United States
Environmental Protection
Agency
Prevention/Pesticides
And Toxic Substances
(7508W)
EPA 738-B-94-002
June 7934
Selected Terms
and Acronyms
Office of Pesticide
Programs
. Recycled/Recyclable
{A, AJ Printeci with Soy/Canola Ink on paperthat
X_lv7 contains at least 50% recycled fiber
-------
-------
INTRODUCTION
Selected Terms and Acronyms, Office of Pesticide Programs defines in
non-technical language many commonly used terms and acronyms appearing in
regulatory documents, reports, correspondence, speeches and testimony, fact
sheets, press releases, and other publications produced by EPA's Office of
Pesticide Programs (OPP). These definitions do not constitute the Agency's official
use of terms and phrases for regulatory purposes, and nothing in this document
should be construed to alter or supplant any other federal document. Official
terminology may be found in the laws and regulations as published in sources such
as the Federal Register, Code of Federal Regulations, Congressional Record, and
elsewhere.
The terms and acronyms included are ones that have appeared in previously
issued lists, supplemented by suggestions from OPP personnel. The terms
selected appear frequently in the Pesticide Program's communications, both oral
and written, internally and with people outside the program.
To suggest changes or additions for future editions, please contact the
Planning and Reregistration Branch, Special Review and Reregistration Division
(7508W), Office of Pesticide Programs, USEPA, Washington, DC 20460.
To obtain additional copies of OPP's Selected Terms and Acronyms, please
contact EPA/NCEPI, PO Box 42419, Cincinnati, OH 45242-0419, telephone
513-891-6561, fax number 513-891-6685. Request publication number
EPA 738-B-94-002.
An Agency-wide list of terms and acronyms, Terms of Environment;
Glossary, Abbreviations, and Acronyms (revised April 1994) also may be obtained
from EPA/NCEPI at the address, telephone and fax number above. Request
publication number EPA 175-B-94-015.
-------
-------
SELECTED TERMS AND ACRONYMS
OFFICE OF PESTICIDE PROGRAMS
AA
AAPCO
AB
ACB
Accelerated
Reregistration
Branch (ARB)
Accelerated
Reregistration
Tracking System
(ARTS)
Acceptable Daily
Intake (ADI)
Accession Number
Active Ingredient
(Al)
Assistant Administrator
See Association of American Pesticide Control Officials.
See Administration Branch.
See Analytical Chemistry Branch.
ARB, within SRRD, manages the reregistration review of
many of the List B, C and D chemicals. ARB staff
manage data requirements, issue Data Call-In Notices,
process industry's data and requests, and coordinate the
development of Reregistration Eligibility Decision (RED)
documents.
ARTS was a computer tracking system used by the
Accelerated Reregistration Branch of SRRD to track
FIFRA '88 List B, C and D chemical data commitments
made by the registrants during Phase 2 of the
accelerated reregistration process. ARTS was replaced
by SMARTS and ultimately by CRMS. See Chemical
Review Management System (CRMS).
Now defunct term for reference dose. See reference
dose (RfD).
Identification number that used to be assigned (for
cataloging purposes) to volumes of studies submitted to
OPP. This numbering system has been replaced by the
Master Record Identification (MRID) system, which
identifies each individual study. See also, Master Record
Identification System.
The chemical or substance in a pesticide product that can
kill, repel, attract, mitigate or control a pest, or that acts
as a plant growth regulator.
ADI
See acceptable daily intake.
-------
Administration
Branch (AB)
Administrative
Record
AI
ai/A
ALISS
A-List Inventory
Support System
(ALISS)
Analytical
Chemistry Branch
(ACB)
Antimicrobial
Program Branch
(APB)
AOAC
APB
AB, within PMSD, provides overall guidance, instruction
and control for both the Office Director and all OPP
Divisions in the areas of personnel and administrative
management.
The permanent, reviewable record of the Agency's
regulatory review and decision process. It consists of a
statement of the Agency's decision (i.e., position
documents); science reviews and chapters; the
associated supporting bibliography; and non-technical
documents (e.g., decision packets, internal and external
correspondence). These documents detail the evolution
of the Agency's decision on a pesticide's status.
See active ingredient.
The amount of pure pesticide active ingredient applied
per acre.
See A-List Inventory Support System.
ALISS was a computer tracking system used by the
Reregistration Branch of SRRD. It captured the history of
data requirements established in the original Registration
Standards and subsequent data requirements for A-List
chemicals. ALISS has been replaced by CRMS. See
Chemical Review Management System (CRMS).
ACB, within BEAD, provides analytical and environmental
chemistry services in support of pesticide registration,
Special Review, and tolerance petition programs. ACB
also provides support to the Office of General Counsel,
the EPA Regional Enforcement Program, and the National
Ground Water Monitoring Program. There are two
laboratories in this branch, one in Beltsville, Maryland,
and one in Bay St. Louis, Mississippi.
APB, within RD, is responsible for processing registration
applications, experimental use permits, and petitions for
tolerances for antimicrobial products.
See Association of Official Analytical Chemists.
See Antimicrobial Program Branch.
-------
Applicant
ARB
ARTS
ASTHO
Association of
American Pesticide
Control Officials
(AAPCO)
Association of
Official Analytical
Chemists (AOAC)
Association of
State and
Territorial Health
Officials (ASTHO)
AX/AL
BAB
BEAD
"Bean Sheet"
Biological
Analysis Branch
(BAB)
The term given to a chemical company or other
organization that has applied to RD to obtain registration
of a pesticide product.
See Accelerated Reregistration Branch.
See Accelerated Reregistration Tracking System.
See Association of State and Territorial Health Officials.
An association of state pesticide regulatory officials
dedicated to the effective enforcement of laws and
implementation of programs that relate to proper and
safe use of pesticides.
An association devoted to the development, testing,
validation and publication of analytical methods for
foods, feeds, drugs, fertilizers, pesticides and other
substances.
Association of state health professionals dedicated to
effective health care and who work with OPPTS on
health issues related to pesticides.
Acronyms indicating that incoming correspondence is
controlled by the EPA Administrator's office (AX) or the
Office of Congressional and Legislative Affairs (AL).
See Biological Analysis Branch.
See Biological and Economic Analysis Division.
The common name for a Data Package Record. See Data
Package Record.
BAB, within BEAD, is responsible for the preparation of
use-data software programs for exposure assessments,
qualitative use assessments, and biological analyses of
pesticides.
-------
Biological and
Economic Analysis
Division (BEAD)
Cancellation
Carcinogenicity
Case-Control
Study
CB
CB I
CB II
CBI
CCB
CERCLA
Certification and
Training Branch
(CTB)
BEAD, one of the seven Divisions that constitutes OPP,
conducts analyses on pesticide use and benefits;
acquires, validates, and interprets technical data relative
to pesticide use; conducts economic analyses on the
impacts of regulatory options; and validates analytical
chemistry methods. BEAD is comprised of the Planning
and Evaluation Staff, and three branches: Biological
Analysis, Economic Analysis, and Analytical Chemistry.
A process authorized under FIFRA section 6 whereby the
Agency stops the sale, distribution and use of a pesticide
product.
The capacity to induce cancer (e.g., malignant tumors).
Epidemiologic study in which the incidence of a disease
end point in exposed and non-exposed (usually human)
populations is compared.
See Communications Branch.
See Chemistry Branch I and II.
See Chemistry Branch I and II.
See.confidential business information.
See Chemical Coordination Branch.
See the Comprehensive Environmental Response,
Compensation, and Liability Act, and the Superfund
Amendments and Reauthorization Act of 1986.
CTB, within FOD, is responsible for directing and
implementing the Agency's regulatory and non-regulatory
pesticide applicator training and certification activities
under sections 4 and 23 of FIFRA. Also, CTB acts as
OPP's liaison to state governments and tribal
governments.
CFR
See Code of Federal Regulations.
-------
Chemical Case
Chemical
Coordination
Branch (CCB)
Chemical
Manufacturers
Association (CMA)
Chemical
Producers and
Distributors
Association
(CPDA)
Chemical Review
Manager (CRM)
Chemical Review
Management
System (CRMS)
Chemical
Specialties
Manufacturers
Association
(CSMA)
For purposes of review and regulation, OPP has grouped
individual pesticide active ingredients that are chemically
similar (e.g., salts and esters of the same chemical) into
chemical cases.
