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Guidance on PFAS Exposure,
Testing, and Clinical Follow-Up
Ned Calonge, Committee Chair
National Academies of Sciences, Engineering and
Medicine (NASEM)
• Created by President Lincoln in 1863, NASEM provides independent, objective advice to inform
policy with evidence, spark progress and innovation, and confront challenging issues for the benefit
of society
• Consensus study process
– Defining the study: sponsors work with leadership on a statement of task, work plan and budget all approved by
the National Research Council Governing Board
– Committee selection and approval: members are selected based on required individual expertise and do not
represent organizations or interest groups; balance and diversity in composition and strict screening for conflicts
of interest are essential aspects
– Committee meetings, information gathering, deliberations and drafting the report: information is gathered through
open meetings, submission of information from outside parties, reviews of the scientific literature, and
investigations of committee members and staff; deliberations and report drafting occurs in closed meetings
– Report review: all reports go through a rigorous review by independent experts with diverse views and
perspectives; the committee must adjudicate all reviewer comments examined by independent review monitors
before final signoff but Academies officials.
2
Committee on the Guidance on PFAS Testing
and Health Outcomes
• Preventive Medicine/Evidence to Decision Methods
NED CALONGE (Chair)
ALEX KEMPER
• Environmental health
MELISSA GONZALES
ERIN HAYNES
• Environmental health/PFAS
LAURA ANDERKO
ERIN BELL
JANE HOPPIN
VERONICA VIEIRA
• Risk Assessment and Environmental Health/PFAS
MARC-ANDRÉ VERNER
3
• Reproduction and Child Development Environmental
Health
TAMARRA JAMES-TODD
XIAOBIN WANG
• Ethics/Environmental Health
KEVIN ELLIOTT
• Environmental Health Laboratory
DANA BOYD BARR
• Occupational Health
BRIAN LINDE
• U.S. Drinking Water Regulation
CHRIS WIANT
• Health and Medicine Division Staff
ELIZABETH BARKSDALE BOYLE Study Director
Introduction and
Background
4
Statement of Task (Abbreviated)
• Review the human health literature for health effects of PFAS
– Limited to seven PFAS measured in CDC’s National Report on Human Exposure to
Environmental Chemicals (MeFOSAA, PFHxS, PFOA, PFDA, PFUnDA, PFOS, and PFNA)
• Develop principles for biological testing and clinical evaluation
given substantial scientific uncertainty
• Characterize human exposure pathways and develop principles
for exposure reduction
• Advice to update CDC ATSDR’s clinical guidance and a strategy
to keep it updated
• Provide recommendations on blood testing
• Provide recommendations on patient follow-up
5
What we were NOT asked to do
• Propose strategies for regulating PFAS
• Discuss strategies for clean-up, disposal, or removal of PFAS
• Suggest replacement chemicals for PFAS
• Propose or review PFAS drinking water standards
• Develop a PFAS Clinical Guidance for ATSDR
• Develop plans for payment of PFAS testing and clinical follow-up
6
The Committee’s Approach
7
Primary Findings,
Conclusions, and
Recommendations
8
Principles for Decision Making Under Uncertainty
• Proportionality: Decisions should balance plausible harms and
benefits proportionally.
• Justice: Decisions should balance harms and benefits fairly across
all individuals, promote health equity, and respect human rights.
• Autonomy: Decisions should incorporate informed decision-
making by individuals and respect their values.
• Feasibility: Decisions should take account of resource availability,
including follow-up services.
• Adaptability: Decisions should respond to new information about
harms, benefits, and other relevant considerations (e.g., health
equity and feasibility).
