Chem-News October 1991
DATE: October 1991
TO: Those Interested in Pesticide Information
FROM: William G. Smith, Senior Extension Associate
INDEX
Page
Pro-Gro Section 18 Request Submitted to DEC 1
PMEP To Assess/Survey Pesticide Use in Cabbage and Livestock
Production Systems in NYS 1
New Release from the Pesticide Management Education Program:
Instructors' Guide for the Northeast Pesticide Applicator Training
Manual 2
New DOT Manual Published 3
Tolerance Proposed for Avermetin B1 on Tomatoes 3
Poly(Vinylpyrrolidone/1-Elcosene) and Poly(Vinylpyrrolidone1/Hexadecne);
Tolerance Exemptions 3
PR Notice 91-2: Accuracy of Stated Percentages for Ingredients
Statement 4
Reregistration Network/Pesticide Uses Dropped 5
New Fish Advisories 8
EPA New Tolerance Policy 9
EPA Advises Consumers that Insect Repellent Containing 2-Ethyl-1-3-
Hexanediol May Pose Risk 9
Pesticides Briefs 9
The Delaney Paradox and Negiligible Risk 10
Pesticide Tolerances 11
Pesticide Reregstration 13
Risk/Benefit Balancing Under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA) 14
*************************
PRO-GRO SECTION 18 REQUEST SUBMITTED TO DEC
A section 18, emergency exemption, has been submitted to the Bureau of
Pesticide Management (NYS Department of Environmental Conservation) and to
the Environmental Protection Agency for the use of Pro-Gro (carboxin and
thiram) on onion seed to control onion smut.
-- W. Smith, PMEP, Cornell University
PMEP TO ASSESS/SURVEY PESTICIDE USE IN CABBAGE AND LIVESTOCK PRODUCTION
SYSTEMS IN NEW YORK STATE
The Pesticide Management Education Program (PMEP) at Cornell
University will assess/survey pesticide use and chemical alternatives to
pest control in dairy cattle and cabbage production systems. Funding for
this project was obtained through a grant from the National Agricultural
Pesticide Impact Assessment Program (NAPIAP) within the U. S. Department of
Agriculture (USDA).
Data collection and database development for actual pesticide use and
alternatives will continue to be a priority in years to come for several
reasons. First, as the Environmental Protection Agency (EPA) determines
that a pesticide active ingredient poses a significant risk to humans
and/or the environment and places it under Special Review, timely and
accurate pesticide-use and alternatives information will be vital when
assessing the benefits for that active ingredient. Secondly, manufacturers
reregistering their products with EPA will rely on the pesticide-use data
to determine the need (economic justification) for reregistering a
particular product. The data is particularly important to companies that
manufacture products labeled for use on minor crops. Public concern for
food safety and the environment will continue.
The Pesticide Management Education Program will collect the data
through several methods. The primary method will be through a two-hour
session in conjunction with Cornell Cooperative Extension (CCE)
Associations. Included in this session will be a one-hour educational
program that will offer growers recertification credits. The remaining
hour will consist of completing a short survey form with assistance from
program staff.
The second method of data collection will be through mail surveys.
The final method will be through on-farm visits where face-to-face
interviews with growers will be conducted.
Surveys, similar to this one being conducted in New York, are now
being undertaken in other states. In short, the information obtained from
these surveys will allow for development of a national data base that will
greatly enhance the pesticide use and alternatives assessment for Special
Review and reregistration, and will provide actual pesticide-use
information.
For further information, please contact the Pesticide Management
Education Program, 5123 Comstock Hall, Cornell University, Ithaca
NY/14853, (607) 255-1866.
--D. Ramil and W.G. Smith, Pesticide Management Education Program
NEW RELEASE FROM THE PESTICIDE MANAGEMENT EDUCATION PROGRAM: INSTRUCTORS'
GUIDE FOR THE NORTHEAST PESTICIDE APPLICATOR TRAINING MANUAL
The Instructors' Guide was developed to assist in the programming of
workshops and training sessions for new pesticide applicators. The concept
of stewardship and pesticide application ethics is introduced to create an
overall guiding ethical dogma for the student. Goals for the instructors
are listed in the beginning of each chapter. The guide was developed in a
horizontal format to allow room for three columns. The left column lists
the major subject headings from each chapter. The center column contains a
short, detailed listing of the information that should be covered in each
chapter. The EPA applicator training evaluation program was used as a
guide to what the agency considers to be sufficient coverage of applicator
training subject material. These evaluation criteria were incorporated
almost entirely into the center column, labeled "Minimum Coverage," of each
chapter. From this, an instructor can determine what the minimum content
of each subject area entails. This is not to encourage covering only the
minimum, but to set a minimum standard that should be embellished on. The
right column was left blank, except for suggested visuals, to allow the
instructor to make personal notes. Most instructors will find that these
notes will become important key elements as they gain experience with the
guide. Training activities are suggested in some chapters to encourage
hands-on activities. The suggested visual aids are placed in pertinent
locations throughout the chapters. A list of these programs and where they
can be obtained is located in the back of the guide. Certainly, this list
is not complete, but it is a starting point and hopefully it will prove to
be useful.
The Instructors' Guide will be available from the Cornell University
Resource Center, 7-8 Business and Technology Park, Ithaca, NY 14850
(607/255-7660). Cost and shipping are as follows:
Cornell campus and field staff (pouch mail only) $6.50
All others in New York State $9.00
Out of state through UPS zone 4 $9.50
Shipping charges prepaid through UPS Zone 4. Additional shipping
charges for Zones 5-8 will be charged at cost.
--Ronald D. Gardner, Pesticide Management Education Program
NEW DOT MANUAL PUBLISHED
The Pesticide Management Education Program (PMEP) has revised an
earlier edition of "The Highway Transportation of Pesticides: A Guide to
the Rules and Regulations." This 135-page manual uses clear, everyday
language to present those portions of the Federal Department of
Transportation (DOT) hazardous materials regulations that apply to
pesticide applicators.
