TSCA/FIFRARegulatory Issues                 1 October 2007    Karen E. Warkentien, Lewis & Harrison LLC   1
Points to Discuss   Relationship between TSCA &    FIFRA   What is subject to TSCA   What is subject to FIFRA   How to...
Relationship between TSCA &FIFRA   Toxic Substances Control Act    (TSCA)       References:          15 USC §§2601-2692...
Relationship between TSCA &FIFRA (Continued)   Federal Insecticide, Fungicide    and Rodenticide Act (FIFRA)       Refer...
Relationship between TSCA &FIFRA (Continued)   TSCA covers all chemical    substances   “Seamless” line between TSCA    ...
Relationship between TSCA &FIFRA (Continued)   FIFRA covers only pesticide    products     Constituent ingredients, such...
What is Subject to TSCA   All chemical substances and    mixtures manufactured,    imported, processed, used,    distribu...
What is Subject to TSCA(Continued)   Exclusions from chemical    substances     Mixtures     Pesticides     Tobacco & ...
What is Subject to TSCA(Continued)   Mixtures     Subject to testing, regulation, and      recordkeeping, but not subjec...
What is Subject to FIFRA   Pesticide active ingredients    (AIs)     Includes the actual AI, as      produced, including...
What is Subject to FIFRA(Continued)   Formulated pesticides     Must be registered in order to sell      and use     Ot...
What is Subject to FIFRA(Continued)   Pesticide devices       Devices are not “registered” but        must conform to EP...
What is Subject to FIFRA(Continued)   Exempted products (§25(b))       Certain pesticide products are        exempt from...
How to Comply with TSCA   Key Provisions         4: Test Rules          Allows EPA to require data where           prod...
How to Comply with TSCA(Continued)     5: Premanufacture and     Significant New Use Notification       Requires submiss...
How to Comply with TSCA(Continued)      8: Reporting/Recordkeeping            8(a): Reporting                 Requires ...
How to Comply with TSCA(Continued)          8(b): TSCA Inventory               Requires EPA to keep a current list of   ...
How to Comply with TSCA(Continued)          8(c): Recordkeeping               Pertains to allegations of adverse effects...
How to Comply with TSCA(Continued)          8(d): Health and Safety Studies               Must submit any health and saf...
How to Comply with TSCA(Continued)          8(e): Substantial Risks Reporting               Pertains to information on s...
How to Comply with TSCA(Continued)      12: Export Notification         Requires notification if chemical or          mi...
How to Comply with TSCA(Continued)      13: Import Notification         Positive Certification:                 “I cert...
How to Comply with TSCA(Continued)               Must be on TSCA Inventory (§8(b))                   If not, must file P...
How to Comply with TSCA(Continued)       Negative Certification:               “I certify that all chemicals in this    ...
How to Comply with TSCA(Continued)      14: Confidentiality       Protects most data and information       Excludes cer...
How to Comply with FIFRA   Key Provisions         3: Registration            Generation and submission of data         ...
How to Comply with FIFRA(Continued)       6: Administrative Review             6(a)(1): Existing stocks                ...
How to Comply with FIFRA(Continued)          6(b): Cancellation               Cancels a registration or changes its     ...
How to Comply with FIFRA(Continued)       7: Establishments        Production must occur in EPA-         registered prod...
How to Comply with FIFRA(Continued)       14: Penalties          Civil and/or criminal penalties may be           levied...
How to Comply with FIFRA(Continued)   Other issues       State registrations          Yearly fee payments          Qua...
How to Comply with FIFRA(Continued)     Other Agencies/Statutes        Child-resistant packaging        DOT shipping re...
TSCA Reference Websites   Information Collection (§8) and Data Development (§4)    http://www.epa.gov/opptintr/chemtest/i...
FIFRA Reference Websites   General Pesticides Page www.epa.gov/pesticides   General Contacts by Office    http://www.epa...
