Federal Insecticide, Fungicide, and Rodenticide Act

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Federal Insecticide,

Fungicide, and Rodenticide

Act

Long title

An Act to regulate the

marketing of economic

poisons and devices, and for

other purposes

(colloquial)

FIFRA

Enacted by

the

Effective

June 25, 1947

Citations

Public law

Codification

Titles

amended

sections

created

§ 136 et

seq.

Legislative history

Signed into law

by President

on June 25, 1947

Major amendments

Federal Environmental Pesticide Control

Act (1972)

The

Federal Insecticide, Fungicide, and Rodenticide Act

(

FIFRA

) is a

federal law that set up the basic U.S. system of

regulation to protect applicators, consumers, and the environment.

It is

administered and regulated by the

(EPA) and the appropriate environmental agencies of the respective

states.

FIFRA has undergone several important amendments since its

inception.

A significant revision in 1972 by the

(FEPCA) and several others have expanded EPA's present

authority to oversee the sales and use of pesticides with emphasis on the

preservation of human health and protection of the environment by "(1)

strengthening the registration process by shifting the burden of proof to the

chemical manufacturer, (2) enforcing compliance against banned and

unregistered products, and (3) promulgating the regulatory framework missing

from the original law".

History

[

]

Mexican Brand Insect Fluid,

"Under the Insecticide Act of 1910"

The

(FIA) of 1910 was the first pesticide legislation

enacted.

This legislation ensured quality pesticides by protecting farmers

and consumers from fraudulent and/or adulterated products by manufacturers and

distributors.

During

there was a marked increase in the

pesticide market, as wartime research and development produced many chemicals

with newly discovered insecticidal properties.

Widespread usage of

pesticides garnered much public and political support due to the resulting

post war food surplus made possible by higher crop yield from significantly

lower pest damage.

Synthetic organic insecticide usage increased from 100

million pounds in 1945 to over 300 million pounds by 1950.

The Federal

Insecticide Act of 1910 set standards for chemical quality and provided

consumers protection but did not address the growing issue of potential

environmental damage and biological health risks associated with such

widespread use of insecticides.

Congress passed the Federal

Insecticide, Fungicide, and Rodenticide Act in 1947 to address some of the

shortcomings of the Federal Insecticide Act.

Congress enacted major revisions to FIFRA in 1972 with the

Federal

Environmental Pesticide Control Act

(FEPCA).

The 1947 law assigned the

responsibility for regulating pesticides.

The 1972 amendment transferred this responsibility to the

and shifted emphasis to protection of the environment and public health.

The amendments required the EPA to assess potential risks the pesticides posed to

humans, the environment, and wildlife and weigh these against their benefits, taking

action against those for which the risks outweighed the benefits.

In 1988,

Congress amended the pesticide registration provisions requiring re-registration of

many pesticides that had been registered before 1984.

The act was amended again

in 1996 by the

More recently the act was amended in

2012 by the Pesticide Registration Improvement Extension Act of 2012.

As of May 2007, there are 28 listed restricted pesticides of different formulas and

mixtures. Any area these pesticides are used or applied is considered a restricted

area.

Major code sections

[

]

Table 2. Major U.S. Code Sections of the Federal Insecticide, Fungicide, and Rodenticide Act

(codified

generally as 7 U.S.C. 136-136y)

7 U.S.C.

Section Title

FIFRA

Short title and table of contents

Section 1

136

Definitions

Section 2

136a

Registration of pesticides

Section 3

136a-1

Reregistration of registered pesticides

Section 4

136c

Section 5

136d

Administration review; suspension

Section 6

136e

Registration of establishments

Section 7

136f

Books and records

Section 8

136g

Inspection of establishments

Section 9

136h

Protection of trade secrets and other information

Section 10

136i

Restricted use pesticides; applicators

Section 11

136j

Unlawful acts

Section 12

136k

Stop sale, use, removal, and seizure

Section 13

136l

Penalties

Section 14

136m

Indemnities

Section 15

136n

Administrative procedure; judicial review

Section 16

136o

Exemption of federal and state agencies

Section 17

136p

Exemption of federal and state agencies

Section 18

136q

Storage, disposal, transportation, and recall

Section 19

136r

Research and monitoring

Section 20

136s

Solicitation of comments; notice of public hearings

Section 21

136t

Delegation and cooperation

Section 22

136u

State cooperation, aid, and training

Section 23

136v

Authority of states

Section 24

136w

Authority of Administrator

Section 25

136w-1

State primary enforcement responsibility

Section 26

136w-2

Failure by the state to assure enforcement of state pesticides use regulations

Section 27

136w-3

Identification of pests; cooperation with Department of Agriculture's program

Section 28

136w-4

Annual report

Section 29

136w-5

Minimum requirements for training of maintenance applicators and service technicians

Section 30

136w-6

Environmental Protection Agency minor use program

Section 31

136w-7

Department of Agriculture minor use program

Section 32

136w-8

Pesticide Registration Service Fees

Section 33

136x

Severability

Section 34

136y

Authorization of Appropriations

Section 35

Note: This table shows only the major code sections. For more detail and to determine when a section was added, the

reader should consult the official printed version of the U.S. Code.