The DOT regulates the commercial transport of hazardous materials on
our public highways. The hazardous materials regulations encompass the
entire trucking and shipping industries and are quite complex. Fines for
noncompliance can be severe.
Topics covered by the manual include the following: determining
whether the material to be transported is a hazardous material, types of
hazardous materials, preparation of shipping papers, marking and labeling
of packages, placarding of vehicles, driver safety, and the safe handling
of hazardous materials. All calculations are presented in clear, step-by-
step exercises. A table listing over 500 pesticide products by name, along
with all of the information needed to prepare shipping papers and to
placard vehicles for each product is included. For pesticides not listed
by product name, a second 23-page table of active ingredients is included.
The manual, which was revised by Linda Seyler, has been extensively
reviewed by representatives of the New York State Department of
Transportation and the New York State Police.
Copies are available from the Cornell University Resource Center, 7
Business and Technology Park, Ithaca, NY 14850; (607) 255-2080. The cost
of $13.00 includes shipping and handling.
--Linda Seyler, Extension Associate, PMEP, Cornell University
TOLERANCE PROPOSED FOR AVERMECTIN B1 ON TOMATOES
The EPA has proposed a food and feed tolerance for the use of the
insecticide avermectin B1 in or on fresh tomatoes and tomato pomace. The
tolerance petition was submitted by Merck Sharp & Dohme Laboratories.
--Pesticide & Toxic Chemical News, 9/18/91
POLY(VINYLPYRROLIDONE/1-ELCOSENE) AND POLY(VINYLPYRROLIDONE/1-HEXADECNE);
TOLERANCE EXEMPTIONS
These rules exempt from the requirement of a tolerance the pesticide
chemicals poly(vinylpyrrolidone/l- eicosene) (CAS Reg. No. 28211-18-9) when
used as an inert ingredient (dispersing agent) and poly(vinylpyrrolidone/l-
hexadecene] (CASE Reg. No. 63231-81-2) when used as an inert ingredient
(dispersing agent) in pesticide formulations applied to growing crops and
raw agricultural commodities after harvest. These proposed regulations
were requested by the GAF Chemicals Corp. (GAF) and effective on July 17,
1991.
--Federal Register, July 17, 1991
PR NOTICE 91-2: ACCURACY OF STATED PERCENTAGES FOR INGREDIENTS STATEMENT
The purpose of this EPA notice is to clarify the Office of Pesticide
Program's policy with respect to the statement of percentages in a
pesticide label's ingredient statement. Specifically, the amount (percent
by weight) of ingredient(s) specified in the ingredient statement on the
label must be stated as the nominal concentration of such ingredient(s), as
that term is defined in 40 CFR 158.153 (i). Accordingly, the Agency has
established the nominal concentration as the only acceptable label claim
for the amount of active ingredient in the product.
For some time the Agency has accepted two different methods of
identifying on the label what percentage is claimed for the ingredient(s)
contained in a pesticide. Some applicants claimed a percentage which
represented a level between the upper and the lower certified limits. This
was referred to as the nominal concentration. Other applicants claimed the
lower limit as the percentage of the ingredient(s) that would be expected
to be present in their product at the end of the product's shelf-life.
Unfortunately, this led to a great deal of confusion among the regulated
industry, the regulators, and the consumers as to exactly how much of a
given ingredient was in a given product. The Agency has established the
nominal concentration as the only acceptable label claim for the amount of
active ingredient in the product.
Current regulations require that the percentage listed in the active
ingredient statement be as precise as possible reflecting good
manufacturing practices 40 CFR 156.10 (g)(5). The certified limits
required for each active ingredient are intended to encompass any such
"good manufacturing practice" variations 40 CFR 158.175 (c)(3).
The upper and lower certified limits, which must be proposed in
connection with a product's registration, represent the amounts of an
ingredient that may legally be present 40 CFR 158.175. The lower certified
limit is used as the enforceable lower limit for the product composition
according to FIFRA section 12(a)(1)(C), while the nominal concentration
appearing on the label would be the routinely achieved concentration used
for calculation of dosages and dilutions.
The nominal concentration would in fact state the greatest degree of
accuracy that is warranted with respect to actual product composition
because the nominal concentration would be the amount of active ingredient
typically found in the product.
It is important for registrants to note that certified limits for
active ingredients are not considered to be trade secret information under
FIFRA section 10(b). In this respect the certified limits will be
routinely provided by EPA to States for enforcement purposes, since the
nominal concentration appearing on the label may not represent the
enforceable composition for purposes of section 12(a)(1)(C).
As described below under Unit V. "COMPLIANCE SCHEDULE," all currently
registered products as well as all applications for new registration must
comply with this Notice by specifying the nominal concentration expressed
as a percentage by weight as the label claim in the ingredient(s) statement
and equivalence statements if applicable (e.g., elemental arsenic, metallic
zinc, salt of an acid). In addition, the requirement for performing sample
analyses of five or more representative samples must be fulfilled. Copies
of the raw analytical- data must be submitted with the nominal ingredient
label claim. Further information about the analysis requirement may be
found in the 40 CFR 158.170. All products are required to provide
certified limits for each active, inert ingredient, impurities of
toxicological significance(i.e., upper limit(s) only) and on a case by case
basis as specified by EPA. These limits are to be set based on
representative sampling and chemical analysis (i.e., quality control) of
the product.
The format of the ingredient statement must conform to 40 CFR 156-
Labeling Requirements For Pesticides and Devices.
After July 1, 1997, all pesticide ingredient statements must be
changed to nominal concentration.
