Pesticide Regulation, Registration and Labeling in Colorado
Overview of Colorado pesticide regulations with emphasis on the registration process.
Pest management is one of the most costly inputs growers (and ultimately consumers) must budget for every year. Pesticides are used extensively in Colorado for a variety of applications. In 2001, Colorado growers reported that $84,277,000 were spent on pesticide inputs alone; the total input expenses were $4,690,339,000 (Colorado Agricultural Statistics, 2002). The registration, use and environmental impact of pesticides and pesticidal devices is carefully controlled by the State of Colorado.
A pesticide is defined by the Colorado Department of Agriculture (CDA) as “any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest or any substance or mixture of substances intended for use as a plant growth regulator, defoliant or desiccant.” The term pesticide includes many kinds of ingredients used in products, such as insecticides, fungicides, rodenticides, insect repellants, weed killers, antimicrobials, and swimming pool chemicals, which are designed to prevent, destroy, repel, or reduce pests of any sort. Antimicrobial “pesticides” include such common household products as toilet bowl and bathroom disinfectants.
A pesticide device is defined by CDA as “any instrument or contrivance, other than a firearm, intended for trapping, destroying, repelling, or mitigating any pest or any form of plant or animal life (other than man and other living bacteria, viruses or other microorganisms on or living in man and other living animals). Examples of devices include water or air filters that claim to remove microorganisms, insect traps that claim to aid in control, and ultrasonic rodent or insect repellents. Pesticide devices are not required to be registered with the United States Environmental Protection Agency (EPA), but their production site is required to be a registered establishment. This establishment number is required to be on the device label. However, each product requires an individual registration with CDA.
Federal Regulation
Federal regulation of the distribution, sale or use of pesticides is governed
by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). Administered
by the EPA, FIFRA requires that pesticide products be registered and labeling
reviewed and accepted by EPA. Additionally, it requires that applicators of
pesticides that may be hazardous be certified. This federal regulatory scheme
applies to the distribution, sale or use of pesticides in any state. EPA is
responsible for regulating labeling and packaging. States are usually delegated
authority to administer pesticide programs and may regulate pesticide use and
sales as long as it does not conflict with the federal scheme.
State Regulation
Within
Colorado, CDA is responsible for enforcing the state’s version of the federal
regulatory scheme. The Colorado Pesticide Act (35-9-11 B 128 C.R.S) covers pesticide
registration requirements and pesticide dealer licensing. The Colorado Pesticide
Applicator Act (35-10-102-128 C.R.S.) regulates the use of pesticides by commercial
applicators. These state laws are intended to protect Colorado’s people
and environment from the adverse effects of pesticides.
The Colorado Pesticide Act requires registration of pesticides and pesticidal devices with CDA prior to advertising, distribution or sale. One of the stated intents of the Pesticide Act is “to assure the dissemination of accurate information regarding the proper and prohibited uses of any pesticide or pesticidal device, and to protect the public health, safety, and welfare of the people of Colorado.” CDA registers approximately 10,000 pesticide products each year. In 2002, CDA registered 38 devices. To determine if a pesticide is registered in Colorado you may use the registration query site on CDA’s web page: http://www.ag.state.co.us/DPI/Pesticides/PPRS/PPRSQuery.htm.
The site is updated daily so that you can determine if a product is registered for the current year. The site is best searched using Microsoft Internet Explorer. It is highly recommended to proceed the product name with the wild card symbol (%).
The Colorado Pesticide Information Retrieval System (CPIRS) http://state.ceris.purdue.edu/doc/co/stateco.html is another source of information pertaining to pesticides currently registered by CDA. CPIRS should be used only for informational purposes. The information may or may not include restrictions specific to Colorado. CPIRS can be searched for specific crops/sites or pests. The data that supports these search features are derived from two different sources the CDA Pesticide Section and the USEPA’s Office of Pesticide Programs Pesticide Product Information System (PPIS). This pesticide information is updated approximately once a month. The specific crop/site and pest are based on the “master label” accepted by EPA and may not accurately reflect the CDA accepted label.
