An Act To Provide the Department of Environmental Protection with Regulatory Flexibility Regarding the Listing of Priority Chemicals
Maine Legislature, Session 125, LD 1129
Committee Amendment CA_A_H421 (House)
Amends: 5 MRSA §8060, 38 MRSA §1693, 38 MRSA §1695, 38 MRSA §1696, 38 MRSA §1697, 38 MRSA §1698, 38 MRSA §1699-A, 38 MRSA §2322

COMMITTEE AMENDMENT 41 " to H.P. 841, L.D. 1129, Bill, "An Act To 
Provide the Department of Environmental Protection with Regulatory Flexibility 
Regarding the Listing of Priority Chemicals" 
Amend the bill by sniking out everything after the enacting clause and before the 
summary and inserting the following: 
'Sec. 1. 5 MRSA §8060, sub-§7 is enacted to read: 
7. Agenda listing required. Notwithstanding any provision of law to the contrary, a 
rule may not be proposed pursuant to Title 38, chapter 16-D unless the chemicals affected 
by that proposed rule were specifically disclosed to the Legislature prior to the initiation 
of the rule-making process as part of a regulatory agenda, except that this subsection may 
not be construed to prohibit an agency from initiating appropriate rule-making 
proceedings in response to any person who petitions for adoption or modification of rules 
pursuant to section 8055. 
Sec. 2. 38 MRS A §1691, as enacted by PL 2007, c. 643, §2, is amended to read: 
§1691. Definitions 
As used in this chapter, unless the context otherwise indicates, the following terms 
have the following meanings. 
1. Alternative. "Alternative" means a substitute process, product, material, chemical, 
strategy or combination of these that serves a functionally equivalent purpose to a 
chemical in a children's product. 
2. Chemical. "Chemical" means a substance with a distinct molecular composition 
or a group of structurally related substances and includes the breakdown products of the 
substance or substances that form through decomposition, degradation or metabolism. 
2-A. Chemical of concern. "Chemical of concern" means a chemical identified by 
the department pursuant to section 1693. 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT" ~"to H.P. 841, L.D. 1129 
3. 
Chemical of high concern. "Chemical of high concern" means a chemical 
identified by the department pursuant to section ~ 
1693-A. 
4. Chemical of low concern. "Chemical of low concern" means a chemical for 
which adequate toxicity and environmental data are available to determine that it is not a 
chemical of high concern, a chemical of concern, a chemical of moderate potential 
concern or a chemical of unknown concern. 
5. Chemical of potential concern. "Chemical of moderate potential concern" means 
a chemical identified by an authoritative governmental entity on the basis of credible 
scientific evidence as being suspected of causing an adverse health or environmental 
effect listed in section 1693, subsection 1. 
6. 
Chemical of unknown concern. "Chemical of unknown concern" means a 
chemical for which insufficient data are available to classify it as a chemical of high 
concern, a chemical of concern, a chemical of moderate potential concern or a chemical 
of low concern. 
7. Children's product. "Children's product" means a consumer product intended for~ 
made for or marketed for use by children under 12 years of age, such as baby products, 
toys, car seats, personal care products and clothing, and any consumer product containing 
a chemical of high concern that when used or disposed of will likely result in a effiI.d!s 
child under 12 years of age or a fetus's being exposed to that chemical. 
8. Consumer product. "Consumer product" means any item sold for residential or 
commercial use, including any component parts and packaging. "Consl:lmer prodl:lct" 
does not include a food or beverage or an additive to a food or beverage, a tobacco 
product or paper or forest products or a pesticide regulated by the federal Environmental 
Protection Agency. 
"Consumer product" also does not include a drug or biologic 
regulated by the federal Food and Drug Administration or the packaging of a drug or 
biologic regl:llated by the federal Food and Drug A:dministration if the packaging is 
regulated by the federal Food and Drug l\dministration., that is sold for: 
A. An indoor use in a residence, child care facility or school; or 
B. An outdoor residential use if a child under 12 years of age may have direct 
contact with the item. 