9
9
Health Effects of PFAS: Findings
10
• From the search of the literature the committee identified:
– 8 Authoritative reviews
– 26 Systematic reviews
– 139 Prospective epidemiologic studies published since 2018
(when the literature search for the most recent authoritative
review was completed)
• Several PFAS were noted to be associated with different
health effects by authoritative bodies
• Effects studied span many different health effect
categories
10
Forest Plot
example:
Kidney cancer
11
Health Effects of PFAS: Conclusions
Sufficient evidence of an association
• Decreased antibody response (in
adults and children)
• Dyslipidemia (in adults and children)
• Decreased infant and fetal growth
• Increased risk of kidney cancer (in
adults)
12
Limited suggestive evidence of an
association
• Increased risk of breast cancer (in adults)
• Increased risk of testicular cancer (in
adults)
• Liver enzyme alterations (in adults and
children)
• Increased risk of pregnancy-induced
hypertension (gestational hypertension
and preeclampsia)
• Thyroid disease and dysfunction (in
adults)
• Increased risk of ulcerative colitis (in
adults)
Recommendations – Exposure Reduction
13
Recommendation 4-1: Clinicians advising patients on PFAS exposure reduction
should begin with a conversation aimed at first determining how they might be
exposed to PFAS (sometimes called an environmental exposure assessment) and
what exposures they are interested in reducing. This exposure assessment
should include questions about current occupational exposures to PFAS (such as
work with fluorochemicals or firefighting) and exposures to PFAS through the
environment. Known environmental exposures to PFAS include living in a
community with PFAS-contaminated drinking water, living near industries that use
fluorochemicals, serving in the military, and consuming fish and game from areas
with known or potential contamination.
Recommendation 4-2: If patients may be exposed occupationally, such as by
working with fluorochemicals or as a firefighter, clinicians should consult with
occupational health and safety professionals knowledgeable about the workplace
practices to determine the most feasible ways to reduce that exposure.
13
Recommendations – Exposure Reduction
Recommendation 4-6: When clinicians are counseling parents of
infants on PFAS exposure, they should discuss infant feeding and
steps that can be taken to lower sources of PFAS exposure. The
benefits of breastfeeding are well known; the American Academy of
Pediatrics, the American Academy of Family Physicians, and the
American College of Obstetricians and Gynecologists support and
recommend breastfeeding for infants, with rare exceptions.
Clinicians should explain that PFAS can pass through breast milk
from a mother to her baby. PFAS may also be present in other foods,
such as the water used to reconstitute formula and infant food, and
potentially in packaged formula and baby food. It is not yet clear
what types and levels of exposure to PFAS are of concern for child
health and development.
14
14
The Committee Found Several Risk-based Serum Levels
Type of Risk-Based
Levels
PFOS
ng/ml
PFOA
ng/ml
Sum of
PFAS*
ng/ml
HBM-I 5 2
HBM-II 20 10
HBM-II (women of
childbearing age) 10 5
EFSA Point of
Departure (women of
childbearing age) 6.9
15
• German Human Biomonitoring
Commission (HBM Commission) develops
human biomonitoring (HBM) values for the
interpretation of concentrations of
environmental chemicals measured in
biological samples.
• HBM-I values are the concentrations
below which effects are not expected
• HBM-II values are the concentrations
above which adverse health effects are
possible
• European Food Safety Authortry (EFSA)
Point of Departure is the modeled estimate
of maternal exposure which would lead to
negligible risk to a breastfed infant
* PFOA, PFOS, PFHxS and PFNA
Graph of Risk-Based & Reference-Based Levels: PFOA
16
16
17
Graph of Risk-Based & Reference-Based Levels: PFOS
17
PFAS Testing and Concentrations that Can Inform
Clinical Care Recommendations
Recommendation 5-2: Clinicians should offer PFAS testing to patients likely to
have a history of elevated exposure. In all discussions of PFAS testing,
clinicians should describe the potential benefits and harms of the testing and
the potential clinical consequences (such as additional follow-up), related social
implications, and limitations of the testing so patient and clinician can make a
shared, informed decision. Patients who are likely to have a history of elevated
exposure to PFAS include those who have
– had occupational exposure to PFAS (such as those who have worked with
fluorochemicals or served as a firefighter);
– lived in communities where environmental and public health authorities or academic
researchers have documented PFAS contamination; or
– lived in areas where PFAS contamination may have occurred, such as near facilities
that use or have used fluorochemicals, commercial airports, military bases,
wastewater treatment plants, farms where sewage sludge may have been used, or
landfills or incinerators that have received PFAS-containing waste.