Product Registration
Before a pesticide can be sold or used in the United States (U.S.), FIFRA requires
that it be registered with the EPA. Under Section 3 of FIFRA, EPA can register
pesticides for use throughout the U.S. EPA evaluates the proposed pesticide
thoroughly to ensure that it will not harm human health or the environment.
Pesticides that pass this evaluation are granted a registration that permits
their sale and use according to requirements set by EPA to protect human health
and the environment. The process of registering a pesticide is a scientific,
legal and administrative procedure through which EPA examines:
The registrant (producer) of the pesticide must provide data from a wide variety of scientific studies conducted according to EPA guidelines. These tests evaluate whether a pesticide has the potential to cause adverse effects on humans, wildlife, fish, and plants, including endangered species and non target organisms. The tests also evaluate possible contamination of surface water or groundwater from leaching, runoff and spray drift. Potential human risks range from short term (acute) toxicity to long term (chronic) effects such as cancer and reproductive system disorders. The data are designed to identify possible harmful effects the chemical could have on humans (its toxicity), the amount of the chemical (or breakdown products) likely to remain in or on food, and other possible sources of exposures to the pesticide (e.g., through use in homes or other places). All of this information is used in EPA’s risk assessment process.
The risk assessment includes consideration of the amounts and types of food people eat and how widely the pesticide is used (that is, how much of the crop is actually treated with the pesticide), as well as chemistry, toxicity and exposure information. EPA also uses data from U.S. Department of Agriculture (USDA) on what foods people eat and the quantity they eat, collected through the Pesticide Data Program. Through these evaluations, EPA is ensuring the overall safety of proposed pesticide uses, as required by the Food Quality Protection Act (FQPA) of 1996.
Tolerance Establishment
Before allowing the use of a pesticide on food crops, EPA sets a tolerance,
or maximum residue limit, which is the amount of pesticide residue allowed to
remain in or on each treated food commodity. A wide margin of safety is included
to ensure that residues remaining in foods are many times lower than amounts
that could actually cause adverse health effects. The tolerance is the residue
level that triggers enforcement actions. That is, if residues are found above
that level, the commodity will be subject to seizure by the government. In setting
the tolerance, EPA must make a safety finding that there is “reasonable
certainty that no harm” will result to human health from the aggregate
and cumulative exposure to the pesticide. EPA considers the toxicity of each
pesticide, how much of the pesticide is applied and how often, and how much
of the pesticide (i.e., the residues) remains in or on food. The tolerance applies
to food imported into this country, as well as to food grown here in the U.S.
Once tolerances are established, they are enforced by the States and several agencies of the Federal government, working together. Food commodities traveling in commerce, including both domestically grown and imported produce, are monitored by the Food and Drug Administration (FDA) and USDA, working closely with the States. Food crops must be within the tolerances set by EPA, or they are subject to seizure and destruction.
Classification of Pesticides
During the registration process, EPA will classify a pesticide as appropriate
for general use, restricted-use or both. Classification depends upon the impact
of the pesticide application on the environment. Pesticides which will not generally
cause unreasonable adverse effects on the environment are classified for general
use. Pesticides which, under the same circumstances, may cause injury to the
applicator or other persons, or have adverse environmental impact, are classified
as restricted-use pesticides (RUP). Federal RUPs are identified by a prominent
statement on the label.
CDA is able to further limit or restrict use beyond that of EPA by designating a pesticide as a state restricted-use pesticides. At present all of the Colorado State RUPs are nonselective herbicides used for industrial weed control with long soil persistence. CDA has designated all products containing the active ingredients of bromacil, diuron, prometon, sodium chloride, sodium metaborate, and tebuthiuron, as State RUPs. Sale and use of State RUPs are restricted to certified applicators or persons under their direct supervision. The restricted status of these products is not included on the product label.
Requirements for Use and Sale of Restricted-use Pesticides
Private Applicators
Private applicators are certified to use RUPs to produce agricultural commodities
on land that they or their employers own or lease. An agricultural commodity
is defined as “any plant, or part thereof, or animal, or animal product,
produced by a person (including farmers, ranchers, vineyardists, plant propogators,
Christmas tree growers, aquaculturalists, floriculturisrs, orchardists, foresters,
or other comparable persons) primarily for sale, consumption, propagation, or
other use by man or animals”(CFR 40 20 171.2 a (5)). In Colorado private
applicators are certified by EPA Region 8 (1-800-227-8917 X 7283).