All pesticides are required to be efficacious. Therefore, the
certified lower limits may not be lower then the minimum level to achieve
efficacy. This is extremely important for products which are intended to
control pests which threaten the public health, e.g., certain antimicrobial
and rodenticide products. Refer to 40 CFR 158.640.
In those cases where efficacy limits have been established, the Agency
will not accept certified lower limits which are below that level for the
shelf life of the product.
As described earlier, the purpose of this Notice is to make the
registration process more uniform and more manageable for both the agency
and the regulated community. It is the Agency's intention to implement the
requirements of this notice as smoothly as possible so as not to disrupt or
delay the Agency's high priority programs, i.e., reregistration, new
chemical, or fast track (FIFRA section 3(c) (3) (B)). Therefore,
applicants/registrants are expected to comply with the requirements of this
Notice as follows:
1. Beginning July 1, 1991, all new product registrations submitted to
the Agency are to comply with the requirements of this Notice.
2. Registrants having products subject to reregistration under FIFRA
section 4(a) are to comply with the requirements of this Notice when
specific products are called in by the Agency under Phase V of the
Reregistration Program.
3. All other products/applications that are not subject to (l) and
(2) above will have until July 1, 1997, to comply with this Notice. Such
applications should note "Conversion to Nominal Concentration" on the
application form. These types of amendments will not be handled as "Fast
Track" applications but will be handled as routine requests.
Contact Tyrone Aiken for information or questions concerning this
notice on (703) 557-5024.
--Anne E. Lindsay, EPA, Registration Division
REREGISTRATION NETWORK / PESTICIDE USES DROPPED
The National Agricultural Chemicals Association is cooperating with a
USDA Minor Use Task Force to inform minor crop producers and other
interested parties about pending cancellations of pesticide registrations.
Please transmit this information as quickly as possible to your contacts in
commodity organizations, grower groups, and others who may be affected.
Carbaryl (Sevin)
Rhône-Poulenc Ag. Company has decided not to support uses of carbaryl
insecticide (Sevin) on onions (Rhône-Poulenc Sevin products are not
registered for this use), chestnuts, maple trees (for sap production),
prickly pear cactus, and oysters. This action is based on the burden of
data requirements specified in the Registration Standard Data Call-in
issued in June 1991. The changes will most likely occur on product labels
issued in 1992. All other crop and non-crop uses for which carbaryl is now
registered will be supported.
Due to extensive testing requirements for individual carbaryl
formulations, however, additional crops may be dropped from individual
carbaryl formulation labels while being maintained on others, and some
entire formulations may be dropped. Rhône-Poulenc expects to make these
decisions regarding formulations sometime in 1992.
For questions regarding these carbaryl uses, contact Dr. Larry Hodges,
Registration Manager, Rhône-Poulenc Ag. Company, P.O. Box 12014, Research
Triangle Park, NC 27709 (tel. 919-549-2870, fax 919-549-2545). Toll-free
telephone lines are also maintained by the USDA National Pesticide Impact
Assessment Program (800-262-0216) and the EPA Office of Pesticide Programs
(800-552-8879) to provide information on support for minor use pesticide
registrations.
--Ray S. McAllister, Director, Regulatory Affairs National
Agricultural Chemicals Association, August 6, 1991
Dicloran (Botran) Fungicide
NOR-AM Chemical Company notified EPA on September 9, 1991 of its
intention to voluntarily cancel U.S. registrations of all products
containing the fungicide active ingredient dicloran (2,6-dichloro-4-
nitroaniline; also known as DCNA), citing the cost of reregistration data
requirements. These products (EPA registration numbers in parentheses) and
respective crops (uses vary among preharvest, postharvest, storage, etc.)
are:
Botran 75W/75WDG Food crops: apricot, carrot, celery, cherry
(45639-110) (sweet), cucumber, endive,
fennel (CA only), garlic, grape,
lettuce, nectarine, onion, peach,
plum/prune, potato, rhubarb, snap
bean, sweet potato, tomato.
Ornamentals: rose, hydrangea, chrysanthemum,
geranium, gladiolus, conifer nursery
stock (CA only).
BOTRAN Technical manufacturing use only.
(45639-128)
BOTEC Peanut Seed Protectant peanut seed treatment.
(45639-121)
BOTRAN Dust formulations apricot, garlic, grapes, lettuce,
4, 6, 8, 10, 12, 15 onion, snap bean, tomato,
(45639-115, -109, -106, ornamentals.
-114, -112, -113)
For questions regarding this action, contact Kenneth W. Chisholm,
Registration Project Manager, NOR-AM Chemical Co., P.O. Box 7495,
Wilmington, DE 19803 (tel. 302-575-2039 fax 302-575- 2013). A number of
formulators and third party registrants also sell products containing
dicloran derived from NOR-AM products which would be canceled effectively
also. NOR-AM has asked EPA for the standard one-year period to sell
existing stocks of technical and end-use products. However, most of the
market for dicloran products is in California, and a CA state registration
that expires 12/31/91 would not likely be renewed.
Ornamite
Uniroyal Chemical Co., Inc. notified EPA on 5/31/91 of its intent to
delete use in greenhouses on ornamentals from the product label for
Ornamite (EPA Registration number 400-426), containing the insecticide
active ingredient propargite, due to costs of specific reregistration data
requirements. Other uses of Ornamite on ornamentals will be retained,
including outdoor application to nurseries and fields. For further
information contact Mr. Fred Hageman, Registrations Manager, Uniroyal
Chemical Co., Inc., Bethany, CT 06524 (tel. 203-393-2163).
Benomyl (Benlate, Tersan)
E.I. Du Pont de Nemours & Co. notified EPA on 9/5/91 that it plans to
voluntarily delete several uses from labels of fungicide products
containing the active ingredient benomyl, due to business considerations.