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20071001 TSCA-FIFRA Presentation

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A basic overview of the requirements for chemicals and pesticides under the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

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20071001 TSCA-FIFRA Presentation

  1. 1. TSCA/FIFRARegulatory Issues 1 October 2007 Karen E. Warkentien, Lewis & Harrison LLC 1
  2. 2. Points to Discuss Relationship between TSCA & FIFRA What is subject to TSCA What is subject to FIFRA How to comply with TSCA How to comply with FIFRA TSCA Reference Websites FIFRA Reference Websites Karen E. Warkentien, Lewis & Harrison LLC 2
  3. 3. Relationship between TSCA &FIFRA Toxic Substances Control Act (TSCA)  References:  15 USC §§2601-2692  40 CFR Subchapter R, Parts 700- 799  Enacted 11 October 1976  Purpose: To prevent unreasonable risks to health or the environment associated with chemical substances Karen E. Warkentien, Lewis & Harrison LLC 3
  4. 4. Relationship between TSCA &FIFRA (Continued) Federal Insecticide, Fungicide and Rodenticide Act (FIFRA)  References:  7 USC §§136-136y  40 CFR Subchapter E, Parts 150-189  Enacted 25 June 1947  Purpose: To regulate the marketing of economic poisons and devices, and for other purposes Karen E. Warkentien, Lewis & Harrison LLC 4
  5. 5. Relationship between TSCA &FIFRA (Continued) TSCA covers all chemical substances “Seamless” line between TSCA & FIFRA  Chemicals are not considered pesticides until they are produced and/or formulated as pesticide products and are subject to registration by EPA Karen E. Warkentien, Lewis & Harrison LLC 5
  6. 6. Relationship between TSCA &FIFRA (Continued) FIFRA covers only pesticide products  Constituent ingredients, such as precursor starting materials, intermediates, and inert ingredients are not considered pesticides until they are incorporated into the final product  R&D compounds are subject to TSCA Karen E. Warkentien, Lewis & Harrison LLC 6
  7. 7. What is Subject to TSCA All chemical substances and mixtures manufactured, imported, processed, used, distributed, or disposed of in the US Existing compounds approved for use are listed on the TSCA Inventory Karen E. Warkentien, Lewis & Harrison LLC 7
  8. 8. What is Subject to TSCA(Continued) Exclusions from chemical substances  Mixtures  Pesticides  Tobacco & tobacco products  Nuclear material  Firearms & ammunition  Foods, food additives, drugs, cosmetics, or devices Karen E. Warkentien, Lewis & Harrison LLC 8
  9. 9. What is Subject to TSCA(Continued) Mixtures  Subject to testing, regulation, and recordkeeping, but not subject to PMN requirements  PMNs need to be filed for any constituent compounds in a mixture (if they are not already on the TSCA Inventory) Karen E. Warkentien, Lewis & Harrison LLC 9
  10. 10. What is Subject to FIFRA Pesticide active ingredients (AIs)  Includes the actual AI, as produced, including any impurities  Does not include the precursors or intermediates  Technical grade AI (TGAI) product is generally registered (but not always) Karen E. Warkentien, Lewis & Harrison LLC 10
  11. 11. What is Subject to FIFRA(Continued) Formulated pesticides  Must be registered in order to sell and use  Other (inert) ingredients  Must be “cleared” by EPA in order to use in any formulation  Must have food tolerances or exemptions if used in or on food or food contact surfaces Karen E. Warkentien, Lewis & Harrison LLC 11
  12. 12. What is Subject to FIFRA(Continued) Pesticide devices  Devices are not “registered” but must conform to EPA regulations concerning production, reporting, and labeling Karen E. Warkentien, Lewis & Harrison LLC 12
  13. 13. What is Subject to FIFRA(Continued) Exempted products (§25(b))  Certain pesticide products are exempt from “registration” but must conform to EPA regulations concerning production, reporting, and labeling  e.g., Cedar, dried blood, clove oil Karen E. Warkentien, Lewis & Harrison LLC 13
  14. 14. How to Comply with TSCA Key Provisions  4: Test Rules  Allows EPA to require data where production and use may present a hazard, risk, or unreasonable risk  May apply to manufacturers and/or processors  Applies to “existing” chemicals Karen E. Warkentien, Lewis & Harrison LLC 14
