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|
Date
Published |
Docket
ID Number |
Details |
March 7, 2006 |
EPA-HQ-OPPT-2002-0051 |
Proposed
Rule: Premanufacture
Notification Exemption for Polymers; Amendment of Polymer
Exemption Rule to Exclude Certain Perfluorinated Polymers
EPA
believes that it can no longer conclude that polymers containing
fluorotelomers as an integral part of the polymer composition
``will not present an unreasonable risk of injury to health
or the environment''
as required for an exemption under section 5(h)(4) of TSCA.
Therefore, EPA is proposing to exclude polymers that contain
such fluorotelomers from the polymer exemption at 40 CFR 723.250.
... Although
EPA does not have specific data demonstrating that polymers
containing perfluoroalkyl moieties other than PFAS, PFAC,
or fluorotelomers present the same concerns as those containing
PFAS, PFAC, or fluorotelomers, EPA is nevertheless proposing
to exclude polymers containing perfluoroalkyl groups, consisting
of a CF3- or longer chain length, that are covalently bound
to either a carbon or sulfur atom where the carbon or sulfur
atom is an integral part of the polymer molecule from the
polymer exemption. Based on available data which indicates
that compounds containing PFAS or PFAC may degrade in the
environment thereby releasing the PFAS or PFAC moiety, and
that fluorotelomers may degrade in the environment to form
PFAC, EPA believes that it is possible for polymers containing
these other types of perfluoroalkyl moieties to also degrade
over time in the environment thereby releasing the perfluoroalkyl
moiety. EPA also believes that once released, such moieties
may potentially degrade to form PFAS or PFAC. EPA
does not believe, therefore, that it can continue to make
the ``will not present an unreasonable risk of injury to health
or the environment'' finding for such polymers and is proposing
to exclude them from the polymer exemption. EPA is
specifically requesting comment on this aspect of the proposed
rule.
A.
Polymers Containing PFAS or PFAC
... Animal test data for PFOS and PFOA have shown liver, developmental,
and reproductive toxicity at very low exposure levels. Animal
test data indicate that PFOA may cause cancer, and an epidemiologic
study reported an increased incidence of bladder cancer mortality
in a small number of workers at a plant that manufactures
perfluorinated chemicals. The number
of carbon atoms on the PFAS/PFAC component may influence the
bioaccumulation potential and the toxicity. In particular,
there is some evidence that PFAS/PFAC moieties with longer
carbon chains may present greater concerns for bioaccumulation
potential and toxicity than PFAS/PFAC moieties with shorter
carbon chains (Refs. 5, 6, and 7)...
B.
Polymers Containing Fluorotelomers or Other Perfluoroalkyl
Moieties
EPA is also proposing to exclude from the polymer exemption
rule polymers that contain fluorotelomers, or that contain
perfluoroalkyl moieties of a CF3- or longer chain length that
are covalently bound to either a carbon or sulfur atom where
the carbon or sulfur atom is an integral part of the polymers
molecule. EPA has concerns with respect to the potential health
and environmental effects of these substances and the Agency
believes that polymers containing such moieties should be
subject to the premanufacture review process so that EPA can
better evaluate and address these concerns. As discussed in
Unit IV.E., there is a growing body
of data demonstrating that fluorotelomer alcohols metabolize
or degrade to generate PFOA. Initial studies have also
demonstrated toxic effects of certain compounds containing
fluorotelomers (derived from the 8-2 alcohol).
Preliminary investigations have found that fluorotelomer alcohols
were present in the air above several cities, indicating that
these substances may be widely distributed and that air may
be a route of exposure. EPA believes that polymers
containing fluorotelomers or perfluoroalkyl moieties that
are covalently bound to either a carbon or sulfur atom where
the carbon or sulfur atom is an integral part of the polymers
molecule may degrade in the environment thereby releasing
fluorotelomer alcohols or other perfluoroalkyl-containing
substances. Accordingly, EPA can no
longer conclude that polymers containing fluorotelomers and
these other perfluoroalkyl moieties ``will not present an
unreasonable risk of injury to health or the environment''
as required for an exemption under section 5(h)(4)
of TSCA. Therefore, EPA is proposing to exclude such polymers
from the polymer exemption at
40 CFR 723.250.
... Canadian
researchers found fluorotelomer alcohols in the air in six
different cities is significant. This
finding is indicative of widespread fluorotelomer alcohol
distribution, and it further indicates that air may be a route
of exposure to these chemicals, which can ultimately become
PFOA. |
July
8, 2005 |
OPPT-2003-0071 |
Final
Enforceable Consent Agreement and Testing Consent Order for
Four Formulated Composites of Fluoropolymer Chemicals; Export
Notification.
