Chemicals Regulation in Latin America: The Existing and Future Patchwork - Maddie Kadas, Principal, Beveridge & Diamond Russell Fraker, Of ...
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Chemicals Regulation in Latin
America: The Existing and
Future Patchwork
Maddie Kadas, Principal, Beveridge & Diamond
Russell Fraker, Of Counsel, Beveridge & Diamond
Overview
• International Drivers Your takeaways
here
• Commonalities
• Types of Existing Laws
• Future Directions
www.bdlaw.com/2017ChemicalsConference 2
International
International Drivers
Drivers
TAKEAWAYS
Assume
adoption of
major treaties –
but with
differences
Awareness and
dialogue about
global
chemicals issues
www.bdlaw.com/2017ChemicalsConference 3
International Commitments
ARGENTINA BRAZIL CHILE COLOMBIA COSTA RICA ECUADOR MEXICO PERU
Basel Convention Hazardous Wastes
X X X X X X X X
Climate Change Convention & Paris GHGs
Agreement X X X X X X X
Stockholm Convention Persistent Organic Pollutants (POPs)
X X X X X X X X
Rotterdam Convention Prior informed consent procedure
hazardous chemicals and pesticides X X X X X X X X
Minamata Convention Mercury
X X X X X X
Montreal Protocol Ozone depleting substances
X X X X X X X X
Chemical Weapons Convention Chemicals used to make chemical
weapons X X X X X X X X
Convention Against Illicit Traffic in Narcotic Narcotics and Precursor Chemicals
Drugs and Psychotropic Substances X X X X X X X X
GHS Adoption Classification and Labeling of Chemicals
X X X X X X
OECD Members Organization for Economic Co-operation IN IN
and Development
X PROGRESS PROGRESS X
MERCOSUR Members (Also Paraguay, Southern Common Market: Customs
Uruguay, Venezuela (suspended) union and trading bloc X X
Andean Community Members (Also Bolivia) Customs union and trading bloc
X X X
Administrative
Administrative Commonalities
Commonalities
Agency Commonalities
TAKEAWAYS
Your takeaways
• Chemicals regulated by several agencies Assume
herechemicals
regulated by several
◦ Primary Agencies: Health, Agriculture, Environment, government agencies
Customs, Labor, Transportation, Security
Assume little
◦ Lack coordination/jurisdictional issues/overlap meaningful
opportunity for
◦ Role for states/provinces in some jurisdictions administrative appeals;
need for know-how
• Little opportunity for judicial review and know-who is key
www.bdlaw.com/2017ChemicalsConference
Administrative Complexities: Mexico
Substance Semarnat Secretary of Environment
Lifecycle Minerals
Phase Toxic Food Ssa Secretary of Health
Fertilizers Pesticides and Pharmaceuticals Explosives
Substances Additives
Hydrocarbons
Sagarpa Secretary of Agriculture
Import and Semarnat, Sagarpa, Semarnat, SE, Ssa, SE Ssa, SE Sedena,
Export Sagarpa, Ssa, Ssa, SE, SHCP, SHCP SHCP SE, SHCP
SE Secretary of Economy
Ssa, SE, Semarnat SHCP SENER
SHCP SE,SHCP
SHCP Secretary of Finance and
Registry Ssa Ssa Ssa Secofi, Ssa Ssa Ssa Public Credit
ASEA
SCT Transport Secretary
Process Semarnat, Semarnat, Ssa, SCT SE, Ssa, Ssa, Sedena,
and Use Ssa, Ssa, STPS STPS, STPS STPS STPS Sedena Defense Secretary
Sagarpa, Sagarpa, SENER
STPS STPS
STPS Secretary of Labor
Storage Ssa, SCT Ssa, SCT, Ssa, SCT SE, SCT, Ssa, SCT Ssa, SCT Sedena,
STPS STPS STPS STPS, CRE STPS STPS STPS
Secofi Secretary of Commerce and
Industrial Development
Transport Ssa, SCT, Ssa, SCT, Ssa, SCT SE, SCT SCT SCT Sedena,
STPS STPS STPS STPS, SCT, SENER Secretary of Energy
Secofi, CRE STPS
Sale Sagarpa, Sagarpa, SE, Ssa SE, CRE SE SE, Ssa Sedena ASEA The National Agency for
SE, Ssa SE, Ssa Industrial Safety and
Environmental Protection in
the Hydrocarbons Sector
Occupational Ssa, STPS Ssa, STPS Ssa, STPS Ssa, ASEA Ssa, Ssa, Ssa, STPS
Health STPS STPS CRE Energy Regulatory
Commission
Source: COFEPRIS
Legal Commonalities
Legal Commonalties
• Numerous laws and regulations TAKEAWAYS
Your takeaways
◦ Determining applicability challenging Build in additional time
here
for determining
compliance
◦ Variety of registrations/authorizations
Be prepared for unique
regulations, even where
◦ Range of liability sources there are governing
international standards
• Inconsistent treatment of chemicals—highly
Just because a product is
regulated/not regulated on the market does not
mean it is fully compliant
• Country-specific regimes (not always based on an
international/US/EU law) or unique hybrids
www.bdlaw.com/2017ChemicalsConference
Toxic Release Inventories
Toxic Release Inventories
(“TRI”) TAKEAWAYS
• Mexico, Chile, Brazil Some countries will
Your takeaways
have TRI and other
• Others reportedly underway reporting
here
• Unique features requirements
Potential for
expansion to include
products that will
become or emit
wastes
TRI Data Can Be
Indicator for: Area to watch for
developments;
• Regulations/policy focus precursor to
chemicals
• Publicly available: NGO inventories
activity/citizens’ suits
www.bdlaw.com/2017ChemicalsConference 8
Chemical Inventories
Typically no comprehensive inventory
TAKEAWAYS
•Mexico, Brazil, Colombia in process of developing
•Use of inventories likely to expand throughout region Your takeaways
•New/new-use chemicals largely unregulated No
here“inventories”
like TSCA/REACH
Default chemicals import/export lists; GHS lists Use and scope of
chemicals lists
•Lists still have ambiguity
can be
•E.g., chemical + compounds, precursors, derivatives, mixtures
ambiguous
•Import authorization ++
Watch for
Not typically harmonized with any international standards developments
•REACH? TSCA?
