[Federal Register Volume 59, Number 140 (Friday, July 22, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-17813]
[[Page Unknown]]
[Federal Register: July 22, 1994]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94D-0051]
Guideline for Establishing a Safe Concentration; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guideline entitled ``Guideline for Establishing a
Safe Concentration.'' This guideline includes information and guidance
to regulated industry and the public on food factors. This guideline is
being made available as a revision to a document entitled ``General
Principles for Evaluating the Safety of Compounds Used in Food-
Producing Animals'' which is a compilation of eight guidelines
(hereinafter referred to as ``the compilation''). The new guideline
replaces guideline IV entitled ``Guideline for Establishing a
Tolerance,'' which is no longer in effect.
DATES: Written comments may be submitted at any time.
ADDRESSES: Submit written requests for single copies of the guideline
to the Communications and Education Branch (HFV-12), Center for
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send two self-addressed adhesive labels to assist
that office in processing your requests. Submit written comments on the
guideline to the Dockets Management Branch (HFA-305), Food and Drug
Administration, rm. 1-23, 12420 Parklawn Dr., Rockville, MD 20857.
Requests and comments should be identified with the docket number found
in brackets in the heading of this document. A copy of the compilation
which includes the new guideline entitled ``Guideline for Establishing
a Safe Concentration'' and received comments are available for public
examination in the Dockets Management Branch between 9 a.m. and 4 p.m.,
Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Margaret A. Miller, Center for
Veterinary Medicine (HFV-156), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1692.
SUPPLEMENTARY INFORMATION: In the Federal Register of December 31, 1987
(52 FR 49589) FDA announced the availability of a compilation of seven
guidelines entitled ``General Principles for Evaluating the Safety of
Compounds Used in Food-Producing Animals.'' The compilation was issued
in accordance with FDA's requirement under the general safety
provisions of sections 409, 512, and 706 of the Federal Food, Drug, and
Cosmetic Act (the act) to determine whether each food additive, new
animal drug, or color additive proposed for use in food-producing
animals is safe for those animals and whether the edible products
derived from treated animals are safe. The pertinent regulations
implementing the statutory provisions are in 21 CFR part 70, 21 CFR
514.1, and 21 CFR part 570.
Under the act, the sponsor of a compound is required to furnish FDA
with the scientific data necessary for demonstrating that residues of
the sponsored compound in the edible products of treated animals are
safe. The compilation was developed to inform sponsors of the
scientific data that FDA believes will provide an acceptable basis for
determining the safety of the compound.
Guidelines state procedures or practices that may be useful to the
persons to whom they are directed, but are not legal requirements.
Guidelines represent the agency's position on a procedure or a practice
at the time of their issuance. A person may follow a guideline or
choose to follow alternate procedures or practices. If a person chooses
to use alternate procedures or practices, then that person may wish to
discuss the matter further with the agency to prevent an expenditure of
money and effort on activities that may later be determined to be
unacceptable to FDA. A guideline does not bind the agency, and it does
not create or confer any rights, privileges, or benefits for or on any
person. When a guideline states a requirement imposed by statute or
regulation, however, the requirement is law and its force and effect
are not changed in any way by virtue of its inclusion in the guideline.
FDA is announcing the availability of a new guideline entitled
``Guideline for Establishing a Safe Concentration'' that includes
information and guidance to regulated industry and the public on food
factors. This guideline is being made available as a revision to the
compilation and replaces guideline IV entitled ``Guideline for
Establishing a Tolerance,'' which is no longer in effect.
The new guideline sets out new consumption values that FDA's Center
for Veterinary Medicine (CVM) will use in partitioning the Acceptable
Daily Intake (ADI) for drug residues among the edible products of food
producing animals. The new daily consumption values for total red meats
and poultry, across all species, are 300 grams (g) of meat (as muscle
tissue), 100 g of liver, 50 g of kidney, 50 g of fat, 100 g of eggs,
and 1.5 liters (l) of milk. These values are a more realistic estimate
of actual food consumption than the values currently used by CVM.
CVM will continue to regulate eggs and milk as independent
commodities, which means that these products are not considered
components of the 500 g of edible muscle and organ tissues. The intake
estimate of milk will remain 1.5 l. CVM will now assume, however, that
an individual consumes an entire portion of meat and edible tissues and
an entire portion of milk on a daily basis. Therefore, a part of the
ADI will be reserved for milk when evaluating products approved in
lactating dairy cows and products seeking approval in both lactating
dairy cows and another animals species. The other part of the ADI will
be partitioned among the animal tissues as described above. For
products approved in both laying hens and other animals, a part of the
ADI will be reserved for eggs.
In addition to incorporating the new food factors, the concept of
negligible tolerance has been omitted from the new guideline because
CVM usually can establish a finite or zero tolerance when assessing the
safety of a drug.
Interested persons may, at any time, submit to the Dockets
Management Branch (address above) written comments on the guideline.
Two copies of any comments are to be submitted, except that individuals
may submit one copy. Comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
Received comments will be considered in determining whether further
revision of the guideline is necessary.
A copy of the compilation which includes the new guideline entitled
``Guideline for Establishing a Safe Concentration,'' is available for
public examination in the office above, between 9 a.m. and 4 p.m.,
Monday through Friday.
Dated: July 15, 1994.
Michael R. Taylor,
Deputy Commissioner for Policy.
[FR Doc. 94-17813 Filed 7-21-94; 8:45 am]
BILLING CODE 4160-01-F
