[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]
HEARING TO CONSIDER THE IMPACTS OF THE ENVIRONMENTAL PROTECTION
AGENCY'S
ACTIONS ON THE RURAL ECONOMY
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON AGRICULTURE
HOUSE OF REPRESENTATIVES
ONE HUNDRED FOURTEENTH CONGRESS
SECOND SESSION
__________
FEBRUARY 11, 2016
__________
Serial No. 114-41
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Agriculture
agriculture.house.gov
______
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COMMITTEE ON AGRICULTURE
K. MICHAEL CONAWAY, Texas, Chairman
RANDY NEUGEBAUER, Texas, COLLIN C. PETERSON, Minnesota,
Vice Chairman Ranking Minority Member
BOB GOODLATTE, Virginia DAVID SCOTT, Georgia
FRANK D. LUCAS, Oklahoma JIM COSTA, California
STEVE KING, Iowa TIMOTHY J. WALZ, Minnesota
MIKE ROGERS, Alabama MARCIA L. FUDGE, Ohio
GLENN THOMPSON, Pennsylvania JAMES P. McGOVERN, Massachusetts
BOB GIBBS, Ohio SUZAN K. DelBENE, Washington
AUSTIN SCOTT, Georgia FILEMON VELA, Texas
ERIC A. ``RICK'' CRAWFORD, Arkansas MICHELLE LUJAN GRISHAM, New Mexico
SCOTT DesJARLAIS, Tennessee ANN M. KUSTER, New Hampshire
CHRISTOPHER P. GIBSON, New York RICHARD M. NOLAN, Minnesota
VICKY HARTZLER, Missouri CHERI BUSTOS, Illinois
DAN BENISHEK, Michigan SEAN PATRICK MALONEY, New York
JEFF DENHAM, California ANN KIRKPATRICK, Arizona
DOUG LaMALFA, California PETE AGUILAR, California
RODNEY DAVIS, Illinois STACEY E. PLASKETT, Virgin Islands
TED S. YOHO, Florida ALMA S. ADAMS, North Carolina
JACKIE WALORSKI, Indiana GWEN GRAHAM, Florida
RICK W. ALLEN, Georgia BRAD ASHFORD, Nebraska
MIKE BOST, Illinois
DAVID ROUZER, North Carolina
RALPH LEE ABRAHAM, Louisiana
JOHN R. MOOLENAAR, Michigan
DAN NEWHOUSE, Washington
TRENT KELLY, Mississippi
______
Scott C. Graves, Staff Director
Robert L. Larew, Minority Staff Director
(ii)
C O N T E N T S
----------
Page
Conaway, Hon. K. Michael, a Representative in Congress from
Texas, opening statement....................................... 1
Prepared statement........................................... 3
Newhouse, Hon. Dan, a Representative in Congress from Washington,
submitted letter............................................... 65
Peterson, Hon. Collin C., a Representative in Congress from
Minnesota, opening statement................................... 4
Witness
McCarthy, Hon. Gina, Administrator, U.S. Environmental Protection
Agency, Washington, D.C........................................ 5
Prepared statement........................................... 7
Supplementary material....................................... 65
Submitted questions.......................................... 68
HEARING TO CONSIDER THE IMPACTS OF THE ENVIRONMENTAL PROTECTION
AGENCY'S ACTIONS ON THE RURAL ECONOMY
----------
THURSDAY, FEBRUARY 11, 2016
House of Representatives,
Committee on Agriculture,
Washington, D.C.
The Committee met, pursuant to call, at 10:00 a.m., in Room
1300 of the Longworth House Office Building, Hon. K. Michael
Conaway [Chairman of the Committee] presiding.
Members present: Representatives Conaway, Neugebauer,
Goodlatte, Lucas, King, Rogers, Thompson, Gibbs, Austin Scott
of Georgia, Crawford, DesJarlais, Gibson, Hartzler, Benishek,
Denham, LaMalfa, Davis, Yoho, Walorski, Allen, Bost, Abraham,
Moolenaar, Newhouse, Kelly, Peterson, David Scott of Georgia,
Costa, Walz, Fudge, McGovern, DelBene, Lujan Grisham, Kuster,
Nolan, Maloney, Aguilar, Plaskett, Adams, Graham, and Ashford.
Staff present: John Goldberg, Josh Maxwell, Patricia
Straughn, Scott Sitton, Stephanie Addison, Faisal Siddiqui,
John Konya, Anne Simmons, Evan Jurkovich, Keith Jones, Nicole
Scott, and Carly Reedholm.
OPENING STATEMENT OF HON. K. MICHAEL CONAWAY, A REPRESENTATIVE
IN CONGRESS FROM TEXAS
The Chairman. Good morning. This hearing of the Committee
of Agriculture to consider the impacts of the Environmental
Protection Agency's actions on the rural economy, will come to
order. I have asked Mike Bost to open us with a prayer.
Michael?
Mr. Bost. If you all would just bow your heads? Dear
Heavenly Father, we thank you so much for the opportunity to
serve this great nation. Lord, we thank you for the freedoms
that we have. We thank you that you have blessed us as you have
with the rich resources, and the ability to use those to make
the world a better place. Lord, guide us and direct us. Give us
wisdom through this hearing. We ask all this in Jesus's name.
Amen.
The Chairman. Thank you, Michael. Well, good morning, and I
want to thank Administrator McCarthy for being here this
morning. Thank you, ma'am. I appreciate you being here. There
is a reason a top issue for nearly every Member of our
Agriculture Committee is related to the regulatory agenda of
the Environmental Protection Agency. Many Members of this
Committee believe that over the years the EPA has pursued an
agenda seemingly absent of any recognition of the consequences
for rural America and production agriculture. The EPA is
creating regulations and policies that are burdensome,
overreaching, and that negatively affect the jobs in the rural
economy.
Perhaps the most poignant example is the EPA's recent
Waters of the U.S. Rule, or, as the EPA likes to call it, the
Clean Water Rule. I will be frank, this rule is not about clean
water. Everyone wants and deserves to drink clean water. This
is not about safe drinking water in Flint, Michigan, which some
have purposely confused with the WOTUS overreach. Rebranding
government overreach as a part of a social media campaign does
not change the content of the rule. This rule is simply the
result of the EPA ignoring stakeholders, including states and
other Federal agencies, and the American people, in order to
egregiously and vastly expand its jurisdiction. This rule is
already tied up in the court system, and I would imagine it
will be there for a number of years.
This is only one of the many instances where I believe the
Agency has ignored Congressional intent. Instead of simply
administering the law, EPA challenges Congress to pass
legislation that gives the Agency more authority. And, if
Congress doesn't act, the EPA will legislate via regulation,
directive, memorandum, or in some instances by intimidation.
This regulate first and ask questions later approach is
starting to backfire. Just this week the Supreme Court
intervened in another overreaching regulatory priority of the
Obama Administration by staying the implementation of the Clean
Power Plan. I am glad that the courts have intervened; however,
it should never have come to this. Just because something
sounds great in theory here in D.C. does not mean that it will
work or have a beneficial impact on our constituents. More
times than not those great theories do nothing but increase the
cost of doing business.
Farmers and ranchers and foresters all take great pride in
their stewardship of the land. They are original
conservationists. When a family's livelihood depends on caring
for natural resources, there is an undeniable economic
incentive to adopt practices that enhance long-term viability.
While it may be popular among some to blame farmers and
ranchers for any and every environmental concern that crops up,
I think that you can acknowledge that nobody cares more about
the environment than those who derive their livelihood from it.
Rural America's economy is dependent on agriculture. Today,
Committee Members will talk about examples in which EPA's
regulatory approach may unjustifiably increase the cost of
doing business for America's farmers and ranchers. These
include the recent Waters of the U.S. rule, the proposed
changes to the ozone standard, and the recently modified
standards for farmworkers, and many others. Regardless of the
degree to which somebody believed individual government
regulations might be justifiable, all regulations must be
developed in a manner that is based on science, and mindful of
the economic consequences. For instance, farmers face
increasing pressure from pests and disease. If existing
pesticide uses were to be prohibited, the increase in crop
losses will undoubtedly impact food prices and food security.
If EPA fails to adequately calculate and/or consider the
economic consequences of these actions, the consequences could
be devastating.
Federal law dictates that the USDA serve as an important
advisor to EPA in the regulation of pesticides. Historically
USDA's expertise and advice has been evident in the actions EPA
has taken to evaluate pesticides and their uses. USDA's
perspective, and the knowledge of production agriculture, is
critical, since we know that crop protection products can
increase farm yields as much as 40 to 70 percent, depending on
the crop. It concerns me to hear the farm communities express
increasingly urgent concerns about the lack of seriousness with
which the EPA takes and incorporates the USDA expertise,
advice, and opinions, especially during formal inter-agency
reviews.
I anticipate that every Member will wish to engage you in a
discussion of specific areas of concern. My hope is that this
hearing will serve to open the door to a more cooperative
working relationship with EPA generally. Farmers and ranchers
believe the EPA is attacking them. They believe little credit
is given to them for the voluntary conservation activities that
they have engaged in for years. This Committee is going to be
an advocate for our farmers, as you would expect.
[The prepared statement of Mr. Conaway follows:]
Prepared Statement of Hon. K. Michael Conaway, a Representative in
Congress from Texas
Good morning. I thank Administrator McCarthy for being here today.
There is a reason a top issue for nearly every Member of the
Agriculture Committee is related to the regulatory agenda of the
Environmental Protection Agency. Many Members of this Committee believe
that over the years, EPA has pursued an agenda seemingly absent any
recognition of the consequences for rural America and production
agriculture. EPA is creating regulations and policies that are
burdensome, overreaching, and that negatively affect jobs and the rural
economy.
Perhaps the most poignant example is EPA's recent power grab with
the Waters of the United States rule. Or, as EPA likes to call it--The
Clean Water Rule. I'll be frank--this rule is not about clean water.
Everyone wants and deserves clean water. This is not about safe
drinking water in Flint, Michigan, which some have purposefully
confused with the WOTUS overreach.
Rebranding government overreach as part of an illicit social media
campaign does not change the content of the rule. This rule is simply
the result of EPA ignoring stakeholders, including states, other
Federal agencies, and the American people, in order to egregiously and
vastly expand its jurisdiction. This rule is already tied up in the
court system, and I would imagine it will be there for many years.
This is only one of many instances where the Agency has blatantly
ignored Congressional intent. Instead of simply administering the law,
EPA challenges Congress to pass legislation that gives the Agency more
authority; and if Congress doesn't act, EPA will legislate via
regulation, directive, memorandum, or in some cases by intimidation.
This regulate first, ask questions later approach is starting to
backfire on the EPA. Just this week, the Supreme Court intervened in
another overreaching regulatory priority of the Obama Administration by
staying the implementation of the so called Clean Power Plan. I am glad
that the courts have intervened. However, it should never have come to
this. Just because something sounds good in theory in Washington, D.C.,
does not mean it will work or have a beneficial impact for our
constituents. More times than not, those great theories do nothing but
increase the cost of doing business.
Farmers, ranchers and foresters all take great pride in their
stewardship of the land. They are the original conservationists. When a
family's livelihood depends on caring for natural resources, there is
an undeniable economic incentive to adopt practices that enhance long-
term viability. While it may be popular among some to blame farmers and
ranchers for any and every environmental concern that crops up, I think
that you can acknowledge that nobody cares more for the environment
than those who derive their livelihood from it.
Rural America's economy is dependent on agriculture. Today,
Committee Members will talk about examples in which EPA's regulatory
approach may unjustifiably increase the cost of doing business for
America's farmers and ranchers. These include the recent WOTUS rule;
proposed changes to the ozone standard, the recently modified standards
for farmworkers, and many others.
Regardless of the degree to which some may believe any individual
government regulation might be justifiable, all regulations must be
developed in a manner that is based on science and mindful of the
economic consequences.
For instance, farmers face increasing pressures from pests and
disease. If existing pesticide uses were to be prohibited, the increase
in crop losses will undoubtedly impact food prices and food security.
If EPA fails to adequately calculate and/or consider the economic
consequences of these actions, the consequences could be devastating.
Federal laws dictate USDA to serve as an important advisor to EPA
in the regulation of pesticides. Historically, USDA's expertise and
advice has been evident in the actions EPA has taken to evaluate
pesticides and their uses. USDA's perspective and knowledge of
production agriculture is critical since we know that crop protection
products can increase farm yields as much as 40 percent to even 70
percent depending on the crop. It concerns me that to hear the farm
community express increasingly urgent concerns about the lack of
seriousness with which EPA takes and incorporates USDA expertise,
advice and opinions, especially during formal interagency review.
I anticipate that nearly every Member will wish to engage you in a
discussion of specific areas of concern. It is my hope that this
hearing will serve to open the door to a more cooperative working
relationship with EPA generally. I want to end this opening statement
with this one last observation. Farmers and ranchers believe the EPA is
attacking them. They believe little credit is given to them for all the
voluntary conservation activities that they have been engaged in for
years. This Committee is going to be an advocate for those farmers.
I thank you again for being here and look forward to a good
discussion.
The Chairman. I appreciate the Administrator being here
this morning, and I will turn to the Ranking Member for any
questions he may have.
OPENING STATEMENT OF HON. COLLIN C. PETERSON, A REPRESENTATIVE
IN CONGRESS FROM MINNESOTA
Mr. Peterson. Thank you, Mr. Chairman, and thank you,
Administrator McCarthy, for joining us. I appreciate you being
here today. And, we have had our share of disagreements, but
you have always been willing to listen to my concerns, and we
don't always get to the same place, but at least you have been
willing to listen. And I am glad that other Members of the
Committee will have an opportunity to share what is happening
in their districts with you today.
I am on record, along with a lot of others, saying that the
EPA is an Agency that has overreached on these rules. I simply
don't believe that there is enough understanding within the
Agency, or the Administration, about what we do in rural
America, and the real consequences of new regulations, and what
they could have on agriculture and the rural economy. The
proposed Clean Power Plan Rule, which, in my opinion, was
rightly put on hold by the Supreme Court this week, is one of
them, as well as the proposed Waters of the U.S. rule, which,
if I read one more time about the farmer exemptions, I am going
to tear my hair out, because I have a full time person on my
staff that does nothing but untangle these water issues under
the current regime. And the problem is we have four Federal
agencies deciding what a wetland is, and they don't agree.
And even within the same Agency you can have somebody in
one county that will have one opinion versus somebody in the
next county that has another. I can guarantee you that if this
rule goes into effect, it is just going to make that worse. We
have had a Memorandum of Understanding between the NRCS and the
Corps of Engineers up in our district on our flood mitigation
that we have been working on, and it just has not worked. We
still have people all over the map. So I don't have a lot of
confidence that just putting some exemptions in there is going
to fix this. I hope there is some other way we can deal with
that.
So I hope today's hearing is, as I said, an opportunity to
get a better grasp on what you are up to, and what we need in
agriculture and rural communities. I hear concerns from my
farmers in my districts all the time about this, and I am sure
other Members do as well. So, again, I thank you for your
willingness to testify before the Committee today, and I look
forward to today's hearings and the questions. I yield back.
The Chairman. I thank the Ranking Member, and I also want
to thank the Administrator this morning, and welcome her to the
witness table. I suspect that she understood there would be
some differences of opinion, and we hope to be respectful with
that. And, with that, I will introduce the Honorable Gina
McCarthy, the Administrator for the U.S. Environmental
Protection Agency in Washington, D.C. And, ma'am, we are ready
to go whenever you are. And, again, thank you for being here.
STATEMENT OF HON. GINA McCARTHY, ADMINISTRATOR, U.S.
ENVIRONMENTAL PROTECTION AGENCY, WASHINGTON, D.C.
Ms. McCarthy. Thank you, and good morning, Chairman
Conaway, Ranking Member Peterson, as well as Members of the
Committee. I really want to thank you for the honor and
opportunity to be here with you this morning.
As stewards of the land, the EPA and farmers share a common
goal in protecting our environment. As lifelong
conservationists, farmers', ranchers', and foresters'
livelihoods depend on healthy land, clean air and water to
produce the food, fuel, and fiber that we rely on. In the 45
years since the EPA's founding we have cleaned up 70 percent of
our nation's air pollution, and hundreds of thousands of miles
of waterways, all while the economy has tripled. Agriculture
advanced too, achieving better yields with less water, lower
risk pesticides, and less fertilizer. I would like to highlight
some of the EPA initiatives furthering our common goals.
Working with USDA, and partnering with the pork and dairy
producers and technical experts, we recently launched an
initiative promoting recycling nutrients from livestock waste.
Annually livestock producers manage more than 1 billion tons of
manure, but that contains valuable nitrogen and phosphorus,
which, if we harness as a renewable fertilizer, can minimize
water pollution and build healthy soils. Participants will be
challenged to use the power of competition to turn innovative
concepts into designs, and ultimately into working
technologies, creating the solutions that are a win for
farmers, the environment, as well as our economy.
The EPA also partners with USDA with the Local Foods, Local
Places Project, promoting walkable, healthy, and economically
vibrant neighborhoods through farmers' markets, co-ops,
community gardens, and other local food enterprises. By
focusing development in existing neighborhoods, we help support
farm economies and protect undeveloped rural lands. Last month
we announced 27 new communities, raising the total number of
communities served to 62 in 29 states, just since the program
started in 2013.
The Clean Water Rule, which we finalized last year,
protects the streams and wetlands that one in three Americans
rely on for drinking water, and farmers and ranchers also need
for their crops and livestock. As Members of this Committee
know, recent Supreme Court rulings created uncertainty
regarding the application of the Clean Water Act to streams and
wetlands. In developing the rule, the EPA and the Army Corps of
Engineers responded to requests to define the scope of the
Clean Water Act more clearly, more predictably, and more
fairly. In doing so, the Clean Water Rule not only maintains
current statutory exemptions, it expands regulatory exclusions
from the definitions of waters of the United States to make it
clear that the rule does not add any additional permitting
requirements on farmers and ranchers, and promotes their
voluntary efforts to protect and enhance clean water. We
continue outreach to the agriculture community, responding to
their concerns, answering their questions, and reinforcing the
fact that all existing agriculture exemptions and exclusions
continue to apply under the Clean Water Rule.
Last year the EPA finalized volume standards for the
Renewable Fuel Standard Program for calendar years 2014, 2015,
2016, and a volume requirement for biomass-based diesel for
2017. The final requirements boost renewable fuel production
and provide for robust, achievable growth of the biofuels
industry. Overall, this final rule requires that total
renewable standards grow by more than 1.8 billion gallons from
2014 to 2016, requiring 11 percent more biofuel production than
the market produced in 2014. Our 2016 advanced fuel standard is
nearly 1 billion gallons, or 35 percent, higher than 2014
actual volumes. The biomass-based diesel standards increases
every year, to reach 2 billion gallons by 2017. That is a 23
percent increase over 2014 actual volumes.
The EPA took steps to improve the administration of the RFS
Program, and continues to approve new agricultural feedstocks,
increasing the number of pathways that biofuel producers may
use to qualify their biofuel under the program. We improved the
quality, transparency, and efficiency of our petition review
process for new biofuel pathways, and conducted lifecycle
analysis on several new feedstocks. The EPA remains committed
to the Renewable Fuel Program, and meeting Congress's intent to
responsibly grow renewable fuels over time.
I recently announced increased protections for the nation's
two million agricultural workers and their families. Every year
thousands of preventable pesticide exposure incidents cause
sick days, lost wages, and medical bills. We can do better. The
EPA's update reflects extensive stakeholder involvement from
the agriculture community, industry, and Federal and state
partners. These provisions will help ensure that farmworkers
nationwide receive annual safety training, prohibit children
from handling agricultural pesticides, and provide workers with
the tools needed to protect themselves and their families from
pesticide exposures.
Again, thank you. I am happy and I am honored to be here to
answer your questions.
[The prepared statement of Ms. McCarthy follows:]
Prepared Statement of Hon. Gina McCarthy, Administrator, U.S.
Environmental Protection Agency, Washington, D.C.
Good morning, Chairman Conaway, Ranking Member Peterson, and
Members of the Committee. Thank you for the opportunity to discuss the
EPA and agriculture.
As stewards of the land, the EPA and farmers share a common goal in
protecting our environment. Inherent conservationists, farmers'
livelihoods depend on healthy land and clean air and water to produce
the food, fuel and fiber we rely on. In the 45 years since the EPA's
founding, we've cleaned up 70 percent of our nation's air pollution and
hundreds of thousands of miles of waterways, and meanwhile our economy
has tripled. Agriculture advanced too--achieving better yields with
less water, lower risk pesticides, and less fertilizer. I would like to
highlight some of the EPA initiatives furthering our common goals.
Nutrient Recycling Challenge
Working with USDA, and partnering with pork and dairy producers and
technical experts, we recently launched an initiative promoting
recycling nutrients from livestock waste. Annually, livestock producers
manage more than 1 billion tons of manure containing valuable nitrogen
and phosphorus, a resource as a renewable fertilizer, and used
properly, can minimize water pollution and build healthy soils.
Challenge participants will harness the power of competition, turning
innovative concepts into designs, and ultimately working technologies,
creating solutions that are a win for farmers, the environment and the
economy.
Local Foods, Local Places
The EPA also partners with USDA in the ``Local Foods, Local
Places'' project, promoting walkable, healthy, and economically vibrant
neighborhoods through farmers' markets, co-ops, community gardens, and
other local food enterprises. Focusing development in existing
neighborhoods helps support farm economies and protect undeveloped
rural lands. Last month we announced 27 new communities, serving 62
communities in 29 states since starting in 2013.
Clean Water Rule
The Clean Water Rule protects the streams and wetlands that one in
three Americans rely on for drinking water, and farmers and ranchers
need for their crops and livestock. As Members of this Committee know,
recent Supreme Court rulings created uncertainty regarding the
application of the Clean Water Act to streams and wetlands. In
developing the rule, the EPA and the U.S. Army responded to requests to
define the scope of the Clean Water Act more clearly, predictably and
fairly. In doing so, the Clean Water Rule not only maintains current
statutory exemptions, it expands regulatory exclusions from the
definition of waters of the United States to make it clear that the
rule does not add any additional permitting requirements on farmers and
ranchers and promotes their voluntary efforts to protect and enhance
clean water. We continue outreach to the agriculture community,
responding to their concerns, answering questions, and ensuring that
all existing agriculture exemptions and exclusions continue to apply.
Renewable Fuel Standard
Last year, the EPA finalized volume standards for the RFS program
for calendar years 2014, 2015, and 2016 and a volume requirement for
biomass-based diesel for 2017. The final requirements boost renewable
fuel production and provide for robust, achievable growth of the
biofuels industry.
Overall, this final rule requires that total renewable standards
grow by more than 1.8 billion gallons from 2014 to 2016, requiring 11
percent more biofuel production than the market produced in 2014. Our
2016 advanced biofuel standard is nearly 1 billion gallons, or 35
percent higher than 2014 actual volumes. The biomass-based diesel
standards increases every year to reach 2 billion gallons by 2017, a 23
percent increase over 2014 actual volumes.
The EPA took steps to improve the administration of the RFS program
and continues to approve new agricultural feedstocks, increasing the
number of pathways that biofuel producers may use to qualify their
biofuel under the program. We improved the quality, transparency, and
efficiency of our petition review process for new biofuel pathways,
clarified qualifying biofuels, and conducted lifecycle analyses on
several new feedstocks. The EPA remains committed to the RFS program
and meeting Congress's intent to responsibly grow renewable fuels over
time.
Agricultural Worker Protection Standards
I recently announced increased protections for the nation's two
million agricultural workers and their families. Every year, thousands
of preventable pesticide exposure incidents cause sick days, lost wages
and medical bills. Changes to the agricultural worker protection
standard reduce the risk of injury or illness resulting from contact
with pesticides while on the job.
The EPA's updates reflect extensive stakeholder involvement from
the agricultural community, industry, and Federal and state partners.
These provisions help ensure farmworkers nationwide receive annual
safety training, prohibit children from handling agricultural
pesticides, and provide workers with the tools needed to protect
themselves and their families from pesticide exposure.
Conclusion
Thank you and I am happy to answer your questions.
The Chairman. Well, thank you, ma'am. The chair would
remind Members that they will be recognized for questioning in
the order of seniority for Members who were here at the start
of the hearing. After that, Members will be recognized in the
order of arrival, and I appreciate Members' understanding. So,
with that, I recognize myself for 5 minutes.
Again, thank you for being here. With the 6th Circuit's
ruling on the Clean Water Plan, difficult to say for those of
us from west Texas, the legitimate concern that, given that
both of those involve what we believe is an overreach by the
Agency, going around Congressional intent, going around the
law, can you talk to us about efforts that your Agency will
make on the intervening 11 or so months that you will be there
to obey the Supreme Court and the 6th Circuit? Will you commit
to not trying to go around the courts with other ways to get at
what you are trying to get done?
Ms. McCarthy. Mr. Chairman, EPA is actually trying to do
what Congress told us to do with the authorities we have, and
we feel confident that both of those rules will be seen as an
appropriate, and proper, and necessary application of the law.
If you look at the Clean Water rule, the reason we did it was
to try to clarify confusion that the Supreme Court actually
raised and created in a couple of their decisions since the
beginning of the last decade.
On the Clean Power Plan, it is a pause in terms of the
implementation and enforcement of the Clean Power Plan, but the
rule is still in effect, and it will add some time to resolve
those issues through the courts, but we feel very confident
that it is going to be borne out to be a legal, lawful, and
necessary law.
The Chairman. Right. It is not unexpected for you to take
that position.
Ms. McCarthy. Well, thank you for listening.
The Chairman. It shouldn't be unexpected.
Ms. McCarthy. I appreciate it.
The Chairman. We have 31 lawsuits, Attorneys General across
the country, farmers and ranchers, those who tried to look at
it, disagree. What I asked, though, was what will you do now,
while those rules, or regulations, are stayed from
implementation? Do we need to restrict your funding in the
appropriations bill to say no monies will be spent on back door
implementation of either the Clean Water Plan or the Clean
Power Plan?
Ms. McCarthy. Actually, what we are trying to do, sir, is
make sure that the guidance that is currently in place in the
Clean Water Rule that was issued in 2008 is implemented as well
as we can. We are certainly going to respect the decisions of
the court. But, as we have heard, there is a lot of confusion.
There are a lot of differences in those decisions, so we are
working with the Army Corps of Engineers to make sure that we
are implementing what is currently in place as best we can, try
to avoid some of those confusions, while we hope to bring
additional clarity when the Clean Water Rule makes its way
through the courts.
On the Clean Power Plan, we will still continue to work
with states that, on a voluntary basis, want to move forward
with us, and we will continue to provide tools and outreach.
But we clearly understand that the courts will be winding
through the process of looking at that rule. The issue
yesterday meant it is going to take a little longer for that to
happen. We will respect that, but, in the meantime, we are
going to continue to address greenhouse gases with the
authorities under the Clean Air Act that are available to us
today.
The Chairman. Okay. Clearly there is a pretty sizable
difference of agreement that the authorities that you used to
issue those rules were an overreach, and so I am a little
troubled by that. Can you talk to us about the input that you
take from USDA with respect to pesticides, and the work that
you are doing there? Are you ignoring USDA? I will give you a
softball, because I suspect you will say no, but can you help
us understand that you do, in fact, value the expertise and the
longstanding trust that farmers and ranchers have with USDA in
this arena, and the distrust that has been created with the EPA
over the other things that are going on? You can't just
separate the issues in a vacuum. They are not siloed up. Our
farmers and ranchers feel under attack. So talk to us about
your respect for the USDA, and their opinions on pesticides.
Ms. McCarthy. Well, sir, I work very closely with Secretary
Vilsack, and my staff work very closely with USDA. We have
great respect for that Agency, the scientific expertise they
bring, and their full knowledge of the agriculture community.
There are laws that require us, even before we propose rules,
to consult with USDA, and we do that. And then we work very
closely with them in the inter-agency process to resolve
differences. So we have a close collaborative relationship. At
times we may disagree, but it is usually about what the law
requires us to do, and there is good discussion, and we always
try to understand the science together, and make the
appropriate decisions.
The Chairman. All right. Thank you, ma'am. I yield back.
The Ranking Member, 5 minutes.
Mr. Peterson. Thank you, Mr. Chairman. I want to focus on
this Clean Power Plan a little bit too. So we are kind of
caught between a situation up in my district. The rural
electrics get their power from North Dakota, but, obviously we
are in Minnesota. Well, Minnesota is apparently working with
you guys on whatever you are up to, and North Dakota is one of
those that sued you.
So when you say you are going to work with states, does
that mean you are going to work with Minnesota, and continue to
develop a plan with Minnesota while this is going on?
Ms. McCarthy. Well, we will continue to work with them on a
voluntary basis, but nothing will be implemented while the stay
is in place. So if Minnesota wants help and tools, we would
always work with every state that does that. But in terms of
actual enforcement of anything, it is clearly on hold until it
resolves itself through the courts.
Mr. Peterson. Well, one of our concerns is there was,
apparently, a 2014 proposal, and then it was finalized, and in
North Dakota you went from 11 percent to 45 percent emissions
reductions, the biggest increase of any state. Well, our rural
cooperative out there in North Dakota, they did some updates to
their plants, back in 2005 or something, 2004, and put $426
million in improvements in their firewalls and so forth, and
then the EPA determined that that was a major overhaul, or
whatever it was. So you forced them go under some new program
to put in scrubbers, and a whole bunch of other stuff. They
sued you. The end result of that was they spent $426 million.
And my real question is: what that did is it dropped the equity
in that co-op from 24 percent down to 12 percent. Are you aware
of that?
Ms. McCarthy. Not the specific instance in which you are
referring, sir.
Mr. Peterson. And so they had signed an agreement with the
RE West to get financing for this $426 million that you forced
them to do. And it says that they can't go below a ten percent
equity in that co-op. Well, they are down to 12 percent now.
And if this is implemented, they will be down to five percent.
So they are going to be in violation of the situation with the
EPA. Are you aware of that?
Ms. McCarthy. Well, sir, if you are referring to the
application of the Clean Power Plan? Is that what we are
talking about there? I know that you were referring to some of
the regional case decisions.
Mr. Peterson. They borrowed money to comply with your other
situation. And in order to get that money they had to agree not
to go below ten percent.
Ms. McCarthy. Right.
Mr. Peterson. So now, if you implement what the Clean Power
Plan says, you are going to force them way below ten percent.
They don't have the money to do this anymore. You have already
taken all their money, and there is no other way in Minnesota--
they won't let them build a power plant, so the only thing we
can do is get electricity from Canada, if you go ahead and
complete this? So we are kind of stuck in this whole thing.
I was going to ask you today to delay this to give us maybe
10 years to try to comply with this so we don't go bankrupt.
But now, with this stay, and I don't know where we are at
anymore, but, I mean, somehow or another we need more time to--
--
Ms. McCarthy. Well, sir, we are more than happy to work
with the state, and, in fact, we have been out there. One of
the things we did was extensive outreach on this, and there was
concern in some states about whether or not they would
internally, in that state, be able to make things work. We
added huge amounts of flexibility in this, and we also engaged
USDA, the Rural Utilities Service, to work with us and with the
rural co-ops. We understand that they have unique challenges,
and we are not going to leave them behind. They deal with some
of the poorest communities, that cannot afford to have energy
increases.
Mr. Peterson. That is exactly correct.
Ms. McCarthy. And so there are a number of programs that we
are bringing to bear, as well as flexibilities that will not
require every facility to make investments.
Mr. Peterson. Well, for whatever reason, they seem to think
that you are not going to have flexibility, and not listen to
them. I don't know why. And some of this power from these
plants goes to North Dakota, but the majority goes to
Minnesota, and we are kind of stuck in this whole thing. And, I
am glad to hear that you are willing to work with them, but
that is not what they have heard. After they spent that $426
million, then you went after them on Hayes, and we were able to
get that stopped. That would have been another thing that would
have bankrupted them. So they just feel like they are in the
middle of a whole deal, and they are not listened to, so if
you----
Ms. McCarthy. Well, I am happy to personally engage as
well. I have been meeting with the rural electric----
Mr. Peterson. I will send them over to your office, and you
can deal with them.
Ms. McCarthy.--co-ops, so--okay, sir.
Mr. Peterson. All right. Thank you.
The Chairman. The gentleman yields back. Mr. King, 5
minutes.
Mr. King. Thank you, Mr. Chairman. Ms. McCarthy, I am over
here, and I appreciate your testimony, and your service here, a
good number of things pop up in our minds that--or come to our
attention. I am just looking at a few headlines here, 6th
Circuit Puts Controversial Waters of the United States, the
WOTUS Rule, On Hold. There is another article that addresses
the Clean Air Act, on hold. And as I am watching this, it seems
as though the Agency has been pushing back against, especially
our farmer producers, and our people that care about and value
their productive real estate.
I just had a couple of phrases here that I have seen emerge
from the EPA over the years, and I wanted to start with this:
water is hydrologically connected to.
You are familiar with that phrase, and you are also
familiar with the phrase significant nexus.
Ms. McCarthy. Yes.
Mr. King. Now, would you have a judgment on which one of
those is the most ambiguous?
Ms. McCarthy. Well, the Clean Water Rule actually tries to
provide clarity to both of those. The ambiguity arose when the
Supreme Court actually raised these issues and suggested that
EPA needed to resolve these. That is what the Clean Water Rule
is all about.
Mr. King. And, of course, I am about clarity, of course,
too.
Ms. McCarthy. Me too.
Mr. King. So with regard to clarity, with the Renewable
Fuel Standard, you have taken a position in past years, back in
about 2012 or 2013, that we had short grain supplies, and high
grain prices, therefore you rolled back the directive on the
RFS. And I will just focus particularly on corn-based ethanol
for simplicity's sake here. And made that judgment
administratively, even though the statute required that those
gallons be more. I notice now that we have a high volume, over-
supply of grain, and low prices that have dropped a little more
than \1/2\ since that period of time, and I don't notice that
the same logic is applied when it comes time to adjust the RFS
for current conditions.
So if it was a good idea to lower the RFS requirement for
corn-based ethanol back when grain supplies were short and
prices were high, why wouldn't it also be a good idea to raise
it, at least up to the statutory standard, when grain prices
are low and supplies are high?
Ms. McCarthy. So the Renewable Fuel Standard that we came
out with provide us an opportunity to get back on track, as
well as provide steady growth. The numbers that you are looking
at in here is our assessment of what we can achieve attempting
full bore to get to the statutory levels, but recognizing that
leaps like this, in this short a timeframe, is not possible. So
we want to achieve those statutory levels, we understand that
is what Congress intended, but there is a growth that we need
to recognize, and factors that impact that that we have to take
into consideration.
Mr. King. You are talking about production and capacity?
You are talking about----
Ms. McCarthy. No, I am not talking about production
capacity.
Mr. King. Then what are you addressing?
Ms. McCarthy. I am addressing the ability for us to be able
to get that fuel into the system.
Mr. King. And that is the blend wall?
Ms. McCarthy. That is correct.
Mr. King. And do you believe you have the administrative
authority to abolish the blend wall?
Ms. McCarthy. Well, these numbers actually push through the
blend wall, because we understand that we need to do that to
continue investments in infrastructure----
Mr. King. And that is answer is yes----
Ms. McCarthy.--that will be necessary to get to----
Mr. King. Do you believe you have the administrative
authority to do that, to abolish the blend wall?
Ms. McCarthy. I believe we are doing everything that the
law says, which is to get to these levels as quickly as
possible, but you have to think of factors like how reasonable
it is to achieve these within this certain period.
Mr. King. What about going to E15?
Ms. McCarthy. Yes.
Mr. King. Do you have the authority to do that?
Ms. McCarthy. We actually approved E15 in use of specific
vehicles----
Mr. King. Year round?
Ms. McCarthy.--mostly the modern vehicles.
Mr. King. Year round?
Ms. McCarthy. Yes.
Mr. King. So we are past the E15 blend wall year round?
There is no vapor pressure requirement that restricts it----
Ms. McCarthy. There is a vapor pressure requirement. Yes,
there is, but we approve the use in the vehicles, and it can be
used. There are certain places where----
Mr. King. Okay. I am addressing practically speaking. I
think I should have prefaced my question with that. Then, also,
with regard to the testing of fuels, my information is that EPA
relied on a Chevron consultant to design the test fuels. Are
you familiar with that?
Ms. McCarthy. No, sir.
Mr. King. Okay. I am going to pose some of these questions
to you in a written form so you have an opportunity to digest
them, and to answer them in a way that is not a high test area
in the hearing here. I have a stack of questions I would ask
that you respond to with regard to testing requirements, and
compliance with the RFS. I would ask you one final question. If
you were the Administrator of the EPA at the time that the RFS
expires, sunsets, would you believe that you have the
administrative authority to extend it beyond its sunset?
Ms. McCarthy. I am not aware that the RFS sunsets, sir.
What are we referring to?
Mr. King. Well, I will put that in my question to you too,
the specific language that is in the statute.
Ms. McCarthy. Okay.
Mr. King. And so that will all come to you, and we will
look forward to working with you.
Ms. McCarthy. I will too as well.
Mr. King. Thank you----
Ms. McCarthy. Thank you, sir.
Mr. King.--very much, and I yield back.
The Chairman. The gentleman yields back. Mr. Costa, 5
minutes.
Mr. Costa. Thank you very much, Mr. Chairman. And I want to
thank the Administrator for being here this morning, and your
efforts to help us solve problems. I want to continue the
conversation for a moment on the Renewable Fuel Standard.
Obviously there is a diversity of opinion as it relates to this
Committee, and Members of the Congress, on how it is applied
and implemented. But can you explain the process that the EPA
will be taking to ensure that the 2017 rules are not delayed
the way the 2014 rules were?
Ms. McCarthy. I can, sir. One of the things we made sure
was to already propose a 2017 standard for biodiesel so that we
could make sure to keep on track. And we have every interest,
now that we are on track, to stay that way.
Mr. Costa. For those of us who believe in alternative fuels
and renewable fuels, but think that cellulosic fuels are really
the next generation of this development, can you explain the
update in the Inspector General's investigation regarding
climate impacts on the Renewable Fuel Standard as to using food
to produce fuel is the most effective way to do that, and
whether that doesn't, in fact, create more pollution issues?
Ms. McCarthy. Well, I know that there have been a number of
looks at this issue and investigations, but my job, as EPA
Administrator, is to implement the law that has been given to
me. And----
Mr. Costa. Which you said is probably the most difficult
law you have to implement?
Ms. McCarthy. It is a very difficult statute, yes. But it
is very clear that cellulosic fuels have not progressed
anywhere near what Congress anticipated, which is one of the
reasons why those statutory levels are so difficult to meet.
Mr. Costa. Well, I want to move on to some local issues. As
you know, California is a very diversified state as it relates
to its agricultural production. The Environmental Protection
Agency recently issued a statement on a risk report indicating
that citrus and cotton honey contained higher levels of
neonicotinoids than other honey, which would be a risk to
pollinators. Now, because of the diversification of our crops,
clearly we are sensitive. We grow a lot of almonds in
California. I think we gave you some. I am an almond grower
myself. It does require bees, and we are sensitive to the
pollination issues, and therefore the impacts of bee deaths and
colony collapses, but why single out two commodities that don't
require bees, at least in my state, that, in fact, we go out of
our way to accommodate bees because a lot of the proximity of
these crops are nearby each other? And, in fact, recent reports
have indicated that colonies have propagated, and they are at
higher levels now than the decline we experienced a few years
ago.
Ms. McCarthy. Well, Congressman, we have been to your area
of the country before together, and I understand how hard the
almond growers actually work, not just to address the pesticide
issues, but certainly to conserve water, and I appreciate very
much all that work. We are happy to work more closely with you
on neonicotinoids. The science is difficult, but it is growing,
and it is getting more robust. We think we are following the
science in our decisions, and if there are issues----
Mr. Costa. Okay, but we are going to need----
Ms. McCarthy.--that we need to resolve----
Mr. Costa.--more of your focus----
Ms. McCarthy.--we will be happy to do that.
Mr. Costa.--on this. The Chairman and I last night were in
a conversation with some orange growers who are dealing with
citrus greening, and they really think that they are being
singled out, because of the way in which the Environmental
Protection Agency has approached this. And I will provide you
more information to follow up. I want to, before my time
expires, go to the larger issue that affects all of American
agriculture, and that is the application of pesticides and
herbicides, and EPA's registration process.
For most of us farmers, we live on our farms. The
application of pesticides and herbicides is made with very
cautious and cost-effective evaluations. We are concerned about
the health impacts. We are concerned about the economic
impacts. You are required to re-evaluate your process on
registrations every 10 years, but it seems the recent
announcement portended for the adoption of precautionary
principle. Can you comment on your precautionary principle, and
do you believe that zero risk is possible when using
application of herbicides and pesticides?
Ms. McCarthy. Sir, we do not utilize the precautionary
principle. Our decisions are based on the law, which is based
on risk.
Mr. Costa. Do you believe zero risk is obtainable?
Ms. McCarthy. It is possible with some, but that is not the
way in which our laws require us to look at this, and we do not
utilize that as the----
Mr. Costa. There have been court decisions, and my time is
about to expire, where various applications of these pesticides
and herbicides have been brought to the courts. And, in some
cases we believe EPA has refused to defend its scientific
decisions on the challenges of these courts. This is very
serious. You are supposed to be the clearinghouse.
Ms. McCarthy. Yes. Well, we vigorously defend our decisions
in court. We do that because we believe we did the right
decision, based on science and the law. There are times when
even a vigorous defense does not carry the day in the court,
and we have to abide by those decisions. But in no way are we
backing off of our decisions, and the way in which we have
always made them, which is based on the law that exists. And we
are continuing to apply that, and vigorously defend it.
Mr. Costa. Well, thank you, Mr. Chairman, and I will have
more information to follow with the witness. Thank you.
The Chairman. The gentleman's time has expired.
I now recognize Mr. Rogers from Alabama, 5 minutes.
Mr. Rogers. Thank you, Mr. Chairman, and, Administrator
McCarthy, thank you for being here today. I am sure it is not a
surprise to you when I tell you that me and my farmer
constituents are very worried and upset over the number of
regulations coming out of the EPA that negatively impact them.
First of all, are you cognizant that there are those concerns
by American farmers, and is there anything that you are
planning to do to address that perspective that they have of
your Agency and its regulations?
Ms. McCarthy. Well, yes, I am aware. There is a lot of work
that we need to do to establish a stronger trust relationship
between the agriculture community and EPA. I have been working
hard for the last few years, trying to get out to farms,
meeting with every farmer, rancher, and forester that wants to
sit down. I am trying to work through the issues, and listen
closely, and learn.
Mr. Rogers. Are there any fundamental changes that you
think that you are going to be able to make--plan to make that
would remedy or alleviate some of those concerns?
Ms. McCarthy. Well, to implement the laws as effectively as
I can. As I noted, we have a number of voluntary programs that
we are initiating back and forth. We have new advisory groups
being started. I think the most important thing we can do is
listen to one another, and try to identify the path forward
that meets our shared goals, because we certainly share the
goals of wanting to protect the environment.
Mr. Rogers. Well, I agree. I think that listening is a good
first step, but you also have to be prepared to act.
Ms. McCarthy. Yes.
Mr. Rogers. And it may mean act in a different way. But
anyway, I am glad you mentioned voluntary programs. I believe
we need to encourage programs that provide farmers with the
resources they need to work with states, and not the EPA, on
water quality problems. Congress did not give the EPA
regulatory authority over family farmers. I am concerned that
the EPA is moving away from voluntary programs that have
verifiable results, and instead intends to create burdensome
regulations. Do you agree that voluntary programs are
important, and an effective way to help reduce pollution, or is
the EPA trying to expand its regulatory authority over non-
point source pollution?
Ms. McCarthy. Absolutely I agree that voluntary programs,
as well as technical support and funding support from the
Federal Government, is an essential way in which we need to
move forward and work together, and that is the vast majority
of our relationship.
Mr. Rogers. Okay. Where in the Clean Air Act did Congress
give the EPA authority to regulate sustainability of
agriculture, non-production practices on farm fields? I don't
see that precedent anywhere.
Ms. McCarthy. Under the Clean Air Act, is that what you
said, sir?
Mr. Rogers. Yes.
Ms. McCarthy. I do not know whether the word sustainability
is written into any law. I think it was an outcome of
understanding, that we need to understand the lifecycle, and
all of the challenges associated with clean air and other
requirements that are being placed on our constituencies,
including farmers, ranchers, and foresters. And it was an open
dialogue to understand how our rules can enhance not just their
health and our health, but our viability as a sector. I think
that is what sustainability is intended to make sure, that we
are thinking about this in a common sense, holistic way, not a
narrow, media by media approach.
Mr. Rogers. I agree, but it didn't give the legal authority
to the EPA. What I am looking for is: do you see in that Act
the legal authority to regulate sustainability?
Ms. McCarthy. We do not regulate sustainability. We do
regulate pollutants under the Clean Air Act, one of which are
greenhouse gases. If that is what you are referring to, sir,
that is because, under the Clean Air Act, the Supreme Court
clearly told us that we had to look at greenhouse gases as a
potential pollutant, and if we found that they were an
endangerment, then we had to take appropriate action. That is
what we are actually doing.
Mr. Rogers. That is the precedent I am looking for. Could
you have someone on your staff get me a copy of that Supreme
Court interpretation?
Ms. McCarthy. Absolutely.
Mr. Rogers. I would appreciate that. And finally, GAO
released a legal decision that the EPA was violating publicity,
propaganda, and anti-lobbying provisions contained in previous
appropriations bills and your Agency, according to GAO, has
been using social media for covert propaganda. What is your
side of that?
Ms. McCarthy. Well, as you might guess, we don't agree. We
do not believe that we have violated any provisions. The GAO
looked at thousands of social media posts that we actually do
every day, because that is how we do our outreach and
education. That is all that they were. They found two instances
that raised questions for them. We disagree with their
decision, but we certainly are working with OMB to make sure
that we have followed every one of their procedures, and we do
everything we need to do.
Mr. Rogers. Thank you, ma'am. I yield back.
Ms. McCarthy. Thank you.
The Chairman. The gentleman's time has expired. Mr. Walz, 5
minutes.
Mr. Walz. Well, thank you, Mr. Chairman, and thank you
Administrator for being here with us today. I appreciate the
work that you have put on this. I appreciate the visits you
have taken to farm country, and am curious a little bit about
what you are hearing out there. But I remain the optimist that
I do think it is possible in this nation to produce food, to
continue to feed, fuel, and clothe the world, at the same time
addressing real world issues of clean air, clean water, and
environmental sustainability. And I think that is what we are
all trying to get at.
A statement that comes up often with my producers out
there--and these are folks that are committed to this, they
don't deny the science, they understand the importance of
regulatory humility.
Ms. McCarthy. Did you say----
Mr. Walz. Regulatory humility. Just a sense of working
with--I have used the term before--a bit of a bunker mentality
about all these things keep coming down without asking us. And
Mr. Rogers was getting at it, and I agree, I am very proud of
the work that this Committee did, and many of our folks working
on the last farm bill, on the conservation piece of it. That
conservation title was lauded by many as being one of the
strongest ever across the spectrum, from producers to
environmental groups.
And you kind of hinted at it, but are those working? Are
those making a difference? Because my attitude on this is we
are far better ahead if we can prevent a problem than dealing
with it afterwards, and getting into the courts, and everything
else that comes with that. Are some of those working? And if
you could maybe pick out one that you think is the way to go?
Ms. McCarthy. Yes. I think the conservation efforts are
absolutely working, and you can see that in many locations. Do
we need to do more? Absolutely, but that is the approach in
which EPA certainly prefers and takes. And, if I wanted to
highlight any, I think that it would be in the Great Lakes
area, areas in which we are actively supporting conservation
efforts, and doing that in a way that will help us prevent
pollution into the Great Lakes, which are causing these harmful
algal blooms.
There is a collaborative spirit. There is funding. There is
technical resources provided to this. These are the kind of
programs we need to have to move forward, and EPA is working
every day with USDA and the NRCS to see how we could advance
their mission as a way to advance our own. I do not need to
duplicate it. I need to respect what they do, and help support
that, and identify ways of appropriately expanding that in
areas where we find there are challenges.
Mr. Walz. I think that story needs to get out there,
because I agree. This is about helping us reach a common goal,
not telling us. And I think that telling us attitude, whether
it is perceived reality, or is reality and a lot of people feel
that way.
Ms. McCarthy. I know.
Mr. Walz. And, if I could, some of it comes from this
statement. This is the one that is confusing on this. Two
statements were made. I think your Agency stated that three to
five--approximately, I am not holding you to that--three to
five percent more jurisdictional waters, but we were also told,
and the red line for me was, if you didn't need a permit
before, you won't need one now. You can't have both those
statements, can you?
Ms. McCarthy. Yes, you actually can, and let me just try to
explain it. The increase in jurisdictional water determinations
is because the rule is much more specific about what is
jurisdictional and what is not, so there is not significant
amount of time wasted asking in areas where there is no
jurisdiction, or where we well know that, from our history,
there is a direct hydrologic connection that is significant
enough to warrant protection. But in terms of the agriculture
community, there is no added permit burden.
Mr. Walz. Unequivocally? I can go back----
Ms. McCarthy. None.
Mr. Walz.--to every one of my producers and say, the way
you are doing things now, if you were up to standards, nothing
changes?
Ms. McCarthy. That is correct. We have actually expanded
clarity on some of the exemptions and exclusions so that we can
make that clearer and clearer as time goes on.
Mr. Walz. Thank you. I am going to segue again just a
little bit, because we mentioned that collaboration with USDA.
What conversations happened on RFS, if you could, in dealing
with----
Ms. McCarthy. With USDA?
Mr. Walz. Yes.
Ms. McCarthy. Lots, at every level.
Mr. Walz. Extensive all the way through the----
Ms. McCarthy. It is, both in how we look at feedstocks, how
we look at those lifecycle impacts, to the numbers we should
put in, to what can be produced, what can be consumed, what can
USDA do, like their advancing of blender pumps, what does EPA
need to do to make sure those blenders can actually go out
there, and all those blends be utilized? We work pretty
constantly on RFS together.
Mr. Walz. And I appreciate that, and I know you do it to
the best of your ability, the idea is to get out there and make
those statements, show that collaboration. And, again, coming
back to that regulatory humility, that we are in this together,
we have common goals, but----
Ms. McCarthy. That is a term I will take to heart as I
leave here. Thank you so much.
Mr. Walz. Thank you, ma'am.
I yield back.
The Chairman. The gentleman yields back. Mr. Thompson, 5
minutes.
Mr. Thompson. Thank you, Mr. Chairman. I haven't seen a lot
of regulatory humility, at least since I have been here. It is
more, unfortunately, just my opinion, regulatory arrogance.
Administrator, thank you for being here. I appreciate you
coming, sitting in the seat, taking tough questions, and your
responses. I want to follow up on Mr. Rogers's questioning, the
response to the last question on this side, regarding the use
of social media.
Ms. McCarthy. Yes.
Mr. Thompson. I found it interesting, since the EPA
disagrees with the regulations that they have been confronted
with, and basically they disagree with the regulators that were
responsible for that, were wrong, in your interpretation, you
are not changing your practices. So my question is, can my
farmers do the same thing? Can they? I mean, they disagree with
the EPA, where there is a question of authority as a basis of
legislative language, as a basis of a now growing trend, and
serious numbers of Supreme Court rulings. Do they get the same
pass that it seems like your Agency is choosing to do when your
feet are held to the fire under regulations?
Ms. McCarthy. We are not doing anything that would skirt
the decision that GAO made, their interpretation of the law.
Our Office of General Counsel believes that they are incorrect
in their interpretation.
Mr. Thompson. So----
Ms. McCarthy. Nevertheless, we have----
Mr. Thompson. So what you are saying--okay. We gave you----
Ms. McCarthy. But nevertheless, we are actually working
with----
Mr. Thompson. If my farmers get an army of----
Ms. McCarthy.--OMB on what the appropriate response is to
that. So they do they have their opinion, we will respond
appropriately to it, but we still have a right to say that
legally we don't think they were correct.
Mr. Thompson. Sounds like----
Ms. McCarthy. That is all.
Mr. Thompson.--my farmers would be better off if they had
an army of government paid attorneys, that is my question,
though. That just happened to come up. Many believe that the
Chesapeake Bay TMDL represents a massive seizure of state
government power by your Agency, and will serve as a blueprint
for regulating watersheds around the nation. Now, through its
standards, controls, and rigid rules the Agency is setting the
stage for taking over many, if not all, land use decisions
nationally. Really a private property grab, in effect becoming
a national zoning board. The TMDL is already having devastating
impacts on farmers. In defending the TMDL, currently on appeal
to the Supreme Court, your Agency has defended it, saying that
the states are developing their own standards.
Now, let me read to you what one state in the Chesapeake
Bay Watershed, Delaware, not my state, wrote of this voluntary
procedure in its watershed improvement plans. The state wrote
that, if the program fails to meet standards acceptable to the
Agency, then ``the EPA has identified a set of potential
consequences to impose. These consequences range from the EPA
taking over responsibility for developing the plans to
increasing their regulatory oversight, and extending their
regulatory authority to additional sources of pollution.'' In
short, this quote is articulating that if each state's
watershed improvement plan doesn't meet EPA standards, the EPA
can then force its own plan on the states, along with punitive
actions.