"Consumer product" does not include a food or beverage or an additive to a food or 
beverage, a tobacco product or paper or forest products or a pesticide regulated bv the 
United States Environmental Protection Agency. 
"Consumer product" also does not 
include a drug or biologic regulated by the United States Department of Health and 
Human Services, Food and Drug Administration or the packaging of a drug or biologic 
regulated by the Food and Drug Administration if the packaging is regulated by the Food 
and Drug Administration. "Consumer product" also does not include an item sold for 
outdoor residential use that consists of a composite material made from polyester resins. 
8-A. Credible scientific evidence. "Credible scientific evidence" means the results 
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of a study, the experimental design and conduct of which have undergone independent 
scientific peer review, that are published in a peer-reviewed journal or publication of an 
authoritative federal or international governmental agency, including but not limited to 
the United States Department of Health and Human Services, National Toxicology 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT" fl" to H.P. 841, L.D. 1129 
Program, Food and Drug Administration and Centers for Disease Control and Prevention; 
the United States Environmental Protection Agency; the World Health Organization; and 
the European Union, European Chemicals Agency. 
8-B. De minimis level. "De minimis level" means: 
A. For a chemical of high concern or priority chemical that is an intentionally added 
chemical in a component of a children's product, the practical quantification limit; or 
B. For a chemical of high concern or priority chemical that is a contaminant present 
in a component of a children's product, a concentration of 100 parts per million. 
9. Distributor. "Distributor" means a person who sells consumer products to retail 
establishments on a wholesale basis. 
9-A. 
Intentionally added chemical. 
"Intentionally added chemical" means a 
chemical that was added during the manufacture of a product or product component to 
provide a specific characteristic, appearance or quality or to perform a specific function. 
10. Manufacturer. "Manufacturer" means any person who manufactured a final 
consumer product or whose brand name is affixed to the consumer product. In the case of 
a consumer product that was imported into the United States, "manufacturer" includes the 
importer or first domestic distributor of the consumer product if the person who 
manufactured or assembled the consumer product or whose brand name is affixed to the 
consumer product does not have a presence in the United States. 
10-A. Practical quantification limit. "Practical quantification limit" means the 
lowest concentration of a chemical that can be reliably measured within specified limits 
of precision, accuracy, representativeness, completeness and comparability during routine 
laboratory operating conditions. 
The practical quantification limit is based on 
scientifically defensible, standard analytical methods. The practical quantification limit 
for a given chemical may be different depending on the matrix and the analytical method 
used. 
11. Priority chemical. "Priority chemical" means a chemical identified as such by 
the commissioner pursuant to section 1694, subsection 1. 
12. Safer alternative. "Safer alternative" means an alternative that, when compared 
to a priority chemical that it could replace, would reduce the potential for harm to human 
health or the environment or that has not been shown to pose the same or greater potential 
for harm to human health or the environment as that priority chemical. 
Sec. 3. 38 MRSA §1693, as enacted by PL 2007, c. 643, §2, is repealed and the 
following enacted in its place: 
§1693. Identification of chemicals of concern 
1. 
Criteria. 
By January 1, 2010, the department, in concurrence with the 
Department of Health and Human Services, Maine Center for Disease Control and 
Prevention, shall publish a list of chemicals of high concern, referred to after September 
1, 2011 as "the list of chemicals of concern." A chemical may be included on the list 
only if it has been identified by an authoritative governmental entity on the basis of 
credible scientific evidence as being: 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT" A "to H.P. 84), L.D. 1129 
A. A carcinogen, a reproductive or developmental toxicant or an endocrine disruptor; 
B. Persistent, bioaccumulative and toxic; or 
C. Very persistent and very bioaccumulative. 
2. 
Revisions. By January 1, 2012, the department, with input from interested 
persons and with the concurrence of the Department of Health and Human Services, 
Maine Center for Disease Control and Prevention, shall remove any chemical from the 
list published pursuant to subsection 1 that it finds is: 
A. Used solely in an item that is not a consumer product, including, but not limited 
to, a food or beverage, drug or biologic, paper or forest product or pesticide; or 
B. Used solely in a consumer product that is exempt from the requirements of this 
chapter pursuant to section 1697. 
