2.3 Special Registrations & Exemption Provisions

2.3 Special Registrations & Exemption Provisions

While standard federal pesticide registration under Section 3 of FIFRA accounts for the vast majority of commercial pesticide products, Congress recognized that rigid registration timelines cannot address emergency pest outbreaks, unique regional agricultural needs, or low-risk natural chemical formulations. Consequently, FIFRA includes specialized provisions allowing federal emergency exemptions, state-issued local registrations, and minimum-risk exemptions. For applicators in Washington State, navigating these specialized registration pathways requires strict attention to documentation and state compliance rules enforced by the WSDA.

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Section 3: Standard Federal Registration Baseline

Section 3 of FIFRA [7 U.S.C. § 136a] represents the standard, comprehensive federal registration pathway. A registrant seeking a Section 3 approval must submit exhaustive scientific studies to the EPA covering active ingredient toxicology, environmental fate (leaching, volatilization, photodegradation), wildlife toxicity, and residue chemistry.

Once granted, a Section 3 registration allows national distribution and application of the product, provided applicators follow all container label directions. However, Section 3 registrations are expensive and require years of EPA scientific review. When unexpected agricultural pest crises emerge or specialized local cropping systems require custom pest solutions, alternative registration mechanisms must be utilized.

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Section 18: Emergency Exemption Provisions

Under Section 18 of FIFRA [7 U.S.C. § 136p] and 40 CFR Part 166, the EPA Administrator may exempt state or federal agencies from any provision of FIFRA if the EPA determines that an emergency condition exists. An emergency condition is defined as an urgent, non-routine situation where an unforeseen pest outbreak will cause severe economic loss or significant public health risks, and no registered Section 3 alternative pesticide is available or effective.

In Washington State, Section 18 exemption requests are prepared by agricultural specialists or public health officials and formally submitted to the EPA by the WSDA.

                                FIFRA SECTION 18
                              EMERGENCY EXEMPTIONS
                               (40 CFR Part 166)
                                       │
         ┌──────────────────┬──────────┴───────────┬──────────────────┐
         ▼                  ▼                      ▼                  ▼
┌─────────────────┐ ┌───────────────┐    ┌──────────────────┐ ┌───────────────┐
│ SPECIFIC        │ │ QUARANTINE    │    │ PUBLIC HEALTH    │ │ CRISIS        │
│ EXEMPTION       │ │ EXEMPTION     │    │ EXEMPTION        │ │ EXEMPTION     │
├─────────────────┤ ├───────────────┤    ├──────────────────┤ ├───────────────┤
│ Unforeseen pest │ │ Invasive pest │    │ Vector-borne     │ │ WSDA immediate│
│ emergency; severe│ │ eradication;  │    │ disease crisis;  │ │ authorization;│
│ economic loss;  │ │ valid up to   │    │ valid up to      │ │ EPA notified  │
│ valid up to 1 yr│ │ 3 years.      │    │ 1 year.          │ │ within 36 hrs.│
└─────────────────┘ └───────────────┘    └──────────────────┘ └───────────────┘

The Four Categories of Section 18 Exemptions

1. Specific Exemption: Requested when an emergency pest situation occurs in a specific crop or site (e.g., an unexpected fungal outbreak threatening Washington red raspberries). Issued for a maximum duration of 1 year.
2. Quarantine Exemption: Issued to control or eradicate an invasive alien pest species not previously established in the United States (e.g., controlling an invasive beetle infestation in Washington timberlands). Valid for up to 3 years.
3. Public Health Exemption: Issued to control a pest vector posing a severe threat to human health (e.g., mosquito vectors transmitting West Nile Virus or Eastern Equine Encephalitis). Valid for up to 1 year.
4. Crisis Exemption: A specialized mechanism where the WSDA authorizes immediate use of an unapproved pesticide before formal EPA review when an unpredictable pest crisis occurs and immediate action is required. WSDA must formally notify the EPA within 36 hours of issuing a Crisis Exemption. If the EPA subsequently disapproves the crisis use, all applications must cease immediately.

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Section 24(c): Special Local Need (SLN) Registrations

Under Section 24(c) of FIFRA [7 U.S.C. § 136v(c)], states are granted statutory authority to register additional uses or formulations of existing federally registered pesticides to meet Special Local Needs (SLN). In Washington State, the WSDA is the lead agency authorized to issue Section 24(c) SLN registrations.

Criteria for an SLN Registration

A Special Local Need exists when an agricultural, forestry, or structural pest problem exists within Washington for which an adequate federally registered Section 3 product is not available. SLN registrations commonly address:

• Adding a new target pest to an existing crop site (e.g., controlling a specific insect on Washington hops).
• Modifying application methods, timing, or dosage rates to suit local Pacific Northwest climate conditions.
• Extending a pesticide label to a specialty seed crop grown exclusively in Washington.

Legal Documentation Mandate for Applicators

When applying a pesticide under a Section 24(c) SLN registration in Washington State, applicators must follow strict compliance rules:

1. Supplemental SLN Label Possession: The applicator must possess a physical copy of the approved WSDA Section 24(c) supplemental label at the application site during storage, mixing, loading, and application.
2. Combined Label Compliance: The applicator must comply with all directions, PPE requirements, and restrictions on both the standard Section 3 container label and the supplemental SLN label.
3. EPA Review & State Duration: WSDA submits issued SLNs to the EPA. The EPA has 90 days to review and object to the SLN. Unless disapproved by the EPA, a Washington SLN registration remains valid for a maximum state cycle of 5 years before requiring renewal.

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Section 25(b): Minimum Risk Exempt Pesticides

Under Section 25(b) of FIFRA [7 U.S.C. § 136w(b)] and 40 CFR § 152.25(g), the EPA exempts certain low-risk pesticide formulations from federal registration requirements entirely. These products are known across the industry as Section 25(b) Minimum Risk Pesticides.

Federal Exemption Criteria

To qualify for a federal Section 25(b) exemption, a product must meet three strict conditions:

1. Specified Active Ingredients: Every active ingredient must be explicitly listed on the EPA's exempt active ingredient list (e.g., peppermint oil, clove oil, garlic oil, rosemary oil, sodium lauryl sulfate, thyme oil).
2. List 4A Inert Ingredients: All inert ingredients must be selected exclusively from the EPA's List 4A (Inerts of Minimal Concern), such as water, corn gluten meal, or beeswax.
3. Labeling Restrictions: The product label must list all active and inert ingredients by name and percentage, and cannot make fraudulent health claims (such as claiming to prevent human disease like Lyme disease or malaria).

The Washington State Registration Mandate (RCW 15.58.050)

Critical State Regulatory Rule: While Section 25(b) products are exempt from federal EPA registration and do not display an EPA Registration Number, they are NOT exempt from state registration in Washington State.

Under the Washington Pesticide Control Act (RCW 15.58.050), all pesticide products—including Section 25(b) minimum risk pesticides—must be formally registered annually with the WSDA prior to commercial distribution or sale in Washington. Applicators using Section 25(b) products commercially must ensure the product is currently registered with the WSDA.