My question is, with all of this authority, in what sense
was there anything voluntary about this process? Your Agency,
directly and indirectly, told states that it wanted what it
wanted, made it clear that there would be consequences to not
delivering on what it wanted, the standards and plans it
expected. How is that voluntary?
Ms. McCarthy. Well, sir, let me try to answer that
question. The Chesapeake Bay TMDL was an opportunity for a
number of states who share a common, both environmental and
economic, interest in having a healthy Chesapeake Bay. That
program allowed them the opportunity to actually meet
compliance, with reducing the standards necessary to get that
healthy again in their own way.
Mr. Thompson. And as the Chairman of the Subcommittee that
includes watersheds, I love the Chesapeake, and----
Ms. McCarthy. Right, I know.
Mr. Thompson.--we are achieving that, but we are just--I am
talking about the overreach here.
Ms. McCarthy. But we have never----
Mr. Thompson. That is just----
Ms. McCarthy.--actually had to intervene. There is great
progress being made through the efforts that each state has
been taking. They do care about the Chesapeake, and they are
making progress. The question was asked, what if people don't
do anything? Well, there is no question that TMDLs are a
regulatory requirement, and so there are things that we could
do if there isn't continued progress as anticipated. We have
never had to use that.
Mr. Thompson. Well, ma'am, I----
Ms. McCarthy. And we don't expect----
Mr. Thompson.--would refer you to the transcripts of when
our Subcommittee on Conservation and Energy Watersheds met, and
your individual in this Philadelphia office clearly said this
was not a regulation because it was voluntary, and then it was
some of the most confusing testimony we ever heard, because it
is being aggressively implemented as a regulatory action, yet,
clearly it was overreach to the 10th degree. And I appreciate
your response, but the uncertainty is still in there.
The Chairman. The gentleman yields back. Ms. Fudge, 5
minutes.
Ms. Fudge. Thank you very much, Mr. Chairman, and thank
you, Administrator McCarthy, for being here today. I am going
to go strictly local today.
Ms. McCarthy. Okay.
Ms. Fudge. I live on the banks of Lake Erie in Ohio. Lake
Erie provides drinking water to millions, and supports
thousands of jobs, and contributes over $1 billion to our local
economies. Yet harmful algal blooms are only intensifying each
year, and we are persistently faced with the threat of open
dumping that we believe to be harmful sediment into open Lake
Erie, and we believe that it is an adverse decision by the Army
Corps.
Despite the great progress made in reversing past
environmental damage, we find ourselves locked in an ongoing
battle over this seemingly non-controversial issue. The EPA
plays a critical role in protecting drinking water and the
health of our lakes. What are you and your Administration doing
to ensure the continued growth and recovery of Lake Erie?
Ms. McCarthy. Well, I am familiar with the issue you raise
with the Army Corps, and I am hoping my understanding is
correct, that the Corps is working with the state, and all the
constituents, to identify ways to stop dredge disposal in
Western Lake Erie. But as you also know, we are working very
hard through our Great Lakes Initiative to actually understand
the science in Western Lake Erie, understand where the sources
of the nutrients that are contributing to those algal blooms
are, and we are actually supporting it with $11 million from
EPA's funds to try to help those upstream farms and agriculture
to find ways of taking conservation efforts, and other
voluntary actions, that will begin to make a real dent in the
challenge we are facing in Western Lake Erie.
Ms. Fudge. Well, thank you, but I certainly hope that you
would check further, because it is my understanding at this
point that even though a court has decided that it is not
appropriate for them to dump the sediment into the open lake,
the Army Corps has decided that they are not going to comply
with the court order.
Ms. McCarthy. I didn't hear that.
Ms. Fudge. And so it is important that we move
expeditiously to determine why, and why they have not requested
the resources that are necessary to contain the sediment.
Ms. McCarthy. Okay.
Ms. Fudge. So I would ask that you would check that
further?
Ms. McCarthy. I am happy to do that.
Ms. Fudge. Thank you. The growth of urban agriculture is
vital to solving the issue of food deserts in many low-income
neighborhoods, many of the ones that I serve. In post-
industrial cities, such as Cleveland, historical contaminants
in the soil can stall the growth of these programs. What role
is EPA playing in ensuring urban land is safe for farming?
Ms. McCarthy. Well, one of the efforts that I mentioned
early in my oral testimony was the Local Food, Local Places
effort, which adds enormous opportunities for urban communities
that are literally food deserts, and to open up and do
planning, and to bring Federal resources to the table that is
really focused on food first, instead of as an afterthought.
There is a great change that is happening in urban areas,
understanding the need for locally grown food, and the value
that that can bring not only for the health, but the vitality
of the community. I would really encourage anybody's active
participation in the Local Food, Local Places initiative,
because that can bring brownfield redevelopment resources to
the table that would address the soil contamination issues you
are identifying. Many of those turn into vital places for
communities to gather and grow food, so do not give up in an
urban area on the ability to grow food, and to make that part
of the community revitalization efforts that everybody is
looking for.
Ms. Fudge. Thank you. And last, seasonal agricultural
runoff is a factor to the growing problem, of course, of algal
blooms in the lake. What steps is EPA taking to address the
lingering pollutants still contaminating river and stream
sediment?
Ms. McCarthy. Well, a couple of things. We have mentioned
the Great Lakes Initiative, but most importantly, that is our
collaboration with USDA, as well as looking at areas of concern
in the Great Lakes where we know we have significant sediment
and water contamination. So it has to be a combination of all
of those efforts. It is not just about stopping what might
continue to be coming in, but it is looking at those hot spots,
if you will, so that we can continue to make progress, which we
have made tremendous progress on. But that is one of the three
areas that the Great Lakes Initiative is focusing on in the
coming years.
Ms. Fudge. Thank you very much. Mr. Chairman, I yield back.
The Chairman. The gentlelady yields back. Mr. Neugebauer, 5
minutes.
Mr. Neugebauer. Thank you, Chairman. Thank you for holding
this hearing. Administrator McCarthy, in my area, the
prevalence of herbicide resistant pig weed has become a major--
--
Ms. McCarthy. I am sorry, where are you? I am sorry, I
can't see you. Thank you. This layered look is hard for me.
Mr. Neugebauer. I even got in a taller chair so you could
see me. In my area, the prevalence of herbicide resistant pig
weed has become a major problem that producers are having
trouble combating. With everything else that is going on in the
cotton industry right now, fighting this pig weed problem is
the last thing they need, and it is becoming one of the
greatest costs many producers face. USDA has approved Dicamba
and 2,4-D, known as Enlist Duo, for use on cotton varieties
with herbicide tolerant traits. EPA is now the sole holdup in
getting this new, and severely needed, technology out to our
producers. Can you give the Committee any update on where
things stand at EPA, and what is the continued holdup by EPA?
Ms. McCarthy. Is this the Dicamba? In early 2016 we
actually proposed for public comment a regulatory decision on
Dicamba for the exact reasons you are talking about. We know
that there is significant interest in this. There has been
tremendous work on the science side. After the comment period
we are going to review those comments, and see how the Agency
can move to a final rule, so that we can get this done and over
the finish line.
Mr. Neugebauer. Now, could you kind of give me some
encouraging timeline here that folks could look forward to?
Ms. McCarthy. Sir, we are working as hard as we can. We
will get it done as soon as we can. If you would like me to
reach back to you after the hearing, I can get more details on
where we might be.
Mr. Neugebauer. That would be helpful.
Ms. McCarthy. All right.
Mr. Neugebauer. Enlist Duo also ran into some trouble last
fall with EPA's decision to request that the court remand
registration back to EPA for further review. This is only the
first time ever that EPA has attempted to vacate a pesticide
registration through a court action currently under FIFRA, and
EPA is required to comply with a number of procedural
safeguards before a pesticide registration can be canceled,
which it has failed to do. What was the Agency's rationale for
taking such an unusual step of asking the court to require EPA
to review the registration of a product so recently approved
for use, and why is the Agency now trying to use the courts as
a means of regulation?
Ms. McCarthy. Actually, we weren't really trying to do
that, sir. The 2,4-D decision that we made on Enlist Duo was a
controversial one, as you may know, but we followed the
science, and we followed the law. The awkward situation we
found ourselves in is after the decision was made, while it was
being challenged in court by the those that disagreed with our
registration, we identified information that the manufacturer,
Dow themselves, had put out, in other public venues, that
raised concern that we did not have the full science data to
make the decision in the most solid way we could, and actually
address what might be synergistic effects.
So instead of waiting for the court to tell us that we had
failed in our science decision, we wanted an ability to take
that back, to work with Dow, to get additional information to
address the issue and to move it forward again, which is
exactly what we are doing. We are actually working with Dow
about what the science is that they put out in other venues,
what data did they have, what data might we need to actually
re-do this decision in a way that we think will be legally
solid and respectful of the full range of science.
Mr. Neugebauer. Now, as to the question that you have not
followed the law procedurally on this. Do you believe you have?
Ms. McCarthy. We do, and we think we actually did it in a
way that will get to a decision much more quickly. The
challenge is that Dow did not give us the full range of data,
and we found it in another venue that was publicly available.
So when we found that out, we worked with Dow, and we have a
system to move forward to respect the full range of science
that we are required to look at.
Mr. Neugebauer. I am always interested in a timeline, you
said quickly, and I have learned quickly in west Texas and
quickly in Washington, D.C. doesn't necessarily have the same
meaning.
Ms. McCarthy. I will double check when I go back, but I am
pretty sure that we have already received a lot of the
information that we have asked Dow to do on 2,4-D, so we don't
think that there is going to be a significant delay in the
reconsideration of this and moving it forward.
Mr. Neugebauer. Well, on those two issues, Administrator,
if you could maybe have your folks kind----
Ms. McCarthy. I will.
Mr. Neugebauer.--of give me a timeline so that I can report
back to the cotton folks?
Ms. McCarthy. I am more than happy to do that.
Mr. Neugebauer. With that, Mr. Chairman, I yield back.
The Chairman. The gentleman yields back. Mr. Aguilar, for 5
minutes.
Mr. Aguilar. Thank you, Mr. Chairman. Thank you,
Administrator, for being here. I too will ask a little bit of a
local question, if you don't mind. I represent the community of
San Bernardino, that has been in the news recently, obviously,
for some terrible acts. While climate change affects us all,
this is incredibly personal for me, and the community that I
represent. I can recall smog days growing up, where we weren't
allowed outside because of the air quality levels, and this is
particularly important because our community sits at the base
of a mountain range that captures smog and air quality issues
that mostly generate from out of the area and blow in with the
trade winds.
I believe the National Ambient Air Quality Standards are a
great benchmark for communities to strive for in order to
improve pollution levels, however, San Bernardino has been in
the unique predicament due to the fact that the smog from Los
Angeles also contributes to the pollution in our region. Are
there resources and tools that the EPA can offer San Bernardino
County as it continues to work toward a management plan to
improve air quality? If not, does the EPA plan to provide any
sort of regulatory relief, or, as Mr. Walz coined, regulatory
humility for counties and areas that are not in compliance?
Ms. McCarthy. Well, let me begin by expressing my
sympathies----
Mr. Aguilar. Thank you.
Ms. McCarthy.--to you, and to those in your community. The
National Ambient Air Quality Standards rightfully establish by
law health standards that we all strive for. We well recognize
that California is challenged in meeting those, and there have
been some unique tools developed that we had the authority to
manage that have provided direct assistance for new
technologies and other efforts to support the state's
aggressive effort at looking at these areas.
There are also tools built into the law itself, so that, if
you have a difficult challenge, you can't meet it, provides
additional time and opportunity to get that done. And part of
the value of the state planning process, and really the
aggressive and--maybe aggressive isn't the word, but the
collaborative process, the outreach that Region 9 does to its
communities to try to work with them hand in hand to address
these challenges is really of great value.
So I am more than happy to make sure that folks come and
sit down, and see if there are particular issues of support
that your community may need to build into a state plan that
would help you achieve these standards quickly. But I want to
just reinforce the fact that the law does not, nor does EPA,
ever require more than can be done. We know that there are
transport challenges, and there are unique geographic
challenges that California faces. So while we hope to continue
to make progress, we understand that that will take time, and
it will take a collaboration, and it will take new technologies
to advance this. And whatever is coming in from other
communities is going to have to be a collaborative, multi-
community effort.
Mr. Aguilar. Sure. We just want to make sure that that is
part of the discussion. And there has been a discussion and
some flexibility in the past. We just want to make sure that
those----
Ms. McCarthy. We will keep that up.
Mr. Aguilar.--standards are still in place. And if we could
follow up with your staff to have----
Ms. McCarthy. That would be great.
Mr. Aguilar.--a little bit of a deeper dive, that would be
very helpful to my office. But with that, I will yield back,
Mr. Chairman. Thank you.
The Chairman. Thank you, Mr. Aguilar. The gentleman yields
back. Mr. Gibbs, 5 minutes.
Mr. Gibbs. Thank you, Mr. Chairman. Administrator, first of
all, thank you for being here. Let me start out for
clarification, my colleague, Ms. Fudge from Ohio, on the Lake
Erie issue, there are two separate issues, the algae bloom
issue in Western Lake Erie, you are correct, they do dredge and
dispose on the lake. The issue which she was unclear on is the
Cleveland Port issue. The Cleveland Port issue is a dredging
issue. It is about PCBs in the State of Ohio, and the Ohio EPA
has sued the Army Corps of Engineers over this issue. And it is
interesting, your Agency has been silent on this issue. So I
want to bring that to your attention, okay? And that is two
separate issues there on Lake Erie.
I do want to talk about: in your testimony you talk about
Waters of the United States Rule. I agree with you on one
aspect of it. Farmers do want clean water and drinking water,
so we agree on that. But my concern is, and it is evident by
what has happened, within 24 hours, when you filed the final
rule in the Federal Register, nearly 30 states filed a lawsuit.
Now it is over 32 states have filed a lawsuit, and numerous
organizations and entities are against this. And so it is clear
that there is concern about this, and obviously the states, it
erodes their states' rights.
And it needs to be made clear, when the Clean Water Act was
passed, the intent of Congress was it was supposed to be a
partnership between the Feds and the states, where the states
would implement and enforce the Clean Water Act under the
guidance of the EPA. Now, you made a statement here to answer
to one of the questions you insinuated that if the rule had to
be extended to include more waters, those waters are regulated.
You are insinuating that states aren't regulating waters. Now,
I, as a farmer, can't go out and dump my hog manure in any
stream that is not WOTUS, Waters of the United States. I would
be breaking the law. So I want to make it clear to the public
that waters that aren't under the authority of the Federal
Government are being regulated in that partnership agreement.
And you agree with that, correct?
Ms. McCarthy. In many states.
Mr. Gibbs. But you do insinuate that, and so----
Ms. McCarthy. Well, it wasn't intended, sir. We are
partners with the state----
Mr. Gibbs. Okay. Now, I also have a----
Ms. McCarthy.--they are primarily responsible.
Mr. Gibbs. I also have a concern that what is going to
happen is it is going to require more permits, Army Corps of
Engineers, and inefficiencies. But we risk the potential to go
backwards in the progress we have made since 1972 in water
quality, and protecting the environment in this country.
Because when you add on so much more red tape and bureaucracy,
people, at some point, throw their hands up in the air and say,
``Well, I might not necessarily have gone the extra route I
would have done. I am going to do just enough to get by, but I
am not going to do it because this is just a bunch of nonsense,
and a bunch of red tape.'' And the bureaucrats go crazy on
them, so I want you to be aware of that fact, that this rule
can make us actually go backwards in--and we are eroding that
partnership agreement that was set up in 1972 with the states.
And obviously, over 30 states have sued you over this, you
ought to pay attention to that.
Now, I want to also get to the part about the GAO Inspector
General report that came out and said that the EPA used covert
propaganda to bias and skew the comment period. I know some of
the people are poo-pooing this, this is not a big deal. I think
this is a big deal because it goes to the integrity of the
whole comment period process. I mean, the process is there so
the stakeholders can put in what they need to, comments, and it
is up to the regulators to use their due diligence to figure
out and make the best rule that works, and protects the
environment in this case. And here you have the Inspector
General of the GAO come out and say, you broke the law, and it
goes to the integrity of the system.
So my question is what has the EPA done to initiate the
reporting violation under the Anti-Deficiency Act, a copy to
the Comptroller General, and the Congress, and the President,
as required by the Anti-Deficiency Act, as you reported to us.
What resources were expended on these legal activities, both
monetary and full time equivalents? What internal action has
been taken in your office to make sure this doesn't happen
again, and has any internal action been taken to punish people
that broke the law in this case? I will let you answer those
questions.
Ms. McCarthy. Well, thank you, sir. I don't think that
folks in the Agency broke the law, but let me answer your
question directly. We are working with OMB--there is a draft
letter at OMB to make sure that we are following our
obligations under the law to respond appropriately to the GAO.
I think the word propaganda is always construed as something
horrible. The propaganda that they were referring to was not
that we lobbied Congress. It was not that we said----
Mr. Gibbs. No, you were lobbying people to lobby us,
because you were trying to educate them----
Ms. McCarthy. No, actually----
Mr. Gibbs.--that this was what you guys want. You guys are
actually proponents of this, and now you have all the state
EPAs suing you----
Ms. McCarthy. The propaganda----
Mr. Gibbs.--over it.
Ms. McCarthy.--issue was that----
Mr. Gibbs. Wake up.
Ms. McCarthy. The propaganda issue was that we used a
system that OMB approves under their guidelines, which was
basically a general message saying, I really care about clean
water. And the GAO was worried that when other people----
Mr. Gibbs. Because you use a----
Ms. McCarthy.--retweeted that----
Mr. Gibbs.--system called----
Ms. McCarthy.--they didn't identify----
Mr. Gibbs.--Thunderclap where they couldn't----
Ms. McCarthy.--it as an----
Mr. Gibbs.--trace it back to the EPA?
Ms. McCarthy.--EPA message.
Mr. Gibbs. Did you use a system called Thunderclap that
couldn't be traced back to the people putting it out? Is that
true? Is that----
Ms. McCarthy. I am sorry?
Mr. Gibbs.--my understanding--pirate social media called
Thunderclap, I believe----
Ms. McCarthy. That was the social media----
Mr. Gibbs. And that that can't be traced back to the people
that are putting it out? Is that true?
Ms. McCarthy. No. What happened is we put it out, other
people re-tweeted it, and when they re-tweeted it, GAO thought
that it wasn't their message, it was EPA's message, and we
didn't properly identify it as such. That is what they said.
But it was a general message, ``I like clean water.'' The other
was a blog that had a hyperlink where we referenced a really
cool program that----
Mr. Gibbs. Well, all I know is----
Ms. McCarthy.--that NGO was doing----
Mr. Gibbs.--as an oversight----
Ms. McCarthy.--and they were worried about.
Mr. Gibbs.--oversight, the GAO said you broke the law, so--
--
Ms. McCarthy. But I don't want to minimize it, sir. We will
pay attention to what GAO said, and we do have a letter in the
process to meet all obligations. We just disagree that it was a
problem.
The Chairman. The gentleman's time has expired. Ms. Adams,
5 minutes. Ms. Adams?
Ms. Adams. Thank you, Mr. Chairman, and Madam
Administrator, thank you so much for being here. While many are
concerned about Federal overreach and environmental management,
actions by the State of North Carolina resulted in tens of
thousands of tons of coal ash spilling into the Dan River in
2013, and the state refused to use its own authority to enforce
proper maintenance and relocation of coal ash ponds at high
risk of spilling into other drinking water.
Administrator McCarthy, it is important that we together
defend and uphold the EPA's final rule on the disposal of coal
combustion residuals from electric utilities. EPA's final rule
on coal ash disposal can only be enforced by states or by a
citizen that sues a company, or a state that violates the
regulation. It is for this reason that I am drafting
legislation to strengthen protection and enforcement of rural
water sources, which would provide rural communities with the
same requirements that citizens in North Carolina now enjoy.
Specifically, the bill would require coal ash pond owners and
operators to be transparent in their surveying and monitoring
of the quality of water in our communities. The bill mirrors
laws that have already been passed by the North Carolina
General Assembly.
My question is, given the continuing threats of coal ash
disposal, what is EPA doing to assess and prevent drinking
water contamination and the risk of catastrophic collapse?
Ms. McCarthy. Well, as you know, we take this issue very
seriously as well. Certainly there have been disasters that we
need to make sure don't get repeated. So, as you know, we just
recently finalized the Coal Ash Rule. That looks at two things.
One is the structural stability of those units, so that we can
make sure that they are stable, and they are being properly
inspected, and, if necessary, repaired. The second is to make
sure that groundwater is protected and actually cleaned up. And
that rule has requirements for both of those efforts. And we
have information on the web so that people can see what is
being done, and what we have identified, in terms of our
assessment of that structural integrity so that information can
be available to the surrounding communities.
Ms. Adams. Thank you. Will EPA provide technical assistance
to low-income and minority communities so they are aware of,
and can understand, the information about coal ash dumps that
utilities are beginning to disclose?
Ms. McCarthy. Congresswoman, this is the first time I am
aware that you are contemplating this type of legislation. We
are happy to work with you on language around that, and talk
about what authorities the Agency might have to support this
effort, even in advance of that legislation moving forward.
Ms. Adams. All right, thank you. The Center for Public
Integrity found that your Civil Rights Office has dismissed
nine out of every ten claims by communities alleging
environmental discrimination, and have never issued a formal
finding of a Title XI violation. Given this poor performance
record of EPA's Office of Civil Rights, do you have any
thoughts about why EPA hasn't ever made a finding of
discrimination under this Title?
Ms. McCarthy. Well, it is easy, from that record, to
understand that the Agency has faced challenges in dealing with
our Title XI complaints. One of the things that I have done
since coming here is to try to aggressively tackle that issue.
We are really committed to building a model civil rights
program, particularly how we handle these. In the last 2 years
we have new leadership in our office. We have developed a
strategy to manage that docket of complaints more effectively.
We, just this fall, released our external compliance strategic
plan, a new civil rights toolkit, so we are doing what we need
to do to get up to speed. But that doesn't mean we don't have a
history that we need to acknowledge, and use that history to
inform how we can be a model agency, moving forward. And we are
trying very hard to make sure that we do that.
Ms. Adams. Well, I certainly hope it improves. It is not
very impressive right now. But thank you very much for your
comments, and, Mr. Chairman, I yield back.
Ms. McCarthy. Thank you.
The Chairman. Ms. Adams yields back. Mr. Austin Scott, 5
minutes.
Mr. Austin Scott of Georgia. Thank you, Mr. Chairman.
Ma'am, thank you for being here. I want to go back real quickly
to what Mr. Neugebauer from Texas was talking about, with the
Dicamba and the 2,4-D issue.
There have been several things that have been approved by
the USDA for months, and farmers start planting cotton in his
state in March. In my state it is more in April, but it takes
time to get the chemicals produced, and through the
distribution network, and to the farm. And if you all take much
longer, quite honestly, they are not going to be available for
us this year. And so I appreciate your commitment to help the
farmer. I hope that we will see you act on these pending
registrations sooner rather than later. And that is one of the
breakdowns that we have between the government and the public,
and the farmer is that it seems the people in the agencies have
no idea when farmers even plant their crops, and what the
agencies are doing to the cost of those crops. And can you tell
me what cotton is trading for? Do you know?
Ms. McCarthy. No, I can't, sir, no.
Mr. Austin Scott of Georgia. It is below the cost of
production right now, and so are a lot of the other
commodities. And so when you take an area like mine, that
produces a tremendous amount of cotton every year, and cotton
is below the cost of production, you would typically look to
another commodity. But they are also below the cost of
production. And I appreciate your comment that you are trying
to help the farmer and the farm, but the government is getting
in the way of the farm being able to survive through these
tough economic times. And things like approving these chemicals
sooner rather than later would at least help us determine what
crop we can plant.
And I want to go to the neonic issue right now, and I
certainly understand the value of pollinators. I mean, without
bees, you have lost the majority of the food in the world. But
there are situations with the pollinator, and the preliminary
risk assessment, and specifically cotton, which I was talking
about earlier, is a self-pollinating crop, and it doesn't
require bees. So did the EPA take that into account as part of
its assessment with pollinators, that cotton does not require
bees for pollination?
Ms. McCarthy. I will have to go back, sir. Which chemical
are we talking about in particular?
Mr. Austin Scott of Georgia. The neonics as a whole, the
whole class.
Ms. McCarthy. Certainly. We certainly are. We are not
making broad brush decisions on neonics. We are looking at each
of them. And, in fact, the decisions that we have been
proposing have been very specific to look at being specific to
the crop, as well as the time of year----
Mr. Austin Scott of Georgia. Let me----
Ms. McCarthy.--and what we can do to both protect the bee
colonies, as well as make sure that these are available when
they are----
Mr. Austin Scott of Georgia. Fair enough.
Ms. McCarthy.--appropriately used.
Mr. Austin Scott of Georgia. I will take that as a
commitment that you will continue to work with the industry----
Ms. McCarthy. We will.
Mr. Austin Scott of Georgia.--and the registrants----
Ms. McCarthy. Absolutely.
Mr. Austin Scott of Georgia.--and I appreciate that. Are
you familiar with the Agency's proposed rule on greenhouse gas
emissions and fuel efficiency standards for medium and heavy
duty engines in vehicles, Phase II?
Ms. McCarthy. Yes.
Mr. Austin Scott of Georgia. Well, would you agree also
that Congress has excluded non-road vehicles that are used
solely for competition from EPA regulatory reach?
Ms. McCarthy. I believe that that is the case, but I am not
as familiar with that as I am my standard rulemaking process--
ongoing rulemaking----
Mr. Austin Scott of Georgia. Fair enough. According to the
EPA website, Congress did.
It is one of the things----
Ms. McCarthy. I believe so.
Mr. Austin Scott of Georgia. We talk a lot about the things
that we told you to do, but there also are things that we
specifically tell the EPA that you do not have the authority to
do. And one of those--I agree with what you said, that you
don't have----
Ms. McCarthy. I don't think so.
Mr. Austin Scott of Georgia.--the authority to regulate
competition vehicles. I am concerned about the fact that in
this 629+ page rule that is supposed to deal with greenhouse
gas emissions for medium and heavy duty engines, that in the
catch-all provision that the rule has attempted to bring back
in to regulation competition vehicles. And I agree with you 100
percent that you don't have the authority to do that, and so I
appreciate you telling me that you----
Ms. McCarthy. Well, Mr. Scott, let me get back to you. I am
sure if that was part of the proposal, we have received a lot
of comments on it. I am happy to close the loop with you on it.
We certainly have not finalized that rule. We are considering
all the comments. But if you think that there was a disconnect,
I am happy to connect with you on it individually, if you would
like.
Mr. Austin Scott of Georgia. I agree with you that Congress
specifically said that you don't have the authority to regulate
competition vehicles, and ma'am, I appreciate your time. And it
is just that it is very disconcerting, as an American, to see
that in 40,000 pages of rules and regs that we have an Agency
that would put something in a heavy duty vehicle rule that
deals with race cars.
The Chairman. The gentleman's time has expired.
Mr. Austin Scott of Georgia. Thank you.
The Chairman. Ms. Plaskett, 5 minutes.
Ms. Plaskett. Thank you, Mr. Chairman. Good morning,
Administrator McCarthy. I wanted to talk with you about the
Virgin Islands. It has a very important relationship with EPA
because of our complete surrounding by water, and our land, and
our sea, our greatest resource, both for our farmers as well as
for all of the industries that we take up. Several years ago,
though, the Virgin Islands was devastated by the closure of our
oil refinery, and that oil refinery meant that we lost hundreds
of millions of dollars in revenue, and hundreds of millions
more in lost economic activity. Just recently, however, the
facility was in a bankruptcy sale, and a private equity firm
has elected to purchase it. And that may lead to the
restoration of more activity on the island. However, there is a
concern that we have with regard to the EPA, and the potential
of the EPA asking that the Government of the Virgin Islands be
a co-permitee on its RCRA, its Resource Conservation and
Recovery Act permit. These permits were originally put out,
again, for Hovensa in 1999, and at no time during the renewals
of those permits had the Virgin Islands Government been
included in it. The Virgin Islands Government ownership doesn't
even make up five percent of the land in this area. We were, by
an Act of Congress, given title to the submerged lands to be
entrusted for the citizens, and at no time has the Virgin
Islands ever elected to operate a refinery, use the facility,
but is really holding those submerged lands in trust.
Now, I understand that Hovensa is no longer the owner, but
there is real concern that we have with Region 2 taking the
position that the Virgin Islands Government must be included as
a co-permitee. It is our belief that Region 2's position is
based on an overly expansive interpretation of RCRA, and is an
unjustified departure from its longstanding Agency policy. I am
sure my colleagues here would see that this could be a problem
if this takes precedent, in that the you have your state and
local governments, which may, by EPA, be forced to become a co-
permitee on hazardous waste areas back home in their own
regions. And so we have really been reaching out to EPA, and
particularly in Region 2, to see how we can resolve this. And I
am not sure if you were aware of this. I wanted to bring this
to your attention. Are you aware of any instance that EPA has
forced a state or territory to be on a RCRA permit, based on
its owning a small portion, five, ten percent of the land that
a facility has?
Ms. McCarthy. I do not know all the uniqueness of this
situation, but it is certainly my understanding that the region
has taken a legal position that, because the part of the land
in which the facility is located is U.S. Virgin Island land,
that there is a connection, and that they should have been on
the permit. Now, having just learned this, I can't tell you
whether we have done this before, whether there are unique
trust responsibilities that we are not looking at, so I am more
than willing to go back and look at the region. But it is very
clear that RCRA has brought in communities, municipalities, and
states into the RCRA responsibility system, even though they
are innocent landholders, and that is respected in the process,
but they become part of the permit in the process, moving
forward.
Ms. Plaskett. Well, it seems to me to be unclear why you
would have an original permit in 1999, and renewals of that
same permit when another owner was operating the facility. Our
ownership has not expanded at any point in this. We have always
had the same five percent of those submerged lands that this
body, Congress, put on the Government of the Virgin Islands to
hold in trust for its citizens. And now, seemingly when there
is no titleholder anymore, because Hovensa has gone into
bankruptcy, the EPA Region 2 has decided that the Virgin
Islands Government must take on responsibility for hazardous
waste and activities that the facility owners were operating
in. I mean, what more can a territory take on? What more can a
government that is already bankrupt take on its back?
Now you have the owner, Hovensa, leaving, purchased by
another entity, and the Federal Government, the Agency, is
forcing us to take responsibility, possibly liability, for
hazardous activity that a private owner had on 95 percent of
that land. It just seems an expansion, because there isn't a
private owner anymore to hold the responsibility, to put it on
the backs of a local government that can do nothing but say,
please don't do this to us.
Ms. McCarthy. Well, this seems like a very unique
circumstance. I would suggest that we follow up with this
conversation, and it is not a decision, or an interpretation,
that I have been engaged in. So why don't we do that?
Ms. Plaskett. I would appreciate that so very much.
Ms. McCarthy. All right.
Ms. Plaskett. Thank you very much.
Ms. McCarthy. Sure.
Ms. Plaskett. Thank you, Mr. Chairman.
The Chairman. The gentlelady's time has expired. I now
recognize the gentleman from Arkansas, Mr. Crawford, for 5
minutes.
Mr. Crawford. Thank you, Mr. Chairman. Thank you,
Administrator McCarthy. I know this has been addressed to some
extent, but we can take a little deeper dive on this issue with
the grassroots campaign effort that took place in your Agency
which is specifically prohibited by Title 18 of the U.S.
Criminal Code. And I don't think we have gotten a satisfactory
answer. Have you or your legal department made efforts before
the grassroots campaign was undertaken to ensure the EPA staff
is familiar with the kind of activity that is prohibited under
the Anti-Lobbying Act?
Ms. McCarthy. We actually were following OMB guidelines
relevant----
Mr. Crawford. Prior to?
Ms. McCarthy.--to the use of Thunderclap, yes.
Mr. Crawford. Okay. That is even worse. If they have
received training in the Anti-Lobbying Act, and then engaged in
lobbying----
Ms. McCarthy. We believe we actually followed those
guidelines, yes.
Mr. Crawford. Well, the GAO disagrees with that. And
whether or not there can be an intent proven, the subterfuge
and the optics of what took place there are certainly worth
considering. I think that there are some valuable lessons here
in the GAO's findings, not the least of which is that the
Administration and your Agency is willing to go so far as
breaking U.S. Criminal Code to push an agenda. We already knew
that you were willing to go to great lengths to push that
agenda, but this brings it into a completely different
perspective.
Second, the GAO findings tell us that these actions set a
dangerous precedent for future rulemaking. So you have
basically compromised the integrity of the rulemaking process.
Ms. McCarthy. Sir, they never----
Mr. Crawford. Now, excuse me----
Ms. McCarthy.--indicated that we were----
Mr. Crawford. Excuse me, I am on my time----
Ms. McCarthy.--any law----
Mr. Crawford.--right now, Administrator.
Ms. McCarthy. I am sorry.
Mr. Crawford. In the age of social media and electronic
communication, it is deeply troubling that agencies are willing
to use these tools to subvert the concerns of the affected
public, and drown out opposition to your own views. And it is
obvious that you were trumpeting your own views, and not taking
into consideration the public's views, when this is a public
rulemaking comment period.
So I don't know how, after all those revelations were made,
did you expect us to believe that during the WOTUS rulemaking
the EPA actually took into account all the views by affected
stakeholders. Or were you just concerned about the views of
your political allies? It appears to me that that was the case.
Ms. McCarthy. Sir, the GAO never indicated that we
referenced a particular rulemaking. They never indicated that
we said anything incorrect. They had one concern relative to
Anti-Lobbying, which was a hyperlink to a program that we were
touting as being really good. One blog from one individual in
the Agency out of thousands was done, and it referenced a
hyperlink, and they could not go back and prove or disprove
whether or not that NGO, at some other place in their webpage,
may have had an ability for people to contact Congress on other
related issues or this one.
We are certainly sensitive to the fact that that hyperlink
referenced an outside of EPA website. There are other agencies
that flag that. We are considering and working with OMB on what
we can do, but if you look at this, there was no intent, and
there was no lobbying on the part of the Agency, or a
reference----
Mr. Crawford. Okay. I think----
Ms. McCarthy.--to that----
Mr. Crawford.--then, we can take this as an example and a
validation of the fact that the rulemaking process is deeply
flawed, and needs to be addressed, because this kind of stuff,
to me, is not reflective of the opportunity that should be
granted to the affected stakeholders. Let me switch gears with
you quickly in the time I have remaining. I was just told
yesterday that the EPA took action against a farmer who didn't
comply with the SPCC rules on on-farm fuel storage by failing
to have an SPCC plan for his oil storage tank that was 5,000
gallons in size, but the 2014 WOTUS specifically says that EPA
can only require compliance for oil storage tanks in excess of
6,000 gallons until such time as the EPA completes a study, and
a new rulemaking process is undertaken.
My understanding is that the study is complete which
recommends a lower exemption threshold, but the rulemaking is
still not finished. So my question to you is why is the EPA
taking enforcement action against individuals who are not out
of compliance, and isn't that a violation of the law?
Ms. McCarthy. Sir, I am happy to look into it and get back
to you. If it just happened yesterday, I am really not familiar
with it.
[The information referred to is located on p. 65.]
Mr. Crawford. Well, is that kind of thing a regular
practice by the Agency?
Ms. McCarthy. I think we have actually been doing a very
good job on the SPCC rules. Many of them, because of changes in
threshold, like 96 percent of them, are no longer impacted by
this rule. And of those----
Mr. Crawford. Okay, let me ask you this----
Ms. McCarthy.--four percent, 97 percent self-certify. So
we----
Mr. Crawford. Do----
Ms. McCarthy.--we are doing pretty good.
Mr. Crawford. Right. Do EPA agents take compliance actions
like this because they know that farmers aren't willing to
fight enforcement actions because it costs them more in legal
costs than it would be to just go ahead and succumb to the EPA
pressure? Am I off base in suggesting that?
Ms. McCarthy. I don't know why you are suggesting it, sir,
but if that is your point of view, you can have it.
Mr. Crawford. It is my point of view, and it is the point
of view of the----
Ms. McCarthy. But I don't know anything about this
enforcement----
Mr. Crawford.--most of the people in my district who farm
and are subject to EPA regulation. I yield back.
The Chairman. The gentleman yields back. Mr. Scott, 5
minutes.
Mr. David Scott of Georgia. Thank you, Mr. Chairman. First
of all, Ms. McCarthy, I think that you, and the EPA, have
drastically manhandled and violated the rights of our farmers,
especially dealing with this water issue. You did break the
law. You did break the law. Now, let me tell you, Ms. McCarthy,
in Section 15 of the Financial Services and General Government
Appropriations Act, it expressly prohibits you from lobbying in
support, or in opposition, to pending legislation or rule.
Further, not only there did you break the law, but in Section
401 of the Department of the Interior's Environment and Related
Agencies Appropriations Act, that is applicable right now,
prohibited the use of the EPA's appropriations for lobbying.
You broke the law. It needs to be admitted. It needs to be
recognized. And, furthermore, you spent taxpayers' money in the
lobbying. And the GAO reports it is $64,610 that you spent in
lobbying from February 2014 to 2015. Now, let us come clean
with this, so we can correct this. There is no way you are
going to correct this if you don't realize that you have
drastically overstepped here. And let us get that cleaned up.
Now, the other part that really gets in my craw is this. I
was born on a farm, grew up on a farm, and there is a reason
why farmers go and develop ditches, and ponds, and wells, and
they are man-made, because that is an insurance policy for the
drought. Our animals still have to be fed, they have to drink.
There are many times when it doesn't rain for 4, 5, 6 weeks.
And that is why we have that. The other point is, this is the
farmer's private property, and it is not navigable waters. It
is there for the purpose of being able to give us protection
when that rain doesn't come. My little farm was a tobacco farm,
and when you go to the tobacco beds, you have to put the plant
in, and you have to have the water right there to go in with
the plant. Suppose it doesn't rain.
Now, that is on that farmer's property. He shouldn't be
permitted for his own property. And then he shouldn't be fined,
the farmer has to pay for a permit on his own property for a
puddle of water, or a ditch, or a pond, or a well that they
made themselves so that they could be able to have that
insurance on a rainy day. And then to violate all of that, the
law itself, to go and lobby, and spend taxpayers' money on it.
That is a damnable thing to do to our farmers, who are faced
with so many other challenges. The EPA needs to reject this
rule, recognize and admit that it broke the law, and then move
to correct and say this will never happen again.
Now, finally, in my last second, I don't want to go over
time, but I want to raise this issue for our cotton folks on
the chlorpyrifos. I guess a better way of saying that is
Lorsban. Anyway, we need this for our cotton producers and for
our pecan producers. As has been said before, by the Chairman
and others, our cotton people are going through a very serious
time economically, and they don't need a doubt of whether or
not they can use this pesticide. So will you please make sure
we can use that? And hopefully put this business aside for the
Clean Water Rule, and let us move forward, and let these
farmers have some peace of mind.
Ms. McCarthy. Thank you for your passion, sir.
The Chairman. The gentleman yields back. Mr. DesJarlais, 5
minutes.
Mr. DesJarlais. Thank you, Mr. Chairman. Ms. McCarthy,
thank you for being here today. Just one follow up on Mr.
Scott's question. He pointed out that GAO determined that you
violated Federal law. Who was in charge of the covert
propaganda and the grassroots lobbying? Who was the person in
charge of that?
Ms. McCarthy. It is actually just part of our outreach and
education, sir. There was no covert propaganda, and there was
no lobbying.
Mr. DesJarlais. So there is nobody over that particular
outreach? There was nobody in charge of that that you are aware
of?
Ms. McCarthy. Sure. We have communications folks that have
been----
Mr. DesJarlais. Okay.
Ms. McCarthy.--doing it. This----
Mr. DesJarlais. Who is the head of that? Who was
responsible for that?
Ms. McCarthy. I would have to go back and look at the exact
time, but we have actually a large education and outreach
group. But none of that----
Mr. DesJarlais. Nobody was punished for it, though, right?
Ms. McCarthy. We don't believe----
Mr. DesJarlais. I understand that the person that is over
it is now promoted and working for the White House, but that is
beside the point. In your opening statement in response to the
Chairman, you made it sound like Congress is imploring you to
move forward with this WOTUS. Where did the idea for WOTUS come
from, and basically who was in charge of drafting this package?
Ms. McCarthy. Actually, the WOTUS, or the Clean Water Rule,
came because the Supreme Court told us that we needed to make
improvements to the law based on science. We needed to prove a
connection. We needed to do a better job.
Mr. DesJarlais. That wasn't Congress, like you----
Ms. McCarthy. So--no, it was----
Mr. DesJarlais.--said in your opening statement. It wasn't
us.
Ms. McCarthy.--followed up--it actually was followed up
by--Congress asked us to take action to address concerns.
Individual stakeholders, members of the ag community.
Absolutely people are looking for us to do a better job than
the 2008 guidance, and to respond to the concerns and
criticisms that the----
Mr. DesJarlais. But you went around Congress and used the
rulemaking process, correct?
Ms. McCarthy. No, sir. We were actually asked to do a
rulemaking for clarification. Whether you disagree with that
rule or not is fine----
Mr. DesJarlais. What is the cost of this?
Ms. McCarthy.--but the EPA didn't generate this on its own.
Mr. DesJarlais. What is the cost going to be to implement
this rule?
Ms. McCarthy. It is actually a net benefit of something in
the order of $184 million.
Mr. DesJarlais. A benefit, not a cost? I mean, because I
have heard it costs anywhere from $180 million up to $500
million, which that would change the way the rulemaking process
works, correct? If the cost is over $100 million, you can't go
around Congress the way you did.
Ms. McCarthy. No, actually, the $100 million threshold
means we go through the inter-agency process, which we did.
Mr. DesJarlais. Yes. Do you know Howard Shelanski?
Ms. McCarthy. Yes, I do.
Mr. DesJarlais. Okay. Have you worked with him on this?
Ms. McCarthy. Yes, I did.
Mr. DesJarlais. Do you know why he won't give the required
documents to the Oversight and Government Reform Committee that
we have been asking for since March 3 of 2015?
Ms. McCarthy. I am not aware of what you are referring to,
sir, no.
Mr. DesJarlais. Okay. We had a hearing about the rulemaking
process, and the fact that this was a major rule, and we have
been asking, and actually have had to now subpoena these
documents for over a year. You don't have any idea why they are
ignoring our request?
Ms. McCarthy. I don't know what the situation is.
Mr. DesJarlais. You have not had any conversations with
him?
Ms. McCarthy. No, sir.
Mr. DesJarlais. Okay. Is this directive more from the White
House?
Ms. McCarthy. What directive are you referring to?
Mr. DesJarlais. The WOTUS ruling itself.
Ms. McCarthy. No----
Mr. DesJarlais. The Waters of the U.S. Because it is
certainly not from Congress. We voted both in the Senate----
Ms. McCarthy. No----
Mr. DesJarlais.--and the House to stop it.
Ms. McCarthy. I just explained to you where the impetus
came from.
Mr. DesJarlais. Yes. And the courts have blocked this,
correct? The implementation.
Ms. McCarthy. It is being litigated in one District Court,
and it is now with the 6th Circuit, where they are looking at
whether or not the District Court has jurisdiction or they do,
but you are absolutely right, we are now stayed in terms of its
implementation until those court issues are resolved.
Mr. DesJarlais. Okay. Well, you act like you are doing us a
favor, but yet we have 31 states and many agricultural
organizations filing lawsuits against you. So you don't think
that maybe there ought to be a reason for pause? Maybe we ought
to scrap this thing, go back to the drawing board, and do it
right?
Ms. McCarthy. We will certainly hear from the courts as to
whether we met the legal test in terms of its merits.
Mr. DesJarlais. So why did the EPA decide that it was
necessary to do this?
Ms. McCarthy. Because of the lack of clarity, and the
inconsistency, and the unfairness of the current process.
Mr. DesJarlais. Okay. But under the Clean Water Act you
were restricted to navigable waters. Mr. Scott talked about
farm ponds, stock ponds, where cattle drink out of. Is that a
navigable water?
Ms. McCarthy. The actual navigable water, the Supreme Court
has told us that that goes well beyond what we would
traditionally think of as navigable, and we have to then
protect waters that have the ability to significantly impact
the biological, physical, and chemical integrity of navigable
waters.
Mr. DesJarlais. You understand----
Ms. McCarthy. Does it respond to ditches on farm lands? We
have done a really good job, if you look at the Clean Water
Rule, to make sure that we are clarifying the word ditch. That
is in the Clean Water Rule, not in----
Mr. DesJarlais. It would take another 10 minutes for you to
describe what is a ditch and what is not a ditch, but I will
just end with the fact that America is frustrated right now
with big government. That is the number one issue with
Americans----
Ms. McCarthy. Okay, sir.
Mr. DesJarlais.--is the overreach of Federal agencies. So I
would hope that you would withdraw a little bit, take your
time, and get this right.
Ms. McCarthy. Thank you, sir.
Mr. DesJarlais. Thank you for being here.
The Chairman. The gentleman's time has expired. Ms. Lujan
Grisham, 5 minutes.
Ms. Lujan Grisham. Thank you, Mr. Chairman. Administrator,
as you are aware, on August 5, 2015 the EPA team that was
investigating the contamination at the Gold King Mine in
Colorado accidentally released 3 million gallons of waste water
into the Animus River, which then flowed into the San Juan
River, which is in New Mexico, part of it, and Lake Powell, and
I think that you actually estimated that in that accidental
release there were 880,000 pounds of metal that was deposited
into the Animus River as a result of the release. Now, while
the initial plume dissipated within several days, I want to
alert you, you may already be aware, that there remain very
serious concerns about the long-term impacts, both
environmentally and for public health. And I am aware that both
the State of New Mexico, through primarily their Environment
Department, but certainly in my communications with the
Governor, and the Navajo Nation and its President, that they
have real concerns over a proposed 1 year EPA monitoring plan,
which doesn't do anything about monitoring groundwater, plants,
crops, wildlife, and certainly doesn't take into consideration
continued runoff. I hope we don't have it too soon, but a
spring runoff, which means that all that sediment gets moved
again.
And so I would agree that the state is correct in assessing
that there needs to be a long-term monitoring impact, that
there ought to be a plan that involves their independent
review. They are there. They are familiar. They are aware,
which I realize is difficult, 20/20 hindsight, we all wish we
had that. You want that expertise so you don't have these kinds
of issues, you don't have these kinds of accidents, and that
you don't have information that may not be accurate, or really
relevant, to the area in which you are testing.
Can you talk to me about your conversations with the State
of New Mexico and the Navajo Nation, and whether you are
entertaining to support them, and fund them, and give them the
resources to assure that the public health of the citizens of
that state are protected?
Ms. McCarthy. Well, we are certainly going to do just that,
in a couple of different ways. We know a lot of those states,
and the Tribes, that were impacted by this spill have been
discussing with us reimbursement of their expenses, your state
did a great job at responding to that. We are sitting down with
them, looking at both a short-term monitoring program and a
long-term one that doesn't just look at the area of the spill,
but does a much broader look at the watershed in general. And
how we cannot just do that with EPA scientists, but they can be
engaged because they have scientific expertise. And
universities in your area have great scientific expertise.
EPA has identified funding for that, and we are going to
work with them to make sure that we do the monitoring that is
necessary to understand any impacts in the watershed.
Ms. Lujan Grisham. Great, because I think that robust
partnership will bring about credibility. I can't agree with
you more about that expertise, which leads me to the second
question I want to ask, which is related to the MS4 watershed
permits in the Middle Rio Grande. It is a completely separate
issue, but it includes 15 individual entities and
jurisdictions. The Middle Rio Grande region is one of three in
the country that were chosen to pilot a regional watershed
approach, and it is the only region in the western United
States to participate. And the problem is, as you are looking
at all of these water issues, or Clean Water related activities
you are including requirements that are developed for eastern
climates. And I don't think that we are using the right
expertise. And I will tell you that everyone in these affected
jurisdictions is really struggling in their relationship with
you, because the aspects of the permit do not make sense in
arid environments. And they, quite frankly, conflict with all
of our state water laws, and many of our Federal water laws
compacts.
Stormwater regulation needs to have the flexibility to make
sure that local managers can suggest alternatives that make
sense for an arid region. Are you aware that we are having
these conflicts, and do you see a way for us to have much more
flexibility so we meet your overall goals, and are
participating productively, but we can do it correctly?
Ms. McCarthy. Well, all of our water programs, by law and
by intent, is a partnership between EPA and the states. I did
not know that there were concerns that had been raised that
have not yet been resolved in these discussions, and they have
to be resolved. They have to be resolved in a way that makes
sense for those communities. And you are absolutely right,
flexibility is the key to doing that.
Ms. Lujan Grisham. I am out of time, Mr. Chairman. Thank
you for your patience again, and we will work with you to get
this resolved. Thank you, sir.
Ms. McCarthy. That would be great. Thank you.
The Chairman. The gentlelady's time has expired. Mr.
Gibson, 5 minutes.
Mr. Gibson. Thanks, Mr. Chairman. Ma'am, I represent parts
of upstate New York, 11 counties, 162 towns. Among those, the
town of Hoosick. And in Hoosick we have a village, Hoosick
Falls. It is a very proud area, and for good reason,
hardworking, good folks. And these are really challenging times
for Hoosick Falls right now due to a chemical that has been
detected, PFOA. We have not had potable water in Hoosick Falls
now for over 6 weeks. We are working on that. We have carbon
filtration process ongoing. We do think in several weeks we
will have potable water. And, at the same time, we are not
monitoring blood levels of the citizens, and we are beginning
the long process of a comprehensive health study. And we are
soon to begin the process of identifying the source of
contamination, and ultimately identifying an aquifer that we
can be confident in, going forward.
Ma'am, in March of 2015 we contacted the EPA, and the
response then was that PFOA was an unregulated chemical, and
that it did not pose a health risk. At the end of the year,
specifically on the 17th of December, EPA came out with a
statement and said that the water is not potable, and,
furthermore, that it posed a risk to health. And so my question
is, how do you go about making this determination, and what
changed from March to December?
And before you answer that, in my research, as I have
worked on this, I have come to find out that there are many
unregulated chemicals. And, ma'am, I think we need a method. We
are going to have to have a method that we then go through all
these unregulated chemicals, and have a way, hopefully with
analytics and automation where we can compress and go through
all the health data so that we can come to these
determinations. Because I can tell you, my people, they are
hurting, and they are very disappointed, and we are looking for
answers.
Ms. McCarthy. Well, I share your concerns, and your
interest in finding ways in which we can more effectively and
quickly address these new chemicals that are entering into some
of our water systems, and we are finding across the country.
Now, I believe that our region has been pretty aggressive in
working with the community, and I want to thank you, and the
community, for how quickly people have been reacting to this
situation, getting bottled water out, getting a new carbon
system in.
EPA has been trying very hard to keep up with new chemicals
that we are finding, to do the science behind that. There is a
systematic process to do that. That is written into the law and
the rules, about recommending first, identifying, going through
a listing process that is public before you can regulate, and
actually working with the states and local communities to adopt
those regulations.
Mr. Gibson. So, ma'am----
Ms. McCarthy. So it is----
Mr. Gibson.--just so I----
Ms. McCarthy.--a long process.
Mr. Gibson.--understand--I am hearing you. So is that the
answer to my question, is----
Ms. McCarthy. No, it is not. That is the preface of how
difficult it is now, and why I agree with you that we need to
do better. We are looking at more automation in how we do the
science around this. But, frankly, if Congress would continue
their push that they are on in re-upping the Toxic Substances
Control Act, we would have more ability to understand what
chemicals are going into products in the system, and what
challenges they may pose, so that we can be better able, in the
end, to find out where they are, and what they are doing, and
the science behind those.
Mr. Gibson. So from March to December, was there something
that changed in our understanding of PFOA, or was it just a
latency in understanding that there was a danger out there?
This is what I am not clear on.
Ms. McCarthy. Yes. I will have to go back and talk to the
region, because I am not sure that I can specifically answer
your question. I believe that the testing that was provided to
the region early on was in a system that wasn't currently in
use. But when we found out that there were existing drinking
supply wells that were being used, part of the challenge for us
was that our recommended levels in some cases was fairly high,
is currently being reconsidered.
We were trying to give the best information that we had,
based on the science we knew, and that is why there was
continued debate back and forth on the level, and what was
safe, and what wasn't. But that is because the science was
changing, and the tests were changing, and what we knew to be
the case, in terms of what people were drinking, was changing
as well.
Mr. Gibson. Okay. Ma'am, we will stay in touch on this. Mr.
Chairman, I am going to have to submit for the record a second
question that has to do with the Hudson River. And, with that,
I yield back.
The Chairman. The gentleman yields back. Ms. Kuster, 5
minutes.
Ms. Kuster. Thank you, Mr. Chairman, and thank you to the
Administrator for being with us today. Always great to have a
New Englander in our Committee. I will be quick. I have two
questions. The first one relates to this Waters of the United
States rule, in conjunction with the EPA regulation on
pesticides, and the Fish and Wildlife ruling regarding the
long-eared bat. And my question on behalf of farmers,
landowners, and timber owners in New Hampshire is how will your
Agency coordinate with USDA and Fish and Wildlife to minimize
confusion about the interplay between these three rules? If you
follow.