18
18
Recommendation 5-3: Clinicians should use serum or plasma concentrations of the sum of PFAS*
to inform clinical care of exposed patients, using the following guidelines for interpretation:
– Adverse health effects related to PFAS exposure are not expected at less than 2 nanograms
per milliliter (ng/mL).
– There is a potential for adverse effects, especially in sensitive populations, between 2 and 20
ng/mL.
– There is an increased risk of adverse effects above 20 ng/mL.
19
PFAS Testing and Concentrations that Can Inform Clinical
Care Recommendations
*Simple additive sum of MeFOSAA, PFHxS, PFOA (linear and branched isomers), PFDA,
PFUnDA, PFOS (linear and branched isomers), and PFNA in serum or plasma. Caution is
warranted when using capillary blood measurements as levels may differ from serum or plasma
levels.
Guidance for Clinicians on Exposure Determination,
PFAS Testing, and Clinical Follow-Up
20
Recommendation 6-1: Clinicians should treat patients with serum PFAS concentration
below 2 nanograms per milliliter (ng/mL) with the usual standard of care.
Recommendation 6-2: For patients with serum PFAS concentration of 2 nanograms
per milliliter (2 ng/mL) or higher and less than 20 ng/mL, clinicians should
encourage PFAS exposure reduction if a source of exposure is identified, especially for
pregnant persons. Within the usual standard of care clinicians should:
– Prioritize screening for dyslipidemia with a lipid panel (once between 9 and 11 years
of age, and once every 4 to 6 years over age 20) as recommended by the American
Academy of Pediatrics (AAP) and American Heart Association (AHA).
– Screen for hypertensive disorders of pregnancy at all prenatal visits per the American
College of Obstetricians and Gynecologists (ACOG).
– Screen for breast cancer based on clinical practice guidelines based on age and
other risk factors such as those recommended by the U.S. Preventive Services Task
Force (USPSTF).
20
Guidance for Clinicians on Exposure Determination,
PFAS Testing, and Clinical Follow-Up
Recommendation 6-3: For patients with serum PFAS concentration of 20
nanograms per milliliter (ng/mL) or higher, clinicians should encourage PFAS
exposure reduction if a source of exposure is identified, especially for pregnant
persons. In addition to the usual standard of care, clinicians should:
• Prioritize screening for dyslipidemia with a lipid panel (for patients over age 2)
following American Academy of Pediatrics (AAP) guidelines for high-risk
children and American Heart Association (AHA) guidance for high-risk adults.
• At all well visits:
– conduct thyroid function testing (for patients over age 18) with serum thyroid
stimulating hormone (TSH),
– assess for signs and symptoms of kidney cancer (for patients over 45),
including with urinalysis, and
– for patients over 15, assess for signs and symptoms of testicular cancer and
ulcerative colitis.
21
21
Areas of additional committee recommendations
• Clinician support to provide more specific exposure reduction (from
drinking water and food sources) and providing authoritative
information sources
• Reporting of laboratory results to state health authorities
• National data collection and reporting of serum levels in children and
pregnant persons
• Public health PFAS support and education for clinicians
• Federal research to evaluate PFAS and infant feeding/breast feeding
.
22
22
Closing thoughts
• Environmental exposures such as PFAS are important components of
disease risk in humans
• A more comprehensive approach to evaluating environmental
exposures is needed to understand the causes and contributors to
chronic disease.
• Such an approach will ultimately depend on breaking down the
barriers between environmental public health and the clinical care
setting.
• Identifying environmental exposures, measuring exposure levels in
patients and providing indicated medical follow-up is a critical frontier
that could and should bring the two disciplines closer together to
improve health of those in our communities.
23
23
Thank you!