Commercial Applicators
Commercial applicators are professionals who are in the business of applying
pesticides or making applications that do not fit under the definition of a
private applicator. Commercial applicators apply pesticides as a major part
of their jobs to land or property that they do not own or lease. Limited Commercial
Applicators apply RUPs to their own or their employer’s business property.
Public Applicators apply RUPs as part of their job with any government agency.
Limited commercial or public applicators who apply only general use pesticides
are not required to register with CDA.
Pesticide Dealers
Any person who distributes either Federal or State RUPs must be licensed with
CDA. Each business location, including branch offices, and each business name
must be licensed. In 2002, 253 RUP dealers were licensed with CDA.
Any person who distributes Federal RUPs must also report to the EPA the business name under which they operate and the name and address of the facility. In Colorado, RUP dealers can contact EPA Region 8 at 1-800-227-8917 X 7283. In addition to notifying EPA, businesses are required to maintain records of RUP sales for two (2) years. The information that must be recorded includes the name and address of the person making the purchase, their certification number and its expiration date, the product name and EPA registration number, the quantity and the date purchased. Failure to comply with these requirements could result in a fine from EPA of $5,500 per violation.
Labels and Labeling
The term “label” means the written, printed or graphic matter on,
or attached to, the pesticide or device or any of its containers or wrappers.
The term “labeling” means all labels and all other written, printed
or graphic matter which:
EPA must accept the language that appears on each pesticide label. A pesticide product can only be used legally according to the directions on the labeling accompanying it at the time of sale. Following label instructions carefully and precisely is necessary to ensure safe use.
The EPA registration number indicates that the pesticide label has been accepted by EPA. The first set of numbers identifies the manufacturer or company and the second set identifies the product. If there is a third set of numbers it indicates the product is subregistered by a company other than the primary registrant. All EPA registered pesticides are required to display the registration number on their label.
One of the most important words in FIFRA is “intended.” Products are considered to be pesticides if they are intended for preventing, destroying, repelling, or mitigating any pest or intended for use as a plant regulator, nitrogen stabilizer, defoliant, or desiccant.
Intent is determined by claims on the label and/or the composition/mode of action of the product as distributed or sold. If the manufacturer, formulator, packager, or shipper makes statements on labels, advertising, product literature, or even verbally, that a product has pesticidal or plant regulator use, then the product is subject to FIFRA.
Only after EPA has reviewed and accepted the labeling and registered the product can a pesticide product be sold. If the manufacturer wants to change the information in the labeling after the product and labeling are registered, EPA must review and accept the change prior to distribution.
Labeling is required under the federal system and is the primary way through which EPA regulates the use of pesticides. Under federal law, it is unlawful to mislabel a pesticide or to use it in a manner inconsistent with its label. When a pesticide is approved by EPA for registration it is said to be labeled. There are two common types of pesticide labels. Section 3 pesticides are the most familiar pesticide labels. Most pesticide uses are registered this way. Other pesticides are registered by EPA for more limited use in certain states, including Colorado. This would include Section 24c labels.
Section
24c Special Local Needs Registrations
Under Section 24c of FIFRA, States, including Colorado, can register additional
uses of a federally registered pesticide. These additional uses are for distribution
and use within a particular state to meet a “special local need” (SLN).
This is designed to allow states to register uses for needs that may be specific
to a small region. Often the potential use area does not represent a large enough
market to justify the effort required by a registrant to obtain a full national
registration.
Although SLNs can be approved for many different reasons and application sites, most involve use on crops. A certain crop grown within Colorado may be attacked by a particularly damaging pest, or Colorado officials may expect it to be attacked sometime during the growing season, thereby creating a special pest problem. The pesticide must have an established tolerance associated with the crop, or be exempted by EPA from the requirement of a tolerance for that crop.
Currently, Colorado has 50 pesticide crop and/or use combinations
approved as Section 24c labels. In 2002, nine new 24c labels were approved;
eight new SLNs have been approved so far in 2003. Many of these are for relatively
minor crops, including onions, greenhouse tomatoes, potatoes, spinach, dry peas,
lentils, chickpeas, and dry beans. A list of Colorado’s current 24c labels
can be seen at the following website:
http://www.colostate.edu/Depts/SoilCrop/extension/CEPEP/24c/special_needs.htm.