Uses listed below will be deleted from the indicated products:
Benlate Fungicide roses, flowers, ornamentals, bulbs, shade trees,
(352-354) greenhouse uses, including hydroponic uses, dip
treatments for pineapples and sugarcane, drench
treatments for strawberry transplants.
Tersan Turf Fungicide all uses on roses, flowers, ornamentals, shade
(352-357) trees, and bulbs.
Du Pont also notified EPA in early September 1991 that it plans to
delete uses of Sinbar Herbicide (active ingredient terbacil) on
strawberries and citrus from the product label (EPA Reg. No. 352-317) due
to business considerations.
All other currently registered uses of Benlate, Tersan, and Sinbar
will be supported by Du Pont. For further information on these changes for
Du Pont products, please contact Mr. Timothy R. Vaux, Business Manager for
Specialty Crops, E.I. Du Pont de Nemours Co., Inc., P.O. Box 80038,
Wilmington, DE 19880-0038 (tel. 302-992-6208 fax 302-992-2935).
Triallate (Far-Go)
Monsanto Agricultural Company has announced that it plans to
voluntarily cancel the use of the herbicide FAR-GO that contains the active
ingredient triallate on canary grass.
For further information contact Dr. Russell Schneider at Monsanto
(301-694-4059).
Linuron
Dupont Agricultural Products has announced that it plans to
voluntarily cancel the use of the herbicide Linuron on cotton. The company
cites the lack of economic incentives to develop the data required for this
use.
For further information contact Marie Chubb at Dupont (Fax No. 302-
992-6470).
Methomyl (Lannate)
Dupont Agricultural Products has announced that it plans to
voluntarily cancel the use of the insecticide Methomyl on watercress. The
company cites that the cost of the studies for this use exceed the
revenues.
For further information contact Dr. Charles Baer at Dupont (302-992-
6260).
Sethoxydim (Poast)
BASF Corporation has announced that it plans to voluntarily cancel the
use of the herbicide sethoxydim Poast for use on ginseng and Plantago
ovata. For further information contact Charlotte Sanson at BASF (191-361-
5483).
-- Reregistration Notification Network, USDA
Ethyl Parathion Insecticide
EPA announced on September 5, 1991 an agreement with registrants of
the insecticide ethyl parathion to voluntarily and immediately cancel all
but nine crop uses, due to alleged hazards to agricultural workers and
wildlife. EPA plans to initiate lengthy formal cancellation proceedings
for the remaining uses.
Use of ethyl parathion on the nine remaining crops (alfalfa, barley,
canola, field corn, cotton, sorghum, soybeans, sunflower, and wheat) will
only be allowed under severe restrictions: certified commercial
applicators only, closed transfer systems, mechanical harvesting of crops,
buffer zones, reentry restrictions, incident reporting requirements, etc.
Sale of products after December 1, 1991 and use after December 31, 1991 for
any other use will be prohibited.
The uses canceled immediately are listed below. This is a hastily
prepared list, subject to verification. EPA is mailing the press
announcement and a Q&A document with details of this action to a wide
cross-section of producers and Extension personnel across the country.
Contact the USDA National Pesticide Impact Assessment Program (800-262-
0216) and the EPA Office of Pesticide Programs (800-552-8879) for
additional information on support for minor use pesticide registrations.
Ethyl Parathion Crop Uses Cancelled by 9/5/91 agreement between EPA and
registrants
almonds gooseberries peas
apples grapefruit pecans
apricots grapes peppers
artichokes grasses (forage) pineapple
avocados honeydew melons plums
beans (dry + snap) hops potatoes
beets (table) irrigation ditches prunes
blackberries kale pumpkin
blackeyed peas kohlrabi quinces
blueberries kumquat radishes
boysenberries leeks rape
broccoli legumes raspberries
Brussels sprouts lemons rice
cabbage lentils rutabagas
cantaloupes lettuce safflower
carrots limes salvia (sage)
cauliflower loganberries spinach
celery mangos squash
cherries melons strawberries
Chinese cabbage sugar beets sugarcane
mosquito abatement muskmelon sweet potatoes
Christmas trees mustard greens sweet corn
clover nectarines swiss chard
collards oats tangelos
cranberries okra tangerines
cucumbers olives tobacco
currants onions tomatoes
dewberries oranges turnips
eggplant ornamental plants vetch
endive (escarole) pastures walnuts
figs peaches watermelon
filberts peanuts
garlic pears
gladiolus
--Ray S. McAllister, National Agricultural Chemicals Association,
9/11/91
NEW FISH ADVISORIES
In general, New York anglers are advised to eat no more than one meal
(1/2 pound) per week of fish taken from fresh waters in New York State.
Women of childbearing age and children under the age of 15 are advised to
eat no fish taken from any fresh waters known to be contaminated.
Now, however, the New York State Health Department's 1991-92 fish and
wildlife advisories include more stringent recommendations on eating white
perch from the lower Niagara Rive and Lake Ontario and less stringent
recommendations for species other than carp and goldfish from Smith Pond,
Long Island.
The new white perch advisory reflects continuing problems with dioxin
contamination in Western Lake Ontario, where dioxins are present in
suspended sediment and lake-bottom sediments from years of discharges from
industries and leaking hazardous waste sites. Recent analyses of white
perch from the mouth of the Niagara River revealed elevated levels of
dioxin.
Chlordane, a termite control pesticide banned in New York State since
1985, has been found in fish in several New York lakes and ponds,
particularly on Long Island. Recent data from Long Island freshwater
ponds, however, indicate significant declines in chlordane levels compared
to previous years. Accordingly, the Dept. of Health is limiting its
previous advisory for Smith Pond (Eat no more than one meal per moth for
all species) to apply to carp and goldfish only. For more, contact: Peter
Slocum, State of New York, Department of Health, (518) 474-7354.