Additional questions or comments may be referred to
• Elizabeth Boyle, eboyle@nas.edu
• Ned Calonge, ned.calonge@cuanschutz.edu
24
24

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OECD Global Forum on the Environment dedicated to Per- and Polyfluoroalkyl Substances: Guidance on PFAS exposure, testing and clinical follow-up | Ned Calonge

  • 1. Guidance on PFAS Exposure, Testing, and Clinical Follow-Up Ned Calonge, Committee Chair
  • 2. National Academies of Sciences, Engineering and Medicine (NASEM) • Created by President Lincoln in 1863, NASEM provides independent, objective advice to inform policy with evidence, spark progress and innovation, and confront challenging issues for the benefit of society • Consensus study process – Defining the study: sponsors work with leadership on a statement of task, work plan and budget all approved by the National Research Council Governing Board – Committee selection and approval: members are selected based on required individual expertise and do not represent organizations or interest groups; balance and diversity in composition and strict screening for conflicts of interest are essential aspects – Committee meetings, information gathering, deliberations and drafting the report: information is gathered through open meetings, submission of information from outside parties, reviews of the scientific literature, and investigations of committee members and staff; deliberations and report drafting occurs in closed meetings – Report review: all reports go through a rigorous review by independent experts with diverse views and perspectives; the committee must adjudicate all reviewer comments examined by independent review monitors before final signoff but Academies officials. 2
  • 3. Committee on the Guidance on PFAS Testing and Health Outcomes • Preventive Medicine/Evidence to Decision Methods NED CALONGE (Chair) ALEX KEMPER • Environmental health MELISSA GONZALES ERIN HAYNES • Environmental health/PFAS LAURA ANDERKO ERIN BELL JANE HOPPIN VERONICA VIEIRA • Risk Assessment and Environmental Health/PFAS MARC-ANDRÉ VERNER 3 • Reproduction and Child Development Environmental Health TAMARRA JAMES-TODD XIAOBIN WANG • Ethics/Environmental Health KEVIN ELLIOTT • Environmental Health Laboratory DANA BOYD BARR • Occupational Health BRIAN LINDE • U.S. Drinking Water Regulation CHRIS WIANT • Health and Medicine Division Staff ELIZABETH BARKSDALE BOYLE Study Director
  • 5. Statement of Task (Abbreviated) • Review the human health literature for health effects of PFAS – Limited to seven PFAS measured in CDC’s National Report on Human Exposure to Environmental Chemicals (MeFOSAA, PFHxS, PFOA, PFDA, PFUnDA, PFOS, and PFNA) • Develop principles for biological testing and clinical evaluation given substantial scientific uncertainty • Characterize human exposure pathways and develop principles for exposure reduction • Advice to update CDC ATSDR’s clinical guidance and a strategy to keep it updated • Provide recommendations on blood testing • Provide recommendations on patient follow-up 5
  • 6. What we were NOT asked to do • Propose strategies for regulating PFAS • Discuss strategies for clean-up, disposal, or removal of PFAS • Suggest replacement chemicals for PFAS • Propose or review PFAS drinking water standards • Develop a PFAS Clinical Guidance for ATSDR • Develop plans for payment of PFAS testing and clinical follow-up 6
  • 9. Principles for Decision Making Under Uncertainty • Proportionality: Decisions should balance plausible harms and benefits proportionally. • Justice: Decisions should balance harms and benefits fairly across all individuals, promote health equity, and respect human rights. • Autonomy: Decisions should incorporate informed decision- making by individuals and respect their values. • Feasibility: Decisions should take account of resource availability, including follow-up services. • Adaptability: Decisions should respond to new information about harms, benefits, and other relevant considerations (e.g., health equity and feasibility). 9 9
  • 10. Health Effects of PFAS: Findings 10 • From the search of the literature the committee identified: – 8 Authoritative reviews – 26 Systematic reviews – 139 Prospective epidemiologic studies published since 2018 (when the literature search for the most recent authoritative review was completed) • Several PFAS were noted to be associated with different health effects by authoritative bodies • Effects studied span many different health effect categories 10
  • 12. Health Effects of PFAS: Conclusions Sufficient evidence of an association • Decreased antibody response (in adults and children) • Dyslipidemia (in adults and children) • Decreased infant and fetal growth • Increased risk of kidney cancer (in adults) 12 Limited suggestive evidence of an association • Increased risk of breast cancer (in adults) • Increased risk of testicular cancer (in adults) • Liver enzyme alterations (in adults and children) • Increased risk of pregnancy-induced hypertension (gestational hypertension and preeclampsia) • Thyroid disease and dysfunction (in adults) • Increased risk of ulcerative colitis (in adults)
