1. law, govt and politics

50 Ways to . . . Chemical Management,
State and Federal Government, and
Preemption Paranoia
Judah Prero
J
ust four months after President Barack H. Obama
assumed the presidency on January 20, 2009, he issued
a memorandum setting an important preemption policy
for his Administration. www.whitehouse.gov/the_press_
office/Presidential-Memorandum-Regarding-Preemption. The
memorandum directed the heads of executive departments and
agencies that preemption of state law should be undertaken
only with full consideration of the legitimate prerogatives of
the states and with a sufficient legal basis for preemption. This
significant policy issue warranted attention at the start of a
new administration. The importance of this issue has been recognized not only by the executive branch of government but
also by the legislative.
Within the context of reform of the chemical management regulatory program under the Toxic Substances Control
Act (TSCA), the issue of preemption has become a political fulcrum. Numerous parties have given opinions specifically
on this issue. Senator Barbara Boxer, chair of the Senate
Committee on Environment and Public Works, has stressed
the importance of the ability of states, such as her home state
of California, to regulate chemicals and has argued that that
ability should remain unimpeded. The National Conference of
State Legislatures has also provided general preemption-related
concerns surrounding the ability of states to mandate testing or
develop standards for chemical substances. Attorneys general
from numerous states have opined on TSCA reform proposals,
with the preemption issue being a significant focus of the comments. Some attorneys general expressed reservations, with
fears that preemption provisions in a modernized TSCA would
effectively eliminate any federal-state partnership on the regulation of toxic chemicals by preventing states from continuing
legislative, regulatory, and enforcement work to address risks to
public health and the environment posed by toxic chemicals.
Other attorneys general have recognized the importance of a
nationally reliable chemical regulatory program that avoids
duplicative and conflicting regulatory schemes, and have supported preemption provisions that are coupled with provisions
that give states specific remedial abilities.
The issue of preemption is clearly significant in driving
the political dynamics for reforming TSCA, and several key
questions are worth exploring. How much oversight does the
federal government have over chemical production and use,
and what are the gaps that a state might need to fill? Have
Mr. Prero is assistant general counsel to the American Chemistry
Council in Washington, D.C. He may be reached at judah_prero@
americanchemistry.com.
states been hindered in filling those gaps by the constraints
of the federal chemical management system? Or are states
just continuing the turf war established by the Constitution
and federalism, national versus state government? This article explores the current role of the federal government in the
sphere of chemical management, the nature of the regulatory power conferred upon EPA under TSCA, how states have
handled chemical management issues, and whether the role of
states in chemical management will truly be impacted under
TSCA reform proposals.
Many federal departments and agencies play a part in
chemical management. Some have the authority to regulate and enforce standards and others focus on science and
research that inform policy decisions. It is a complex system
that encompasses monitoring, managing, regulating, investigating, and providing information on chemicals and chemical
exposures.
The U.S. Environmental Protection Agency (EPA) regulates and monitors chemicals released into the air, waterways,
and soil, and it sets standards for air quality, drinking water,
and pesticide residues on soil. EPA’s chemicals program
addresses pollution prevention, risk and exposure assessment,
and the management of chemicals in commercial use. EPA
ensures that communities have access to information about
local chemical hazards and funds cleanups at abandoned sites.
Statutes under the jurisdiction of EPA that regulate chemicals and chemical use include the Toxic Substances Control
Act; the Federal Insecticide, Fungicide, and Rodenticide Act;
the Clean Air Act, which includes the Accidental Release
Prevention requirements and the Risk Management Plan Rule;
the Safe Drinking Water Act; the Resource Conservation
and Recovery Act; and the Comprehensive Environmental
Response, Compensation, and Liability Act, which includes
the Emergency Planning and Community Right-to-Know Act.
While often overlooked, other agencies also regulate chemical use. The Consumer Product Safety Commission (CPSC)
creates chemical standards for manufacturers and retailers of
consumer products. CPSC enacted chemical standards, including those related to phthalates (a group of chemicals used to
soften and increase the flexibility of plastic and vinyl), cadmium, and lead. The Food and Drug Administration (FDA)
of the Department of Health and Human Services ensures
that food is safe to eat and that drugs and medical devices
are safe to use. The FDA regulates pharmaceuticals and food
additives and monitors ingredients in cosmetic products. The
Occupational Safety and Health Administration (OSHA) of
the Department of Labor issues and enforces health and safety
Published in Natural Resources & Environment Volume 29, Number 4, Spring 2015. © 2015 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion
thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association.
standards to protect individuals from work-related injury and
disease. OSHA has established mandatory exposure limits for
nearly 500 substances and comprehensive health standards for
materials such as asbestos, lead, and hexavalent chromium.