CCB, within HED, is responsible for tracking and
coordinating HED's commitments related to registration,
reregistration and Special Review, and for integrating
individual discipline-specific review components into
complete human health risk assessments/risk
characterizations.
A trade organization that represents the industrial
chemical industry.
A trade organization whose members include smaller
pesticide formulators, manufacturers and distributors.
An SRRD employee whose responsibility is to manage
and coordinate the reregistration or Special Review
process for one or more pesticide chemicals. Also called
a Review Manager (RM). See also Reregistration, and
Special Review.
CRMS is a new electronic data management system
which enables SRRD staff to manage information
pertinent to reregistration. The status of each chemical
and its generic data requirements are tracked in CRMS.
Originally named the National Association of Insecticide
and Disinfectant Manufacturers, CSMA is a pesticide
industry trade organization which sponsors the Chemical
Specialties Manufacturers Association Political Action
Committee.
-------
Chemistry Branch
I and II
Child-Resistant
Packaging (CRP)
Cholinesterase
Inhibition
Cholinesterases
Chromatography
Clean Water Act
(CWA)
CMA
Code of Federal
Regulations (CFR)
CB l-Tolerance Support and CB ll~Reregistration Support
are two branches within HED that were formerly known
as the Dietary Exposure Branch (DEB). CB I and CB II
evaluate analytical methods and residue, metabolism, and
dietary exposure data. These analyses are used to
estimate dietary exposure to pesticides and may lead to
recommendations for or against proposed pesticide
residue tolerances in food or feed, and reassessment of
tolerances.
FIFRA regulations (40 CFR 162.16) require that certain
residential-use pesticides meeting or exceeding specified
toxicity criteria be packaged so as to offer protection to
children and adults from injury or illness resulting from
accidental ingestion or contact.
An inhibition in the effectiveness of cholinesterase, often
caused by a chemical such as an organophosphate or
carbamate pesticide. This inhibition can result in nervous
system disorders such as excess salivation, cramps,
dyspnea, anxiety, and death. See also, cholinesterases.
Enzymes, which when situated in the nervous system,
help regulate the transmission of nerve impulses. There
are two common types: that which is found in the brain
peripheral nervous system and red blood cells; and
pseudocholinesterase, which is found in plasma.
A process that separates a chemical mixture into its
component parts for subsequent identification and
quantification.
This statute includes the provisions for implementing the
NPDES program. The Office of Water administers this
program. See also, National Pollutant Discharge
Elimination System and permits.
See Chemical Manufacturers Association.
The categorized set of regulations that implement federal
statutes. Regulations that pertain to EPA are at 40 CFR.
-------
Colorimetric
Analysis
Communications
Branch (CB)
Comprehensive
Environmental
Response,
Compensation,
and Liability Act
(CERCLA)
Confidential
Business
Information (CBI)
Confidential
Statement of
Formula (CSF)
CORT Studies
CPDA
CRMS
A method of chemical analysis by which the
concentration of a compound in solution can be
determined by measuring the strength of its color by
visual or photometric methods.
CB, within FOD, develops and operates programs that
disseminate pesticide and OPP information to the public.
Commonly known as "Superfund," this statute includes
provisions for the cleanup of existing hazardous waste
sites and requires that releases of hazardous substances
in quantities greater than established reportable quantities
be reported to the National Response Center. Under
CERCLA §103, the application of a pesticide product
registered under FIFRA is exempt from regulation.
CERCLA is implemented by EPA's Office of Solid Waste
and Emergency Response, Office of Emergency and
Remedial Response.
Material that contains trade secrets or commercial or
financial information that has been claimed as
confidential by the submitter (usually the registrant).
Procedures for handling CBI are described in the CBI
manual for OPP.
A list showing the identity of the ingredients contained in
a pesticide formulation. The list is submitted by a
registrant or applicant at the time of application for
registration or change in formulation.
The set of toxicology studies consisting of chronic
feeding (C); oncogenicity, which is now referred to as
carcinogenicity (O); reproduction (R); and teratology (T),
which now is referred to as developmental toxicity.
These studies are required for all food/feed use pesticides
and one or more may also be required for non-food/feed
use pesticides. Chronic feeding effects, carcinogenicity,
and developmental toxicity must be tested in two
species, reproduction in one.
See Chemical Producers and Distributors Association.
See Chemical Review Management System.
-------
CRP
CSF
CSMA
CTB
CWA
DAA
Data Call-In
(DCI) Notice
Data Package
Record ("Bean
Sheet")
DCI
DEB
Delaney Clause
Dermal Absorption/
Penetration
Dietary Exposure
Branch (DEB)
See child-resistant packaging.
See Confidential Statement of Formula.
See Chemical Specialties Manufacturers Association.
See Certification and Training Branch.
See Clean Water Act.
Deputy Assistant Administrator.
A DCI notice, as provided by FIFRA §3(c)(2)(B), is a
notice that is issued by R.D or SRRD to registrants. A
DCI Notice requires the submission of specific data to
support the reregistration or continued registration of a
pesticide. Failure to submit these data can result in
suspension of the registered products.
A form attached to material (e.g., data submitted by a
registrant) transferred from one OPP Division to another
for review. The material is assigned a record number and
a bar code which are used to track the material in PRATS
(formerly, the On-Line Tracking System).
See Data Call-In Notice.
See Chemistry Branch I and Chemistry Branch II.
Found in Section 409(c)(3)(A) of the Federal Food, Drug,
and Cosmetic Act (FFDCA), the Delaney clause prohibits
food additive or drug tolerances for any substance
(including pesticides) that causes cancer in test animals
or in humans, if the substance is added to or
concentrates in processed food or feed.
A process by which a chemical enters the skin (e.g., a
pesticide enters the skin of an applicator) and then
moves into the body as an internal dose; it usually is
expressed as a percentage of an amount applied to the
surface of the skin.
See Chemistry Branch I and Chemistry Branch II.
8
-------
Dietary Risk
Evaluation System
(ORES)
Docket File
Domestic
Application
Dosimetry
Downstream
Processors
ORES
EAB
EC
Ecological Effects
Branch (EEB)
Economic Analysis
Branch (EAB)
A computerized tool for analyzing human dietary
exposures to individual pesticides and comparing the
exposures to known toxicity levels. The ORES is the
responsibility of the Science Analysis Branch within HED.
ORES was formerly known as the Tolerance Assessment
System (TAS).
A file maintained in the public docket (Room 1132 CM2,
for OPP) for materials that pertain to Special Review and
Reregistration of pesticides. Instructions for docketing
are at 40 CFR 155. Materials in the docket are available
for public inspection unless they are marked as
confidential business information. The OPP product and
review managers are responsible for submitting materials
for inclusion in the docket files. Comments submitted to
OPP by the public are filed at the OPP docket location.
Contact PRPRB/FOD.
Pesticide application in and around houses, office
buildings, motels and other living or working areas; now
termed residential use. See residential use.
Process of measuring a dose (i.e., of a pesticide,
radiation, medicine, etc.).
Industries dependent on crop production, such as
canneries and food processors.
See Dietary Risk Evaluation System.
See Economic Analysis Branch.
See emulsifiable concentrate.
EEB, within EFED, is responsible for assessing pesticide
effects on non-target species including fish, birds, small
mammals, beneficial insects, and plants.
EAB, within BEAD, provides quantitative usage data and
economic analyses for EPA's pesticide regulatory
program, including analyses of economic impacts of
pesticide regulatory policies and of individual program
actions under the various sections of FIFRA.
-------
EOF
EEB
EEC
EFED
EFGWB
ELI
Emergency
Exemption
Emergency
Suspension
Emulsifiable
Concentrate (EC)
Emulsifier
End-Use Product
(EP)
Environmental
Defense Fund
(EOF)
See Environmental Defense Fund.
See Ecological Effects Branch.
See Estimated Environmental Concentration.
See Environmental Fate and Effects Division.
See Environmental Fate and Groundwater Branch.
See Environmental Law Institute.
See FIFRA Section 18 (emergency exemption).
Suspension of pesticide product registration under FIFRA
section 6(c) due to an imminent hazard. Emergency
suspension immediately halts distribution, sale and
sometimes use of effected pesticides. See also,
Suspension of Registration.
A type of pesticide formulation that contains the active
ingredient, one or more petroleum solvents, and an
emulsifier that allows the formulation to be mixed with
water. The strength of this concentrate usually is stated
in pounds of active ingredient per gallon of concentrate.
