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Karen E. Warkentien, Lewis & Harrison LLC 1
TSCA/FIFRA
Regulatory Issues
1 October 2007
Karen E. Warkentien, Lewis & Harrison LLC 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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)
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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 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 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 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 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 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 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 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 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 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 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
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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 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 32
How to Comply with FIFRA
(Continued)
Other Agencies/Statutes
Child-resistant packaging
DOT shipping regulations
OSHA requirements
Karen E. Warkentien, Lewis & Harrison LLC 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
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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/establishments.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