[Federal Register Volume 59, Number 70 (Tuesday, April 12, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8699]
[[Page Unknown]]
[Federal Register: April 12, 1994]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 93D-0259]
Action Levels for Aflatoxins in Animal Feeds; Revised Compliance
Policy Guide; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a revised Compliance Policy Guide (CPG) 7126.33
entitled ``Action Levels for Aflatoxins in Animal Feeds.'' The CPG
revises the action levels for aflatoxins in peanut products intended
for animal feed use (i.e., peanuts, peanut meal, peanut hulls, peanut
skins, and ground peanut hay) and provides guidance on levels of
aflatoxin contamination of peanut products intended for use in animal
feeds which, in the agency's view, may be necessary to support a charge
of adulteration under certain provisions of the Federal Food, Drug, and
Cosmetic Act (the act). FDA is inviting public comment concerning the
revised action levels for peanut products that contain aflatoxins and
that are shipped in interstate commerce for use in animal feeds.
DATES: Written comments by June 27, 1994.
ADDRESSES: Submit written requests for single copies of revised CPG
7126.33 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
revised CPG 7126.33 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
revised CPG 7126.33 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: Daniel G. McChesney, Center for
Veterinary Medicine (HFV-222), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1728.
SUPPLEMENTARY INFORMATION: FDA's use of action levels is defined in
Sec. 509.4(c)(1) (21 CFR 509.4(c)(1)) of FDA's regulations governing
unavoidable contaminants in animal food and food-packaging material.
FDA is announcing that it has revised CPG 7126.33 ``Action Levels for
Aflatoxins in Animal Feeds'' to reflect changes in the action levels
for aflatoxins in peanut products intended for animal feed use, in
accordance with Sec. 509.4(c)(2), and to provide guidance on levels of
aflatoxin contamination of peanut products. FDA is inviting public
comment on the revised action levels for aflatoxins in peanut products
shipped in interstate commerce and intended for certain food-producing
animals. The revised action levels are: (1) 100 parts per billion (ppb)
aflatoxins for peanut products intended for breeding beef cattle,
breeding swine, or mature poultry; (2) 200 ppb aflatoxins for peanut
products intended for finishing swine (i.e., 100 pounds or greater);
and (3) 300 ppb aflatoxins for peanut products intended for finishing
(i.e., feedlot) beef cattle.
The original 20 ppb action level remains unchanged for aflatoxins
in peanut products for use by immature animals, dairy animals, and for
aflatoxins in peanut products for which the intended use is not known
(CPG 7126.33). Both the revised action levels and the one that remains
unchanged were the subject of a memorandum that FDA's Associate
Commissioner for Regulatory Affairs issued on December 7, 1990, to the
FDA field offices (hereinafter referred to as the December 7, 1990,
memorandum) (Ref. 1).
Aflatoxins are added poisonous or added deleterious substances
which, depending upon their level in food or feed, may cause the food
or feed to be adulterated under section 402(a)(1) of the act (21 U.S.C.
342(a)(1)). This section states that a food (or feed) is deemed to be
adulterated if it bears or contains an added poisonous or deleterious
substance ``which may render [the food (or feed)] injurious to
health.'' If the government charges such a violation of the act, the
government must show that there is a reasonable possibility of harm.
Thus the action levels for aflatoxin are intended to represent levels
of contamination above which, in the agency's view, the government
could satisfy the ``may render it injurious'' test under section
402(a)(1) of the act.
Based on available scientific data, the agency believes that
consumption of products containing aflatoxins in excess of 20 ppb may
be injurious to the health of humans and immature animals, and that if
such products are fed to dairy cattle, aflatoxin residues in fluid milk
products that approach 0.5 ppb, the current action level for aflatoxin
residues in such products (CPG 7106.10), may result. In 1989, FDA
published revised action levels for aflatoxin in corn intended for use
in animal feed (Ref. 2). FDA revised the action levels, which appear in
CPG 7126.33, because it was able to further define subgroups for which
levels of aflatoxin greater than 20 ppb may be necessary to support a
``may be injurious to health'' charge of adulteration under section
402(a)(1) of the act. Thus, for finishing swine, aflatoxin levels in
excess of 200 ppb can support the charge, while levels above 300 ppb
aflatoxin in corn and peanut products can support a charge under
section 402(a)(1) of the act when the corn or peanut products are
intended for finishing (i.e., feedlot) beef cattle. For breeding beef
cattle, breeding swine, and mature poultry, corn and peanut products
containing aflatoxin in excess of 100 ppb aflatoxin can support the
adulteration charge. Furthermore, FDA concluded from its evaluation
that meat and eggs from these animals would not contain increased
residues of aflatoxin. For immature animals and dairy cows, aflatoxin
levels in excess of 20 ppb can support the adulteration charge. For all
other species and commodities the action level remains at 20 ppb until
revisions to CPG 7126.33 are warranted.
In deciding to revise the action levels for aflatoxin in peanut
products, FDA relied on the data in the support paper entitled
``Background Paper to Support Action Levels for Aflatoxin-Contaminated
Corn'' (Ref. 2). Based on this information, FDA concluded that the
inclusion of aflatoxin-contaminated peanut products in animal feed at
the revised action levels would have a negligible effect on the tissue
residue.
Accordingly, the agency has adopted and will use the revised action
levels as a basis for guiding its enforcement of section 402(a)(1) of
the act, provided FDA is assured that peanut products in interstate
commerce that contain more than 20 ppb aflatoxin are destined for the
appropriate subgroups of animals. Without such assurance, the agency
may conclude that the peanut products could be destined for humans,
immature animals, or dairy cattle and, if it bears or contains more
than 20 ppb aflatoxin, FDA believes that the Government would probably
prevail in an enforcement action charging adulteration under section
402(a)(1) of the act.
In December 7, 1990, memorandum (Ref. 1) the agency recognized that
all action levels, including those for aflatoxins, must be viewed and
used as guidance rather than a definitive enforcement standard. The
agency's action levels are not binding on the courts, the public
(including food producers), or the agency. (See 55 FR 20782 (May 21,
1990).) There may be situations where circumstances warrant enforcement
action at levels below an action level or where enforcement action is
not warranted even though an action level is exceeded. In considering
enforcement action where aflatoxin levels are below the pertinent
action level, FDA field offices must take into account the agency's
ability to support the adulteration charge that will be included in the
complaint. If a field office believes that enforcement action is
warranted at levels below an action level, then the recommendation for
enforcement action should include all compelling reasons for pursuing
such action. Similar consideration is required if a field office
believes that enforcement action where aflatoxin levels are above
pertinent action levels is not warranted.
The statements made in CPG 7126.33 are not intended to bind the
courts, the public, or FDA or to create or confer any rights,
privileges, immunities, or benefits on or for any private person, but
are intended merely for internal FDA guidance.
References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Memorandum from the Associate Commissioner for Regulatory
Affairs to the Regional Food and Drug Directors and District
Directors, December 7, 1990.
2. ``Background Paper to Support Action Levels for Aflatoxin-
Contaminated Corn,'' March 1989.
Interested persons may, on or before June 27, 1994, submit to the
Dockets Management Branch (address above) written comments regarding
this notice. Two copies of any comments are to be submitted, except
that individuals may submit one copy.
This notice is issued under 21 CFR 10.85.
Dated: March 28, 1994.
Gary Dykstra,
Acting Associate Commissioner for Regulatory Affairs.
[FR Doc. 94-8699 Filed 4-11-94; 8:45 am]
BILLING CODE 4160-01-F