A chemical that aids in suspending one liquid in another,
usually an organic chemical in an aqueous solution.
A pesticide formulation for field or other end use. The
labelling bears instructions for using or applying the
product (as packaged and sold, or after dilution by the
applicator) for controlling pests or regulating plant
growth. The term excludes products with labelling that
allows use of the product to formulate other pesticide
products.
An environmental public interest group whose purpose
to protect environmental quality and public health.
is
10
-------
Environmental
Fate Data
Environmental
Fate and Effects
Division (EFED)
Environmental
Fate and
Groundwater
Branch (EFGWB)
Environmental Law
Institute (ELI)
EP
EPA Compendium
of Acceptable
Uses
EPA Endangered
Species Bulletin
Scientific data that characterize a pesticide's fate in the
ecosystem, considering its degradation inducers (light,
water, microbes), pathways and resultant degradation
products.
EFED, one of the seven Divisions that constitutes OPP, is
responsible for assessment of pesticide effects on non-
target animal and plant species in the natural
environment and groundwater. EFED is made up of the
Science Analysis and Coordination Staff, the Ecological
Effects Branch, and the Environmental Fate and
Groundwater Branch. This Division was created by the
OPP reorganization of July 1988 when the Hazard
Evaluation Division was split into EFED and HED.
EFGWB, within EFED, reviews and evaluates data on:
pesticide fate and transport; aspects of pesticide
leachability; and ground water effects. Also, EFGWB
manages and coordinates human and environmental
monitoring activities in support of the pesticide
regulatory program.
The ELI conducts research on current developments in
environmental law; publishes the "Environmental
Reporter."
See end-use product.
List of federally registered pesticides with their uses and
approved maximum acceptable application rates and
other use restrictions; this outdated system was replaced
by the use index. The use index has subsequently been
replaced by LUIS. See LUIS.
Bulletin that contains lists of species (including birds,
fish, mammals, and plants) in jeopardy because they or
their habitats are threatened by pesticides. The bulletin
also contains pesticide use information necessary to
protect the species.
11
-------
Epidemiology
Estimated
Environmental
Concentration
(EEC)
EUP
Experimental Use
Permit (EUP)
F0 Adult
F, Adult
F, Pup
Fla or Fib
F2Pup
FDA
The branch of medicine that deals with the frequency
and occurrence of diseases in populations and the
establishment of causal relationships between these
diseases and environmental (including pesticide exposure)
and other factors.
The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
See experimental use permit.
A permit authorized under FIFRA section 5 that is granted
by the Agency to allow a pesticide producer to conduct
testing of a new pesticide, product and/or use, outside of
the laboratory. The testing is generally conducted on ten
or more acres of land or water surface. EUPs are most
commonly used for large-scale testing of efficacy and
gathering of environmental fate, ecological effects, and
crop residue chemistry data. EUPs are processed by
Product Manager Teams in RD product branches.
Initial parent in a multigenerational reproduction study.
Adult of the first generation (i.e., an FT pup reared to
sexual maturity and used for breeding the next
generation).
First generation pup.
First generation pup; a or b indicates the first or second
litter, respectively.
Second generation pup.
See Food and Drug Administration.
12
-------
Federal Food,
Drug, and
Cosmetic Act
(FFDCA)
Federal
Insecticide,
Fungicide, and
Rodenticide Act
(FIFRA)
Federal Record
Center
Federal Register
(FR)
FFDCA
FHB
Field Operations
Division (FOD)
FIFRA
FIFRA Scientific
Advisory Panel
(SAP)
FFDCA regulates, among other things, the use of drugs
(human and veterinary), and chemicals in cosmetics and
human and animal foods. It includes the legal
requirement that tolerances (maximum residue limits) be
established for pesticide residues in and on raw
agricultural commodities, processed food and feed items
(see sections 408 and 409). These tolerances are
established by EPA.
FIFRA sets forth regulations for the sale, distribution and
use of pesticides in the U.S. FIFRA was last amended in
1988 and is thus known as FIFRA '88.
A repository for archived records and out-of-date data;
the information is retrievable.
A daily government publication where all federal
regulatory actions, including proposed rules, final rules,
and notices, are published.
See Federal Food, Drug, and Cosmetic Act.
See Fungicide-Herbicide Branch.
FOD is one of the seven Divisions that constitutes OPP.
It oversees implementation of OPP regulatory actions,
directs pesticide applicator training and certification, and
manages the public docket. Within FOD, there are five
branches: Regional Operations; Public Response and
Program Resources; Communications; Occupational
Safety; and Certification and Training.
See Federal Insecticide, Fungicide, and Rodenticide Act.
An independent group of scientists, authorized under
FIFRA, to render scientific opinions on pesticide issues
and advise the Assistant Administrator for the Office of
Prevention, Pesticides, and Toxic Substances.
13
-------
FIFRA Section
6(a)(2), Adverse
Effects Data
FIFRA Section 18
(Emergency
Exemption)
FIFRA Section
24{c) Special
Local Need (SLN)
Registration
Flowable
FDD
FOIA
The provision in FIFRA which requires the registrant to
submit to EPA any studies or other information regarding
unreasonable adverse effects of a pesticide, at any time
after its registration.
A provision in FIFRA under which EPA can grant an
emergency exemption to a state or another federal
agency that allows the use for a limited period (usually
one year) of a pesticide product that is not registered for
that particular use. The exemption is requested and
authorized because a pest problem is unanticipated
and/or severe and there is no time or interest by a
registrant to register the product for that use.
Registrants cannot apply for emergency exemptions.
Registration of a pesticide product under FIFRA section
24(c) by a state agency for a specific use that is not
federally registered (however, the active ingredient must
be federally registered for other uses). The special use is
specific to that state and is often minor; thus, it may not
economically warrant a full federal registration by the
registrant. SLNs have full federal registration status;
they are processed by product manager teams in RD.
SLN registrations cannot be issued for new active
ingredients, food-use active ingredients without
tolerances, or for a registration that has been cancelled or
suspended under FIFRA section 3(c)(2)(B). A 24{c)
registered product cannot be shipped across state lines,
and may be used only in the state of issuance.
Formulations in which the active ingredients are finely
ground insoluble solids mixed with a liquid as a
suspension. Flowables are mixed with water for
application.
See Field Operations Division.
Freedom of Information Act. Legislation that ensures the
availability of federally generated information to the
public.
14
-------
Food and Drug
Administration
(FDA)
FR
Fungicide-
Herbicide Branch
(FHB)
Generally
Recognized as
Safe (GRAS)
Genetic
Engineering
GLP
Good Laboratory
Practice (GLP)
GRAS
The federal agency responsible for carrying out the
provisions of the Federal Food, Drug, and Cosmetic Act
(FFDCA), which includes pesticide tolerance
enforcement. See also, Federal Food, Drug, and
Cosmetic Act.
See Federal Register.
FHB, within RD, carries out regulatory responsibilities on
herbicide and fungicide products. FHB is responsible for
processing applications for registration, experimental use
permits, and petitions for tolerances for these classes of
pesticides.
Designation by FDA that a chemical or substance
(including certain pesticides) added to food is considered
safe by experts, and so is exempted from the usual food
additive tolerance requirements of FFDCA section 409.
Directed transfer of permanent genetic information
between species. This may include organisms that the
Agency considers to be microbial pest control agents.
Some higher plants have been "genetically engineered" to
produce a pesticide or other compound not produced by
the native plant.
See good laboratory practice.
Protocols established in 40 CFR 160 to assure the quality
and integrity of data submitted by registrants. Provisions
of the GLP standards include recordkeeping, personnel,
and laboratory equipment requirements.
See generally recognized as safe.
15
-------
Group A, Bt, B2,
C, D, E Carcinogen
Hazard
Hazard Ratio
HOT
Health Effects
Division (HED)
HED
Qualitative classification of chemicals for human
carcinogenic potential based on the Agency's Carcinogen
Assessment Guidelines. Group A includes known human
carcinogens. Group B, which is subdivided into
categories B, and B2, contains probable human
carcinogens. B, is reserved for agents that have limited
evidence of carcinogenicity from epidemiologic studies
and sufficient evidence from animal studies; B2 is for
agents for which there is sufficient evidence from animal
studies and inadequate or no data from epidemiologic
studies. Group C contains possible human carcinogens
for which there is limited animal evidence; Group D
includes chemicals that have no carcinogenic information
or insufficient information to classify the chemicals; and
Group E consists of chemicals that are not expected to
be human carcinogens.