This site is updated each time a new 24c label is approved.
SLN Labels
Section 24c labels are valid only in the state of issue. The applicator must
possess a copy of the Colorado label when the pesticide is applied. The supplemental
24c labeling prepared by the manufacturer must be obtained from the dealer that
supplies the product. In some instances the 24c label is available only to individuals
who have signed a waiver of liability and indemnification (i.e., Prowl 3.3EC
Herbicide in dry bulb onions). However, these are not label provisions that
would be enforceable by EPA or CDA.
Violation of a Section 24c label is a violation of FIFRA. For private applicators, civil penalties of up to $1,000 per offense may be assessed following a warning letter. Commercial applicators may receive civil penalties of up to $5,000 for each violation. Violations can also result in criminal penalties of as much as $25,000 and 1 year in jail.
SLN Requests
The official request for a 24c registration comes from a pesticide manufacturer
or formulator to CDA. University researchers, cooperative extension personnel,
commodity groups, growers, and others can inform the manufacturer of the need,
but the request must come from the registrant.
When there is an existing or expected local pest problem, CDA may grant a SLR registration if there is:
CDA, in consultation with CSU, determines if the request meets the requirements and then forwards state approved labels to EPA. If the EPA Administrator rejects a state registration, it cannot remain effective for more than 90 days. If not disapproved, it becomes a federal registration for that state only and is then subject to EPA actions such as suspension and cancellation procedures.
Section 18 Emergency Exemptions
Under Section 18 of FIFRA, EPA can allow State and Federal agencies to permit
an additional use (not specified by the pesticide’s label) during a short
term pest management crisis in a specific locality. A Section 18 Exemption is
an exemption form the FIFRA requirement for registration due to an emergency
situation. Since use under a Section 18 Exemption is an “unregistered use,”
the manufacturer or distributor is not allowed to advertise or promote the use
of the product, even though the use is legal under the conditions of the Section
18 Exemption granted by EPA.
Under FQPA, EPA must establish formal tolerances (maximum allowable residue levels) to cover all pesticide residues in food, even residues resulting from emergency uses. Tolerances established for emergency exemption uses are time limited to correspond to the use season. In establishing a tolerance, EPA must make the finding that there is “reasonable certainty that no harm” will result to human health from aggregate and cumulative exposure to the pesticide, as required by the FQPA health based standard. Establishment of these tolerances, with their expiration dates, are published in the Federal Register.
Emergency exemptions are used when there are no other federally registered pesticides available to control a serious pest problem and there would be significant economic loss without the use of the Section 18 pesticide.
Several Types of Emergency Exemptions Exist:
Specific Exemption
When a pest outbreak has occurred or is about to occur and there is not a registered
pesticide for that use or purpose, a request for an EPA exemption from the registration
requirement for a particular pesticide that will control the pest may be made
by CDA. Information including the nature, scope, and the frequency of the problem;
the specific pest(s) involved; which pesticide will be used and in what amounts;
the economic benefits anticipated; and an analysis of possible adverse effects
must be supplied. EPA grants the exemptions. Reports must be filed when the
treatment is over. A specific exemption is only good for a specified amount
of time (maximum of one year) and for a designated area.
Quarantine or Public Health Exemption
This exemption may be granted to prevent the introduction or spread of a foreign
pest into or throughout the U.S. or to prevent a public health problem. No pesticide
that has been suspended by EPA may be used. Information including the nature,
scope, and the frequency of the problem; the pest involved; which pesticide
or pesticides will be used and in what amounts; the economic benefits anticipated;
and an analysis of possible adverse effects must be supplied. Public Health
Exemptions requests should include a discussion of the availability of medical
treatments for the health problems associated with the pest. EPA grants the
exemptions. Reports must be filed when the treatment is over.