  15. 15. How to Comply with TSCA(Continued)  5: Premanufacture and Significant New Use Notification  Requires submission of PMN/SNUN 90-days prior to commencement of manufacturing  May result in SNUR or 5(e) Order  Proposed 5(e) orders must be issued at least 45 days before the end of the PMN review period (halfway through)  PMN submitter has 30 days to file objections and negotiate consent order Karen E. Warkentien, Lewis & Harrison LLC 15
  16. 16. How to Comply with TSCA(Continued)  8: Reporting/Recordkeeping  8(a): Reporting  Requires reporting of production or import of certain chemicals under PAIR (Preliminary Assessment Information Rule)  Exempts R&D, byproducts, impurities, and nonisolated intermediates Karen E. Warkentien, Lewis & Harrison LLC 16
  17. 17. How to Comply with TSCA(Continued)  8(b): TSCA Inventory  Requires EPA to keep a current list of chemicals  Public Inventory lists products by name and CAS number  Confidential Inventory lists products by generic descriptor  Producers may have EPA search the confidential inventory to determine is a chemical is “new” subject to a filing of a Bona Fide Intent to Manufacture Karen E. Warkentien, Lewis & Harrison LLC 17
  18. 18. How to Comply with TSCA(Continued)  8(c): Recordkeeping  Pertains to allegations of adverse effects on health or the environment  Not limited to listed chemicals  Must maintain for 30 years (health) or 5 years (everything else) Karen E. Warkentien, Lewis & Harrison LLC 18
  19. 19. How to Comply with TSCA(Continued)  8(d): Health and Safety Studies  Must submit any health and safety studies conducted by or known to producer for chemicals that are subject to listing via rulemaking  Pertains to chemical alone or in a mixture  Includes both formal studies and compilations of data Karen E. Warkentien, Lewis & Harrison LLC 19
  20. 20. How to Comply with TSCA(Continued)  8(e): Substantial Risks Reporting  Pertains to information on substantial risks to health or the environment  Not limited to listed chemicals  Must be reasonably supportive of substantial risk assertion  EPA has issued guidance to make this determination  Types of effects: Mammalian toxicity, human health effects, environmental effects  Must be reported within 15 working days Karen E. Warkentien, Lewis & Harrison LLC 20
  21. 21. How to Comply with TSCA(Continued)  12: Export Notification  Requires notification if chemical or mixture to be exported is subject to any rules or orders Karen E. Warkentien, Lewis & Harrison LLC 21
  22. 22. How to Comply with TSCA(Continued)  13: Import Notification  Positive Certification:  “I certify that all chemical substances in this shipment comply with all applicable rules or orders under TSCA and that I am not offering a chemical substance for entry in violation of TSCA or any applicable rule or order under TSCA.” Karen E. Warkentien, Lewis & Harrison LLC 22
  23. 23. How to Comply with TSCA(Continued)  Must be on TSCA Inventory (§8(b))  If not, must file PMN at least 90 days prior to use  R&D exemption does not require PMN  Abbreviated PMN filings for LVE/LoREX and TMEA  Exemption notice for polymers  Must comply with any rules issued under §§5, 6, or 7 Karen E. Warkentien, Lewis & Harrison LLC 23
  24. 24. How to Comply with TSCA(Continued)  Negative Certification:  “I certify that all chemicals in this shipment are not subject to TSCA.”  Use for all chemicals that are not subject to TSCA  Blanket Certification  Covers multiple shipments of the same chemical during one year  Must be filed in each Customs District  Positive and negative certifications require separate blanket certification Karen E. Warkentien, Lewis & Harrison LLC 24
  25. 25. How to Comply with TSCA(Continued)  14: Confidentiality  Protects most data and information  Excludes certain health and safety data  15 & 16: Enforcement  15 specifies what is unlawful  16 specifies civil and criminal penalties Karen E. Warkentien, Lewis & Harrison LLC 25
  26. 26. How to Comply with FIFRA Key Provisions  3: Registration  Generation and submission of data  May cite existing data on file, if available, subject to offers to pay original data submitters  Subject to processing fees and yearly maintenance fees  Submission/citation of data required by regulations/rulemaking Karen E. Warkentien, Lewis & Harrison LLC 26