Additional regulatory programs address other aspects of chemical use, such as transportation and security. Chemicals and
their uses are regulated by a broad federal safety net comprised
of a multitude of programs and many agencies.
The federal government is involved as well in the research
and monitoring of chemicals and exposure. The Agency for
Toxic Substances and Disease Registry investigates exposures to hazardous substances at sites nationwide and provides
information concerning health impact information about
specific chemicals and risk levels. The National Center for
Environmental Health of the Centers for Disease Control and
Prevention conducts biomonitoring and reports on human
exposures to chemicals, and conducts studies and provides
technical assistance during emergency events and releases.
The National Toxicology Program coordinates toxicological research efforts and collaborates with other agencies to
increase data sharing. Accordingly, the federal government
possesses a wealth of information concerning chemicals and
chemical use and exposure.
Yet, even with these regulatory and oversight programs in
place, states have found areas in which to enact chemicalsrelated laws. These types of laws include restrictions on the
use of bisphenol A (BPA) in food and beverage containers;
restrictions on the use of certain flame retardants; reporting
or warning programs; biomonitoring programs; and “Green
Chemistry”-related programs. These laws have remained in
effect, and preemption-related litigation has not ensued en
masse. State laws also address only a sliver of what the federal
government addresses under numerous programs.
A robust federal system that addresses many aspects of
chemical manufacture and use notwithstanding, some states
insist that they must be allowed to do even more. This insistence by some states, that they must be allowed to regulate
chemicals as they see fit, is true even if EPA’s role is expanded
and enhanced in a modernized TSCA. On the other hand,
industry proponents and others have serious concerns about
allowing states to regulate beyond EPA requirements.
TSCA: Police or Commerce?
In U.S. constitutional law, police power is the capacity of the
states to regulate behavior and enforce order within their territory for the betterment of the health, safety, morals, and
general welfare of their inhabitants. Under the Tenth Amendment to the U.S. Constitution, the powers not specifically
delegated to the federal government are reserved to the states
or to the people. This law implies that the federal government
does not possess all possible powers, because states reserve
some powers and the people reserve others. In the environmental and public health contexts, states have exercised their
traditional police powers and historical regulation of the environment by regulating the emissions and wastes from facilities
located within their geographical boundaries. The goal of
these state laws is to protect the environment and population
located near these facilities. States are best suited to manage
state-specific concerns, whether they are due to geography, climate, or presence of a specific industry, and states can address,
on a local level, the issues presented. States are thus sometimes
better equipped than the federal government to respond to
local concerns and address the environmental issues their citizens face.
On the other hand, the Constitution bestows upon
Congress the power to regulate commerce among the several states. The scope of this power is the basis for much of the
environmental and economic federal legislation enacted by
Congress. Because federal environmental laws explicitly regulate or impact industrial and commercial activities, they have
a nexus to the regulation of commerce. Furthermore, because
many of the media regulated—such as air and water—do not
stay confined to one geographic area, it is logical that the pollution issue being addressed be handled in a consistent fashion
from state to state, with a centralized response, which the federal government can provide.
Without federal preemption,
a modernized TSCA would
create more uncertainty than
it would resolve.
Although it is under the jurisdiction of EPA, TSCA is not
akin to the traditional environmental statutes discussed earlier, which regulate environmental media (air, water, waste).
TSCA regulates the manufacture, processing, distribution,
and use of chemicals in products. Because most products are
distributed nationally, product regulation may significantly
impact interstate commerce. A logical regulation method
would be to take a national approach to regulating chemicals
in products that are distributed nationwide, or chemicals in
commerce.
The role of federal preemption in the TSCA context, then,
would be to ensure that a product that enters interstate commerce is regulated for safety in the same fashion in all fifty
states. This type of regulation is consistent with other product approval and safety laws. The federal government has
traditionally regulated how certain nationally marketed new
products are approved for commerce and has regulated what
is necessary for them to remain in commerce. For example, in
the product approval realm, the federal government, through
the FDA, retains sole authority to approve pharmaceuticals and medical devices for the market. Regarding safety, the
National Highway Traffic Safety Administration issues safety
standards for vehicles, an authority granted by the National
Traffic and Motor Vehicle Safety Act of 1966. When that act
was being debated, Senator Abraham Ribicoff summed up the
need for the legislation: “It is obvious that 50 states cannot
individually set standards for automobiles that come into those
states from a mass production industry.” (Congressional Record,
vol. 112, Part I (June 24, 1966)), p. S14232. Preemption in the
TSCA context ensures that products and chemicals are uniformly safe for intended uses across all fifty states.