Inherent toxicity of a compound. Hazard identification of
a given substance is an informed judgment based on
verifiable toxicity data from appropriate animal models or
information from human studies.
A term used by the Ecological Effects Branch to compare
an animal's daily dietary intake of a pesticide to its LD50
value. A ratio greater than 1.0 indicates that the animal
is likely to consume an amount of pesticide exceeding
the dose at which 50 percent of animals of the same
species would be killed.
See highest dose tested.
HED is one of the sevenvDivisions that constitutes OPP.
It is responsible for assessment of pesticide effects on
human health. This Division was created by the OPP
reorganization of July 1988 when the Hazard Evaluation
Division was split into EFED and HED. HED is made up
of seven branches: Science Analysis; Chemical
Coordination; Toxicology-Insecticide and Rodenticide
Support; Toxicology-Herbicide, Fungicide, and
Antimicrobial Support; Chemistry Branch (--Tolerance
Support; Chemistry Branch Il-Reregistration Support; and
the Occupational and Residential Exposure Branch.
See Health Effects Division.
16
-------
Highest Dose
Tested (HOT)
Hydrolysis
Hyperplasia
Hypoplasia
ICR
Imminent Hazard
Indemnification
Inert Ingredient
Information
Collection Request
(ICR)
The highest dose of a chemical or substance tested in a
study.
The decomposition of organic compounds by interaction
with water.
An increase in the number of cells in a tissue or organ
(excluding tumor formation) that increases the bulk of the
organ. Hyperplasia is sometimes a precursor to tumor
formation.
A condition of arrested development in which an organ or
part remains below the normal size or in an immature
state.
See Information Collection Request.
A situation that exists when the continued use of a
pesticide during the time required for a cancellation
proceeding would be likely to result in unreasonable
adverse effects on humans or the environment or will
involve unreasonable hazard to the survival of an
endangered species.
A provision of FIFRA section 15 that requires EPA to pay
end-users, dealers, and distributors for the cost of stock
on hand at the time a pesticide registration is suspended
under section 6(c). Only certain end-users are entitled to
an automatic indemnity.
An ingredient in a pesticide product's formulation that
has no direct pesticidal activity but can be biologically
active (such as water, solvents, emulsifiers, surfactants,
clay, or propellants).
EPA prepares an ICR for rules, proposed rules, surveys,
or guidance documents that contain information
gathering requirements. The ICR is a description of what
information is needed, why the information is needed,
how it will be collected, and how much the information
collection will cost. The Agency submits each ICR to
OMB for approval.
17
-------
Information
Services Branch
(ISB)
Insecticide and
Rodenticide Branch
(IRB)
Integrated Pest
Management (IPM)
Interregional
Research Project
No. 4 (IR-4)
Intrastate Product
In Vitro
In Vivo
IPM
IR-4
IRB
ISB
ISB, within PMSD, provides information management
support to the OPP regulatory program. These services
include assessing information needs, directing the OPP
security program, and maintaining liaison with
information contacts and organizations outside OPP.
IRB, within RD, is responsible for processing applications
for registration, experimental use permits, and petitions
for tolerances for pesticides in these use classes.
The concept and practice of using a variety of methods
(cultural, pesticidal, biological, etc.) to control pests.
A program sponsored by the U.S. Department of
Agriculture (USDA). IR-4 provides national leadership
and coordination for information on the clearance of
minor use pesticides and generates data to support
minor-use registrations.
A pesticide product that was registered by a state for
sale and use only in that state. Because the product was
not federally (EPA) registered, it could not be transported
across state boundaries. Intrastate products were
identified by a product number greater than 3000 (e.g.,
1573-4880). All intrastate products have now been-
converted to full federal registration or cancelled.
Testing or occurring outside an organism (e.g., in a test
tube or a culture dish).
Testing or occurring inside an organism.
See integrated pest management.
See Interregional Research Project No. 4.
See Insecticide and Rodenticide Branch.
See Information Services Branch.
18
-------
Label Use
Information
System (LUIS)
LADD
LC
50
LD
50
LD,
lo
LOT
Leaching
LEL
Lifetime Average
Daily Dose (LADD)
LUIS is a computer data base of label directions for
pesticide usage. Information contained in LUIS includes:
use sites, application type, timing, equipment, dosage,
application frequency, reentry and preharvest restrictions,
geographic limitations, and selected limitations to use.
Data are extracted by product but may be aggregated by
active ingredient. The system currently focuses on
information needed to support reregistration. Additional
information (e.g., pests, more use limitations) will be
added to the system to support Special Reviews and
other reregistration activities.
See lowest acceptable daily dose. Also see lifetime
average daily dose.
Lethal concentration of a substance that is expected to
cause death in 50 percent of a test population. Usually
used for birds or aquatic organisms, or for mammalian
inhalation toxicity studies.
Lethal dose taken by mouth or absorbed through the skin
that is expected to cause death in 50 percent of the test
animals treated. If a chemical has an LD50 of 10 mg/kg,
it is more toxic than one having an LD50 of 100 mg/kg.
Lethal dose, low. The lowest dose in an animal study at
which lethality occurs.
The lowest dose tested in a study.
Movement of a substance downward or out of the soil as
the result of water movement.
See lowest effect level.
Used for estimating excess lifetime cancer risk.
19
-------
List A Pesticides
List B Pesticides
List C Pesticides
List D Pesticides
LOEL
Lowest Acceptable
Daily Dose (LADD)
Lowest Effect
Level (LED
Lowest Observed
Effect Level
(LOEL)
LUIS
Maintenance Fee
The statutorily defined list that originally contained 350
active ingredients (grouped into 194 chemical cases)
subject to reregistration. These chemicals, for which
Registration Standards were written prior to FIFRA '88,
are primarily food-use chemicals. They account for 85 to
90 percent of the total volume of food use pesticides
used in the U.S.. See also, List B, C, and D pesticides,
and reregistration.
The second group of approximately 229 active
ingredients (grouped into 149 cases) subject to
reregistration. This list includes the food-use chemicals
that are not on List A and other agricultural pesticides.
See also, List A, C, and D pesticides, and reregistration.
The third group of approximately 289 active ingredients
(grouped into 150 cases) subject to reregistration. This
list primarily includes antimicrobials. See also, List A, B,
and D pesticides, and reregistration.
The remaining approximately 288 active ingredients
(grouped into 117 cases) subject to reregistration. This
list includes many pesticide types including microbials
and biochemicals. See also, List A, B, and C pesticides,
and reregistration.
See lowest observed effect level.
The largest quantity of a chemical that will not cause a
toxic effect, as determined by laboratory animal studies.
See lowest observed effect level (LOEL).
The lowest dose in a study which produces an
observable adverse effect.
See Label Use Information System.
An annual fee required of registrants for each pesticide
product retained for registration.
20
-------
Manufacturing Use
Product (MR or
MUP)
Margin of
Exposure (MOE)
Margin of Safety
(MOS)
Master Record
Identification
Number (MRID #)
Maximum
Contaminant Level
(MCL)
Maximum
Contaminant Level
Goal (MCLG)
Maximum
Permitted Intake
(MPI)
Maximum Residue
Level (MRL)
Maximum
Tolerated Dose
(MTD)
Any product intended (labelled) for formulation or
repackaging into other pesticide products.
A numerical value that characterizes the amount of
safety to a toxic chemical—a ratio of exposure to a
toxicological endpoint, usually the NOEL. Formerly
referred to as the Margin of Safety (MOS).
See margin of exposure (MOE).
A unique cataloging number assigned to an individual
study at the time of submission to the Agency.
An enforceable concentration level for chemical
contaminants that are often found in drinking water
supplies; the MCL is based on technical and feasibility
considerations and is set by the Agency's Office of
Ground Water and Drinking Water.
A suggested limit on the concentration of chemical
contaminants in water that will be protective of human
health. An MCLG is not enforceable at the federal level;
however, many states do enforce them.
An outdated term relative to daily human dietary
exposure. The MPI was expressed in mg/day and was
calculated by multiplying the acceptable daily intake by
the body weight of a human (60 kg is a standard
assumption).
