United States Prevention, Pesticides EPA712-C-96-181
Environmental Protection and Toxic Substances August 1996
Agency (7101)
&EPA Residue Chemistry
Test Guidelines
OPPTS 860.1460
Food Handling
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INTRODUCTION
This guideline is one of a series of test guidelines that have been
developed by the Office of Prevention, Pesticides and Toxic Substances,
United States Environmental Protection Agency for use in the testing of
pesticides and toxic substances, and the development of test data that must
be submitted to the Agency for review under Federal regulations.
The Office of Prevention, Pesticides and Toxic Substances (OPPTS)
has developed this guideline through a process of harmonization that
blended the testing guidance and requirements that existed in the Office
of Pollution Prevention and Toxics (OPPT) and appeared in Title 40,
Chapter I, Subchapter R of the Code of Federal Regulations (CFR), the
Office of Pesticide Programs (OPP) which appeared in publications of the
National Technical Information Service (NTIS) and the guidelines pub-
lished by the Organization for Economic Cooperation and Development
(OECD).
The purpose of harmonizing these guidelines into a single set of
OPPTS guidelines is to minimize variations among the testing procedures
that must be performed to meet the data requirements of the U. S. Environ-
mental Protection Agency under the Toxic Substances Control Act (15
U.S.C. 2601) and the Federal Insecticide, Fungicide and Rodenticide Act
(7U.S.C. I36,etseq.).
Final Guideline Release: This guideline is available from the U.S.
Government Printing Office, Washington, DC 20402 on The Federal Bul-
letin Board. By modem dial 202-512-1387, telnet and ftp:
fedbbs.access.gpo.gov (IP 162.140.64.19), internet: http://
fedbbs.access.gpo.gov, or call 202-512-0132 for disks or paper copies.
This guideline is also available electronically in ASCII and PDF (portable
document format) from the EPA Public Access Gopher (gopher.epa.gov)
under the heading "Environmental Test Methods and Guidelines."
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OPPTS 860.1460 Food handling.
(a) Scope—(1) Applicability. This guideline is intended to meet test-
ing requirements of both the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) (7 U.S.C. 136, et seq.) and the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301, et seq.}.
(2) Background. The source material used in developing this har-
monized OPPTS test guideline is OPP 171-4 Results of Tests on the
Amount of Residue Remaining, Including A Description of the Analytical
Methods Used (Pesticide Assessment Guidelines, Subdivision O: Residue
Chemistry, EPA Report 540/09-82-023, October 1982). This OPPTS
guideline should be used in conjunction with OPPTS 860.1000, Back-
ground.
(b) Purpose. Studies must be conducted to determine residues in food
or feed resulting from treatment of food/feed handling establishments with
pesticides.
(c) Definitions. Terms used in this guideline have the meanings set
forth at 40 CFR 162.3 and at 40 CFR part 158. In addition, for the purposes
of this guideline, the following definitions apply:
Crack and crevice treatment is application of small amounts of pes-
ticides into cracks and crevices in which pests hide or through which they
may enter a building. Such openings commonly occur at expansion joints,
between different elements of construction, and between equipment and
floors. These openings may lead to voids such as hollow walls, equipment
legs and bases, conduits, motor housings, and junction or switch boxes.
Food areas of food handling establishments include areas for receiv-
ing, serving, storing (dry, cold, frozen, raw), packaging (canning, bottling,
wrapping, boxing), preparing (cleaning, slicing, cooking, grinding), storing
edible waste, and enclosed processing systems (mills, dairies, edible oils,
syrups).
A food handling establishment is an area or place other than a private
residence in which food is held, processed, prepared, and/or served.
General treatment is application to broad expanses of surfaces such
as walls, floors, and ceilings, or as an outside treatment.
Nonfood areas of food handling establishments include garbage room,
lavatories, floor drains (to sewers), entries and vestibules, offices, locker
rooms, machine rooms, boiler rooms, garages, mop closets, and storage
(after canning or bottling).
Space treatment is the dispersal of pesticides into the air by foggers,
misters, aerosol devices or vapor dispensers for control of flying pests.
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Spot treatment is application to limited areas where pests are likely
to occur, but which will not be in contact with food or utensils and will
not ordinarily be contacted by workers. Those areas may occur on floors,
walls, and bases or undersides of equipment. For this purpose, a "spot"
will not exceed 2 ft2.
(d) Procedure. (1) Establishments to be treated will be typical com-
mercial operations selected from among the various types listed under each
of the categories shown in the following Table 1.:
Table I—Categories and Representative Types of Food Handling Establishments
Category
Representative Types
Food services1
Manufacturing establishments2
Processing establishments3
Restaurants, cafeterias, taverns, delicatessens, mess halls,
school and institutional dining areas, hospitals, mobile
canteens, vending machines, grocery stores and mar-
kets.
