[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR180.1]

[Page 312-315]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 180--TOLERANCES AND EXEMPTIONS FROM TOLERANCES FOR PESTICIDE CHEMICALS 
IN FOOD--Table of Contents
 
          Subpart A--Definitions and Interpretative Regulations
 
Sec. 180.1  Definitions and interpretations.

                     Definitions and Interpretations


    (a) Administrator, without qualification, means the Administrator of 
the Environmental Protection Agency.
    (b) Agency, without qualification, means the Environmental 
Protection Agency.
    (c) [Reserved]
    (d) Registration Division means the unit established within the 
Environmental Protection Agency charged with administration of the 
Pesticide Residue amendment to the Federal Food, Drug, and Cosmetic Act 
(section 408).
    (e) Raw agricultural commodities include, among other things, fresh 
fruits, whether or not they have been washed and colored or otherwise 
treated in their unpeeled natural form; vegetables in their raw or 
natural state, whether or not they have been stripped of their outer 
leaves, waxed, prepared into

[[Page 313]]

fresh green salads, etc.; grains, nuts, eggs, raw milk, meats, and 
similar agricultural produce. It does not include foods that have been 
processed, fabricated, or manufactured by cooking, freezing, 
dehydrating, or milling.
    (f) Where raw agricultural commodities bearing residues that have 
been exempted from the requirement of a tolerance, or which are within a 
tolerance permitted under section 408 are used, the processed foods will 
not be considered unsafe within the meaning of section 406 if:
    (1) The poisonous or deleterious pesticide residues have been 
removed to the extent possible in good manufacturing practice; and
    (2) The concentration of the pesticide in the preserved or processed 
food when ready to eat is not greater than the tolerance permitted on 
the raw agricultural commodity.
    (g) For the purpose of computing fees as required by Sec. 180.33, 
each group of related crops listed in Sec. 180.34(e) and each crop group 
or subgroup listed in Sec. 180.41 is counted as a single raw 
agricultural commodity in a petition or request for tolerances or 
exemption from the requirement of a tolerance.
    (h) Tolerances and exemptions established for pesticide chemicals in 
or on the general category of raw agricultural commodities listed in 
column A apply to the corresponding specific raw agricultural 
commodities listed in column B. However, a tolerance or exemption for a 
specific commodity in column B does not apply to the general category in 
column A.

----------------------------------------------------------------------------------------------------------------
                       A                                                        B
----------------------------------------------------------------------------------------------------------------
Alfalfa.......................................  Medicago sativa, (alfalfa, lucerne); Onobrychio viciaefolia
                                                 (sainfoin, holy clover, esparcet); and Lotus corniculatus
                                                 (birdsfoot trefoil); and varieties and/or hybrids of these.
Bananas.......................................  Bananas, plantains.
Beans.........................................  Cicer arietinum (chick peas, garbanzo beans); Lupinus spp.
                                                 (including sweet lupine, white sweet lupine, white lupine, and
                                                 grain lupine). Phaseolus spp. (including kidney beans, lima
                                                 beans, mung beans, navy beans, pinto beans, snap beans, and
                                                 waxbeans); Vicia faba (broad beans, fava beans); Vigna spp.
                                                 (including asparagus beans, blackeyed peas and cowpeas).
Beans (dry)...................................  All beans above in dry form only.
Beans (succulent).............................  All beans above in succulent form only.
Blackberries..................................  Rubus eubatus (including bingleberries, black satin berries,
                                                 boysenberries, Cherokee blackberries, Chesterberries, Cheyenne
                                                 blackberries, coryberries, darrowberries, dewberries, Dirksen
                                                 thornless berries, Himalayaberries, hullberries, Lavacaberries,
                                                 lowberries, Lucretiaberries, mammoth blackberries,
                                                 marionberries, nectarberries, olallieberries, Oregon evergreen
                                                 berries, phenomenalberries, rangerberries, ravenberries,
                                                 rossberries, Shawnee blackberries, and varieties and/or hybrids
                                                 of these).
Broccoli......................................  Broccoli, chinese broccoli (gia lon, white flowering broccoli).
Cabbage.......................................  Cabbage, Chinese cabbage (tight-heading varieties only).
Caneberries...................................  Rubus spp. (including blackberries; Rubus caesius (youngberry);
                                                 Rubus loganbaccus (loganberry); Rubus occidentalis, idaeus, and
                                                 strigosus (red and black raspberries); and varieties and/or
                                                 hybrids of these.
Celery........................................  Celery, Florence fennel (sweet anise, sweet fennel, finochio)
                                                 (fresh leaves and stalks only).
Cherries......................................  Sour cherries, sweet cherries.
Citrus fruits.................................  Grapefruit, lemons, limes, oranges, tangelos, tangerines, citrus
                                                 citron, kumquats, and hybrids of these.
Endive........................................  Endive, escarole.
Lettuce.......................................  Lettuce, head; and lettuce, leaf
Lettuce, head.................................  Lettuce, head; crisphead varieties only
Lettuce, leaf.................................  Lettuce, leaf; cos (romaine), butterhead varieties
Marjoram......................................  Origanum spp. (includes sweet or annual marjoram, wild marjoram
                                                 or oregano, and pot marjoram).
Melons........................................  Muskmelons, including hybrids and/or varieties of Cucumis melo
                                                 (including true cantaloupe, cantaloupe, casaba, Santa Claus
                                                 melon, crenshaw melon, honeydew melon, honey balls, Persian
                                                 melon, golden pershaw melon, mango melon, pineapple melon,
                                                 snake melon); and watermelons, including hybrids and/or
                                                 varieties of (Citrullus spp.).
Muskmelons....................................  Cucumis melo (includes true cantaloupe, cantaloupe, casaba,
                                                 Santa Claus melon, crenshaw melon, honeydew melon, honey balls,
                                                 Persian melon, golden pershaw melon, mango melon, pineapple
                                                 melon, snake melon, and other varieties and/or hybrids of
                                                 these.)
Onions........................................  Dry bulb onions, green onions, and garlic.
Onions (dry bulbs only).......................  Garlic, onions (dry bulbs only), shallots (dry bulbs only).
Onions, green.................................  Green onions, leeks, spring onions or scallions, Japanese
                                                 bunching onions, green shallots, or green eschalots.
Oriental radish (root and tops)...............  Raphanus sativus var. longipinnatus (root and tops), including
                                                 Chinese or Japanese radish (both white and red), winter radish,
                                                 daikon, lobok, lo pak, and other cultivars and/or hybrids of
                                                 these.
Peaches.......................................  Peaches, nectarines