Comparable to a U.S. tolerance, the Maximum Residue
Level is recognized by many countries as an enforceable
limit on pesticide residues in foods. MRLs are set by the
Codex Alimentarius Commission, a United Nations
agency staffed and funded jointly by the World Health
Organization and the Food and Agriculture Organization.
The maximum dose that an animal species can tolerate
for a major portion of its lifetime without significant
impairment or toxic effect other than carcinogenicity.
21
-------
MCL
MCLG
Metabolism
Metabolite
Microbial Pest
Control Agent
(MPCA)
Miscible
MOE
MOS
MP
MPCA
MPI
MRID
MRL
MTD
MUP
Mutagenic
NACA
NARA
See maximum contaminant level.
See maximum contaminant level goal.
The process by which chemicals are transformed and
stored in an organism—animal or plant.
Any substance produced by metabolism. See
metabolism.
A microorganism (e.g., virus, bacterium, fungus,
protozoan) that is used as a pesticidal agent, usually to
infect and kill the target pest, or to compete with
undesirable microbial pests in the environment. Testing
guidelines in Section M of the Pesticide Assessment
Guidelines apply.
Capable of being mixed; often used to describe certain
pesticide formulations.
See margin of exposure.
See margin of safety (now margin of exposure).
See manufacturing use product.
See microbial pest control agent.
See maximum permitted intake.
See master record identification number.
See Maximum Residue Level.
See maximum tolerated dose.
See manufacturing use product.
The property of a substance (or mixture of substances) to
produce genetic changes.
See National Agricultural Chemicals Association.
National Agrichemical Retailers Association.
22
-------
MAS
NASDA
National Academy
of Sciences (NAS)
National
Agricultural
Chemicals
Association
(NACA)
National Center
for Environmental
Publications and
Information
(NCEPI)
National Coalition
Against the Misuse
of Pesticides
(NCAMP)
National Institute
for Environmental
Health Sciences
(NIEHS)
National Pest
Control
Association
(NPCA)
National Pesticide
Information
Retrieval System
(NPIRS)
See National Academy of Sciences.
National Association of State Departments of Agriculture.
An eminent society of elected scholars dedicated to
furthering science and the general welfare.
An association representing the interests of most major
pesticide companies and the uses of pesticides in
agriculture.
NCEPI is EPA's clearinghouse and primary distribution
center for nontechnical Agency publications. Single
copies of publications in stock are sent free of charge.
Catalogs of EPA publications (order #EPA 212-B-93-001)
and OPP publications (order #EPA 730-B-94-001) may be
requested. Contact: EPA/NCEPI, PO Box 42419,
Cincinnati, OH 45242-0419, telephone 513-891-6561,
fax 513-891-6685.
NCAMP was formed to serve as a national network
committed to pesticide safety and the adoption of
alternative pest management strategies that reduce or
eliminate a dependency on toxic chemicals.
As part of the National Institutes of Health, NIEHS
performs basic research, including genetic and cancer
studies, that relates to environmental health sciences.
An association whose members include companies
engaged in the integrated management of insects,
rodents, birds, and other pests that inhabit buildings or
structures.
The commercially-available version of the Pesticide
Product Information System (PPIS). In addition to PPIS
information, NPIRS also includes Pesticide Document
Management System data (e.g., MRID number, study
title, title page from submitted study). See also,
Pesticide Product Information System.
23
-------
National Pesticides
Telecommuni-
cations Network
(NPTN)
National Pollutant
Discharge
Elimination System
(NPDES)
National Pollutant
Discharge
Elimination System
(NPDES) Permit
National Technical
Information
Service (NTIS)
Natural Resources
Defense Council
(NRDC)
NCAMP
NCEPI
Neoplasm
NIEHS
No Observable
Effect Level
(NOEL)
NPTN, located at Texas Tech University, is a network
from which the public can get answers to their pesticide-
related questions by calling a toll-free phone number
(1-800-858-7378) that is funded by the Agency.
A provision of the Clean Water Act which prohibits
discharge of pollutants into waters of the U.S. unless a
special permit is issued by EPA, a state or, where
delegated, a Native American tribal government.
A permit issued by the Office of Water that allows
dischargers of pollutants (e.g., a chemical manufacturing
facility) to purposely discharge contaminated effluent into
waters of the U.S..
An organization that sells certain government
publications including EPA documents such as testing
guidelines. Orders can be placed at NTIS, Attention:
Order Desk, 5285 Port Royal Road, Springfield, VA
22161; telephone (703) 487-4650.
The NRDC is dedicated to protecting endangered natural
resources and improving the quality of the human
environment.
See .National Coalition Against the Misuse of Pesticides.
See National Center for Environmental Publications and
Information.
Literally, new growth; a benign (e.g., adenoma) or
malignant (e.g., carcinoma) tumor.
See National Institute for Environmental Health Sciences.
The highest dose level (quantity) of a substance
administered to a group of experimental animals that
demonstrates the absence of effects observed or
measured at higher dose levels. The NOEL should
produce no biologically significant differences between
the group of treated animals and a control group of
unexposed animals maintained under identical conditions.
See also, NOAEL.
24
-------
NOAEL
NOEL
NOIC
NOIS
Notice of Intent
to Cancel (NOIC)
Notice of Intent
to Suspend (NOIS)
NPCA
NPDES
NPDES Permit
NPIRS
NPTN
NRDC
NTIS
Occupational
and Residential
Exposure Branch
(OREB)
No observable adverse effect level. See no observable
effect level.
See no observable effect level.
See notice of intent to cancel.
See notice of intent to suspend.
Notification sent to registrants when the Agency decides
to cancel (terminate) the registrations of products
containing a pesticide, either for administrative reasons or
because the chemical has been shown to cause
unreasonable adverse effects. See also, suspension of
registration.
Notification sent to a registrant when the Agency decides
to suspend (halt) product sale and distribution because of
failure to meet an obligation, such as submission of data
in a timely and/or acceptable manner, or because of
imminent hazard. See also, suspension of registration
and emergency suspension.
See National Pest Control Association.
See National Pollutant Discharge Elimination System.
See National Pollutant Discharge Elimination System
Permit.
See National Pesticide Information and Retrieval System.
See National Pesticides Telecommunications Network.
See Natural Resources Defense Council.
See National Technical Information Service.
OREB, within HED, is responsible for review and
evaluation of data regarding the exposure of people to
pesticides.
25
-------
Occupational
Safety Branch
(OSB)
OD
ODW
OECD Guidelines
OES
Office of
Endangered
Species (OES)
Office of Ground
Water and Drinking
Water (OGWDW)
Office of
Information and
Regulatory Affairs
(OIRA)
Office of
Pesticide
Programs (OPP)
OGWDW
OSB, within FOD, develops and recommends Agency
policy and implements a strategy for pesticide
occupational safety programs. Through cooperative
agreements, grants, or contracts, OSB manages external
efforts that contribute to a better understanding of the
phenomena of worker exposure to pesticides, the health
problems created, and identification and demonstration of
practicable and effective means to reduce exposure.
Office Director
See Office of Ground Water and Drinking Water.
Testing guidelines prepared by the Organization of
Economic and Cooperative Development of the United
Nations. These guidelines assist in the preparation of
protocols for toxicological, environmental fate, etc.
studies.
See Office of Endangered Species.
OES is part of the Fish and Wildlife Service, U.S.
Department of the Interior.
Promulgates drinking water standards (MCLs) and/or
issues Health Advisories for pesticides known or
suspected to contaminate groundwater. Formerly called
the Office of Drinking Water (ODW).
OIRA, within the Office of Management and Budget
(OMB), reviews all EPA regulations, Information
Collection Requests, major policy statements and
Congressional testimony.
OPP and the Office of Pollution Prevention and Toxics
comprise the two offices within the Office of Prevention,
Pesticides, and Toxic Substances. OPP is comprised of
seven Divisions: Biological and Economic Analysis;
Environmental Fate and Effects; Field Operations; Health
Effects; Program Management and Support; Registration;
and Special Review and Reregistration.
See Office of Ground Water and Drinking Water.
26
-------
OIRA
OLTS
OMB
Oncogenicity
On-Line Tracking
System (OLTS)
0PM
OPP
OREB
OSB
PAG
PAI
Pathogen
PBA
PCO
PDMS
Personal
Protective
Equipment (PPE)
PES
Pest
See Office of Information and Regulatory Affairs.