--Health and Environment Digest
EPA NEW TOLERANCE POLICY
EPA has issued a new policy under which the Agency will deny certain
pending petitions for pesticide tolerances. The denials will occur if the
petitioner has not responded within 75 days after being notified by the
Agency that the data supporting the petition are inadequate. The new
tolerance petition policy was published in the Federal Register on Sept. 4
and went into effect on Oct. 1, 1991.
Bonnie Poli, National Program Leader, Pesticide Education, 9/3/91
EPA ADVISES CONSUMERS THAT INSECT REPELLENT CONTAINING 2-ETHYL-1-3-
HEXANEDIOL MAY POSE RISK
EPA is issuing a notice to consumers advising them that use of the
insect repellent 2-ethyl-1,3-hexanediol may pose a risk of birth defects to
pregnant women. The products are applied on the skin and are sold
primarily in the Northeastern and upper Midwestern states to repel black
flies.
EPA's action is based on its review of preliminary data submitted to
the Agency on July 31 by Union Carbide Corp., the sole manufacturer. Within
the past two weeks, the four registrants of the pesticide have voluntarily
submitted requests for cancellation of their registrations. Effective 30
days after publication of this action in the Federal Register any
distribution and sale of existing stocks of products by registrants would
be prohibited.
The list of the insect repellents containing 2-ethyl-1,3-hexanediol
are:
6-12 Plus Insect Repellent stick and liquid,
Off!
Insect Repellent IV,
6100 Formula 2 Fly and Mosquito Repellent Gel,
Johnson Wax 6017 Formula 10,
BF-100 Blackfly Repellent Solution.
Bonnie Poli, National Program Leader, Pesticide Education, 9/3/91
PESTICIDE BRIEFS
--The final Farmworker Protection Rule is scheduled to be issued by
EPA by October 26, 1991 according to an EPA official.
--The Pesticides and Groundwater Strategy has been approved by the
Office of Management and Budget (OMB) and is scheduled to be released next
month according to an agency official.
--Cyanamid to sell malathion business
American Cyanamid has announced that it has signed an agreement to
sell their malathion business to Cheminova of Lemvig, Denmark. Cyanamid
will remain in the business as a distributor of malathion for Cheminova for
the next three years.
--Ken Bakshi, American Cyanamid
THE DELANEY PARADOX AND NEGLIGIBLE RISK
The Environmental Protection Agency (EPA) regulates pesticides under
two laws, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
and the Federal Food, Drug, and Cosmetic Act (FFDCA). FIFRA requires that
pesticides be licensed or "registered" with EPA prior to sale and use in
the United States. The FFDCA gives EPA the authority to set legally
enforceable limits, or "tolerances" for pesticide residues in foods. The
FFDCA specifies that a food containing a pesticide for which no tolerance
has been established, or with a residue exceeding an established tolerance,
is considered adulterated and subject to seizure. EPA sets tolerances for
pesticide residues remaining in raw foods under section 408 of the FFDCA.
Under section 409 of the FFDCA, EPA sets food additive tolerances for
pesticide residues which concentrate in processed foods above raw food
tolerances, or are the result of pesticide application during or after
food processing.
EPA's task of regulating pesticides and their residues in foods has
been complicated by the different standards in FIFRA and FFDCA, and the
different standards within the FFDCA itself. In particular, section 409 of
the FFDCA contains the "Delaney Clause" which, when read literally,
absolutely prohibits the establishment of food additive tolerances where
evidence indicates that the pesticide may cause cancer in humans or
animals, no matter how small or minimal the risk. On the other hand, FIFRA
requires EPA to weigh the risks and benefits of a pesticide when deciding
whether to allow the continued use of that pesticide. Similarly, section
408 of the FFDCA requires EPA to consider the necessity for the production
of an adequate, wholesome and economical food supply in setting tolerances.
Thus, in contrast to the Delaney Clause, FIFRA and section 408 of the FFDCA
require consideration of the level of risk and the benefits of pesticide
use.
This inconsistency in standards has been called the "Delaney Paradox"
by the National Academy of Sciences (NAS), an expert non-governmental body.
In 1985, EPA commissioned the NAS to examine the scientific and regulatory
implications of the varying food safety standards contained in FIFRA and
the Delaney Clause of the FFDCA. One result of the inconsistency is that
the same pesticide residues which may be legal on a raw food could render a
processed food unacceptable under the law. Under these circumstances, for
example, EPA could set a section 408 tolerance for apples for a pesticide
that posed a negligible risk of cancer. But if the apples were processed
into apple juice and pesticide residues became concentrated to higher
levels than in the raw commodity, (Various processes such as milling,
drying, or juicing in some cases cause the relative amount of pesticide to
increase in the processed food as compared to the raw food. For example,
in drying, the ratio of the amount of pesticide to the rest of the food
could increase as water is removed. Concentration of residues does not
necessarily make a food unsafe for consumption because dietary exposure to
a pesticide depends on the concentration of pesticide remaining on food and
the quantity of food consumed.) then under a strict interpretation of the
Delaney Clause, EPA could not set a section 409 tolerance for processed
apples. As a matter of practice, EPA would then decline to set a section
408 tolerance for the pesticide in raw apples because it would be difficult
to ensure that treated apples would not be processed into apple juice.
Consequently, EPA would not allow use of the pesticide on apples at all,
even if EPA believed that it was as safe as other apple pesticides already
on the market.
In 1987, the NAS issued its study of the Delaney Clause, and reached
four principal conclusions:
1. All pesticides should be regulated on the basis of a consistent
standard, so that there is no "double standard" for raw vs. processed foods
or for old vs. new pesticides. The NAS found no public health reasons for
treating residues on raw or processed foods differently.