EPA
has issued a testing consent order (Order) that incorporates
an enforceable
consent agreement (ECA) with
AGC Chemicals Americas,
Inc.; Daikin
America, Inc.; Dyneon, LLC;
and E.I. du Pont de Nemours
and Company
(the Companies)...
...
Data developed from the ECA testing will contribute to the
Agency's [EPA] efforts to determine whether municipal and/or
medical waste incineration of
fluoropolymer
(FP) chemicals
is a potential source and/or pathway of environmental and
human exposure to perfluorooctanoic acid (PFOA)...
NOTE:
There were 159 documents attached to this Docket. FAN has
downloaded each document and they are available at
http://www.fluorideaction.org/pesticides/pfoa-eca/index.html
Also
see List of Fluoropolymer
Chemicals to be used in incineration tests |
March
4, 2004 |
ORD-2003-0011 |
Announcement:
Longitudinal Study of Young Children's Exposures in their
Homes to Selected Pesticides, Phthalates, Brominated Flame
Retardants, and Perfluorinated Chemicals
(A Children's Environmental Exposure Research Study--CHEERS).
Abstract: The U.S. EPA's Office of Research and Development's
National Exposure Research Laboratory proposes to conduct
a two-year longitudinal field measurement study of young children's
(aged 0 to 3 years) potential exposures to current-use pesticides
and selected phthalates, polybrominated diphenyl ethers, and
perfluorinated
compounds that may be found in residential environments. The
study will be conducted in Duval County, Jacksonville, Florida
over a two-year period from 2004 to 2006. Sixty young children
will be recruited into this study in two cohorts: (1) infants
recruited into the study soon after birth, and, (2) children
recruited into the study at approximately 12 months of age.
The study involves up to six monitoring events to each home
during the two-year study period during which environmental,
personal, biological, and activity pattern data will be collected.
Each monitoring event consists of four visits to each participant's
home. Aggregate exposure estimates will be conducted for the
current-use pesticides and selected phthalates in the study.
The data collected on the polybrominated diphenyl ethers and
the perfluorinated compounds will provide valuable information
on concentrations of these compounds in residential environments,
the potential magnitude for exposure, and the temporal and
spatial variability of these chemicals in residences.
The data collected in this study is very important to the
EPA's Program Offices. The reasons for collecting this data
are to better identify the exposure factors, routes, and pathways
of exposure for these chemicals, thus improving the Agency's
ability to regulate these chemicals, conduct meaningful risk
assessments, and develop future studies.
Part
A: Supporting Statement
- EPA ICR Number: 2126.01 - 61 pages
From Table 2:
• Of 16 pesticides included in this study, 4 are
fluorinated:
Bifenthrin, Fipronil, lamda-Cyhalothrin, and Cyfluthrin
I, II, III, IV, total
•
Perfluorinated chemicals:
Perfluorooctanoic acid (PFOA) and Perfluorooctane sulfonate
(PFOS)
From
Table 3: List of chemicals to be analyzed in biological
media:
• one is fluorinated: 4-fluoro-3-phenoxybenzoic
acid
• Perfluorooctanoic acid/Perfluorooctane sulfonate |
|
Sept
30, 2003
|
None
|
PFOS
/ PFOAS. September 30, 2003. Federal Register.
Candidate Chemicals for Possible Inclusion in Future
Releases of the National Report on Human Exposure to Environmental
Chemicals.
DEPARTMENT
OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
Group
1
N-methyl
perfluorooctanesulfonamidoacetate (M570)
Perfluorinated carboxylic acid metabolites of telomer alcohol
or
telomer acrylate (n = 3)
Perfluorobutane sulfonate (PFBS)
Perfluorooctanoic acid fluoride
Perfluorooctanoic acid (PFOA) ammonium salt*
PFOA ethyl ester
PFOA free acid
PFOA methyl ester
PFOA potassium salt*
PFOA silver salt*
PFOA sodium salt*
Perfluorooctane sulfonate
(PFOS)
ammonium salt*
PFOS diethanolamine
salt*
PFOS lithium
salt*
PFOS potassium
salt*
* PFOA and
PFOS
measured as a consequence of exposure
to any PFOA
or
PFOS salt.
