20071001 TSCA-FIFRA Presentation

Karen E. Warkentien, Lewis & Harrison LLC 1

TSCA/FIFRA

Regulatory Issues

1 October 2007


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

http://www.epa.gov/opptintr/chemtest/index.htm

http://www.epa.gov/oppt/newchems/

http://www.epa.gov/oppt/newchems/pubs/pmnforms.htm

http://www.epa.gov/oppt/newchems/pubs/guideman.htm

http://www.epa.gov/oppt/newchems/pubs/cnosnurs.htm

http://www.epa.gov/oppt/newchems/pubs/import.htm

http://www.epa.gov/opptintr/chemtest/pubs/imex.htm

http://www.epa.gov/oppt/newchems/pubs/invntory.htm

http://www.epa.gov/opptintr/iur/

http://www.epa.gov/opptsfrs/home/guidelin.htm

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/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

http://www.epa.gov/pesticides

http://www.epa.gov/pesticides/contacts/index.htm

http://www.epa.gov/opprd001/forms/

http://www.epa.gov/PR_Notices/

http://www.epa.gov/pesticides/registrationkit/

http://www.epa.gov/pesticides/fifra6a2/

http://www.epa.gov/compliance/monitoring/programs/fifra/establishments.html

http://www.epa.gov/compliance/monitoring/programs/fifra/establishments.html

http://www.epa.gov/opptsfrs/home/guidelin.htm

http://www.epa.gov/oppfead1/international/trade-issues.htm



http://cfpub.epa.gov/locator/index.cfm

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