Ms. McCarthy. That is a very good question that I am not
sure I can answer. I will have to get back to you, because you
have just baffled me with the bat question, connecting with the
Clean Water and the other issues I understood.
[The information referred to is located on p. 66.]
Ms. Kuster. Yes. I mean----
Ms. McCarthy. That one threw me----
Ms. Kuster.--basically, I am trying to get some guidance,
because I have more trees than people, so it is a big timber
area. I have farmers, I have landowners working on
conservation. And as these three rules come together, it is
obviously going to limit the way they can use their property.
And I just want to try to get them some guidance, because I
just wonder if there is coordination. That is basically what I
am looking at.
Ms. McCarthy. Well, certainly I haven't been a part of it,
so I better figure it out.
Ms. Kuster. That would be great. Thank you. Thank you very
much.
Ms. McCarthy. Okay.
Ms. Kuster. Yes, the bat threw me the first time too, but
apparently it is an important bat.
Ms. McCarthy. Well, they all are. They all are.
Ms. Kuster. And then the second question, this relates to
the Clean Power Plan, and the biomass energy. I am the co-Chair
with my Republican colleague, Mr. Westerman, of the Biomass
Caucus here in the Congress. I understand that the Supreme
Court issued a stay this week on the Clean Power Plan.
My question goes beyond the stay. There is confusion in the
biomass energy world regarding whether or not biomass will be
treated as a carbon neutral form of energy. We have submitted
letters to you. I am just curious whether a determination has
been made, and whether biomass will be treated as carbon
neutral under the Clean Power Plan.
Ms. McCarthy. Well, that is a question I understand, so
thank you. You helped me recover a little bit. Biomass is
actually a really important part of, and we expect it to be,
many states' compliance strategies that they would use for the
Clean Power Plan. And so we know that there have been questions
raised. The rule itself identifies biomass that we think is
carbon neutral that would be enormously helpful to consider,
but we also recognize that there are other things that the
states are looking for, for guidance.
So we have actually notified folks that we are going to be
pulling together a workgroup, and we are doing webinars on this
to get people up to speed so that we can have the right
questions, and develop the right answers, for how a state can
feel confident to have biomass be an effective part of their
compliance strategy. We are sure it will be, but there are
uncertainties about what EPA might approve, and we want to make
sure that we are working with everybody to get that done.
Ms. Kuster. So I would love to just issue an invitation
from the Biomass Caucus. We would love to set up an event here
on the Hill with your team to educate Members of Congress, as I
say, bipartisan from all over the country, to learn more about
this interpretation, and then we can help to take that----
Ms. McCarthy. That would be great. I know that many of your
Members have prompted this----
Ms. Kuster. Great.
Ms. McCarthy.--workshop to happen. Maybe we could do it
right after, and we can give you a sense of where we are.
Ms. Kuster. Okay. That would be great. I have to go to
another committee, but I will have my staff stick around to
connect with you. Thank you----
Ms. McCarthy. Thank you.
Ms. Kuster.--so much. Thanks for being here, and I yield
back.
The Chairman. The gentlelady yields back.
Ms. Kuster. With time to spare.
The Chairman. I noticed that. Thank you very much. Mr.
LaMalfa, 5 minutes.
Mr. LaMalfa. Thank you, Mr. Chairman. Ms. McCarthy, I
appreciate your attendance here today, and willingness to
answer all these questions. Just to tag off of something Austin
Scott talked about a while ago, where there is a great concern
amongst the racing community, and the car enthusiasts, that you
have a regulation coming down on basically stock cars that have
been converted for racing. If you want your outfit to be known
as the Entertainment Prevention Agency amongst millions of
racers around the country, I would certainly recommend not
pursuing that, so please check into that, and----
Ms. McCarthy. I will, sir----
Mr. LaMalfa.--let me hear your answer on that.
Ms. McCarthy. Thank you.
Mr. LaMalfa. Now, a follow up on something from a couple
months ago with one of your colleagues too. We have in my
district something known as Iron Mountain Mine, above Redding,
California. It is above the Sacramento River, which affects
water supplies for 20 million Californians, and many, many
hundreds of thousands of acres of agriculture. Iron Mountain
Mine's situation wouldn't be that much different than the Gold
King Mine, and the Animus River situation as well. So I had
asked for a report a couple months ago from that. So would you
please see to it that I can get that report so that I know that
our----
Ms. McCarthy. Yes, sir.
Mr. LaMalfa.--situation there is stable on that? Because we
certainly can't have that affecting that many Californians on
that mine. So thank you.
Ms. McCarthy. Sure.
Mr. LaMalfa. On the issue of Section 404, and the
exemptions that are provided for agriculture under the Clean
Water Act, normal farming activities, ranching, forestry, et
cetera, including repeat plowing, seeding, cultivating, minor
drainage, harvesting for that production of the food and the
fiber and forest products, conservation practices, et cetera,
no additional requirements, for example, that an activity be
continuous are included.
Some of my constituents are continuous cropping on these
lands, otherwise you lose your ability to have that exemption.
Nowhere in the law does it specify that, but that is what is
being carried out in my district by EPA or your associates.
Sometimes we refer to them as henchmen, but in the Army Corps
of Engineers that are carrying out some very outside the law
activities with this regulation. So do you agree that section
404 does make no additional requirements that an activity be a
continuously cropped, as we see it in the law?
Ms. McCarthy. I am not aware of it, but I certainly will
have to get back to you on it, sir.
[The information referred to is located on p. 66.]
Mr. LaMalfa. Okay. So continuous cropping activities, we
feel, are not required under the----
Ms. McCarthy. And I don't know what actions you are
referring to, so I should dig into it.
Mr. LaMalfa. Well, they are coming down hard on people,
fining them, or making them, in some cases, seek permits to do
what they have been doing. Or if they just let the land idle
for a few years, which is good, fallowing the land, and----
Ms. McCarthy. That is what people do, sure.
Mr. LaMalfa. Sure. And for market conditions, whatever
those might be. You shouldn't have to have a new permit--which
sometimes folks seeking permits are afraid they are going to
end up with a 3 year waiting process for getting the permit
issued to them, is the EPA or Army Corps going to pay their
land payments and tax payments while they sit and wait for
these decisions?
I have another one so I have to go fast, I apologize.
Section 110 of the Consolidated Appropriations Act of 2016
specifically prohibits funds from this Act for being used to
require a permit for the regulation. That is what was alluded
to my colleagues a while ago. Are you aware of that exemption
under section 404 as well, under that appropriation? It was an
appropriation amendment that specified no funds are to be used,
so----
Ms. McCarthy. For which specific----
Mr. LaMalfa. It was under Section 110 of the Appropriations
Act of 2016 that no funds are to be used under Section 404
requiring these permits.
Ms. McCarthy. No, I am not aware of it. I will look at it.
Mr. LaMalfa. Okay. Well, that is a direct law put in place.
So I will look forward to your answers on that.
Ms. McCarthy. Thank you.
Mr. LaMalfa. Again, moving quickly here, EPA and Army Corps
of Engineers continue to rely upon EPA's interpretation of the
Clean Water Act, imposing these regulations that stray far from
the Congressional intent. Again, indeed, you mentioned several
times following the law. It is pretty clear in the law and the
exemptions, and then follow up by these amendments and the
Appropriation Act that we have done here. So we believe that we
are the ones that set that course there, and that the EPA is to
follow it.
So as long as they have exceptions to the exemptions, and
that is where it is very problematic. There are exemptions on
that, but if the EPA is looking for exceptions to exemptions in
your rulemaking, then who is making the law here? That is what
a lot of people are really concerned about, is that we are not
the lawmakers anymore. Will you direct your Agency to cease
regulating activities that the Clean Water Act exempts?
Ms. McCarthy. We should not be doing anything other than
exempting those activities.
Mr. LaMalfa. Okay. Thank you. My time has expired. I will
have some follow up questions. I appreciate, again, your
answers today.
The Chairman. The gentleman's time has expired. Mrs.
Walorski, 5 minutes.
Mrs. Walorski. Thank you, Mr. Chairman. And, Administrator,
thanks so much. I am over here. I said hello earlier, and I
again wanted to invite you to northern Indiana, to my district,
for a couple of reasons. So I have sat here, and you have too,
for 2 hours, and here is the issue in my district. In northern
Indiana, who I represent, we have one of the largest
manufacturing districts in the country, not just the Midwest.
In the southern part of the state, we have coal mines, and we
are strewn throughout with ag, heavy agriculture, as well.
And so, I look at this, and I have said since the day I
came to Congress, and even prior, Indiana is a good role model
for being good stewards of the environment, being good stewards
of the economy. And I could show you in my district places
where we are really out of the box, and we are doing things
that are incredibly creative to be such good stewards of the
environment. But nobody is a better steward of the environment
than the family farmer, because their complete livelihood
depends on taking care of that area. So I do agricultural tours
every single time I am in the district, and on the last
agricultural tour, we have been able to diversify. We have been
able to do great things in our state. We have been able to do
some really clean water, things that are exemplary.
When I came away from there--and I am old enough to
remember when the EPA was really considered a partner with
industry, a partner with farmers, and really kind of came
alongside, especially in our state. We have an incredible
Indiana Department of Environmental Management that comes
alongside. Not to be punitive, not to penalize, but to
incentivize, and to keep people from really getting in trouble.
I came away from this agricultural tour really having an
understanding that, in my mind, what I heard from my farmers,
is that today's EPA has become a punitive revenue generator for
big government.
And it bothers me, because I sit on this Committee, and I
know there are a lot of well intentions, but when it comes to
this WOTUS rule, and I understand exactly why the frustration
is so high in this room on both sides. This is not a partisan
issue today. This is an issue of Americans, and farmers, and
Members that represent them trying to come to grips with an
understanding, in a state like Indiana, we are in a target
virtually in every single portion of what we do and what we
lead our nation in, in coal, in ag, and in heavy manufacturing.
The toll on jobs because of this issue of heavy handed
government; there is really no other way to explain it. I
understand your intention, but I also understand that I have
been around long enough that we have been able to have great
gains in this country with a partner in the EPA.
And when we talked about humility, and we talked about
attitude, there is a gigantic tone problem. When I come out of
my district hearing from people from all over the state saying,
it is a punitive regulating system, and when EPA comes calling,
we don't even have chance to even implement rule number one,
and here comes implementation of rule number two. And I am
curious, especially on WOTUS, because I agree with my
colleagues here. I would ask you to pull this rule and bring
stakeholders around this, and let us do it right. Let us do it
balanced. I am not calling for one extreme or the other. I
believe there is a balance between good stewards of the
economy, and I can tell you that my state does that.
But my question is this. So when we talk, on one hand you
say the EPA doesn't intend to regulate every ditch. On the
other hand, we look at actual implementation of the rule. The
ditch exemption appears to leave some room. So here is my
question. So is the ditch exemption automatically given if a
business, farmer, or local government believes it is exempt, or
do they have to prove it is exempt?
Ms. McCarthy. The way in which the law works is that, if
there is a question that you are going to be destroying or
polluting what might be a water----
Mrs. Walorski. A question from the EPA?
Ms. McCarthy. No. That would be the individual landowner
might be concerned that their activity would be doing that, and
they may be----
Mrs. Walorski. On their private land?
Ms. McCarthy. On their private land or elsewhere----
Mrs. Walorski. Yes.
Ms. McCarthy.--then that question is raised by that
landowner, and they ask the appropriate questions. That usually
and often goes to USDA or others, and filters its way through.
But we are not changing the dynamic of how the rule or how the
guidance was implemented----
Mrs. Walorski. Yes, but let us just say worst case
scenario. Worst case scenario, some farmer ends up with
somebody, somehow, says that he is not in compliance, and he
must do X, Y, Z. Would the Waters of the U.S. Rule, as it is
now, and what we are talking about with this exemption, could a
farmer potentially face any kind of legal action if he was
strongly on the side that he is not out of compliance, and
somebody from EPA comes in and says, you are? If this goes all
the way to the end, could somebody, like a farmer, be
penalized, and face legal action, and have to defend himself on
a question of water on his own land?
Ms. McCarthy. There have been enforcement cases. There have
not been a great deal, compared to the way in which people get
to work together to answer these questions, and to get permits
done. I will honestly tell you, in my heart of hearts, we
worked very hard on this rule to make the clarity you need so
that you, as a farmer, can actually be assured that if someone
asks that question, you know the answer.
Mrs. Walorski. Yes, I know. In all honesty, you missed the
mark, and I would again ask that this rule be repealed, and we
go back and----
Ms. McCarthy. Right.
Mrs. Walorski.--allowed to come to the table. Thank you,
Mr. Chairman.
Ms. McCarthy. I appreciate it.
Mrs. Walorski. Sorry for the extra time.
The Chairman. The gentlelady's time has expired. Mr.
Abraham, 5 minutes.
Mr. Abraham. Thank you, Mr. Chairman. Thank you,
Administrator McCarthy, for being here. I will echo, certainly,
the bipartisan support you have seen here, that our farmers,
ranchers, foresters, aquaculture farmers, they are their own
best stewards of their property. They are not going to do
anything to harm their livelihood, but, more importantly,
nothing to harm their children and their family.
To Mr. Austin Scott's reference of asking you the price of
cotton, I won't put you on the spot and ask you the planting
season of cotton, or corn, or soybeans, or anything like that.
But it lends to the question: I am fearful that the EPA, as a
bureaucracy, wants to literally drive the car, but doesn't know
how to start the car. And when you don't know the basic facts
of growing times, when you apply pesticide, and how important
those windows are to maintain agricultural integrity, then it
begs the question of who should know these answers? And my
answer to myself is you should know.
We talked about pesticides, so I am going to go to my
questions here, and with respect to your Agency's roles in
reviewing and approving the use of pesticide, does the EPA
examine the health and safety of an herbicide under the Federal
Insecticide, Fungicide, Rodenticide Act any differently if its
proposed use is tied to a genetically engineered plant versus
if it is not? And does the Agency meet its registration
obligation equally in both cases? So I guess my question, is it
common for products tied to GE plants to be at your Agency
several years while registration dates are renegotiated
multiple times?
Ms. McCarthy. My understanding is that we have had a great
deal of success in eliminating extensions of time overall for
all of our program. Actually, quite remarkably. We are mostly
keeping to those windows. Are there additional challenges with
genetically engineered products? If they are, then that is
where the science comes in, and we explore it. They are not
treated differently than looking at how we always look at
pesticides, which is by the science, trying to stick with the
legal timelines in windows that we have to make our decisions.
Mr. Abraham. And I will follow up with a question on the
science issue. The President has stressed the importance and
the value of transparency, and EPA's actions to ensure the use
of sound science and reliable data. EPA is increasingly reliant
on epidemiological and modeling data, looking at the
occurrences, correlations, and extremely unlikely scenarios to
essentially overrule volumes of actual hard science, laboratory
and monitoring data, historically relied on around the world
for decades. Why was this fundamental change in policy not put
out for public notice and comment so that impacted stakeholders
would have an opportunity to comment on this transition to such
a heavy reliance on just the worst case scenario presumptions,
modeling, studies?
Ms. McCarthy. I am not aware that there has been any change
in policy direction, sir, so I am happy to look at the specific
decision that you are referring to.
Mr. Abraham. I will look forward to that answer, because I
am under the understanding that there has been quite a
transition away from the hard science in looking at----
Ms. McCarthy. So I am happy to answer it, if that is a
concern.
Mr. Abraham. And my last question: let us keep dealing with
this raw data, this hard science. I have heard about serious
matters regarding EPA policies based on human research data
that may not be reliable. For years EPA has relied on hundreds
of quality studies, evaluating all aspects of human
susceptibility to pesticides. These included studies designed
to make sure that children would be protected, and certainly we
want that. Even though EPA uses those high quality assessments
for 20 years, EPA now relies primarily on epidemiology studies,
and some journal articles in which EPA has never, I am told,
again, seen the raw data to determine if these studies are
reliable or accurate. Case in point, I am told that Columbia
University, who conducted a key study, refused to provide the
raw data to EPA, even though EPA partially funded the study.
EPA has likely relied on information based on raw data that
cannot be reviewed for accuracy. And I am running out of time,
and I will submit this question, is it correct that the EPA has
not gotten access to that raw data, or are you simply refusing
to disclose them? And if you have the information, why are you
not disclosing that information for the public to review? And I
will look forward to your answers to that question. I yield
back, Mr. Chairman.
The Chairman. The gentleman yields back. Mr. Newhouse, 5
minutes.
Mr. Newhouse. Thank you, Mr. Chairman. Administrator
McCarthy, thank you for being here. Let me start by calling
your attention to a letter I sent to you last month in regard
to a company called Omak Wood Products. It is Omak, Washington,
Okanogan County. As you know, we have had, the last 2 years,
record setting catastrophic fires, wildfires.
Ms. McCarthy. Yes.
Mr. Newhouse. It has had a tremendously negative impact on
our communities. This Omak Wood Products Company is one of the
largest employers in this small community. I think over 185
people work at the mill, $60 million impact to the community.
Unfortunately, they have announced recently that they plan to
shut down at the end of February. The people in the City of
Omak are working very, very hard to find someone to come in and
take over the mill. One of the issues, though, is they don't
have an operating permit. Two years ago EPA promised a re-write
of the permit that would more accurately reflect the operations
at the plant. And I can tell you, without that permit, they are
having a very difficult time finding anybody interested in
reopening the plant. So if you could look into that, I would
very much appreciate your attention.
Ms. McCarthy. I would be happy to do that.
Mr. Newhouse. I have a copy of that letter. It is submitted
for the record, but I can give you another copy, if you----
[The information referred to is located on p. 65.]
Ms. McCarthy. That would be great. Thank you.
Mr. Newhouse. I have a couple of questions, Administrator.
Section 303 of the Clean Water Act clearly gives the states the
authority to develop water quality standards and then submit
those plans to you to confirm that they comply with the CWA.
Ms. McCarthy. That is correct.
Mr. Newhouse. I don't think Section 303 gives EPA power,
though, to establish those criteria for the state, and last
year EPA indicated it would reject the State of Washington's
water quality standards on the basis of two things. First, that
it doesn't account for the consumption of 175 grams of fish per
day which, I might add, is the equivalent of eating 38 cans of
tuna a month. And second, for people who actually consume that
much fish, it doesn't account for the cancer risk level of
10-\6\, or 1/
1,000,000. So I
am concerned that your Agency's proposed rule is significantly
more stringent than required to protect human health, it is
inconsistent with existing policy, and could cost my state
billions of dollars for compliance. Could you discuss for me
just real briefly, I know we have a short amount of time on how
EPA arrived at these levels, and explain why your Agency is
seeking to impose standards that far exceed your own water
quality guidelines for states?
Ms. McCarthy. Well, I am very familiar with this issue, in
terms of work that is going on between the State of Washington
and EPA, where the State of Washington has recently proposed
water quality standards. We have been starting a process to do
that ourselves. We are perfectly happy to defer to the state on
their water quality standard, should those come out in a way
that we think does two things, is safe for human health, as
well as protect the Tribal treaty rights which we are obligated
to protect, under treaty law.
Mr. Newhouse. Okay. Well, let me follow up, then, real
quickly. For your proposed cancer risk level, in order to have
a 10-\6\ you would need to reduce some of the agents
on the EPA's toxic pollutant list to get this less than the
naturally occurring levels. That means that the river, as it
flows naturally, would not meet the levels.
A 2013 study conducted by Washington State industries,
counties, and municipalities found that even the most advanced
technology available, and with billions of dollars in upgraded
resources, few facilities would be able to meet those
standards. So my question is, where does EPA think it derives
the authority and the power to tell states they have to meet
these standards that they have no part in formulating, and,
number two, are in no way grounded in sound science?
Ms. McCarthy. Well, we can certainly have this
conversation, because I know we are running out of time, but I
will assure you that the region working on this, our Region 10,
is in close contact with Washington and stakeholders in the
business community there to understand how we can come to a
conclusion, either through the state effort or our own, to be
reasonable, rational, make sure we have standards that can be
achieved, and that no way take away the flexibility that states
have in terms of how they achieve it.
Mr. Newhouse. I appreciate that answer. I do have more
questions, but I will have to submit them for the record.
Again, thank you for being here.
Ms. McCarthy. Thank you.
The Chairman. The gentleman yields----
Mr. Newhouse. Thank you, Mr. Chairman.
The Chairman.--back. Mr. Kelly, for 5 minutes.
Mr. Kelly. Thank you, Mr. Chairman, and thank you,
Administrator, for being here. My first question is: 3 years
ago Mississippi farmers and beekeepers created a Mississippi
Bee Stewardship Program to enhance cooperation and
communication between beekeepers and pesticide applicators.
This has increased not just goodwill between these two groups,
but we expect to find that this has increased pollinator health
as well.
Unfortunately, despite the good work that Mississippi is
doing, the EPA is undermining those relationships. While both
our farmers and beekeepers thought they had addressed many of
their pollinator and pesticide issues, farmers in my state are
losing access to key products, and will be unable to protect
their crops from pests, threatening their livelihood.
Additionally, beekeepers have concerns that an economic hit to
the farmers would mean that they would be unable to host bees
on their farms. Please explain to me what EPA is doing to
ensure that my constituents will have the time proven products
and the new effective products available to meet their needs.
Ms. McCarthy. Well, one of the things we should really talk
about where this concern is coming from, because I know, in
working through the pollinator strategy, we recognize that one
of the key things that needed to be done is an agreement and an
understanding between beekeepers and their own farmers about
how to protect those pollinators, while at the same time
allowing those crops to be properly managed. So if there is a
disconnect there, I would really love to understand that,
because it was one of the highlights that said the Federal
Government doesn't need to get involved in this, as long as
that communication is working and happening. And so if we have
missed the boat, I would really love to be able to work with
you on it to figure out how we might turn that around.
Mr. Kelly. And I will. I will make sure that we get you
that information so you understand, because they actually
started before you asked them to and now they feel like they
are----
Ms. McCarthy. Exactly. This is the conversation we wanted
to have happened.
Mr. Kelly. Okay. I was going to joke about our accents,
because I didn't know if we needed an interpreter or not,
because we speak a little different English.
Ms. McCarthy. I can understand you.
Mr. Kelly. But after the hearing today, I am not sure that
we are not different in more ways than just our accent. And one
of the smartest terms I heard today was regulatory humility.
Ms. McCarthy. Yes.
Mr. Kelly. And I can tell you, I have not seen that
displayed. And, if you look back, you have 32 states who have
filed a lawsuit over WOTUS. I think you have both the House and
the Senate who the majority of Members, regardless of which
party, think it is not being implemented correctly. I think you
have courts that are saying that it is not being implemented
correctly. And what I see is the EPA sticking a flag in and
saying, we are right, and the rest of America is wrong. We are
right, and we will defend--and I have heard several times you
say, we defend this action. I don't agree with what the court
said on that. I don't agree with GAO that we broke the law. I
don't agree with this. We will defend our science, we will do
this. That is not humility. That is the opposite of that. That
is arrogance. I am smarter than you, I don't care how many of
you are, and how many different backgrounds you come from, but
I am smarter than you, and I am right, and you are wrong. And a
Member asked you earlier, repeal WOTUS. Do away with it. It is
not that it is a bad idea, but the rule that we have now, I can
tell you that the majority of America does not believe protects
them, and they believe it is punitive, and not helpful. We need
clean water. No one understands that more than me.
One of the most crucial resources we have in America is
clean drinking water, is water to water our crops. We all want
the same thing. But the rule that we have now does not
accomplish that. But we are so entrenched that we have to have
this rule. And if you would repeal the rule, step back, get
with Congress, get with farmers, get with environmentalists,
get a whole group of people in a room and say, what do we want
to achieve, and what is the most effective way to do that? And
let us all take our pride out of it, because we are all
prideful, regardless of what we are. But to get back to the
humility, and get the smart people in the room, get a group or
a commission together, and let us come out with a WOTUS that
works. Because I can tell you, businesses, farmers,
legislatures, courts, everyone right now knows that this WOTUS
rule that we have is not the right rule. Let us quit sticking a
flag in the ground and defending something that doesn't work,
and let us come up with something that does protect our clean
drinking water. And, Mr. Chairman, I yield back.
The Chairman. The gentleman yields back. Mr. Goodlatte, 5
minutes.
Mr. Goodlatte. Thank you, Mr. Chairman, and welcome,
Administrator McCarthy. I want to go back further than WOTUS
and talk about the EPA's Chesapeake Bay TMDL scheme, because
that really is the precursor to what is going on nationwide
with WOTUS. I think that you would agree that the Bay TMDL is
both significant and unique for a variety of reasons. In fact,
early in the implementation process, EPA documents mentioned
that many specifics of the Bay TMDL were novel in comparison to
past EPA TMDLs, and that this blueprint could serve as a
template for other watersheds throughout the nation. Further,
the concerns voiced by agriculture, forestry, and home building
industries, in addition some local communities, and to the
TMDL's numerous legal challenges, speak to the enormous impact
that the EPA's actions have had, and will continue to have, in
the Bay region. Given this, shouldn't the EPA have conducted an
analysis to estimate the cost of such an important rule?
Ms. McCarthy. It is my understanding that we have been in
that process of----
Mr. Goodlatte. Since 2009, and you are almost to the
halfway assessment point, and you have implemented this
process, but have never done a cost-benefit analysis to
determine whether the cost of this to all of these parties
isn't--and the taxpayers of my district, and all the other
districts in these six states isn't greater than the benefits
to the Bay?
Ms. McCarthy. Well, sir, what we tried to do was to allow
states the flexibility to choose their own paths forward. And,
because of that, it would have been extraordinarily difficult
to provide any certainty about what that cost might be----
Mr. Goodlatte. That is actually not what happened, if I
may, because the states have, for the past quarter century,
done just that. And in fact, that is what the Clean Water Act
provides for. It says that the Federal Government gets to set
the standard, and the states get to write the plan, and
implement the plan to meet the standard. And a lot of progress
was made over those 25 years. Sedimentation has been reduced in
the Bay by more than 50 percent, nitrogen and phosphorous by
more than 40 percent, before this TMDL ever even began. And yet
the EPA said, that is not good enough, and went ahead with
putting pressure on the states, threatening the states that if
they didn't change the way they did it, that there would be
costs and other consequences to them.
So, in fact, up until March of 2009, your Agency had
assured us that no TMDL would be implemented before there was
an economic analysis. So how much has your TMDL cost the
affected states, and on average, how much has the TMDL cost the
average farmer or producer in the Chesapeake Bay Watershed?
Ms. McCarthy. I can't answer that question yet.
Mr. Goodlatte. I know you can't, because you never did the
homework. You never did the work necessary to prove that this
was a worthwhile undertaking. The Commonwealth of Virginia
estimated that the cost just to Virginia alone would be more
than $16 billion. But the EPA never came back and said, ``Well,
here is a calculation of the added benefits, benefits beyond
what was already taking place.'' The Chesapeake Bay is getting
healthier, has been getting healthier for many, many years.
That is a good thing. We all support that. But when you take
the law into your own hands, and do it contrary to what the
Clean Water Act provides, you get lawsuits, rather than
progress.
Your Agency has been implementing the TMDL for several
years now, and, in fact, I understand that next year you will
be releasing the Chesapeake Bay TMDL midpoint assessment.
Therefore it would seem that you would have had ample time
to conduct such an analysis of the cost and the benefits of it.
Why did you not conduct an economic analysis prior to
implementation, or at least at some point in the last few
years?
Ms. McCarthy. Sir, we are in the midst of that process. I
do not know when it will be completed. My understanding is that
it is being worked on by the Agency.
Mr. Goodlatte. You may well be well past the midpoint
assessment before you ever determine whether this should have
been done in the first place. And, therefore, all of the costs
that have gone forward, if they were not justified, then the
EPA should not have issued regulations without having that done
first. Does the EPA not view the financial impact of the rules
it inflicts upon America's farmers, and homeowners, and
taxpayers, and small communities that dot the Shenandoah Valley
in my district, do you not view that financial impact to be of
importance?
Ms. McCarthy. One of the reasons why we are doing the TMDL
the way we are is to allow not just us to consider the most
cost effective paths forward, but allow the communities
themselves.
Mr. Goodlatte. Mr. Chairman, my time has expired, but I
really have to express my ongoing dismay that this Agency, for
all these many years that we have been talking about this, have
received just that, talk, and no information that would justify
this major impact on these six states, which have, quite
frankly, the guinea pigs for the rest of the country, which is
now facing a similar assault under WOTUS, and why both of those
measures are now before our courts. Thank you, Mr. Chairman.
The Chairman. The gentleman's time has expired. Mr.
Moolenaar, 5 minutes.
Mr. Moolenaar. Thank you, Mr. Chairman. Administrator
McCarthy, thanks for being here with us today.
Ms. McCarthy. Thank you.
Mr. Moolenaar. I am from Michigan, and am neighboring
Genesee County, and would like to talk with you about the Flint
water situation. And, as of yesterday, there were some concerns
raised by a family in Flint, and you may have heard these
concerns, but their point was: Melissa Mays, as reported in the
Detroit Free Press, said that we saw more information on Google
than we did from the EPA. We asked them for help, and got
nothing. And I guess what I would like to ask is have you been
to Flint.
You were there, I believe, on February 2, and really put
the focus of blame on the state. And the Governor has
apologized, people have lost their jobs in the state over this
matter. The EPA Region 5 Administrator, Susan Hedman, resigned.
Was that over the Flint water situation?
Ms. McCarthy. Her explanation to me was that it was because
she knew that she had already become a focus of attention, and
she thought the entire focus should be on what we do for the
people of Flint. It was a courageous act on her part.
Mr. Moolenaar. Do you still maintain, as you did when you
came to Flint, that the EPA did everything right?
Ms. McCarthy. I did not maintain that. What I said was that
a situation like Flint should never have happened.
Mr. Moolenaar. Right.
Ms. McCarthy. I explained what I thought were inadequacies
of the state oversight and primacy. They are the ones that have
the authority under the law, and they are the ones with the
primary obligation. But I in no way said that EPA had done some
kind of thorough analysis of what else we could have, or should
have, done.
Mr. Moolenaar. Well, let us just analyze it for a minute
here, because my understanding is the EPA was aware as of
February of last year that corrosion controls that would have
prevented lead from leeching from the pipes were not being
implemented, that there were serious concerns about raised
levels of lead. In fact, above the enforcement action level of
the EPA.
EPA was aware of that, and did nothing. And we are almost a
year later, and the EPA did nothing. Can you explain to me why
that happened?
Ms. McCarthy. Well, I would say that, I believe, in April
of last year was when the state actually told us, and corrected
a misimpression they gave us, that corrosion control was not
happening. EPA vigorously, from that point forward, recommended
to the state that they take action to get corrosion control up
and running. Were there other things that we could have done,
or should have done? That is the focus of our attention at this
point.
Mr. Moolenaar. If I could----
Ms. McCarthy. But we did oversee this and recommend the
appropriate steps for the state to take.
Mr. Moolenaar. Okay. So you are saying that was in April?
Ms. McCarthy. I believe so.
Mr. Moolenaar. My understanding is that on February 25 a
resident from Flint, Ms. Walters, who had four children who
have lead poisoning----
Ms. McCarthy. Right.
Mr. Moolenaar.--contacted Miguel Del Toro, a manager at
your EPA----
Ms. McCarthy. Yes.
Mr. Moolenaar.--Midwest Water Division, informing him that
Flint is not treating water with standard corrosion controls
that prevent lead pipes from leeching lead. Also, Del Toro,
your employee, learned that the taps were being pre-flushed for
several minutes prior to sampling when they did water tests on
this. So that is February 25. The EPA has been notified that
the corrosion controls are not being implemented, and that the
testing process is flawed.
Now, my understanding is, under the Safe Drinking Water
Act, you have the authority for action authorized when there is
imminent and substantial endangerment to health. And so my
question is, if you knew this in February, why was there no
action taken for almost a year?
Ms. McCarthy. Well, my understanding in February was that
we did ask the State of Michigan whether or not corrosion
control was happening. They gave us an indication that it was.
We relied on that, but at the same time, we did work
specifically to test Ms. Walters's home, and it is not unusual,
nor is it an indication of corrosion control happening or not,
to have a high lead level in a particular home. That can occur
for a variety of reasons, including a disruption in the street.
So one house does not dictate whether corrosion control is
happening and effective. But in no way did Miguel ignore this
individual's circumstance----
Mr. Moolenaar. And believe me, I am not saying----
Ms. McCarthy.--or contact the state.
Mr. Moolenaar. I am not saying Miguel did it. I am saying
the upper levels of the EPA did, and that is where I am,
because Miguel actually e-mailed colleagues at the EPA,
relaying his concerns about this faulty testing mechanism. And
also, in follow up tests, when they actually used the right
testing mechanism, there were lead levels of nearly 400 parts
per billion, 27 times the EPA's threshold. That is March 3,
again, almost a year ago, and still nothing happened.
Now, I want to go again to June 24, again, when Mr. Del
Toro wrote to the head of the EPA's Drinking Water Division,
calling Flint's lack of corrosion controls a major concern.
Again, no action from the EPA. Finally, I am told, that, rather
than taking action, a legal opinion was requested on the
authority of the EPA to step in, I have to believe that anyone
who looks at the documentation of the law would be able to give
the opinion that the EPA has authority in this matter. Wouldn't
you agree with that?
Ms. McCarthy. Well, when you say no action was taken by
EPA, you minimize the communication that EPA had that we
normally have with states, that are very clear that corrosion
controls should have been done from day one, and it needed to
continue.
Mr. Moolenaar. If you----
Ms. McCarthy. It was the State of Michigan that was
challenging whether or not additional testing was necessary to
make that determination.
Mr. Moolenaar. And people have lost their jobs over that.
Now the question is, if you knew that it wasn't happening, why
did you not take action?
Ms. McCarthy. I can explain to you my interaction with
that, but it is a much longer conversation----
Mr. Moolenaar. Well----
Ms. McCarthy.--than that. We clearly did everything we
could to get the State of Michigan to do what they were
supposed to do. When I became aware and engaged, that is when
you saw an enforcement action taken.
Mr. Moolenaar. And my understanding is the communications
between the EPA Region 5 regarding this matter have been
requested. The Governor has released all of his communications.
When can we expect to see the documentation on the
communications from Region 5 EPA?
Ms. McCarthy. We have numerous FOIA requests that are in--
--
Mr. Moolenaar. But this is pretty important.
Ms. McCarthy. There is nothing actually more important
right now than getting that city clean water. And you will see
a large Federal presence, including EPA, who is responsible to
get that done.
Mr. Moolenaar. Okay. Well, when----
The Chairman. John, you are well over.
Mr. Moolenaar. Thank you, Mr. Chairman.
Ms. McCarthy. But I will respond, sir.
Mr. Moolenaar. Well, I would like to know when you are
going to have those documents public, I guess is the question.
Ms. McCarthy. Okay. I will be happy to take that back. We
have a number of requests. I don't know what the schedule is.
The Chairman. The gentleman's time has expired.
Mr. Moolenaar. Thank you, Mr. Chairman.
The Chairman. Mr. Davis, 5 minutes.
Mr. Davis. Thank you, Mr. Chairman. Administrator McCarthy,
thanks for being here. Did your staff prepare for a question
from me about individual septic systems being included in the
definition of a sewage treatment facility in the WOTUS rule?
Ms. McCarthy. No.
Mr. Davis. They did not?
Ms. McCarthy. Should I slap them?
Mr. Davis. Yes. I believe last time, at a Transportation
and Infrastructure Committee hearing, I said they should be
fired if they didn't do it, because this would be my fourth
time. Do you believe individual septic systems are included in
the language that says sewage treatment facilities should be
exempt from the WOTUS clarification?
Ms. McCarthy. I am not familiar with the issue, sir, so I
don't want to venture a yes or no answer.
Mr. Davis. I will remind you, at a joint hearing between
the House and the Senate on Transportation and Infrastructure,
I did ask you the same question----
Ms. McCarthy. Really?
Mr. Davis.--and your response was that we don't regulate
individual septic system discharge for non-source point
pollution. But you do, and I still have yet to have my question
answered if they would be considered under the sewage treatment
facility exemption under the existing WOTUS rule. I don't have
a lot of time left. I have some other issues I want to get to.
Ms. McCarthy. Sorry. I am sorry, go ahead.
Mr. Davis. That is okay. I will get back to you, and I will
give you guys another chance at the next hearing. But I am
disappointed that your staff once again did not have a prepared
answer on this, knowing that I was going to ask for the fourth
time. That just makes me, as a Member of Congress, feel as
though this is more of a check the box issue for the EPA, and
those who work with, and----
Ms. McCarthy. I wouldn't want----
Mr. Davis.--I am sorry that they did not prepare you for
that. But I----
Ms. McCarthy. I have great respect, and I would not want
you to think that.
Mr. Davis. I, as a former staffer, would not put you in a
situation like that again. This is very disappointing to us,
and I am disappointed in those that are sitting behind you. I
do want to ask you, I know you mentioned earlier in the
hearing, that you are trying to ensure that there is a better
working relationship between the ag sector and the EPA. There
are a lot of folks that don't think that the EPA actually
accounts for the economic consequences of some of your
regulatory proposals. I also asked you at our last hearing we
had whether or not you have worked with the USDA to appoint a
member of agriculture to the EPA Science Advisory Board. That
was my language in the farm bill that I offered 2 years ago.
What is the status of getting that person appointed?
Ms. McCarthy. On the standing committee?
Mr. Davis. Yes.
Ms. McCarthy. Yes. We actually, as recently as last week,
met with USDA so we can finalize that standing committee. We
understand how important it is, and we have been working hard
to make sure that we respect people's interest in getting the
right applicant pool, and we will be working with USDA on those
choices.
Mr. Davis. I appreciate that. It has been 2 years since the
passage of the farm bill. This is something that I asked you
about before.
Ms. McCarthy. That I am aware of.
Mr. Davis. I just don't think the EPA's actions, again, I
don't expect you to take away from every hearing our concerns,
but I do expect the folks who are sitting behind you to follow
up. And my legislative intent was to get somebody from
agriculture to work with you so that maybe, when you came here
today, you wouldn't have had to talk about how you are going to
work to bridge that relationship, to bridge that gap with our
agricultural community. It is very disappointing.
And you can wonder why our ag sector, when it has taken 2
years for a simple request to appoint somebody from agriculture
to a standing advisory board, has not been done, why they don't
trust the EPA. It is very, very disappointing on my end. I
would hope that by the next time we meet, and I know we will,
that we could see much more progress on this. Two years has
been long enough, and agriculture deserves that attention that
you mentioned you want to give it.
Ms. McCarthy. Yes.
Mr. Davis. You would prove it a lot by accomplishing this
and getting somebody in ag on that science advisory committee.
So, with that, I want to make my Chairman very happy by
yielding back the remainder of my time.
The Chairman. The gentleman yields back. Mr. Yoho, 5
minutes.
Ms. McCarthy. Thank you.
Mr. Yoho. Thank you, Mr. Chairman, I appreciate it. Ma'am,
thank you for being here. First, I thank you for your Agency's
work and continued efforts in combating citrus greening in my
State of Florida. Experts believe that over 70 percent of our
groves are infected, and we have seen a dramatic decrease in
production. USDA estimates this season's harvest to be 69
million boxes, and that is the smallest crop we have had in 50
years. That is down from the 240 million boxes. Could you speak
to what your Agency is doing to help the situation? I know you
guys are doing good work on that. Is there anything that you
need from us to help facilitate that?
Ms. McCarthy. Sir, we are taking this situation
extraordinarily seriously, as you indicate that it is. And I
know that we met with the Florida Senate and House delegations
to talk about what we have already done on our recent
registrations to bring more tools to the table, but we are also
in the middle of looking at an emergency exemption request that
will look at the potential to authorize use of antibiotics. And
we are working with both CDC and FDA, which is the process for
that, and we are going to try to get that done as soon as
possible.
Mr. Yoho. I appreciate that. And if we can help facilitate
that, or extrapolate work from other crops, whether it is the
apples, or the grapefruits, or any of that, our state, and
those people that love oranges, would be greatly appreciative.
Ms. McCarthy. We are happy to call on you. Thank you for
that offer.
Mr. Yoho. And I am concerned that my farmers are not
getting access to the tools they need to provide food for the
world. Without the pesticides and other scientific advances, 40
percent of global crop production could be lost because of the
effects of weeds, pests, and disease. And I understand that the
average research and development costs for just one new
pesticide crop protection product to reach the market is
roughly $256 million, and the average timeframe for a pesticide
to be approved by the EPA and reach the market is about 10
years. And I understand we have to do our due diligence to make
sure that a product is safe, but we have had products that were
approved by the EPA, and then pulled after this kind of effort.
And what are your thoughts on that?
Ms. McCarthy. Well, we certainly should look at what the
full range of effort has been, and what the average is, but I
want to look at more recent data, and see if we have been able
to do a much better job at advancing that. It is clear we want
to do our job to make sure that it is safe, and being
effectively applied----
Mr. Yoho. Absolutely.
Ms. McCarthy.--but----
Mr. Yoho. I mean, we need to do that.
Ms. McCarthy. I don't think that the timelines you have
indicated are the timelines that the Agency operates under at
this point, sir. But if there is more work that needs to be
done, we should do it.
Mr. Yoho. And then I just want to say that I am concerned
about how long it takes for the EPA to approve new products, as
we just talked about, for the farmers or the growing
communities. And I am also concerned that the EPA is drifting
away from its goal set by Congress, which includes decisions
based on sound science, rather than on input from outside
groups trying to limit the use of the safe options for farmers.
Some of the nonprofit groups will oppose the use of pesticides,
no matter what their value in protecting U.S. farmers, and
addressing world hunger, no matter how safe they are. But those
interest groups should know that the crop protection can
greatly reduce malnutrition for millions of children and adults
over the next few years by safely protecting crops, and safely
increasing yields. They will also keep costs in the U.S. lower.
Will you commit to me today that, as the law requires, you will
base your decisions in the EPA on sound science, and only on
sound science?
Ms. McCarthy. Yes. It is sound science, and the law.
Mr. Yoho. And we see this with some of the pesticides that
the outside groups are saying, this is bad, neonicotinoids on
the honeybees----
Ms. McCarthy. Sir, I want to indicate, relative to your
first question, one of the most important things is to get new
chemicals onto the market that are much less harmful, and much
more effective, so you are absolutely right on both those
questions, and their linkages, and that is what we have to work
toward.
Mr. Yoho. All right. And I would like for you to show
strong leadership. Your Agency has so much power to put a pause
on the WOTUS, as many people have talked about in here. With 26
states suing the Federal Government and the EPA, until we can
reach a better solution, if you could just back off, and I
would agree with Mr. Kelly, the things he brought up.
And then the standard of testing methodology that we have
seen in the lead situation in Michigan, what I have seen is you
have to run the water, or don't run the water. There is not a
standard that everybody is using. And if you don't have a
standard, you get skewed results. So I hope you address that,
and I am out of time, and I yield back.
Ms. McCarthy. We have grave concerns, and we will.
The Chairman. The gentleman's time----
Ms. McCarthy. Thank you.
The Chairman.--has expired. Mr. Allen, 5 minutes.
Mr. Allen. Thank you, Mr. Chairman, and thank you,
Administrator McCarthy, for being here today. And, of course--
--
Ms. McCarthy. There you are.
Mr. Allen. Yes, I am right here, so----
Ms. McCarthy. I am so sorry. I don't know how I lost you.
Mr. Allen. Well, those lights are kind of bright. I have
learned a lot here today at the hearing. I hope that you and
your staff are taking good notes, and learning a little bit
about some of the things that we have to deal with. I am a new
Member of Congress. I am from Georgia, and, of course, you have
heard the concerns about our farmers and others. But what I
have learned is there is an obvious disconnect between the
American people and your Agency, and your ability to carry out
the laws that are established by the United States Congress.
I guess my question is, what have you learned from this
hearing today, and what do you plan to do about it?
Ms. McCarthy. I think that I have learned that we have not
just differences of opinion, but an understanding of what the
Agency is doing, our intent in doing that, and that we have a
lot of work to do to have a trusting relationship to both be
able to talk to one another, but to listen to those concerns,
and effectively get them into our policies and regulations.
Mr. Allen. Would you do this: we are the people's House,
and we report to the people. What I would like to see is a plan
by your Agency to do just what you said you plan to do. In
other words, if you would lay out a strategy somehow that we
are going to get on the same page, and how are we going to do
that, because we have differences in science. You have an
important job. There is no question that we have issues. We
brought those issues before you today. I mean, Flint, out in
Colorado, there are mistakes that have been made.
I will say that, just from my observation, as a long-term
member of the business community, that part of that strategy
needs to be prioritization. In other words, you are doing
things that are affecting the economy, and affecting our
farmers' ability to operate their farms, but then you are
letting these other things slip through the cracks. So you need
to reprioritize your systems, and I would like to see that in
your strategy.
The last question that I have is relative to the economic
impact. When you, say Waters of the U.S., again, we have talked
about where did that rule come from? And you need to understand
that over \1/2\ of our farmers are retiring, and have been
since 2009. And only 56 percent--is there a second generation
that is coming along? Obviously, you feel our frustration, and
our frustration is their frustration. When you start talking
about taking people's property away from them because they have
retained water so that they can sustain their farm, that is a
serious, serious issue. You have millions of comments on the
thing, and continue with the rule. So you can certainly
understand the concern there.
But from an economic standpoint, is your Agency at all
connected to the fact that this economy is growing at less than
two percent, and has been for the last 7 years, and that what
responsibility does your Agency have for that lackluster
growth? Have you actually gotten together and talked and is the
growing of the economy important to you?
Ms. McCarthy. Always, yes.
Mr. Allen. I mean, these are jobs we are talking about. We
are talking about--every American deserves the opportunity at a
good job. We have, some say 90 million people who are not
working today. And one of your strategies that I would
recommend is that you go back and look, and see what your
Agency could do to grow this economy, and how you could grow
the economy. And any further comments, as far as what you are--
what you are going to move forward, while I have 44 seconds
remaining?
Ms. McCarthy. No, sir. I will certainly take to heart what
you suggest. I do think we try very hard to understand how we
can meet our mission, but do it in a way that actually advances
the economy, moving forward. But I have no question that there
are challenges in agriculture, and that those challenges have
to be part of the discussion we have when we interact with this
sector.
Mr. Allen. And you realize that has to be a bottom up
approach? In other words, the farmers have to be included in
that process?
Ms. McCarthy. Yes.
Mr. Allen. I yield back, Mr. Chairman.
The Chairman. The gentleman yields back. Ms. McCarthy, we
are almost there. Two more questioners. Mr. Benishek, 5
minutes.
Ms. McCarthy. Thank you, Mr. Chairman.
Mr. Benishek. Thank you, Mr. Chairman.
Ms. McCarthy. Hello.
Mr. Benishek. Welcome, Ms. McCarthy.
Ms. McCarthy. Thank you.
Mr. Benishek. Last September the EPA published an interim
recommendation for environmental standards and eco labels for
use in Federal procurement. And one of the recommendations for
lumber excludes several credible standards that are widely used
in the United States, including the Sustainable Forest
Initiative, and the American Tree Farmer System standards. And
we understand that this recommendation was made without
consultation with the Department of Agriculture, who not only
have a lot of expertise in forest management and forest
projects, but who also publicly stated that the Sustainable
Forest Initiative, and the American Tree Farmer System
standards can be used to verify sustainability of forest
products. Furthermore, it is supposedly based on a
determination by the Department of Energy that has no formal
analysis behind it. So can you explain the basis of this
recommendation for Federal procurement?
Ms. McCarthy. Well, sir, I do know that it is related to
the Federal Government wanting to make sure that their
purchasing reflected the full range of interests of the public.
Mr. Benishek. Well, we already----
Ms. McCarthy. I am----
Mr. Benishek.--the Forest Service, or the Department of
Agriculture has already determined that this is a sustainable
thing. So what other factor are you taking into account?
Ms. McCarthy. We were actually utilizing a certification
program that was up and running that we thought had credibility
because of its history. But we have recently been asked to
consider opening that up other certification that----
Mr. Benishek. What is the certification program that you
are using?
Ms. McCarthy. It is basically a third party certification,
and I apologize.
Mr. Benishek. Well, which one is that?
I mean, these are the two most widely used certification
processes in timber management in the country, the ones that I
have outlined.
Ms. McCarthy. Yes, and we are certainly opening up the
discussion so that we can expand that. We have no interest in
taking away the opportunity to use legitimate and very well
tested third party certification.
Mr. Benishek. Why wouldn't you consult with the Department
of Agriculture prior to making this kind of a rule?
Ms. McCarthy. I am not sure that wasn't done, sir, but I
certainly can check.
[The information referred to is located on p. 66.]
Mr. Benishek. Well, it is----
Ms. McCarthy. And you are right, if it is a forestry issue,
we should be consulting appropriately with all the right
Federal partners on this.
Mr. Benishek. So when is that going to be fixed, then?
Ms. McCarthy. Say that again?
Mr. Benishek. You said you are going to look into it, so
when is that going to happen?
Ms. McCarthy. We already are looking into it. I just can't
put my finger on it, sir, but I know that it is part of the
work that we are doing, ongoing. I can get back to you on what
the timeline might be.
Mr. Benishek. So is the timeline a month?
Ms. McCarthy. I don't know, sir, I can get back to you.
Mr. Benishek. Three years?
Ms. McCarthy. I can get back to you.
Mr. Benishek. All right. I yield back.
The Chairman. The gentleman yields back. Mr. LaMalfa for an
additional 5 minutes. He had a couple of questions.
Mr. LaMalfa. Thank you, Mr. Chairman, for your indulgence.
Ms. McCarthy, once again, I will try and just keep this to
asking for an offline clarification, and then a couple yes and
nos. So I----
Ms. McCarthy. Okay.
Mr. LaMalfa.--appreciate your time, and your grace with
which you have answered the questions today. Just to bring your
attention quickly, a Presidential memorandum recently issued,
it is called The Mitigating Impacts on Natural Resources from
Development, and Encouraging Related Private Investments. I
don't expect you to know this, and not to put you on the spot
here, but, again, Mitigating Impacts on Natural Resources from
Development, and Encouraging Related Private Investments. It is
a fairly new Presidential memorandum.
It appears to be carrying the weight of an Executive Order,
and seems like quite a significant departure from current
policy. Looking like it is going to go back and re-assess every
possible impact that a man-made activity might have on public
land, or any natural resource on Federal projects. So do you
plan to follow this policy, and can you walk me through, in a
letter later on, how you do plan--are you aware of that title?
Ms. McCarthy. I have not been made familiar with the
details, so I will have to get back to you on how----
Mr. LaMalfa. I believe it was out in October.
Ms. McCarthy.--my Agency would respond. We have very little
ownership of Federal lands.
[The information referred to is located on p. 67.]
Mr. LaMalfa. Okay. Well, it might have an effect on all
Federal lands, we are still catching up, I would appreciate it
if your office can clarify to that in a letter offline here.
And on the previous questions I had on Clean Water Act, again,
regarding plowing, this is very important to several of my
constituents have gotten in some hot water up in the district
there on the section 404 exemption of the Clean Water Act.
Current Clean Water Act regulations provide that plowing
``will never involve a discharge, unless it changes any of
water in the United States to dry land.'' I am familiar with
that with growing rice, about the 1985 sodbuster, swampbuster
regulations came in through FSA, where we are not to take
swamps, or change waterways, things of that nature. Big things.
Since we do have this section 404 exemption, does this
regulation really, truly mean what it says? Because that is
what my growers are wondering, that there is an exemption for
section 404 under plowing.
Ms. McCarthy. My understanding is for plowing, yes.
Mr. LaMalfa. Okay. Was this regulation intended to assure
farmers that their plowing would not be regulated under the
Clean Water Act?
Ms. McCarthy. That would be its intent, yes.
Mr. LaMalfa. Okay. And it might be repetitive here, but I
have to do this. Does it mean that plowing is not regulated
under the Clean Water Act unless it actually changes waters to
dry land?
Ms. McCarthy. Waters to dry land?
Mr. LaMalfa. Something deemed as waters of the United
States. If it is changing it from water----
Ms. McCarthy. Or the other way around----
Mr. LaMalfa.--unless you are doing something----
Ms. McCarthy.--change land to water.
Mr. LaMalfa. Water--yes. A watered land to a dry land,
which is what I talked about maybe in the swampbuster,
sodbuster, and FSA. So you agree with that?
Ms. McCarthy. Yes.
Mr. LaMalfa. Okay.
Ms. McCarthy. I think.
Mr. LaMalfa. Can farmers continue to rely on this is the
important takeaway here. Can they continue to rely on the
regulation, as interpreted under section 404, as an exemption,
and continue plowing their fields?
Ms. McCarthy. Yes.
Mr. LaMalfa. Okay. All right, Mr. Chairman, thank you.
Thank you for your time and indulgence. I yield back.
The Chairman. You bet. The gentleman yields back. I have a
couple of questions up here. When you were talking to Mr.
DesJarlais earlier about water jurisdiction, you said that
biological, chemical, and physical indicators must exist to
determine if the water is jurisdictional, yet the rule uses
biological, chemical, or physical. So can you clarify which is
which?
Ms. McCarthy. It would be an or.
The Chairman. Or? Okay.
Ms. McCarthy. Yes.
The Chairman. All right. So that would----
Ms. McCarthy. It basically means that you have an ability
to----
The Chairman. An or is a lot broader----
Ms. McCarthy.--pollute and destroy the downstream water.