  • 13. Recommendations – Exposure Reduction 13 Recommendation 4-1: Clinicians advising patients on PFAS exposure reduction should begin with a conversation aimed at first determining how they might be exposed to PFAS (sometimes called an environmental exposure assessment) and what exposures they are interested in reducing. This exposure assessment should include questions about current occupational exposures to PFAS (such as work with fluorochemicals or firefighting) and exposures to PFAS through the environment. Known environmental exposures to PFAS include living in a community with PFAS-contaminated drinking water, living near industries that use fluorochemicals, serving in the military, and consuming fish and game from areas with known or potential contamination. Recommendation 4-2: If patients may be exposed occupationally, such as by working with fluorochemicals or as a firefighter, clinicians should consult with occupational health and safety professionals knowledgeable about the workplace practices to determine the most feasible ways to reduce that exposure. 13
  • 14. Recommendations – Exposure Reduction Recommendation 4-6: When clinicians are counseling parents of infants on PFAS exposure, they should discuss infant feeding and steps that can be taken to lower sources of PFAS exposure. The benefits of breastfeeding are well known; the American Academy of Pediatrics, the American Academy of Family Physicians, and the American College of Obstetricians and Gynecologists support and recommend breastfeeding for infants, with rare exceptions. Clinicians should explain that PFAS can pass through breast milk from a mother to her baby. PFAS may also be present in other foods, such as the water used to reconstitute formula and infant food, and potentially in packaged formula and baby food. It is not yet clear what types and levels of exposure to PFAS are of concern for child health and development. 14 14
  • 15. The Committee Found Several Risk-based Serum Levels Type of Risk-Based Levels PFOS ng/ml PFOA ng/ml Sum of PFAS* ng/ml HBM-I 5 2 HBM-II 20 10 HBM-II (women of childbearing age) 10 5 EFSA Point of Departure (women of childbearing age) 6.9 15 • German Human Biomonitoring Commission (HBM Commission) develops human biomonitoring (HBM) values for the interpretation of concentrations of environmental chemicals measured in biological samples. • HBM-I values are the concentrations below which effects are not expected • HBM-II values are the concentrations above which adverse health effects are possible • European Food Safety Authortry (EFSA) Point of Departure is the modeled estimate of maternal exposure which would lead to negligible risk to a breastfed infant * PFOA, PFOS, PFHxS and PFNA
  • 16. Graph of Risk-Based & Reference-Based Levels: PFOA 16 16
  • 17. 17 Graph of Risk-Based & Reference-Based Levels: PFOS 17
  • 18. PFAS Testing and Concentrations that Can Inform Clinical Care Recommendations Recommendation 5-2: Clinicians should offer PFAS testing to patients likely to have a history of elevated exposure. In all discussions of PFAS testing, clinicians should describe the potential benefits and harms of the testing and the potential clinical consequences (such as additional follow-up), related social implications, and limitations of the testing so patient and clinician can make a shared, informed decision. Patients who are likely to have a history of elevated exposure to PFAS include those who have – had occupational exposure to PFAS (such as those who have worked with fluorochemicals or served as a firefighter); – lived in communities where environmental and public health authorities or academic researchers have documented PFAS contamination; or – lived in areas where PFAS contamination may have occurred, such as near facilities that use or have used fluorochemicals, commercial airports, military bases, wastewater treatment plants, farms where sewage sludge may have been used, or landfills or incinerators that have received PFAS-containing waste. 18 18
  • 19. Recommendation 5-3: Clinicians should use serum or plasma concentrations of the sum of PFAS* to inform clinical care of exposed patients, using the following guidelines for interpretation: – Adverse health effects related to PFAS exposure are not expected at less than 2 nanograms per milliliter (ng/mL). – There is a potential for adverse effects, especially in sensitive populations, between 2 and 20 ng/mL. – There is an increased risk of adverse effects above 20 ng/mL. 19 PFAS Testing and Concentrations that Can Inform Clinical Care Recommendations *Simple additive sum of MeFOSAA, PFHxS, PFOA (linear and branched isomers), PFDA, PFUnDA, PFOS (linear and branched isomers), and PFNA in serum or plasma. Caution is warranted when using capillary blood measurements as levels may differ from serum or plasma levels.