Even within the chemical regulatory context, there is
precedent for federal preemption. State labeling and other
warning requirements are routinely considered to be preempted by federal requirements, particularly where Congress
Published in Natural Resources & Environment Volume 29, Number 4, Spring 2015. © 2015 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion
thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association.
has found a need for national uniformity or the federal requirement reflects a balance of competing interests. For example,
the Proposition 65 point-of-sale warning requirements in
California were held to be preempted by U.S. Department
of Agriculture labeling requirements under the Federal Meat
Inspection Act in American Meat Institute v. Leeman, 180 Cal.
App. 4th 728 (2010), and the Proposition 65 warning requirements as applicable to nicotine replacement therapy products
were held to be preempted by FDA’s warning requirements in
Dowhal v. SmithKline Beecham Consumer Healthcare, 32 Cal.
4th 910 (2004). On a policy basis, labeling and other warning
requirements directly impact interstate commerce, as products
marketed nationally typically must convey warnings uniformly
in all states. Where a state or locality has adopted its own
labeling or other warning requirement, the manufacturer or
distributor often must meet those requirements for its products
nationwide. Different requirements would mean a multiplicity
of labels, with added cost and burden, but little added benefit.
Federal preemption, therefore, is appropriate.
Traditional environmental statutes such as the Clean Air
Act and Clean Water Act often have a narrower, federal preemption provision. These statutes relate primarily to health or
environmental impacts that may be local in nature. The potential variety of locale-specific conditions does not lend itself to
a system of standardized regulation. Being that different states
and localities may be affected more by a certain form of pollution than the rest of the nation, states need the ability to address
those specific issues. Lack of federal preemption would have
relatively less impact on interstate commerce, as only localespecific issues are addressed through a diverse set of standards.
Furthermore, the regulation concerns how the pollutant in a
medium needs to be addressed, not how the underlying chemical
enters the commerce stream as a product in the first instance.
Accordingly, there is a solid reason for why preemption under
most environmental statutes looks different than preemption for
a federal chemical approval statute such as TSCA.
So Why All the Concern?
As mentioned, the scope of preemption in TSCA reform proposals is the subject of great attention and debate. To industry,
preemption is important because TSCA regulates goods in
commerce. Without federal preemption, a modernized TSCA
would create more uncertainty than it would resolve. States
would continue to have excessive latitude to create their own
programs on top of the expanded EPA role. This ambiguity
could impose on business huge transactional costs, complex
and costly compliance procedures, and litigation and risk
management efforts, resulting in fewer consumer choices and
higher prices, and frustrate the distribution of consumer and
commercial products. No improvement in chemical or product
safety necessarily follows from this burden.
Furthermore, the reach of economic activity has expanded
significantly since TSCA was enacted in 1976. State laws and
regulations that might have made sense when markets were
primarily local can now produce conflicts in an age where
markets are regional, national, and global. Modern economic
realities now demand the use of preemption to ensure one
uniform, federal chemical regulatory system in the United
States. Even state programs that mirror the federal programs
undermine a unified national U.S. market and can hinder
nationwide distribution systems for chemicals and products
that incorporate TSCA-regulated chemicals and materials.
There are already many federal programs that regulate,
evaluate, and disseminate information about chemicals.
These programs, when working in tandem with a modernized system to evaluate the safety of chemicals in commerce
for their intended use, should provide a state with a rather
solid basis to fulfill the responsibility to provide a safe environment for its citizens. When local concerns or gaps have
arisen, the statutes have allowed for states to act, to address
air and water pollution issues, for example. Furthermore, the
TSCA modernization proposal put forth by the late Senator
Frank Lautenberg (D-NJ) and Senator David Vitter (R-LA),
the “Chemical Safety Improvement Act” (CSIA), would allow
states to petition EPA to regulate when state-specific concerns
must be addressed. Such a petition process has precedent in,
among other laws, the Federal Food, Drug, and Cosmetic Act.
No states take a comprehensive approach similar to programs undertaken pursuant to TSCA in which a chemical
undergoes a scientific evaluation to determine its safety
prior to entry into commerce. Most chemical-related state
laws regulate chemicals in products or specific uses that, on
the federal level, are not regulated by EPA under TSCA,
but are regulated under other statutes by other agencies
such as the FDA or CPSC. Consequently, it is interesting to note they might be preempted by statutes other than
TSCA. (These laws are limited in scope and application.
Putting aside constitutional issues, this limitation exists
because most states do not have the monetary resources
and manpower to implement a state TSCA-like program.)
It is also difficult to envision why states would need their
own assessment programs. Rather, they need the ability to
obtain sound and reliable information on chemical safety
from EPA so that they can address chemical-related issues
that may arise in their state. While TSCA contains, and a
modernized TSCA would contain, risk management-related
provisions, those portions are but one part of the federal
chemical management system. With robust and systematic
chemical assessments for high priority chemicals, such as
those called for under the Lautenberg-Vitter proposal, states
should not need to engage in their own separate chemicalspecific risk management regulation. The other portions of
TSCA, namely the steps in the new chemical review process and systematic review of existing chemicals, should not
require state-based programs.
