18 December 2001
Source:
http://www.access.gpo.gov/su_docs/aces/fr-cont.html
[Federal Register: December 18, 2001 (Volume 66, Number 243)]
[Notices]
[Page 65214]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18de01-102]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01D-0503]
Draft Compliance Policy Guide: ``Filth from Insects, Rodents, and
Other Pests in Food;'' Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft compliance policy guide (CPG) currently
entitled ``Filth from Insects, Rodents, and Other Pests in Food.'' The
purpose of this draft CPG is to revise, clarify, and redefine existing
guidance on the interpretation of filth in foods within the context of
current science. The draft CPG will provide written guidance to FDA
components as well as to the industry.
DATES: Submit written or electronic comments on this draft CPG by
February 19, 2002.
ADDRESSES: Submit written requests for single copies of the draft CPG
``Filth from Insects, Rodents, and Other Pests in Food'' to the
Director, Division of Compliance Policy (HFC-230), Office of
Enforcement, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857. Send two self-addressed adhesive labels to assist
that office in processing your request, or FAX your request to 301-827-
0482. See the SUPPLEMENTARY INFORMATION section for electronic access
to the document.
Submit written comments on the draft CPG to the Dockets Management
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit electronic comments to http://
www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT:
Technical Questions Concerning Filth in Foods: Alan R. Olsen,
Microanalytical Branch (HFS-315), Office of Plant, Dairy Foods, and
Beverages, Center for Food Safety and Applied Nutrition, Food and Drug
Administration, 200 C St. SW., Washington, DC 20204, 202-205-4438, FAX
202-205-4091.
Questions Concerning Regulatory Actions: MaryLynn Datoc, Division
of Compliance Policy (HFC-230), Office of Enforcement, Office of
Regulatory Affairs, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-0413, FAX 301-827-0482.
SUPPLEMENTARY INFORMATION:
I. Background
FDA has developed a draft CPG to revise, clarify, and redefine
existing guidance on foods that contain filth from insects, rodents,
and other pests to reflect recent advances in science. The purpose of
this draft CPG is to provide clear policy to FDA's field and
headquarters staff with regard to filth from insects, rodents, and
other pests in foods. It also contains information that may be useful
to the regulated industry and to the public.
The draft CPG, when finalized, will supersede the current CPG and
represents the agency's current thinking on the subject. It does not
create or confer any rights for or on any person and does not operate
to bind FDA or the public. An alternative approach may be used if such
an approach satisfies the requirements of applicable statutes or
regulations.
This level 1 guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115).
II. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written or electronic comments on the draft CPG
entitled ``Filth from Insects, Rodents, and Other Pests in Food.'' Two
copies of any comments are to be submitted, except that individuals may
submit one copy. Comments should be identified with the docket number
found in brackets in the heading of this document. A copy of the draft
CPG and received comments may be seen in the Dockets Management Branch
(address above) between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Copies of the draft CPG may also be downloaded to a personal
computer with access to the Internet. The Office of Regulatory Affairs
home page includes the draft CPG and may be accessed at http://
www.fda.gov/ora under ``Compliance References.''
Dated: December 11, 2001.
Dennis E. Baker,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 01-31024 Filed 12-17-01; 8:45 am]
BILLING CODE 4160-01-S
Source: http://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-600.html
(Draft - Not for Implementation)
Sec. 555.600 - Filth *from Insects, Rodents, and Other Pests* in Foods (CPG 7120.18)
INTRODUCTION
This draft compliance policy document will be an update to the Compliance Policy Guides Manual (2000 edition). It is a revised Compliance Policy Guide and will be included in the next printing of the Compliance Policy Guides Manual once finalized. It is intended for FDA personnel and may also be used by the industry. It is available to the public. This draft guidance document represents the Agency's current thinking on filth from insects, rodents, and other pests based on recent advances in science. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulation, or both.
BACKGROUND
*Recent scientific advances have increased the precision of the scientific criteria used to interpret the regulatory significance of adulteration involving insects, rodents, and other pests in foods. The revisions of this guideline are based on those advances in science.*
*TERMS AND DEFINITIONS:
Attraction - drawn by a sensory stimulus such as odor, color, etc. Observations indicating the presence of pests exhibiting attraction include, but are not limited to:
1. Inspectional observations such as live flies observed on exposed product in cutting room (attracted to human food) or rodent tracks observed in dust in a trash disposal area (attracted to filth).Or
2. Analytical observations such as a filth exhibit identified as one insect entrance hole, 1/4 inch in diameter, penetrating to inside of a product container (attracted to human food) or static material found to contain one egg case of the oriental cockroach (attracted to filth).