Group 2
Lambda cyhalothrin
Perfluorodecanesulfonate (PFDS) ammonium salt
Perfluorooctanesulfonamidoacetate (M556)
Trifluralin
Group
3
PFOS-related
compounds (n = 11; a heterogeneous group)
Fluoroalkyl
ethers (n = 6)
Fluoroalkyl iodides (n = 3)
Other
phased-out PFCs related to PFOS
chemistries
(n = 13)
Perfluorinated carboxylic acid metabolites
of telomer alcohol or
telomer acrylate (n = 3)
Perfluorinated chemicals not assigned to a structural class
(n = 2)
Perfluorinated homologues of <strong>PFOS</strong>
and PFOA (n = 2)
Perfluorinated quaternary ammonium chemicals (n = 2)
Perfluoroalkanes (n = 3)
Perfluoroalkyl acids and salts (n = 6)
Perfluoroalkyl alcohols (n = 4)
Perfluoroalkyl carboxylic acid fluorides (n = 2)
Perfluoroalkyl esters (n = 5)
Perfluoroalkyl iodides (n = 6)
Perfluoroalkyl sulfonamides (n = 10)
Perfluoroalkyl sulfonates (n = 75)
Perfluoroalkyl sulfonyl fluorides (n = 4)
Perfluoroglycol acid fluorides (n = 5)
Group
4
Fluoroalkyl ethers (n
= 6)
Fluoroalkyl iodides (n = 3)
Gamma, omega-perfluoroalkyl alcohols
(n = 3)
Other phased-out PFCs related to
PFOS chemistries
(n = 13)
Perfluorinated carboxylic acid metabolites
of telomer alcohol or
telomer acrylate (n = 3)
Perfluorinated chemicals not assigned to a structural class
(n = 2)
Perfluorinated homologues of PFOS
and PFOA (n = 2)
Perfluorinated quaternary ammonium chemicals (n = 2)
Perfluoroalkanes (n = 3)
Perfluoroalkyl acids and salts (n = 6)
Perfluoroalkyl alcohols (n = 4)
Perfluoroalkyl carboxylic acid fluorides (n = 2)
Perfluoroalkyl esters (n = 5)
Perfluoroalkyl iodides (n = 6)
Perfluoroalkyl sulfonamides (n = 10)
Perfluoroalkyl sulfonates (n = 75)
Perfluoroalkyl sulfonyl fluorides (n = 4)
Perfluoroglycol acid fluorides (n = 5)
Group
5
Perfluorinated compounds
that the U.S. Food and Drug Administration
has approved as
indirect food additives (n = 16)
Perfluoroalkyl acids and salts (n = 2)
|
April
16, 2003 |
OPPT-2003-0012 |
PFOA:
Perfluorooctanoic Acid, Fluorinated Telomers; Request
for Comment, Solicitation of Interested Parties for Enforceable
Consent Agreement Development, and Notice of Public Meeting.
-- EPA has prepared a preliminary risk assessment (Ref. 1)
on perfluorooctanoic acid (PFOA) (Octanoic acid, pentadecafluoro-;
(CAS No.) 335-67-1) and its salts, predominantly
ammonium perfluorooctanoate (APFO) (Octanoic acid, pentadecafluoro-,
ammonium salt (CAS No. 3825-26-1)). This
preliminary
assessment indicates potential nationwide human exposure to
low levels of PFOA...
-- The major fluoropolymers manufactured
using PFOA salts are polytetrafluoroethylene (PTFE) and polyvinylidine
fluoride (PVDF). PTFE has hundreds of uses in many industrial
and consumer products, including soil, stain, grease, and
water resistant coatings on textiles and carpet; uses in the
automotive, mechanical, aerospace, chemical, electrical, medical,
and building/construction industries; personal care products;
and non-stick coatings on cookware. PVDF is used primarily
in three major industrial sectors: Electrical/electronics,
building/ construction, and chemical processing.
-- EPA has also received data which indicate that the 8-2
telomer alcohol (1-Decanol, 3,3,4,4,5,5,6,6,7,7,8,8,9,9,10,10,10-heptadecafluoro-
(CAS No. 678-39-7)) although not itself made with PFOA,
can be metabolized by living organisms or biodegrade under
environmental conditions to produce PFOA ... anecdotal
evidence of the atmospheric presence of telomer alcohols in
a multi-city North American survey
suggests that telomers may be one source of environmental
PFOA
...