The Chairman. All right.
Ms. McCarthy. That is right.
The Chairman. So or is a much broader interpretation. Also,
and I know you are tired of talking about the GAO report on
social media, but whatever you do, however you do it, there
ought to be an audit trail. There ought to be a path by which
we can track back to how it happened, and who happened, all
those kind of good things. But use of a tool like Thunderclap,
which hides that--can you commit that whatever you are going to
do with social media that you will leave in play, or you will
use tools, or leave in place an audit trail, an ability to see
where it came from, and who did it within your organization?
Are you--and not use----
Ms. McCarthy. Well, I certainly know who worked on these
issues internally----
The Chairman. Well, I know that, but I----
Ms. McCarthy.--and GAO really was concerned that we--
sorry----
The Chairman. We are almost there.
Ms. McCarthy.--retweet----
The Chairman. Right.
Ms. McCarthy.--was not able to be tracked back to EPA. So
one of the things I tried to explain, although I don't agree
with GAO, I am not disrespecting their decision. So we will
work with OMB. It is Office of Management and Budget that did
the guidance on how you use this Thunderclap----
The Chairman. Okay.
Ms. McCarthy.--and we followed it. And we will make sure
that we----
The Chairman. All right.
Ms. McCarthy.--address the----
The Chairman. There are other innovations coming in. There
is one called Kik, and others that allow you to anonymously do
things, and we don't want our----
Ms. McCarthy. The one thing you can be sure of, it will
never be me.
The Chairman. I got you. Well, second, let me apologize for
how cold it is in this room. There are other offices----
Ms. McCarthy. It is cold in this room.
The Chairman.--in our suite that are like ovens, and so
apparently our system doesn't know the difference between
wintertime and summertime, so----
Ms. McCarthy. So I can now----
The Chairman. I apologize to that.
Ms. McCarthy. That is okay.
The Chairman. We do have a number of Members, and we, the
Committee, have a number of questions we would like to submit
for the record. We would appreciate a timely response to those.
Not like you don't have enough to do, we are going to add to
that. But we would like a timely response to that.
Again, thank you for being here this morning. I know you
anticipated that this was not going to be the most fun you
could have on a Thursday, but----
Ms. McCarthy. I thought it was incredibly informative----
The Chairman. I----
Ms. McCarthy.--and respectful----
The Chairman. Well, thank you----
Ms. McCarthy.--so thank you.
The Chairman.--very much. You are very kind with that.
Thank you for being with us for 3 hours this morning. I
appreciate that.
Under the rules of the Committee, the record of today's
hearing will remain open for 10 calendar days to receive
additional material and supplementary written responses from
the witness to any questions posed by a Member. This hearing of
the Committee of Agriculture is adjourned. Thank you.
[Whereupon, at 1:01 p.m., the Committee was adjourned.]
[Material submitted for inclusion in the record follows:]
Submitted Letter by Hon. Dan Newhouse, a Representative in Congress
from Washington
January 28, 2016
Hon. Gina McCarthy,
Administrator,
U.S. Environmental Protection Agency,
Washington, D.C.
Dear Administrator McCarthy,
This letter is in regard to Omak Wood Products LLC located in Omak,
Washington in Okanogan County. As you may know Okanogan County was home
to record setting wildfires over the last two summers. This has had an
extremely negative effect on the community, Federal forests and the
Colville Confederated Tribe.
Three years ago Omak Wood Products opened for operation.
Contributing over $60 million to the local economy and employing over
185 people, Omak Wood Products has been an economic driver and one of
the largest employers of this small community. Now the mill has
announced plans for a complete shutdown at the end of February.
The community of Omak has worked tirelessly to find another
investor so there will be no lapse in operation and loss of jobs.
However, Omak Wood Products has not been issued an operating permit,
which leaves any potential investor in a state of uncertainty.
Two years ago the EPA promised a re-write of the permit to more
accurately reflect the current operations of the mill. Without the
updated permit investors are unwilling and unable to move forward in
the process of keeping the mill in production.
It is imperative that the permit is re-written and issued
immediately, so investors can continue with their process of acquiring
the operation.
I ask that you act swiftly in issuing this permit, to ensure jobs
are not lost and an already struggling economy is not dealt another
devastation. Thank you for your consideration of this request.
Sincerely,
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Hon. Dan Newhouse,
Member of Congress.
______
Supplementary Material Submitted by Hon. Gina McCarthy, Administrator,
U.S. Environmental Protection Agency
Insert 1
Mr. Crawford.--then, we can take this as an example and a
validation of the fact that the rulemaking process is deeply
flawed, and needs to be addressed, because this kind of stuff,
to me, is not reflective of the opportunity that should be
granted to the affected stakeholders. Let me switch gears with
you quickly in the time I have remaining. I was just told
yesterday that the EPA took action against a farmer who didn't
comply with the SPCC rules on on-farm fuel storage by failing
to have an SPCC plan for his oil storage tank that was 5,000
gallons in size, but the 2014 WOTUS specifically says that EPA
can only require compliance for oil storage tanks in excess of
6,000 gallons until such time as the EPA completes a study, and
a new rulemaking process is undertaken.
My understanding is that the study is complete which
recommends a lower exemption threshold, but the rulemaking is
still not finished. So my question to you is why is the EPA
taking enforcement action against individuals who are not out
of compliance, and isn't that a violation of the law?
Ms. McCarthy. Sir, I am happy to look into it and get back to
you. If it just happened yesterday, I am really not familiar
with it.
The EPA is are unaware of any situation such as the one described.
The EPA respects the limits of its legal authorities as provided by
law. The EPA's job is to assure compliance with the environmental laws
as passed by Congress so that communities can be safeguarded from
exposure to unhealthy pollutants and the environment can be protected.
Insert 2
Ms. Kuster. Thank you, Mr. Chairman, and thank you to the
Administrator for being with us today. Always great to have a
New Englander in our Committee. I will be quick. I have two
questions. The first one relates to this Waters of the United
States rule, in conjunction with the EPA regulation on
pesticides, and the Fish and Wildlife ruling regarding the
long-eared bat. And my question on behalf of farmers,
landowners, and timber owners in New Hampshire is how will your
Agency coordinate with USDA and Fish and Wildlife to minimize
confusion about the interplay between these three rules? If you
follow.
Ms. McCarthy. That is a very good question that I am not sure
I can answer. I will have to get back to you, because you have
just baffled me with the bat question, connecting with the
Clean Water and the other issues I understood.
The Clean Water Rule does not itself establish any new requirements
regarding either the use of pesticides or compliance with the
Endangered Species Act. As a result, issuance of the Clean Water Rule
does not change current requirements regarding application of
pesticides to waterbodies or provisions of the ESA, including
provisions associated with listing of the long-eared bat. New Hampshire
is one of the four states where the Pesticide General Permit (PGP)
applies statewide. The EPA coordinated closely with USDA on the
development of the 2011 permit. The EPA continues to coordinate closely
with USDA and is currently consulting with the NMFS and FWS in the
development and re-issuance of the 2016 PGP. Consideration of relevant
endangered or threatened species will occur during that consultation.
Insert 3
Mr. LaMalfa. On the issue of Section 404, and the exemptions
that are provided for agriculture under the Clean Water Act,
normal farming activities, ranching, forestry, et cetera,
including repeat plowing, seeding, cultivating, minor drainage,
harvesting for that production of the food and the fiber and
forest products, conservation practices, et cetera, no
additional requirements, for example, that an activity be
continuous are included.
Some of my constituents are continuous cropping on these
lands, otherwise you lose your ability to have that exemption.
Nowhere in the law does it specify that, but that is what is
being carried out in my district by EPA or your associates.
Sometimes we refer to them as henchmen, but in the Army Corps
of Engineers that are carrying out some very outside the law
activities with this regulation. So do you agree that section
404 does make no additional requirements that an activity be a
continuously cropped, as we see it in the law?
Ms. McCarthy. I am not aware of it, but I certainly will have
to get back to you on it, sir.
When Congress enacted CWA Section 404(f) in 1978, the statute
included the term ``normal'' to characterize farming, ranching, and
forestry practices covered by the exemption. ``Normal'' farming,
ranching, and forestry practices are those that are established or
ongoing. The agencies have not interpreted ``normal'' to mean
``continuous'' but rather that farming, ranching, or forestry has been
previously established and ongoing on the property. If lands are left
fallow, for example, as part of crop rotation or to rest soils, such
lands remain subject to the exemptions. The agencies are always glad to
answer landowner questions regarding the [section] 404(f) exemptions
and to help landowners conduct their activities in waters consistent
with the statute.
Insert 4
Mr. Benishek. Last September the EPA published an interim
recommendation for environmental standards and eco labels for
use in Federal procurement. And one of the recommendations for
lumber excludes several credible standards that are widely used
in the United States, including the Sustainable Forest
Initiative, and the American Tree Farmer System standards. And
we understand that this recommendation was made without
consultation with the Department of Agriculture, who not only
have a lot of expertise in forest management and forest
projects, but who also publicly stated that the Sustainable
Forest Initiative, and the American Tree Farmer System
standards can be used to verify sustainability of forest
products. Furthermore, it is supposedly based on a
determination by the Department of Energy that has no formal
analysis behind it. So can you explain the basis of this
recommendation for Federal procurement?
* * * * *
Mr. Benishek. Why wouldn't you consult with the Department of
Agriculture prior to making this kind of a rule?
Ms. McCarthy. I am not sure that wasn't done, sir, but I
certainly can check.
Under Executive Order 13693--Planning for Federal Sustainability in
the Next Decade--the EPA issued recommendations to assist Federal
purchasers in identifying and procuring environmentally sustainable
products. The EPA's Interim Recommendation for the lumber/wood category
is based on the Department of Energy's Fiscal Year 2016 (FY16) Priority
Products List.
As a result of stakeholder inquiries since the release of the
Interim Recommendation, the EPA has met and is continuing to work with
USDA and DOE's Office of Sustainable Environmental Stewardship to gain
further information. The EPA's Standards Executive is reaching out to
the Sustainable Forestry Initiative, the American Tree Farm System, and
the other forestry labels that stakeholders have requested the EPA
consider. The EPA will be in touch with these groups regarding the
agency's review of forestry labels and their alignment with the
National Technology Transfer and Advancement Act, the OMB Circular A-
119, and related Federal policies that guide the EPA's use of voluntary
consensus standards and private-sector conformity assessment
activities. In addition, the EPA continues its progress with piloting
the Guidelines for Assessing Standards and Ecolabels for Use in Federal
Procurement, and hopes that information gleaned from this process will
inform thinking related to the lumber/wood category. Finally, DOE
continues to conduct research to inform their FY16 Priority Products
List. The EPA looks forward to reviewing all of this additional data to
inform if and how the lumber/wood category of Interim Recommendations
might be revised.
The EPA has, and will continue to provide, mechanisms for public
input as we develop these recommendations. The agency issued Federal
Register Notices on the initial draft guidelines in 2014 and in March
2015 for the launch of our pilot work.\1\ Those FRNs were open to
public comment and they marked the beginning of our efforts to engage
multi-stakeholder panels whose counsel will be considered as we move to
finalize our recommendations. Further, any Federal acquisition
requirements stemming from the recommendations would include a public
comment process prior to incorporation into the Federal Acquisition
Regulations. As such, FAR Case 20 15-033 has been developed in order to
integrate the new requirements of E.O. 13693 into the FAR. All next
steps related to this case, including as to when it will be available
to the public, are viewable at http://www.acq.osd.mil/dpap/dars/
far_case_status.html.
---------------------------------------------------------------------------
\1\ Federal Register Notice, February 27, 2014, ``Draft Guidelines
for Product Environmental Performance Standards and Ecolabels for
Voluntary Use in Federal Procurement'' (79 FR 11102) [See Attachment
1]. https://www.gpo.gov/fdsys/pkg/FR-2014-02-27/pdf/2014-04329.pdf.
Federal Register Notice, March 19, 2015, ``Agency Information
Collection Activities; Proposed Collection and Comment Request;
Assessment of Environmental Performance Standards and Ecolabels for
Federal Procurement'' (80 FR 14372). [See Attachment 2] https://
www.gpo.gov/fdsys/pkg/FR-2015-03-19/pdf/2015-06275.pdf.
---------------------------------------------------------------------------
Insert 5
Mr. LaMalfa.--appreciate your time, and your grace with which
you have answered the questions today. Just to bring your
attention quickly, a Presidential memorandum recently issued,
it is called The Mitigating Impacts on Natural Resources from
Development, and Encouraging Related Private Investments. I
don't expect you to know this, and not to put you on the spot
here, but, again, Mitigating Impacts on Natural Resources from
Development, and Encouraging Related Private Investments. It is
a fairly new Presidential memorandum.
It appears to be carrying the weight of an Executive Order,
and seems like quite a significant departure from current
policy. Looking like it is going to go back and re-assess every
possible impact that a man-made activity might have on public
land, or any natural resource on Federal projects. So do you
plan to follow this policy, and can you walk me through, in a
letter later on, how you do plan--are you aware of that title?
Ms. McCarthy. I have not been made familiar with the details,
so I will have to get back to you on how----
Mr. LaMalfa. I believe it was out in October.
Ms. McCarthy.--my Agency would respond. We have very little
ownership of Federal lands.
The Presidential Memorandum, ``Mitigating Impacts on Natural
Resources from Development and Encouraging Related Private
Investment,'' was issued on November 3, 2015, and applies to the
Departments of the Interior, Defense, and Agriculture and to the EPA
and NOAA. A key goal of the Memorandum is to ``increase private
investment in natural resource restoration'' and to accomplish this by
ensuring that ``[f]ederal policies are clear, work similarly across
agencies, and are implemented consistently across agencies.'' Section 1
calls on agencies to ``adopt a clear and consistent approach for
avoidance and minimization of, and compensatory mitigation for, the
impacts of their activities and the projects they approve.'' Clear
policies with respect to mitigation are expected to offer opportunities
for increasing private investment in natural resource restoration.
General ``principles'' guiding this effort are defined in section 3,
and section 4 calls on selected agencies to review and update specific
manuals, handbooks, and policies. As indicated in section 5(b), the
Memorandum is to be ``implemented consistent with applicable law.''
______
Submitted Questions
Response from Hon. Gina McCarthy, Administrator, U.S. Environmental
Protection Agency
September 6, 2016
Hon. K. Michael Conaway,
Chairman,
House Committee on Agriculture,
Washington, D.C.;
Hon. Collin C. Peterson,
Ranking Minority Member,
House Committee on Agriculture,
Washington, D.C.
Dear Mr. Chairman/Congressman Peterson: *
---------------------------------------------------------------------------
* Editor's note: There were identical letters sent to the Chairman
and Mr. Peterson. For the purpose of publishing they have been
combined.
Thank you for the opportunity to respond to the questions for the
record following the February 11, 2016, hearing on impacts of the
Environmental Protection Agency's actions on the rural economy.
Enclosed are the EPA's responses to the questions.
If you have any further questions, please contact me or your staff
may contact Sven-Erik Kaiser at [Redacted] or [Redacted].
Sincerely,
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Nichole Distefano,
Associate Administrator.
Questions Submitted by Hon. K. Michael Conaway, a Representative in
Congress from Texas
Question 1. The GAO report on illegal grassroots lobbying points to
the tweet ``I love clean water'' as one of the violations. What we have
failed to discuss was EPA's use of the innovative tool ``Thunderclap''
to push that tweet to more viewers, around 1.8 million. In addition to
twitter, EPA used Facebook and YouTube for an aggressive social media
campaign for the WOTUS rule. Did EPA count responses to the social
media campaign as comments in support of the rule? How many of those
people actually read and understood the details of the rule?
Answer. The EPA did not count responses on social media as
comments. For any statements made in the preamble of the final rule or
to the public regarding the number of comments received, the EPA only
counted comments submitted to the docket or sent to the dedicated e-
mail address for this rulemaking.
Question 2. The 6th Circuit Court of Appeals, in its order to
temporarily stay the rule, found that the burden of the WOTUS Rule
outweighed any harm to the agencies in keeping the status quo. What are
your thoughts on this?
Answer. The EPA and the U.S. Army Corps of Engineers revised their
longstanding definition of the term ``waters of the United States'' to
provide the public with more consistent, predictable, and
understandable regulations defining the scope of the Clean Water Act
(CWA). The result is a new rule intended to be faster, easier, and
cheaper to implement saving the public time and money. Delaying
implementation of the Clean Water Rule prevents the agencies from
providing the public with these significant improvements. The agencies
are, however, fully complying with the 6th Circuit order by staying
implementation of the Clean Water Rule and implementing the prior
regulations consistent with the best science and the law.
Question 3. Assuming the Administration will continue to keep the
final rule as written, and that the rule is to be implemented, will you
consider delaying implementation of the rule to provide the time
necessary for the Agencies to get adequately trained and for the
regulated community to understand how Federal jurisdictional decisions
will be made so that they can comply?
Answer. The agencies are using the time created by the stay to
address questions regarding the Clean Water Rule raised by states,
local governments, and the public, and to provide agency field staff
with additional training to ensure we are in the best possible position
to fairly and effectively implement the rule when the stay is lifted.
We will also continue to update information and respond to questions
when the new rule goes into effect to provide the public with the
transparency and clarity needed to make use of the new rule more timely
and less costly.
Question 4. How is EPA ensuring that the new Waters of the United
States (WOTUS) Rule is not being utilized or implemented, in light of
the current nationwide stay? What actions has EPA taken to ensure that
all EPA regions and staff are not using or implementing the Rule?
Answer. The EPA and the U.S. Army Corps of Engineers distributed
national guidance to their field offices on the same day the 6th
Circuit stay was issued directing all field staff to cease implementing
the Clean Water Rule and instead resume application of the agencies'
prior regulations defining the scope of CWA jurisdiction. The agencies
regularly work with their field staff to respond to questions and to
ensure the stay is being implemented consistent with the court's
decision.
Question 5. Do you believe that the Army Corps is capable of
executing the Clean Water Act 404 program without EPA's involvement?
Why or why not?
Answer. The EPA and the U.S. Army Corps of Engineers have worked
together effectively in the implementation of the CWA section 404
program for more than 40 years since enactment of the statute in 1972.
The agencies will continue to build from their experience to make
future implementation of the section 404 program even more responsive
to permit applicants as we work to protect human health and the
environment.
Question 6. When dealing with interagency disagreements and
responses to public comments during the development of the WOTUS Rule,
who had the final say on what was and was not considered a Water of the
U.S.?
Answer. Final decisions regarding the Clean Water Rule were made
jointly by senior policy managers at the Department of the Army and the
EPA following extensive collaboration and discussion and consistent
with science and the law.
Question 7. EPA has made it a point to state that ditches are not
included as jurisdictional in the final Waters of the United States
rule. However, if a ditch can be classified as a tributary, and ditches
are generally formed through excavation activities, could you clarify
what types of ditches are truly exempt?
Answer. The agencies have stated consistently that most ditches
were subject to regulation under the CWA during the 1970s, 1980s, and
1990s--and that actual regulation was inconsistent and unclear causing
uncertainty for landowners such as farmers and ranchers. A key goal of
the Clean Water Rule is to eliminate this uncertainty and make clear
for landowners, for the first time, the types of ditches that are and
are not covered by the CWA. An important part of the new Clean Water
Rule is a list of waters, including many types of ditches, that are
always excluded from regulation under the CWA. The new rule makes clear
that most ditches on farmlands, including all ditches that flow only
after it rains, or ditches excavated from dry land, are never covered
under the CWA. In addition, the new rule preserves all farming,
ranching, and forestry exemptions, including ditch exemptions. These
exemptions in Federal law allow landowners to construct irrigation
ditches and maintain drainage ditches, for example, without needing to
get permits or approval from the government.
Question 8. Would the ditch exemption be automatically given if the
business, farmer, or local government believes their ditch is exempt,
or do they have to prove the ditch is exempt? Will they have to ask for
the exemption?
Answer. The agencies wrote the Clean Water Rule to make it clear
and understandable. The rule does not change the longstanding
application of the section 404(f) exemptions. The public, for example,
is not required to obtain confirmation or approval from the government
that an exemption applies. The agencies are available at no cost,
however, to answer questions regarding jurisdiction, and the U.S. Army
Corps of Engineers can provide landowners with written jurisdictional
determinations regarding the status of ditches on their property.
Question 9. What actions have the Agency taken to ensure the Clean
Water Act's prior converted cropland exemption is being preserved?
Answer. The Prior Converted Cropland (PCC) exclusion was written
into the agencies' CWA regulations in 1993 to provide the public with
certainty regarding the jurisdictional status of these wetlands. This
regulatory exclusion was not changed by the Clean Water Rule, and the
preamble to the final rule makes clear that there will be no change in
the implementation of the exclusion as the Clean Water Rule is put into
effect. The public can be certain the PCC exclusion will continue to be
implemented as it has been since 1993.
Question 10. What actions have the Agency taken to ensure the Clean
Water Act exemptions for normal farming activities under Section 404(f)
are being preserved?
Answer. The agencies issued regulations following enactment of the
CWA section 404(f) exemptions in 1978 and these regulations were not
changed by the Clean Water Rule. The agencies made clear in the
Preamble to the final Clean Water Rule and in information published on
their websites that there will also be no change to implementation of
the section 404(f) exemptions resulting from the Clean Water Rule. The
public can be certain that the section 404(f) exemptions will continue
to be applied as they have been since their enactment in 1978.
Question 11. On December 14, 2015, the Government Accountability
Office (GAO) published a legal opinion finding that the EPA violated
Federal law by engaging in covert propaganda and grassroots lobbying.
How do you plan to rectify what many in the agricultural community
consider a flawed rule from a flawed process?
Answer. In promulgating the Clean Water Rule, the EPA complied
fully with the CWA and all laws applicable to the rulemaking process.
The GAO opinion did not comment on or examine the EPA's rulemaking
process. The GAO evaluated the EPA's use of certain social media
platforms tools during the time of the rulemaking to determine whether
they violated restrictions that prohibit using Federal funds for either
(1) indirectly lobbying Congress in support of, or in opposition to
pending legislation or (2) publicity that is self-aggrandizing, purely
partisan, or conceals the agency's role in sponsoring the material.
After examining a database of social media outreach materials, the GAO
took issue with only a single EPA blog post with two hyperlinks to
articles on third party websites and the EPA's use of a social media
tool called ``Thunderclap.'' The alleged violations had no impact on
the EPA's rulemaking process or on the EPA's compliance with any law
applicable to the rulemaking, including the Administrative Procedure
Act.
Question 12. What role did USDA play in the development of the
WOTUS rule? When did EPA begin the process of developing the rule? When
did you first engage USDA?
Answer. The agencies consulted with other Federal agencies,
including the U.S. Department of Agriculture, throughout the process of
developing the Clean Water Rule. USDA provided comments on the Clean
Water Rule to the Office of Management and Budget (OMB) consistent with
the interagency review process governed by Executive Order 12866. EPA
and the U.S. Army Corps of Engineers used these comments in working to
meet a key Clean Water Rule goal of improving clarity and
predictability for farmers and reducing regulatory burdens on
agricultural lands. The agencies began consulting with the USDA staff
as a part of the process to prepare jurisdictional guidance during the
first term of the Obama Administration and throughout the subsequent
process of developing the Clean Water Rule. USDA has consistently
emphasized agriculture's outstanding stewardship track record in
delivering water resource benefits locally, regionally, and nationally.
Question 13. Some observers suggest that the proposed 70 parts per
million (ppm) standard for ozone is below naturally occurring
background levels. By reducing the ozone standard to 70 ppm, large
swaths (largely rural) of the country will likely be designated as
nonattainment. If this is correct, the new standard would be virtually
unachievable. In light of this, how does EPA justify the billions, if
not trillions, of dollars of burdensome costs that could be expected to
be borne ultimately by the American people and their communities to
attempt to comply with an impossible standard?
Answer. The EPA projections show that the vast majority of U.S.
counties will meet the revised standards by 2025 without taking
additional action to reduce emissions. Existing and proposed Federal
rules, such as Tier 3 vehicle standards, Mercury and Air Toxics
Standards, and measures to address the 2010 sulfur dioxide National
Ambient Air Quality Standards (NAAQS) will help states meet the
standards by reducing ozone forming pollution.
Uncontrollable background concentrations of ozone, from sources
like natural events, e.g., wildfires, or foreign emissions, are not
expected to preclude attainment of a revised ozone standard with a
level of 70 ppb. In addition, Congress established requirements for
implementing the health based NAAQS standards that recognize issues
like background ozone and interstate transport to ensure that states
are not responsible for emissions they cannot reasonably control. The
Clean Air Act does not require states to demonstrate attainment of
NAAQS in all areas. Areas that are significantly affected by emissions
outside their control may receive special consideration.
When setting the level of a NAAQS, the EPA is prohibited by law
from considering the costs of implementation. Courts, including the
Supreme Court, have held uniformly that the EPA may not consider issues
of implementation costs when establishing NAAQS. The Clean Air Act
directs the EPA to set NAAQS at a level requisite to protect public
health with an adequate margin of safety and to protect the public
welfare from any known or anticipated adverse effects of air
pollutants.
Question 14. Our country has made great strides in reducing our
ozone levels--roughly 33% reduction since 1980--by keeping the
standards practical and attainable. However, EPA is now pursuing a
standard that cannot be achieved and therefore whose health benefits
would never be realized. What is EPA's justification for creating an
ozone standard that is set so low that it cannot be reasonably achieved
while recognizing that the health benefits from such a standard will
never be reached?
Answer. The EPA believes that a primary ozone standard with a level
of 70 ppb will substantially improve public health protection across
the country and will provide the adequate margin of safety the law
requires--including for children, who are one of the groups most at
risk from ozone exposure. The public health benefits of a 70 ppb ozone
NAAQS are significant--estimated at $2.9 to $5.9 billion annually in
2025. It is also worthwhile to note that the EPA projections show that
the vast majority of U.S. counties will meet the revised standards by
2025 without taking additional action to reduce emissions. Existing and
proposed Federal rules, such as Tier 3 vehicle standards, Mercury and
Air Toxics Standards, and measures to address the 2010 sulfur dioxide
NAAQS will help states meet the standards by reducing ozone forming
pollution.
Question 15. What specific impact would being designated as a
nonattainment area under the new standard have on job creation and
economic growth in rural communities?
Answer. Once the EPA sets a new air quality standard, or revises an
existing standard, the Clean Air Act requires the EPA to designate
areas as meeting the standards (attainment areas) or not meeting them
(nonattainment areas) based on local air quality. The agency also may
designate an area as unclassifiable, meaning there is not enough
information to make a determination. States make area designations
recommendations, and the EPA works closely with states and Tribes as it
finalizes the initial designations and boundaries for any nonattainment
areas.
All states with nonattainment areas must develop emission
inventories and implement a preconstruction permitting program designed
to provide additional air quality safeguards for those areas. For
nonattainment areas classified ``moderate'' or higher, which are
unlikely to be rural areas, states must develop state implementation
plans showing how the areas will meet the standards. These plans must
include reasonable available control technology standards for certain
types of ozone producing emission sources in the nonattainment area.
They also can include Federal measures that will result in local
emissions reductions, such as national mobile source requirements.
States may take area-specific considerations into account in developing
these plans.
Question 16. EPA finalized the recent 2015 stringent ozone standard
when it hadn't even released implementation rules for the last standard
set in 2008. In fact, states were forced to make designations under the
standard without final implementation rules from EPA. Doesn't it make
sense to get the 2008 standard implemented before burdening states with
double-regulation?
Answer. The EPA and state co-regulators share a long history of
managing ozone air quality under the Clean Air Act, underpinned by a
wealth of previously issued EPA rules and guidance. The overall
framework and policy approach reflected in the implementing regulations
for the 2008 ozone standards provide an effective and appropriate
template for the general approach states would follow in planning for
attainment of the 2015 ozone NAAQS. Planning and implementation work to
meet the 2015 ozone standard will build on progress states have already
made to plan for and meet the 2008 standards. In particular for areas
where states are still actively working toward attaining the 2008 ozone
NAAQS, the EPA is committed to helping air agencies identify and take
advantage of potential planning and emissions control efficiencies that
may occur within the horizon for attaining the 2015 standards.
Following past precedent, the EPA intends to propose revoking the 2008
standards and provide transition rules intended to help avoid any
potential inefficiencies as states begin implementing the Clean Air
Act's requirements for the 2015 standards.
Question 17. The National Association of Clean Air Agencies
testified to EPA that the new ozone standard ``will have a profound
impact on the work of state and local air pollution control agencies.''
Did EPA assess what impact implementing the new ozone standards would
have on state and local agencies already implementing the 2008
standard--shouldn't these standards be harmonized?
Answer. As provided in the previous answer, the EPA and state co-
regulators share a long history of managing ozone air quality under the
Clean Air Act, underpinned by a wealth of previously issued EPA rules
and guidance. Planning and implementation work to meet the 2015 ozone
standard will build on progress states have already made to plan for
and meet the 2008 standards. The overall framework and policy approach
reflected in the implementing regulations for the 2008 ozone standards
provide an effective and appropriate template for the general approach
states would follow in planning for attainment of the revised ozone
NAAQS. In particular for areas where states are still actively working
toward attaining the 2008 ozone NAAQS, the EPA is committed to continue
helping air agencies identify and take advantage of potential planning
and emissions control efficiencies that may occur within the horizon
for attaining the 2015 standards. Following past precedent, the EPA
intends to propose revoking the 2008 standards and provide transition
rules intended to help avoid any potential inefficiencies as states
begin implementing the Clean Air Act's requirements for the 2015
standards.
Question 18. EPA chose to project the costs of its new ozone
standard to 2025, 8 years after counties will be designated as
nonattainment. What consequences will those counties face while
designated nonattainment?
Answer. The Clean Air Act requires that within 3 years of the EPA
setting a new air quality standard, or revising an existing standard,
the EPA must designate areas as meeting the standards (attainment
areas) or not meeting them (nonattainment areas) based on local air
quality. The agency also may designate an area as unclassifiable,
meaning there is not enough information to make a determination.
Governors make initial designations recommendations, and the EPA works
closely with states and Tribes as it determines initial designations
and boundaries for nonattainment areas.
All states with nonattainment areas must develop emission
inventories and implement a preconstruction permitting program designed
to provide additional air quality safeguards for those areas. States
with nonattainment areas classified as ``Moderate'' or higher must
develop state implementation plans showing how the areas will meet the
standards. These states also must adopt reasonable available control
technology standards for certain types of emission sources in the
nonattainment. They also can included Federal measures that will result
in local emissions reductions, such as national mobile source
requirements.
Question 19. EPA chose to project the costs of its new ozone
standard to 2025. Since EPA bases its entire economic analysis on
predicted 2025 air quality, will the Agency support extending
compliance deadlines under the standards to 2025?
Answer. The Clean Air Act governs the process and timing for
initial area designations and associated compliance deadlines after the
EPA establishes a new or revised NAAQS. Following Clean Air Act
requirements, the EPA anticipates the following schedule for the 2015
ozone NAAQS:
By October 2017: the EPA issues final area designations;
those designations likely would be based on 2014-2016 air
quality data. If preconstruction permitting program
requirements for the nonattainment area do not already exist,
Federal permitting regulations apply until they are replaced by
state adopted programs;
2019: States submit area-specific inventories of ozone
producing emissions;
2020 to 2021: For nonattainment areas classified as
``Moderate'' and above, states, and any Tribes that choose to
do so, complete development of implementation plans, outlining
how they will reduce pollution to meet the standards. State and
Tribal plans can include Federal measures, and any local or
statewide measures needed to demonstrate that a nonattainment
area will meet the standards by its attainment date; and
2020 to 2037: Nonattainment areas are required to meet the
primary (health) standard at varying deadlines throughout this
time, depending on the severity of an area's ozone problem.
Question 20. I am concerned that EPA continues to propose new
programs like the Urban Waters program and the Resilient Finance Center
rather than finding ways to support these goals through the Agency's
core programs. What is EPA doing to ensure that these programs aren't
creating a fragmented approach to water resource protection?
Answer. The Urban Waters Program and the Water Infrastructure and
Resiliency Finance Center are examples of initiatives that cross water
program boundaries and are most effectively supported in ways that
reflect this multi-program relationship. The Water Infrastructure and
Resiliency Finance Center, for example, identifies financing approaches
to help communities make better informed decisions for local needs such
as drinking water, wastewater, and storm water infrastructure. The
Center increases collaboration between state and local governments and
the private-sector, expands public-private partnerships, and increases
the use of Federal credit programs. These are all actions that reach
beyond the activities of one core Federal water program and, instead,
serve to enhance and strengthen multiple Federal, state, and local
objectives. We believe that managing these programs outside a single
core program, therefore, allows the EPA to more effectively integrate
and support multiple water efforts and to take advantage of these
initiatives and reduce potential fragmentation in Federal, state, and
local clean water programs.
Question 21. Will EPA use the time the Supreme Court has provided
everyone to better understand electric grid operations so you will
better understand and account for the cost and reliability issues
associated with your assumptions about unprecedented growth in
renewables? Do you agree with President Obama and Secretary Vilsack
that agricultural products can help reduce the nation's carbon
emissions? Why does the Clean Power Plan by default treat carbon from
agricultural crops the same as fossil fuel emissions?
Answer. On February 9, the Supreme Court granted a motion to stay
the Clean Power Plan. As a result of that action, states are not
currently required to submit a state plan or a request for extension by
September 6, 2016.
A core principle of the Clean Power Plan (CPP) is the importance of
providing states the flexibility to develop their own approaches to
address carbon dioxide (CO2) emissions. This flexibility
recognizes the unique circumstances of each state when it comes to
their energy mix, and their approaches to energy efficiency and
renewable energy. In the CPP, states have the flexibility to choose
whether or not to include biomass as part of their state plans, and if
so, the flexibility to describe the types of biomass that are being
proposed for use under their state plans, how those proposed feedstocks
or feedstock categories should be considered as ``qualified biomass''
(i.e., a biomass feedstock that is demonstrated as a method to control
increases of CO2 levels in the atmosphere), and explain the
proposed valuation of biogenic CO2 emissions.
The EPA generally acknowledges the CO2 and climate
policy benefits of waste-derived biogenic feedstocks and certain
forest- and agriculture-derived industrial byproduct feedstocks. The
final rule also provides that states may demonstrate that the use of
agricultural and forest biomass feedstocks appropriately control
increases of CO2 levels in the atmosphere.
Question 22. How long has EPA been working on its Biogenic
Accounting Framework for agricultural crops? When does EPA anticipate
finishing that process?
Answer. As part of the EPA's effort to advance the technical
understanding of the role of biomass in addressing greenhouse gas
emissions, in November 2014 the EPA released the second draft of its
scientific report, Framework for Assessing Biogenic Carbon Dioxide for
Stationary Sources. The revised report takes into account Science
Advisory Board peer review recommendations on the 2011 Draft Framework,
as well as the latest information from the scientific community and
other stakeholders. In February 2016, the biomass SAB Advisory panel
delivered its draft final peer review report to the full chartered SAB
for a quality review. The full chartered SAB held a public, in person
quality review meeting at the end of March 2016 and offered its
recommendations on the draft final peer review report to the biomass
SAB Advisory Panel. EPA is reviewing recommendations from the full
chartered SAB as well as those finalized by the biomass SAB Advisory
Panel. More information on the chartered SAB meeting can be found at
http://yosemite.epa.gov/sab/sabpeople.nsf/WebCommittees/BOARD.
Question 23. The public is threatened by insect-borne diseases--
West Nile Virus is a good example. Some of the critical products used
to control mosquitoes are also the backbone of Integrated Pest
Management plans. These include a class of pesticides known as OP's.
Tell me more about EPA's plans for OP's used to protect public health
against very dangerous and prolific pests. How is EPA considering the
importance of these products to human health in its risk assessments?
Is EPA following established protocols for consultations with CDC and
other Federal agencies with public health expertise?
Answer. The EPA recognizes that certain organophosphate pesticides
are important tools in strategies to control pests that vector
diseases. The EPA considers the benefits, both public health and
others, of these pesticides, along with their risks, before making any
regulatory decisions. The EPA consults with the Centers for Disease
Control and Prevention when making a regulatory decision for any
pesticide used to control a pest of public health significance. In
addition, EPA consults with the Secretary of Health and Human Services
on the identification of pests of significant public health importance
and solicits the views of the Secretary on certain environmental
pesticide regulations. The EPA also frequently consults with other
interested stakeholders to ensure that the agency has a complete
picture of the benefits and have properly evaluated any proposed
mitigation. Fortunately there are a number of other EPA registered
products that can be used for effective mosquito control.
The EPA is currently evaluating the organophosphates in our
statutorily mandated registration review program. The agency will take
comment on our assessments before consideration of any risk management.
In addition, the EPA will engage with the registrants and the public
health community to ensure that we are considering all relevant data in
our assessments. Where states, localities, other Federal agencies, and
user groups have relevant information that could aid in the analysis,
the agency will utilize this information as well. Similarly, as new
scientific information becomes available that changes our understanding
of potential risks as well as pesticide efficacy, we can revisit our
decisions.
Question 24. Exactly how many new products or product uses have
been brought into the market, and, how many products and uses have been
restricted or effectively lost under your tenure as Administrator?
Answer. Approximately 170 new active ingredients and more than
1,700 new uses of previously registered active ingredients have been
registered during my tenure. During the same time period, the EPA made
about 165 registration review decisions on active ingredients and
approximately 300 uses have been canceled. Registration review is the
agency's current re-evaluation program, which focuses on the pesticide
active ingredient rather than products or uses.
Of the 165 registration review decisions on active ingredients,
about \1/2\ of these decisions required no changes or minor label
changes. Labeling changes can include removing uses, reducing
application rates and adding protections for vulnerable populations to
address specific human health and ecological concerns. They also
improve clarity so that the user can better understand the label and
use the product safely. The other \1/2\ of the decisions made involved
voluntary cancellation by the registrants primarily for business
reasons.
Question 25. Rather than going through normal public process to
propose to cancel a registration--has the Agency ever asked a court to
order to vacate a registration? If so, please describe those
circumstances.
Answer. Subsequent to registering Enlist Duo, the EPA became aware
of previously existing information about possible synergistic effects
that had not been considered as part of the initial registration
decision. As a result, the agency could no longer represent to the
Court that its conclusions were correct regarding whether issuance of
the registration met the standard in the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) and whether the buffer zones
included in the registration support the finding that the registration
will have no effect upon threatened or endangered plant species. The
EPA therefore sought from the Court an order of remand with vacatur.
This is the first time that the EPA has asked a court to vacate a
pesticide registration.
Question 26. EPA is supposed to take into account the benefits of a
product, such as protection of the public health from disease-carrying
pests, protection of our nation's buildings and infrastructure,
protection of the food supply. However, recent EPA activities appear to
focus disproportionately on the hazard side of that assessment while
discounting factors like exposure and benefits. What additional data
does the EPA need in order to better account for pesticide benefits?
Answer. Under FIFRA, the EPA must ensure that a pesticide does not
cause ``unreasonable adverse effects.'' An important factor in that
determination is the consideration of other factors including the
benefits associated with the use of the pesticide. The EPA typically
starts the evaluation of a pesticide by conducting risk assessments to
determine if there are any ``risks of concern'' before weighing the
other factors. However, before taking any registration action, the EPA
considers the benefits the pesticide offers and the impacts of any
mitigation option on the users of the pesticide (that is, any loss of
benefits). A risk-benefit analysis is applied to ecological and
occupational risks under FIFRA.
When considering the use of a pesticide on food, the agency must
consider all dietary risk from residues that result from a pesticide
use and establish a tolerance (or exemption) under the Federal Food,
Drug, and Cosmetic Act (FFDCA). Generally, the safety standard for the
review of pesticide chemical residues under the FFDCA is a risk-based
standard that requires the EPA to make a ``reasonable certainty of no
harm'' determination when it establishes a pesticide tolerance to
regulate the amount of pesticide residue in food. When making a
determination under FFDCA, the EPA normally considers options for
meeting the safety standard and tries to select the one with the least
impact on the user community. If the safety standard of FFDCA is not
met, benefits cannot be considered in order to allow the use of the
pesticide.
Benefits may be considered when making a regulatory decision under
FIFRA when considering ecological or risks posed to workers. In
assessing the benefits of the use of agricultural pesticides, the EPA
largely relies on information generated by the land-grant university
system, USDA, and other stakeholders. Information on non-agricultural
uses, including public health, residential, and industrial uses, is
more limited and the EPA relies heavily on our public process to
solicit information about the pests targeted by specific pesticides and
the advantages a specific pesticide may have in particular situations.
Question 27. I understand that EPA will complete and release its 5
year re-issuance of the Clean Water Act-based Pesticide General Permit.
What changes should we expect to see in the reissued Pesticides General
Permit based on the new Clean Water Rule expansion?
Answer. The Clean Water Rule does not itself establish any new
requirements regarding the use of pesticides. As a result, issuance of
the Clean Water Rule does not change the National Pollutant Discharge
Elimination System (NPDES) requirements regarding application of
pesticides to waterbodies. The EPA's experience with the Pesticide
General Permit (PGP) during the last four years demonstrates it is
working well to ensure that use of pesticides is being managed to
minimize potential regulatory burdens while effectively protecting the
nation's water resources and public health. Conditions and requirements
in the EPA's proposed PGP remain largely unchanged from the 2011 PGP.
Final decisions regarding re-issuance of the PGP will reflect public
input and coordination with stakeholders.
Question 28. Please provide a comprehensive list of all Agency
actions, not just rulemakings, over the last 8 years and those planned
through the end of 2016 that restricted or have the potential to
restrict existing or new uses of pesticides.
Answer. The pesticide registration review process began in 2006
with the first decisions being made a few years later. To date, 165
decisions have been made. Of these decisions, 83 involved requests from
the registrants to voluntarily cancel their registrations, in most
cases for business decisions that were independent of the agency's
review. For the remaining 82, many required no change to the
registration or minor label clarification to make it easier for the
user to understand and use the product correctly. The EPA's anticipated
registration review schedule can be found at www.epa.gov/pesticide-
reevaluation/registration-review-schedules [See Attachment 3].
During the same time period, the EPA has registered approximately
170 new pesticide active ingredients and over 1,700 new uses of
already-registered active ingredients, providing numerous new products
for use in agricultural and non-agricultural settings. These newly
registered products are designed to address emerging pest pressures and
will have a significant role in the marketplace.
Of these regulatory decisions to restrict or cancel certain
registrations, the EPA made these decisions after careful consideration
of all available data and consistent with existing statutory
requirements. For example:
In 2010, the EPA announced its decision to terminate all
uses of endosulfan due to unacceptable risks to farmworkers and
wildlife. The EPA signed a Memorandum of Agreement with the
registrants of endosulfan that resulted in voluntary
cancellation and provided for a phase-out of all existing
endosulfan uses in the United States in order to allow time for
growers to transition to newer alternatives;
In 2012, the EPA limited the use of chlorpyrifos by
significantly lowering pesticide application rates and creating
``no-spray'' buffer zones around public spaces, including
recreational areas and homes, due to concerns for unacceptable
risks to children and bystanders;
In 2014, the EPA canceled propoxur pet collars. In the fall
of 2013, the EPA completed the propoxur pet collar risk
assessment. The EPA's risk assessment indicated risks of
concern to children from exposure to pet collars containing
propoxur;
In 2015, the EPA reached an agreement with Reckitt
Benckiser, the manufacturer, to cancel all distribution of 12
consumer use d-CON products that did not meet the EPA's current
safety standards, raising concerns for risks to children and
pets. Additionally, eight of the 12 products pose unacceptable
risks to certain wildlife;
In 2015, the EPA proposed to revoke all chlorpyrifos
tolerances due to concerns with estimated exposure from
drinking water in certain watersheds. A final tolerance rule is
anticipated in March 2017;
On November 24, 2015, while the issuance of the initial
registration was being challenged in Federal court, the EPA
sought the remand and vacatur of the Enlist Duo registration
because the EPA became aware of previously existing information
about possible synergistic effects that had not been provided
to the EPA or considered as part of the initial registration
decision. The EPA cannot be sure, without a full analysis of
the new information, that the current registration does not
cause unreasonable effects to the environment, which is a
requirement of the registration standard under FIFRA;
On July 2, 2013, the Pollinator Stewardship Council and
others, petitioned for review of the sulfoxaflor registration
in the Ninth Circuit Court of Appeals. On September 10, 2015,
the Court issued its opinion, finding that the registration was
not supported by substantial evidence to demonstrate no
unreasonable adverse effects to honey bees would result from
the registration of [sulfoxaflor]. Although the initial
sulfoxaflor submission contained all the data the EPA
determined was necessary by the EPA for registration of a new
agricultural insecticide, the Court vacated the registrations
and remanded them to the EPA to ``obtain further studies and
data regarding the effects of sulfoxaflor on bees as required
by the EPA regulations.'' The vacatur of the sulfoxaflor
registrations became effective November 12, 2015. As the
registrations were no longer in effect under FIFRA, on the same
date the EPA issued a cancellation order to address existing
stocks. Although the product registrations were vacated, the
tolerances for sulfoxaflor residues on treated commodities that
were established under the FFDCA, remain in place; and
On March 4, 2016, the EPA issued a notice of intent to
cancel the registration of four pesticide products containing
the insecticide flubendiamide owing to the registrants' failure
to comply with a required condition of their registrations. The
particular condition obligated the registrants to request
cancellation if, after receiving additional required data, the
EPA determined that use of flubendiamide did not meet the FIFRA
standard for registration. Prior to issuing the notice, the EPA
concluded that the continued use of flubendiamide will result
in unreasonable adverse effects on the environment,
particularly benthic invertebrates, which are an important part
of the aquatic food chain, particularly for fish.
Over the past 8 years, the EPA has issued a number of regulations
with the intention of providing clarity to the regulated community and
other stakeholders or to update information that has become inaccurate
or out of date. Examples of these rulemaking efforts include:
Minimum Risk (Published 12/28/2015): This final rule more
clearly describes the active and inert ingredients permitted in
products eligible for the exemption from regulation for minimum
risk pesticides. These changes maintain the availability of
minimum risk pesticide products while providing more consistent
information for consumers, clearer regulations for producers,
and easier identification by states, Tribes and the EPA as to
whether a product is in compliance with the exemption;
Crop Grouping (Published Phase 1: 12/7/2007; Phase 2: 12/8/
2010; Phase 3 8/22/2012; Phase 4: anticipated 2016): These
final rules are likely to reduce the number of residue
chemistry studies required to establish a tolerance for a crop
within these crop groupings because instead of testing each
crop individually, only the representative crops would need to
be tested. Thus, the new crop groups ease the process for an
entity to request and for the EPA to set pesticide tolerances
on greater numbers of crops. Pesticides will be more widely
available to growers for use on crops, particularly specialty
crops;
Data Requirements for Antimicrobials (158W) (Published 5/8/
2013): the EPA revised the data requirements for antimicrobial
pesticide products to reflect current scientific and regulatory
practice, and to provide the regulated community with clearer
and transparent information about the data needed to support
pesticide registration decisions for antimicrobial products.
The EPA would use this information to conduct risk assessments
for a particular pesticide;
Prions as Pests (Published 2/28/2013): In 2003, the EPA
determined that a prion (proteinaceous infectious particles) is
a ``pest'' under FIFRA and that a product intended to reduce
the infectivity of prions on inanimate surfaces (i.e., ``prion
product'') is considered to be a pesticide. The EPA believes
that regulating prion-related products protects human health
and the environment against unreasonable adverse effects and
ensures that such products are effective;
Export Labeling (Published 1/18/2013; Revisions Published
12/19/2014): the EPA revised the regulations pertaining to the
labeling of pesticide products and devices that are intended
solely for export. Pesticide products and devices intended
solely for export are now able to meet the agency's export
labeling requirements by attaching a label to the immediate
product container or by providing collateral labeling that is
either attached to the immediate product being exported or that
accompanies the shipping container of the product being
exported at all times when it is shipped or held for shipment
in the United States. Collateral labeling ensures the
availability of the required labeling information, while
allowing pesticide products and devices that are intended
solely for export to be labeled for use in, and consistent with
the applicable requirements of the importing country; and
Data Compensation (Published 2/5/2014): the EPA revised its
regulations governing procedures for the satisfaction of data
requirements under FIFRA, which are codified in 40 CFR Part
152, subpart E. These provisions include, among other things,
procedures for the protection of exclusive use and data
compensation rights of data submitters. The EPA updated the
regulations to accommodate statutory changes and changes in
practice that have occurred since 1984; to make minor changes
to clarify the regulations; and to make changes that would
simplify the procedures and reduce burdens for certain data
submitters. The revisions did not otherwise make substantive
changes to the requirements.
At times, however, the EPA has determined that significant changes
to its regulations are needed to improve public health. For example, in
November 2015, the EPA finalized revisions to the Agricultural Worker
Protection Standard. This final rule revised the Federal regulations
issued under FIFRA that direct agricultural worker protection (40 CFR
Part 170). The changes reflected current research on how to mitigate
occupational pesticide exposure to agricultural workers and pesticide
handlers, and strengthened the protections provided to agricultural
workers and handlers under the worker protection standard. The changes
improved elements of the existing regulation, such as training,
notification, communication materials, use of personal protective
equipment, and decontamination supplies, thus preventing exposure to
pesticides among agricultural workers and pesticide handlers;
vulnerable groups, such as minority and low-income populations, child
farmworkers, and farmworker families; and the general public. The EPA
is working closely with affected stakeholders, including state
agricultural agencies, to ensure that they have the necessary
information and training to implement these new protections.
Similarly, the EPA is now working to develop a final rule to revise
the Federal regulations governing the certified pesticide applicator
program (40 CFR Part 171). This action is intended to improve the
competence of certified applicators of restricted use pesticides (RUPs)
and to increase protection for noncertified applicators of RUPs
operating under the direct supervision of a certified applicator
through enhanced pesticide safety training and standards for
supervision of noncertified applicators. State agricultural agencies,
as well as many other stakeholders, provided valuable comments and
suggestions in response to the EPA's proposed rule. We will work with
stakeholders to ensure that the revised competency standards can be
implemented effectively by state agencies.
Question 29. Federal law includes very specific actions that a
Federal agency must take before promulgating new regulations. The
Office of Pesticide Programs has circumvented this process by sending
pesticide registrants letters that outline new regulatory provisions.
This ``regulation by letter'' procedure was used by EPA in 2013 to
mandate registrants include pollinator statements and a graphic on
certain products, and in 2009 for a labeling initiative. What is EPA's
rationale for circumventing the Administrative Procedure Act (APA),
which includes notice and comment, economic and small business impact
analysis, etc.?
Answer. The EPA does not ``regulate by letter'' and FIFRA does not
provide for such a regulatory mechanism to make changes to pesticide
registrations. The EPA pesticide program is a licensing program that is
based on an adjudicatory system. As a licensing program, the agency
must ensure that the license complies with the law and continues to
comply with the law. As such, decisions to grant a new license or
change/modify an existing license are not subject to APA rulemaking,
but the procedural requirements of FIFRA. When the EPA receives new
information and determines that the license may lead to unreasonable
adverse effects on the environment, the agency may offer the registrant
a way to correct the imbalance in a timely manner. The August 2013
letter regarding labeling changes for the neonicotinoid insecticides is
one example. However, if the registrant chooses not to address the
concerns raised in such an offer, the agency can take appropriate steps
under FIFRA to compel any necessary changes to the pesticide
registration to mitigate unreasonable adverse effects on the
environment. The letter itself is not self implementing; in the absence
of voluntary agreement from a registrant, FIFRA prescribes steps that
the agency must take to impose new mitigation measures.
Question 30. EPA's honeybee acute toxicity proposal would restrict
approved crop protection tools from use when a grower is under a
pollination contract. The proposal clearly did not have the support of
conventional or organic growers, or the national beekeeper
organizations, or the USDA, which sent a letter to the Agency
criticizing the proposal. Honeybees are not native species; they are
essentially livestock and the property of the beekeeper. Why is EPA
attempting to regulate contracts between private parties? Has the
Agency produced an analysis to show the benefit expected if the rule is
implemented?
Answer. With greater attention put on protecting pollinators as
well as their important role in agricultural production, the EPA's
acute mitigation strategy, EPA's Proposal to Mitigate Exposure to Bees
from Acutely Toxic Pesticide Products, is aimed at providing greater
protection to bees where acute risk is presumed to be the highest,
namely when nearly certain exposure (i.e., contract pollination
scenarios) and presence of an acutely toxic pesticide coincide. The
intent of the proposed acute mitigation strategy is to protect managed
(contracted) bees at commercial pollination sites, and also likely
provide protection for other pollinators near the treatment area.
The proposed approach is to clarify and strengthen the existing
language for the acutely toxic compounds in the immediate term. The
agency will also assess each compound under the registration review
program, with a robust data set identified in our Risk Assessment
Framework for Pollinators that also evaluates potential sub-lethal and
chronic impacts to pollinators at both the individual and colony level.
As a result, chemical-specific, risk based labeling will be developed.
As part of its planning and analysis prior to issuing its proposal, the
agency did consider the potential cost to growers.
The EPA is currently reviewing the wide range of comments it
received in response to the proposal. Based upon comments received, we
are developing options on moving forward. While doing so, the agency
will continue to weigh both the level of protection to bees, and the
potential impact to growers.