2. A uniform "negligible risk" rather than a "zero risk" standard for
carcinogens in food, consistently applied, would best enable EPA to improve
the overall safety of the food supply, and would result in only modest
reductions in the benefits of pesticide use to farmers.
3. EPA should set its regulatory priorities by focusing first on the
most worrisome pesticides used on the most-consumed crops.
4. The Agency should adopt a comprehensive analytical framework for
forecasting the broad-scale impact of its pesticide-specific regulatory
actions on the overall safety of the food supply.
Based on these conclusions, EPA has attempted to implement a
consistent negligible risk standard under each of the provisions of the
laws governing pesticides. In the case of FIFRA and FFDCA section 408
which require risk/benefit balancing, EPA has treated risk in the range of
1 in 1 million (meaning that, at most, an individual would have a one in
one million chance of developing cancer if exposed over a lifetime) as a
reference point and required that substantial benefits be demonstrated for
any risk which exceeds that level. As to the Delaney Clause, EPA has
adopted an interpretation which does not prohibit the establishment of food
additive regulations posing a de minimis risk (a risk so minimal that it is
not worth considering). These two actions, while not completely equivalent,
allow for each of the standards under the various provisions to be
substantially more compatible.
EPA's interpretation of the food additive laws was challenged in a
petition filed on May 25, 1989 by the State of California, the Natural
Resources Defense Council (NRDC), Public Citizen, the AFL-CIO, and several
individuals. The petition requested that EPA revoke 14 food additive
regulations for 7 pesticides. The petitioners argued that the food
additive regulations should be revoked because the pesticides to which the
regulations applied were probable or possible animal carcinogens and thus
the regulations violated the Delaney Clause. On February 19,1991, EPA
issued a Final Order upholding its interpretation that the law supports a
de minimis exception to the Delaney Clause for pesticide uses which create
at most a de minimis risk. In applying this de minimis standard, EPA
declined to revoke several food additive tolerances but found that two food
additive tolerances exceeded a de minimis level and would have to be
revoked. The petitioners have sought review of this decision in federal
court.
EPA has been working with the United States Department of Agriculture
(USDA) and the Food and Drug Administration (FDA) to develop legislation,
as part of the President's Food Safety Plan, which would amend FIFRA and
FFDCA to establish a consistent "negligible" risk standard for evaluating
the safety of pesticide residues in raw and processed foods. Additional
information is available from EPA on the provisions of the President's Food
Safety Plan.
--U.S. EPA, For Your Information, 8/91
PESTICIDE TOLERANCES
As part of its program to regulate the use of pesticides, EPA is
responsible for setting "tolerances," which are the maximum amount of
pesticides that may remain in or on food and animal feed. Tolerances are
set at levels that ensure that the public (including infants and children)
is protected from unreasonable health risks posed by eating foods that have
been treated with pesticides in accordance with label directions.
To set tolerances that are protective of human health, EPA needs
information about the anticipated amount of pesticide residues found on
food, the toxic effects of these residues, and estimates of the types and
amounts of foods that make up our diet. A tolerance petitioner (generally
a pesticide manufacturer) begins the tolerance-setting process by proposing
a tolerance level, which is based on field trials reflecting the maximum
residue that may occur as a result of the proposed use of the pesticide.
The petitioner also must provide food residue and toxicity studies to show
that the proposed tolerance would not pose an unreasonable health risk.
Studies of Pesticide Residues in Foods
EPA requires petitioners to submit several types of information to
estimate the amount and type of pesticide residues that may remain in food
products. One requirement is for product chemistry data, which is
information about the content of pesticide products, including the
concentration of the ingredients and any impurities. EPA also requires
information about how plants and animals metabolize (break down)
pesticides to which they are exposed, and whether residues of the
metabolized pesticides are detectable in food or feed. Any products of
pesticide metabolism, or "metabolites," that may be significantly toxic are
considered along with the pesticide itself in setting tolerances.
Field experiments are required for pesticides and their metabolites
for each crop or crop group for which a tolerance is requested, including
each type of raw food derived from the crop. In these studies, the
pesticide is applied to crops in a manner similar to that described by the
use directions that eventually will appear on the pesticide label if the
tolerance petition is approved. Finally, pesticide manufacturers must
provide information on residues found in many processed foods (such as
raisins), and in animal products if animals are exposed to pesticides
directly or through their feed.
Toxicology Studies
A pesticide's potential for causing adverse health effects-such as
cancer, birth defects and other reproductive disorders, and adverse effects
on the nervous system or other organs-is identified through a battery of
toxicity tests. Tests are conducted for both short-term or "acute"
toxicity and long-term or "chronic" toxicity. In several series of tests,
laboratory animals are exposed to different doses of a pesticide, and EPA
scientists evaluate the tests to find the highest level of exposure that
did not cause any effect. This level is called the "No Observed Effect
Level," or NOEL. When evaluating pesticides for potential effects other
than cancer, the Agency divides that level by an uncertainty factor,
usually 100 or more, to determine what is called the Reference Dose (RfD).
(This 100-fold factor compensates for the fact that humans could be more
sensitive than the animals used in laboratory tests). At or below the RfD,
it is assumed that daily exposure over a lifetime will not pose significant
risks to health. In addition, EPA routinely requires multi-year laboratory
animal feeding studies to screen pesticides for cancer effects.
Food Consumption Estimates
The next step in the process is to estimate the amount of the
pesticide to which the public may be exposed through the food supply. EPA
uses the Dietary Risk Evaluation System (DRES) to estimate the amount of
the pesticide in the daily diet, which is based upon a national food
consumption survey conducted by the U.S. Dept. of Agriculture. The USDA
survey provides information about the diets of the overall U.S. population
and a number of subgroups, including several different ethnic groups,
regional populations, and age groups, such as infants and children.