-- PFOA
exposures and releases to the environment may also come from
the distribution of PFOA in aqueous dispersions of fluoropolymers
used by processors to apply coatings to metals and textiles,
a topic which industry is also attempting to resolve.
-- Preliminary data suggest that only
higher perfluorinated homologues (chemicals with carbon chain
lengths of eight and higher) would be converted into PFOA
via normal environmental pathways.
3
of several documents in Docket:
March
13, 2003. Environmental,
Health and Safety Measures Relating to Perfluorooctanoic
Acid and its Salts (PFOA).
Letter to US EPA from Dr. Larry Wendling, VP, Performance
Materials Division, 3M Company (9 pages). Federal Register
Docket OPPT-2003-0012-0007
Aug
1, 2003. Perfluorooctanoic
Acid. Physiochemical Properties and Environmental Fate Data.
Submitted to US EPA from Michael A. Santoro, Director, Environmental
Health Safety and Regulatory Affairs, 3M; and George H.
Millet, Director - Quality, Environmental, Health &
Safety, Dyneon LLC, 3M Company. Federal
Register Docket OPPT-2003-0012-0164
Aug
1, 2003. Submission
of Monitoring Data Pursuant to the 3M LOI dated March 13,
2003 and APFO Users LOI dated March 14, 2003. Letter
to US EPA from Michael A. Santoro, Director, Environmental
Health Safety and Regulatory Affairs. 3M. Federal
Register Docket OPPT-2003-0012-0163
March
1, 2000. Sulfornated
Perfluorochemicals in the Environment: Sources, Dispersion,
Fate and Effects. Prepared by 3M. This report is part
of Federal Register Docket OPPT-2002-0043; for US EPA's
Dec 9, 2002, Final Rule on Perfluoroalkyl Sulfonates; Significant
New Use Rule.
|
Dec
9, 2002
|
OPPT-2002-0043
|
Perfluoroalkyl
Sulfonates; Significant New Use Rule.
FINAL RULE. EPA is issuing a significant new use rule
(SNUR) under section 5(a)(2) of the Toxic Substances Control
Act (TSCA) for 75 substances including perfluorooctanesulfonic
acid (PFOSH) and certain of its salts (PFOSS), perfluorooctanesulfonyl
fluoride (POSF), certain higher and lower homologues of PFOSH
and POSF, and certain other chemical substances, including
polymers, that are derived from PFOSH and its homologues.
These chemicals are collectively referred to as perfluoroalkyl
sulfonates, or PFAS. This rule requires manufacturers and
importers to notify EPA at least 90 days before commencing
the manufacture or import of these chemical substances for
the significant new uses described in this document.
--
Manufacture or import of any chemical listed in Table 1, Unit
I.A., solely for one or more of the following
specific uses shall not be considered as a significant new
use subject to reporting under this section:
i.
Use as an anti-erosion additive in fire-resistant phosphate
ester aviation hydraulic fluids.
ii.
Use as a component of a photoresist substance, including a
photo acid generator or surfactant, or as a component of an
anti-reflective coating, used in a photomicrolithography process
to produce semiconductors or similar components of electronic
or other miniaturized devices.
iii.
Use in coatings for surface tension, static discharge, and
adhesion control for analog and digital imaging films, papers,
and printing plates, or as a surfactant in mixtures used to
process imaging films.
iv. Use as an intermediate only to produce other chemical
substances to be used solely for the uses listed in Unit II.A.2.i.,
ii., or iii.
Documents
added to this Docket: |
Federal
Register
Docket No. |
Date
of Document |
Title |
Author |
No.
of pages |
0PPT-2002-0043-0005 |
March
1, 2000 |
Sulfonated
Perfluorochemicals in the Environment: Sources, Dispersion,
Fate and Effects. |
3M |
51
|
0PPT-2002-0043-0006 |
February
5, 1999 |
The
Science of Organic Fluorochemistry |
3M |
12 |
0PPT-2002-0043-0007 |
January
21, 1999 |
Perfluorooctane
Sulfonate: Current Summary of Human Sera, Health and Toxicology
Data. |
3M |
129 |
0PPT-2002-0043-0008 |
May
26, 1999 |
Fluorochemical
Use, Distribution and Release Overview |
3M |
347 |
0PPT-2002-0043-0009 |
July
7, 2000 |
3M.