  27. 27. How to Comply with FIFRA(Continued)  6: Administrative Review  6(a)(1): Existing stocks  Permits sales of existing stocks when pesticides are suspended or cancelled if there is no imminent risk of harm  6(a)(2): Adverse effects data  Submission of any factual information concerning unreasonable adverse effects  Timelines for submission of data vary based on severity of effect Karen E. Warkentien, Lewis & Harrison LLC 27
  28. 28. How to Comply with FIFRA(Continued)  6(b): Cancellation  Cancels a registration or changes its classification if it causes unreasonable adverse effects  6(c): Suspension  Immediately suspends a registration that poses an imminent threat  Must be tied to a cancellation order  6(f)(1): Voluntary Cancellation  Allows a registrant to voluntarily cancel a registration  Generally allows sales of existing stocks Karen E. Warkentien, Lewis & Harrison LLC 28
  29. 29. How to Comply with FIFRA(Continued)  7: Establishments  Production must occur in EPA- registered producing establishments  Must file yearly reports on production  Also applies to foreign producers for any products imported into the US  10: Confidential Information  Certain information pertaining to quality control procedures, inert ingredients, and marketing and sales data may be claimed confidential Karen E. Warkentien, Lewis & Harrison LLC 29
  30. 30. How to Comply with FIFRA(Continued)  14: Penalties  Civil and/or criminal penalties may be levied for failing to follow the regulations  17: Imports and Exports  Generally prohibits import of unregistered pesticides  Need to file Notice of Arrival form  Requires notification for export of unregistered pesticides Karen E. Warkentien, Lewis & Harrison LLC 30
  31. 31. How to Comply with FIFRA(Continued) Other issues  State registrations  Yearly fee payments  Quarterly/yearly sales reports (some states)  Submission of any additional data required by regulations/rulemaking  Submission of adverse effects data (some states) Karen E. Warkentien, Lewis & Harrison LLC 31
  32. 32. How to Comply with FIFRA(Continued)  Other Agencies/Statutes  Child-resistant packaging  DOT shipping regulations  OSHA requirements Karen E. Warkentien, Lewis & Harrison LLC 32
  33. 33. TSCA Reference Websites Information Collection (§8) and Data Development (§4) http://www.epa.gov/opptintr/chemtest/index.htm New Chemicals (§5) http://www.epa.gov/oppt/newchems/ PMN Forms and Information (§5) http://www.epa.gov/oppt/newchems/pubs/pmnforms.htm PMN Guidance Documents ( 5) http://www.epa.gov/oppt/newchems/pubs/guideman.htm Consent Orders and Significant New Use Rules (§5(e)) http://www.epa.gov/oppt/newchems/pubs/cnosnurs.htm Import/Export of New Chemicals (§§12 and 13) http://www.epa.gov/oppt/newchems/pubs/import.htm Import/Export Requirements (§§12 and 13) http://www.epa.gov/opptintr/chemtest/pubs/imex.htm TSCA Inventory (§8(b)) http://www.epa.gov/oppt/newchems/pubs/invntory.htm TSCA Inventory Update Reporting (§8(b)) http://www.epa.gov/opptintr/iur/ Testing Guidelines http://www.epa.gov/opptsfrs/home/guidelin.htm EPA Employee Directory http://cfpub.epa.gov/locator/index.cfm Karen E. Warkentien, Lewis & Harrison LLC 33
  34. 34. FIFRA Reference Websites General Pesticides Page www.epa.gov/pesticides General Contacts by Office http://www.epa.gov/pesticides/contacts/index.htm#office Application Forms http://www.epa.gov/opprd001/forms/ Pesticide Registration (PR) Notices http://www.epa.gov/PR_Notices/ Pesticide Registration “Kit” http://www.epa.gov/pesticides/registrationkit/ Adverse Effects Reporting ( 6(a)(2)) http://www.epa.gov/pesticides/fifra6a2/ Pesticide Establishment Registration and Reporting ( 7) http://www.epa.gov/compliance/monitoring/programs/fifra/establis hments.html Testing Guidelines http://www.epa.gov/opptsfrs/home/guidelin.htm Import and Export ( 17) http://www.epa.gov/oppfead1/international/trade-issues.htm EPA Employee Directory http://cfpub.epa.gov/locator/index.cfm Karen E. Warkentien, Lewis & Harrison LLC 34

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