See on-line tracking system.
Office of Management and Budget.
See carcinogenicity.
OLTS is a computerized tracking system used to track
data review records.
Office of Personnel Management.
See Office of Pesticide Programs.
See Occupational and Residential Exposure Branch.
See Occupational Safety Branch.
See Pesticide Assessment Guidelines.
See pure active ingredient.
Any disease-producing organism, bacteria, virus or
fungus.
See preliminary benefit analysis.
See pest control operator.
See pesticide document management system.
Clothing and equipment worn by pesticide handlers
(mixers, loaders and applicators) and re-entry workers,
which is designed or intended to reduce their exposure to
pesticides, during or after application.
See Planning and Evaluation Staff.
Any insect, rodent, nematode, fungus, weed or any other
form of terrestrial or aquatic plant or animal life, or any
virus, bacteria, or other micro-organism which the
Administrator declares to be a pest. See FIFRA section
2(1).
27
-------
Pest Control
Operator (PCO)
Pesticide
Assessment
Guidelines (PAG)
Pesticide
Document
Management
System (PDMS)
Pesticide Incident
Monitoring System
(PIMS)
Pesticide Product
Information
System (PPIS)
Pesticide
Registration
Activity Tracking
System (PRATS)
Pesticide
Regulation (PR)
Notice
A person or company that applies pesticides as a
business (e.g., exterminator). Often used to describe
such a service for household applications as compared to
agricultural applications.
Protocols listed in 40 CFR 158 that provide registrants
with guidelines on how to do studies. They are published
by EPA but are not legal documents. Copies of the
Guidelines can be obtained from the National Technical
Information Service.
The Agency-maintained collection of documents of
regulatory significance to pesticides, including submitted
studies. The documents are microfiched and indexed by
an on-line retrieval system that anyone in OPP can use.
A collection of human and environmental poisoning
events related to specific pesticides that were reported to
OPP. PIMS was discontinued in 1981 due to budgetary
constraints and the unverifiable nature of its data; it was
based on volunteered information.
A data base that provides information on more than
60,000 currently and formerly federally registered
pesticide products and other non-pesticide chemicals.
For each federally registered product, PPIS can provide
the product name, registrant name and address, EPA
registration number, type of formulation, signal word,
types of pesticide activity, active ingredient names and
percentages, application sites, and pests controlled.
Also, PPIS contains information on whether the product
has been classified for general or restricted use.
An on-line tracking system to monitor the science
reviews of data submissions. Also, PRATS is used to
request actions (e.g., risk assessments, ORES runs, etc.)
from the OPP science divisions. PRATS replaces the
OLTS.
A written notice from OPP to pesticide registrants that
communicates important changes in regulatory policy,
procedures, and/or regulations. Each PR Notice is
assigned a two-part number beginning with the year
issued followed by a cardinal number (e.g., 87-1, 87-2).
28
-------
Petition
Phenology of
Crops
PHI
PIMS
Planning and
Evaluation Staff
(PES)
Planning and
Reregistration
Branch (PRB)
PM
PMSD
Policy and
Special Projects
Staff (PSPS)
PPE
PPIS
PPSS
PR Notice
PRATS
PRB
Pre-Harvest
Interval (PHI)
See tolerance petition.
The development of crops through the seasons.
See pre-harvest interval.
See Pesticide Incident Monitoring System.
PES, within BEAD, is primarily responsible for formulating
BEAD budgets and program plans, administrative
management, science integration and program evaluation,
and coordination of preparation for hearings.
PRB, within SRRD, manages the reregistration process for
some of the List B, C and D chemicals; manages much of
the product reregistration process; and handles
administrative, budget, personnel, contracts, systems
and outreach activities for SRRD.
See Product Manager.
See Program Management and Support Division.
PSPS, within OPP, serves as the program's primary
means for analyzing and responding to external critiques
of program activities and policies. PSPS also develops
policy initiatives and key regulations.
See personal protective equipment.
See Pesticide Product Information System.
See Program Planning and Support Staff.
See Pesticide Registration Notice.
See Pesticide Registration Activity Tracking System.
See Planning and Reregistration Branch.
The time between the last pesticide application and
harvest of the treated crop.
29
-------
Preliminary
Benefit Analysis
(PBA)
Price Elasticity
Product Manager
(PM) Team
Program
Management and
Support Division
(PMSD)
Program Planning
and Support Staff
(PPSS)
Protocol
PRPRB
PSPS
Public Response
and Program
Resources Branch
(PRPRB)
Summary of a pesticide's uses and benefits; developed
by BEAD for the preliminary determination (PD 2/3) stage
of a Special Review.
The percentage change in the quality of a good or a
service in response to a percentage change in its market
price.
An organizational unit in each of the three RD product
branches, primarily responsible for: processing
applications for new and amended product registration,
petitions for tolerances, experimental-use permits, and
special local need applications. Each of the PM teams is
headed by a product manager (equivalent to a section
head) and staffed by reviewers. Each PM Team has a
number (e.g., PM 21).
PMSD, one of the seven Divisions that constitutes OPP,
provides administrative support to all OPP Divisions;
prepares program plans and budget proposals; manages
the indemnification process; and provides overall
leadership for OPP management program. PMSD is
comprised of four branches: Administration; Resource
Management and Evaluation; Information Services; and
Systems.
PPSS, within HED, is responsible for formulating HED
budgets and program plans, and for administrative
management of budget, personnel, contracts and
systems for HED.
A study plan or method. Testing protocols for data
requirements appear in the Pesticide Assessment
Guidelines.
See Public Response and Program Resources Branch.
See Policy and Special Projects Staff.
PRPRB, within FOD, manages the OPP Freedom of
Information (FOIA) program, the public docket, and the
National Pesticides Telecommunications Network (NPTN).
See also, docket file and NPTN.
30
-------
Pure Active
Ingredient (PA!)
Q star, Q! star,
QUA
Qualitative Use
Assessment (QUA)
RAC
RAF
Rainbow Report
Raw Agricultural
Commodity (RAC)
RB
RBC
RCRA
RD
RED
Test substance required for certain pesticide studies.
Pure active ingredients do not have inert ingredients
added.
A mathematical value that represents the upper 95th
percent confidence limit of the slope of a curve that
describes the carcinogenic response of a tested
compound; the curve is derived from the results of
carcinogenicity studies. Q., * represents potency of
effect. It is expressed as: (mg of chemical/kg of body
weight/day)'1. The Q,* is multiplied by an exposure
value to give an estimate of excess cancer risk. (Q^
also is used in conjunction with LADD.)
See qualitative use assessment.
A report that provides a summary of the major uses of a
pesticide including percent of crop treated, percent of
pesticide used on a site, and other available usage
information.
See raw agricultural commodity.
See Risk Assessment Forum.
An SRRD/OPP document, "Status of Pesticides in
Reregistration and Special Review," which lists and
provides the status of all pesticides now or ever in
reregistration or Special Review. Known also as the
"Rainbow Report" because its chapters are printed on
different colors of paper.
A human food or animal feed crop that has not been
processed (e.g., raw carrots, apples, corn or eggs).
See Reregistration Branch.
See red blood cell.
See Resource Conservation and Recovery Act.
See Registration Division.
See Reregistration Eligibility Decision document.
31
-------
Red Blood Cell
(RBC)
Reference Dose
(RfD)
Registrant
Registration
Registration
Division (RD)
Registration
Number
One of the formed cell types found in the blood;
responsible for carrying oxygen from the external
environment to all cells and tissues of the body. RBC is
often used in conjunction with the type of cholinesterase
that occurs in the red blood cell (e.g., RBC
cholinesterase).
An estimate of the level of daily exposure to a pesticide
residue which, over a 70-year human life span, is
believed to have no significant deleterious effects. RfDs
are based upon data for noncarcinogenic effects of
substances, even those which also may be carcinogenic.
Formerly called the acceptable daily intake (ADI).
The term given to a pesticide manufacturer that has a
registered pesticide product.
The process and final Agency action that authorizes the
legal sale, distribution, and use of a pesticide product.
The process includes OPP's consideration of scientific,
legal, and regulatory requirements of the product and
results in issuance of a Notice of Registration to the
registrant.
RD is one of the seven divisions that constitutes OPP. It
is responsible for processing all registration, tolerance,
and experimental use permit actions. RD is comprised of
four branches: Anti-microbial Program; Fungicide-
Herbicide; Insecticide-Rodenticide; and Registration
Support.