Phase-out
Plan for POSF-Based Products. Letter from William Weppner
(3M) to Charles Auer (US EPA) |
3M |
11 |
0PPT-2002-0043-0010 |
August
31, 2000 |
Hazard
Assessment and Biomonitoring Data on Perfluorooctane Sulfonate
- PFOS, with cover memo from Jennifer Seed, EPA OPPT to
Charles Auer, EPA OPPT |
US
EPA. |
30 |
EPA's
response to Waste Not:
Waste Not questioned whether PFAS chemicals previously on
the list of pesticide inerts would continue to be listed,
whether one named chemical on the inerts list was included
in the SNUR, and whether its understanding of the status of
sulfluramid products was correct. Waste Not also asked whether
EPA would identify crops on which these products were used.
EPA confirms that none of the PFAS chemicals on the inerts
list identified by Waste Not, including the named chemical
without a CAS number provided, are currently formulated into
pesticide products, and they will all be removed from the
EPA List 3 Inerts list the next time that list is updated.
EPA notes that, although these PFAS chemicals will remain
on the List 3 Inerts list until that list is updated, the
manufacture or import of chemicals listed in this rule for
use as inert ingredients in pesticide products would be a
significant new use subject to this rule. Although TSCA does
not regulate chemicals manufactured for use solely as pesticide
active ingredients, chemical intermediates and pesticide inert
ingredients are subject to regulation under TSCA. With respect
to Waste Not's comment concerning the current status of registered
insecticide products containing sulfluramid, EPA concurs with
the list of active and cancelled products provided by Waste
Not. There are currently 16 products listed as active and
3 products cancelled. Three of the four products listed as
transferred, EPA Registration Nos. 11540-21, 1812-330, and
1812-329, are the same as the three products listed as cancelled.
The fourth product listed as transferred, EPA Registration
No. 11540-20, is the same as the active product under EPA
Registration No. 499-45. All pesticide
products containing sulfluramid are under a specific timeline
to be phased out by 2016. The pesticide products that
are registered are for use in a variety of enclosed termite,
ant, and roach bait stations. These
products are pre-filled and sold only in child-resistant packaging•.
Products containing sulfluramid have not been registered for
food or crop uses.
•
Note:
August 2001: The
largest pesticide penalty in New York State history
- $950,000 - was levied against S.C.
Johnson for illegally distributing unsafe sulfluramid
roach baits. According to NY State Attorney General Elliot
Spitzer. "This product was marketed for home use
and was labeled as child resistant when it was not."
|
|
April
5, 2002 |
|
Perfluoroalkyl
Sulfonates, Proposed Significant New Use Rule; Extension of
Comment Period - EPA is extending the existing comment period
for the proposed significant new use rule (SNUR) on perfluoroalkyl
sulfonates published on March 11, 2002, in the Federal Register.
In response to a request from the International
Imaging Industry Association, the comment period is being
extended by 90 days, until July 9, 2002. |
March
11, 2002
|
OPPTS-50639C
|
PFAS:
Perfluoroalkyl
Sulfonates; Proposed Significant New Use Rule.
EPA is proposing a supplemental significant new use rule (SNUR)
under section 5(a)(2) of the Toxic Substances Control Act
(TSCA) for the following 75 substances:
Perfluorooctanesulfonic acid (PFOSH)
and certain of its salts (PFOSS), perfluorooctanesulfonyl
fluoride (POSF), certain higher and lower homologues of PFOSH
and POSF, and certain other chemical substances, including
polymers, that are derived from PFOSH and its homologues.
These chemicals are collectively referred to as perfluoroalkyl
sulfonates, or PFAS. This proposed rule would require
manufacturers and importers to notify EPA at least 90 days
before commencing the manufacture or import of these chemical
substances for the significant new uses described in this
document. EPA believes that this action is necessary because
the PFAS component of these chemical substances may be hazardous
to human health and the environment.
-- In
the original proposed SNUR (65 FR 62319, October 18, 2000),
these chemicals had been referred to collectively as perfluorooctylsulfonates,
or PFOS, but commenters
noted that this generic usage of PFOS was inconsistent with
3M's use of PFOS to refer only to chemicals with an eight-carbon,
or C8, chain length. Many of the chemicals in the proposed
SNUR included a range of carbon chain lengths, although they
all did include C8 within the range. Accordingly,
EPA will use the generic term PFAS to refer to any chain length,
including higher and lower homologues as well as C8, and the
term PFOS to represent only those chemicals which are predominantly
C8.
