CPG Sec 550.050 Canned Ackee, Frozen Ackee, and Other Ackee Products- Hypoglycin A Toxin

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CPG Sec. 550.050 Canned Ackee, Frozen Ackee,
and Other Ackee Products - Hypoglycin A
Toxin
You may submit either electronic or written comments regarding this guidance at any time.
Submit electronic comments to http://www.regulations.gov. Submit written comments to the
Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket
number listed in the notice of availability that publishes in the Federal Register.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Regulatory Affairs
April 2014
Contains Nonbinding Recommendations
Table of Contents
I. Introduction
II. Background
III. Policy
IV. Regulatory Action Guidance
V. Specimen Charges
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this
topic. It does not create or confer any rights for or on any person and does not operate to bind
FDA or the public. You can use an alternative approach if the approach satisfies the requirements

of the applicable statutes and regulations. If you want to discuss an alternative approach, contact
the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate
FDA staff, call the appropriate telephone number listed on the title page of this guidance.
I. Introduction:
The purpose of this Compliance Policy Guide is to provide guidance for FDA staff on canned
ackee, frozen ackee, and other ackee products that contain the toxin hypoglycin A.
FDA's guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should
be viewed only as recommendations, unless specific regulatory or statutory requirements are
cited. The use of the word should in Agency guidances means that something is suggested or
recommended, but not required.
II. Background:
Ackee is a tropical fruit that grows to be approximately 4 inches long when mature. The
immature, unripe fruit is green. When the healthy fruit is mature, the rind is yellow with more or
less of an overlay of bright red and has three bulging seams. As the fruit ripens, it splits open
along the seams into three sections revealing the edible part of the fruit, i.e., the fleshy, pale
yellow arils. At the top of the arils is a round, black, glossy, hard seed. Between the seed and
each aril is a pinkish membrane (raphe).
Hypoglycin A, a heat stable toxin, is found at high levels in the unripe arils, seeds, raphe, and
rind of ackee (roughly at a level of 1000 parts per million (ppm)). Ingestion of hypoglycin A may
result in no symptoms or symptoms that range from mild (e.g., some vomiting) to severe (e.g.,
vomiting with profound hypoglycemia, drowsiness, muscular exhaustion, prostration, and
possibly coma and death). When ackee is fully ripe, the hypoglycin A drops to negligible levels
in the arils and raphe, making them safe to consume (although the raphe is removed prior to
packaging). However, the rind and seeds still have high levels of hypoglycin A when the fruit is
fully ripe and should not be consumed. If the fruit is not properly processed, the finished product
may contain more than a negligible level of hypoglycin A and could pose a health risk.
Ackee can be picked from the tree when fully ripe (i.e., when the rind is fully open) and
processed the same day. However, the usual practice for most processors is to purchase fruit that
is mature (i.e., when the fruit is mostly yellow in color with more or less of an overlay of bright
red) and unopened or just beginning to split along the seams (i.e., when the fruit is not fully ripe).
The fruit is typically spread out on ripening racks where it continues to ripen (splitting wide
open). Processing staff monitor the fruit while it ripens looking for fruit that has fully opened and
is ready for processing. Staff will also remove and discard ackees that are not fit for processing
(e.g., fruits that fail to open). If the fruit does not ripen by splitting fully open within three to four
days, the fruit is discarded. If the fruit does ripen, there is a dramatic, rapid loss of hypoglycin A

in the arils and raphe. The ripened fruit is selected for processing and the outer rind and any
attached debris are removed and discarded. Additionally, the fruit is inspected for bruising or
damage to the arils or seeds and other blemishes that indicate the fruit is not suitable for
processing. Such bruised and damaged fruit are also discarded. Prior to further processing and
packaging, the black seeds and raphe are removed, and the arils are visually inspected for
damage, blemishes, or signs of spoilage. Prior to canning or freezing, the arils are carefully
washed in brine solutions. Additional visual inspections are performed to identify any arils that
show signs of damage or spoilage or signs of any raphe that may still be present. Although
complete removal of the raphe may not always be possible, if the fruit is fully ripe, the amount of
hypoglycin A in the raphe is negligible.
The presence of hypoglycin A in the finished ackee product at levels above 100 ppm can be
attributed to improper processing of the product and may pose a health risk. Problems during the
processing of ackee that can lead to potentially harmful levels of hypoglycin A above 100 ppm in
the finished product include (1) the inability of employees to identify and select fruit that is ripe
and fully opened; (2) purchasing fruit that appears ripened but may have been opened by the
supplier before the fruit is naturally ripe; (3) heat shocking the fruit to make it split open faster
than nature intended (such that the levels of hypoglycin A would not drop to negligible levels in
the arils and raphe); and (4) improper cleaning and washing of the arils.
FDA has determined that canned ackee, frozen ackee, or other ackee products containing
concentrations of hypoglycin A above 100 ppm have not been processed properly and that
finished product may be injurious to health.
III. Policy:
Under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
342(a)(4)), a food shall be deemed adulterated if it has been prepared, packed, or held under
insanitary conditions whereby it may have been rendered injurious to health. Canned ackee,
frozen ackee, and other ackee products may be considered adulterated within the meaning of
section 402(a)(4) of the FD&C Act when hypoglycin A is present in the food at levels greater
than 100 ppm.
Canned ackee, frozen ackee, and other ackee products offered for import and that appear to be
adulterated within the meaning of section 402(a)(4) of the FD&C Act in that the products appear
to have been prepared and packed under insanitary conditions whereby they may have been
rendered injurious to health, shall be refused admission under section 801(a)(3) of the FD&C Act
(21 U.S.C. 381(a)(3)).
IV. Regulatory Action Guidance:
The following represents criteria for recommending seizure or import refusal to CFSAN/Office
of Compliance/Division of Enforcement (HFS-605):

Canned ackee, frozen ackee, or other ackee product contains greater than 100 ppm of hypoglycin
A.
The method of analysis for hypoglycin A is described in the Journal of AOAC International,
volume 85, no. 4: 933-937, 2002 (G. Ware. “Method Validation Study of Hypoglycin A
Determination in Ackee Fruit”).
V. Specimen Charges:
Domestic Seizure
The article of food was adulterated when introduced into and while in interstate commerce and is
adulterated while held for sale after shipment in interstate commerce, within the meaning of 21
U.S.C. 342(a)(4), in that it has been prepared and packed under insanitary conditions whereby it
may have been rendered injurious to health.
Import Refusal
The article of food is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C
Act in that it appears to be adulterated within the meaning of section 402(a)(4) of the FD&C Act
in that it appears to have been prepared and packed under insanitary conditions whereby it may
have been rendered injurious to health.
Issued: 04/09/2014