Regulations

[

]

In order to be considered for use, pesticides had to undergo 120 tests with regards to safety and its actual

effectiveness. Because of these rigorous test, only 1 in 139,000 actually make it through to be used in agriculture.

[

]

This act directly

forbids

certain substances and certain uses of those substances, as distinguished

from other legislation regulating pesticides, which impose costs on certain practices but do not

outlaw

any.

FIFRA established a set of pesticide regulations:

[

]

FIFRA established registration for all

, which is only done after a period of data collection to

determine the effectiveness for its intended use, appropriate dosage, and hazards of the particular material.

When registered, a label is created to instruct the final user the proper usage of the material. If instructions

are ignored, users are liable for any negative

consequences.

Label directions are designed to maximize the effectiveness of the product, while protecting the applicator,

consumers, and the environment.

Only a few pesticides are made available to the general public. Most pesticides are considered too hazardous for

general use, and are restricted to certified applicators. FIFRA established a system of examination and

certification both at the private level and at the commercial level for applicators who wish to purchase and

use

. The distribution of restricted pesticides is also monitored.

The EPA has different review processes for three categories of pesticides:

, and

conventional pesticides.

The three categories have a similar application process, but have different data

requirements and review policies.

Depending on the category of pesticide, the review process can take several

years.

After a pesticide is registered with the EPA, there may be

requirements to consider.

In addition to the rules and regulations given by the EPA, the states may also offer an additional set of rules

and registration requirements for a registered pesticide. They can also request annual usage reports from the

pesticide users.

In addition to the FIFRA, the Pesticide Registration Improvement Act of 2003 amended the authorized fees for certain

products, assessed the process of collecting maintenance fees, and decided on a review process for approving the

pesticides. The Pesticide Registration Improvement Act of 2007 renewed these changes to stay in place until 2012. The

purpose of the PRIA is to ensure a smooth implementation of pesticide rules and regulations to its users.

Import and export

[

]

Pesticides intended for import into the U.S. require a complete Notice of Arrival (NOA) through U.S. Customs and

Border Protection. If this NOA is not complete the product would not make it through customs. The NOA lists the

identity of the product, the amount within the package, the date of arrival, and where it can be inspected. There are

also other rules listed below:

It must comply with standards set with the U.S. pesticide law

The pesticide has to be registered with the EPA, except if it's on the exemption list

It cannot be adulterated or violative

There must be proper labeling

The product must have been produced in an EPA registered establishment that files annually

Pesticides intended for export to other parts of the world do not have a registration requirement under certain

conditions. The conditions are as follows:

The foreign purchaser has to submit a statement to the EPA stating it knows the product is not registered and

can't be sold on U.S. soil.

The pesticide must contain a label that "Not Registered for Use in the United States"

The label requirements must be met and the label must contain the English language and the language of the

receiving country(ies).

The pesticide must comply with all FIFRA establishment registration and reporting requirements

It must comply with FIFRA record keeping requirements

Note: An EPA registered establishment is one that produces pesticides, the active ingredients in pesticides, and

devices for pesticide use and reports initial and annual production.

On April 22, 2016, the

issued a memorandum announcing its intent to begin preliminary

research to assess the EPA's inspections of, and enforcement against, illegal pesticide imports.

The objective of

this project is to "determine whether the EPA's Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) import

inspection program is effectively deterring, identifying and confiscating illegal pesticide imports, to protect human

health and the environment."

Registration of pesticide products

[

]

Before a company can register its pesticide products with the EPA, it must know what the EPA considers a pesticide

under the law.