Crisis Exemption
A crisis exemption may be used if it is found that there is no readily available
pesticide registered to control the pest and there is not time to request and
get approval for a specific exemption. No pesticide that has been suspended
or cancelled may be used. EPA must be notified 36 hours prior to pesticide use
under the crisis provisions when feasible. If the product will be used for more
than two weeks after the crisis exemption is declared, then a full Section 18
request must be submitted to EPA within the two weeks.
Colorado Section 18 Emergency Exemptions
A total of 15 Section 18 Emergency Exemptions were issued in 2002 and five were
crisis exemptions. All of the crisis exemptions had some relationship to the
severe drought conditions in Colorado during 2002. One hundred and sixty-one
(161) permits (number of potential users) were issued. A total of 64,874 acres
were treated in Colorado under Section 18 permits. To view Colorado’s current
Section 18’s visit:
http://www.colostate.edu/Depts/SoilCrop/extension/CEPEP/sec18/exemptions.htm.
You can view EPA’s current and recent actions by using the
EPA Section 18 Database at http://cfpub1.epa.gov/oppref/section18/search.cfm.
The information provided in the database includes: the site (e.g., the crop
being protected); the pest posing the emergency; the state or federal agency
which applied for the exemption; the date of application and EPA’s response.
If a tolerance was established, the date of the publication of that tolerance
in the Federal Register is given, and the date the tolerance expires. The database
is updated biweekly. The options for searching the database are: (1) search
by commodity (site), chemical or applicant; (2) search by a specific date; or
(3) search by date range.
The Section 18 Process:
The following criteria must be met to get a Section 18 approved:
EPA must perform:
If the emergency appears valid and the risks are acceptable, EPA approves the Emergency Exemption request. EPA will deny an exemption request if the pesticide use may cause unreasonable adverse effects to health or the environment, or if emergency criteria are not met. Colorado may withdraw an exemption request at any point in the process.
Using Section 18 Products
Pesticide applicators must have and follow the conditions contained in the EPA
letter granting the Section 18, as well as the full label for the EPA-registered
product. Usually the registrant also prepares supplemental labeling that is
distributed with the product, which should include all the restrictions in the
EPA letter. Users must have both this supplemental labeling as well as the EPA
registered label in their possession at the time of application. Product for
Section 18 uses can only be distributed or sold by dealers licensed by CDA.
A permit is required from CDA in order to use the Section 18 product. To obtain a permit contact CDA’s Pesticide Registration Section at 303-239-4144. Prior to obtaining a permit, applicators must either be licensed as commercial or private applicator.
Permits can be issued over the phone to allow immediate purchase
of the product. Permittees must provide their certified applicator license number.
CDA will mail a written permit application within a few days of the phone call.
Included in this packet will be an “Application to apply for a permit”
for the specific Section 18. The application must be completed and returned
within ten (10) days of the date on CDA’s letter. If the application is
not returned, your right to use the Section 18 product will be revoked and further
administrative action could be taken against you. CDA will provide a copy of
the EPA approval letter to each permittee with the Section 18 permit application.
The supplemental labeling prepared by the manufacturer must be obtained from
the dealer that supplies the product.
Permittees must record the following pesticide application information:
Section 18 permittees are subject to inspection by CDA Inspectors. CDA Inspectors will request the information outlined above. In 2002, 63% of all Section 18 permittees were inspected.
Permittees are required to submit final reports on the use of
the product to CDA. The reports are due on a specific date, which will be indicated
in the CDA packet. The final report forms are provided by CDA. In addition to
the required records, the final report must provide CDA with:
Commercial applicators applying Section 18 products must notify the growers of pertinent precautionary information, as outlined in the permit packet.
Section 25b Minimal Risk Labels
Except in very limited circumstances, any substance that makes a pesticidal
claim must be registered by EPA before it can be legally sold or distributed.
One such exemption to the registration requirement is for those pesticides
under Section 25b of FIFRA. In 1996, EPA exempted certain minimum risk pesticides
from FIFRA requirements if they satisfy certain conditions. EPA exempted
the products described in 40 CFR 152.25(g) in part to reduce the cost and
regulatory burdens of EPA and to focus EPA’s limited resources on pesticides
which pose greater risk to humans and the environment.
All pesticides sold in Colorado, including 25b exempted products, must be registered by the Colorado Department of Agriculture. In 2002, CDA registered 58 Section 25b products.
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