[[Page 314]]


Peas..........................................  Cajanus cajan (includes pigeon peas); Cicer spp. (includes chick
                                                 peas and garbanzo beans); Lens culinaris (lentils); Pisum spp.
                                                 (includes dwarf peas, garden peas, green peas, English peas,
                                                 field peas, and edible pod peas). [Note: A variety of pesticide
                                                 tolerances have been previously established for peas and/or
                                                 beans. Chick peas/garbanzo beans are now classified in both the
                                                 bean and the pea categories. For garbanzo beans/chick peas
                                                 ONLY, the highest established pea or bean tolerance will apply
                                                 to pesticide residues found in this commodity.]
Peas (dry)....................................  All peas in dry form only.
Peas (succulent)..............................  All peas in succulent form only.
Peppers.......................................  All varieties of peppers including pimentos and bell, hot, and
                                                 sweet peppers.
Rapeseed......................................  Brassica napus, B. campestris, and Crambe abyssinica (oilseed-
                                                 producing varieties only which include canola and crambe.)
Sorghum (grain)...............................  Sorghum spp. [sorghum (grain), sudangrass (seed crop), and
                                                 hybrids of these grown for its seed].
Sorghum (fodder, forage)......................  Sorghum ssp. [(sorghum (fodder, forage), sudangrass, and hybrids
                                                 of these grown for fodder and/or forage)].
Squash........................................  Pumpkins, summer, and winter squash.
Sugar apple...................................  Annona squamosa L. (sugar apple, sweetsop, anon), and its hybrid
                                                 A. squamosa L.xA. cherimoya M. (atemoya). Also A. reticulata L.
                                                 (true custard apple).
Summer squash.................................  Fruits of the gourd (Cucurbitaceae) family that are consumed
                                                 when immature, 100% of the fruit is edible either cooked or
                                                 raw, once picked it cannot be stored, has a soft rind which is
                                                 easily penetrated, and if seeds were harvested they would not
                                                 germinate; e.g., Cucurbita pepo (i.e., crookneck squash,
                                                 straightneck squash, scallop squash, and vegetable marrow);
                                                 Lagenaria spp. (i.e., spaghetti squash, hyotan, cucuzza); Luffa
                                                 spp. (i.e., hechima, Chinese okra); Momordica spp. (i.e.,
                                                 bitter melon, balsam pear, balsam apple, Chinese cucumber);
                                                 Sechium edule (chayote); and other cultivars and/or hybrids of
                                                 these.
Sweet potatoes................................  Sweet potatoes, yams.
Tangerines....................................  Tangerines (mandarins or mandarin oranges); tangelos, tangors,
                                                 and other hybrids of tangerine with other citrus.
Tomatoes......................................  Tomatoes, tomatillos.
Turnip tops or turnip greens..................  Broccoli raab (raab, raab salad), hanover salad, turnip tops
                                                 (turnip greens).
Wheat.........................................  Wheat, triticale.
----------------------------------------------------------------------------------------------------------------