•Harmonization and data acceptance will be key
www.bdlaw.com/2017ChemicalsConference
www.bdlaw.com/2017ChemicalsConference
Chemical and Sector Specific
Regulations
Often underlying international driver
TAKEAWAYS
Highly
Easy to legislate (single focus) hazardous and
PBT chemicals
likely to be
regulated
Highly regulated substances and products Certain
PBTs, pesticides, fertilizers, pharmaceuticals, cosmetics, products likely
food additives, batteries, electronics to be
regulated
10HazCom / GHS
• Most based on old OSHA
model adopted through
Existing technical standards
HazCom & • Derived from labor law Your takeaways
labeling laws requirements, but can apply to here
manufacturers and importers
Regional shift to GHS
• Brazil & Uruguay, 2009
Can raise • Spanish / Portuguese required
• Ecuador & Honduras, 2013
import, • In-country emergency phone
number Argentina & Mexico, 2015
marketability •
• Country-specific nuances re
& compliance formats, applicability, • Costa Rica, 2017
issues enforcement • Colombia, proposed 2017
• Chile, in development
www.bdlaw.com/2017ChemicalsConference 11GHS Hazard Classification
Most countries adopt all GHS hazard classes:
physical, health, environmental
TAKEAWAYS
Health hazard classification issues Your takeaways
Health hazard
here
classification is
♦ Mixture rule: constituent of >0.1% (or >1.0%) confers its hazard class on the
mixture uniquely
♦ Substance classifications drawn from international sources: e.g., IARC
problematic
♦ May not adopt flexibility of UN Purple Book Beware the
mixture rule
Scope variations Applicability of
GHS is not
♦ Industrial chemicals harmonized
♦ Chemical products not marketed to individual consumers
♦ Chemical products used in a workplace
♦ All chemical products
♦ All products, ill-defined scope
www.bdlaw.com/2017ChemicalsConferenceGHS Hybrid Regulations
Costa Rica Hazardous
Chile Hazardous Product
Chemical Product Labeling
Import Control (2016) TAKEAWAYS
(2017)
Your takeaways
•Amended version of pesticide •Amended version of pesticide GHS is “going
here
import control labeling rule viral”
•Covers substances & •Covers all chemical products So, is everything
mixtures, including “finished marketed to individual hazardous now?
products” consumers
•Uses GHS health hazard •Uses all GHS hazard classes Agencies may
classification not understand
•Several country-specific label their own
•Requires Health Ministry elements regulations
authorization to transport •Requires registration as a
•Applied by Customs at point hazardous chemical product
of import
www.bdlaw.com/2017ChemicalsConferenceChemicals in Products
Emerging priority
TAKEAWAYS
• Inspired by SAICM, EU directives Your takeaways
Hazardous
• Consumer safety regulations: e.g., children’s products, paints, here
classification may
inks be hazardous to
• May implicate strong consumer protection statutes your product
Product safety:
Regulation of chemicals over product life-cycle potential back-
door to
• Product design (“DfE”) “hazardous substance” restrictions restrictions on
• Product testing & certification “hazardous
substances”
• Product labeling (disclosure of “hazardous substances”)
• Product end-of-life producer responsibility
www.bdlaw.com/2017ChemicalsConferenceProposed Chemical Registries
Brazil bill re: National Registry of Industrial
Chemical Substances
TAKEAWAYS
• Drafted by agency-led, multi-stakeholder working group Your takeaways
• Would require registration of production & imports >1 ton/year Broad-based
here
• Multi-agency committees would assess risks & impose risk
initiatives show
management measures momentum
toward chemical
• Public consultation in 2016; revision in progress registry laws
Colombia draft decree re: Integral Management of Expect burdens
Chemical Substances for Industrial Use of classification
& assessment
• Joint proposal of four ministries on industry
• Would require registration of all substances for industrial use
• Would require company self-assessments & risk management plans
• Public consultation in 2017
www.bdlaw.com/2017ChemicalsConferenceGap Analysis
Overreliance Assumption
on GHS that “stricter is
Mix-&-match TAKEAWAYS
classification better”
drafting Your takeaways
Hybridization of
here
international
High standards with
Unclear scope local law
aspirations / Closed
low capacity rulemaking definitions Stringency bias
processes
Implementation
gaps leave “real”
Interagency law unclear
National pride
jurisdiction
Enforcement country-specific
issues
via HTS codes approaches
www.bdlaw.com/2017ChemicalsConferenceLooking Ahead
Increasing focus on “hazardous substances”
TAKEAWAYS
Seepage of GHS classification into other areas of law
Your takeaways
Watch
here for the
National chemical inventories & registries expansion of
“hazardousness”
Regional spread of regulatory models Latin America –
the next
Ongoing pursuit of “harmonization” laboratory of
chemical laws
SAICM 2020 inflection point
Opportunities to shape emerging regimes – now is the time
www.bdlaw.com/2017ChemicalsConferenceThank you!
Maddie Kadas Russell Fraker
Principal Of Counsel
Austin, Texas Washington, DC
mkadas@bdlaw.com rfraker@bdlaw.com
Your takeaways
here
www.bdlaw.com/2017ChemicalsConference 18You can also read