Tolerance Decisions
Finally, for non-cancer risks EPA compares the estimated amount of
pesticide in the daily diet to the Reference Dose. If the DRES analysis
indicates that the dose consumed in the diet by the general public or key
subgroups exceeds the Reference Dose, then generally EPA will not approve
the tolerance. Similarly, for potential carcinogens, EPA ordinarily will
not approve the tolerance if the dietary analysis indicates that exposure
will cause more than a negligible risk of cancer (i.e., the theoretical
risk is more than about one in one million).
EPA believes that the tolerance process is protective of human health
because it is based on extensive animal tests and on a combination of
conservative assumptions and risk assessment practices. Tolerances are set
at the lowest level necessary to accommodate the maximum application rate
and frequency being approved for the pesticide use, even if higher levels
would be safe for human consumption.
Enforcing Tolerances
Tolerances are enforced by the Food and Drug Administration (FDA), the
US. Dept. of Agriculture (USDA), and state enforcement agencies.
Inspectors commonly sample food and feed products before they enter the
channels of trade so that any violations may be traced to their sources.
Tolerances established by EPA apply equally to domestically grown and to
imported food. Imported foods may be denied entry into the U.S. if they
are found to contain pesticide residue levels that exceed the established
U.S. tolerances, or for which there are no U.S. tolerances.
--U.S. EPA, For Your Information, 8/91
PESTICIDE REREGISTRATION
The Environmental Protection Agency (EPA) is required by law to
reregister existing pesticides that originally were registered years ago
when the standards for government approval were less stringent than they
are today. This comprehensive reevaluation of pesticide safety is critical
to protecting human health and the environment and maintaining public
confidence in our food supply. In 1988, Congress amended the Federal
Insecticide, Fungicide, sand Rodenticide Act (FIFRA) to strengthen and
accelerate EPA's reregistration program. This fact sheet provides an
overview of the nine-year reregistration scheme mandated by "FIFRA '88,"
which applies to each registered product containing any active ingredient
registered before November 1, 1984.
Lists of Pesticides to be Reregistered
In 1988, approximately 600 groups of related pesticide active
ingredients, or "cases,"--representing 1,150 active ingredients in 45,000
formulated products--required reevaluation. Following FIFRA '88
requirements, EPA divided these 600 cases into four lists: Lists A, B, C,
and D.
List A. List A consists of the 194 chemical cases (350 individual
active ingredients) for which EPA had issued Registration Standards prior
to the effective date of FIFRA '88. The Registration Standards program,
begun in 1980, was a systematic process for reevaluating existing
pesticides. Each Registration Standard summarized available information
for a given pesticide case, and identified the conditions that registrants
had to meet before EPA would reregister it, such as submitting additional
data.. In 1988, the 194 Standards issued accounted for about 85 percent of
the total volume of conventional pesticides used in the U.S.
Lists B, C, and D. The remaining pesticides were divided into three
lists based upon their potential for exposure and other facts, with B being
of highest concern and D of least. Some of the classification criteria
included potential for residues of concern in food or drinking water;
significance of outstanding data requirements; potential for worker
exposure; Special Review or restricted-use status; and unintended adverse
effects to animals and plants.
The Reregistration Process
FIFRA '88 established mandatory reregistration time frames and duties.
The law requires EPA to complete its reregistration review over
approximately a 9-year period. The five phases of the reregistration
process are described below. Because EPA already had performed substantial
review of the List A chemicals under the Registration Standards program, in
essence List A chemicals move directly to Phase 5. Products of registrants
who fail to comply with the requirements of any of the phases are subject
to cancellation or administrative suspension action.
Phase 1: Listing of Active Ingredients
FIFRA '88 required EPA to publish lists A, B, C, and D within 10
months. As required, EPA also asked registrants of these pesticides
whether they intended to seek reregistration.
Phase 2: Declaration of Intent and Identification of Studies
Phase 2 required registrants to notify EPA whether or not they
intended to reregister their products; to identify and commit to providing
necessary new studies; and to pay the first installment of the
reregistration fee. During this phase, EPA issued guidance to registrants
for preparing their Phase 2 and Phase 3 responses. Phase 2 activities were
completed during 1990.
Phase 3: Summarization of Studies
During Phase 3, following EPA guidance, registrants were required to
submit summaries and reformatted acceptable studies, "flag" studies
indicating adverse effects, re-commit to satisfying all applicable data
requirements, and pay the final installment of the reregistration fee.
Phase 3 ended in October 1990.
Phase 4: EPA Review and Data Call-In's
In Phase 4, EPA must review all Phase 2 and 3 submissions and require
restraints to meet any unfulfilled data requirements within four years.
Phase 4 ends in July 1992.
Phase 5: Reregistration Decisions
In this Phase, EPA reviews all the studies that have been submitted
for a chemical case, and decides whether or not to reregister products
containing the active ingredients in that case. A pesticide will be
considered eligible for reregistration if its data base is substantially
complete, and if it does not cause unreasonable adverse effects to people
or the environment when it is used according to product label directions
and restrictions.
Status of Reregistration
The overall trend for all four lists is a substantial reduction in the
number of pesticides being supported for reregistration by pesticide
companies. The number of chemical "cases" being considered for
reregistration declined from about 600 in 1988 to about 400 in early 1991.
Pesticide product registrations declined from about 45,000 to 20-25,000.
Registrants are not supporting for reregistration about half of the
original List B, C, and D active ingredients.
EPA generally views this decline in pesticide product registrations as
a positive result. In many instances, the pesticides that dropped out had
not been produced or marketed for many years. However, the decline in
pesticide registrations also could have a negative impact on the so-called
"minor uses," or specialty pesticide uses with limited market potential.
EPA is participating in joint government, industry, and user efforts to
help preserve needed minor uses.
EPA issued the first six Reregistration Eligibility Documents (REDs)
by early 1991, and expects to issue many more during the next few years.