Under the Lautenberg-Vitter proposal, states continue
to have significant authority, preemption notwithstanding.
The involvement of state agencies in the regulatory process is
encouraged. Specifically, many state-based regulatory authorities would not be impacted if they did not conflict with EPA
requirements or regulate manufacturing or use—even once EPA
made a determination as to safety. States would be able to continue establishing chemical and product reporting requirements.
States would play a pivotal role in helping EPA by providing relevant exposure data, which would enable EPA to identify and
prioritize chemicals. The involvement of state agencies throughout the entire process of identifying, assessing, and regulating
priority substances would be encouraged. By involving state governments in this manner, the proposed structure would result in
a uniform national system of chemical regulation that addresses
the needs of the states in their roles as guardians for their citizens, and it would avoid the potential for duplication and
conflict between state and federal decisions.
Published in Natural Resources & Environment Volume 29, Number 4, Spring 2015. © 2015 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion
thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association.
By establishing a strong, centralized chemical management
system, with federal preemption, EPA will be able to address
safety and risk issues from chemical uses nationwide. A myriad of state and local chemical regulatory programs would be
unnecessary and preempted, thus eliminating conflicts and
inconsistencies in how citizens are protected from the same
exposure to chemicals. Resulting impediments to interstate
commerce that would otherwise increase the cost of products
will be eliminated. However, state and local governments will be
able to focus on local, higher priority issues by freeing resources
otherwise allocated to duplicative, state chemicals regulations.
Preemption exists today under TSCA. Risk management
actions, rules, and orders issuing from EPA with respect to a
It is difficult to see how a
reformed TSCA would truly
make a significant impact on
the ability of states to take
actions deemed necessary for
environmental protection.
chemical will generally preempt state and local restrictions
on that chemical that address the same risk. Under TSCA
today, states may apply to EPA for a waiver of preemption. In
practice, few states or localities have adopted restrictions for
the chemicals EPA has subjected to regulatory actions, and,
therefore, few occasions have arisen for this preemption provision to come into play—EPA has almost never been asked
for a waiver. Under the Lautenberg-Vitter proposal, all existing state laws will continue to be in force and effect until such
time as EPA acts specifically on a chemical and chemical use.
Only then would a state regulation be preempted by the federal action. To the extent that the bill contains “strong federal
preemption” language, it only extends to how a state can regulate an individual chemical in TSCA-like ways. The specific
scope of that preemption will be decided by EPA on a caseby-case, chemical-by-chemical basis. Thus, the preemption of
any and all existing state laws and regulations will be decided
by EPA and customized by EPA in its safety determination of
a specific chemical. Preemption under the Lautenberg-Vitter
proposal is by no means sweeping, nor will it impair the ability
of any state—in any fashion—to protect its citizens.
The Lautenberg-Vitter proposal was drafted to remedy the
host of issues EPA has faced in efforts to implement TSCA.
TSCA’s provisions were intended to ensure that chemicals that
pose an unreasonable risk to health or the environment could
be regulated appropriately. Under today’s TSCA, EPA has not
been able to meet this goal effectively. Therefore, the proposal
would strengthen EPA’s regulatory authority by imposing a more
systematic, centralized, and effective evaluation process to assure
new chemical products can come to market without questions
about safety, and existing chemicals can be determined safe for
their intended uses in order to remain on the market. It places
the role of central “product regulator” back in the hands of EPA,
where it belongs. The preemption provisions reflect this new
reality. Yet, the proposal also recognizes the need for states to
participate in the process and address states’ needs and concerns.
When read as a whole, the proposal properly balances the need
to ensure the growth and success of commerce nationally with
the need of states to protect their citizens.
States have legitimate concerns about protecting the safety
and health of their citizens, but the existing federal programs
that regulate chemical exposure address many of these concerns and allow states to take necessary actions. It is difficult
to see how a reformed TSCA with a strengthened preemption provision, as per the Lautenberg-Vitter proposal, would
truly make a significant impact on the ability of states to take
actions deemed necessary for environmental protection. States
retain the ability to protect their citizens from risks to human
health and the environment under a host of other federal statutes and even under the Lautenberg-Vitter proposal. When
the discussion of TSCA modernization moves from the political to the practical, perhaps significant advancement of the
proposals will occur.
Published in Natural Resources & Environment Volume 29, Number 4, Spring 2015. © 2015 by the American Bar Association. Reproduced with permission. All rights reserved. This information or any portion
thereof may not be copied or disseminated in any form or by any means or stored in an electronic database or retrieval system without the express written consent of the American Bar Association.