Question 31. Environmental activists recently sued the EPA claiming
that the Agency should regulate seeds treated with systemic pesticides
as pesticides themselves and regulate those seeds under FIFRA. Congress
has expressed its intent that seeds are not subject to the same
regulatory requirements as applied pesticides, and in recent years has
found that treated seeds are safe and offer significant value to
farmers, which is consistent with EPA's long-held view. Furthermore,
restricting seed treatments would likely lead to them being replaced
with spray or soil applications and that switch would not result in
improved environmental protection. Do you intend to vigorously defend
the Agency's determination that economically-beneficial coated seeds
are ``treated articles''?
Answer. With respect to the litigation filed by public interest
groups, on March 14, 2016, the EPA filed a motion with the district
court in the Northern District of California to dismiss the case
against the EPA. A hearing on this motion was held on May 12, 2016, and
the following day the court issued an order deferring a decision on the
merits of the EPA's motion to dismiss until the EPA produced an
administrative record. The EPA has complied with the court's order and
expects the court to address its jurisdiction (the subject of the
motion to dismiss) during summary judgment proceedings. Under the
current litigation schedule, summary judgment motions are to be filed
in September and should be argued in October 2016.
Question 32. Seed treatments deliver a very precise application
that shields seeds from the insects and diseases that exist in the soil
during early developmental stages. Do you agree that seed treatments
reduce the environmental impact of the production process by decreasing
the number of spray applications of agrichemical products lessening
exposure to non-target species, including humans, pollinators and the
environment?
Answer. In general, the EPA agrees that seed treatments are
effective at reducing environmental exposure and impact, as compared to
spray applications of agrichemical foliar products, to humans and the
environment. In addition, the EPA has engaged in discussions with the
American Seed Trade Association, equipment manufacturers, and pesticide
registrants to encourage broader adoption of best management practices
intended to reduce the potential for drift of contaminated dust during
the planting of pesticide-coated seeds that have resulted in incidents
to honeybees. These efforts have included the development of
alternative lubricants used in pneumatic planters to reduce dust
generated through the abrasion of treated seed during planting as well
as the development of more effective seed coatings to enhance pesticide
adherence to the seed.
Question 33. When this Committee passed both H.R. 872 in the 113th
Congress and H.R. 897 last year we discussed the outbreaks of West Nile
Virus and even concerns about Malaria across many regions of the
country. Today, there is a new threat to human health called the Zika
virus, which is also transmitted through mosquitos. The World Health
Organization has gone so far as to declare a public health emergency of
international concern. There are no vaccines or a reliable diagnostic
test. I believe that America will be better adept to combat the spread
of the virus with our world renowned researchers and response by the
public health community. However, our country is currently being
hamstrung by an ill-advised court decision that was in contradiction
with EPA's own assessment under the Clean Water Act and the Federal
Insecticide, Fungicide, and Rodenticide Act. In some states, the burden
and liabilities of obtaining a duplicative NPDES permit are limiting or
delaying mosquito control applications that protect human health. Will
the Administration support the passage of this important legislation?
Answer. The Administration believes that legislation removing CWA
Act protections for public health and water quality is not the answer
for effective and timely action to respond to the threat of mosquito-
borne illness.
Question 34. Major farm organizations have written EPA concerning
the need for new, effective weed management tools. Prominent academics,
farm group leaders and many others have said multiple modes of action
are the most effective way to deal with weed resistance issues while
preserving environmentally beneficial cropping systems like no-till or
conservation tillage. Yet when it comes to crop protection product
registrations at EPA, some innovative products that can help growers
meet these goals have been either sitting at your Agency for several
years, or in some cases courts have intervened to vacate registrations.
What conversations are you having with USDA and the industry to
minimize the concerns raised in court actions and to ensure the near-
term availability of new, more effective weed management chemistries?
Answer. The EPA recognizes the negative impacts of weed resistance
and understands the needs of growers for new weed control technology.
The EPA's review of herbicides proposed for use on genetically modified
seed requires thorough and scientifically rigorous assessments for both
human health and the environment. The agency has intensified
communications and information sharing with USDA in handling these
actions, and is building a framework for a streamlined process that
also addresses new measures for avoiding the onset of new resistance
issues.
Because the emergence of herbicide resistance is an increasing
problem in the United States, the EPA has been working directly with
the USDA and industry to construct a comprehensive resistance
management program. By developing these new strategies, the EPA hopes
to promote a more efficient registration process while simultaneously
preserving the longevity of important new herbicide tools. Meanwhile,
the agency will continue to work closely with the USDA in the review of
herbicides submitted in association with herbicide-tolerant traits to
ensure that our two agencies perform a thorough scientific review of
the potential impacts on human health and the environment associated
with the proposed use of additional herbicides on herbicide-tolerant
crops.
In addition, in the spring of 2016, the EPA requested public
comment on two Pesticide Registration Notices (PRNs) that focus on
strategies to combat or slow pesticide resistance, and preserve the
useful life of pesticide chemistries. One of these PRNs aims to improve
resistance management information contained on the labels of all
conventional pesticide products.\1\ The other PRN focuses on the
agency's proposed strategy for addressing herbicide resistance.\2\ The
EPA expects to finalize these two PRNS in late 2016.
---------------------------------------------------------------------------
\1\ https://www.epa.gov/pesticide-registration/prn-2016-x-draft-
guidance-pesticide-registrants-pesticide-resistance.
\2\ https://www.epa.gov/pesticide-registration/prn-2016-xx-draft-
guidance-herbicide-resistance-management-labeling-education.
Question 35. EPA recently asked the 9th Circuit Court of Appeals to
remand a pesticide registration back to EPA for further review because
of concerns under the Endangered Species Act. This is the only time
ever where EPA has attempted to vacate a pesticide registration through
a court action. Currently under FIFRA, EPA is required to comply with a
number of procedural safeguards before a pesticide registration can be
canceled, which they have failed to do. What was the Agency rationale
for taking such an unusual step of asking a Court to require EPA to
review the registration of a product so recently approved for use and
why is the Agency now trying to use the Courts as a means to regulate?
Answer. The EPA felt compelled to seek remand and vacatur because
the EPA discovered, after granting the registration for Enlist Duo,
that Dow had made claims of ``synergistic herbicidal weed control'' in
its Provisional and Non-provisional patent applications to the U.S.
Patent and Trademark Office for Enlist Duo. This new information
suggests the two active ingredients used in combination could result in
greater toxicity to non-target plants than believed by the EPA at the
time the agency granted the registration. This information was not
provided to the EPA by Dow prior to the EPA issuing the Enlist Duo
registration. This new information could lead the EPA to a different
decision on the restrictions on use of Enlist Duo, including those
necessary to ensure the protection of listed species in the context of
the Endangered Species Act.
Because the EPA had become aware of previously existing information
about possible synergistic effects that it did not consider, the agency
could no longer represent to the Court that its conclusions were
correct regarding whether issuance of the registration met the standard
in FIFRA and whether the buffer zones included in the registration
support the finding that the registration will have no effect upon
threatened or endangered plant species. The EPA therefore sought from
the Court an order of remand with vacatur.
Question 36. The United States has the world's most rigorous
pesticide registration and review processes. We regulate pesticide by
assessing `risk' to determine whether and how a product can be used
safely. In evaluating risk, `hazard' (whether something can cause harm)
and `exposure' (whether something you'll be exposed to harm) are
balanced against the benefits of using a product. This is something EPA
should be confident in and proud to defend. As a matter of fact, EPA
does a great job defending the merits of our risk-based system when
commenting on the EU's precaution-based regulatory scheme. But,
recently it seems when EPA regulatory decisions are challenged in the
U.S., you seem reluctant to defend or, even more troubling, unable to
properly provide evidence of the Agency's scientific decisions. How can
you better inform the public and skeptics that the products EPA
registers are thoroughly tested and protective of human health,
vulnerable species and the environment?
Answer. The EPA agrees that it has one of the world's most rigorous
registration and reevaluation processes. The agency always strives to
base its decisions on the best available science. However, science is
constantly evolving, and new scientific information can come to light
at any time and change our understanding of potential risks from
pesticides. If any pesticide is found to present risks to human health
or the environment that cannot be mitigated or managed through other
measures, the agency has to make a finding that the pesticide no longer
meets the FIFRA standard for registration or under the Federal Food,
Drug, and Cosmetic Act for pesticide tolerances. In that case, then the
agency will move quickly to take appropriate regulatory action. Any
such action, however, would have to be supported by the best available,
peer-reviewed science. The EPA scientific assessment approaches are
publicly available at http://www2.epa.gov//pesticide-registration/
understanding-science-behind-epas-pesticide-decisions [See Attachment
4].
Question 37. There have been several instances where courts, local
governments or other organizations have challenged EPA regulatory
decisions. What can Congress do to educate the public, localities,
courts and other institutions about the rigors of the pesticide
registration process and to increase the public's confidence in EPA's
pesticide registration decisions?
Answer. As stated in the response above, the EPA agrees that it has
one of the world's most rigorous registration and reevaluation
processes. The agency always strives to base its decisions on the best
available science. In addition, the EPA believes that by makings its
decisions in a transparent manner, including through the active
solicitation of public participation in the process, we demonstrate the
scientific soundness of our decisions.
Question 38. The Committee has heard about a serious matter
regarding EPA policies based on human research data that may not be
reliable. For years, EPA relied on hundreds of quality studies
evaluating all aspects human susceptibility to pesticides called
organophosphates--otherwise known as OP's. These included studies
designed to make sure that children would be protected. Even though EPA
used those high-quality assessments for 20 years; EPA now relies
primarily on three epidemiology publications and some journal articles
in which EPA, I am told, EPA does not have access the raw data to
determine if these studies are reliable or accurate. The Committee has
been advised that Columbia University--who conducted the key study--
refused to provide the raw data to EPA even though EPA provided funding
for the study. So, it appears EPA is relying on information based on
raw data that cannot be reviewed for accuracy. If it is correct that
EPA has not gotten access to that raw data, Federal regulations
designed to enhance the credibility of the Federal rulemaking process
have likely been violated. Data Quality Act violations and conflict of
interest violations could have also occurred.
EPA held a meeting in May 2013 with researchers from Columbia
University about the Columbia Study. Is there a transcript of the
discussion that took place at that meeting? Were minutes taken at the
meeting and made available?
Answer. The agency wrote a summary of the 2013 meeting with
researchers from Columbia University. This summary is contained in
``Appendix 6 Columbia Center for Children's Environmental Health
(CCCEH) Epidemiology Data Acquisition `Raw Data Request' '' of EPA's
December, 2014 human health risk assessment for chlorpyrifos which can
be found at www.regulations.gov in docket ID number: EPA-HQ-OPP-2008-
0850-0195, (Drew, et al., D424485, December 29, 2014) [See Attachment
5].
Question 38a. Did the Federal Government provide any funding for
any or all of the three epidemiology studies, most notably the study
from Columbia University's Center for Children's Health commonly
referred to as the Columbia Study, the ``CHAMCOS'' study and, also, the
Mt. Sinai study which were relied upon by the Agency to raise issue
about potential effects on infants and children in the human health
assessment and Proposed Rule to revoke tolerances for chlorpyrifos?
Please provide details on any and all funding EPA provided for any
portion of the three studies.
If yes:
Question 38a. (Yes i.) Does the Agency have in its possession all
the raw data from the studies? (Raw data would include but is not
limited to interview data with participants, blood and urine analysis,
interviews with the children, etc.)
Question 38a. (Yes ii.) For which of these studies does EPA possess
the raw data?
Question 38a. (Yes iii.) Why have the data not been made available
to registrants affected by the Agency's actions or in response to FOIA
requests?
If no:
Question 38a. (No i.) Why not? How does this lack of possession and
lack of availability of the data not conflict with the 2009
Presidential memorandum which says that if scientific and technical
information is developed and used by the Federal Government, it should
ordinarily be made available to the public? [``. . . mandating
disclosure of scientific and technical information developed and used
by the Federal Government.''] Why is the Agency not complying then with
the goal of that memorandum for transparency in the use of scientific
information in policy making?
Question 38a. (No ii.) How can EPA say that its use of epidemiology
data for chlorpyrifos is transparent when the Agency did not obtain and
consider the underlying raw data for the studies it relied upon or
provide minutes from the meeting with the researchers?
Question 38a. (No iii.) Without the raw data, how can the Agency
confirm there is no negative data, null results or confounding factors
that would have changed the Agency's conclusions about the studies? How
is such a decision consistent with EPA's reliance for chlorpyrifos risk
assessment purposes on epidemiology studies for which the Agency cannot
obtain and consider the raw data?
Question 38a. (No iv.) EPA says that it is relying on
``uncertainty'' created by the epidemiology studies to set the FQPA
additional safety factor for chlorpyrifos. But hasn't EPA created this
uncertainty by failing to obtain and consider the raw data for the
epidemiology studies the Agency is relying upon?
Combined answer. The EPA provided funding for the Columbia Center
for Children's Environmental Health (CCCEH), the Mount Sinai Center for
Children's Environmental Health and Disease Prevention Research, and
Center for the Health Assessment of Mothers and Children of Salinas
(CHAMACOS) cohort at the Center for Environmental Research and
Children's Health (CERCH). The EPA and the National Institute of
Environmental Health Sciences (NIEHS) jointly provided funding to the
CCCEH under the 1997 and 2003 Request for Applications (RFAs). The
approximate EPA funding for the 5 year CCCEH awards was $3.9 million
under the 1997 RFA (matched by NIEHS) and $3.6 million under the 2003
RFA (NIEHS provided $3.5 million).
Similarly, the EPA and the NIEHS jointly provided funding to the
Mount Sinai Center for Children's Environmental Health and Disease
Prevention Research under the 1997 and 2003 RFAs. The approximate EPA
funding for the 5 year Center awards was $3.9 million under the 1997
RFA and $4.0 million under the 2003 RFA (matched by the NIEHS with $4.1
million under the 1997 RFA and $3.8 million under the 2003 RFA).
The EPA and the NIEHS also jointly provided funding to the CERCH
under the 1997, 2003, and 2009 RFAs. The approximate EPA funding for
the 5 year Center awards was $4.5 million under the 1997 RFA (NIEHS
provided $4.2 million), $3.6 million under the 2003 RFA (NIEHS provided
$3.3 million), and $3.6 million under the 2009 FRA (NIEHS provided $4.2
million).
In the summer of 2015, Dr. Dana Barr of Emory University provided
the agency with limited raw urine and blood data in her possession from
the three cohorts. However, the files provided from Dr. Barr are not
useful for the agency's current purpose of assessing risk to
chlorpyrifos. The files provided from Dr. Barr do not contain the
biomonitoring data from the key publications from CCCEH which describe
associations between blood levels of chlorpyrifos and
neurodevelopmental deficits in children. The EPA does not have any of
the other measurements of the children in the cohort (e.g.,
chlorpyrifos blood data, interviews, test or IQ scores). The CCCEH
researchers have not provided these data, asserting that the pesticide
component of the cohort study was privately funded, not federally
funded, and therefore disclosure of underlying data is not required.
The agency received two FOIA requests specifically asking for raw data
on the three U.S. children's cohorts. For the first FOIA request, EPA-
HQ-2016-002089, the requester was provided all the responsive records
(i.e., the files provided by Dr. Barr) and the request was closed March
2, 2016. For the second request, EPA-HQ-2016-003947, the agency did not
have any additional files beyond those provided for the first request.
The second FOIA was closed on March 23, 2016.
While the EPA strives to ensure that data underlying research it
relies upon are accessible to the extent possible, it does not believe
that it is appropriate to refuse to consider published studies in the
absence of underlying data. The EPA frequently relies on peer reviewed
studies in the public literature across agency programs without
possessing underlying data and the Federal courts have made clear that
the EPA is not required to obtain or analyze the raw data in order to
rely on such studies. If the EPA and other governmental agencies could
not rely on published studies without conducting independent analyses
of the raw data underlying them, then much relevant scientific
information would become unavailable for use in setting standards to
protect public health and the environment.
In the past, the EPA sought to obtain the original raw data used to
support certain epidemiological analysis of in utero exposure to
chlorpyrifos and subsequent adverse neurodevelopmental health outcomes
in children generated by the CCCEH to support the human health risk
assessment of chlorpyrifos. Prior to the 2013 meeting with CCCEH
investigators, the EPA thought these data would be important to both
clarify the exposure-response relationship observed in the epidemiology
study relative to the current regulatory endpoint (acetylcholinesterase
inhibition), and also to resolve uncertainties regarding study
participants co-exposure to other environmental contaminants, among
other areas of uncertainties. CCCEH researchers did not agree to
provide these data; however, the researchers met with the EPA and
discussed the agency's questions about the data to help determine
whether further review of the raw data might assist the EPA in
resolving uncertainties. As a result of this meeting, the EPA concluded
that access to the raw data would not provide answers to the EPA's
questions. Indeed, based on discussions in that meeting as well as
further work conducted by agency staff, the EPA has gained additional
information to better clarify and characterize the major issue areas
identified as uncertainties.
In the summer of 2015, the EPA again requested the raw data from
Columbia University. The Columbia University investigators again denied
the EPA's request. However, the investigators did provide additional
summary information on the blood biomonitoring data. The agency has
made this additional information publicly available. The EPA continues
to engage with Columbia University on this topic.
Question 39. Related to the use of these epidemiology studies, in
2011, EPA said that it was reviewing a Scientific Advisory Panel report
regarding the Agency's Draft Epidemiology Framework and would, also
during 2011, release a revised version of the framework for public
comment.
Why has the Agency not completed this task?
Question 39a. How can the Agency's reliance on the Draft
Epidemiology Framework to integrate the epidemiology studies into the
risk assessment for chlorpyrifos be reasonable when, contrary to EPA's
promise, the framework has not been revised consistent with SAP
recommendations and made available for public comment?
Answer 39-39a. Although use of epidemiology is common in other
agency regulatory programs, epidemiology studies focusing on pesticides
have only become available in the last few years. Thus, epidemiology
data are less frequently used in evaluation of pesticides. The EPA
decided that additional experience was needed in applying the ``Draft
Framework for Incorporating Human Epidemiologic & Incident Data in
Health Risk Assessment'' prior to its finalization. Obtaining such
experience is consistent with the recommendations of the Federal
Insecticide, Fungicide, and Rodenticide Act Science Advisory Panel
(FIFRA SAP) (2010) to ``conduct a broader analysis'' to improve the
written description of the process of integration of epidemiology with
other lines such as animal toxicity data. The ongoing work on
chlorpyrifos and the organophosphates are examples of such experience.
The FIFRA SAP commended the agency for developing the draft Framework
and was ``impressed with the documentation presented.'' The agency also
notes that the FIFRA SAP was supportive of the key components of the
draft Framework, namely the use of problem formulation to assess data
availability and quality early in the process and the modified Bradford
Hill criteria as an internationally accepted tool for assessing
epidemiology and laboratory animal data. Because the FIFRA SAP was
basically supportive of the overall approach, the agency believes use
of the draft Framework in its current form is appropriate prior to the
finalization of the document.
Question 39b. What are the number and total cost of all of the
animal studies conducted by registrants that EPA has required and/or
evaluated over the years to assess the potential toxicity and health
risks of the OP pesticides, for which the proposed reliance on the
three controversial epidemiology studies would trump, invalidate, or
dismiss all of the animal study results?
Answer. The EPA has established data requirements (40 CFR) so that
the agency can conduct appropriate risk assessments, including risks to
human health. The relevant studies are associated with the
toxicological data requirements for a food use. There are generally 30
studies that may be required but some pesticides may have more studies
and some may have fewer. The organophosphate (OP) pesticides typically
have completed all of the required studies since their initial
registration, through reregistration, and to date during registration
review. The EPA does not know the cost of generating these data for any
particular company or chemical.
The agency has not limited the number of studies reviewed to the
three epidemiology cohorts. In fact, the agency has reviewed hundreds
of studies from laboratory animals, cell systems (including human),
biomonitoring, and epidemiology on a variety of scientific areas
related to human health effects. These studies were evaluated together
in a weight of evidence analysis.
Question 39c. What is the biological mechanism of toxicity that
accounts for supposed differences between the controversial
epidemiology studies and the mountain of reliable data from animal
toxicology studies? What is the biological plausibility of the results
observed and any conjectured mechanisms of action? What are all of the
possible confounding factors that could affect, influence, or produce
the results observed, and how have they been accounted for in the
reports that EPA has relied on? Who/what is/are the unexposed cohort
that shows that the effects allegedly found in the controversial
epidemiology studies could reasonably be attributable to pesticide
exposure?
Answer. The EPA conducted detailed evaluations of the scientific
literature on the neurodevelopmental potential of chlorpyrifos and
other OPs as part of reviews by the FIFRA SAP in 2008 and 2012 along
with the 2014 human health risk assessment for chlorpyrifos and the
2015 literature review for all the OPs. This includes review of
registrant submitted studies along with studies from the scientific
literature. Biological plausibility of the findings from the
epidemiology studies are found in numerous studies conducted in
laboratory animals and using new technologies, including human cells.
There are a large number of animal studies using rats and mice from a
dozen laboratories worldwide which have reported neurodevelopmental
effects in offspring exposed to chlorpyrifos in the womb or after
birth. Some in vitro studies, like those recommended by the NAS in the
2007 report on Toxicity in the 21st Century, conducted at very low
concentrations have suggested several biological mechanisms which could
underlie effects at low exposure levels as seen in the epidemiological
studies.
These studies present strong evidence that developmental
neurotoxicity of chlorpyrifos and other OPs may not be due to
acetylcholinesterase inhibition per se, but to other actions on
critical aspects of neuronal development. There are a number of
biologically plausible molecular events proposed for chlorpyrifos and
other OPs effects on the developing nervous system, with ongoing
academic research pursuing many of these potential pathways. Some of
the more promising mechanisms represent molecular initiating events
(binding to the morphogenic site of AChE, muscarinic receptors, or
tubulin), cellular responses (alterations in neuronal proliferation,
differentiation, neurite growth, or intracellular signaling) and
responses at the level of the intact nervous system (serotonergic tone,
axonal transport). Overall, there is good evidence that
neurodevelopmental effects may not be solely a function of
acetylcholinesterase inhibition.
The EPA is including epidemiologic research results from three
prospective birth cohort studies. These include: (1) The Mothers and
Newborn Study of North Manhattan and South Bronx performed by the
Columbia Children's Center for Environmental Health (CCCEH) at Columbia
University; (2) the Mt. Sinai Inner-City Toxicants, Child Growth and
Development Study or the ``Mt. Sinai Child Growth and Development
Study;'' and (3) the Center for Health Assessment of Mothers and
Children of Salinas Valley (CHAMACOS) conducted by researchers at
University of California, Berkeley.
In these epidemiology studies, mother-infant pairs were recruited
for the purpose of studying the potential health effects of
environmental exposures during pregnancy on subsequent child
development. Each of these cohorts evaluated the association between
prenatal chlorpyrifos or OPs exposure with adverse neurodevelopmental
outcomes in children through age 7 years and to limited extent up to 11
years old. The CCCEH Mother's and Newborn study and the Mt. Sinai Child
Growth and Development study participants were likely exposed to
chlorpyrifos and other OPs through the diet and through residential use
of the pesticide for indoor pest control. The CHAMACOS cohort
participants were employed as farm laborers or were residing in homes
with farm laborers. The CHAMACOS study participants likely experienced
exposure to OPs through the diet and from occupational exposure
(primarily inhalation and dermal routes), as well as probable indirect
take-home exposures.
Biomonitoring data were collected from individuals within each
cohort. The unexposed children in the epidemiology studies are those
whose biomonitoring data are low and often below the limit of
detection, i.e., so low as to not be measurable. The unexposed children
are derived from the same populations and location in the same living
and economic conditions as the exposed or highly exposed children. In
this way, important issues such as socioeconomic status are similar
across the entire group of exposed and unexposed.
The EPA focused its review on research results from these three
epidemiological cohort studies due to the considerable strengths in
study design, conduct, and analyses. Investigators from each study
cohort utilized a strong study design (prospective birth cohort),
measured pesticide exposure using several different methods including
biomarkers, and measured neurodevelopment effects in children using
well-established assessment tools in both clinical and research
settings. In addition, the investigators have accounted for potentially
confounding variables including socioeconomic status and other
environmental exposures. Evaluation of these confounding variables is
important to reduce the chances of a false positive study result.
Across these cohort studies, investigators collected relevant
information on demographic characteristics and other environmental
exposures and used this information in the statistical analysis. Other
environmental exposures considered by the investigators were blood
lead, environmental tobacco smoke, polyaromatic hydrocarbons (PAHs),
methylmercury, or other non-OPs. The EPA and the FIFRA SAP (2008 and
2012) believe that the cohort study authors were able to appropriately
measure and model the effect of potential confounding variables on the
study outcomes.
The agency held another meeting of the FIFRA SAP on April 19-21,
2016 to review a new analysis using the blood biomonitoring data from
the Columbia University epidemiology study.
Question 39d. Given the pesticide uses registered today, what is
the relevance of the pesticide exposures that allegedly caused effects
observed in the controversial epidemiology studies to the current
regulatory picture?
Answer. Agricultural use of OPs remain today for many crops across
the United States. Agricultural workers (including women who may be
pregnant) who mix, load, and/or apply pesticides, as well as those who
work in previously treated fields (e.g., harvesting citrus fruit) are
exposed to high levels of OPs. In addition, some areas of the country
are predicted to have OPs or their more toxic degradates in drinking
water. Exposure to OPs through food to the entire country is also
expected.
Question 39e. Please explain in layman's terms the process for
``Systematic Review of scientific literature for laboratory animal
studies & epidemiology studies'' used by the Agency. How does this
differ from the Agency's review of studies and data it requires
registrants to conduct and submit in support of pesticide
registrations? How do the two processes supplement, complement, or
contradict each other?
[http://www.epa.gov/sites/production/files/2015-10/documents/op-risk-
assessment-approach.pdf. Also https://ntp.niehs.nih.gov/pubhealth/hat/
noms/index-2.html.]
Answer. In recent years, the National Academies' National Research
Council (NRC) has encouraged the agency to move towards systematic
review processes to enhance the transparency of scientific literature
reviews that support chemical-specific risk assessments to inform
regulatory decision making (NRC 2011, 2014). The NRC defines systematic
review as ``a scientific investigation that focuses on a specific
question and uses explicit, pre-specified scientific methods to
identify, select, assess, and summarize the findings of similar but
separate studies'' (NRC 2014). According to the NRC, systematic reviews
``have several common elements: transparent and explicitly documented
methods, consistent and critical evaluation of all relevant literature,
application of a standardized approach for grading the strength of
evidence, and clear and consistent summative language.''
The EPA's approach to reviewing scientific data include: data
collection, data review, and integration procedures. Therefore, the
agency's standard review approaches for assessing toxicology data
submitted by registrants and for integrating the registrant supported
data with information from the open literature are consistent with the
NRC's recommendations for systematic review. As such, although the
terminology may differ, the approaches are consistent and similar.
Question 39f. With such a requirement for an extensive base of
these studies, how, according to your own Framework, does the Agency
weigh an epidemiology study that is not conducted to the same standards
as that required for a registrant study and where you do not even have
in your possession the raw data?
Answer. Most laboratory animal studies submitted to the agency by
the registrants follow the EPA and Organisation for Economic Co-
operation and Development (OECD) guidelines and thus have specific and
defined study designs. Epidemiology studies do not have such OECD
guidelines; moreover, epidemiology studies can vary significantly in
their study design.
The EPA developed a ``Draft Framework for Incorporating Human
Epidemiologic & Incident Data in Health Risk Assessment'' in 2010 which
was reviewed by the FIFRA SAP and received public comment. The Panel
commended the agency for developing the draft Framework and was
``impressed with the documentation presented.'' The agency also notes
that the Panel was supportive of the key components of the draft
Framework, namely the use of problem formulation to assess data
availability and quality early in the process and the modified Bradford
Hill criteria as an internationally accepted tool for assessing
epidemiology and laboratory animal data.
In the draft Framework, the agency describes several areas for
consideration of the quality of epidemiology studies: exposure
assessment, confounding factors, statistical analysis, potential bias
in observational research, interpretation of null studies, external
validity (generalizability). The SAP concurred with these identified
scientific areas for consideration and suggested additional ones
including sample size and associated statistical power, and outcome
assessment. The EPA has assessed all of these considerations as part of
the evaluation for chlorpyrifos and the OPs. The EPA focused its review
for OPs on research results from the three epidemiological cohort
studies due to the considerable strengths in study design, conduct, and
analyses demonstrated in these investigations. Investigators from each
study cohort utilized a similarly strong study design (prospective
birth cohort); measured pesticide exposure using several different
methods including environmental indicators as well as specific and non-
specific biomarkers of chlorpyrifos; ascertained developmental outcomes
using validated assessment tools well-established in both clinical and
research settings; and, measured, analyzed, selected and statistically
adjusted for potentially confounding variables including socioeconomic
status and other environmental exposures using reasonable and
appropriate methods.
The EPA believes the draft framework is consistent with updates to
the World Health Organization/International Programme on Chemical
Safety mode of action/human relevance framework, which highlight the
importance of problem formulation and the need to integrate information
at different levels of biological organization. Similarly, the EPA's
draft Framework is consistent with recommendations from the NRC in its
2009 report on Science and Decisions \3\ * that describes the
importance of using problem formulation at the beginning of a complex
scientific analysis.
---------------------------------------------------------------------------
\3\ NRC (National Research Council). (2009). Science and decisions:
Advancing risk assessment. Washington, D.C.: The National Academies
Press. http://www.nap.edu/openbook.php?record_id=12209.
* Editor's note: the document referred to is retained in Committee
file.
Question 39g. From 1996 when FQPA was enacted through the current
date, EPA has made multiple, specific formal findings based on
extensive reliable databases that FQPA safety factors for OP
insecticides can be reduced or eliminated. The Agency has proceeded to
regulate the uses of these pesticides in the marketplace on that basis,
and has therefore determined that the residue tolerances are safe.
FFDCA 408(b)(2)(A)(1) requires the Administrator to ``. . . modify or
revoke a tolerance if the Administrator determines it is not safe.''
What specific determination have you now made that the chlorpyrifos
tolerances are ``not safe''?
Answer. The EPA periodically reviews existing registered pesticides
to ensure they can be used safely, without unreasonable risks to human
health and the environment. The periodic review of pesticide
registrations is required by FIFRA. The registration review program is
intended to make sure that, as the ability to assess risk evolves and
as policies and practices change, all registered pesticides continue to
meet the statutory standard of no unreasonable adverse effects. The EPA
will review each registered pesticide at least every 15 years to
determine whether it continues to meet the FIFRA standard for
registration.
As part of registration review, the EPA assesses any changes that
have occurred since the last registration decision to determine whether
the pesticide still satisfies the statutory standard for registration.
The EPA considers any new data or information on the pesticide and
decides whether a new risk assessment must be conducted. In the case of
chlorpyrifos and the OPs, many of the epidemiology studies, mechanistic
studies, and laboratory animal studies on the neurodevelopmental
effects of OPs were published after reregistration was completed in
2006. As such, there is significant new information relevant to the
human health effects of this group of pesticides which require a re-
analysis of scientific information relevant for the FQPA Safety Factor.
As section 408(b)(2)(C) of the FFDCA instructs the EPA, in making
its ``reasonable certainty of no harm'' finding, that in ``the case of
threshold effects, an additional tenfold margin of safety for the
pesticide chemical residue and other sources of exposure shall be
applied for infants and children to take into account potential pre-
and postnatal toxicity and completeness of data with respect to
exposure and toxicity to infants and children.'' Section 408(b)(2)(C)
further states that ``the Administrator may use a different margin of
safety for the pesticide chemical residue only if, on the basis of
reliable data, such margin will be safe for infants and children.''
Given the totality of the evidence, there is sufficient uncertainty in
the human dose-response relationship for neurodevelopmental effects
which prevents the agency from reducing or removing the statutory 10X
FQPA Safety Factor.
Question 40. For the chlorpyrifos risk assessment, the Office of
Pesticide Programs conducted a highly refined dietary assessment for
possible residues on food and found no risks of concerns. Why then does
the Agency rely on only an unrefined, screening level assessment to
claim risks from drinking water as the basis for the Proposed Rule?
Answer. The December 2014 drinking water assessment conducted by
the EPA is a refined, higher tier assessment that examined potential
exposure to chlorpyrifos and its transformation product, chlorpyrifos-
oxon, at a national and a regional scale in order to locate where
concentrations in drinking water may be of concern. The assessment
followed a tiered approach, investigating not only maximum pesticide
label rates, but also lower rates to identify uses and watersheds that
would not be expected to be problematic. The uses that exceeded the
drinking water level of concern in the regional analysis were further
explored, e.g., evaluating exposure on a watershed basis. This ``proof
of concept'' example showed an overlap of potential chlorpyrifos use
sites that may result in an exceedance of the drinking water level of
concern with watersheds that supply source water for community drinking
water systems. The exercise demonstrated that chlorpyrifos applications
result in variable drinking water exposures that are highly localized
and that the highest exposures generally occur in small hydrologic
regions where there is a high percent cropped area on which
chlorpyrifos use could occur.
The EPA finished a regional analysis for two regions of the
country, the Pacific Northwest and South Atlantic-Gulf, to demonstrate
the feasibility of this methodology and to solicit public comment on
the approach. The EPA is currently finalizing the regional assessment
for the remaining regions of the United States. In addition to the
refined spatial scale at which the analysis was completed, two
additional aspects of this drinking water assessment that contribute to
its complexity and sophistication are the incorporation of surface
water monitoring data and drinking water treatment effects. Results of
surface water monitoring are presented and compared to model-estimated
concentrations. This analysis showed that when modeling scenarios are
parameterized to reflect reported use and estimated drinking water
concentrations are adjusted to reflect percent cropped area, the
estimated modeled concentrations are within an order of magnitude of
the measured concentrations reported in the monitoring data. Finally,
typical water treatment processes were considered in predicting
residues in finished drinking water.
Question 41. The EPA has stated that its drinking water assessment
for chlorpyrifos is incomplete. Has the Agency ever before based a
proposed tolerance revocation on an incomplete drinking water
assessment?
Answer. The national scale drinking water assessment for
chlorpyrifos was completed in 2014 and showed that many uses at maximum
label rates and rates lower than maximum would result in concentrations
exceeding the drinking water level of concern. Because of these
results, further analysis was conducted to look at the spatial
distribution of estimated drinking water concentrations at a regional
scale. This exercise is a higher level refinement and not generally
completed or required for most pesticides. As such, the EPA finished a
regional analysis for two regions of the country, the Pacific Northwest
and South Atlantic-Gulf, to demonstrate the feasibility of this
methodology and to solicit public comment on the approach. The EPA is
currently finalizing the regional assessment for the remaining regions
of the United States.
Question 41a. While the Agency reached this high level of
refinement for the food dietary assessment since the passage of FQPA in
1996, why has the Agency not reached a comparable level of refinement
in their assessment methodologies for drinking water over that same
time period of 20 years?
Answer. The level of sophistication of the EPA's drinking water
assessments has greatly improved over the past 20 years. Drinking water
assessments, including the assessment conducted for chlorpyrifos, now
include the ability to account for the impact of different soils,
agronomic practices, meteorological data, application methods and
timing, buffers, volatility, and application technology, just to name a
few areas where our modeling capabilities have improved. Current
drinking water assessments also better account for the percentage of
community drinking water intake watersheds that could be treated by the
pesticide and drinking water treatment effects. Monitoring data, when
available, also plays a larger role in our ability to predict and
characterize pesticide concentrations under actual use conditions.
Question 41b. Since the Agency has had that much time to refine
their drinking water assessment methodology, why then is there a rush
to decision on chlorpyrifos?
Answer. The chlorpyrifos drinking water assessment is highly
refined and incorporates all currently available data and methodologies
for predicting exposure through drinking water. The timeline for
decision making was set by the U.S. Court of Appeals for the Ninth
Circuit.
Question 41c. Why does the Agency refuse to use reliable data from
tens of thousands of water monitoring samples for chlorpyrifos and
other pesticides, and instead insist on using modeling procedures that
are not validated by data, and produce conflicting conclusions?
Answer. The EPA uses mathematical models as well as monitoring data
to generate exposure estimates for drinking water and aquatic exposure
assessments. Modeling and monitoring data are both important tools that
provide different types of information that can be used for assessing
pesticide concentrations in water. Models calculate estimated drinking
water concentrations using laboratory data that describe how fast a
pesticide breaks down to other chemicals and how it moves in the
environment. In addition, modeling provides an efficient tool for
exploring the impact of different environmental factors such as soil
type and meteorological conditions on estimated pesticide
concentrations in water. Although computer modeling provides an
indirect estimate of pesticide concentrations, these concentrations can
be estimated continuously over long periods of time, and for places
that are of most interest for a particular pesticide. Modeling is a
useful tool for characterizing vulnerable sites, and can be used to
estimate peak concentrations from infrequent, large storms (https://
www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-
water-exposure-models-used-pesticide) [See Attachment 6].
Monitoring data provide snapshots of pesticide concentrations in
time at specific locations. When the monitoring sites reflect areas
that have a likelihood of pesticide occurrence in water (based on
pesticide use as well as local runoff or leaching vulnerability), when
sampling occurs during the time frame in which pesticides are expected
to be used, and when the sampling is frequent enough to estimate
exposures for the endpoints of concern, it is more likely that the EPA
will be able to incorporate that data quantitatively. Monitoring data
will typically underestimate upper bound or peak concentrations due to
insufficient sampling frequency. While this is more of a concern for
surface water monitoring, it can still be a consideration for
groundwater monitoring. Therefore, monitoring data often are expected
to provide a lower bound estimate of exposure for purposes of risk
assessment. Statistical methods are being developed to address the
uncertainty in estimating upper bound pesticide concentrations from
monitoring data.
Often, sampling frequency and location are limiting factors in
comparing monitoring results to modeling or in using monitoring data
quantitatively. However, monitoring data can also be valuable in adding
context to the exposure assessments. For instance, detections of a
given pesticide can provide a measure of a lower bound of exposure.
While the data may not be robust enough to ensure a high-end exposure
has been observed, the detections do indicate that transport has
occurred in the study. At a minimum, qualitative data can provide a
balance against modeled estimates and can be useful for
characterization of risk conclusions.
The EPA uses all reliable laboratory and field/monitoring data to
assess pesticide exposure in drinking water. In the case of
chlorpyrifos, water monitoring data from the U.S. Geological Survey
(USGS) National Water-Quality Assessment Program (NAWQA), USEPA/USGS
Pilot Reservoir Monitoring Program, USDA Pesticide Data Program (PDP),
and California Department of Pesticide Regulation (CDPR) were evaluated
in the 2011 preliminary drinking water assessment with reference to an
acute exposure to chlorpyrifos and its degradation product
chlorpyrifos-oxon. For the 2014 assessment, additional water monitoring
data from Washington State Department of Ecology and Agriculture (WSDE/
WSDA) Cooperative Surface Water Monitoring Program, Dow AgroSciences
(Orestimba Creek), and Oregon Department of Environmental Quality were
evaluated and presented as part of the drinking water assessment
update.
Additionally, model simulations were completed to represent two
different water monitoring datasets--WSDE/WSDA and Orestimba Creek. For
both of these water monitoring programs, enough information was
available, including chlorpyrifos use information, as well as the
percent cropped area, to parameterize the model. In these simulations,
the modeled concentrations were within an order of magnitude of the
measured concentrations. This suggests that the modeling results are
not overly conservative and provide reliable estimates in the absence
of all the necessary information to put monitoring results into proper
context.
Question 42. The Agency has publicly advocated for harmonization in
tolerances among trading partner countries.
Why has EPA taken the step of this Proposed Rule with no agreement
among other countries and seemingly no evaluation of or concern about
potential impact on trade?
Answer. In making its tolerance decisions, the EPA seeks to
harmonize U.S. tolerances with international standards whenever
possible, consistent with U.S. food safety standards and agricultural
practices. However, the EPA is unable to determine at this time that
aggregate exposures to chlorpyrifos are safe. The timing of this
proposal is the result of a U.S. Court of Appeals for the 9th Circuit
Court order to respond to that petition by October 31, 2015. This
proposal also implements the agency findings made during the
registration review process required by section 3(g) of FIFRA (7 U.S.C.
136(a)(g)) which the EPA is conducting in parallel with its petition
response. That process requires the EPA to re-evaluate existing
pesticides every 15 years to determine whether such pesticides meet the
FIFRA registration standard set forth in FIFRA section 3(c)(5), 7
U.S.C. 136a(c)(5). In part, that standard requires the EPA to ensure
that dietary risks from the pesticide meet the FFDCA section 408 safety
standard. Section 408 directs that the EPA may establish or leave in
effect a tolerance for pesticide only if it finds that the tolerance is
safe, and the EPA must revoke or modify tolerances determined to be
unsafe (FFDCA 408(b)(2)(A)(i)). Section 408(b)(2)(A)(ii) defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' In its Revised Human Health Risk
Assessment, the EPA determined some exposures to chlorpyrifos may be
unsafe. The Revised Human Health Risk Assessment * is available at
www.regulations.gov in the chlorpyrifos docket (EPA-HQ-OPP-2008-0850-
0195).
---------------------------------------------------------------------------
* Editor's note: the document referred to is retained in Committee
file.
Question 42a. What is your obligation under the World Trade
Organization Sanitary Phytosanitary Agreement (WTO SPS) in this
respect, and how has it been fulfilled?
Answer. The EPA ensures that its tolerance decisions are in keeping
with the World Trade Organization's Sanitary and Phytosanitary Measures
Agreement. Consistent with that agreement, the effective date the EPA
is proposing for the revocation of chlorpyrifos tolerances in the
proposed rule ensures that the tolerances will remain in effect for a
period sufficient to allow a reasonable interval for producers in the
exporting countries to adapt to the requirements of these modified
tolerances. The EPA plans to issue a notice by the fall of 2016 with
updates to part of its risk assessment, including a refined drinking
water assessment. With the issuance of the notice, the EPA will notify
the WTO and ask for further comment on the proposed rule and underlying
science. The EPA will consider WTO's comments prior to issuing a final
decision.
Question 43. By establishing a policy of ``no net loss'' for
natural resources, doesn't the Presidential Memorandum: Mitigating
Impacts on Natural Resources from Development and Encouraging Related
Private Investment change how NEPA operates by requiring agencies to
avoid, minimize, and fully mitigate impacts to natural resources? Will
EPA follow the policies of the memorandum in the NEPA process? Is it
correct that NEPA does not ``mandate protection of the environment,''
but requires impacts to be identified? By establishing a policy of ``no
net loss'' for natural resources, doesn't the Presidential Memorandum
change the function of NEPA by requiring agencies to authorize only
actions that avoid, minimize, and fully mitigate impacts to natural
resources?
Answer. The EPA and other Federal agencies have extensive
experience consistently implementing the provisions of the National
Environmental Policy Act (NEPA) while working to achieve a ``no net
loss'' of natural resources goal. The administration established a
nationwide ``no net loss'' of wetlands goal in 1989, for example, that
has been very successful in reducing annual conversion and destruction
of wetlands without changing the operation of NEPA. The EPA is
confident, based on our experience, that the new Presidential
Mitigation Memorandum does not alter the way NEPA has traditionally
been implemented or change its basic function.
Questions Submitted by Hon. Collin C. Peterson, a Representative in
Congress from Minnesota
Question 1. The EPA has been reviewing biogenetic carbon-dioxide
emissions for a few years now and it's seemed to come to a head with
the Clean Power Plan. My understanding is that under the current
framework for biogenetic carbon-dioxide, agricultural residue is
treated the same as fossil fuels in Clean Power Plan compliance, unless
it's sustainably grown. Using agricultural residues for energy
production, bioproducts, and biofuels already happens. We want our
farmers to be a part of the solution and I'm a bit perplexed how grown
plants are treated the same as fossil fuels. Can you explain the
current framework the EPA is using to assess biogenetic carbon-dioxide
emissions? And are you consulting with USDA in regard to determining
``sustainably grown'' so our farmers can participate?
Answer. On February 9, 2016, the Supreme Court granted a motion to
stay the Clean Power Plan (CPP). As a result of that action, states are
not currently required to submit a state plan or a request for
extension by September 6, 2016.
In the final CPP, states have the flexibility to choose whether or
not to allow affected sources to use biomass as a compliance option to
meet their emission standards. The CPP gives states the flexibility to
describe the types of biomass that are being proposed for use under
their state plans, how those proposed feedstocks or feedstock
categories should be considered as ``qualified biomass'' (i.e., a
biomass feedstock that is demonstrated as a method to control increases
of CO2 levels in the atmosphere), and explain the proposed
valuation of biogenic CO2 emissions.
The EPA generally acknowledges the CO2 and climate
policy benefits of waste-derived biogenic feedstocks and certain
forest- and agriculture-derived industrial byproduct feedstocks. The
final rule also provides that states may use agricultural and forest
biomass feedstocks if they adequately demonstrate that the use of such
feedstocks appropriately controls increases of CO2 levels in
the atmosphere.
As part of the EPA's effort to advance the technical understanding
of the role of biomass in addressing greenhouse gas emissions, in
November 2014, the EPA released the second draft of its scientific
report, Framework for Assessing Biogenic Carbon Dioxide for Stationary
Sources. The revised report takes into account Science Advisory Board
peer review recommendations on the 2011 Draft Framework, as well as the
latest information from the scientific community and other
stakeholders. The EPA developed the revised Framework as a policy-
neutral framework for assessing biogenic CO2 emissions from
stationary sources--it was not developed as technical guidance in
conjunction with any specific policy or program. The EPA's continued
refinements of the Framework will parallel the EPA's consideration of
biomass in the context of its policies and programs.
As in the case of other scientific and policy processes, for
biomass topics we consult with relevant experts, such as our colleagues
at USDA, states, stakeholders, and academic and research scientists to
provide information and examples of existing and potential programs
recognized as carbon-beneficial and therefore possible approaches to
achieving the goals articulated in the President's Climate Action Plan.
Question 2. I was contacted by an ag procession plant in my
district and discovered that not only do plants have to have an OSHA
worker protection plan, but apparently EPA also requires a worker
protection plan. And now with the Food Security Modernization Act
(FSMA), there will be a third requirement that will also involve worker
training. Is there any coordination between OSHA and DPA in regard to
what these worker protection plans encompass? Is there flexibility for
plants to use one plan to cover both requirements? Or do they literally
have to have two separate plans?
Answer. First, to the extent that these concerns with the
Agricultural Worker Protection Standard (WPS) rule were raised in
regard to an agricultural processing plant, please note that post-
harvest uses of pesticides are excepted from the requirements of the
WPS (170.303(b)(5)), so the WPS does not apply to the use of pesticides
in agricultural processing plants and such processing plants are not
otherwise affected by the WPS.
Second, the WPS also does not require a written worker protection
plan. Employers only need to comply with the provisions of the rule,
but are not required to develop a written plan describing how they will
meet the requirements of the rule. The EPA has also coordinated with
the Occupational Safety and Health Administration to ensure there is
not overlap of our regulations.
Questions Submitted by Hon. Christopher P. Gibson, a Representative in
Congress from New York
Question 1. The Hudson River Natural Resource Trustees--USF&W and
NOAA--have publicly called for additional environmental dredging of the
Hudson River Superfund site by GE and asked EPA to delay GE's
decommissioning of its cleanup operations before certifying the cleanup
as complete. Would EPA be willing to meet with these environmental
leaders to discuss the Agency's reasoning behind its Hudson River
dredging decision?
Answer. The EPA has discussed the decommissioning of General
Electric's sediment processing facility and other operations with the
Federal Natural Resource Trustees for the Hudson River. In particular,
the U.S. Fish and Wildlife Service (FWS) and the National Oceanic and
Atmospheric Administration (NOAA) actively participate in meetings of
the Hudson River Community Advisory Group (CAG), and both NOAA and FWS
have taken part in CAG meetings at which the EPA explained its reasons
for approving GE's facility decommissioning.
Question 2. According to my constituents, EPA responded in December
2015 to the Natural Resource Trustees' that the cleanup is inadequate
and will not meet EPA's own goals. In this response to Hudson River
environmental leaders, EPA Assistant Administrator Mathy Stanislaus and
Regional Administrator Judith Enck agreed to an expedited 5 year review
to determine whether the Hudson River Superfund cleanup has met its
goals. The following month, R.A. Enck published an Op-Ed in the Albany
Times Union stating the cleanup has achieved its goals.
What will EPA do to ensure the 5 year review is conducted without
bias, expeditiously in conformance with EPA guidance, and in a manner
that ensures the input of the Trustees as equal partners and of the key
environmental and other stakeholders?
Answer. The second 5 year review for the site is underway and is
being conducted in accordance with the EPA guidance. The EPA is working
closely with all stakeholders to ensure a thorough and unbiased 5 year
review. The stakeholders, including the Federal trustees, New York
State Department of Environmental Conservation and Department of
Health, and representatives of the Community Advisory Group (including
non-governmental organizations) were invited by the EPA to participate
on the Five Year Review team. Five Year Review team meetings are being
held monthly through the fall.
Question 3. Is EPA considering any additional options that have not
already been pursued to promote further clean-up and safeguarding of
the Hudson River?
Answer. The second 5 year review is underway and the EPA is working
closely with all stakeholders to ensure a thorough 5 year review. The
stakeholders, including the Federal trustees, the New York State
Department of Environmental Conservation and Department of Health, and
representatives of the Community Advisory Group (including
nongovernmental organizations) were invited by the EPA to participate
on the Five Year Review Team. The EPA supports the trustees' continuing
efforts to safeguard the Hudson River and will continue to cooperate
and communicate with Federal and state natural resource trustees on the
Hudson River remediation.
Questions Submitted by Hon. Vicky Hartzler, a Representative in
Congress from Missouri
The following questions relate to the Agency's Worker
Protection Standards (WPS) rule [40 CFR 170 et seq.] which was
signed by the Administrator on September 28, 2015 and published
in the Federal Register on November 2, 2015.
Statutory Requirements
Section 25(a)(2)(B) of the Federal Insecticide Fungicide and
Rodenticide Act (7 U.S.C. 136w(a)(2)(B)) states: ``At least 30
days prior to signing any regulation in final form for
publication in the Federal Register, the Administrator shall
provide the Secretary of Agriculture with a copy of such
regulation.'' Section 25(a)(3) (7 U.S.C. 136w(a)(3)) of FIFRA
also states: ``At such time as the Administrator is required
under paragraph (2) of this subsection to provide the Secretary
of Agriculture with a copy of proposed regulations and a copy
of the final form of regulations, the Administrator shall also
furnish a copy of such regulations to the Committee on
Agriculture of the House of Representatives and the Committee
on Agriculture, Nutrition and Forestry of the Senate.''
Question 1. Please state for the record the date on which EPA
provided to the Secretary of Agriculture the final copy of the WPS rule
that was signed on September 28, 2015.
Answer. The EPA sent the draft final Worker Protection Standard
rule to the Secretary of Agriculture on May 13, 2015. This draft final
rule did not include provisions for authorized or designated
representatives. After further deliberations, the EPA decided to
restore these provisions, with certain limitations and modifications.
The EPA provided the revised draft final rule to USDA on June 22, 2015.
As required under section 25(a)(2)(D) of FIFRA, the EPA announced the
notification to the Secretary of Agriculture for this review in the
Federal Register (80 FR 28838, May 20, 2015).
Question 2. Please state for the record the date on which EPA
provided to the House Committee on Agriculture the final copy of the
WPS rule that was signed on September 28, 2015.
Answer. As required under section 25(a)(3) of FIFRA, the EPA sent
the pre-promulgation draft of the final rule to the U.S. House of
Representative's Committee on Agriculture and to the U.S. Senate's
Committee on Agriculture, Nutrition, and Forestry on May 14, 2015. In
addition, as required under the Congressional Review Act (5 U.S.C. 801
et seq.), the EPA submitted a report containing the final copy of the
rule that was signed on September 28, 2015, and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States on October 9, 2015.
The WPS rule (40 CFR 170.311) grants a designated
representative the right to certain pesticide information used
on a farm upon presentation of a written, signed authorization
by a worker. Please answer the following questions related to
this provision.
Question 3. With a letter to the House Agriculture Committee from
Assistant Administrator Jim Jones dated May 12, 2015 Mr. Jones enclosed
a ``draft final rule revising and updating the agricultural Worker
Protection Standard.'' Please cite the section of the rule submitted to
the Committee on May 12, 2015 that contains language granting either to
``authorized representatives'' or ``designated representatives'' access
to farm-specific pesticide information.
Answer. The May 12, 2015 draft final rule did not include
provisions for authorized or designated representatives. The proposed
rule, published March 19, 2014, included provisions relating to
authorized representatives in the draft sections 170.5 and 170.11(b)(2)
and on pages 15479-15480 of the preamble a discussion of the
provisions, but as of May 12, 2015, the EPA was not intending to
finalize those provisions. After further deliberations, the EPA decided
to restore these provisions, with certain limitations and
modifications. The EPA provided the revised draft final rule to USDA on
June 22, 2015. Pursuant to the Congressional Review Act (5 U.S.C. 801
et seq.), the final version of the rule was submitted to Congress on
October 9, 2015.
Question 4. Please provide to the Committee copies of any comments,
including e-mails, memos or other documents, submitted to EPA from the
U.S. Department of Agriculture or other executive department offices,
including the White House, that relate to the original proposed
provision relating to ``authorized representative'' and to the
provision in the final rule relating to ``designated representative.''