A hyphenated, two-part number assigned by RD to
identify each product registration (e.g., 1253-79). The
first part of the number is the assigned company number
(called the establishment number), which is specific to a
given chemical company; the second part is the specific
product number. The registration number must appear
on the product's label, as required by 40 CFR 156.10.
See also, Supplemental Registration.
32
-------
Registration
Standard (RS)
Registration
Support Branch
(RSB)
REI
Reregistration
A former reregistration process and resulting document
that characterized a pesticide's available scientific data
base and the Agency's position on the registered uses of
that pesticide. All chemical cases that had Registration
Standards issued prior to the enactment of FIFRA '88
now are on List A.
RSB, within RD, is responsible for: the emergency
exemption program under section 18 of FIFRA; issuance
of section 24(c) special local needs registrations; the
clearance requests for exemption from a tolerance for
inert ingredients; the tolerance revocation program; the
management and coordination of minor or specialty use
tolerance petitions submitted under the Federal Food,
Drug, and Cosmetic Act; the review of acute toxicity
data for products; and child-resistant packaging.
See restricted entry interval.
OPP's process of re-examining supporting scientific data,
re-assessing human health and environmental risks, and
making reregistration decisions for all pesticides initially
registered before November 1, 1984. Reregistration
priority is given to chemicals with the highest potential
for exposure—high-volume and food-use chemicals (i.e.,
List A chemicals). Through this priority process, four
lists of pesticides (Lists A, B, C, and D), were established
under FIFRA '88.
The reregistration process consists of the Agency
identifying the studies necessary to conduct human
health and environmental risk assessments; obtaining and
reviewing these studies; estimating potential risks;
imposing any regulatory controls needed to manage those
risks; and reregistering pesticide products whose risks are
not unreasonable. See also, Reregistration Branch;
Accelerated Reregistration Branch; Planning and
Reregistration Branch; Data Call-In; and List A, B, C, and
D Pesticides.
33
-------
Reregistration
Branch (RB)
Reregistration
Eligibility
Decision (RED)
Document
Residential Use
Resource
Management and
Evaluation Branch
(RMEB)
Resource
Conservation and
Recovery Act
(RCRA)
Restricted Entry
Interval (RED
Restricted Use
Pesticide
Review Manager
(RM)
RB, within SRRD, manages the reregistration review
process for the List A pesticides. This includes planning,
scheduling, and coordinating HED, EFED, PMSD, and
BEAD inputs, conducting the administrative review, and
preparing and issuing Reregistration Eligibility Decision
(RED) documents and Tolerance Reassessments.
RED documents summarize the findings of EPA's
reregistration review process for individual chemical
cases, and reflect the Agency's decisions on risk
assessment and risk management for the uses of
pesticides. Besides summaries of risk assessments, RED
documents include requirements for risk reduction,
product-specific data to support product reregistration,
and any additional generic data needed on the active
ingredient(s).
Pesticide application in and around houses, office
buildings, apartment buildings, motels, and other living or
working areas.
RMEB, within PMSD, provides overall management,
direction, guidance and support to OPP divisions and
offices on the development and implementation of
program and budget plans.
RCRA is a law under which EPA regulates the
transportation, storage, and disposal of hazardous waste.
It is implemented by the Office of Solid Waste, Office of
Solid Waste and Emergency Response.
The time after the end of a pesticide application during
which entry into the treated area is restricted. Formerly
called the reentry interval.
A pesticide that is available for purchase and use only by
certified pesticide applicators or persons under their
direct supervision. This designation is assigned to a
pesticide product because of its relatively high degree of
potential human and/or environmental hazard.
See Chemical Review Manager.
34
-------
RfD
See reference dose.
Risk (Adverse Risk)
for Endangered
Species — Aquatic
Risk (Adverse Risk)
for Endangered
Species --
Terrestrial
Risk Assessment
Risk Assessment
Forum (RAF)
Risk
Characterization
Risk for Non-
Endangered
Species
RM
RMEB
RPAR
RS
RSB
RUP
Risk to species if anticipated pesticide residue levels
equal 1/10 of LD10 or 1/20 of LC50.
Risk to species if anticipated pesticide residue levels
equal 1/5 of LC10 or 1/10 of LC50.
A process in which the hazard and exposure potential of
an environmental agent are described, and a risk
characterization is developed. See also: Risk
Characterization.
The RAF consists of Agency risk assessment (RA) expert
scientists who study technical Agency-wide RA issues
and refer their findings to the Risk Assessment Council.
The RAF was established to promote consensus on RA
issues within the Agency.
In general, a determination of the likelihood of a hazard to
occur in a population exposed to pesticide chemicals.
This likelihood may be expressed as a numerical
probability or as a margin of exposure. Simply stated:
RISK = Hazard x Exposure.
Risk to species if anticipated pesticide residue levels are
equal to or greater than LC50.
See Chemical Review Manager.
See Resource Management and Evaluation Branch.
Rebuttable Presumption Against Registration (former
name for Special Review).
See Registration Standard.
See Registration Support Branch.
See restricted use pesticide.
35
-------
SAB
SAB
SACS
Safe Drinking
Water Act (SDWA)
SAP
SARA
SB
Science Advisory
Board (SAB)
Science Analysis
Branch (SAB)
Science Analysis
and Coordination
Staff (SACS)
See Science Advisory Board.
See Science Analysis Branch.
See Science Analysis and Coordination Staff.
The SDWA is the basis for protecting persons receiving
water from public drinking water systems from harmful
contaminants. It directs the EPA Administrator to
develop: (1) National primary drinking water regulations
that incorporate maximum contaminant levels; (2)
Underground Injection Control regulations to protect
underground sources of drinking water; and (3)
Groundwater protection grant programs for the
administration of sole source aquifer demonstration
projects and for wellhead protection area programs.
See FIFRA Scientific Advisory Panel.
See the Superfund Amendments and Reauthorization Act
of 1986; and the Comprehensive Environmental
Response, Compensation, and Liability Act (CERCLA).
See Systems Branch.
An group of scientists established by Congress to provide
independent scientific and engineering advice to the EPA
Administrator on the technical basis for Agency
regulations. The SAB conducts open meetings and its
reports are available to the public.
SAB, within HED, integrates human and animal
toxicological data along with dietary exposure data to
determine the dietary risk for pesticides, conducts
statistical analyses, manages the HED Peer Review
process, and evaluates data pertaining to the human
health impacts of biological pesticides.
SACS, within EFED, supports the assessment of
environmental pesticide hazards by integrating individual
discipline-specific review components into an overall
statement of risk. SACS also provides quality control on
EFED's scientific output, analyzes science policy issues
and recommends resolution of issues.
36
-------
SDWA
Section 6(a)(2)
Section 18
Section 24(c)
SETAC
SFIREG
SLN
SMARTS
Society for
Environmental
Toxicology and
Chemistry
(SETAC)
Solution
SOP
Special Local Need
(SLN or FIFRA
Section 24(c))
See Safe Drinking Water Act.
See FIFRA Section 6(a){2) (adverse effects data).
See FIFRA section 18 (emergency exemption).
See FIFRA section 24(c) (special local need registration).
See Society for Environmental Toxicology and Chemistry.
See State FIFRA Issues, Research and Evaluation Group.
See FIFRA section 24(c) (special local need registration).
Simple Maintenance of ARTS; an expanded computer
program version of now defunct ARTS. See ARTS.
A professional society for environmental toxicologists and
chemists. Publishes a journal entitled Environmental
Toxicology and Chemistry and sponsors symposia on
various environmental issues that relate to toxicology and
chemistry.
A formulation or use dilution of a pesticide that dissolves
in the carrier liquid or diluent and will not settle out or
separate in an aqueous medium.
See standard operating procedure.
See FIFRA section 24(c).
37
-------
Special Review
(SR)
Special Review
Branch (SRB)
Special Review
Procedure
Special Review
and Reregistration
Division (SRRD)
SR
SRB
Special Review is the process through which existing
pesticides suspected of posing unreasonable risks to
human health, the environment, or non-target organisms
are referred for review by the Administrator or the
Assistant Administrator. The review requires intensive
risk and benefit analyses with the opportunity for public
comment. If the risk of any pesticide use is found to
outweigh social and economic benefits, regulatory action
can be initiated. Regulations pertaining to Special
Review procedures are found at 40 CFR Part 154.
