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

     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

     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,    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."

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-

     (b) Purpose. Studies must be conducted to determine residues in food
or feed resulting from treatment of food/feed handling establishments with

     (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,

     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.

            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
                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-
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
            (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,

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

     (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).

     (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.