Answer. USDA's comments, and the EPA's responses to the proposed
rule and the final rule, are included in the public docket as part of
the Executive Order documentation, and those comments and responses
related to the authorized representative and the designated
representative are available from under docket ID EPA-HQ-OPP-2011-
0184.\4\ This provision was not an area of significant deliberation
during the interagency review process for this rulemaking.
---------------------------------------------------------------------------
\4\ https://www.regulations.gov/document?D=EPA-HQ-OPP-2011-0184-
2520 [See Attachment 8].
Question 5. In the final WPS rule (Federal Register, page 67513,
November 2, 2015), EPA states that it ``has been convinced by comments
in support to retain the option for a designated representative.''
Please provide the Committee copies of the comments to which the
Agency refers in the Federal Register notice.
Answer. The EPA received a significant number of comments in
support of and in opposition to retaining the proposal for the
designated or authorized representative. Few of the comments presented
new information or information substantially different from that known
to the EPA at the time the proposed rule was published, and as a
result, the comments--both pro and con--collectively convinced EPA that
it was correct in its initial opinion that a designated representative
provision is reasonable and appropriate. However, some commenters
provided recommendations that appear to be appropriate remedies for
legitimate concerns about the proposed requirement. The EPA
reconsidered the proposed option and alternatives, and concluded that
retaining the option for a worker to designate a representative was
necessary for their ability to access pesticide hazard information, but
specified in more detail the requirements for designating a
representative and for a designated representative's request
information. See 40 CFR Part 170.311(b)(9).
Although the EPA considers the collective comments--pro and con--as
confirming the agency's decision to include a designated representative
provision in the WPS, the comments below in support of the designated
representative option for enhancing access to pesticide hazard
communications information provide additional insight.
Migrant Clinicians Network.\5\
---------------------------------------------------------------------------
\5\ https://www.regulations.gov/document?D=EPA-HQ-OPP-2011-0184-
2291 [See Attachment 9].
Farmworker Advocacy Network.\6\
---------------------------------------------------------------------------
\6\ https://www.regulations.gov/document?D=EPA-HQ-OPP-2011-0184-
2250 [See Attachment 10].
American Public Health Association.\7\
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\7\ https://www.regulations.gov/document?D=EPA-HQ-OPP-2011-0184-
1846 [See Attachment 11].
Florida Legal Services.\8\
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\8\ https://www.regulations.gov/document?D=EPA-HQ-OPP-2011-0184-
2166 [See Attachment 12].
Telamon Corporation.\9\
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\9\ https://www.regulations.gov/document?D=EPA-HQ-OPP-2011-0184-
0179 [See Attachment 13].
Question 5a. Were any of the comments received by the Agency after
the close of the comment period?
Answer. Some comments were received after the comment period
closed. All were included in the docket, regardless of the date they
were submitted; and were considered in developing the final rule. These
comments received after the close of the comment period were not
significantly different and did not raise issues or present new
information than those submitted by the close of the comment period.
Question 5b. Were any of these comments the result of ex parte
communications? Please supply copies of those comments?
Answer. All comments related to the Worker Protection Standard
rulemaking received by the EPA during the period between proposal and
publication of the final rule were added to the docket, where they
became a matter of public record available for review (except for those
portions of comments submitted under business confidentiality claims or
containing personal privacy information). Written comments appear in
the docket as submitted.
Question 6. The Federal Register notice of November 2, 2015 says
that ``EPA is unaware of issues related to worker representatives in
those states.'' [referring to Texas and California].
Please provide the Committee with any analysis or documents used by
EPA in analyzing the Texas and California provisions.
Answer. The only documents the EPA reviewed related to the Texas
and California provisions were the regulations for Texas and California
related to agricultural worker representatives.
The Texas Agricultural Hazard Communication Act at (http://
www.statutes.legis.state.tx.us/Docs/AG/htm/AG.125.htm.htm) [See
Attachment 14] establishes procedures for the designated
representative's access to information about hazardous chemicals to
improve the health and safety of agricultural workers. In addition,
Texas provided comments on the proposed rule related to the provision,
noting that the requirement to provide the information should coincide
with the record retention schedule and should be in writing.
The California Code of Regulations, Sections 6723 and 6761 at
(http://www.cdpr.ca.gov/docs/legbills/calcode/subchpte.htm#a0303) [See
Attachment 15], establish requirements for employers to provide, upon
request from an employee representative, access to any records or
documents required to be maintained under the regulation.
Question 6a. Please provide the Committee any documents or analysis
prepared or utilized by EPA that demonstrates that the Texas and
California provisions have directly resulted in greater worker safety.
Answer. The EPA is not aware of any documents or analyses that
assess improvements in worker safety as a direct result of these
provisions.
Question 7. Please provide the Committee with documents or
memoranda it used to analyze the OSHA regulation and its applicability
in requiring similar provisions in an agricultural setting.
Answer. The EPA considered the requirements of the U.S.
Occupational Safety and Health Administration's regulation at 29 U.S.C.
section 1910.1020 (https://www.osha.gov/pls/oshaweb/
owadisp.show_document?p_table=STANDARDS&p_id=
10027) [See Attachment 16], and believes similar requirements should
apply to agriculture. As cited in the preamble to the proposed Worker
Protection Standard (March 19, 2014), in adopting the Hazard
Communication Standard (HCS), OSHA stated there was evidence to
indicate potential for chemical exposure in every type of industry, and
that lack of knowledge about those hazardous chemicals puts employees
at significant risk of experiencing material impairment of health (52
FR 31852; August 24, 1987;) (59 FR 6126; February 9, 1994). The OSHA
rule applies to general industries, maritime, and construction
employers who are responsible for records of employee exposure to toxic
substances or harmful physical agents, among other requirements, but
expressly does not apply to agricultural employers per 29 CFR Part
1928.21(b). The OSHA rule requires that the employer provide to the
designated representative (or requesting employee) access to the
employee's exposure record upon their request, in a reasonable time,
place, and manner.
The Worker Protection Standard requires agricultural employers to
maintain pesticide application records and Safety Data Sheets when
workers are on the establishment. These records provide the exposure
and hazard information, parallel to those required under OSHA's rules
for other industries. Farmworkers, in terms of demographics, are
similar to construction workers, in that their jobs may be short term,
of low economic status; and they may be low literacy and non-English
speaking. The EPA believes that agricultural production can comply with
these requirements with little disruption. The EPA recognizes that a
significant number of workers face disadvantages that can reasonably
make them reluctant to ask their employers for information related to
their pesticide exposure, and finds that access to the information
through a designated representative, similar to the requirement in
OSHA's HCS, is feasible and appropriate to protect worker safety.
Question 8. Does the authorization from the worker to the
designated representative need to be notarized?
Answer. The authorization does not need to be notarized.
Question 9. Once a farmer is presented with a written, signed
authorization, does the farmer have a legal obligation to provide the
information?
Answer. Under the Worker Protection Standard, the designated
representative authorization must also be accompanied by a request
letter containing certain information. If a valid designated
representative authorization is accompanied by a valid request for
information required by the WPS to be provided, then the farmer does
have a legal obligation to provide only the information required by the
rule.
Question 10. Once the designated representative has the
information, are there restrictions on what the designated
representative may do with the information? (If so, please cite the
section of the regulation restricting use of the information.)
Answer. The Worker Protection Standard does not place restrictions
on what the farmworker or designated representative may do with the
information.
Question 11. Once the designated representative has obtained the
information from the farmer, does the designated representative have
any obligation to transmit or share that information with the worker
who authorized access to the information? (If so, please cite the
section of the regulation.)
Answer. The Worker Protection Standard does not impose on the
farmworker or designated representative any obligation to transmit or
share that information with the worker who authorized access to the
information.
Question 12. The section of the WPS immediately preceding that
related to designated representatives ( 170.309(8)) states that ``any
treating medical personnel or any person acting under the supervision
of treating medical personnel'' may request pertinent information and
may do so either orally or in writing. Thus, it appears that the access
granted to designated representatives serves a purpose other than
providing for the medical treatment of a worker who has been exposed to
a pesticide.
What purposes, other than those related to the health or exposure
of a worker to a pesticide, does 170.309(9) serve?
Answer. Workers and handlers may be reluctant to request the
information for themselves due to their inability to communicate
effectively with, or fear of, their employer, or because they may not
be able to understand the information without help. The required
information can be of value to workers before medical care is sought:
First, having information available in non-emergency situations could
help workers be aware of symptoms before they occur, help them avoid
exposure, and possibly enhance the reporting of illnesses. Second,
having access to the required information in advance of any medical
need means emergency medical personnel would not have to lose critical
time tracking down information instead of treating the ill or injured
person. Third, having information available in non-emergency situations
could help workers be aware of symptoms of chronic illnesses,
potentially enabling them to seek treatment earlier in the course of
the illness.
Because of the potential burden to agricultural employers, the rule
does not require that the required pesticide application information
and Safety Data Sheets that provide the hazard information must be
provided in any language other than English, although many farmworkers
and pesticide handlers are not literate in English or even their native
languages. Therefore there are potentially many circumstances these
individuals could need the assistance of a designated representative to
have ``meaningful access'' to the information such as having it
translated in order to be able to make use of the information.
Additionally, many farmworkers could be limited in their ability to get
transportation back to an employer's establishment after employment but
would need the assistance of a designated representative to access the
information they desire.
Question 12a. Please cite EPA's statutory authority to require a
farmer to grant access to third parties for proprietary pesticide
information when that access is not related to worker safety?
Answer. As discussed in the response to the previous question, the
ability for a worker or handler to have meaningful access to the
required pesticide application and hazard information is very much
related to worker safety. In the 1992 rule, and continued in this
revision, access to exposure information and first aid and other
medical information is required for medical personnel in cases of
injury or illness. For the reasons cited above the worker may not be
able to access or make use of the information provided and would need a
designated representative to get meaningful access to that information
in order to understand the hazards of the chemicals he/she is working
around, be better able to protect themselves, recognize potential signs
of exposure or illness, and know how to respond appropriately if
needed. The EPA's statutory authority to establish requirements to
protect worker safety is outlined in the rule and derives from FIFRA's
mandate to prevent unreasonable adverse effects on ``the environment'',
which FIFRA section 2(j) defines as including humans. Agricultural
workers are clearly part of ``the environment'' for purposes of FIFRA,
as discussed in U.S. Senate. S. Rep. No. 92-883 (Part II), 92nd
Congress, 2nd Session at 43-46 (1972). U.S. Code Congressional and
Administrative News 1972, p. 4063.
Question 13. 170.305 of the regulation states that a ``designated
representative means any persons designated in writing by a worker or
handler to exercise a right of access on behalf of the worker or
handler to request and obtain a copy of the pesticide application and
hazard information required by 170.309(h) in accordance with
170.311(b) of this part.''
Are there any provisions in the WPS restricting who may be a
designated representative? (If so, please cite the section of the
regulation.)
Answer. There are no restrictions on who may be a designated
representative.
Question 13a. Would the WPS permit organizations like anti-
pesticide activist groups to serve as designated representatives?
Answer. Any person or organization can serve as the designated
representative if they have been properly designated in writing and the
request conforms to section 170.311(b)(9).
Question 14. If a designated representative had information related
to pesticide use on a farm and wished to publish that information
broadly, are there provisions in the WPS to prevent that from
happening? (If so, please cite the section of the regulation)
Answer. The Worker Protection Standard does not include provisions
that would prevent a farmworker or designated representative from
publishing the information required under section 170.309(h).
Question 15. If a designated representative had gained information
related to pesticide use on a farm through a written declaration
authorized under 170.311(b) and wanted to use that information
publicly to exert pressure on a farmer to stop the farmer from using
that pesticide, are there provisions in the WPS to prevent that from
happening? (If so, please cite the provision)
Answer. The Worker Protection Standard does not include provisions
that would prevent a farmworker or designated representative from using
the information required under section 170.309(h) publicly.
Question 16. Many hired workers in agriculture--by most estimates
more than 50% of the hired labor force--work in agriculture by
presenting documents that contain false names, social security numbers,
green cards or other information. An employer, such as a farmer, is
legally required to accept such documents if they appear to be genuine.
Because of this fact, it may be possible for an individual to present
himself or herself to a farmer claiming to be a designated
representative for a worker with a name that does not appear on the
farmer's records. If the designated representative states that the
individual worker did work on the farm but under a different name, what
is the farmer's legal obligation?
Is the farmer's legally obliged to release the pesticide
information? (If not, please cite the section of the regulation
releasing the farmer from legal responsibility)
Answer. Where a person claiming to be a designated representative
presents the name of a worker or handler that does not appear on the
employer's records, the employer could refuse to provide the requested
information unless other evidence, documentation or information known
to the employer reasonably supports a conclusion that the worker or
handler being represented by the designated representative was actually
employed on the establishment.
Question 16b. If the farmer does not release the information, is
the farmer protected under the WPS? (Please cite the specific
provision).
Answer. Yes. If a designated representative's request for
information does not meet the requirements of section 170.311(b)(9), an
employer's refusal to provide the requested information would not be a
violation of FIFRA.
Question 16c. If a designated representative has been found to be
abusing this provision of the WPS, what sanctions would that individual
face? (Please cite the specific provisions)
Answer. The Worker Protection Standard does not include provisions
that would provide sanctions against a designated representative.
Question 17. Given the concerns that have been raised by the
agriculture community over the designated representative provision,
would EPA be willing to suspend implementation of the provision and
revise it after consultation with representatives of the agricultural
community and re-proposing it in the Federal Register?
Answer. The EPA included a representative access provision in the
proposed rule, specifically requested comment on potential problems it
could cause (79 FR 15444, 15479), and received many pertinent comments
from a broad range of commenters, few of which identified likely
problems that were significantly different from those contemplated by
the EPA at the time of proposal. The EPA does not expect that an
additional comment period would produce significantly different
information, but in any case, any person who has such information may
submit it at any time for the EPA to review.
If the agency is presented with evidence that this provision of the
rule is creating undue burden for the agricultural community, or the
provision is being abused by certain designated representatives, the
agency will consider whether the evidence warrants regulatory action in
response. However, the EPA does not believe there are sufficient
grounds for changing the rule at this time.
Questions Submitted by Hon. Jeff Denham, a Representative in Congress
from California
Question 1. The National Association of Clean Air Agencies
testified to EPA that the new 2015 ozone standard ``will have a
profound impact on the work of the state and local air pollution
control agencies.'' This is troubling, especially considering many of
these same agencies are still working on the 2008 ozone standard, which
has yet to be fully implemented.
Given its geographical layout and persistent droughts, California's
Central Valley has had to expend exceptionally more resources to keep
up with every reaching air standards.
What type of assurance is the EPA giving our states and local
governments, municipalities, and businesses that the EPA is not setting
them up to fail by constantly moving the clean air goalpost?
Answer. The EPA and state co-regulators share a long history of
managing ozone air quality under the Clean Air Act (CAA), underpinned
by a wealth of previously issued EPA rules and guidance. The overall
framework and policy approach reflected in the implementing regulations
for the 2008 ozone standards provide an effective and appropriate
template for the general approach states would follow in planning for
attainment of the revised 2015 ozone NAAQS. In particular for
California areas where the state and districts are still actively
working toward attaining the 2008 ozone NAAQS, the EPA is committed to
continue helping these air agencies identify and take advantage of
potential planning and emissions control efficiencies that may occur
within the horizon for attaining the 2015 standards. Following past
precedent, the EPA intends to propose revoking the 2008 standards and
provide transition rules intended to help avoid any potential
inefficiencies as states begin implementing the Clean Air Act's
requirements for the 2015 standards.
Question 2. Taking into account EPA's accidental release of farm
information to environmental activist groups in 2013, farmers and
ranchers in my district are understandably concerned about the lack of
data security measures preventing the EPA from collecting superfluous
farm information.
In light of the 2013 incident--as well as other highly damaging
breaches into OPM and DOD--what improvements has the EPA made, or is
the EPA making, to ensure it only collects the information it needs,
and that such information is secure?
Answer. The EPA is continually working to improve its processes for
collecting and managing data related to environmental protection
programs. For example, the EPA recently established through rulemaking
the minimum set of NPDES program data based on the EPA's current
reporting requirements (see Appendix A to 40 CFR Part 127) [See
Attachment 7]. During the development of this rulemaking, the EPA
carefully considered input from authorized state programs, provided in
comments and meetings, to match the minimum set of NPDES program data
to the existing regulations and practice, including how these data are
currently used by the EPA and authorized state programs. The EPA and
states streamlined the NPDES electronic reporting requirements down to
the minimum number of data elements needed to oversee management of the
NPDES programs in the most efficient manner possible
In addition, due to comments received during the NPDES Electronic
Reporting Rule [see: Comment Response Document for the NPDES Electronic
Reporting Rule (Final Rule),* EPA-HQ-OECA-2009-0274-0575, available at:
http://www.regulations.gov], the EPA is masking facility specific
information for unpermitted CAFOs that are not in violation of the CWA,
responding to particular privacy concerns raised regarding operators
living in close proximity to these facilities.
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* Editor's note: the document referred to is retained in Committee
file.
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More broadly, the EPA is taking steps to improve the agency's
information security posture and meet the Administration's
cybersecurity cross-agency priority goals. The EPA improved the use of
strong authentication for logging onto the EPA network, improved anti-
phishing protections, and coordinated with the Department of Homeland
Security to improve asset and vulnerability management and malware
defenses.
Question 3. Your Agency's honeybee acute toxicity proposal could
restrict the use of over 3,000 crop protection products when a grower
has contracted for pollination services. These products are primarily
derived from 76 Active Ingredients. How did EPA decide on these Active
Ingredients? Were risk assessments and benefits analysis conducted, as
is required by law, before this proposal was published?
Answer. EPA's Proposal to Mitigate Exposure to Bees from Acutely
Toxic Pesticide Products is aimed at providing greater protection to
bees where acute risk is presumed to be the highest, namely when
certain exposure (i.e., contract pollination scenarios) and presence of
an acutely toxic pesticide coincide. For this proposed risk mitigation
strategy, the agency focused only on a subset of compounds identified
as highly toxic to bees, which are likely to have the greatest adverse
effect on bees. The 76 active ingredients are those that have been
determined via testing to have an acute contact toxicity value less
than 11 micrograms per bee, based on data required to be submitted by
pesticide registrants. Limiting our focus to these compounds was
intended to gain the greatest benefits of protection to bees with the
least impact to growers. The agency will assess each compound under the
registration review program, with a more thorough and robust data set
as identified in our Risk Assessment Framework for Pollinators. As a
result, additional chemical-specific, risk-based labeling will be
developed based upon the results of these subsequent assessments.
As part of its planning and analysis prior to issuing the proposal,
the EPA considered the potential cost to growers. The agency is
currently reviewing the wide range of comments it received in response
to the proposal and is considering how to proceed. Based upon the
comments received, we are developing options on moving forward.
Throughout this process, the agency continues to weigh both the level
of protection to bees, and the potential cost to growers.
Question 4. I'm sure you're aware of the advances residue-detecting
technologies have made, with some being able to detect parts-per-
billion. With this kind of preciseness, a tolerance-restricted
pesticide could be found on an unrelated crop in a negligible but
detectable amount, say by way of cross breezes or other unintentional
factors. Is EPA taking this into consideration, to ensure that
incidents such as these do not condemn an entire crop?
Answer. The EPA is aware of the issues associated with the stated
concern and note that enforcement questions related to the presence in
or on food of a pesticide chemical residue for which there is no
established EPA tolerance or tolerance exemption is under the purview
of the U.S. Food and Drug Administration (FDA), not the EPA. Questions
regarding the FDA's practices with respect to testing and enforcement
activities related to low level pesticide chemical residues found in or
on food should be directed to the FDA.
Question 5. Some special interest groups have been demanding that
the EPA now operate outside its existing FIFRA scope and regulate pre-
treated seeds. Given that there is still no solid scientific evidence
to necessitate a change in oversight does the EPA intend to continue
respecting this distinction?
Answer. With respect to the litigation filed by public interest
groups, on March 14, 2016, the EPA filed a motion with the district
court in the Northern District of California to dismiss the case
against the EPA. A hearing on this motion was held on May 12, 2016, and
the following day the court issued an order deferring a decision on the
merits of the EPA's motion to dismiss until the EPA produced an
administrative record. The EPA has complied with the court's order and
expects the court to address its jurisdiction (the subject of the
motion to dismiss) during summary judgment proceedings. Under the
current litigation schedule, summary judgment motions are to be filed
in September and should be argued in October 2016. Treated seeds that
meet the requirements of the treated article exemption at 40 CFR Part
152.25(a) are exempt from regulation under FIFRA and the EPA has not
proposed to amend that regulation.
Question Submitted by Hon. Ted S. Yoho, a Representative in Congress
from Florida
Question. Administrator McCarthy, it is my understanding that on
October 27, 2015, FOIA request EPA-HQ-2016-000771 was submitted to EPA.
This FOIA requests copies of communication from 2011 to the present
between the U.S. Environmental Protection Agency, U.S. Food and Drug
Administration and U.S. Department of Agriculture related to the
biopesticide active ingredient banda de Lupinus albus doce (BLAD) and
the end use product Problad Plus (EPA Registration Number 84876-1). It
is my understanding no information related to this request has been
provided or released to date. Can you explain any reasons for this
delay? Can you provide an expected timeline when information should be
released?
Answer. The EPA responded to request EPA-HQ-2016-000771 and sent
all requested records. This FOIA request is closed.
Questions Submitted by Hon. Mike Bost, a Representative in Congress
from Illinois
Question 1. Resistance Management is a critical concern for all
farmers. Corn farmers have experienced increasing resistance problems
with using traited corn. Resistance has developed in weeds, and pests
like Corn Rootworm. Soil Applied Insecticides are registered by EPA for
use on corn, including corn with traits, and have been proven effective
in controlling rootworm and also improving yields. Is EPA planning to
restrict the use of Soil Applied Pesticides with traited corn?
Answer. The EPA has not taken any regulatory actions to restrict
the use of soil applied insecticides on corn. In response to signs of
resistance to Bt traits in the corn rootworm, the EPA has developed
new, more protective requirements designed to delay corn rootworm
resistance to genetically engineered Bt corn. The EPA announced its new
requirements in February 2016. As part of those requirements, the EPA
is recommending against the use of soil applied insecticides for
control of corn rootworm on corn rootworm traited corn except under
limited circumstances and in consultations with experts. This
recommendation is based on published scientific literature that
indicates the use of soil applied insecticides for corn rootworm can
present an additional resistance risk to Bt traits and on advice from
the EPA's FIFRA Scientific Advisory Panel. Information and materials
from this SAP meeting is available at https://www.epa.gov/sap/meeting-
materials-december-4-6-2013-scientific-advisory-panel [See Attachment
17].
Question 2. I am very concerned that EPA has not been coordinating
with USDA on matters crucial to farmers and consumers regarding the
importance of crop and environmental protection and on the economic
benefits to farmers who use pesticides to protect their crop yields to
feed America and the world. I understand that USDA has been willing to
work with EPA. However, USDA is appropriately concerned about not being
consulted about the calculation of the benefits provided to agriculture
and farm production through the use of pesticides.
For example, the Chief Economist at USDA sent a letter on April 6,
2015, to EPA criticizing EPA for publishing an analysis on the
economics of soybean production which USDA said was misleading,
incomplete, incorrect, and that ``as a whole USDA disagrees with the
assessment.''
The letter further said that ``USDA is disappointed that EPA
published the re-
port . . . without offering USDA an opportunity . . . to correct the
misrepresentations of economic costs and benefits that underlie this
report.'' I certainly agree with USDA that USDA and EPA need to work
together and note that Federal regulations require that coordination or
an opportunity for USDA to provide input to EPA if that determination
would result in the suspension, cancellation, or change in
classification of a pesticide.
In August, USDA sent a second letter to EPA, signed by Sheryl
Kunickis, Director of Research, Education and Economics, saying that
the May 29, 2015, EPA proposal on mandatory pesticide label
requirements would be especially harmful to ``numerous specialty crop
farmers and the rural economics they contribute to across the U.S.''
USDA was also concerned about the fact that the EPA ``proposal has the
potential to negatively impact . . . organic production . . . .''
Consultations between EPA and USDA are required in the Federal
Insecticide, Fungicide, and Rodenticide Act in sections 2 (minor uses),
3 (minor uses), 4 (public health issues), and section 6 (suspensions,
cancellations, imminent hazards; advance notice of EPA actions, and
other FIFRA provisions mandate the opportunity for USDA input). Some
consultations are required by regulation or OMB Circulars.
For all of 2015 and through the date of your response in 2016, can
you please describe in appropriate detail consultations, discussions,
and meetings EPA has conducted with USDA on the above examples on the
following types of actions: determinations of economic benefits to
farmers, including specialty crop farmers, regarding the use of
specific pesticides; label requirements and changes; issues related to
minor crops; public health matters; and the consideration of decisions
to restrict, limit, cancel, or suspend the use of pesticides?
In your answers please include specific information including
dates, participants, actions taken, and the outcome of those
consultations, discussions, and meetings.
Answer. The following provides some examples of the discussions the
EPA has had with USDA from January 1, 2015, through March 15, 2016.
These consultations are summarized in the table below.
The EPA typically consults with USDA through the Office of Pest
Management Policy (USDA-OPMP). OPMP then coordinates with other
entities associated with USDA, including the Integrated Pest Management
(IPM centers), as appropriate. For some reviews, therefore, the EPA is
not in direct contact with all the participants. The EPA regularly
coordinates and consults directly with USDA's Animal and Plant Health
Inspection Service's (APHIS) Biotechnology Regulatory Services (BRS) on
matters related to biotechnology and agriculture. Similarly, the EPA
consults directly and regularly with Interregional Project 4 (IR-4) on
matters related to uses of pesticides on minor crops (i.e., crops grown
on less than 300,000 acres). In addition, for the past several years,
the EPA has scheduled monthly meetings with OPMP to provide for
coordination on a wide variety of pesticide regulatory matters.
The EPA and BRS coordinate on genetically-engineered (GE) crops
which are resistant to herbicides and insects. In addition, EPA and BRS
coordinate on GE microorganisms. The EPA has also coordinated closely
with USDA-APHIS-BRS on the registration of herbicides containing
rimsulfuron and nicosulfuron designed for use on Inzen sorghum (Inzen
sorghum is a type of sorghum that is conventionally bred to be
resistant to the effects of rimsulfuron and nicosulfuron herbicides).
The registration of these herbicides could benefit sorghum growers who
cultivate the Inzen sorghum line by providing improved weed control.
Although Inzen sorghum is the product of conventional breeding and is
not a GE crop, the EPA reached out to BRS. BRS assisted with an
analysis which showed the potential for resistant trait conventionally
bred into the sorghum to cross with wild relatives which could become
resistant to the herbicides that are proposed for use on Inzen sorghum
and subsequently pose challenges to their control in agricultural
production. The EPA issued these registrations on February 3, 2016.
USDA and HHS reviewed the EPA's assessment of an application for a
new use of deltamethrin for the purpose of mosquito control. The review
was led by USDA-OPMP (Office of Pest Management Policy), but the
participating offices are not known. No comments were submitted. EPA
found that the proposed use was a `minor use' as defined by FIFRA
2(ll)(2), `lack of economic incentive.' As such, the registrant was
eligible for a new period of exclusive use over the data submitted in
support of the registration.
In addition to consultations over specific pesticides, the EPA
engages with USDA over basic concepts that contribute, over time, to
pesticide decisions. USDA also reviews rules proposed and finalized by
EPA under FIFRA and as part of the inter-agency review coordinated by
the Office of Management and Budget. For example:
The EPA has been collaborating with USDA, as well as FWS and
the National Marine Fisheries Service (NMFS) to develop interim
scientific methods to assess the potential risks of pesticides
to Federally endangered and threatened species and designated
critical habitats, based on recommendations from the April 2013
National Academy of Sciences report, ``Assessing Risks to
Endangered and threatened Species from Pesticides.''
Specifically, USDA has provided expertise on pesticide uses for
the draft pilot Biological Evaluation for diazinon and
assistance with the use of the National Agricultural Statistics
Service Cropland Data Layer to help define the footprint of
agricultural use patterns;
The EPA is in regular communication with USDA regarding
biotechnology per the Federal Coordinated Framework for the
Regulation of Biotechnology. For over 15 years, the EPA, USDA,
and FDA have participated in monthly biotechnology calls where
each agency shares regulatory updates, hot topics, and
information on international activities. The EPA, FDA, and
USDA-APHIS-BRS also have Memoranda of Understanding in place
regarding coordination and information sharing as well as other
MOU's associated with specific topic areas, e.g., coordination
and collaboration on the potential environmental release of GE
microorganisms. Additionally, through the Emerging Technologies
Interagency Policy Coordination Committee, the EPA is working
with USDA on updating the coordinated framework for
biotechnology;
For over three years, the EPA has been in regular
communication with USDA-ARS regarding corn rootworm resistance
management issues. During the corn growing season, the EPA
participates in monthly conference calls with corn rootworm
entomologists, including USDA researchers. The EPA received
comments from USDA's OPMP (EPA-HQ-OPP-2014-0805-0076) in
response to its solicitation for public comment on a corn
rootworm mitigation strategy. The EPA modified its proposal to
account for those comments and comments from others. Prior to
releasing the proposed draft strategy and prior to announcing
an agreement in January 2016, the EPA communicated with OPMP to
notify OPMP of the release;
The EPA is consulting with USDA-ERS (Economic Research
Service) to better understand the value of pollinators,
especially managed honey bees, and how pesticide use may
influence the habitat for wild pollinators. This information
will help the EPA better characterize the risks pesticides pose
to managed and wild pollinators;
USDA reviewed the final rule to revise the Worker Protection
Standard (WPS) and the proposed rule revising the standards for
Certified Applicators. The review was coordinated by USDA-OPMP.
The Animal and Plant Health Inspection Service (USDA-APHIS) and
Forest Service (USDA-FS) participated significantly in the
review of the Certified Applicators proposed rule; both
entities run certification programs. An outcome of the
discussion with USDA was that the EPA expanded the definition
of farms and familial relationships eligible for the owner and
immediate family exemptions to the WPS;
The EPA and USDA have been coordinating closely for several
years on the important issue of herbicide resistance. Weed
resistance to herbicides has become a major economic and
agronomic problem in U.S. agriculture in field crops such as
corn, soybeans, cotton, and wheat, as well as minor and
specialty crops. The EPA has proactively engaged USDA-OPMP and
USDA-APHIS's Biotechnology Regulatory Service (APHIS-BRS) in
this key area. This joint effort also includes the Weed Science
Society of America (WSSA) and other stakeholders, where in
2012, WSSA published two special editions of their Journal of
Weed Science that were the culmination of collaboration between
EPA, USDA and WSSA. In addition to weed resistance to
herbicides, the EPA is working with USDA and other stakeholders
in efforts to manage insect and plant pathogen resistance to
pesticides; and
The EPA, USDA-OPMP, and USDA-APHIS-BRS have on several
occasions participated jointly in a wide range of outreach and
education efforts. In July 2015 the EPA and OPMP participated
in a tour of herbicide-resistant weed problems in Iowa
agriculture. Joining the group were weed scientists from the
University of Kentucky and Iowa State University. In other
outreach activities, USDA/OPMP joined EPA to discuss herbicide
resistance and other issues of mutual interest at a meeting
with the Commodity Research and Opportunities Partnership
(CROP), an organization that represents corn, cotton, wheat,
sorghum, and soybean growers.
While the EPA does not have detailed records of every consultation
held with USDA regarding pesticide regulatory matters, the following
table provides examples of the wide variety of interactions between the
EPA and USDA over the past 2 years:
------------------------------------------------------------------------
Subject Meeting Dates Participants
------------------------------------------------------------------------
Pesticide-specific consultations
------------------------------------------------------------------------
Rimsulfuron and January 29, 2015; USDA-APHIS-BRS
Nicosulfuron February 27, 2015
registrations on
sorghum
Sulfonylurea May 27, 2015 USDA-OPMP
herbicides
Deltamethrin minor Draft reviewed by USDA-OPMP
use assessment USDA and HHS,
October-November,
2015
Neonicotinoid April 30, 2015, USDA-OPMP; USDA-IR-4
insecticides presentation by
AgInfomatics on
benefits
------------------------------------------------------------------------
Endangered Species
------------------------------------------------------------------------
Endangered Species Continued discussions USDA-OPMP, USDA-NASS
Risk Assessments for from January 1, 2015
Pesticides to present including
bi-weekly conference
calls and a week-
long interagency
workshop with EPA,
FWS, and USFWS in
January 2016
Federal Endangered July 14, 2015 USDA-OPMP, USDA-NASS
Species Task Force
(FESTF) meeting
------------------------------------------------------------------------
Biotechnology
------------------------------------------------------------------------
Biotechnology Monthly for 15+ years EPA, USDA, FDA
Coordination Calls
Discussion of USDA- March 10, 2016 EPA, USDA-FAS
FAS' mission, new
breeding
technologies and how
the products may
impact trade in
agricultural
commodities.
Biotechonology MOUs On-going discussions EPA, USDA-APHIS-BRS
Working with USDA on August 2015 and EPA, USDA-APHIS, USDA-OSEC
the Emerging ongoing discussion
Technologies
Interagency Policy
Coordination
Committee to update
the coordinated
framework for
biotechnology
Corn Rootworm Monthly during corn EPA, USDA ARS
Resistance growing season for
Management 3+ years
------------------------------------------------------------------------
Pollinators
------------------------------------------------------------------------
Value of pollinators September 2, 2015, USDA-ERS
and on-going
discussions
Pollinator habitat December 1, 2015, and USDA-ERS
on-going discussions
Pollinator health As needed since May USDA-OSEC, USDA-OPMP, USDA-
task force 2014 (EPA and USDA ARS, USDA-FSA, USDA-NRCS
co-chair the task
force)
------------------------------------------------------------------------
Rules
------------------------------------------------------------------------
Worker Protection May to July, 2015 USDA-OPMP
Standard revisions
Certified Applicator April to July, 2015 USDA-OPMP, USDA-APHIS,
revisions USDA-FS
------------------------------------------------------------------------
Herbicide Resistance
------------------------------------------------------------------------
Herbicide Resistance March 16, 2015, USDA-OPMP
Internationally seminar by Dr. Steve
Powles, University
of Western Australia
Herbicide Resistance September 24, 2015, USDA-OPMP
Management with WSSA
representatives USDA-APHIS-BRS
October 23, 2015
Herbicide Resistance February 10, 2016, USDA-OPMP
Management Proposal Weed Science Society USDA-OPMP, USDA-ARS, USDA-
of America NRCS, USDA-NIFA, USDA-
March 16, 2016, NASS, USDA-IR-4
Federal IPM
Coordinating
Committee meeting
------------------------------------------------------------------------
Methyl Bromide
------------------------------------------------------------------------
Golden nematode-- September 22, 2015 USDA-APHIS, EPA--Region 10
conference call to
discuss alternatives
for quarantine and
control in Idaho
------------------------------------------------------------------------
Outreach/Education
------------------------------------------------------------------------
Iowa Crop Tour on July 7-10, 2015 USDA-OPMP
herbicide resistant
weeds
Interagency Meeting February 10, 2016 USDA-APHIS-BRS, USDA-OPMP
on weed control
issues
Commodity Research & October 8, 2015 USDA-OPMP
Opportunities
Partnership (CROP)--
representing corn,
cotton, wheat,
sorghum, and soybean
growers
Discussion with USDA September 9, 2015 USDA-APHIS-BRS
on Sorghum-
Johnsongrass Gene
Flow Seminar &
Persistence of Crop
Alleles in the Weed
Populations
Webinar with Tribal June 11, 2015 USDA-APHIS-BRS
Nations on
Genetically
Engineered crops
Glyphosate resistance July 14, 2015 USDA-ERS
economics (webinar)
USDA Stakeholder March 12-13, 2015 USDA-OPMP
Workshop on
Coexistence--resista
nce management for
biopesticides and
herbicides
Sulfonylurea April 1, 2015 USDA-OPMP
herbicide meeting
with registrants
Golden nematode-- September 22, 2015 USDA-APHIS, EPA--Region 10
conference call to
discuss alternatives
for quarantine and
control in Idaho
------------------------------------------------------------------------
Question 3. Reliable data and analyses are critical to sound
regulation. I have heard about a serious matter regarding EPA policies
based on human research data that may not be reliable.
For years, EPA relied on hundreds of quality studies evaluating all
aspects human susceptibility to pesticides called organophosphates.
This included studies designed to make sure that children would be
protected. Even though EPA used those high-quality assessments for 20
years the Agency now relies primarily on three epidemiology studies and
some journal articles. Limiting the diversity of data creates a greater
likelihood of inaccurate results. Why has EPA changed this process? Has
limiting the number of studies increased the likelihood of inaccurate
assessments? Was this change reviewed by a Scientific Advisory Panel?
Was it subject to notice and public comment? Why is the Agency keeping
this data from the public?
Answer. The EPA periodically reviews existing registered pesticides
to ensure they can be used safely, without unreasonable risks to human
health and the environment. The periodic review of pesticide
registrations is required by FIFRA. The registration review program is
intended to make sure that, as the ability to assess risk evolves and
as policies and practices change, all registered pesticides continue to
meet the statutory standard of no unreasonable adverse effects. The EPA
will review each registered pesticide at least every 15 years to
determine whether it continues to meet the FIFRA standard for
registration.
As part of registration review, the EPA assesses any changes that
have occurred since the last registration decision to determine whether
the pesticide still satisfies the statutory standard for registration.
The EPA considers any new data or information on the pesticide and
decide whether a new risk assessment must be conducted. In the case of
chlorpyrifos and the organophosphate pesticides, many of the
epidemiology studies, mechanistic studies, and laboratory animal
studies on the neurodevelopmental effects of organophosphate pesticides
were published after reregistration was completed in 2006.
The EPA developed a ``Draft Framework for Incorporating Human
Epidemiologic & Incident Data in Health Risk Assessment'' in 2010 which
was reviewed by the FIFRA SAP and received public comment. The Panel
commended the agency for developing the draft Framework and was
``impressed with the documentation presented.'' The agency also notes
that the Panel was supportive of the key components of the draft
Framework, namely the use of problem formulation to assess data
availability and quality early in the process and the modified Bradford
Hill criteria as an internationally accepted tool for assessing
epidemiology and laboratory animal data.
The agency has not limited the number of studies reviewed. In fact,
the agency has reviewed hundreds of studies from laboratory animals,
cell systems (including human), biomonitoring, and epidemiology on a
variety of scientific areas related to human health effects. These
studies were evaluated together in a weight of evidence analysis.
Therefore, there is significant new information relevant to the
human health effects of organophosphate pesticides.
Question 3a. I have recently been told that one of the studies that
the EPA relies upon was conducted by Columbia University and that they
have refused to provide the raw data to the Agency even though EPA
partially funded the study. Is that true? At any point has EPA been
allowed to review the raw data? Do you believe that its use is in
compliance with the Administrative Procedures Act? How many times has
this study been utilized for registrations and registration reviews?
Was that study and its underlying data reviewed by a Scientific
Advisory Panel? Was it subject to notice and public comment?
Answer. The EPA frequently relies on peer reviewed studies in the
public literature across agency programs without possessing underlying
data and the Federal courts have made clear that the EPA is not
required by Federal law to obtain or analyze the raw data in order to
rely on such studies. The EPA therefore believes its consideration of
these data is consistent with the Administrative Procedure Act. If the
EPA and other governmental agencies could not rely on published studies
without conducting independent analyses of the raw data underlying
them, then much relevant scientific information would become
unavailable for use in setting standards to protect public health and
the environment.
In the past, the EPA sought to obtain the original raw data used to
support certain epidemiological analysis of in utero exposure to
chlorpyrifos and subsequent adverse neurodevelopmental health outcomes
in children generated by the Columbia Center for Children's
Environmental Health (CCCEH) to support the human health risk
assessment of chlorpyrifos. Prior to the 2013 meeting with CCCEH
investigators, the EPA thought these data would be important to both
clarify the exposure-response relationship observed in the epidemiology
study relative to the current regulatory endpoint (acetylcholinesterase
inhibition), and also to resolve uncertainties regarding study
participants co-exposure to other environmental contaminants, among
other areas of uncertainties. CCCEH researchers did not agree to
provide these data; however, the researchers met with the EPA and
discussed the agency's questions about the data to help determine
whether further review of the raw data might assist the EPA in
resolving uncertainties. As a result of this meeting, the EPA concluded
that access to the raw data would not provide answers to the EPA's
questions. Indeed, based on discussions in that meeting as well as
further work conducted by agency staff, the EPA has gained additional
information to better clarify and characterize the major issue areas
identified as uncertainties.
In the summer of 2015, the EPA made another attempt to obtain the
raw data from Columbia University. The Columbia University
investigators again denied the EPA's request. However, the
investigators did provide additional summary information on the blood
biomonitoring data. The agency has made this additional information
publicly available.
Also in summer of 2015, Dr. Dana Barr of Emory University provided
the agency with limited raw data in her possession from the three
cohorts. However, the files provided from Dr. Barr are not useful the
agency's current purpose of assessing risk to chlorpyrifos. The files
provided from Dr. Barr do not contain the biomonitoring data from the
key publications from CCCEH which describe associations between blood
levels of chlorpyrifos and neurodevelopmental deficits in children. The
agency has received two FOIA requests specifically asking for raw data
on the three US children's cohorts. For the first FOIA request, EPA-HQ-
2016-002089, the requester was provided all the responsive records
(i.e., the files provided by Dr. Barr) and the request was closed March
2, 2016. For the second request, EPA-HQ-2016-003947, the agency did not
have any additional files beyond those provided for the first request.
The second FOIA was closed on March 22, 2016.
The agency has taken a stepwise, objective and transparent approach
in evaluating, interpreting, and characterizing the strengths and
uncertainties associated with all of the available lines of scientific
information related to the human health effects of chlorpyrifos. This
stepwise approach has included multiple reviews by the FIFRA SAP and
other experts in addition to multiple opportunities for public comment.
The stepwise evaluation began with the September 2008 FIFRA SAP
meeting involving a preliminary review of the literature for
chlorpyrifos, with a particular focus on women and children (USEPA,
2008). In 2010, the EPA developed a draft ``Framework for Incorporating
Human Epidemiologic & Incident Data in Health Risk Assessment'' which
provides the foundation for evaluating multiple lines of scientific
evidence, including epidemiology, in the context of the understanding
of the adverse outcome pathway (or mode of action (USEPA, 2010). The
draft framework, which includes two key components: problem formulation
and use of the modified Bradford Hill criteria, was reviewed favorably
by the SAP in 2010 (FIFRA SAP, 2010). The EPA's draft framework is
consistent with updates to the World Health Organization/International
Programme on Chemical Safety mode of action/human relevance framework,
which highlight the importance of problem formulation and the need to
integrate information at different levels of biological organization.
Because the SAP was basically supportive of the overall approach
and the framework is consistent with recent, similar efforts by the
WHO, the agency believes use of the draft framework in its current form
is appropriate prior to the finalization of the document. The EPA used
the draft framework for the 2014 chlorpyrifos revised risk assessment
and the preliminary risk assessment for seven organophosphates in 2015.
Currently, we are incorporating comments from the SAP and the public,
and plan to finalize the framework in 2017.
In 2011, the agency released ``Chlorpyrifos: Preliminary Human
Health Risk Assessment for Registration Review,'' focusing on the AChE
inhibiting potential of chlorpyrifos (USEPA, 2011) and included
assessment of exposures from dietary (food, water), occupational and
residential pathways. The 2011 preliminary risk assessment was released
for public comment. Also in 2011, the chlorpyrifos physiologically
based pharmacokinetic-pharmacodynamic model (PBPK-PD) was reviewed by
the FIFRA SAP (FIFRA SAP, 2011). [This model was used in the 2014
revised human health risk assessment described below.]
In 2012, the agency convened another meeting of the FIFRA SAP on
chlorpyrifos which incorporated the newest experimental data related to
AChE inhibition and both cholinergic and non-cholinergic adverse
outcomes, including neurodevelopmental studies on behavior and
cognition effects (FIFRA SAP, 2012). Similarly, the agency also
performed a more in-depth analysis of the biomonitoring data and of
epidemiological studies from three major children's health epidemiology
cohort studies in the U.S., as well as developed plausible hypotheses
on MOAs/AOPs leading to neurodevelopmental outcomes (USEPA, 2012a).
Following the 2012 SAP meeting, the agency solicited additional input
from Federal experts in the areas of Magnetic Resonance Imaging (MRI)
and neurobehavioral testing in children to further clarify results
obtained by examination of the epidemiological studies.
In December, 2014, the agency released ``Chlorpyrifos: Revised
Human Health Risk Assessment for Registration Review'' * which went
through public comment in 2015.
---------------------------------------------------------------------------
* Editor's note: the document referred to is retained in Committee
file.
---------------------------------------------------------------------------
Similarly, the agency's ``Literature Review on Neurodevelopment
Effects & FQPA Safety Factor Determination for the Organophosphate
Pesticides'' was released for public comment in September, 2015.
The agency held another meeting of the FIFRA SAP in April 2016, to
review a new analysis using the blood biomonitoring data from the
Columbia University epidemiology study.
Question 3b. It has also been brought to my attention that one of
the authors of the study, Frederica Perera, Dr.P.H., Ph.D., of the
Columbia University School of Public Health, is a member of the Board
of Trustees of the Natural Resources Defense Council. The Natural
Resources Defense Council has sued the EPA on a number of occasions to
challenge pesticide registrations and often the supporting risk
assessments. Has the EPA's Office of Inspector General been made aware
of this conflict of interest? Has the Agency suspended use of the
Columbia University epidemiology study in its risk assessment process
until these concerns can be addressed?
Answer. While recipients of Federal grants are subject to conflict
of interest rules designed to insure that the competition for grants is
fair and that the use of grant funds is appropriately managed, they are
not otherwise subject to conflict of interest restrictions
disqualifying them from eligibility to receive a grant based on
affiliations with organizations that have sued the agency or supported
particular regulatory activities. Accordingly, the EPA has not related
this matter to the EPA Inspector General, nor has the EPA suspended its
consideration of these data.
Question 3c. If it is correct that EPA has not gotten access to
that raw data, Federal regulations designed to enhance the credibility
of the Federal rulemaking process have likely been violated. Data
Quality Act violations and conflict of interest violations may have
also occurred.
Answer. The EPA frequently relies on peer reviewed studies in the
public literature across agency programs without possessing underlying
data and the Federal courts have made clear that the EPA is not
required by Federal law, including Federal rulemaking procedures, to
obtain or analyze the raw data in order to rely on such studies. If EPA
and other governmental agencies could not rely on published studies
without conducting independent analyses of the raw data underlying
them, then much relevant scientific information would become
unavailable for use in setting standards to protect public health and
the environment.
The EPA's consideration of epidemiological data supporting the
EPA's chlorpyrifos assessment is in keeping with the EPA's guidelines
implementing the Information Quality Act. Those guidelines recognize
that in some circumstances complete access to all methods and data
cannot occur due to privacy, trade secrets, intellectual property, and
other confidentiality protections. In those instances, EPA guidelines
provide that the EPA should, to the extent practicable, apply
especially rigorous robustness checks to analytic results and carefully
document all checks that were undertaken. Original and supporting data
may not be subject to the high and specific degree of transparency
provided for analytic results; however, the EPA should apply, to the
extent practicable, relevant agency policies and procedures to achieve
reproducibility, given ethical, feasibility, and confidentiality
constraints.
Questions Submitted Hon. David Rouzer, a Representative in Congress
from North Carolina
EPA National Enforcement Initiatives
Question 1. One of EPA's current enforcement initiatives for the
Fiscal Years 2014-2016 expands enforcement action against our nation's
animal agriculture operations. EPA is currently undergoing a process to
modify the NEIs and this presents an opportunity that we support--
returning this priority to the standard enforcement program--which is
prudent considering the current NEI has not produced demonstrable water
quality benefits. Administrator McCarthy, will you work to ensure that
the new enforcement initiatives are based on sound science and
demonstrated environmental benefits, rather than a doubling-down of
efforts that have only acted to generate further distrust of EPA by
America's farmers and ranchers?
Answer. The EPA identifies National Enforcement Initiatives based
on public and stakeholder input, as well as extensive science-based
analysis about public health threats from pollution. We recently
announced the EPA's selection of the FY 2017-2019 National Enforcement
Initiatives. Building on progress we've made from the current cycle of
initiatives, the EPA determined that to protect American communities,
it was important to retain its national initiative to prevent animal
waste from contaminating surface and ground water. This will help focus
important time and resources on protecting communities from improperly
managed animal waste, which can result in water quality impairment,
fish kills, algal blooms, contamination of drinking water sources, and
transmission of disease-causing bacteria and parasites associated with
food and waterborne diseases.
NPDES Electronic Reporting Rule
Question 2. This rule (finalized by EPA on September 25, 2015) will
result in EPA collecting farm information from states that goes beyond
the scope of the Federal program. Taking into account EPA's accidental
release of farm information to environmental activist groups in 2013,
the lack of data security measures to prevent EPA from collecting non-
NPDES farm information is very concerning to our nation's farmers and
ranchers. Administrator McCarthy, can you ensure us that no superfluous
information will be collected by the EPA through the electronic
reporting rule?
Answer. The minimum set of NPDES program data that the EPA will
collect through the NPDES Electronic Reporting Rule does not go beyond
the scope of the Federal program and is based on the EPA's current
reporting requirements (see Appendix A to 40 CFR Part 127) [See
Attachment 7].
During the development of this rulemaking the EPA carefully
considered input from authorized state programs, provided in comments
and meetings, to match the minimum set of NPDES program data to the
existing regulations and practice, including how these data are
currently used by the EPA and authorized state programs. The EPA, in
close collaboration with the states, streamlined the NPDES electronic
reporting requirements down to the minimum number of data elements
needed to oversee management of the NPDES programs in the most
efficient manner possible. In particular, these data are necessary to
properly identify potential sources of wastewater and storm water
pollution and to assess the effectiveness of authorized NPDES programs.
In particular, the EPA worked with authorized NPDES programs to
ensure that the final rulemaking accurately captures EPA's existing
Federal NPDES reporting requirements on Concentrated Animal Feeding
Operations [e.g., 40 CFR Part 122.21(i)(1), 122.23, and 122.42(e)(4)].
Additionally, besides inspection information, authorized state programs
are only required to share with the EPA data on facilities that are
required to obtain NPDES permits under Federal requirements.
Question 3. Last September, the EPA published Interim
Recommendations for environmental standards and ecolabels for use in
Federal procurement. EPA's recommendation for lumber excludes several
credible standards that are widely used in the United States, including
the Sustainable Forestry Initiative (SFI) and American Tree Farm System
(ATFS) standards, which represent 70% of the certified acres in the
U.S. EPA has signaled that this recommendation is mandatory for Federal
procurement. Under what circumstances may a Federal procurement officer
purchase wood products that do not meet this FSC requirement, such as
those certified to SFI or ATFS? And, given the significant volume of
sustainably harvested timber that is seemingly excluded from Federal
purchasing, please explain the process for EPA amending this
recommendation in the future.
Answer. Under Executive Order 13693--Planning for Federal
Sustainability in the Next Decade--the EPA issued recommendations to
assist Federal purchasers in identifying and procuring environmentally
sustainable products. The EPA's Interim Recommendation for the lumber/
wood category is based on the Department of Energy's Fiscal Year 2016
(FY16) Priority Products List.
As a result of stakeholder inquiries since the release of the
Interim Recommendation, the EPA has met and is continuing to work with
USDA and DOE's Office of Sustainable Environmental Stewardship to gain
further information. The EPA's Standards Executive is reaching out to
the Sustainable Forestry Initiative, the American Tree Farm System, and
the other forestry labels that stakeholders have requested the EPA
consider. The EPA will be in touch with these groups regarding the
agency's review of forestry labels and their alignment with the
National Technology Transfer and Advancement Act, the OMB Circular A-
119, and related Federal policies that guide the EPA's use of voluntary
consensus standards and private-sector conformity assessment
activities. In addition, the EPA continues to progress with piloting
our Guidelines for Assessing Standards and Ecolabels for Use in Federal
Procurement (the Guidelines), and hopes that information gleaned from
this process will inform thinking related to the lumber/wood category.
Finally, DOE continues to conduct research to inform their FY16
Priority Products List. The EPA looks forward to reviewing all of this
additional data to inform if and how the lumber/wood category of
Interim Recommendations might be revised.
The EPA has, and will continue to provide, mechanisms for public
input as we develop these recommendations. The agency issued Federal
Register Notices on the initial draft guidelines in 2014 and in March
2015 for the launch of our pilot work.\10\ Those FRNs were open to
public comment and they marked the beginning of our efforts to engage
multi-stakeholder panels whose counsel will be considered as we move to
finalize our recommendations. Further, any Federal acquisition
requirements stemming from the recommendations would include a public
comment process prior to incorporation into the Federal Acquisition
Regulations (FAR). As such, FAR Case 20 15-033 has been developed in
order to integrate the new requirements of E.O. 13693 into the FAR. All
next steps related to this case, including as to when it will be
available to the public, are viewable at http://www.acq.osd.mil/dpap/
dars/far_case_status.html.