  • 20. Guidance for Clinicians on Exposure Determination, PFAS Testing, and Clinical Follow-Up 20 Recommendation 6-1: Clinicians should treat patients with serum PFAS concentration below 2 nanograms per milliliter (ng/mL) with the usual standard of care. Recommendation 6-2: For patients with serum PFAS concentration of 2 nanograms per milliliter (2 ng/mL) or higher and less than 20 ng/mL, clinicians should encourage PFAS exposure reduction if a source of exposure is identified, especially for pregnant persons. Within the usual standard of care clinicians should: – Prioritize screening for dyslipidemia with a lipid panel (once between 9 and 11 years of age, and once every 4 to 6 years over age 20) as recommended by the American Academy of Pediatrics (AAP) and American Heart Association (AHA). – Screen for hypertensive disorders of pregnancy at all prenatal visits per the American College of Obstetricians and Gynecologists (ACOG). – Screen for breast cancer based on clinical practice guidelines based on age and other risk factors such as those recommended by the U.S. Preventive Services Task Force (USPSTF). 20
  • 21. Guidance for Clinicians on Exposure Determination, PFAS Testing, and Clinical Follow-Up Recommendation 6-3: For patients with serum PFAS concentration of 20 nanograms per milliliter (ng/mL) or higher, clinicians should encourage PFAS exposure reduction if a source of exposure is identified, especially for pregnant persons. In addition to the usual standard of care, clinicians should: • Prioritize screening for dyslipidemia with a lipid panel (for patients over age 2) following American Academy of Pediatrics (AAP) guidelines for high-risk children and American Heart Association (AHA) guidance for high-risk adults. • At all well visits: – conduct thyroid function testing (for patients over age 18) with serum thyroid stimulating hormone (TSH), – assess for signs and symptoms of kidney cancer (for patients over 45), including with urinalysis, and – for patients over 15, assess for signs and symptoms of testicular cancer and ulcerative colitis. 21 21
  • 22. Areas of additional committee recommendations • Clinician support to provide more specific exposure reduction (from drinking water and food sources) and providing authoritative information sources • Reporting of laboratory results to state health authorities • National data collection and reporting of serum levels in children and pregnant persons • Public health PFAS support and education for clinicians • Federal research to evaluate PFAS and infant feeding/breast feeding . 22 22
  • 23. Closing thoughts • Environmental exposures such as PFAS are important components of disease risk in humans • A more comprehensive approach to evaluating environmental exposures is needed to understand the causes and contributors to chronic disease. • Such an approach will ultimately depend on breaking down the barriers between environmental public health and the clinical care setting. • Identifying environmental exposures, measuring exposure levels in patients and providing indicated medical follow-up is a critical frontier that could and should bring the two disciplines closer together to improve health of those in our communities. 23 23
  • 24. Thank you! Additional questions or comments may be referred to • Elizabeth Boyle, eboyle@nas.edu • Ned Calonge, ned.calonge@cuanschutz.edu 24 24