Old Manwith a CaneRegulatory Affairs, Policy & Compliance
The Regulatory Toolkit
One click to the place where an account is created or a registration begins, so you can start directly rather than searching an agency’s whole website. Agencies change their systems from time to time, so treat this as a starting point rather than the final word, and confirm the specific account, portal, and form at the time you file. If a link ever looks out of date, let me know and I will fix it.
Regulatory portal directory
One click to open an account.
| Agency / body | Portal or system | Purpose | Where to start |
|---|---|---|---|
| US EPA — pesticides | Central Data Exchange (CDX) and the Pesticide Submissions Portal (PSP) | Create the registrant account, obtain a company number, and file FIFRA registration data | cdx.epa.gov Click Register with CDX, then add the Pesticide Submission Portal service. Request a company number via PSP Company Number Requests. |
| US EPA — establishments | Section Seven Tracking System (SSTS) inside CDX | File annual pesticide establishment production reports (Form 3540-16) | cdx.epa.gov Same CDX account; add the SSTS role. Reports are due by March 1 each year. |
| US FDA — food | FDA Industry Systems (FURLS) | Food facility registration, LACF, prior notice, and related filings | access.fda.gov Click Create New Account, pick the Center and system (for example Food Facility Registration). Uses Form 3537. |
| US FDA — all centers | Electronic Submissions Gateway (ESG) | Transmit eCTD and center submissions securely | esg.fda.gov Request a test account first, then production. WebTrader (browser) or AS2 (system to system). |
| US FDA — CFSAN | CFSAN Online Submission Module (COSM) | New dietary ingredient and food contact substance notifications | access.fda.gov Reached within FDA Industry Systems; migrated from FURLS for these notifications. |
| USDA — organic | National Organic Program and the Organic INTEGRITY Database (AMS) | Confirm and record organic certification of operations | organic.ams.usda.gov/integrity Obtain organic certification through a USDA accredited certifying agent; INTEGRITY lists certified operations and certifiers. |
| California CDFA | Fertilizing Materials (FFLDRS) ExtraView database | Fertilizer and Organic Input Material license and label registration | inspect.cdfa.ca.gov Click Enroll New User. Label review typically takes 60 to 90 days. |
| OMRI | OMRI online application and Application Kit | List an input for compatibility with the USDA National Organic Program | www.omri.org/get-listed The Application Kit (omri.org/kit) grants two years of online access. Contact apply@omri.org. |
| Health Canada — PMRA | Electronic Pesticide Regulatory System (ePRS) | Register pest control products in Canada | www.canada.ca Assemble an eIndex, compile the package to PRZ format, and submit through the Secure Web Portal. |
| CFIA — Canada | Fertilizer and supplement program | Register fertilizers and supplements in Canada | inspection.canada.ca Pre-market assessment applies to some products; check the class before applying. |
Regulatory forms directory
One click to the form, or to the index page that always carries the current version.
| Agency | Form | What it is | Link |
|---|---|---|---|
| US EPA | Blank forms index (all 8570 forms) | Landing page linking every pesticide registration form | www.epa.gov |
| US EPA | 8570-1 | Application for Pesticide Registration / Amendment | www.epa.gov |
| US EPA | 8570-4 | Confidential Statement of Formula (CSF) | www.epa.gov |
| US EPA | 8570-27 | Formulator's Exemption Statement | www.epa.gov |
| US EPA | 8570-34 | Certification with Respect to Citations of Data | www.epa.gov |
| US EPA | 8570-35 | Data Matrix | www.epa.gov |
| US EPA | 8570-36 / 37 | Physical and Chemical Properties summary and self-certification | www.epa.gov |
| US EPA | 3540-16 | Pesticide Report for Pesticide-Producing Establishments | cdx.epa.gov |
| US FDA | 3537 / 3537a | Food Facility Registration and Cancellation | access.fda.gov |
| US FDA | 2541 series | Food Canning Establishment registration and process filing (LACF) | access.fda.gov |
| US FDA | Forms index | FDA reports, manuals, and forms landing page | www.fda.gov |
| CA CDFA | 513-020 | Fertilizing Materials License Application | www.cdfa.ca.gov |
| CA CDFA | 513-023 | Conventional Fertilizing Material Label Registration Application | www.cdfa.ca.gov |
| CA CDFA | OIM | Organic Input Material registration (filed online) | inspect.cdfa.ca.gov |
| OMRI | Application Kit | Order the kit to unlock the online application | www.omri.org/kit |
| Health Canada | eIndex Builder | Assemble the electronic index for a PMRA submission | www.canada.ca |
Want a hand actually filing, or a second pair of eyes before you submit? That is exactly what I am here for.