The department may periodically review and revise the list published pursuant to 
subsection 1. The department may add chemicals to the list if, in the judgment of the 
Department of Health and Human Services, Maine Center for Disease Control and 
Prevention, the chemical meets one or more of the criteria in subsection 1. 
3. 
Removal by petition. 
A person may petition the department to remove a 
chemical from the list published pursuant to subsection 1. 
The department, in 
concurrence with the Department of Health and Human Services, Maine Center for 
Disease Control and Prevention, may grant a petition if the person demonstrates to the 
satisfaction of the department that the chemical: 
A. Does not meet the criteria for listing pursuant to subsection 1; or 
B. Meets the c~iteria for removal from the list pursuant to subsection 2. 
Upon receipt of a petition under this subsection, the department shall notify interested 
persons and provide an opportunity for review and comment on the evidence submitted 
by the petitioner. The department shall make a determination within 180 days of receipt 
of the petition and notify interested persons of the basis for its decision. If the petition is 
granted, the department shall immediately remove the chemical from the list published 
pursuant to subsection I. 
Sec. 4. 38 MRSA § 1693-A is enacted to read: 
§1693-A. Identification of chemicals of high concern 
1. List. By July 1, 2012, the department shall publish a list of no more than 70 
chemicals of high conc~rn. The Department of Health and Human Services, Maine 
Center for Disease Control and Prevention, in consultation with the deprutment, shall 
develop the list. To be listed as a chemical of high concern, a chemical must be on the 
list of chemicals of concern pursuant to section 1693 and meet the eligibility criteria of 
subsection 2. 
2. Criteria. A chemical of concern on the list of chemicals of concern pursuant to 
section 1693 may be included in the list published pursuant to subsection 1 if the 
department. in concurrence with the Department of Health and Human Services. Maine 
Center for Disease Control and Prevention, determines that there is strong credible 
scientific evidence that the chemical is a reproductive or developmental toxicant, 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT" A "toH.P.841,L.D.1129 
endocrine disruptor or human carcinogen, and there is strong credible scientific evidence 
that the chemical meets one or more of the following criteria: 
A. The chemical has been found through biomonitoring studies to be present in 
human blood, human breast milk, human urine or other bodily tissues or fluids; 
B. The chemical has been found through sampling and analysis to be present in 
household dust, indoor air or drinking water or elsewhere in the home environment; 
or 
C. The chemical has been added to or is present in a consumer product used or 
present in the home. 
3. Updates. The commissioner shall review the list published pursuant to subsection 
at least every 3 years. The commissioner shall remove any chemical from the list of 
chemicals of high concern that has been designated as a priority chemical pursuant to 
section 1694 or that no longer meets any of the criteria of subsection 2. 
The 
commissioner may identify additional chemicals of high concern according to the criteria 
and requirements of this section. The list of chemicals of high concern may not consist of 
more than 70 or fewer than 10 chemicals of high concern, unless fewer than 10 chemicals 
of high concern meet any of the criteria under subsection 2. 
4. Rules. The department shall adopt rules to implement the provisions of this 
section. Rules adopted pursuant to this subsection are routine technical rules as defined 
in Title 5, chapter 375, subchapter 2-A. 
Sec. 5. 38 MRSA § t 694, as enacted by PL 2007, c. 643, §2, is amended to read: 
§1694. Identification of priority chemicals 
Effective July 1, 2012, a chemical is eligible for designation as a priority chemical 
only if that chemical has been identified and listed as a chemical of high concern pursuant 
to section 1693-A. 
1. Criteria. The commissioner may designate a chemical of high concern as a 
priority chemical if the commissioner finds, in concurrence with the Department of 
Health and Human Services, Maine Center for Disease Control and Prevention: 
A. 