    (i) Unless otherwise specified, tolerances and exemptions 
established under the regulations in this part apply to residues from 
only preharvest application of the chemical.
    (j) Unless otherwise specified in this paragraph or in tolerance 
regulations prescribed in this part for specific pesticide chemicals, 
the raw agricultural commodity to be examined for pesticide residues, 
shall consist of the whole raw agricultural commodity.
    (1) The raw agricultural commodity bananas, when examined for 
pesticide residues, shall not include any crown tissue or stalk.
    (2) Shell shall be removed and discarded from nuts before 
examination for pesticide residues.
    (3) Caps (hulls) shall be removed and discarded from strawberries 
before examination for pesticide residues.
    (4) Stems shall be removed and discarded from melons before 
examination for pesticide residues.
    (5) Roots, stems, and outer sheaths (or husks) shall be removed and 
discarded from garlic bulbs and dry bulb onions, and only the garlic 
cloves and onion bulbs shall be examined for pesticide residues.
    (6) Where a tolerance is established on a root vegetable including 
tops and/or with tops, and the tops and the roots are marketed together, 
they shall be analyzed separately and neither the pesticide residue on 
the roots nor the pesticide residue on the tops shall exceed the 
tolerance level, except that in the case of carrots, parsnips, and 
rutabagas, the tops shall be removed and discarded before analyzing 
roots for pesticide residues.
    (7) The crowns (leaves at the top of the fruit) shall be removed and 
discarded from pineapples before examination for pesticide residues.
    (8) The term lima beans means the beans and the pod.
    (9) The term peanuts means the peanut meat after removal of the 
hulls.
    (k) The term pesticide chemical means any substance that is a 
pesticide within the meaning of the Federal Insecticide, Fungicide, and 
Rodenticide Act, including all active and inert ingredients of such 
pesticide.
    (l) The term negligible residue means any amount of a pesticide 
chemical remaining in or on a raw agricultural commodity or group of raw 
agricultural commodities that would result in

[[Page 315]]

a daily intake regarded as toxicologically insignificant on the basis of 
scientific judgment of adequate safety data. Ordinarily this will add to 
the diet an amount which will be less than 1/2,000th of the amount that 
has been demonstrated to have no effect from feeding studies on the most 
sensitive animal species tested. Such toxicity studies shall usually 
include at least 90-day feeding studies in two species of mammals.
    (m) The term nonperishable raw agricultural commodity means any raw 
agricultural commodity not subject to rapid decay or deterioration that 
would render it unfit for consumption. Examples are cocoa beans, coffee 
beans, field-dried beans, field-dried peas, grains, and nuts. Not 
included are eggs, milk, meat, poultry, fresh fruits, and vegetables 
such as onions, parsnips, potatoes, and carrots.
    (n) The term tolerance with regional registration means any 
tolerance which is established for pesticide residues resulting from the 
use of the pesticide pursuant to a regional registration. Such a 
tolerance is supported by residue data from specific growing regions for 
a raw agricultural commodity. Individual tolerances with regional 
registration are designated in separate subsections in 40 CFR 180.101 
through 180.999, as appropriate. Additional residue data which are 
representative of the proposed use area are required to expand the 
geographical area of usage of a pesticide on a raw agricultural 
commodity having an established ``tolerance with regional 
registration.'' Persons seeking geographically broader registration of a 
crop having a ``tolerance with regional registration'' should contact 
the appropriate EPA product manager concerning additional residue data 
required to expand the use area.
    (o) The term pesticide chemical residue means a residue on or in a 
raw agricultural commodity or processed food of:
    (1) A pesticide chemical; or
    (2) Any other added substance that is present on or in the commodity 
or food primarily as a result of the metabolism or other degradation of 
a pesticide chemical.
    (p) The term food commodity means:
    (1) Any raw agricultural commodity (food or feed) as defined in 
section 201(r) of the Federal Food, Drug, and Cosmetic Act (FFDCA); and
    (2) Any processed food or feed as defined in section 201(gg) of the 
FFDCA.

[36 FR 22540, Nov. 25, 1971]

    Editorial Note: For Federal Register citations affecting Sec. 180.1, 
see the List of CFR Sections Affected, which appears in the Finding Aids 
section of the printed volume and on GPO Access.