Communicative behavior - oscillating between filth (e.g., garbage, mammalian excreta or other sources of pathogens) and human food. Observations indicating the presence of pests exhibiting communicative behavior include, but are not limited to:
1. Inspectional observations such as a rodent runway exhibiting smear marks and numerous rodent excreta pellets observed between a garbage can and a raw materials storage bin.Or
2. Analytical observations such as finding filth from the American cockroach in a filth exhibit of food product and finding cockroach excreta in a filth exhibit collected from the toilet facility.
Endophily - observed willingness to enter buildings. Observations indicating the presence of pests exhibiting endophily include, but are not limited to:
1. Inspectional observations such as live cockroaches observed on the north wall approximately 10 feet from the northeast corner inside building A of the production plant.Or
2. Analytical observations such as striated hair identified as belonging to the Asian musk shrew, Suncus murinus, an endophilic species.
Exophily - observed reluctance to enter buildings. Observations indicating the presence of pests exhibiting exophily include, but are not limited to:
1. Inspectional observations such as live sparrows observed on the roof over the open loading dock door on the south side of a building but no sparrows observed entering the building.Or
2. Analytical observations such as a filth exhibit identified as the corn earworm, an exophilic insect.
Synanthropy - association with humans or their dwellings. Observations indicating the presence of pests exhibiting synanthropy include, but are not limited to:
1. Inspectional observations such as live flies observed in the vicinity of the main production facility, both inside and outside the facility.Or
2. Analytical observations such as a filth exhibit identified as one adult house fly, Musca domestica L., a synanthropic species.
POLICY:
Regulatory action criteria are organized into three categories: vectors (pests that carry pathogens from one host, source or place to another), indicators of insanitary conditions, and incidental pests. Each category has a unique forensic profile to interpret the regulatory significance of adulteration from potentially food-contaminating pests.
The following forensic profiles are used to interpret the regulatory significance of adulteration from food-contaminating pests.
Forensic Category I. Vectors
This category includes vectors of foodborne pathogens regardless of whether a microbiological hazard is detected. A pest should meet all of the attributes in the following profile in order to be placed in category I:
1. Synanthropy
2. Endophily
3. Attraction to filth and to human food
4. Communicative behavior
5. Past or present evidence that foodborne pathogens are associated with natural populations of the pest
Examples include, but are not limited to: house fly, oriental cockroach, pharaoh ant, house mouse.
Forensic Category II. Pests that are Indicators of Insanitation.
This category includes pests whose presence in food or in the vicinity of food processing or storage areas is an indication of insanitary conditions. A pest should meet all of the attributes of any one of the following profiles (A., B., or C.) in order to be placed in Category II.
A. Opportunistic Pests
1. Synanthropy
2. Endophily
3. Attraction to stored food
4. Communicative behavior
Examples include, but are not limited to: common silverfish, Argentine ant, lesser bandicoot rat.
B. Adventive Pests
1. Synanthropy
2. Endophily
3. A lack of attraction to stored food
4. A lack of communicative behavior
Examples include, but are not limited to: cluster fly, cellar spider, pigeon, little brown bat.
C. Obligatory Pests (storage insects and other stored-product pests)
1. Synanthropy
2. Endophily
3. Attraction to stored food
4. A lack of communicative behavior
Examples include, but are not limited to: granary weevil, confused flour beetle, cigarette beetle, Indianmeal moth, cheese skipper, booklouse.
D. Parasites and Predators
1. synanthropy
2. endophily
3. attraction to a host or prey that fits a profile from category I or category II
Examples include, but are not limited to: lesser ensign wasp, warehouse pirate bug, window pane fly, house pseudoscorpion.
Forensic Category III. Incidental Pests
This category includes agricultural pests, nuisance pests and other incidental pests that do not meet the attributes of one of the profiles described in category I and category II.*
Specific numerical defect action levels for *incidental pests* or insect fragments in foods (refer to Food Defect Action Levels, 1998, Industry Activities Staff, HFS-565, FDA, 200 C Street, S.W., Washington, DC 20204) do not include *category I pests or category II pests, unless there are specific references to category I or category II pests* in the Regulatory Action Guidance section of the Compliance Policy Guide.
For guidance regarding insect contamination resulting from insanitary storage conditions, refer to
*(a) Sec. 555.500 (for CPG 7120.24) All Food Sanitation (Including Bacteriological) Inspections - Classification of Establishmentsand
(b)* Sec. 580.100 (for CPG 7103.01) Food Storage and Warehousing - Adulteration - Filth (Domestic and Import).
*For lists of additional examples of pests in the various categories, refer to Fundamentals of Microanalytical Entomology: A Practical Guide to Detecting and Identifying Filth in Foods. A.R. Olsen, T.H. Sidebottom and S.A. Knight, editors. CRC Press. 1996.*
*Material between asterisks is new or revised.*
Issued: 1/1/73
Revised: 11/9/79, 2/1/89
Reissued: 10/1/80
Revised: 12/11/2001 [DRAFT-Not for Implementation - See Federal Register
notice published on 12/18/2001]
_______________________________
Page created: tc December 17, 2001