An issue not addressed by NOSB or USDA;
Criteria for space requirements could be difficult to establish;
Further reduces producer/certifier flexibility.
Option 3--Establish Requirements for Access to Pasture.
Pros: Would satisfy commenter concerns;
Would address animal safety concerns;
Allows for various animal space requirements;
Cons: An issue not addressed by NOSB or USDA;
Compliance verification could be difficult;
May not be appropriate for all species of livestock;
Further reduces producer/certifier flexibility.
Option 4--Explore Feasibility of Allowing Livestock Products Labeled as
Organic To Include Additional Label Claims, Such as Pasture-Raised,
Free-Range or Never Confined in a Feedlot
Pros: Provides consumers with more product information;
Allows producers to market to a further defined niche.
Cons: Could cause consumer confusion;
Could devalue the term organic;
Limited verification for label claims.
USDA is interested in exploring other options. Additionally, we are
seeking comments on the following questions: Should the rule ban
confined animal feeding operations? Would requiring access to pasture
satisfy commenters, including those who oppose factory farming? What
economic impact would these options have on organic livestock
producers? How would additional labeling claims affect the marketing of
organic livestock products?
Would annual or semi-annual organic certification site visits be
sufficient to ensure that routine, continuous confinement is not
occurring? How should certifiers determine that confinement is being
employed in accordance with the regulations?
How should access to pasture be defined? Should a species-by-
species approach be taken? When permitted by regulation, should the
duration and frequency of confinement be resolved on a case-by-case
basis between certifier and producer?
Issue Paper 2.--The Use of Antibiotics and Parasiticides in Organic
Livestock Production
1. Goal
USDA's goal is to establish clear, consistent regulations that
stimulate the growth of the organic livestock sector, satisfy consumer
expectations and allow organic livestock producers flexibility in
making site-specific, real-time management decisions.
2. Issue
In its proposed rule published December 16, 1997 (62 FR 65850),
USDA specifically requested public comment on the use of animal drugs
in the production of organic livestock. Many commenters advocated the
adoption of the National Organic Standards Board (NOSB) recommendations
on both antibiotics and parasiticides. The NOSB recommendations
prohibit the use of antibiotics and parasiticides in organic production
except under certain clearly delineated animal health conditions.
Many other commenters go beyond the options proposed by USDA and
the NOSB by advocating an absolute prohibition on the use of
antibiotics in organic livestock production. Further, commenters who
specifically mention the use of parasiticides as an area of concern
assert that the language in the proposed rule defining the term routine
use of parasiticides as administering a parasiticide to an animal
without cause is inadequate. These commenters suggest that it would be
too easy for producers to find cause to administer a parasiticide, and
that they might therefore become reliant on parasiticides rather than
on preventative measures. Some commenters would prefer a complete ban
on the use of all animal medications, including antibiotics and
parasiticides, in organic livestock production.
3. Background
The OFPA prohibits only the use of subtherapeutic doses of
antibiotics and of synthetic internal parasiticides on a routine basis.
Since young animals are especially vulnerable to disease, USDA believed
there was sufficient justification for additional protection in the
early days of life. To ensure the health of animals during critical
periods, USDA also allowed the therapeutic use of antibiotics in dairy
and breeder stock because of the animals' longevity and the potential
for infections arising from pregnancy and delivery. USDA attempted to
capture the statutory prohibition on routine use of parasiticides by
defining such use as, administering a parasiticide to an animal without
cause.
4. Options
In light of these comments, USDA is analyzing options to assist in
determining the proper role for antibiotics and parasiticides in
organic livestock production. Options under consideration, along with
USDA's assessment of the pros and cons of each option, are listed
below:
Option 1--Prohibit all use of antibiotics and parasiticides.
Pros: Consistent with many comments.
Cons: Animal health could be adversely affected, particularly that
of young animals;
Inconsistent with NOSB recommendations;
Compliance verification could be difficult;
Could limit industry growth by preventing the production of some
types of livestock in specific geographic areas.
[[Page 57626]]
Option 2--Prohibit the Use of All Animal Medications, Other Than
Vaccinations, Including Antibiotics and Parasiticides.
Pros: Consistent with some comments.
Cons: Animal health could be adversely affected, particularly that
of young animals;
Inconsistent with NOSB recommendations;
Compliance verification could be difficult;
Could limit industry growth by preventing the production of some
types of livestock in specific geographic areas.
Option 3--Allow the Therapeutic Use of Antibiotics and the Non-Routine
use of Parasiticides Under Specific Animal Health Conditions.