--
PFAS not subject to a significant new use determination:
--
As a component of a photoresist substance, including a photo
acid generator or surfactant, or as a component of an anti-reflective
coating, used in a photomicrolithography process to produce
semiconductors or similar components of electronic or other
miniaturized devices.
-- specific use of the 3M formulations FC93 and FC98, which
contain three of the PFAS chemicals (CAS Nos. 2795-39-3, 67584-42-3,
and 68156-01-4) listed in Table 2, Unit I.A, as an anti-erosion
additive in fire- resistant phosphate ester aviation hydraulic
fluids, was critical to the safe performance of large cargo
and passenger aircraft, and that there are at present no viable
alternatives to PFAS for this use...
the total aggregate use of PFAS in this application by all
aviation consumers is less than 5,000 lbs per year (2,273
kg), and that because these systems are sealed at the
time of manufacture, worker exposures and releases to the
environment are minimal.
-- Under consideration for exemption:
Commenters in the photography
industry, in addition to raising the
semiconductor applications addressed earlier in this section,
also identified as critical the use of certain PFAS chemicals
in surface tension and static discharge control coatings on
films, papers, and printing plates, and as surfactants and
defoamers in solutions used to process films and papers, particularly
in both traditional and laser medical imaging and in some
industrial and consumer film products. The
industry estimated the total annual use of these PFAS chemicals
in medical imaging for disease diagnosis
at 30,600 kg (67,320 lbs), with another 5,400
kg (11,880 lbs) used per year in industrial (i.e., oil pipeline
x-ray; aerial reconnaissance photography) and some
consumer applications. Some information on specific chemicals
used in these applications, as well as on the sources of those
chemicals, was claimed as confidential.
|
March
11, 2002 |
OPPTS-50639D |
PFAS:
Perfluoroalkyl
Sulfonates; Significant New Use Rule. FINAL
RULE. EPA is issuing a significant
new use rule (SNUR) under section 5(a)(2) of the Toxic Substances
Control Act (TSCA) for 13
chemicals, including polymers, that are derived
from perfluorooctanesulfonic acid (PFOSH) and its higher and
lower homologues. These chemicals are collectively referred
to as perfluoroalkyl sulfonates, or PFAS. This rule
requires manufacturers and importers to notify EPA at least
90 days before commencing the manufacture or import of these
chemical substances for the significant new uses described
in this document. EPA believes that this action is necessary
because the PFAS component of these chemical substances may
be hazardous to human health and the environment. The required
notice will provide EPA with the opportunity to evaluate an
intended new use and associated activities and, if necessary,
to prohibit or limit that activity before it occurs. This
action promulgates a portion of the proposed SNUR originally
published in the Federal Register of October 18, 2000. This
action also removes from the SNUR two chemicals that were
listed erroneously in that original proposal. Published elsewhere
in today's issue [see below] of the Federal Register is a
supplemental proposed rule which addresses the remainder of
the chemicals listed in the original proposed SNUR. |
March
6, 2002 |
none |
Forty-Ninth
Report of the TSCA Interagency Testing Committee. Request for
Comments. |
Feb
23, 2001 |
none |
Perfluorooctyl
Sulfonates; Notice of Public Meeting. |
Nov
21, 2000 |
OPPTS-50639A |
Perfluorooctyl
Sulfonates, Proposed Significant New Use Rule; Extension of
Comment Period. SUMMARY: EPA is
extending the existing comment period for the proposed significant
new use rule (SNUR) on perfluorooctyl sulfonates published
on [[Page 69890]] October 18, 2000, in the Federal Register.
In response to several requests, the comment period is being
extended by 45 days, until January 1, 2001. The comment period
was scheduled to close on November 17, 2000. The proposed
SNUR under section 5(a)(2) of the Toxic Substances Control
Act (TSCA) applies to the following chemical substances: perfluorooctanesulfonic
acid (PFOSA) and certain of its salts (PFOSS), perfluorooctanesulfonyl
fluoride (PFOSF), certain higher and lower homologues of PFOSA
and PFOSF, and certain other chemical substances, including
polymers, that contain PFOSA and its homologues as substructures.
All of these chemical substances are referred to collectively
in the proposed rule as perfluorooctyl sulfonates, or PFOS.
The proposed rule would require manufacturers and importers
to notify EPA at least 90 days before commencing the manufacture
or import of these chemical substances for the significant
new uses described in this document. |
Oct
18, 2000 |
OPPTS-50639 |
Perfluorooctyl
Sulfonates. Proposed Significant New Use Rule.