According to section 2(u) of FIFRA, 7 U.S.C. section 136(u), the term "pesticide" is defined as the

following:

any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest,

any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant, and

any nitrogen stabilizer, except that the term "pesticide" shall not include any article that is a "new animal

drug" within the meaning of section 321(w)[1] of title 21, that has been determined by the Secretary of Health

and Human Services not to be a new animal drug by a regulation establishing conditions of use for the article,

or that is an animal feed within the meaning of section 321(x)[1] of title 21 bearing or containing a new animal

drug. The term "pesticide" does not include liquid chemical sterilant products (including any sterilant or

subordinate disinfectant claims on such products) for use on a critical or semi-critical device, as defined in

section 321 of title 21. For purposes of the preceding sentence, the term "critical device" includes any device

which is introduced directly into the human body, either into or in contact with the bloodstream or normally

sterile areas of the body and the term "semi-critical device" includes any device which contacts intact mucous

membranes but which does not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of

the body.

An applicant will have to prove that the pesticide active ingredient, pesticide product, or proposed new use of a

registered pesticide will not cause unreasonable adverse effects on human health and environment.

An unreasonable

adverse effect is "(1) any risk that is unreasonable to man or the environment that takes social, economic, and

environmental costs as well as benefits into consideration and (2) any dietary risk that could be the result of a

pesticide used with any food lacking consistency with the standards listed under Section 408 of the

"(FDCA).

The applicant must provide scientific data from any combinations of over 100

different tests conducted under EPA guidelines to assess these potential adverse short-term and long-term

effects.

There is considerable public interest in the contents of pesticide registration studies, which has led

to conflict over public access to these materials.

These competing interests as well as legislation addressing access

has been covered separately under

In some cases, manufacturers choose to

conduct addition work to satisfy requirements for peer-reviewed literature, as was the case for the herbicide,

Publication of registration studies in the peer-reviewed literature not only provides unlimited

public access, but also ensures sufficient rigor to satisfy the scientific community at large.

Under Section 408 of the

(FFDCA), the EPA can also regulate the amount of

pesticide residues permissible on or in food/feed items, by establishing a "safe" level meaning there is "a reasonable

certainty of no harm" from the exposure to the residue whether directly from the consumption of such food or from

other non-occupational sources.

For food crops, the EPA is required to establish a "tolerance" level, the

maximum "safe" level of pesticide present on or in the particular food/feed commodity.

The EPA may also choose to

provide an exemption to the requirement of an established tolerance level, allowing any amount of a pesticide residue

to remain on or in food or feed as long as the exemption meets FFDCA safety standards.

Successfully registered

pesticides must conform to approved uses and conditions of use, which the registrant must state on the label.

Reregistration of pesticides

[

]

A majority of older registered were required to be reregistered under guidelines set by Amendments in 1972, 1988, and

1996 (Table1) in order to meet current health and safety standards, labeling requirements, and for risk regulation and

moderation.

The

(FQPA), amended FIFRA to require all older pesticides to cause no

harm to infants, children, and sensitive individuals within

"reasonable certainty".

Through the reregistration

program, older pesticides are eligible for reregistration if they have a complete database and not cause unreasonable

health and environmental risks if used as directed in accordance to their labels.

FQPA also requires the EPA to

review pesticides on a 15-year cycle to ensure all pesticides meet contemporary safety and regulatory standards.

Fees

[

]

Initial and final fees for reregistration of food or feed use active ingredients are $50,000 and $100,000-$150,000,

respectively.

Reregistration fees for non-food use pesticides are $50,000-$100,000. Annual maintenance fees are

also imposed: $425 per product up to fifty products and a maximum of $20,000 per company.

For each product over

fifty, the fee is $100, for a maximum fee of $35,000.

Fees may be reduced or waived for small business registrants,

public health pesticides, or minor use pesticides at the EPA's discretion, and failure to pay reregistration fees or

maintenance fees may result in cancellation of a product registration.

Regulated non-pesticidal products not requiring registration

[

]

are chemicals added to enhance the performance or efficacy and/or alter the physical properties of the

pesticidal agents.

More than 200 EPA registered pesticides recommends specific addition of one or more adjuvants

into the pesticidal mixture to improve overall efficacy.

Recognized as "other ingredients", the EPA also

establishes tolerance levels for adjuvants, but they are not required to be registered. Examples of adjuvants

include:

acidifying agents,

buffering agents,

anti-foam agents,

defoaming agents,

anti-transpirants,

dyes and brighteners,

compatibility agents,

crop oil concentrates,

oil surfactants,

deposition agents,

drift reduction agents,

foam markers,

feeding stimulants,

herbicide safeners,

spreaders, extenders,

adhesive agents,

suspension agents,

gelling agents,

synergists,

wetting agents,

emulsifiers,

dispersing agents,

penetrants,

tank and equipment cleaners,

neutralizers,

water absorbents, and

water softeners.