Special Review formerly was known as Rebuttable
Presumption Against Registration (RPAR).
SRB, within SRRD, is responsible for managing the
Special Review process for chemicals that have met or
exceeded the risk criteria for unreasonable adverse
affects, as set forth in 40 CFR 154. The Special Review
process provides a framework for intensive risk/benefit
review of pesticides, and preparation of documents
stating the Agency's position (Position Documents).
Subsequent action may include risk reduction measures,
cancellation of some or all uses, emergency suspension/
cancellation, and hearing coordination.
A written procedure for use within the Special Review
Branch that communicates to the staff the various steps
involved in initiating and completing tasks commonly
associated with managing Special Reviews.
SRRD is one of the seven Divisions that constitutes OPP.
It manages Special Reviews and the reregistration
process. More specifically, SRRD develops Special
Review and reregistration eligibility decisions; issues
related data call-in notices; issues Special Review
Position Documents, RED documents and follow-up
reports; and administers the product reregistration
process. The Division is comprised of the immediate
office staff and four branches: Special Review;
Reregistration; Accelerated Reregistration; and Planning
and Reregistration.
See Special Review.
See Special Review Branch.
38
-------
SRRD
See Special Review and Reregistration Division.
Standard
Operating
Procedure (SOP)
STARS
State FIFRA
Issues, Research
and Evaluation
Group (SFIREG)
Strategic Targeted
Activities for
Results System
(STARS)
Superfund
Amendments and
Reauthorization
Act of 1986
(SARA)
Supplemental
Registration
Surrogate Data
Suspension
A written procedure that conveys procedures for various
functions performed by OPP staff. SOPs address both
technical and administrative matters.
See Strategic Targeted Activities for Results System.
SFIREG is a group of state pesticide regulatory officials
who work with OPP staff to identify and resolve
overlapping state and federal regulatory and research
issues.
EPA's administrative management tracking system.
STARS tracks each Program office's most important
activities, and provides feedback showing how well each
is doing in achieving the goals and objectives set forth in
its mission. Program offices submit data on outputs and
accomplishments to the Office of Policy, Planning and
Evaluation (OPPE), which compiles quarterly STARS
reports.
SARA is the legislation that reauthorized the Superfund
program in 1986. In addition, this law made several
amendments to CERCLA and established the provisions
for SARA Title III—the Emergency Planning and
Community Right-to-Know Act (EPCRA).
An arrangement by which a registrant licenses another
company to market its registered name (i.e., distribute
pesticide product under the second company's
registration). A supplemental registration is identified by
a three part number (e.g., 1342-6-2): the first and
second parts are the primary registrant's registration
number, and the third part is the supplemental
registrant's company number.
Data from studies which involve test organisms or a test
substance that are used to estimate the characteristics or
effects on another organism or of another substance.
Finely divided solid particles mixed in a liquid.
39
-------
Suspension of
Registration
Systemic Poison
Systems Branch
(SB)
TAIS
TC
TD
Technical Grade
Active Ingredient
(TGAI)
Technical Grade
Product
TEP
An action authorized under FIFRA section 3(c){2)(B) that
temporarily halts further distribution and sales of a
pesticide product. Suspension is commonly imposed
because the registrant has failed to adequately meet data
submission requirements. The registrant can request a
hearing to discuss data issues and the suspension can be
lifted when the requirements are met.
A suspension of registration also can be issued under
FIFRA section 6(c) due to an imminent hazard. This type
of suspension halts distribution, sale and sometimes use
of affected pesticide products. The registrant has the
right to an expedited hearing on the question of whether
an imminent hazard exists. See also, NOIS and
emergency suspension.
Poison that travels through the body and affects one or
more parts of the body, distant from the point of entry.
SB, within PMSD, is the central point within OPP for
automatic data processing systems analysis and design.
Services provided include: ADP facilities and hardware,
data input, and retrieval support from the computerized
data bases.
See.time and accounting information system.
See toxic concentration.
See toxic dose.
The pesticide chemical in pure form (usually 95-100%
active ingredient) as it is manufactured by a chemical
company prior to being formulated into an end-use
product (e.g., wettable powders, granules, emulsifiable
concentrates).
A registered manufactured-use product that is composed
of technical grade active ingredient.
See typical end-use product.
40
-------
Teratogenic
TGAI
Theoretical
Maximum Residue
Contribution
(TMRC)
Time and
Accounting
Information
System (TAIS)
TMRC
Tolerance
Tolerance Petition
Toxic
Concentration (TC)
Toxic Dose (TD)
The property of a substance or mixture of substances to
produce structural deviations or malformations, not
heritable, in or on an animal embryo or fetus.
See technical grade active ingredient.
The theoretical maximum amount of a pesticide in the
daily diet of an average human. This theoretical amount
assumes that the diet is composed of all food items for
which there are tolerance-level residues of the pesticide.
The TMRC unit is expressed as mg (of pesticide)/kg (of
body weight)/day.
A system for recording the time spent by OPP
professional staff and first-line supervisors (i.e., section
heads) on various OPP work projects. The collected
information is used for budgetary analysis and resource
management.
See theoretical maximum residue concentration.
Maximum permissible levels for pesticide residues
allowed in or on commodities for human food and animal
feed. Under the Federal Food, Drug, and Cosmetic Act,
EPA is responsible for establishing tolerances. Whenever
a pesticide is registered for use on a food or feed crop, a
tolerance or exemption from the requirement of a
tolerance must be established. Established tolerances
and exemptions for pesticide chemicals in or on raw
agricultural commodities are listed in 40 CFR 180.
Tolerances for pesticides in processed food are at 40
CFR 185; and tolerances for pesticides in processed
animal feed are listed at 40 CFR 186. Tolerances are
enforced by the Food and Drug Administration and the
U.S. Department of Agriculture.
A formal request to establish a new tolerance or modify
(raise, lower or revoke) an existing tolerance.
The concentration at which a substance produces a toxic
effect.
The dose at which a substance produces a toxic effect.
41
-------
Toxicity, Acute
Toxicity, Chronic
Toxicity,
Subchronic
Toxic Substances
Control Act
(TSCA)
TSCA
Typical End-Use
Product (TEP)
Use Index
The property of a substance or mixture of substances to
cause effects in an organism through a single or short-
term exposure. Acute toxicity is established through
scientifically verifiable data from animal or human
exposure tests. Values often are expressed as LD50 or
LC50 in units mg/kg or mg/l. Acute toxicity studies
include oral, dermal and inhalation studies.
The property of a substance or mixture of substances to
cause effects of an extended duration in an organism,
usually upon repeated or continuous exposure over most
or all of the lifetime of that organism. Occasionally,
chronic toxicity can result from single or very short
duration exposures. Chronic toxicity is established
through scientifically verifiable data from animal or
human exposure tests. Values are expressed as NOEL,
NOAEL, and LEL, usually in mg/kg/day. Chronic toxicity
studies in mammalian species include carcinogenicity and
chronic feeding.
The property of a substance or mixture of substances to
cause effects in an organism from (usually) more than
one exposure (dosing) but less than lifetime exposure.
For pesticides, subchronic studies are often for 90 days
of exposure conducted in a rodent or the dog. Values are
expressed as NOEL, NOAEL, or LEL in mg/kg/day.
Subchronic studies may include oral, dermal, inhalation
and reproduction studies.
TSCA is a law administered by the Office of Pollution
Prevention and Toxics that governs the manufacture and
use of toxic industrial chemicals. TSCA excludes drugs,
pesticides, cosmetics and radioactive agents.
See Toxic Substances Control Act.
A term used in data requirements to convey direction to a
data producer to use a commonly used end-use product
as the test substance.
Compilation of everything on a label for each pesticide
product, including the use sites and application rates.
The Use Index is prepared by BEAD. See also, EPA
Compendium of Acceptable Uses and LUIS.
42
-------
Volatility
Water Soluble
Packaging
"Weight of
Evidence"
Approach
Wettable Powder
(WP)
WP
The property of a substance to become a vapor or gas
without chemical change.
Packaging that dissolves in water; this type of packaging
is used to reduce exposure risks to mixers and loaders.
Evaluation based on a qualitative assessment of the
available scientific evidence.
Dry formulation material that must be mixed with water
or other liquid before it is applied.
See wettable powder.
43
-------
------- |