The chemical has been found through biomonitoring to be present in human 
blood, including umbilical cord blood, breast milk, urine or other bodily tissues or 
fluids; 
B. The chemical has been found through sampling and analysis to be present in 
household dust, indoor air, or drinking water or elsewhere in the home environment; 
or 
C. The chemical has been found through monitoring to be present in fish, wildlife or 
the natural environment; 
D. The chemical is present in a consumer product used or present in the homet~ 
E .. The chemical has been identified as a high production volume chemical by the 
foderal Environmental Protection Agency; or 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT" A "to H.P. 841, L.D. 1129 
F. The sale or use of the chemical or a product containing the chemical has been 
banned in another state within the UHited States. 
The commissioner shall designate at least 2. priority chemicals by JanUal)' 1, 2011. 
2. Designation. The commissioner shall designate at least 2 priority chemicals by 
January 1, 2011. The commissioner shall review the list of chemicals of high concern at 
least every 3 years and may designate additional priority chemicals if the commissioner 
finds that the chemicals meet one of the criteria listed in subsection 1. 
The commissioner shall adopt rules to implement the provisions of this section. 
Rules adopted pursuant to this section are routine technical rules as defined in Title 5, 
chapter 375, subchapter 2-A. 
Sec. 6. 38 MRSA §1695, sub-§l, as enacted by PL 2007, c. 643, §2, is amended 
to read: 
1. Reporting of chemical use. Not later than 180 days after a priority chemical is 
identified pursuant to section 1694, a person who is a manufacturer or distributor of a 
children's product for sale in the State that contains a priority chemical in an amount 
greater than a de minimis level shall notify the department in writing unless waived by 
the commissioner pursuant to this section or exempt from this chapter pursuant to section 
1697. This written notice must identify the children's product, the number of units sold or 
distributed for sale in the State or nationally, the priority chemical or chemicals contained 
in the children's product, the amount of such chemicals in each unit of children's product 
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and the intended purpose of the chemicals in the children's product. 
Sec. 7. 38 MRSA §1696, sub-§l, as enacted by PL 2007, c. 643, §2, is amended 
to read: 
1. 
Authority. The board may adopt rules prohibiting the manufacture, sale or 
distribution in the State of a children's product containing a priority chemical in an 
amount greater than a de minimis level if the board finds, after consideration of 
information filed under section 1695 and other relevant information submitted to or 
obtained by the board, that: 
A. Distribution of the children's product directly or indirectly exposes children and 
vulnerable populations to the priority chemical; and 
B. 
One or' more safer alternatives to the priority chemical are available at a 
comparable cost. 
If there are several available safer alternatives to a priority chemical, the board may 
prohibit the sale of children's products that do not contain the safer alternative that is least 
toxic to human health or least hannful to the environment. 
A rule established pursuant to this subsection must specify the effective date of the 
prohibition, which may not be sooner than 12 months after notice of the proposed rule is 
published as required under Title 5, section 8053, subsection 5. Rules adopted pursuant 
to this subsection are major substantive rules as defined in Title 5, chapter 375, 
subchapter 2-A. 
Sec. 8. 38 MRSA §1696, sub-§2, ~~A and B, as enacted by PL 2007, c. 643, 
§2, are amended to read: 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT"~ "to H.P. 841, L.D. 1129 
A. Presume that an alternative is a safer alternative if the alternative is not a chemical 
ofhtgh concern; 
B. Presume that a safer alternative is available if the sale of the children's product 
containing the priority chemical has been banned by another state witpin the United 
States based on the availability of a safer alternative; 
Sec. 9. 38 MRSA §1697, sub-§§9 to 11 are enacted to read: 
9. 
Regulatory efficiency. 
The department may, in exercising its discretionary 
authority under this chapter, consider the extent to which a chemical of high concern in a 
children's product is adequately regulated by the Federal Government or an agency of this 
State to reduce or prevent the same public health threats that would be the basis for 
II 
addressing the chemical under this chapter. 