REDs announce that products containing the active ingredient are eligible
for reregistration; products will be reregistered once product-specific
data and labeling are submitted to and accepted by the Agency. Even after
a pesticide is reregistered, however, EPA will continue to reassess it
based on new information that becomes available. Reregistration is but one
major milestone in a continuing review process.
In conclusion, as a result of FIFRA '88, EPA has greatly accelerated
the pesticide reregistration process. A new and more efficient
infrastructure has been developed, and EPA is moving ahead briskly with the
reregistration effort. The wave of reregistration decisions will rise
steadily during the 1990's, until the task set forth by Congress and the
American public is completed.
--U.S .EPA, For Your Information, 6/91
RISK/BENEFIT BALANCING UNDER THE FEDERAL INSECTICIDE, FUNGICIDE, AND
RODENTICIDE ACT (FIFRA)
Pesticides are biologically active chemicals that kill or modify the
behavior of problem insects, animals, microorganisms, weeds, and other
pests. With pesticides, farmers can grow more and greater varieties of food
more cheaply; home owners can control pests in their lawns, gardens and
homes; and public health officials can control pests potentially harmful to
our health. But there are disadvantages as well as benefits from using
pesticides. By law, EPA must weigh the risks of pesticides to human health
and the environment against their benefits with a multi-step process called
risk/benefit balancing.
RISK ASSESSMENT
There are four steps in EPA's risk assessment process: hazard
identification, dose/response assessment, exposure assessment, and risk
characterization.
Hazard Identification. EPA evaluates a pesticide's inherent toxicity
-i.e., the types and degrees of harmful effects a pesticide may cause.
This is done principally by evaluating laboratory studies conducted on
animals. For example, laboratory studies attempt to determine if a
chemical is an eye irritant, causes acute poisoning, causes birth
defects, or causes cancer, among other effects.
Dose/Response Assessment. A pesticide's potential for causing adverse
health effects is identified through a battery of short-term or
"acute" and long-term or "chronic" toxicity testing. In several
series of tests, laboratory animals are exposed to different doses of
a pesticide, and EPA scientists evaluate the tests to find the level
of exposure in each of those studies that did not cause any non-cancer
effect. This level is called the "No-Observed-Effect-Level," or NOEL.
The most appropriate NOEL is divided by an uncertainty factor, usually
100 or more, to determine what is called the Reference Dose (RfD)
(once known as the Acceptable Daily Intake, ADI). At or below this
level, it is assumed that daily exposure over a lifetime will not pose
significant risks to health. In addition, EPA routinely requires
multi-year laboratory animal feeding studies to screen pesticides for
cancer effects. The Agency uses a "negligible risk" standard to
address the risk of cancer from exposure to a pesticide through the
food supply. EPA defines a negligible risk to mean that the estimated
cancer risk can be no greater than a risk of one in one million or
less (meaning that, at most, an individual would have a one in one
million chance of developing cancer if exposed over a lifetime).
Exposure Assessment. Once harmful health effects are identified in
the laboratory tests, EPA must estimate the level, duration,
frequency, and route of exposure for people. For example: Are people
who regularly mix and apply pesticides exposed? Is there a chance of
exposure to people through food and drinking water? Can plants and
animals other than the targeted pests be harmed or killed by the
pesticide?
Risk Characterization. Finally, the risk from exposure to pesticides
is estimated by integrating the above factors. By combining estimates
of likely or actual pesticide exposure with the toxicity of the
pesticide, EPA can characterize the risks that it poses. This usually
involves extrapolating exposure in animals to humans because little
direct information about the effects on humans is available. EPA
relies on animal studies, assuming that the human response is
qualitatively similar to that of animals and that humans will be at
least as sensitive, and frequently, more sensitive to the effects of
the pesticide.
BENEFIT ASSESSMENT
EPA conducts a benefit assessment when deciding on whether to cancel a
pesticide, and evaluates benefits when approving the use of a new pesticide
under a conditional registration. The purpose of a benefit assessment is
to determine the effectiveness and economic value of a pesticide compared
to alternative chemical and nonchemical controls. A benefit assessment is
specific for each registered use site (e.g., corn, soybeans, tomatoes,
etc.). A benefit assessment is essentially an analysis of likely economic
consequences resulting from the restriction or cancellation of a pesticide,
and includes:
Biological Analysis. The purpose of this analysis is to identify
the importance of the pesticide in controlling the intended pest.
As part of this process, EPA collects information on the nature
and extent of the pest problem, the effectiveness of the
pesticide and other chemical and non-chemical controls, and the
biological impacts of controlling the pest. For agricultural
pesticides, the analysis would compare the effects on crop yield
or quality for the pesticide and its alternatives; the
information is used to determine the pesticide's value in the
production of the crop.
Economic Analysis. An economic analysis translates the
biological impact of yield loss, reduced crop quality, and
alternative pest control methods into economic terms. EPA
evaluates the economic impacts that are expected to occur for all
of the affected sectors of the economy. For agricultural
pesticides, economic effects include the costs and ability of
farmers to produce the crops and, where appropriate, the
subsequent costs to consumers who purchase those foods. In
addition, secondary effects such as local employment are
evaluated when appropriate. A low cost pesticide that produced
substantial benefits to farmers, resulted in lower food costs to
consumers, and had few alternatives, would be rated as having
high benefits. On the other hand, if there were several
alternatives to a pesticide that were comparably priced and
equally effective, the pesticide would have relatively low
benefits.
--U.S .EPA, For Your Information, 8/91
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Disclaimer: Please read
the pesticide label prior to use. The information contained at this web
site is not a substitute for a pesticide label. Trade names used herein
are for convenience only; no endorsement of products is intended, nor is
criticism of unnamed products implied. Most of this information is historical
in nature and may no longer be applicable.
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