This
Notice provides highly disturbing data on significant and
severe health effects from animal studies that used very low
exposure levels. It also provides the list of the chemicals
to be phased out of production by 3M. Due to the severity
of effects EPA is proposing a zero production level of these
chemicals by 2003.
The
Notice states:
EPA is proposing a significant new use rule (SNUR) under section
5(a)(2) of the Toxic Substances Control Act (TSCA) for the
following chemical substances: Perfluorooctanesulfonic acid
(PFOSA) and certain of its salts (PFOSS), perfluorooctanesulfonyl
fluoride (PFOSF), certain higher and lower homologues of PFOSA
and PFOSF, and certain other chemical substances, including
polymers, that contain PFOSA and its homologues as substructures.
All of these chemical substances are referred to collectively
in this proposed rule as perfluorooctyl sulfonates, or PFOS...
All of these chemical substances have the potential to degrade
back to PFOSA in the environment, and PFOSA does not degrade
further. PFOSA is highly persistent in the environment
and has a strong tendency to bioaccumulate. Studies have found
PFOS in very small quantities in the blood of the general
human population as well as in wildlife, indicating that exposure
to the chemicals is widespread, and recent tests have raised
concerns about their potential developmental, reproductive,
and systemic toxicity (Refs. 1, 2, and 3). These factors,
taken together, raise concerns for long term potential adverse
effects in people and wildlife over time if PFOS should continue
to be produced, released, and built up in the environment.
This
proposed rule would require manufacturers and importers to
notify EPA at least 90 days before commencing the manufacture
or import of these chemical substances for the significant
new uses described in this document. EPA believes that this
action is necessary because the chemical substances included
in this proposed rule may be hazardous to human health and
the environment. The required notice would provide EPA with
the opportunity to evaluate an intended new use and associated
activities and, if necessary, to prohibit or limit that activity
before it occurs.
Environmental
Fate. The basic building block of all of the PFOS chemicals
is PFOSF, which is used as an intermediate in the production
of the PFOS chemicals. PFOSA results from the chemical or
enzymatic hydrolysis of PFOSF. Current information strongly
supports that PFOSA is an extremely stable substance which
resists breakdown by chemical or biological processes. Therefore
PFOSA is the ultimate degradation product from PFOS chemicals
and will persist in that form (Refs. 1 and 2)...
Table
5
Anticipated Annual U.S. Production Volume (Pounds) for
PFOS Use Categories |
Use
category |
2000
|
2001 |
2002 |
2003 |
Surface
treatment |
2,356,700 |
0 |
0 |
0 |
Paper
protection |
2,670,700
|
0 |
0 |
0 |
Performance
chemicals |
1,462,500
|
1,011,900 |
443,700
|
0 |
Total
|
6,489,900 |
1,011,900 |
443,700
|
0 |
Surface
treatment
applications provide soil, oil, and water resistance
to personal apparel and home furnishings. Specific
applications in this use category include protection
of apparel and leather, fabric/upholstery, and carpet.
These applications are undertaken in industrial settings
by customers such as textile mills, leather tanneries,
finishers, fiber producers, and carpet manufacturers.
PFOS chemicals are also used in aftermarket treatment
of apparel and leather, upholstery, carpet, and automobile
interiors by the general public or professional applicators
(Ref. 4).
|
Paper
protection
applications provide grease, oil, and water resistance
to paper and paperboard as part of a sizing agent
formulation. Specific applications in this use category
include food contact applications (plates, food containers,
bags, and wraps) regulated by the Food and Drug Administration
(FDA) under 21 CFR 176.170, as well as non-food contact
applications (folding cartons, containers, carbonless
forms, and masking papers). The application of sizing
agents is undertaken mainly by paper mills and, to
some extent, converters who manufacture bags, wraps,
and other products from paper and paperboard (Ref.
4).
|
Performance
chemicals
category are used in a wide variety of specialized industrial,
commercial, and consumer applications. Specific applications
include fire fighting foams, mining and oil well surfactants,
acid mist suppressants for metal plating and electronic
etching baths, alkaline cleaners, floor polishes, photographic
film, denture cleaners, shampoos, chemical intermediates,
coating additives, carpet spot cleaners, and as an insecticide
in bait stations for ants (Ref. 4). |
|
|
|
|
|