10. Inaccessible components. The requirements of sections 1695 and 1696 do not 
apply to a priority chemical contained in a component of a children's product that during 
reasonably foreseeable use and abuse would not come into direct contact with a child's 
skin or mouth, such as inaccessible components of children's products. The department 
may adopt a rule, based on a case-by-case evaluation, to subject such components to the 
requirements of sections 1695 and 1696. Rules adopted pursuant to this subsection are 
routine technical rules as defined in Title 5, chapter 375, subchapter 2-A. 
11. Contaminants. The requirements of sections 1695 and 1696 do not apply to a 
priority chemical that occurs in a product component only as a contaminant if the 
manufacturer had in place a manufacturing control program and exercised due diligence 
to minimize the presence of the contaminant in the component. 
Sec. 10. 38 MRSA §1698, first ~, as enacted by PL 2007, c. 643, §2, is amended 
to read: 
The department is authorized to participate in an interstate clearinghouse to promote 
safer chemicals in consumer products in cooperation with other states and governmental 
entities. The department may cooperate with the interstate clearinghouse to classify 
existing chemicals in commerce into one of -4- 2. categories: chemicals of high concern, 
chemicals of moderate concern, chemicals of potential concern, chemicals of tmknown 
concern and chemicals of low concern. 
Sec. 11. 38 MRSA §1699-A, sub-§2, as enacted by PL 2007, c. 643, §2, is 
amended to read: 
2. 
Certificate of compliance. 
If there are grounds to suspect that a children's 
product is being offered for sale in violation of this chapter, the department may request 
the manufacturer or distributor of the product to provide a certificate of compliance with 
the provisions of this chapter. Within -W 30 days of receipt of a request under this 
subsection, the manufacturer or distributor shall: 
A. Provide the department with the certificate attesting that the children's product 
does not contain the priority chemical; or 
B. Notify persons who sell the product in this State that the sale of the children's 
product is prohibited and provide the department with a list of the names and 
addresses of those notified. 
COMMITTEE AMENDMENT 
~~~. 
;,' '-'" 
\~~ 
I 
COMMlITEE AMENDMENT" A 
"to H.P. 841, L.D. 1129 
Sec. 12. 38 MRSA §2322, sub-§8, as enacted by PL 2009, c. 579, Pt. A, §3, is 
amended to read: 
8. Toxic chemical. "Toxic chemical" means a chemical that has been identified as a 
chemical of high concern pursuant to section 1693 or a chemical the use or release of 
which is subj ect to reporting under the SARA, Title III, Section 312 or 313. 
Sec. 
13. 
Delayed 
priority 
chemical 
reporting; 
retroactivity. 
Notwithstanding the Maine Revised Statutes, Title 38, section 1695, subsection 1, a 
manufacturer or distributor of a children's product containing a priority chemical 
identified pursuant to Title 38, section 1694 is not required to comply with the reporting 
requirements of Title 38, section 1695, subsection 1 until the effective date of this 
section. This section applies retroactively to July 8, 2011.' 
SUMMARY 
This amendment replaces the bill. The amendment makes a number of changes to the 
priority chemical program. 
I. 
It prohibits the Department of Environmental Protection from initiating 
rulemaking under the Maine Revised Statutes, Title 38, chapter 16-D unless the chemical 
at issue has been included in a regulatory agenda disclosed to the Legislature pursuant to 
the Maine Administrative Procedure Act or the rulemaking is in response to a petition by 
a person to adopt or modify a rule pursuant to the Maine Administrative Procedure Act. 
2. It changes the name of the list of "chemicals of high concern" to "chemicals of 
concern." Conforming name changes are made throughout the amendment. By January 
I, 2012, the department is required to remove chemicals from the original list that are 
exempt from regulation. A person may petition for removal of chemicals that don't meet 
the listing criteria. 
3. By July I, 2012, a new list of up to 70 "chemicals of high concern" must be 
developed by the Department of Health and Human Services, Maine Center for Disease 
Control and Prevention and published by the Department of Environmental Protection 
based on a finding of strong credible evidence of toxicity and one or more indicators of 
likely exposure. 
4. 