---------------------------------------------------------------------------
\10\ Federal Register Notice, February 27, 2014, ``Draft Guidelines
for Product Environmental Performance Standards and Ecolabels for
Voluntary Use in Federal Procurement'' (79 FR 11102). [See Attachment
1] https://www.gpo.gov/fdsys/pkg/FR-2014-02-27/pdf/2014-04329.pdf.
Federal Register Notice, March 19, 2015, ``Agency Information
Collection Activities; Proposed Collection and Comment Request;
Assessment of Environmental Performance Standards and Ecolabels for
Federal Procurement'' (80 FR 14372). [See Attachment 2] https://
www.gpo.gov/fdsys/pkg/FR-2015-03-19/pdf/2015-06275.pdf.
Question 4. President Obama stated on January 21, 2009 that ``The
Freedom of Information Act should be administered with a clear
presumption: In the face of doubt, openness prevails. . . . All
agencies should adopt a presumption in favor of disclosure, in order to
renew their commitment to the principles embodied in FOIA, and to usher
in a new era of open government. The presumption of disclosure should
be applied to all decisions involving FOIA.''
However, on September 10, 2015, a Federal district court opinion
issued September 10, 2015, noted that EPA ``continues to demonstrate a
lack of respect for the Freedom of Information Act process . . . .''
``The Court is left to wonder whether EPA has learned from its mistakes
or if it will merely continue to address FOIA requests in the clumsy
manner that has seemingly become its custom. Given the offensively
unapologetic nature of EPA's recent withdrawal notice, the Court is not
optimistic that the Agency has learned anything.''
In addition, a recent (January 2016) report of the House Committee
on Oversight and Government Reform strongly criticized the failure of
Federal agencies to properly implement FOIA. Major problems included
long delays and redacting information that should be made public.
Improper redaction is a very serious ``invisible'' problem since FOIA
requesters cannot determine if the Agency is following the law. What
specific steps will EPA undertake to do a better job in responding to
FOIA requests?
Would you support legislation providing independent agencies--such
as the Inspector General offices of the various Departments--the
authority to confidentially sample FOIA responses and determine if the
Agency is improperly redacting material? In my view, that is likely to
be the only way to determine if an Agency is complying with the law
regarding redactions.
Answer. The EPA takes its FOIA responsibilities seriously and is
focused on creating more efficient work processes to ensure FOIA
responses are prepared effectively and at lower cost. This includes
adopting industry best practices for the delivery of information
technology services in areas such as cloud computing, mobile technology
and workplace standards. The EPA received close to 11,000 new FOIA
requests in FY 2015 and successfully processed over 11,000 requests,
reducing its FOIA backlog by several hundred requests.
The EPA also has improved its records management policies and
procedures, including recent updates to the Records Management Policy
(https://www.epa.gov/sites/production/files/2015-03/documents/cio-
2155.3.pdf) [See Attachment 18] and new procedures to assist employees
in the management of various types of electronic records. In addition,
the agency's FOIA Expert Assistance Team was established in the fall of
2015. The team, part of the Office of General Counsel, is charged with
overseeing and coordinating efforts on the agency's most complex FOIAs.
The EPA has also deployed new technology tools, such as centralized
searching and electronic review, to efficiently process large or
complex requests.
The EPA already provides the Inspector General and Congress with
information in non-redacted format upon request. In addition, the EPA
has recently finalized the update of agency-wide and office level FOIA
procedures to clarify roles and responsibilities for responding to
requests, including line by line review and limited redaction.
Question 5. Americans are at an increasing threat from vector-borne
diseases. West Nile Virus and encephalitis have been serious problems
for the last several years, but new diseases such as dengue fever and
chikungunya are now an increasing threat to Americans and particularly
infants. Sadly, new vector-borne threats continue to emerge. In Mexico
and South America, the mosquito-borne Zika virus is responsible for
infants being borne with significant birth defects. EPA is proposing
very aggressive action to restrict the use of some critical mosquito
control products. How is the Agency incorporating new public health
threats into its risk assessments for products used in vector control?
Answer. The EPA is not currently proposing any actions to restrict
the use of mosquito control products. The agency has recently released
preliminary risk assessments that show risks of concern for some
compounds; however, these are preliminary in nature and subject to
change if additional data come to light. When refined risk assessments
still show a concern, changes in use patterns or applications can
sometimes be effective in mitigating the risk and allowing the compound
to still be used in mosquito control.
When making a regulatory decision, the EPA considers the benefits
(both public health and other) of these pesticides, along with their
risks. The EPA consults with CDC when making a regulatory decision for
any pesticide used to control a pest of public health significance. The
EPA also frequently consults with other interested stakeholders to
ensure that the agency has a complete picture of the benefits and have
properly evaluated any proposed mitigation.
Question 6. The Federal rulemaking process includes very specific
actions that a Federal Agency must take before promulgating new
regulations. Some recent activities by the Office of Pesticide Program
appear to circumvent the rulemaking process by sending pesticide
registrants letters that outline new regulatory provisions. This
``regulation by letter'' procedure was used by EPA in 2013 to mandate
registrants include pollinator statements and a graphic on certain
pesticide products, and in 2009 for the Agency's pyrethroid and
pyrethrin labeling initiative. What is EPA's rationale for
circumventing the Administrative Procedure Act (APA), which includes
notice and comment, economic and small business impact analysis, etc.?
Will EPA provide the Committee with assurances that it will abandon
this policy of ``regulation by letter'' and instead follow the
procedures and analysis required by the APA?
Answer. The EPA does not ``regulate by letter'' and FIFRA does not
provide for such a regulatory mechanism to make changes to pesticide
registrations. The EPA pesticide program is a licensing program that is
based on an adjudicatory system. As a licensing program, the agency
must ensure that the license complies with the law and continues to
comply with the law. As such, decisions to grant a new license or
change/modify an existing license are not subject to APA rulemaking,
but the procedural requirements of FIFRA. When the EPA receives new
information and determines that the license may lead to unreasonable
adverse effects on the environment, the agency may offer the registrant
a way to correct the imbalance in a timely manner. The August 2013
letter regarding labeling changes for the neonicotinoid insecticides is
one example. However, if the registrant chooses not to address the
concerns raised in such an offer, the agency can take appropriate steps
under FIFRA to compel any necessary changes to the pesticide
registration to mitigate unreasonable adverse effects on the
environment. The letter itself is not self implementing; in the absence
of voluntary agreement from a registrant, FIFRA prescribes steps that
the agency must take to impose new mitigation measures.
Question 7. What farmers and communities in my district care about
is the ability to defend against pest threats to their crops, food,
homes and health. We have heard a lot today about what actions EPA has
or is planning to take that impact the use of pesticides. I believe it
would be very helpful to this Committee for EPA to develop a
comprehensive list of all the Agency actions, and, not just
rulemakings, during the last 8 years and those planned through the end
of this year that restricted, or have the potential to restrict,
existing or new uses of pesticides. Will you work with the Committee to
determine what actions should be on that list so that Members can
determine whether and how best to conduct appropriate oversight
pursuant to our statutory obligations?
Answer. The EPA routinely provides opportunities for public comment
on many pesticide regulatory actions. For example, before registering a
new active ingredient or a significant new use of an already-registered
active ingredient, the EPA engages stakeholders through its public
participation process. Similarly, all registration review activities,
including work plans, risk assessments, and proposed decisions, are the
subject of public comment periods to ensure that stakeholders can
provide the EPA with the highly quality information needed to make
pesticide regulatory decisions.
The pesticide registration review process began in 2007 with the
first decisions being made a few years later. To date, 165 decisions
have been made. Of these decisions, 83 involved requests from the
registrants to voluntarily cancel their registrations, in most cases
for business decisions that were independent of the agency's review.
For the remaining 82, many required no change to the registration or
minor label clarification to make it easier for the user to understand
and use the product correctly. Our anticipated registration review
schedule can be found at www.epa.gov/pesticide-reevaluation/
registration-review-schedules [See Attachment 3].
During the same time period, the EPA has registered approximately
170 new pesticide active ingredients and more than 1,700 new uses of
already registered active ingredients, providing numerous new products
for use in agricultural and non-agricultural settings. These newly
registered products are designed to address emerging pest pressures and
will have a significant role in the marketplace.
Of these regulatory decisions to restrict or cancel certain
registrations, the EPA made these decisions after careful consideration
of all available data and consistent with existing statutory
requirements. For example:
In 2010, the EPA announced its decision to terminate all
uses of endosulfan due to unacceptable risks to farmworkers and
wildlife. The EPA signed a Memorandum of Agreement with the
registrants of endosulfan that resulted in voluntary
cancellation and provided for a phase-out of all existing
endosulfan uses in the United States in order to allow time for
growers to transition to newer alternatives;
In 2012, the EPA limited the use of chlorpyrifos by
significantly lowering pesticide application rates and creating
``no-spray'' buffer zones around public spaces, including
recreational areas and homes, due to concerns for unacceptable
risks to children and bystanders;
In 2014, the EPA canceled propoxur pet collars. In the fall
of 2013, the EPA completed the propoxur pet collar risk
assessment. The EPA's risk assessment indicated risks of
concern to children from exposure to pet collars containing
propoxur;
In 2015, the EPA reached an agreement with Reckitt
Benckiser, the manufacturer, to cancel all distribution of 12
consumer use d-CON products that did not meet the EPA's current
safety standards, raising concerns for risks to children and
pets. Additionally, eight of the 12 products pose unacceptable
risks to certain wildlife;
In 2015, the EPA proposed to revoke all chlorpyrifos
tolerances due to concerns with estimated exposure from
drinking water in certain watersheds. A final tolerance rule is
anticipated in March 2017;
On November 24, 2015, while the issuance of the initial
registration was being challenged in Federal court, the EPA
sought the remand and vacatur of the Enlist Duo registration
because the EPA became aware of previously existing information
about possible synergistic effects that had not been provided
to the EPA or considered as part of the initial registration
decision. The EPA cannot be sure, without a full analysis of
the new information, that the current registration does not
cause unreasonable effects to the environment, which is a
requirement of the registration standard under FIFRA;
On July 2, 2013, the Pollinator Stewardship Council and
others, petitioned for review of the sulfoxaflor registration
in the Ninth Circuit Court of Appeals. On September 10, 2015,
the Court issued its opinion, finding that the registration was
not supported by substantial evidence to demonstrate no
unreasonable adverse effects to honey bees would result from
the registration of [sulfoxaflor]. Although the initial
sulfoxaflor submission contained all the data the EPA
determined was necessary by the EPA for registration of a new
agricultural insecticide, the Court vacated the registrations
and remanded them to the EPA to ``obtain further studies and
data regarding the effects of sulfoxaflor on bees as required
by EPA regulations.'' The vacatur of the sulfoxaflor
registrations became effective November 12, 2015. As the
registrations were no longer in effect under FIFRA, on the same
date the EPA issued a cancellation order to address existing
stocks. Although the product registrations were vacated, the
tolerances for sulfoxaflor residues on treated commodities that
were established under the FFDCA, remain in place; and
On March 4, 2016, the EPA issued a notice of intent to
cancel the registration of four pesticide products containing
the insecticide flubendiamide owing to the registrants' failure
to comply with a required condition of their registrations. The
particular condition obligated the registrants to request
cancellation if, after receiving additional required data, the
EPA determined that use of flubendiamide did not meet the FIFRA
standard for registration. Prior to issuing the notice, the EPA
concluded that the continued use of flubendiamide will result
in unreasonable adverse effects on the environment,
particularly benthic invertebrates, which are an important part
of the aquatic food chain, particularly for fish.
Over the past 8 years, the EPA issued a number of regulations
within the intention of providing clarity to the regulated community
and other stakeholders or to update information that has become
inaccurate or out of date. Examples of these rulemaking efforts
include:
Minimum Risk (Published 12/28/2015): This final rule more
clearly describes the active and inert ingredients permitted in
products eligible for the exemption from regulation for minimum
risk pesticides. These changes maintain the availability of
minimum risk pesticide products while providing more consistent
information for consumers, clearer regulations for producers,
and easier identification by states, Tribes and the EPA as to
whether a product is in compliance with the exemption;
Crop Grouping (Published Phase 1: 12/7/2007; Phase 2: 12/8/
2010; Phase 3 8/22/2012; Phase 4: anticipated 2016): These
final rules are likely to reduce the number of residue
chemistry studies required to establish a tolerance for a crop
within these crop groupings because instead of testing each
crop individually, only the representative crops would need to
be tested. Thus, the new crop groups ease the process for an
entity to request and for the EPA to set pesticide tolerances
on greater numbers of crops. Pesticides will be more widely
available to growers for use on crops, particularly specialty
crops;
Data Requirements for Antimicrobials (158W) (Published 5/8/
2013): the EPA revised the data requirements for antimicrobial
pesticide products to reflect current scientific and regulatory
practice, and to provide the regulated community with clearer
and transparent information about the data needed to support
pesticide registration decisions for antimicrobial products.
The EPA would use this information to conduct risk assessments
for a particular pesticide;
Prions as Pests (Published 2/28/2013): In 2003, the agency
determined that a prion (proteinaceous infectious particles) is
a ``pest'' under the FIFRA and that a product intended to
reduce the infectivity of prions on inanimate surfaces (i.e.,
``prion product'') is considered to be a pesticide. The EPA
believes that regulating prion-related products protects human
health and the environment against unreasonable adverse effects
and ensures that such products are effective;
Export Labeling (Published 1/18/2013; Revisions Published
12/19/2014): The EPA revised the regulations pertaining to the
labeling of pesticide products and devices that are intended
solely for export. Pesticide products and devices intended
solely for export are now able to meet the agency's export
labeling requirements by attaching a label to the immediate
product container or by providing collateral labeling that is
either attached to the immediate product being exported or that
accompanies the shipping container of the product being
exported at all times when it is shipped or held for shipment
in the United States. Collateral labeling ensures the
availability of the required labeling information, while
allowing pesticide products and devices that are intended
solely for export to be labeled for use in, and consistent with
the applicable requirements of the importing country; and
Data Compensation (Published 2/5/2014): The EPA revised its
regulations governing procedures for the satisfaction of data
requirements under FIFRA, codified in 40 CFR part 152, subpart
E. These provisions include, among other things, procedures for
the protection of exclusive use and data compensation rights of
data submitters. The EPA updated the regulations to accommodate
statutory changes and changes in practice that have occurred
since 1984; to make minor changes to clarify the regulations;
and to make changes that would simplify the procedures and
reduce burdens for certain data submitters. The revisions did
not otherwise make substantive changes to the requirements.
At times, however, the EPA has determined that significant changes
to its regulations are needed to improve public health. For example, in
November 2015, the EPA finalized revisions to the Agricultural Worker
Protection Standard. This final rule revised the Federal regulations
issued under FIFRA that direct agricultural worker protection (40 CFR
170). The changes reflected current research on how to mitigate
occupational pesticide exposure to agricultural workers and pesticide
handlers, and strengthened the protections provided to agricultural
workers and handlers under the worker protection standard. The changes
improved elements of the existing regulation, such as training,
notification, communication materials, use of personal protective
equipment, and decontamination supplies, thus preventing exposure to
pesticides among agricultural workers and pesticide handlers;
vulnerable groups, such as minority and low-income populations, child
farmworkers, and farmworker families; and the general public. We are
working closely with affected stakeholders, including state
agricultural agencies, to ensure that they have the necessary
information and training to implement these new protections.
Similarly, the EPA is now working to develop a final rule to revise
the Federal regulations governing the certified pesticide applicator
program (40 CFR part 171). This action is intended to improve the
competence of certified applicators of restricted use pesticides (RUPs)
and to increase protection for noncertified applicators of RUPs
operating under the direct supervision of a certified applicator
through enhanced pesticide safety training and standards for
supervision of noncertified applicators. State agricultural agencies,
as well as many other stakeholders, provided valuable comments and
suggestions in response to the EPA's proposed rule. We will work with
stakeholders to ensure that the revised competency standards can be
implemented effectively by state agencies.
Questions Submitted by Hon. Ralph Lee Abraham, a Representative in
Congress from Louisiana
Question 1. In response to my question about whether EPA treats
herbicides used with crops improved through biotechnology differently
than it treats all other herbicides, you stated that such herbicides
``are not treated differently than looking at how we always look at
pesticides, which is by the science trying to stick with the legal
timelines and windows that we have to make our decisions.''
Furthermore, you indicated the Agency is reducing the number of
renegotiation extensions overall under the Pesticide Registration
Improvement Act. Yet it is my understanding that EPA has consistently
imposed disproportionate burdens and delays on registration activities
related to biotechnology that it does not impose on similarly situated
products that are not related to biotechnology.
Please provide this Committee with examples of registration
timelines, including all applicable registration renegotiations (the
number of times a PRIA date was renegotiated and for how long) that
support your statement that registrations tied to biotech traits are
completed in the same general timeframe from submission to final label
as registrations with no biotech crop application.
Answer. The EPA assesses risks and benefits for each pesticide
registration application, striving to complete regulatory decisions
within the timeframes designated under PRIA. The EPA employs the same
process to review applications for herbicide uses on biotech crops as
it does for other applications, identifying any risks of concern and
conducting assessments to understand and address those risks. As with
all applications, the EPA must address risk issues identified in the
course of scientific review as well as comments received through the
public participation process. Overall, the EPA has reduced the number
of renegotiation extensions under PRIA. However, different chemicals
and use patterns may present different risks, sometimes requiring more
in depth and complex assessments to address them. More complex risks
assessments may exceed average review timeframes in order to produce
scientifically sound and legally defensible decisions.
The most complex reviews for new registration can involve the
review and evaluation of requests to register pesticides for use on
herbicide tolerant crops. While the number of applications in recent
years are small, the review times range from approximately 2 years to
approximately 6 years. These review times depend upon many factors,
including any risk concerns identified and the time needed to negotiate
risk mitigation strategies to address any potential unreasonable
adverse effects, the need to wait to make a registration decision under
FIFRA until other agencies make necessary safety findings under other
relevant statutes, and the need to make the requisite findings under
the Endangered Species Act.
An example of added complexity to a registration's risk assessment
for an herbicide use on herbicide tolerant crops is in the case of the
Endangered Species Act. The EPA intends to complete endangered species
assessments for new herbicide tolerant crop uses based on the Overview
Document-compliant method. An assessment that is Overview Document-
compliant follows the procedures and methods described in the Overview
Document * (see www.epa.gov/sites/production/files/2014-11/documents/
ecorisk-overview.pdf). The EPA will complete these effect
determinations as resources allow. To maximize impact within these
limited resources, the initial registrations (e.g., Enlist Duo) are not
nationwide in scope, and to the extent practical will focus on
situations where EPA can make ``no effect'' decisions.
---------------------------------------------------------------------------
* Editor's note: the document referred to is retained in Committee
file.
Question 2. Please provide this Committee with examples of
registration decisions, other than those related to biotechnology,
where EPA has intentionally delayed its approval until after another
Federal agency takes action on the crop associated with a pesticide's
use pattern.
Answer. While we are not aware of any other actions where the EPA's
decision rested on another Federal agency taking action first, there
have been circumstances where the EPA determined that consultation with
another Federal agency would improve the decision making for a
particular registration application. The new active ingredient decision
for the antibiotic kasugamycin is an example of a non-biotechnology
registration decision in which the EPA consultation with other Federal
agencies was a contributing factor in the need to renegotiate the PRIA
due date. To better understand the potential for bacterial resistance
resulting from pesticidal use of the antibiotic, the EPA consulted with
both the Centers for Disease Control and the Food and Drug
Administration.
Questions Submitted by Hon. Dan Newhouse, a Representative in Congress
from Washington
Question 1. Last year, a Federal judge in Washington State ruled
several dairies in my district were culpable of ``open dumping'' of
manure under the Resources Conservation and Recovery Act--commonly
referred to as RCRA--based solely on escalated nitrate levels in nearby
wells. This is unprecedented for a number of reasons, but primarily
that nitrates were ruled as a ``solid waste'' under RCRA. Especially
given that EPA's regulations under RCRA find the definition of solid
waste, ``does not apply to agricultural wastes, including manures and
crop residues, returned to the soil as fertilizers or soil
conditioners.'' While there are environmental laws our nation's dairies
are subject to--and that's a good thing--it seems clear to me that RCRA
was not intended to be one of them. Administrator McCarthy, I would be
interested to know if EPA has any desire or intent to revisit the
regulations promulgated under RCRA based on this judge's misguided
decision?
Answer. The EPA has no current plans to develop or issue
regulations under the resource Conservation and Recovery Act related to
animal feeding operations.
Question 2. In the dairy RCRA decision, the judge said of USDA's
Natural Resource and Conservation Service (NRCS) manure lagoon
construction standards, that, ``even assuming the [manure] lagoons were
constructed pursuant to NRCS standards, these standards specifically
allow for permeability and, thus, the lagoons are designed to leak.''
This is another reason why take such exception with this judge's
decision, because in my experience in agriculture, I know that NRCS is
the gold standard in technical assistance to farmers. Briefly, and
generally, I was wondering if you could give your thoughts on NRCS and
your Administration's relationship with them. Do you have confidence in
NRCS standards?
Answer. The EPA supports the goals of USDA's Natural Resources
Conservation Service waste treatment lagoon standards providing that
lagoons should be constructed, operated and maintained without
polluting air or water resources; that additional measures should be
considered to prevent a sudden breach or accidental release into
surface water bodies, riparian areas, and critical habitat; and that
additional measures of safety should be taken to prevent lagoon seepage
into underlying shallow aquifers or aquifers that provide domestic
water supplies.
Question 3. Administrator McCarthy, as you are aware, Section 7 of
the Endangered Species Act directs EPA to consult with Fish and
Wildlife Services if a proposed action may impact an animal or plant
listed as endangered. Over the past several years, EPA has been the
target of lawsuits claiming it has failed to consult with Fish and
Wildlife or the National Marine Fisheries Service on pesticide
registration. In recent years, I understand your Agency has been
working with the Services on implementing a collaborative approach, and
is piloting that approach on a handful of active pesticide ingredients
undergoing review. While I appreciate that EPA is now trying to meet
its consultation requirements, I am concerned that the initial draft
reviews for the first three active ingredients considered under this
pilot are approximately 3,000 pages each. How do you expect this work
to be productive or helpful to manufacturers, the farmers that use
these products, or the species it's supposed to be protecting?
Answer. The EPA acknowledges there is a large amount of information
posted in support of the pilot biological evaluations (BEs) for
chlorpyrifos, diazinon and malathion. However, the background
information that has been made available is the basis for the EPA's
effects determination for all threatened and endangered species and
designated critical habitat in the United States. The main sections,
which include the problem formulation and exposure and effects
characterization, are approximately 250-350 pages, and the remaining
appendices and attachments include supplemental information that
interested parties can refer to if they wish to see the underlying data
for our analysis.
The EPA released the draft BEs for these three pesticides on April
6, 2016. On May 5, 2016, the EPA, Fish and Wildlife Service (FWS),
National Marine Fisheries Service (NMFS), and USDA held a public
webinar for all external stakeholders to discuss the process and
interim scientific methods used to make effects determinations for the
three pilot chemicals, including a roadmap on how to navigate the
various sections, appendices, and attachments of the draft BEs. There
were 189 attendees for the webinar.
The agencies recognize the need for further refinement of the
interim scientific methods including an early screening step that
effectively allows for a focus of resources on ESA-listed species and
designated critical habitat where exposure to pesticides is likely to
result in adverse direct and indirect effects. In addition, on June 29
and 30, 2016, the agencies held a 2 day workshop to offer a forum for
stakeholder suggestions for refining some of the interim scientific
methods used in the draft BEs: 105 attended the workshop in person and
58 more over the phone.
Question 4. In the 2014 Farm Bill, there was a requirement
directing the EPA, Fish and Wildlife, and National Marine Fisheries
provide two reports updating our Committee on the progress of
developing a workable approach on collaborative ESA consideration in
pesticide registration. We did receive one of those reports in November
2014, but the second one is long overdue. Do you have a sense of when
we might expect that next report?
Answer. The agencies are currently working on the second Report to
Congress and expect to provide this final report by the end of 2016.
Question 5. Administrator McCarthy, you testified at the hearing
that EPA is working closely with the businesses and the regulated
community on how Washington State's new water quality standards will be
implemented. However, it was my understanding that, the regional
administrator and regional manager for the Office and Water and
Watersheds told a broad coalition of business and industry early in the
process that EPA was unwilling to negotiate the fish consumption rate
or cancer risk level. Can you tell me specifically what has EPA done to
work with the regulated communities in Region 10 and Maine on human
health criteria?
Answer. The EPA has met with industry representatives (as well as
environmentalists, Tribes, and local governments) on many occasions to
discuss water quality standards designed to protect public health in
the Pacific Northwest. Additionally the EPA Region 1 Regional
Administrator held an open conference call for interested stakeholders
to discuss Maine WQS in February 2015. In all of these discussions, the
EPA has been clear that it is our preference that states develop water
quality standards to protect the state's designated uses for its waters
(e.g., fishing, swimming) using the best available science.
Question 6. For thirty years or more, EPA, FDA, and the best
available science have concluded that there is essentially no
additional risk of cancer at exposures based on risk levels of 10-
\6\ as applied to the exposure of the general population (in the
case of water quality standards a fish consumption rate) as long as the
average consumption rate for more high exposed populations does not
create a risk of more than 10-\4\. What scientific human
health research has EPA developed or relied on to conclude that in
Maine, Oregon, Idaho and Washington that high Tribal consumption rates
must be protected to 10-\6\?
Answer. The EPA encourages states to consider local and regional
data when it is available in developing water quality standards that
protect the uses of its waters such as for fishing. In many areas of
the country, such as in Maine, Oregon, Idaho and Washington, Tribes
have protected treaty rights that provide for reserved fishing rights.
Additionally local and regional data show that these Tribal members
consume much more fish. In Maine, the Wabanaki study shows rates of
Tribal fish consumption from 286 grams per day to over 500 grams per
day. In the northwestern states there are several fish consumption
surveys that show that Tribal fish consumption rates over 1,000 grams
per day. To provide for the Federal treaty rights of these Tribal
members, the EPA expects states to consider these site-specific higher
fish consumption rates as well as a 10-\6\ cancer risk.
Question 7. EPA and other Federal agencies have long considered
standards that protect within the range of risk levels of 10-
\6\ to 10-\4\ to represent a de minimis risk of
incurring cancer. What scientific research has EPA developed or relied
on to conclude that 10-\6\ is now an upper bound risk level
for the protection of public health?
Answer. The EPA considers 10-\6\ as a de minimis risk
level but allows states to choose higher risk levels to protect their
populations. However, treaties in Washington envision fish free from
contaminants. To comply with these Tribal treaty rights, 10-
\6\ is a close approximation of a de minimis level of risk. The
10-\6\ risk level is appropriate when the EPA or states take
treaty rights into consideration when developing water quality
standards.
Question 8. EPA has stated numerous times over many
Administrations--including in its 2000 Human Health Methodology--that
there is no real difference between 10-\6\ and 10-
\5\ in terms of risk management, as long as more highly exposed
populations are protected to 10-\4\. It is easy to
understand why, as it is the difference between a theoretical
additional risk of one millionth of a percent (0.000001%) and one
hundred thousand of percent (0.00001%). Even at a risk level of
10-\4\, the additional risk over an entire lifetime is an
additional on ten thousandth of a percent (0.0001%). This is why
Federal agencies, including EPA, have long considered these risk levels
to represent the equivalent of no additional risk of additional
cancers. If EPA applied its current and long-standing risk management
guidance to Washington State, we would expect no new cases of cancer
based on exposure to waters meeting the standards. Imposing more
stringent risk management levels, reinventing a new zero, would provide
no additional benefit to public health. What scientific research has
EPA developed or relied on to conclude that risk levels of 10-
\6\ and 10-\5\ no longer represented essentially the
same level of risk? What scientific research has EPA developed or
relied on to conclude that water quality standards now require a more
stringent application of risk levels in developing water quality
standards?
Answer. The EPA's use of a 10-\6\ cancer risk level is a
risk management decision, which EPA considers appropriate for the
general population. It is important to note that when developing the
2000 Human Health Methodology for deriving numeric water quality
criteria, identified in your question, we undertook a review of
language from other agency mandates (e.g., The Clean Air Act, the Food
Quality Protection Act) and believe the target of a 10-\6\
risk level is consistent with agency-wide practice. While the
Methodology presents a range of acceptable cancer risk levels for the
general population, states and authorized Tribes are specifically
encouraged to consider highly exposed population groups when
determining a protective cancer risk level including, in the case of
the State of Washington, taking into account the important principles
of treaty rights and environmental justice.
Question 9. Throughout the Pacific Northwest, background
concentrations of PCBs and Arsenic exceed the criteria EPA has proposed
for Washington State, and the criteria that EPA has advised in comments
should be developed by Idaho and Washington. Can EPA provide an
analysis of impact its proposed PCB and arsenic criteria would have on
section 303(d) listings of impaired water bodies, and what those
listings would mean under the prohibition of new expanded discharge
until the criteria are met? Can EPA provide an economic impact analysis
of the impact its proposed PCB criteria will have on private and public
facilities that hold NPDES permits and on permitted storm water
discharges?
Answer. The EPA evaluated the potential costs to NPDES dischargers,
and the potential for incremental water body impairments, associated
with state implementation of the EPA's proposed criteria. This analysis
is contained in the record for the EPA's proposed rule for the State of
Washington. Since the proposed rule was published, the EPA obtained
additional water quality monitoring data from the State Department of
Ecology's Environmental Information Management database for PCBs and
will identify additional potential incremental impairments, if any, in
any revised economic analysis that the EPA develops for the State of
Washington.
Question 10. The economic impact analysis EPA provided with its
proposed rule in Washington State represents that there was no surface
water data that indicated ambient concentrations of PCBs above the EPA
proposed criteria. The Washington State Department of Ecology has
published studies showing that all of Puget Sound and its major
tributaries, including the Strait of Juan de Fuca, have PCB levels
above the EPA proposed criteria. Can EPA explain why this data was not
considered in its economic impact analysis? Has EPA identified
treatment technologies that can achieve the proposed PCB criteria? If
so, what does it cost to install and operate those technologies?
Answer. Since preparing the economic analysis for the proposed
rule, the EPA has obtained additional PCB monitoring data and will
analyze these data and report the potential incremental impairment
results, if any, in any revised economic analysis that the EPA develops
for the State of Washington. Currently, the quantification limit in the
State of Washington for PCBs is 0.1 mg/L, which is several orders of
magnitude greater than the proposed revised criteria of 0.0000073 mg/L
for freshwater and marine waters.
Question 11. EPA's scientists have consistently stated that a
Probabilistic Risk Assessment (PRA) approach represent the more
advanced and better scientific approach to risk assessment. Why isn't
EPA using a PRA approach to develop water quality criteria and other
standards? Does the Agency have plans to move to that approach,
considering its commitment to using the best science, and if so, when
would that take place?
Answer. The EPA is evaluating current probabilistic risk assessment
approaches to water quality standards in the literature. As of now, no
states have submitted human health criteria based on such an approach.
Question Submitted by Hon. Trent Kelly, a Representative in Congress
from Mississippi
Question. Three years ago, a coalition of Mississippi beekeepers
and farmers came together to identify how they could work
collaboratively and do their part in tackling some of the bee health
concerns. After numerous meetings and conversations this group
ultimately concluded that agricultural pesticide exposure had little
impact on honeybee health in Mississippi but instead factors like
Varroa mites and the diseases they carry were much bigger issues, which
need to be addressed. However, this coalition did acknowledge that
communication between beekeepers and farmers would further reduce the
risk of pesticide exposure and the group decided to launch a voluntary
effort called the Mississippi Bee Stewardship Program. The goal of this
program was to enhance communication and cooperation between our
state's beekeepers and agricultural pesticide applicators. This
stewardship program encompasses a pragmatic set of best management
practices which deal with things like hive placement on the farm,
identification of hive locations, and pesticide applicators being aware
of the presence of foraging bees. A ``bee awareness'' flag was even
designed to help people on the farm know where bees are located. This
program has energized the agricultural industry is Mississippi and has
created a more cooperative environment among beekeepers and farmers.
The coalition I referred to earlier is now in the process of conducting
assessments to determine the effectiveness of the enhanced
communication with the hope that it has reduced and will continue to
reduce pesticide exposure to bees.
Last summer, the White House commissioned a Federal Task Force to
focus on developing policy initiatives that would lead to improved
pollinator health. Among the initiatives highlighted in the Task
Force's report, included efforts to deal with habitat loss and
additional research on pollinator parasites and diseases, and more
local efforts to manage relationship between farmers and beekeepers,
which was the interest in supporting the development of ``state managed
pollinator protection plans.'' The Mississippi Bee Stewardship Program
has been held up nationally as a model of the desired state management
plan approach and our state's department of agriculture should
commended for taking this more flexible approach that collaboration
rather than going in a more prescriptive, one-size-fits-all, direction.
Unfortunately, following the greater sense of good will and
collaboration that was formed between beekeepers and farmers through
the development of the Mississippi Bee Stewardship Program, recent
actions by EPA in regard to key chemistries that farmers rely upon
(Sulfoxaflor, or Tranform') and further attacks on
imidacloprid and seed treatments are beginning to undermine those
relationships. Growers and beekeepers in Mississippi thought that they
had addressed their pesticide/managed pollinator issues and could see
the path forward but now I am hearing about concerns from many of my
farm constituents about losing or diminished access to key pesticide
products due to EPA's interest in protecting managed honeybees.
These products are vital to the protection against devastating
pests that threaten farmers' crops and livelihood. The announcements
and proposals from EPA are creating concerns in the relationships
between farmers and beekeepers and will result in less collaboration in
the future. It is perceived that the loss of these key crop protection
products is the result of numerous lawsuits or environmental activists'
claims over the process that EPA utilizes in the data collection and
pesticide registration & review process. In addition, I am hearing from
individual beekeepers in my state that have major concerns that if the
farmers lose these key chemistries and are forced to sustain a major
economic loss, they will not have a place to host their bees on the
farms, thus creating a domino economic effect on the beekeepers as
well.
Recently, we were notified that farmers are beginning to tell
beekeepers they cannot host bees on the farm in Mississippi due to
concerns and frustrations that key products to protect their crop are
being taken away by EPA from the threats and frivolous lawsuits filed
by beekeepers and environmental groups. This is of great concern to me.
In this situation, EPA's responses to claims and pressure from a
fraction of the beekeeping industry and challenges from environmental
groups is going to ultimately harm innocent beekeepers and find them
with no farm to host their bees, driving wedge in the positive
relationships that have developed over the last several years and
impacting the beekeeper's ability to make a living.
Many of these beekeepers are not a part of the national beekeeper
groups and do not have their perspective represented or heard. What
further outreach to beekeepers that host bees on farms and farmers is
EPA planning in order to discuss these concerns?
My office would be happy to facilitate these conversations.
Answer. The question well describes the complex stakeholder
dynamics, conflicting agendas, and cautions regarding both the vocal
and silent voices that makes pollinator protection and pesticide use a
challenging issue. The EPA also understands the concern about existing
and new chemistries and their importance to both growers and
beekeepers.
The agency agrees that the Mississippi State Plan, and the work
done in Mississippi between growers and beekeepers, is a model. Indeed,
the Mississippi State Plan, the North Dakota State Plan, and several
others, were the first to demonstrate that a local response to the
issue of pollinator protection was the best way to match the needs and
resources of the local community with this issue. That work formed the
basis for developing the efforts around Managed Pollinator Protection
Plans (MP3s).
In March 2016, the EPA, in collaboration with USDA, the National
Association of State Departments of Agriculture and the Honey Bee
Health Coalition, held a 2 day symposium on MP3s. The Symposium was
designed to bring together a wide range of stakeholders in order to
share the tools, insights and relationships necessary for states,
Tribal and other stakeholders to pursue the development of MP3 plans
effectively and efficiently.
Because MP3s are locally based, reflecting those that live and work
in a state or Tribe, they serve as a forum for state and local
stakeholders to participate. The EPA has been encouraging and
emphasizing communication between growers and beekeepers as a key
component of MP3s. As another component of MP3s, the EPA and USDA are
also working with the National Integrated Pest Management (IPM) Center
to investigate and promote commodity-based, and/or local-based best
management practices that balance pollinator protection and crop
production. The National IPM Center will work with State IPM
Coordinators to identify crop/pesticide/pollinator needs and support
them through information development and dissemination.
Through continued work to evaluate and develop MP3s, the EPA
intends to support the states and Tribes in identifying their needs and
finding solutions for pollinator protection and crop production.
Questions Submitted by Hon. Suzan K. DelBene, a Representative in
Congress from Washington
Question 1. Last September, the EPA published Interim
Recommendations for environmental standards and ecolabels for use in
Federal procurement. EPA's recommendation for lumber excludes several
standards that are widely used in the United States, including the
Sustainable Forestry Initiative (SFI) and American Tree Farm System
(ATFS) standards, which represent 70% of the certified acres in the
U.S. and 95% of the certified acres in Washington State. EPA has
signaled that this recommendation is mandatory for Federal procurement.
Under what circumstances may a Federal procurement officer purchase
wood products that do not meet this FSC requirement, such as those
certified to SFI or ATFS? And, given the significant volume of
sustainably harvested timber that may be excluded from Federal
purchasing, please explain the process for EPA amending this
recommendation in the future.
Answer. Under Executive Order 13693--Planning for Federal
Sustainability in the Next Decade--the EPA issued recommendations to
assist Federal purchasers in identifying and procuring environmentally
sustainable products. The EPA's Interim Recommendation for the lumber/
wood category is based on the Department of Energy's Fiscal Year 2016
(FY16) Priority Products List.
As a result of stakeholder inquiries since the release of the
Interim Recommendation, the EPA has met and is continuing to work with
USDA and DOE's Office of Sustainable Environmental Stewardship to gain
further information. The EPA's Standards Executive is reaching out to
the Sustainable Forestry Initiative, the American Tree Farm System, and
the other forestry labels that stakeholders have requested the EPA
consider. The EPA will be in touch with these groups regarding the
agency's review of forestry labels and their alignment with the
National Technology Transfer and Advancement Act, the OMB Circular A-
119, and related Federal policies that guide the EPA's use of voluntary
consensus standards and private-sector conformity assessment
activities. In addition, the EPA continues its progress with piloting
the Guidelines for Assessing Standards and Ecolabels for Use in Federal
Procurement, and hopes that information gleaned from this process will
inform thinking related to the lumber/wood category. Finally, DOE
continues to conduct research to inform their FY16 Priority Products
List. The EPA looks forward to reviewing all of this additional data to
inform if and how the lumber/wood category of Interim Recommendations
might be revised.
The EPA has, and will continue to provide, mechanisms for public
input as we developthese recommendations. The agency issued Federal
Register Notices on the initial draft guidelines in 2014 and in March
2015 for the launch of our pilot work.\11\ Those FRNs were open to
public comment and they marked the beginning of our efforts to engage
multi-stakeholder panels whose counsel will be considered as we move to
finalize our recommendations. Further, any Federal acquisition
requirements stemming from the recommendations would include a public
comment process prior to incorporation into the Federal Acquisition
Regulations. As such, FAR Case 20 15-033 has been developed in order to
integrate the new requirements of E.O. 13693 into the FAR. All next
steps related to this case, including as to when it will be available
to the public, are viewable at http://www.acq.osd.mil/dpap/dars/
far_case_status.html.
---------------------------------------------------------------------------
\11\ Federal Register Notice, February 27, 2014, ``Draft Guidelines
for Product Environmental Performance Standards and Ecolabels for
Voluntary Use in Federal Procurement'' (79 FR 11102). [See Attachment
1] https://www.gpo.gov/fdsys/pkg/FR-2014-02-27/pdf/2014-04329.pdf.
Federal Register Notice, March 19, 2015, ``Agency Information
Collection Activities; Proposed Collection and Comment Request;
Assessment of Environmental Performance Standards and Ecolabels for
Federal Procurement'' (80 FR 14372). [See Attachment 2] https://
www.gpo.gov/fdsys/pkg/FR-2015-03-19/pdf/2015-06275.pdf.
Question 2. What actions has the EPA taken to educate organic and
conventional pesticide users about biopesticides?
Answer. The EPA is committed to encouraging the development and use
of low-risk biopesticides as alternatives to conventional chemical
pesticides. In 1994, the EPA created the Biopesticides and Pollution
Prevention Division (BPPD) and specifically focused it on raising the
profile of biopesticides and helping them get licensed. BPPD, in the
Office of Chemical Safety and Pollution Prevention--Office of Pesticide
Programs, is responsible for regulatory activities associated with
biologically-based pesticides, and is recognized as the international
authority on biopesticides. In partnership with USDA and the IR-4
Specialty/Minor Crop Project at Rutgers University, the EPA supported
88 projects through the Biopesticide Demonstration Grant Program. From
2004-2010, the program invested more than $1.3 million to research the
efficacy of biopesticides for specialty and minor crops.
The EPA is actively working with growers and grower organizations
interested in using biopesticides. Our intent is to ensure growers have
the information they need to incorporate biopesticides into their pest
management programs.
In recent years, the EPA has attended several food producer and
marketer meetings that have included representatives of small fruit and
vegetable growers. The EPA is establishing relationships with these
stakeholders to provide them with information on the benefits offered
by biopesticides.
Additionally, the EPA is implementing a biopesticide strategy that
includes developing case studies on biopesticide successes, especially
instances in which biopesticides have offset conventional pesticide use
without negatively impacting grower costs.
Question 3. As the number of biopesticide registration actions has
increased, has EPA directed any additional resources to the
Biopesticide and Pollution Prevention Division? What steps has EPA made
or is EPA planning to take to ensure biopesticide Pesticide
Registration Improvement Act (PRIA) timeframes are met and to reduce
the number of biopesticide renegotiations?
Answer. In recent years, the EPA has provided additional staffing
resources to help address the growing number of registration requests
for biopesticides.
Over the past 5 years, the EPA reduced the renegotiation rate from
61.6 percent in Fiscal Year (FY) 2010 to 18 percent in FY 2015. At this
point in FY 2016, the renegotiate rate is approximately 14.6 percent,
which is lower than the rate for conventional pesticides. We have
achieved these reductions through a number of measures:
More thorough screening of applications upon submission to
ensure that they meet the outlined criteria for completeness at
the beginning of the review process;
Identification of registration package deficiencies early in
the review process. This allows time for companies to fix
packages without having to renegotiate; and
At industry's request, providing training seminars for
registrants and consultants to help ensure packages are
submitted correctly.
Questions Submitted by Hon. Sean Patrick Maloney, a Representative in
Congress from New York
Question 1. Currently, hundreds of residents in my district lack
access to a clean water source as a result of contaminated groundwater
from the Hopewell Precision superfund site. Thankfully, after years of
effort, a solution is at hand. The EPA is working with stakeholders to
finalize the design of infrastructure that will connect the impacted
homes to a viable water source. I appreciate the real progress that
we've made on this issue, and want to recognize EPA Region II
Administrator Judith Enck for her tireless work on this. Ultimately
though, successful completion of the project will require funding from
the EPA.
I ask you that you fully fund this project, and do all you can to
ensure that those impacted finally get the access to a clean water
source. I also ask that you work with my office on this priority, and
let me know how I can help make sure this gets done.
Answer. The EPA anticipates the decision to fund the site should be
made this fiscal year. While the costs of the entire cleanup of the
Hopewell Precision Site will not be fully funded this year, it is
anticipated that the full cost of the cleanup will be funded over
several budget cycles which will not impact the multi-year schedule for
completion. The first stage of work is hiring a contractor, which will
take several months from the initiation of funding.
Question 2. As you know, the EPA has been overseeing General
Electric's work to remove Polychlorinated biphenyls (PCBs) from the
Hudson River. I appreciate the significant progress that the EPA and GE
have made in this effort in the last few years. But I am concerned that
unless further action is taken there is a significant risk that an
unacceptable level of PCBs could remain in the Hudson.
In December 2015, my office helped to facilitate a meeting between
the EPA and local stakeholders to address those concerns. I appreciate
that the EPA took the time to meet with us. I was extremely gratified
to see the EPA announce in the wake of the meeting its intent to
conduct an expedited 5 year review of the Hudson River, to determine
what further actions will be necessary.
Can you please confirm that the EPA still plans on conducting an
expedited 5 year review? If so, what is the anticipated timeline? I ask
that you ensure that the review occurs in a manner that allows for a
thorough, science-based approach. Successful completion of this review
is vital to ensuring the long-term health of the Hudson River and its
watershed.
I also ask that you meet with me and local stakeholders so we can
speak with you about this issue and share with you our thoughts on how
we can best cooperate on the shared goal of a clean, healthy Hudson
River.
Answer. The second 5 year review for the site is underway and is
being conducted in accordance with the EPA guidance. The EPA is working
closely with all stakeholders to ensure a thorough and unbiased 5 year
review. The stakeholders, including the Federal trustees, New York
State Department of Environmental Conservation and Department of
Health, and representatives of the Community Advisory Group (including
non-governmental organizations) were invited by the EPA to participate
on the Five Year Review team. Five Year Review team meetings are being
held monthly through the fall.
[attachment 1]
Federal Register
Vol. 79, No. 39
Thursday, February 27, 2014
Notices
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2013-0579; FRL-9906-98]
Draft Guidelines; Product Environmental Performance Standards and
Ecolabels for Voluntary Use in Federal Procurement; Reopening of
Comment Period
agency: Environmental Protection Agency (EPA).
action: Notice; reopening of comment period.
summary: EPA issued a notice in the Federal Register issue of
November 27, 2013, concerning public review and comment on draft
guidelines with a potential approach for using nongovernmental product
environmental performance standards and ecolabels in Federal
purchasing. This document reopens the comment period for two months,
until April 25, 2014. The Agency received several requests to extend
the comment period to allow more time for stakeholder review,
collaboration, and response.
dates: Comments, identified by docket identification (ID) number
EPA-HQ-OPPT-2013-0579, must be received on or before April 25, 2014.
addresses: Follow the detailed instructions as provided under
addresses in the Federal Register document of November 27, 2013.
for further information contact: Alison Kinn Bennett, Pollution
Prevention Division (7409M), Office of Pollution Prevention and Toxics,
Environmental Protection Agency, 1200 Pennsylvania Ave. NW.,
Washington, D.C. 20460-0001; telephone number: (202) 564-8859; e-mail
address: [email protected].
supplementary information: This document reopens the public comment
period established in the Federal Register issue of November 27, 2013
(78 FR 70938) (FRL-9394-7). In that document, EPA announced for public
review and comment draft guidelines intended to provide a transparent,
fair, and consistent approach to using nongovernmental product
environmental performance standards and ecolabels in Federal
purchasing, consistent with Federal standards policy and sustainable
acquisition mandates. These draft guidelines have been developed in
response to requests via a wide variety of stakeholder engagement
channels from suppliers, manufacturers, environmental organizations,
Federal purchasers, and other stakeholders over the last several years.
EPA is hereby reopening the comment period to April 25, 2014.
To submit comments, or access the docket, please follow the
detailed instructions as provided under addresses in the November 27,
2013 Federal Register document. If you have questions, consult the
person listed under for further information contact.
List of Subjects
Environmental protection, Ecolabels, Government procurement,
Guidelines, Standards.
Dated: February 20, 2014.
Wendy C. Hamnett, Director, Office of Pollution Prevention and
Toxics.
[FR Doc. 2014-04329 Filed 2-26-14; 8:45 a.m.]
BILLING CODE 6560-50-P
[attachment 2]
Federal Register
Vol. 80, No. 53
Thursday, March 19, 2015
Notices
ENVIRONMENTAL PROTECTION AGENCY
[EPA-HQ-OPPT-2014-0838; FRL-9923-58]
Agency Information Collection Activities; Proposed Collection and
Comment Request; Assessment of Environmental Performance Standards and
Ecolabels for Federal Procurement
agency: Environmental Protection Agency (EPA).
action: Notice.
summary: In compliance with the Paperwork Reduction Act (PRA), this
document announces that EPA is planning to submit an Information
Collection Request (ICR) to the Office of Management and Budget (OMB).
The ICR, entitled: Assessment of Environmental Performance Standards
and Ecolabels for Federal Procurement, and identified by EPA ICR No.
2516.01 and OMB Control No. 2070--new, represents a new request. Before
submitting the ICR to OMB for review and approval under the PRA, EPA is
soliciting comments on specific aspects of the proposed information
collection that is summarized in this document. The ICR and
accompanying material are available in the docket for public review and
comment. EPA is also announcing the testing of draft guidelines and a
pilot project on an assessment approach for recognizing product
environmental performance standards and ecolabels for Federal
procurement in the following three categories: Furniture, building
flooring, and building paints/coatings/removers. An additional purchase
category may be piloted, depending on available resources and other
considerations. EPA is seeking comment on the criteria/qualifications
that will be used for the selection of the multi-stakeholder panel
members, who will refine the draft guidelines for specific sectors. In
addition, EPA is seeking volunteer standards development organizations
and ecolabel programs to be assessed per the draft guidelines.
dates: Comments on multi-stakeholder panel member criteria/
qualifications must be received on or before April 20, 2015.
Expressions of interest to participate in the pilot and comments on the
ICR must be received on or before May 18, 2015.
addresses: Submit your expressions of interest to participate in
the pilot and comments on the ICR and multi-stakeholder panel member
criteria/qualifications, identified by docket identification (ID)
number EPA-HQ-OPPT-2014-0838, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not
submit electronically any information you consider to be
Confidential Business Information (CBI) or other information
whose disclosure is restricted by statute.
Mail: Document Control Office (7407M), Office of Pollution
Prevention and Toxics (OPPT), Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, D.C. 20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://
www.epa.gov/dockets.
for further information contact:
For technical information contact: Julie Shannon, Chemistry,
Economics, and Sustainable Strategies Division (7409M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW., Washington, D.C. 20460-0001; telephone number:
(202) 564-8834; e-mail address: [email protected].
For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address: [email protected].
supplementary information:
I. Testing of Updated Draft Guidelines
In the Federal Register of November 27, 2013 (78 FR 70938) (FRL-
9394-6), EPA issued for public comment draft guidelines for product
environmental performance standards and ecolabels for voluntary use in
Federal procurement. EPA's goal in developing these draft guidelines is
to create a ``transparent, fair, and consistent approach to selecting
product environmental performance standards and ecolabels to support
the Agency's mission and Federal sustainable acquisition mandates.''
The fundamental aim of the draft guidelines is to establish a cross-
sector framework to be used in recognizing non-governmental
environmental standards (and consequently, environmentally preferable
products meeting these standards) for use in Federal procurement.
The draft guidelines include four sections:
1. Guidelines for the process for developing standards refers to the
procedures used to develop, maintain, and update an
environmental standard.
2. Guidelines for the environmental effectiveness of the standards
refers to the criteria in the environmental standard or
ecolabel that support the claim of environmental
preferability.
3. Guidelines for conformity assessment refers to the procedures and
practices by which products are assessed for conformity to
the requirements specified by standards and ecolabeling
programs.
4. Guidelines for Management of Ecolabeling Programs refers to the
organizational and management practices of an ecolabeling
program.
EPA has responded to public comments and released a new version of
the ``Guidelines for the Environmental Effectiveness of the Standards''
at http://www.epa.gov/draftGuidelines/responses.html. The majority of
public comments supported EPA undertaking--with key external entity and
stakeholder participation--additional work to further refine the draft
guidelines and test a potential approach to assessing standards and
ecolabels. Therefore, in this next phase of work, EPA is contracting
with an entity to convene a coordinating Governance Committee, product
category-specific multi-stakeholder panels, and independent assessment
entity(ies) to develop and pilot test an approach in three product
categories: Furniture, building flooring, and building paints/coatings/
removers. These sectors were chosen because they meet some or all of
the following criteria:
Potentially significant environmental and/or human health
impact (based on lifecycle assessments and hazard and risk
assessments).
Opportunity for environmental and/or human health
improvement through private sector standards/ecolabels.
Significant volume of Federal purchases.
Current Federal sustainable acquisition mandates in the
category are limited, out-of-date, and/or could be augmented
with private sector standards.
An additional to-be-determined purchase category may be piloted,
depending upon available resources and other considerations. In
addition, due to significant interest, EPA will explore the potential
for the draft guidelines to apply to service sector standards and
ecolabels (e.g., services related to building maintenance, cafeterias,
and professional consultants, among others). The potential pilot for
this sector would not assess service sector standards; rather the
analysis and recommendations could potentially position the draft
guidelines to accommodate such assessments in 2016 and beyond.
II. Opportunity To Participate in a Pilot
Standards development organizations, ecolabel programs, and
certification entities that have product environmental performance
standards and/or ecolabels that cover one or more of the three product
categories, and could be considered for use in Federal procurement per
E.O. 13514, entitled: Federal Leadership in Environmental, Energy, and
Economic Performance (74 FR 52117, October 8, 2009), the Federal
Acquisition Regulation (FAR) (48 CFR 23.103), and Federal Government
standards policy, should consider submitting those standards and
ecolabels for assessment as a part of the pilot project.
Those standards and ecolabels assessed will provide information per
product-category specific checklists (based on the draft guidelines),
to be developed by multi-stakeholder panels, as described at http://
www.epa.gov/epp/draftGuidelines/pilot.html. Each purchase category
panel shall include a balanced group of relevant stakeholders in the
environmental and human health performance standards and ecolabels
space and ensure an objective, open, and consensus-driven process and
credible results. The stakeholder types that may be represented on the
multi-stakeholder panels include, but are not limited to:
Standards development organizations.
