U.S. Environmental Protection Agency

EPA Air Emissions Test Methods

EPA Agency-Wide Quality Documents

EPA Antimicrobials

EPA Ecotox Database

EPA Electronic Pesticide Registration Submissions

EPA Employee Directory

EPA Enforcement Response Policies

EPA Envirofacts Master Chemical Integrator

EPA Environmental Models

EPA FIFRA Scientific Advisory Panel

EPA Food and Feed Commodity Vocabulary

EPA GLP Advisories

EPA GLP List of Inspections

EPA Home Page

EPA IRIS Toxicology Reviews

EPA Office of Acquisition Management

EPA Office of Enforcement and Compliance Assurance

EPA OCSPP Harmonized Test Guidelines

EPA Office of Pesticides

EPA Restricted Use Products

EPA Science Policy Issues

EPA SW-846 online

EPA Tolerance Reassessment & Reregistration

National Pesticide Information Retrieval System

Endocrine Disruptor Screening SEP

Environmental Fate Database

Pesticide Product Label System (PPLS)

PhysProp Database

Study Report Templates

U.S. Food and Drug Administration

CDER Guidance Documents

CDER Home Page

CDER New and Generic Drug Approvals

CDER Regulatory Information

CDRH Device Advice

CDRH Device Training Courses

CFSAN HACCP Home Page

CVM Guidance Documents

FDA Basics For Industry

FDA Compliance Program Manual

FDA E-mail Updates Sign-up

FDA FOIA Warning Letters

FDA Guidance Documents

FDA Industry Portal

FDA Pesticide Analytical Manual

FDA’s GCP Guidance

FDA’s List of Disqualified Clinical Investigators

FDA Debarment List

GCP Regulations

HHS Office for Human Research Protections (OHRP)

HHS Personnel Directory

Non-Clinical GLP Inspections Outcome

Comparison of GLP between FDA, EPA, and OECD

Inspections, Compliance, Enforcement, and Criminal Investigations (ICECI)

ICECI Compliance Policy Guides

FDA FOIA Frequently Requested 483

ICECI Inspection Reference Documents

Good Manufacturing Practices Regulations

Federal Government

Code of Federal Regulations (CFR) On-line

Commerce and Business Daily (CBD) On-line

Federal Register On-line

Internal Revenue Service (IRS) On-line

Legislative Information on the Internet (Thomas)

NIOSH Registry of Toxic Effects of Chemical Substances

OSHA Search Page

Safety Reporting Portal

USDA Animal Welfare Information Center

USDA APHIS – Biotechnology Regulatory Services (BRS)

USDA ARS – Agricultural Research Service

USDA FSIS – Food Safety Inspection Service

International

Argentine’s FDA Home Page

Britain’s BARQA – Professional Society for QA

Britain’s MHRA GLP

Britain’s MHRA GCP

Britain’s MHRA GMP and GDP (Good Distribution Practice)

Britain’s MHRA GPvP (Good Pharmaco-Vigilance Practice)

Britain’s Pesticides Chemical’s Regulation Directorate (CRD)

Canada’s Health-Canada Drugs and Health Products

Canada’s Health-Canada Veterinary Drugs

Canada PMRA Home Page

Canada PMRA Publications

Danish Quality Assurance Group

Dutch Association of Research Quality Assurance

EUR-Lex Portal to European Union law

European Commission EU Policies

European Medicines Agency Home Page

European Medicines Agency Inspections Page

Europe’s EU On-line

French Society of Quality Assurance

German Society for Good Research Practice

ICH Topics and Guidelines

ISO On-line

Italian Society for Applied Pharmacological Sciences

Japan’s CERI Database

Japan Society of Quality Assurance

Korea Society of Quality Assurance

OECD Chemical Safety Page

OECD GLP

OECD Guidelines for the Testing of Chemicals

OECD Pesticides Page

Spanish Society of Quality Assurance in Research

Swedish Association of Research Quality Assurance

Swiss Professional Association of Quality Assurance

UN’s Food and Agriculture Organization

Pesticide Regulatory Files Review

QAI has reviewed hundreds of pesticide regulatory files for compliance with EPA’s Label Review Manual and PR Notice 98-10. Our team includes industry professionals with extensive backgrounds in regulatory affairs and formulation chemistry. QAI can conduct a similar review of registration, production, and advertising files for EPA-registered products to preemptively identify potential regulatory problems, and correct procedures before possible EPA intervention.
Tasks include:

  • A complete review of the submissions to EPA, and of EPA’s responses.
  • A complete review of all final printed labels, and submissions to States.
  • A complete review of the CSF and formulations “recipes”, including documentation of suppliers.
  • A complete review of Quality Control analysis results.
  • A complete review of all labeling and advertising, including promotional materials.

Our reports include suggestions of improvements to your procedures to improve compliance with regulatory requirements.

Label Review Manual
PR Notice 98-10
PR Notice 2007-4

Other Resources

American Association of Pharmaceutical Scientists

American Chemical Society

AOAC Home Page

ASTM Home Page

Bruce McKay’s Pesticide Industry Information

CDMS Pesticide MSDS

Check Biotech

Chemical Producers & Distributors Association

Codex Database

CropLife America

EXTOXNET Toxicology

IR-4 Home Page

ISO 17025 Accreditation Bodies and Information

Keller & Heckman Home Page

Labcompliance Home Page

Labcompliance’s Glossary

Nelac Institute

Monsanto’s ag Biotechnology Page

National Pesticide Information Center

Parenteral Drug Association

Pesticide Active Ingredient Information

Regsource – Regulatory Resources

SETAC Home Page

SQA Home Page

Toxicology Data Network

U. of Akron Chemical Database