The Department of Environmental Protection, in rule, is required to specify 
appropriate de minimis levels for each chemical of high concern. "De minimis level" is 
defined. For a chemical present in a product as a contaminant, the de minimis level is 
parts per million. 
For a chemical that's intentionally added to a product by a 
manufacturer, the de minimis level is the practical quantification limit, which is the 
lowest concentration ofthe chemical that can be reliably and accurately measured. 
5. 
The Commissioner of Environmental Protection is required to review the 
published list of chemicals of high concern at least every 3 years and may, with the 
concurrence of the Department of Health and Human Services, Maine Center for Disease 
Control and Prevention, remove chemicals that no longer meet the listing criteria and may 
add chemicals that meet the criteria. The list of chemicals of high concern may not 
consist of more than 70 or fewer than 10 chemicals, unless fewer than 10 meet the listing 
criteria. 
COMMITTEE AMENDMENT 
COMMITTEE AMENDMENT" A" to H.P. 841, L.D. 1129 
6. 
Effective July 1, 2012, a "priority chemical" may be designated only if the 
chemical has been listed on the list of chemicals of high concern. 
7. The definition of "children's product" is amended by limiting it to those products 
intended, made and marketed for use by children under 12 years of age and other 
consumer products through which a child under 12 years of age or a fetus is likely to be 
exposed to a chemical of concern. 
8. The definition of "consumer product" is narrowed to mean items sold for indoor 
use in a residence, child care facility or school, or for outdoor residential use if children 
may have direct contact with the items. 
9. Definitions of "credible scientific evidence" and "practical quantification limit" 
have been added. 
10. The criteria to be considered for designating a priority chemical are reduced from 
to 3. 
11. 
In determining whether a safer alternative is available, the Department of 
Environmental Protection may presume that a safer alternative is available if another state 
bans that chemical only if that state based its action on the availability of safer 
alternatives. 
12. It provides that the Department of Environmental Protection may consider the 
extent to which a chemical is adequately regulated by the Federal Government or another 
state agency in Maine in exercising its discretionary authority under the law. 
13. It provides that the following are exempt from the requirements for disclosing 
infonnation for priority chemicals and from any sales prohibition: 
A. Inaccessible components, except that the Department of Environmental Protection 
may adopt a rule based on a case-by-case evaluation to subject inaccessible 
components to those requirements; and 
B. A priority chemical that occurs in a product component only as a contaminant, if 
the manufacturer had a manufacturing control plan and exercised due diligence. 
14. It allows a manufacturer 30 days instead of 10 days to respond to the Depattment 
of Environmental Protection's request for a certificate of compliance. 
15. 
It provides that any repOlting requirements for products containing existing 
priority chemicals that have been adopted by rule by the Department of Environmental 
Protection are extended to the effective date of this legislation. It makes this provision 
retroactive to the date the reports are currently required, July 8, 2011. 
FISCAL NOTE REQUIRED 
(See attached) 
COMMITTEE AMENDMENT 
Approved: 05/24111 
;!va<=. 
LD 1129 
LR 1541(02) 
An Act To Provide the Department of Environmental Protection with Regulatory Flexibility 
Regarding the Listing of Priority Chemicals 
Fiscal Detail and Notes 
Fiscal Note for Bill as Amended by Committee Amendment '14 " 
Committee: Environment and Natural Resources 
Fiscal Note Required: Yes 
Fiscal Note 
Minor cost increase - Other Special Revenue Funds 
Requiring the Department of Environmental Protection (DEP) to decide petitions for de-listing of chemicals as 
chemicals of high concern, to notify interested persons and to provide opportunities for review and comment within 
days of submission, to engage in rulemaking to specify appropriate de minimis levels for each chemical of high 
concern and to submit an agency regulatory agenda to the appropriate joint standing committee and to the Secretary of 
State will result in minor administrative costs that the DEP can absorb within existing budgeted resources. Additional 
costs to the Maine Center for Disease Control and Prevention in the Department of Health and Human Services can be 
absorbed within existing budgeted resources. 
LR1541(02) - Fiscal Note - Page 1 of 1