Devices and instruments used to trap or kill pests or plant life, but not including equipment used to apply pesticides

when sold separately, are also regulated but not required to be registered.

Pesticide "intermediates" used in the

synthesis or manufacture of the pesticide products may be regulated but are also not required to be registered with

FIFRA.

However, these pesticide intermediates may be regulated by the

Enforcement

[

]

Under FIFRA no individual may sell, use, nor distribute a pesticide not registered with the

(EPA). A few exceptions allow a pesticide to be exempt from registration requirements. There must be

a label on each pesticide describing, in detail, instructions for safe use. Under the act, the EPA must identify each

pesticide as "general use", "restricted use", or both. "General use" labeled pesticides are available to anyone in the

general public. Those labeled as "restricted use" require specific credentials and certifications through the EPA

(certified applicator).

Although FIFRA is generally enforced by the EPA, Sections 23, 24, 26 and 27 extend primary enforcement authorities to

the states.

However, EPA authority always supersedes state authority, and primary state authority can be rescinded

if the state fails to assure safe enforcement of pesticides usage.

Section 9 authorizes inspection of pesticides in

storage for sale or distribution.

Under Section 13, EPA may issue a Stop Sale, Use or Removal Order (SSURO) to

prevent the sale or distribution of violative pesticides and for the authority to seize these pesticides.

Section

15 provides indemnity payments for suspended or cancelled registrations.

Section 16 allows for a judicial review

process for individuals or entities affected by an EPA order or action.

Section 14 establishes civil and federal penalties for violative acts.

Some examples of these unlawful acts

include:

Distributing, selling, or delivering any unregistered pesticide.

Making any advertising claim about a pesticide not included in the registration statement.

Selling any registered pesticide if its content does not conform to label data.

Falsification of any test-related information or the submission of any false data to support registration.

Selling an adulterated or misbranded pesticide.

Detaching, altering, defacing, or destroying any part of a container or label.

Refusing to keep records or permit authorized EPA inspections.

Making a guarantee other than that specified by the label.

Advertising a restricted-use pesticide without giving the product classification.

Making a restricted-use pesticide available to a non-certified applicator (except as provided by law).

Using a pesticide in any manner not consistent with the label.

Civil penalties

[

]

When determining civil penalties, the EPA would take into consideration the severity of infraction, effects of

penalties, and size of business.

Under Section 14 (a)(1), commercial applicators, wholesalers, dealers, and

retailers "may be assessed a civil penalty…of not more than $5,000 for each offense".

Private applicators would be

given a warning for the first offense, and a fine up to $1000 may be assessed for each subsequent violation.

Federal/criminal penalties

[

]

Violative acts are charged as misdemeanors and subject to fines and/or imprisonment.

A private applicator is

subject to $1000 and/or 30 days imprisonment.

A commercial applicator is subject to $25,000 and/or up to one year

imprisonment.

A manufacturer or producer is subject to $50,000 and/or up to one year imprisonment.

Special review

[

]

FIFRA requires the EPA to continually monitor and update registered pesticides for any new information concerning

their safety. Registrants are required to promptly report any new evidence of adverse side effects and to continually

conduct studies to aid in risk assessments.

If new information indicates adverse side effects, then EPA may conduct

a special review to assess the risks and benefit of continued use of the suspect pesticide.

With the completion of a

special review, EPA may choose to amend or cancel the registration.

Pesticides and endangered species

[

]

The

protects and promotes animal and plant recovery of ones in danger of extinction due to

human activity. Under this act the EPA must also consider the dangers to animals and plants when registering a new

pesticide. The pesticide must not harm the listed endangered and threatened animals and habitats. To be sure this

program is implemented, some labels will direct users of the pesticides to bulletins with specific information

regarding use. The protection program has 2 main goals: (1) provide the best protection of endangered species from

pesticides and (2) minimize the impact of the program on pesticide users.

To protect the endangered species with the EPA program, the following was implemented:

sound science is used to assess risk to the listed species

there is an attempt at finding means to avoid concerns of listed species

When concerns of the listed species aren't avoidable, they consult with the Fish and Wildlife Services scientist

Implement usage limitations when the Fish and Wildlife service express a potential adverse effect on a

particular species based on a biological opinion

In order to implement the usage limitations mentioned above, the EPA will:

add a generic label to the pesticide

develop bulletins containing habitat location and pesticide use limitations

distributing the bulletins containing this information to pesticide users

providing a toll-free number for users to contact regarding information in bulletins and how to obtain one.