TSCA/FIFRA Regulatory Compliance

TSCA/FIFRA
Regulatory 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 comply with TSCA
 How to comply with FIFRA
 TSCA Reference Websites
 FIFRA Reference Websites

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


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

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

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


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


(Continued)
 Exclusions from chemical
substances
 Mixtures
 Pesticides
 Tobacco & tobacco products
 Nuclear material
 Firearms & ammunition
 Foods, food
additives, drugs, cosmetics, or
devices

(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)


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)

(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


(Continued)
 Pesticide devices
 Devices are not “registered” but
must conform to EPA regulations
concerning
production, reporting, and labeling


(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


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


(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


(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


(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


(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)


(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


(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


(Continued)
 12: Export Notification
 Requires notification if chemical or
mixture to be exported is subject to
any rules or orders


(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.”


(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


(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


(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


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


(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


(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


(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


(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


(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)


(Continued)
 Other Agencies/Statutes
 Child-resistant packaging
 DOT shipping regulations

 OSHA requirements


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


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


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