Plants engaged in the manufacture of candy, ice cream,
spaghetti or macaroni, food mixes, or breakfast cereal
and bakeries, breweries, wineries, soft drink bottling
plants, pizza plants.
Plants engaged in the slaughtering and/or packing of
meats, poultry, and seafood; dairies and plants engaged
in the processing of dairy products; plants engaged in
the processing of spices and herbs, edible fats and oils,
beverages (coffee, tea), and frozen fresh food; fruit and
vegetable canneries; pickle factories; grain mills.
1 Any food handling establishment whose principal business involves the sale of food directly to the
consuming public. The manufacture and/or processing of food by such an establishment is only inciden-
tal to achieving its principal business objective.
2 Any food handling establishment whose principal business involves the production and/or packag-
ing of man-made foods which are normally intended for sale through or by food service establishments.
Such foods generally comprise two or more ingredients which have been altered in such a manner as
to change their basic identity.
3 Any food handling establishment whose principal business involves the upgrading and/or preserva-
tion of raw agricultural commodities in such a manner as to maintain their essential identity. Such estab-
lishments may sell their product directly to the consuming public and/or food service or food handling
establishments.
(2) Data obtained from tests conducted in two different types of estab-
lishments in each category will normally be adequate for clearance of the
pesticide for use in all types of establishments defined by the category
of which the test establishment is a part. Careful judgment will have to
be applied in selecting the types of establishments to be tested as well
as the number of tests necessary in order to ensure adequate representation
of that category. More than two types of establishments may require test-
ing as the individual case indicates. Existing sanitation programs and prac-
tices, as well as the type of building construction (wood, cement block,
etc.) at a plant site, are important factors that should be considered. Usage
will normally involve application of the pesticide as a space, general, spot,
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or crack and crevice treatment, and will include both nonfood and food
areas of the establishment used as the test site. Acceptable results from
a test of the most rigorous type of treatment (space > general > spot >
crack and crevice) will preclude need for residue tests involving less rigor-
ous treatments, and will allow registration of the pesticide for use by the
less rigorous methods. In fact, in many cases, one thorough study rep-
resenting worst-case residues will suffice to cover use in all types of estab-
lishment. Petitioners are advised to submit a protocol before initiating a
residue study intended to support use in food handling establishments.
Treatment of establishments for purposes of this test should be performed
in accordance with proposed labeling.
(3) The experiment should be designed to reflect all possible avenues
of contamination, taking into account the physical and chemical properties
of the pesticide, proximity of foods and protective barriers as may be spec-
ified in the regulation, mode of application, and use restrictions.
(4) Consideration should be given to at least the following residue
transfer routes where applicable:
(i) Direct deposition of spray droplets on foods, direct absorption of
fumigant, or airborne dust particles.
(ii) Volatilization of residual deposits and subsequent absorption into
foods.
(iii) Direct transfer of residues from treated spaces (countertops, cup-
boards, utensils, packaging materials, etc.).
(iv) Volatilization with condensation on surfaces where food is subse-
quently placed.
(v) Leakage or weeping of the chemical from devices or impregnated
materials hung in food establishments for pest control.
(vi) Transfer of the pesticide through pesticide barriers (e.g. from im-
pregnated shelf papers to packaged food).
(vii) Tracking of residues from bait stations or sprayed areas to foods
or food contact surfaces by pests, or contamination from fallen insects.
(viii) Deposition of solid or crystalline chemicals resulting from re-
peated sprays on ceilings over food handling areas.
(ix) Distribution of vapors, droplets, or particulate matter through
forced ventilation systems (central air conditioning, duct heating systems).
(x) Distribution of residues in continuous process food operations
from treatment of ends and tailings, conveyor lines, boats, etc, when oper-
ation is shut down (e.g. flour mills).
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(5) Many sources of contamination may be eliminated (or greatly di-
minished) through restrictions, variations in the mode of application, type
of establishment treated or nature of the product or formulation. Data
should be submitted to establish the relative importance of these factors
on the levels of residue which may be expected to result from the pes-
ticidal application. Experiments should be conducted by analyses of rep-
resentative foods subjected to exposure by any of the above routes which
are potential avenues of contamination.
(6) The selection of samples for analyses in the more specialized uses,
e.g. flour mills, would be apparent. In the more generalized exposure situa-
tions, e.g. grocery stores, it is suggested that the selection of samples for
analyses represent a range of foods such as an oily food (e.g. butter), baked
cereal products (e.g. bread), beverages (e.g. milk), raw and processed
meats, and fresh fruits and vegetables (e.g. lettuce).
(7) In order to demonstrate the residues resulting from the wide vari-
ation of conditions anticipated in actual situations, and to gauge the poten-
tial for misuse, the experiment should include some exaggerated exposure.
This might include spraying at a 2x rate, exposure of foods for longer
periods than might normally be expected, or even exposure of some foods
when there is a restriction to cover foods when treating.
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