Pros: Consistent with NOSB recommendations;
Allows for the protection of animal health;
Animal production could be enhanced;
Provides producer/certifier flexibility to respond to rapidly
changing animal health conditions.
Cons: Compliance verification could be difficult.
USDA is interested in exploring other options. Additionally, we are
seeking comments on the following questions: What economic impact would
the prohibition of all medication, including antibiotics and
parasiticides, have on organic livestock producers?
Under what conditions, if any, could an animal for slaughter
receive a synthetic internal parasiticide? An external parasiticide?
What about breeding stock or dairy animals?
Should we make provisions for the use of synthetic parasiticides
where other measures has proven ineffective?
Would annual or semi-annual organic certification site visits be
sufficient to ensure that preventative measures are being carried out
and that antibiotics and parasiticides are being administered in
accordance with the Act and its regulations? When permitted by
regulation, should the use of antibiotics and parasiticides be resolved
on a case-by-case basis between certifier and producer?
Issue Paper 3. Termination of Certification by Private Certifiers
1. Goal
USDA's goal is to implement the Organic Foods Production Act (OFPA)
at the local level, while utilizing, to the extent possible, the
existing infrastructure of organic certification.
2. Issue
Many commenters on USDA's proposed rule, published December 16,
1997 (62 FR 65850), assert that the proposed process for termination of
certification would be unduly bureaucratic and would complicate local
certifiers' efforts to ensure the integrity of the organic label.
3. Background
In the proposed rule, USDA sought to balance the public policy goal
of withdrawing certification from a farmer or handler who violates the
Act against the constitutional protections afforded to entities
certified under the OFPA. The National Organic Standards Board did not
make any specific recommendation on this issue. Under the OFPA,
accredited certifiers are agents of the Secretary in carrying out their
responsibilities under the Act. Certifiers' authority is derived from
their accreditation under the OFPA.
USDA, acting directly or through accredited certifiers, cannot
suspend or revoke a certification once granted without providing due
process of law, which requires providing an opportunity to be heard
before the suspension or revocation of certification.
A certified entity must be afforded the opportunity for a hearing
before certification can be suspended or revoked. Although private
certifiers have expressed considerable dissatisfaction with this
process, there is no legal mechanism to allow private certifiers to
suspend or revoke certifications. Thus, section 205.219(b) of our
proposed rule, stated that if a certifying agent had reason to believe
that a certified operation had violated the Act, the certifying agent
would recommend that USDA terminate certification. After review of the
recommendation, the Administrator of the Agricultural Marketing Service
could institute proceedings to terminate certification.
4. Options
USDA continues to review comments on this issue and to consider
various alternatives that would achieve the objectives expressed in the
comments. Options under consideration, along with USDA's assessment of
the pros and cons of each option, are listed below. USDA welcomes
alternative suggestions.
Option 1--Create a Uniform and Efficient Information System To Inform
the Public of USDA Actions To Suspend or Revoke Certification
Pros: Would provide timely information concerning the compliance
status of certified entities;
Provides necessary and timely information about the compliance
status of a certified entity during the pendency of an enforcement
action.
Cons: Does not fulfill commenters' desire for revocation authority
at the certifier level;
Does not fulfill commenters' desire for immediate revocation, since
certification would remain in full effect pending case resolution.
Option 2--Provide for an Expedited Process, Including Special Rules of
Practice and Shortened Time Frames, To Review Certifier Recommendations
and Make Determinations
Pros: Would provide due process;
Could result in quicker resolution of enforcement issues;
Might reduce enforcement costs for all parties to the dispute.
Cons: Does not fulfill commenters' desire for revocation authority
at the certifier level;
Does not fulfill commenters' desire for immediate revocation, since
certification would remain in full effect pending case resolution.
Option 3--Design an Informal Alternative Procedure To Resolve
Enforcement Issues on an Expedited Basis Short of an Adjudicatory
Hearing
Pros: Would provide due process;
Could result in quicker resolution of enforcement issues;
Might reduce enforcement costs for all parties to the dispute.
Cons: Does not fulfill commenters' desire for revocation authority
at the certifier level;
Does not fulfill commenters' desire for immediate revocation, since
certification would remain in full effect pending case resolution.
A 45-day comment period is provided for interested persons to
provide comment. This period is deemed appropriate because any comments
received will be considered in the development of a revised National
Organic Program proposed rule.
Authority: 7 U.S.C. 6501-6522.
Dated: October 23, 1998.
Eileen S. Stommes,
Deputy Administrator Transportation and Marketing.
[FR Doc. 98-28880 Filed 10-23-98; 2:54 pm]
BILLING CODE 3410-02-P