Ecolabel program managers/system owners.
Conformity assessment bodies.
Federal purchasers.
Other large institutional purchasers such as state
governments or universities.
Manufacturers and/or vendors in the product categories
targeted for assessment.
Professional societies, users groups, and industry
consortia.
Research and development organizations and academia.
Non-governmental organizations widely respected for their
work on public health, environmental protection, and
sustainability issues.
Federal Government agencies knowledgeable in conformity
assessment.
EPA is seeking input from the public regarding the multi-
stakeholder panel member criteria/qualifications. EPA proposed the
following:
Knowledge of the environmental and/or human health impacts
of the particular product category.
Experience working with diverse stakeholders towards
consensus.
Familiarity with the draft Guidelines and Federal
sustainable acquisition mandates.
Familiarity with standards development and conformity
assessment approaches.
Ability to devote the necessary time to the panel (including
one meeting and regular conference calls).
Willingness to sign a conflict of interest disclosure form.
III. Information Collection Request (ICR)
A. What comments are sought on the ICR?
Pursuant to the PRA section 3506(c)(2)(A) (44 U.S.C.
3506(c)(2)(A)), EPA specifically solicits comments and information to
enable it to:
1. Evaluate whether the proposed collection of information is
necessary for the proper performance of the functions of
the Agency, including whether the information will have
practical utility.
2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the
validity of the methodology and assumptions used.
3. Enhance the quality, utility, and clarity of the information to
be collected.
4. Minimize the burden of the collection of information on those who
are to respond, including through the use of appropriate
automated electronic, mechanical, or other technological
collection techniques or other forms of information
technology, e.g., permitting electronic submission of
responses.
In particular, EPA is requesting comments from very small
businesses and nonprofit organizations (those that employ less than 25)
on examples of specific additional efforts that EPA could make to
reduce the paperwork burden for very small businesses and nonprofit
organizations affected by this collection.
B. What information collection activity or ICR does this apply to?
Title: Assessment of Environmental Performance Standards and
Ecolabels for Federal Procurement.
ICR number: EPA ICR No. 2516.01.
OMB control number: OMB Control No. 2070--New.
ICR status: This ICR is for a new information collection activity.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the Code of Federal Regulations (CFR), after appearing
in the Federal Register when approved, are listed in 40 CFR part 9, are
displayed either by publication in the Federal Register or by other
appropriate means, such as on the related collection instrument or
form, if applicable. The display of OMB control numbers for certain EPA
regulations is consolidated in 40 CFR part 9.
Abstract: EPA is engaging in this collection pursuant to the
authority in the Pollution Prevention Act (42 U.S.C. 13103(b)(11)),
which requires EPA to ``Identify opportunities to use Federal
procurement to encourage source reduction'' and section 12(d) of the
National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272
note), which requires Federal agencies to ``use technical standards
that are developed or adopted by voluntary consensus standards bodies,
using such technical standards as a means to carry out policy
objectives or activities.'' Federal agencies need this assessment per
the draft guidelines to determine which, among sometimes dozens of
private sector standards within a single purchase category, are
appropriate and effective in meeting Federal procurement goals and
mandates.
Federal agencies must comply with the following sustainability-
related purchasing mandates: Section 2(h) of E.O. 13514; section 6002
of the Resource Conservation and Recovery Act (42 U.S.C. 6002); section
9002 of the Farm Security and Rural Investment Act (7 U.S.C. 8102); the
Energy Policy Act (42 U.S.C. 13201 et seq.); section 2(d) of E.O.
13423, entitled: Strengthening Federal Environmental, Energy, and
Transportation Management (72 FR 3919, January 26, 2007); and the FAR,
including 48 CFR part 23, entitled: Environment, Energy and Water
Efficiency, Renewable Energy Technologies, Occupational Safety, and
Drug-Free Workplace (see http://www.whitehouse.gov/omb/
procurement_index_green).
Via NTTAA, Federal agencies are required to ``use technical
standards that are developed or adopted by voluntary consensus
standards bodies, using such technical standards as a means to carry
out policy objectives or activities,'' except when an agency determines
that such use ``is inconsistent with applicable law or otherwise
impractical.'' OMB Circular A-119, entitled: Federal Participation in
the Development and Use of Voluntary Consensus Standards and in
Conformity Assessment Activities, reaffirms Federal agency use of non-
governmental standards in procurement.
While Federal purchasing policy is clear for the several standards
and ecolabels that are listed in statute, regulation, or Executive
Order, the lack of independently assessed information about and Federal
guidance on using other product environmental performance standards and
ecolabels often results in an inconsistent approach by Federal
purchasers and confusion and uncertainty for vendors and manufacturers.
Burden statement: The annual public reporting and record-keeping
burden for this collection of information is estimated to average 8.5
hours per response. Burden is defined in 5 CFR 1320.3(b).
The ICR, which is available in the docket along with other related
materials, provides a detailed explanation of the collection activities
and the burden estimate that is only briefly summarized here:
Respondents/Affected Entities: Entities potentially affected by
this ICR are standards development organizations, ecolabeling programs,
and environmental certification entities.
Estimated total number of potential respondents: 20.
Frequency of response: Once during 2015 pilot; and, a to-be-
determined frequency depending upon learnings from the pilot.
Estimated total average number of responses for each respondent: 2.
Estimated total annual burden hours: 340 hours.
Estimated total annual costs: $24,711.20 for burden hours, and $0
estimated costs for capital investment or maintenance and operational
costs.
C. What is the next step in the process for this ICR?
EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to
announce the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the technical person listed under
for further information contact.
Authority: 44 U.S.C. 3501 et seq.
Dated: March 11, 2015.
James Jones, Assistant Administrator, Office of Chemical Safety and
Pollution Prevention.
[FR Doc. 2015-06275 Filed 3-18-15; 8:45 a.m.]
BILLING CODE 6560-50-P
[attachment 3]
[https://www.epa.gov/pesticide-reevaluation/registration-review-
schedules]
Registration Review Schedules
Through the Pesticide Registration Review program (https://
www.epa.gov/pesticide-reevaluation/registration-review-process), EPA
reviews all registered pesticides at least every 15 years, as mandated
by the Federal Insecticide, Fungicide, and Rodenticide Act.
EPA always strives to base its decisions on the best available
sound science. However, science is constantly evolving, and new
scientific information can come to light at any time and change our
understanding of potential risks from pesticides. The review of new
data could potentially prolong the risk assessment and decision-making
process and change this schedule.
Below is a schedule of the status of different pesticides
undergoing the registration review process. This schedule is subject to
change based on shifting priorities and is intended to be a rough
timeline. The schedule will be updated regularly to reflect any
timeline changes, and to include anticipated deliverables for later
dates.
Explanation of List
The registration review process (https://www.epa.gov/pesticide-
reevaluation/registration-review-process#process%20components)
includes:
Docket Openings (https://www.epa.gov/pesticide-reevaluation/
registration-review-docket-opening-schedule).
Draft Risk Assessments (https://www.epa.gov/pesticide-
reevaluation/registration-review-process#case%20development).
Proposed Interim Decisions/Proposed Decisions (https://
www.epa.gov/pesticide-reevaluation/registration-review-
process#decision).
Interim Decisions/Decisions (https://www.epa.gov/pesticide-
reevaluation/registration-review-process#decision).
EPA commits to an open and transparent process by accepting public
comments at most stages of the process. These are collected in each
chemical's docket at www.regulations.gov and all comments submitted
will be accounted for in the Agency's regulatory decisions for each
chemical.
The schedule is also categorized by the fiscal year's (FY)
quarters. Please note the following timeframes:
Quarter 1 (Q1): October-December
Quarter 2 (Q2): January-March
Quarter 3 (Q3): April-June
Quarter 4 (Q4): July-September
Registration Review Schedules
Draft Risk Assessments
FY16 Quarter 3
2,4-D salts and esters
Atrazine
Carfentrazone-ethyl
Chlorethoxyfos
Copper salts
Cymoxanil
Diazinon
Kresoxim-Methyl
Linuron
Malathion
Mineral Acids
Propazine
Simazine
Spinosad/Spinetoram
FY16 Quarter 4
Acephate
Cyclanilide
Cyprodinil
Dimethomorph
Etofenprox
Fenpropathrin
Flumethrin
Glycolic acid and salts
Imiprothrin
Mepiquat chloride
Metalaxyl/mefenoxam
MGK-264
Momfluorothrin
Oxytetracycline
Phenothrin (Sumithrin)
Phosmet
Prallethrin
Pyrethrins
Tau-fluvalinate
Tefluthrin
Tetramethrin
Proposed Interim Decisions/Interim Decisions
FY16 Quarter 3
Antimycin-A
Clethodim
Flufenacet
Flurprimidol
Fosamine ammonium
Glufosinate
Lithium hypochlorite
Methoxyfenozide
Sucrose octanoate
Sulfonylurea (SU) herbicides
Bensulfuron-methyl
Chlorimuron-ethyl
Chlorsulfuron
Flazasulfuron
Foramsulfuron
Halosulfuron-methyl
Imazosulfuron
Iodosulfuron-methyl-Na
Mesosulfuron-methyl
Metsulfuron-methyl
Nicosulfuron
Orthosulfamuron
Primisulfuron-methyl
Prosulfuron
Rimsulfuron
Sulfometuron-methyl
Sulfosulfuron
Thifensulfuron-methyl
Triasulfuron
Tribenuron-methyl
Trifloxysulfuron-Na
Triflusulfuron-methyl
Tebufenozide
FY16 Quarter 4
Azoxystrobin
Boric Acid
Diquat Dibromide
Ethephon
Hexazinone
Hymexazol
Interim Decisions/Decisions
FY16 Quarter 3
Alpha-chlorohydrin
Chlorfenapyr
Cyanamide
FY16 Quarter 4
2-(Decylthio)ethanamine hydrochloride (DTEA-HCl)
Aliphatic alcohols, C1-C5
Bentazon
Propoxur
Propoxycarbazone
Sodium Acifluorofen
Thidiazuron
Contact Us (https://www.epa.gov/pesticide-reevaluation/forms/
contact-us-about-pesticide-reevaluation) to ask a question, provide
feedback, or report a problem.
[Accessed September 8, 2016]
[attachment 4]
[https://www.epa.gov/pesticide-registration/understanding-science-
behind-epas-pesticide-decisions]
Understanding the Science behind EPA's Pesticide Decisions
Science is the backbone of the EPA's decision-making. The Agency's
ability to pursue its mission to protect human health and the
environment depends upon the integrity and quality of the science on
which it relies. The environmental policies, decisions, guidance, and
regulations that impact the lives of all Americans must be grounded, at
a most fundamental level, in sound, high quality science.
The EPA regulates pesticides to ensure that they do not pose
unreasonable risks to human health or the environment. As part of that
effort, the EPA requires extensive test data from pesticide producers
that demonstrate pesticide products can be used without causing harm to
human health and the environment.
We evaluate information from all kinds of sources--pesticide
companies, other governments, academia, and the published scientific
literature. EPA scientists and analysts carefully review these data to
determine whether to register (license) a pesticide product or use and
whether specific restrictions are necessary. EPA maintains a
transparent, public process for assessing potential risks to human
health when evaluating pesticide products.
On this page:
Risk Assessment Process
Ecological Risk Assessment
Human Health Risk Assessment
Epidemiology Studies
When EPA Receives New Studies
Scientific Integrity and Transparency
Risk Assessment Process
The process EPA uses for evaluating the potential for health and
ecological effects of a pesticide is referred to as a risk assessment.
The risk assessment is crucial to the overall decision-making process
for pesticides, both new and existing. New pesticides must be evaluated
before they can enter the market. Existing pesticides must be re-
evaluated periodically to ensure that they continue to meet the
appropriate safety standard. EPA's decision-making relies on a risk
management process, which is conducted in registration for new
pesticide chemicals (https://www.epa.gov/pesticide-registration) or new
uses of existing chemicals, or reregistration or registration review in
the case of a general review of an existing chemical (https://
www.epa.gov/pesticide-reevaluation).
There are two main components to the risk assessment:
Ecological Risk Assessment
Human Health Risk Assessment
Ecological Risk Assessment
EPA conducts ecological risk assessments to determine what risks
are posed by a pesticide and whether changes to the use or proposed use
are necessary to protect the environment. Many plant and wildlife
species can be found near or in cities, agricultural fields, and
recreational areas. Before allowing a pesticide product to be sold on
the market, the EPA ensures that the pesticide will not pose any
unreasonable risks to plants, wildlife, and the environment. This is
done by evaluating data submitted in support of registration regarding
the potential hazard that a pesticide may present to non-target plants,
fish, and wildlife species. In addition, EPA reviews scientific studies
available in the open literature.
Ecological risk assessments include three phases, and are generally
conducted following the Guidelines for Ecological Risk Assessment
(https://www.epa.gov/osa/basic-information-about-risk-assessment-
guidelines-development).
Human Health Risk Assessment
A human health risk assessment process estimates the nature and
probability of adverse health effects in people who may be exposed to
chemicals in the food and water they consume or in the air they
breathe; through their work; or as a result of activities that may lead
to contact with pesticide residues on treated surfaces now or in the
future.
EPA uses the National Research Council's process for human health
risk assessments:
1. Hazard Identification: Examines whether a pesticide has the
potential to cause harm to humans and/or ecological
systems, and if so, under what circumstances.
2. Dose Response Assessment: Examines the numerical relationship
between exposure and effects.
3. Exposure Assessment: Examines what is known about the frequency,
timing, and levels of contact with a pesticide.
4. Risk Characterization: Examines how well the data support
conclusions about the nature and extent of the risk from
exposure to pesticides.
Epidemiology Studies
EPA considers epidemiology studies that are available as part of
its human health risk assessment data and actively supports the
Agricultural Health Study (https://aghealth.nih.gov/). EPA reviews the
available epidemiological information using a peer reviewed framework
with well-accepted evaluation factors that specifically consider links
between pesticide exposure and health outcomes.
Epidemiology Framework: EPA developed a framework to
incorporate epidemiology into risk assessment as one component
of our work in this area. Concepts in the framework are based
on peer-reviewed, robust principles and tools, and incorporate
improvements based on recommendations from the National
Academies' National Research Council reports on Toxicity
Testing in the 21st Century (http://www.nap.edu/catalog/11970/
toxicity-testing-in-the-21st-century-a-vision-and-a) and
Advancing Risk Assessment (http://www.nap.edu/catalog/12209/
science-and-decisions-advancing-risk-assessment). This
methodology was reviewed in 2010 by the Federal Insecticide,
Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory
Panel (SAP) (https://www.epa.gov/sap), an advisory panel of
outside experts.
EPA is beginning to implement systematic review procedures
consistent with the recommendations of EPA's Integrated Risk
Information System (IRIS) (https://www.epa.gov/iris) workshops, the
National Toxicology Program (http://ehp.niehs.nih.gov/1306711/), and
others. As this process proceeds, the EPA anticipates improved
transparency of how scientific information across a broad spectrum of
scientific disciplines are integrated into our risk assessment and
decision-making process.
When EPA Receives New Studies
EPA actively seeks out and considers new studies, and accounts for
this information in pesticide regulatory decisions. When compelling
data make it clear that regulatory action must be taken, the Agency
responds appropriately.
We look closely at every study to determine whether the results are
scientifically sound. Our analysis gives greater weight to high quality
and well documented studies and those findings confirmed by multiple
sources. Ultimately, the Agency looks at all of the studies to decide
what the preponderance of evidence shows.
EPA has practices in place and enforcement policies to help ensure
that studies represent sound science. Once studies are submitted to the
Agency, EPA scientists conduct extensive analysis of the data to ensure
that the design of the study is appropriate and that the data are
collected and analyzed accurately.
EPA uses its peer-reviewed framework (https://www.epa.gov/
pesticide-registration/understanding-science-behind-epas-pesticide-
decisions#framework) to incorporate additional epidemiological studies
into the risk assessment. Additional information on the risk assessment
process for pesticides (https://www.epa.gov/pesticide-science-and-
assessing-pesticide-risks/overview-risk-assessment-pesticide-program).
EPA guidance on the review of open literature (https://www.epa.gov/
pesticide-science-and-assessing-pesticide-risks/guidance-identifying-
selecting-and-evaluating-open).
Transparency and Scientific Integrity
At the EPA, scientific integrity is closely linked to transparency.
The Agency remains committed to transparency in its interactions with
all members of the public and has released Agency-wide principles and
policies to clarify the importance of scientific integrity:
EPA's Scientific Integrity Policy February 2012 (https://
www.epa.gov/risk/policy-epa-scientific-integrity) builds on the
EPA's long history of scientific safeguards and further ensures
that sound science drives Agency decision making.
EPA's Principles of Scientific Integrity (https://
www.epa.gov/osa/epas-principles-scientific-integrity-fact-
sheet) outlines foundational principles that promote a culture
of scientific integrity, public involvement, the use of peer
review and Federal Advisory Committees, and the development of
Agency scientists. It also establishes a Scientific Integrity
Committee to implement the Agency-wide Scientific Integrity
policy.
Annual Report on Scientific Integrity: The 2014 Annual
Report (https://www.epa.gov/osa/2014-annual-report-scientific-
integrity) highlights EPA's scientific integrity successes.
Additional information on EPA's Scientific Integrity Policies
(https://www.epa.gov/osa/basic-information-about-scientific-integrity).
Learn about EPA and the Open Government Initiative (https://
www.epa.gov/open).
Contact Us (https://www.epa.gov/pesticide-registration/forms/
contact-us-about-pesticide-registration) to ask a question, provide
feedback, or report a problem.
[Accessed September 8, 2016]
[attachment 5]
Excerpt of Revised Chlorpyrifos Human Health Risk Assessment
Appendix 6. Columbia Center for Children's Environmental Health (CCCEH)
Epidemiology Data Acquisition ``Raw Data'' Request
I. Action Requested
To fulfill identified information needs for the purposes of
incorporating the Columbia Center for Children's Environmental Health
(CCCEH) epidemiology data into the Human Health Risk Assessment (HHRA)
for chlorpyrifos, the agency sought to obtain certain ``raw data'' from
CCCEH researchers. Specifically, EPA requested the original analytic
data file used to support analyses presented in the peer-reviewed,
published epidemiology studies concerning in utero chlorpyrifos
exposure (V. Rauh, et al., 2011; V.A. Rauh, et al., 2006; Whyatt, et
al., 2004). CCCEH researchers did not agree to provide these data,
however, the researchers met with EPA and discussed the agency's
questions about the data to help determine whether further review of
the raw data might assist EPA in resolving uncertainties. As a result
of new information gathered through an on-site meeting and other
sources, EPA is no longer pursuing the request for the original
analytic data file from CCCEH researchers. This memorandum details the
new information gained that resolves or renders unobtainable the
previously identified information needs.
II. Background
EPA considers many different types of scientific information when
performing a human health risk assessment (HHRA) of pesticide exposure
in the human population. Traditionally, EPA uses toxicology, product
and residue chemistry, and industrial hygiene studies as well as
measured and modeled human and environmental exposure information to
support assessment of environmental risks. In its preparation of the
HHRA for chlorpyrifos, the agency has evaluated environmental
epidemiology studies of the potential risk of long-term
neurodevelopmental effects such as delayed motor skill acquisition or
reduced intelligence quotient (IQ) measures among children who
experienced pesticide exposure during gestational development. There
are three prospective birth cohort studies in the U.S. that examine
pesticide exposure (as well as other environmental toxicants) to the
pregnant mother and fetus, and then measure neurological and
neurodevelopmental performance in children as they grow older. EPA has
provided some of the funding support for each of these studies. Authors
hypothesize that in utero and early life exposure may influence brain
development and effect neurological functioning in children. These
studies include the CHAMACOS study in the Salinas Valley, CA, the Mt.
Sinai children's environmental health study (Mt. Sinai study), and the
Columbia Center for Children's Environmental Health (CCCEH).
The CCCEH study is the only one of the three studies that measures
maternal and fetal exposure to chlorpyrifos specifically; the other two
cohorts measure exposure to organophosphate pesticides generally.
Authors with the CCCEH study reported reduced birth weight and birth
length among neonates more highly exposed to chlorpyrifos during
gestation (as measured by cord blood concentration of chlorpyrifos)
(Whyatt, et al., 2004). Similarly, authors observed slower motor skill
acquisition and reduced mental capacity among infants who were more
highly exposed to the chemical in utero (V.A. Rauh, et al., 2006). In
2011, authors from all three birth cohort studies concurrently reported
evidence of reduced measures of intelligence (Wechslar intelligence
scale scores) by increasing in utero chlorpyrifos and/or
organophosphate exposure (M.F. Bouchard, et al., 2011; Engel, et al.,
2011; V. Rauh, et al., 2011).
Given the value of this information to the agency's HHRA for
chlorpyrifos, EPA requested the FIFRA SAP to provide external peer
review of the strengths and limitations of the epidemiology data for
use in the chlorpyrifos HHRA (FIFRA SAP September 2008 and April 2012).
The agency identified two major areas in which additional information
was needed to fully incorporate these data into the HHRA: additional
measures of environmental exposure to chlorpyrifos in the CCCEH cohort
to discern whether acetyl cholinesterase inhibition was likely to have
occurred in connection with reported adverse outcomes, and also the
role of other environmental chemicals (lead, polycyclic aromatic
hydrocarbon (PAH), other organophosphate pesticides) in the observed
adverse neurological effects reported in relation to in utero
chlorpyrifos exposure.
To fulfill these information needs for the purposes of
incorporating the epidemiology data into the chlorpyrifos HHRA, the
agency sought to obtain certain ``raw data'' from the Columbia Center
for Children's Environmental Health (CCCEH) study. Specifically, EPA
requested the original analytic data file used to support analyses
presented in the peer-reviewed, published epidemiology studies
concerning in utero chlorpyrifos exposure (V. Rauh, et al., 2011; V.A.
Rauh, et al., 2006; Whyatt, et al., 2004). CCCEH did not agree to
provide the data based upon these initial inquiries and they asserted
that because EPA did not fund the pesticide exposure component of their
cohort study EPA was not legally entitled to review their underlying
data. CCCEH did agree, however, to meet and discuss EPA's questions
about the data to help determine whether further review of the raw data
might assist EPA in resolving uncertainties. As a result on April 15,
2013, EPA scientists and CCCEH researchers held an all-day meeting at
the CCCEH data center (Mailman School of Public Health, New York City,
NY) to discuss EPA's information needs and whether acquisition of the
full analytic data would be necessary or valuable to EPA's assessment.
Addendum 1 delineates the questions EPA posed to CCCEH study staff at
this all-day meeting.
III. Resolution of Information Needs
A. Epidemiology Study Exposure Characterization
The primary rationale supporting EPA's request for ``raw data''
from the CCCEH researchers relates to the agency's need to determine
whether the levels of chlorpyrifos exposure in the environment
(apartments, apartment building or other outdoor environment, or
dietary exposure) of CCCEH study participants were above or below
levels that may elicit a greater than 10% inhibition of
acetylcholinesterase enzyme levels, the current regulatory endpoint.
During the April 2013 meeting, EPA learned that this type of
information is neither available nor obtainable. CCCEH researchers
estimated relative pesticide exposure using several different exposure
methods including 48-hour air sampling with personal monitor, 2-week
integrated stationary air monitoring, maternal urinary concentration of
TCPy (urinary metabolite of chlopryrifos) during the last trimester of
pregnancy, maternal urinary concentration of TCPy at delivery, and
umbilical cord blood and meconium at delivery. To determine whether a
significant change in acetyl cholinesterase levels may have occurred as
a result of actual environmental exposure, temporal concordance between
pesticide use and the chlorpyrifos measurement is needed, i.e.,
exposure estimation at the time of pesticide application is optimal.
The CCCEH study design did not incorporate pre- and post-pesticide use/
exposure measurement in the study protocol. Therefore, this information
was not collected and is not retrospectively obtainable.
In addition, EPA requested any additional information obtained by
researchers as to specific pesticide products used to better understand
the pattern and frequency of organophosphate pesticide use among cohort
participants. This information was solicited from participants in a
written questionnaire administered during a follow-up period
(unpublished copy of questionnaire obtained by EPA Oct. 2012). In
response to the EPA inquiry, researchers recalled that the Whyatt
(2002) publication described the challenges of collecting pesticide
product information in etiologic epidemiology studies, and in the on-
site meeting in April 2013 confirmed that the information quality in
the CCCEH written questionnaire responses is very low. This information
was deemed of such poor quality by CCCEH data analysts that the data
were not coded or entered into the analytic data file. Therefore, EPA
learned that this specific request for ``raw data'' concerning
pesticide product use is not available.
As a surrogate for this information, CCCEH researchers suggested
EPA contact the New York City Department of Health to obtain a linked
dataset of CCCEH study participant residential address and public
housing pesticide usage. The linked dataset provides aggregated
pesticide usage data at the cohort participant building-level only. EPA
has obtained and reviewed these data (June 2013) and determined that
pursuing a data reconstruction exercise is the most appropriate way to
estimate environmental pesticide exposure that would have to occur
among CCCEH study participants. EPA has conducted such analysis and
included it in the revised human health risk assessment.
B. Co-Exposure to Other Environmental Contamin[a]nts
A second major concern raised by EPA, FIFRA SAP peer reviewers, and
public commenters is the ability of the CCCEH study authors to
accurately measure and statistically model the relationship between
other environmental chemicals (lead and PAH, specifically) or other
pesticides (diazinon, propoxur) that may influence fetal brain
development and childhood neurodevelopmental performance, and also be
related to chlorpyrifos exposure (these are ``potentially confounding''
exposures). EPA's concern stems from the understanding that if these
other exposures are not sufficiently considered in the epidemiological
analysis, then an incorrect inference and conclusion may result (i.e.,
a potential false positive association). For example, prenatal and
early life exposure to lead in the environment has been causally linked
to adverse neurodevelopmental outcomes similar to those measured in the
CCCEH cohort study including intelligence measures. EPA was concerned
about the potential error in the CCCEH study if lead levels were not
appropriately considered, i.e., the apparent chlorpyrifos effect on
neurodevelopment observed in the study may have been due to the lead
exposure.
However, EPA has confirmed with study authors that lead levels and
chlorpyrifos levels in cord blood are not statistically associated in
this population. Plotting blood lead levels against cord blood
chlorpyrifos levels illustrates that the two exposures are extremely
weakly (linearly) correlated in this cohort (r<1%) (V.A. Rauh, et al.,
2006). Further, EPA learned from unpublished, supplemental analyses
performed by CCCEH researchers upon EPA request that postnatal blood
lead levels and prenatal chlorpyrifos levels are also not strongly
statistically associated (Andrews, January 21, 2013). This is plausible
because of intensive lead abatement programs on-going in New York City
during the time period of this study. According to the New York City
Department of Health, the number of children with elevated blood lead
levels declined 92% between 1995 and 2008.\75\ Therefore, because the
two exposures are not related, it is not likely that pre- or postnatal
blood lead exposure could explain the observed association with
chlorpyrifos.
---------------------------------------------------------------------------
\75\ http://www.nyc.gov/html/doh/html/data/stats-childlead.shtml.
---------------------------------------------------------------------------
Furthermore, during the April 2013 meeting CCCEH researchers
pointed out that based upon available information it appears that lead
and chlorpyrifos may affect the brain differently. It is well
understood that lead affects the neurodevelopmental sub-domain leading
to outward motivation and aggression; while research within the CCCEH
cohort indicates chlorpyrifos may affect inward motivation, information
processing and organization (V. Rauh, et al., 2011; V.A. Rauh, et al.,
2006; Wright, et al., 2008). Additionally, MRI imaging studies of lead
affected persons and preliminary brain imaging studies of chlorpyrifos
affected persons show different MRI patterns, grey matter as opposed to
white matter compositional patterns, respectively (Brubaker, Dietrich,
Lanphear, & Cecil, 2010; Brubaker, et al., 2009; Cecil, et al., 2008;
Cecil, et al., 2011; V.A. Rauh, et al., 2012). Therefore, given that
neither pre- nor postnatal lead levels and chlorpyrifos levels are not
statistically associated with one another in the CCCEH study, and the
different ways through which lead and chlorpyrifos appear to influence
neurodevelopmental domains EPA concludes that lead exposure did not
likely confound (bias or render incorrect) the observed association
between chlorpyrifos exposure and neurodevelopment in this study
population.
Peer review panelists participating on the April 2012 FIFRA SAP
panel identified the concern that authors had not fully considered the
long-term effects of polycyclic aromatic hydrocarbon (PAH) exposure, a
ubiquitous air pollutant in inner-city areas such as NYC, in the
observed association between chlorpyrifos and neurodevelopmental
outcomes. Specifically, panelist argued that `a shift in environmental
exposures over time' such that postnatal PAH exposure may have combined
with the measured in utero pesticide exposure to result in the observed
ND outcomes. During the April 2013 meeting, authors clarified that the
study design did not include a repeat measure of exposures over time,
so an analysis of postnatal PAH exposures is not possible. In the
published studies, authors were able to control for the effect of
prenatal PAH through statistical adjustment. In addition, authors
examined the possible modifying role of prenatal PAH in this
epidemiological association and did not observe any evidence of a
different risk estimate between chlorpyrifos and ND among those more
highly exposed to PAH. Concerning the role of postnatal environmental
exposures, CCCEH researchers also stated their belief that their
overall study results illustrate that it is gestational exposure, and
not early life exposure, that influences neurodevelopment in the study
population. They state that the longitudinal analyses of infant and
child neurodevelopment in relation to in utero chlorpyrifos exposure
illustrates a persistent effect of the prenatal environment (M.
Bouchard, et al., 2003; M.F. Bouchard, et al., 2011; Engel, et al.,
2007; Engel, et al., 2011; Eskenazi, et al., 2004; Eskenazi, et al.,
2007; V. Rauh, et al., 2011; V.A. Rauh, et al., 2006; Whyatt, et al.,
2004). EPA concluded that CCCEH researchers utilized best practices in
statistical analysis of epidemiological data concerning the role of
prenatal PAH in neurodevelopmental outcomes, and that a study of
repeated, postnatal PAH exposure was beyond the scope of the current
CCCEH study, and would require a follow-up study not yet undertaken.
EPA was also interested to learn more about the co-exposure to
other organophosphate pesticides among CCCEH study participants.
Specifically, EPA as well as external peer review panelists noted the
uncertainty as to the degree to which exposure to multiple acetyl
cholinesterase inhibiting pesticides exposures over time and/or
concurrent in time may have influenced study results. CCCEH researchers
agreed that a more clear understanding of the role of mixtures--
exposure to multiple OP pesticides overall or concurrent in time--on
these neurodevelopmental outcomes is desirable; however they also
recognized that the current sample size is too small to perform this
type of analysis. To better understand the role of exposure to a
mixture of OP pesticides a new cohort study with a larger sample size
and different design is required. Therefore, EPA concluded that co-
exposure to multiple organophosphate mixtures is not currently
obtainable.
For risk characterization purposes, EPA was also interested in
understanding the relative contributions of various environmental
exposures on ND outcomes, (e.g., PAH, environmental tobacco smoke,
chlorpyrifos). Researchers noted that a preliminary indication of the
relative contribution of various risk factors for intelligence measures
in these cohorts can be seen through examination of supplemental tables
published by CCCEH researchers, i.e., the beta-coefficients provided in
published supplemental tables provide an indication of the relative
contribution of each risk factor (V. Rauh, et al., 2011). However,
CCCEH researchers indicated that to gain a true reflection the causal
model in the population a series of studies in other study populations
is needed. EPA and CCCEH researchers agreed that these studies will
likely accumulate over time, however they are not currently available.
IV. Conclusions
In the past, EPA sought to obtain the original analytic data file
used to support certain epidemiological analysis of in utero exposure
to chlorpyrifos and subsequent adverse neurodevelopmental health
outcomes in children generated by the Columbia Center for Children's
Environmental Health (CCCEH) to support the Human Health Risk
Assessment (HHRA) of chlorpyrifos. EPA believed these data were
important to both clarify the exposure-response relationship observed
in the epidemiology study relative to the current regulatory endpoint
(acetylcholinesterase inhibition), and also to resolve uncertainties
regarding study participants co-exposure to other environmental
contaminants, among other areas of uncertainties. CCCEH researchers did
not agree to provide these data, however, the researchers met with EPA
and discussed the agency's questions about the data to help determine
whether further review of the raw data might assist EPA in resolving
uncertainties. As a result of this meeting and additional discussions
with CCCEH staff, EPA concluded that access to the raw data would
either not provide answers to EPA's questions or that the information
EPA sought could be obtained without analyzing the raw data. Indeed,
based on discussions in that meeting as well as further work conducted
by agency staff, EPA has gained additional information to better
clarify and characterize the major issue areas identified as
uncertainties. For these reasons, EPA decided that it would not further
pursue its request for the analytic data file from the CCCEH
researchers.
Works Cited
Andrews, H.F. (January 21, 2013). [Clarification of Relation between
Blood Lead and Cord Blood Levels of Chlorpyrifos in the Columbia Center
for Children's Environmental Health (CCCEH) Studies (Electronic mail
communication)].
Bouchard, M., Gosselin, N.H., Brunet, R.C., Samuel, O., Dumoulin,
M.J., & Carrier, G. (2003). Atoxicokinetic model of malathion and its
metabolites as a tool to assess human exposure and riskthrough
measurements of urinary biomarkers. Toxicol. Sci., 73(1), 182-194. doi:
10.1093/toxsci/kfg061.
Bouchard, M.F., Chevrier, J., Harley, K.G., Kogut, K., Vedar, M.,
Calderon, N., . . . Eskenazi, B. (2011). Prenatal exposure to
organophosphate pesticides and IQ in 7-year-old children. Environ.
Health Perspect., 119(8), 1189-1195. doi: 10.1289/ehp.1003185.
Brubaker, C.J., Dietrich, K.N., Lanphear, B.P., & Cecil, K.M.
(2010). The influence of age of leadexposure on adult gray matter
volume. Neurotoxicology, 31(3), 259-266. doi: 10.1016/
j.neuro.2010.03.004.
Brubaker, C.J., Schmithorst, V.J., Haynes, E.N., Dietrich, K.N.,
Egelhoff, J.C., Lindquist, D.M., . . . Cecil, K.M. (2009). Altered
myelination and axonal integrity in adults with childhood lead
exposure: a diffusion tensor imaging study. Neurotoxicology, 30(6), 867-
875. doi: 10.1016/j.neuro.2009.07.007.
Cecil, K.M., Brubaker, C.J., Adler, C.M., Dietrich, K.N., Altaye,
M., Egelhoff, J.C., . . . Lanphear, B.P. (2008). Decreased brain volume
in adults with childhood lead exposure. PLoS Med., 5(5), e112. doi:
10.1371/journal.pmed.0050112.
Cecil, K.M., Dietrich, K.N., Altaye, M., Egelhoff, J.C., Lindquist,
D.M., Brubaker, C.J., & Lanphear, B.P. (2011). Proton magnetic
resonance spectroscopy in adults with childhood lead exposure. Environ.
Health Perspect., 119(3), 403-408. doi: 10.1289/ehp.1002176.
Engel, S.M., Berkowitz, G.S., Barr, D.B., Teitelbaum, S.L., Siskind,
J., Meisel, S.J., . . . Wolff, M.S. (2007). Prenatal organophosphate
metabolite and organochlorine levels and performance on the Brazelton
Neonatal Behavioral Assessment Scale in a multiethnic pregnancy cohort.
Am. J. Epidemiol., 165(12), 1397-1404. doi: 10.1093/aje/kwm029.
Engel, S.M., Wetmur, J., Chen, J., Zhu, C., Barr, D.B., Canfield,
R.L., & Wolff, M. S. (2011). Prenatal exposure to organophosphates,
paraoxonase 1, and cognitive development in childhood. Environ. Health
Perspect., 119(8), 1182-1188. doi: 10.1289/ehp.1003183.
Eskenazi, B., Harley, K., Bradman, A., Weltzien, E., Jewell, N.A.,
Barr, D.B., . . . Holland, N.T. (2004). Association of in utero
organophosphate pesticide exposure and fetal growth and length of
gestation in an agricultural population. Environmental Health
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Eskenazi, B., Marks, A.R., Bradman, A., Harley, K., Barr, D.B.,
Johnson, C., . . . Jewell, N.P. (2007). Organophosphate pesticide
exposure and neurodevelopment in young Mexican-American children.
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Rauh, V., Arunajadai, S., Horton, M., Perera, F., Hoepner, L., Barr,
D.B., & Whyatt, R. (2011). Seven-year neurodevelopmental scores and
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Appendix 6. Addendum 1: Columbia University Epidemiology Studies
The agency is obligated to review and address peer review comments
in support of regulatory decisions. The following is a list of key
issues about the epidemiological studies carried out by researchers at
Columbia University that were raised in peer review comments. These
issues require EPA to have access to the raw data for additional
analyses by the agency.
(1) Further analysis of other chemical exposures (e.g., lead, PAHs,
other pesticides) to address, if possible, their impact or
contribution as modulating factors on the measured
outcomes.
2012 SAP--``it should be noted that it cannot be stated
that chlorpyrifos is the sole contributor to the observed
outcomes.''
2012 SAP--``In an earlier examination of the same cohort,
Perera, et al. (2009) reported an association between a
decrease in full-scale IQ and verbal IQ in 5-year-olds with
prenatal polycyclic aromatic hydrocarbons (PAH) exposure
rather than chlorpyrifos, thus, raising an issue of the
shift in chemical exposure association with increase in
age. In each of these analyses, statistical modeling showed
that the exposures were independently associated with IQ,
and no significant interaction was observed with the other
chemical. While this is a statistically sound approach to
determine independent responses, panel members noted that
it is very difficult to identify the independent
physiological effects of a single chemical in this type of
multi-chemical exposure scenario.''
2012 Federal Peer Review--``even low levels of lead can
impact neurodevelopment, and even that the observed
neurobehavioral deficits are more pronounced at lower blood
lead levels when compared with higher blood lead levels''.
2008 SAP--``In order to eliminate the possible causes of
neurodevelopmental effects by other pesticides in the
Columbia study, it is suggested that EPA should repeat the
pre-post residential cancellation analysis done for
chlorpyrifos using other pesticide measurements, such as
malathion diacid (MDA), a specific metabolite of malathion.
The outcomes from those additional analyses will either
confirm or reject EPA's preliminary conclusion that
chlorpyrifos is likely to play a role in the
neurodevelopmental outcomes.''
2008 SAP--``It would be useful to examine the results of a
statistical analysis that includes all three AChE-
inhibiting insecticides in the analysis model as
dichotomous variables (above or below LOD) in combination
with continuous measurements for these variables. This type
of analysis would likely not change the results, but it
could be helpful in illustrating threshold or dose response
effects.''
(2) Further analysis and information to address and, if possible,
better characterize uncertainty around outcome measures on
learning/memory/IQ.
2012 SAP--Alternative considerations for non-quantified
samples: ``little use was made of techniques to integrate
non-quantified samples into the statistical test . . . .
Various methods were reviewed by the July 2010 SAP that can
be applied to either normally or lognormally distributed
data that include a significant (even a majority) of non-
detectable sample . . . . Specifically, the use of
`probability plots' was described that can yield an
estimate of the geometric mean of the distribution [GM],
the geometric standard deviation [GSD], and corresponding
percentiles.''
Federal Peer Review--``There is a scatterplot showing the
raw scores for overall IQ and for each of the subtests, but
it is not possible to obtain the necessary information to
compare the distributions of these scores with the norms
for the test or with any other study sample. Ideally, the
means and standard deviations for these scores should be
presented for either a non-exposed or a non-exposed
combined with low exposed group and these should be
compared to a moderate or high-exposed group as was done
for the BSID-II in the Rauh, et al., 2006 paper. Here the
uncertainties stem from the assumptions that are made when
regression analyses are performed. The main issue here is
that outliers can greatly influence the slope of the
function.''
Federal Peer Review--A between group analysis using
inferential statis-
tics, as was done for the Bayley Scales of Infant
Development II in the
Rauh, et al., 2006 paper, should be performed on each
variable in both stud-
ies (i.e., the Child Behavior Checklist in Rauh, et al.,
2006, and the full
scale IQ and subscales for the WISC-IV in the Rauh, et
al., 2011 study).
This would be the most direct and least problematic
method for deter-
mining whether exposure to chlorpyrifos resulted in
significant decreases in
IQ or significant increases in behavioral problems ``. .
. no information was
provided regarding the qualifications of the individuals
who administered
and scored the tests. ''
(3) Further analysis to assess, if possible, whether individual
cohort members had the potential for exposure to
chlorpyrifos and/or other acetylcholinesterase (AChE)
inhibiting pesticides (e.g., diazinon, propoxur),
prenatally and/or postnatally, at levels leading to greater
than 10% AChE inhibition (the level used to derive the
regulatory point of departure).
2012 SAP--recommended conducting a dose reconstruction
analysis--``data on the concentration of chlorpyrifos in
various media (i.e., house dust, air and water) while
market basket data exists on the concentration of
chlorpyrifos on food. These data provide the main tools for
developing an effective exposure assessment and a
subsequent reconstruction of potential dose.'' The agency
has begun such analysis but the current draft analysis is
limited without data on the exposure information relevant
to individual women such that environmental chlorpyrifos
exposure can then be linked to measures of blood
chlorpyrifos.
2012 SAP--recommended the agency consider issues related
to multiple chemical exposure (i.e., mixtures) to
chlorpyrifos and other key AChE inhibiting pesticides
identified by the Columbia University studies (diazinon,
propoxur). Assumptions of co-exposure will likely be
grossly over-estimated without access to the raw data; such
raw data may enable the agency to evaluate actual co-
exposure information for individuals from air monitoring
samples and blood samples.
[attachment 6]
[https://www.epa.gov/pesticide-science-and-assessing-pesticide-
risks/about-water-exposure-models-used-pesticide]
About Water Exposure Models Used in Pesticide [Assessments]
On this Page
General Information about Water Models
Model Names and Specific Uses
Surface Water Models
GENEEC
FIRST
Surface Water Concentration Calculator
Tier 1 Rice Model
PFAM
KABAM
Ground Water Models
SCI-GROW
PRZM-GW
References
Water Models
When EPA's Office of Pesticide Programs (OPP) assesses the risk of
a pesticide, it considers the exposure to the pesticide as well as the
toxicity of the pesticide. For both drinking water and aquatic exposure
assessments, reliable field monitoring data, when available, as well as
mathematical models can be used to generate exposure estimates.
Monitoring and modeling are both important tools for assessing
pesticide concentrations in water and can provide different types of
information. Monitoring tells the user what is happening under current
use practices and under typical conditions. Although monitoring data
can provide a direct estimate of the concentration of a pesticide in
water at a particular time and at a particular location, it may not
provide reliable estimates for exposure assessments because sampling
may not occur where and when the highest concentrations of a pesticide
are found.
For drinking water and aquatic exposures assessments, OPP typically
relies on mathematical models to generate exposure estimates. These
models calculate estimated environmental concentrations (EECs) using
laboratory data that describe how fast the pesticide breaks down to
other chemicals and how it moves in the environment. The guidelines for
these laboratory studies can be found at the following website: Series
835--Fate, Transport and Transformation Test Guidelines (https://
www.epa.gov/test-guidelines-pesticides-and-toxic-substances/series-835-
fate-transport-and-transformation-test). Although computer modeling
provides an indirect estimate of pesticide concentrations, models can
estimate concentrations continuously over long periods of time and for
vulnerable areas of interest for a particular pesticide. Modeling can
also be used to compare estimated concentrations with toxicity data to
determine the risk a pesticide poses to both drinking water and aquatic
systems. Another benefit of computer modeling is in determining how
various mitigation practices affect the amount of the pesticide that
can run off into water.
In estimating pesticide concentrations in aquatic environments, OPP
uses a tiered approach. The intent of this approach is to estimate
pesticide concentrations in water from sites that are highly vulnerable
to runoff or leaching. With this approach, pesticides that pass Tier I
will likely pose a low possibility of harming human health, wildlife,
or the environment. Failing a tier, however, does not necessarily mean
the chemical is likely to cause health or environmental problems, but
rather that there is a need to move to a higher tier and conduct a more
refined assessment. This tiered modeling system is designed to provide
a thorough analysis of each pesticide, while at the same time focus
OPP's efforts on those pesticides that pose the greatest potential
risk. For more information on this approach, refer to the archives
about Science Policy Issues and Guidance Documents related to Tolerance
Reassessment Advisory Committee (TRAC). Search EPA Archive (https://
archive.epa.gov/).
Model Names and Specific Uses
For estimating upper bound concentrations of pesticides in drinking
water, OPP uses FIRST (FQPA Index Reservoir Screening Tool) as a Tier I
model for surface water exposure assessments and PRZM-GW for
groundwater exposure assessments. For estimating upper bound
concentrations of pesticides in other aquatic environments, OPP uses
the Tier I model GENEEC2 (GENeric Estimated Environmental
Concentration) for surface water exposure assessments. View these and
other models (https://www.epa.gov/pesticide-science-and-assessing-
pesticide-risks/models-pesticide-risk-assessment).
For Tier II surface water exposure assessments, OPP uses the
Surface Water Concentration Calculator (SWCC), which accommodates the
specific characteristics of the chemical and includes more site-
specific information regarding the application method and impact of
local daily weather on the treated field over a period of 30 years. At
the Tier II level, the SWCC uses maximum application rates and
frequencies for a vulnerable drinking water reservoir or vulnerable
pond. Additional refinements in application rates may be considered if
usage data indicate they are appropriate. Currently, scientists in the
Environmental Fate and Effects Division (EFED) of the Office of
Pesticide Programs (OPP) are exploring the use of the SWCC for Tier I
level assessments. View the SWCC and other models (https://www.epa.gov/
pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-
assessment).
For Tier II groundwater exposure assessments, refinement strategies
for PRZM-GW can be used to estimate pesticide concentrations in
groundwater. These refinement strategies include consideration of
representative scenarios, additional fate parameters, annual
application retreatment, well setbacks, and representative exposure
durations of concern.
Although exposure models make it easy to evaluate the impacts of
numerous variables in the environment, the results of these models are
highly dependent on the accuracy of the chemical parameters that are
used as inputs and the ability of the model to represent what occurs in
the environment. In order to improve transparency and confidence in
these models, EFED Scientists present new model developments at the
Environmental Modeling Public Meetings (EMPM) (https://www.epa.gov/
pesticide-science-and-assessing-pesticide-risks/environmental-modeling-
public-meeting-information), which are held on a semiannual basis. In
addition, the code and documentation for all EFED/OPP water models are
posted on the web page for models used in pesticide risk assessment
(https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/
models-pesticide-risk-assessment).
The following is a more detailed summary of OPP's current Tier I
and Tier II aquatic exposure models along with links to user manuals
that can be downloaded.
Surface Water Models
Pesticides can enter surface waters through runoff, spray drift,
and deposition. Once pesticides have entered surface waters, they are
exposed to a number of physical, chemical, and microbial processes that
impact the fate of the pesticides. These processes include
photodegradation, volatilization, biodegradation, absorption/
adsorption, chemical degradation, leaching, and sedimentation. To
better understand the fate of pesticides in surface waters, OPP has
developed a number of models that capture these processes and predict
the concentration of pesticides in surface waters. These models range
from simple screening models that require few inputs to more complex
models that reflect the dynamics of the surface water ecosystem. Below
is a description of the surface water models that OPP uses in its
pesticide exposure assessments.
GENEEC2
The GENeric Estimated Environmental Concentration (GENEEC 2.1) is a
screening model to predict environmental concentrations of pesticides
in surface water for aquatic exposure assessments. The model, which was
recompiled to operate in the Microsoft' Windows
7' environment, is a legacy model for EPA and is currently
available on the Water Models--Previous Versions (https://www.epa.gov/
pesticide-science-and-assessing-pesticide-risks/pesticide-water-models-
previous-versions#
geneec2) Web page. For the most part, the Surface Water Concentration
Calculator (SWCC) has replaced GENEEC2 for estimating environmental
concentrations of pesticides in surface water for aquatic exposure
assessments. View current models (https://www.epa.gov/pesticide-
science-and-assessing-pesticide-risks/models-pesticide-risk-
assessment).
In the past, OPP used GENEEC2 as a Tier I screening model for
assessing exposure of aquatic organisms and the environment to
pesticides. GENEEC2 provides a rapid screen to separate the low risk
pesticides from those that need more refined assessments. The model
estimates high level exposure values of pesticides in surface water
from a few basic chemical characteristics and pesticide label use and
application information.
GENEEC2 considers adsorption of the pesticide to soil or sediment,
incorporation of the pesticide at application, direct deposition of
spray drift into the water body, and degradation of the pesticide in
soil before runoff and within the water body. It is a single-event
model, meaning that it assumes one single large rainfall/runoff event,
which occurs on a 10-hectare field and which removes a large quantity
of pesticide at one time from the field to a pond. In this case, the
pond has a 20,000 cubic water volume and is 2 meters deep. The GENEEC2
program is generic in that it does not consider differences in climate,
soils, topography or crop in estimating potential pesticide exposure.
GENEEC2 is expected to overestimate pesticide concentrations in
surface water for most sites and may be inappropriate for some
chemicals, especially those that are persistent and/or have a high
sorption coefficient, as well as frequently applied pesticides. In
these cases, users should go directly to a higher tiered assessment
using the more sophisticated Surface Water Concentration Calculator
discussed below.
FIRST
OPP uses the Tier I model, FQPA Index Reservoir Screening Tool
(FIRST), to assess exposure to pesticides in drinking water. Using a
few basic chemical parameters (e.g., half-life in soil) and pesticide
label application information, FIRST estimates peak values (acute) and
long-term (chronic) average concentrations of pesticides in water. Like
GENEEC, it is based upon the linked PRZM and EXAMS models and is a
single-event process. However, it is different from GENEEC in several
aspects. As with the Tier II modeling for drinking water, FIRST uses an
Index Reservoir (https://www.epa.gov/pesticide-science-and-assessing-
pesticide-risks/development-and-use-index-reservoir-drinking-water)
watershed based on the Shipman City Lake in Illinois.
FIRST also uses Percent Cropped Area (PCA) factors, which consider
the percentage of the watershed that is cropped rather than assuming
that the whole watershed is cropped. The program automatically adjusts
the output in accordance with the user-specified maximum percent of
crop area in any watershed. For more information, see the FIRST User's
Manual (https://www.epa.gov/pesticide-science-and-assessing-pesticide-
risks/first-version-10-users-manual) and Model Description.
Surface Water Concentration Calculator
Currently, OPP uses the Surface Water Concentration Calculator
(SWCC) for higher level, refined (Tier II) estimations of pesticide
concentrations in surface waters for drinking water and aquatic
exposure assessments. The SWCC is designed to simulate the
environmental concentration of a pesticide in the water column and
sediment and is used for regulatory purposes by the EPA's Office of
Pesticide Programs (OPP). The SWCC uses the Pesticide Root Zone Model
(PRZM) version 5.0+ (PRZM5) and the Variable Volume Water Body Model
(VVWM), replacing the older PE5 shell (last updated November 2006),
which used PRZM3 (Carousel, et al., 2005) and EXAMS (Burns, 2004). This
updated model was designed to improve users' interactions with the
program and facilitate maintenance and operation of the software.
For aquatic assessments, the SWCC uses the standard pond scenario,
and for drinking water assessments, the SWCC uses the index reservoir/
percent crop area factors.
PRZM5 is a process or ``simulation'' model that calculates what
happens to a pesticide in a farmer's field on a day-to-day basis. It
considers factors such as rainfall and evapotranspiration as well as
how and when the pesticide is applied. It has two major components:
hydrology and chemical transport. The hydrologic component for
calculating runoff and erosion of soil is based on the Soil
Conservation Service curve number technique and the Universal Soil Loss
Equation (NRCS, 2003; Wischmeier and Smith, 1978).
Evapotranspiration of water is estimated from pan evaporation data.
Total evapotranspiration of water includes evaporation from crop
interception, evaporation from soil, and transpiration by the crop.
Water movement is simulated by the use of generalized soil parameters,
including field capacity, wilting point, and curve number. The chemical
transport component simulates pesticide application on the soil or on
the plant foliage. Dissolved, sorbed, and vapor-phase concentrations in
the soil are estimated by considering surface runoff, erosion,
degradation, volatilization, foliar washoff, advection, dispersion,
retardation, among others.
Each PRZM5 modeling scenario represents a unique combination of
climatic conditions, crop specific management practices, soil specific
properties, site specific hydrology, and pesticide specific application
and dissipation processes. Each simulation is conducted using multiple
years of rainfall data to cover year-to-year variability in runoff.
Daily edge-of-field loadings of pesticides dissolved in runoff waters
and sorbed to sediment, as predicted by PRZM5, are discharged into a
standard water body (either the standard pond or the Index Reservoir)
simulated by the VVWM model. Additional information about the PRZM5
model can be found on our models page (https://www.epa.gov/pesticide-
science-and-assessing-pesticide-risks/models-pesticide-risk-
assessment).
The VVWM simulates the processes that occur in the water body by
using the runoff and spray drift loading generated by PRZM5 to estimate
the fate, persistence, and concentration of a pesticide in a water body
on a day-to-day basis. As such, the model accounts for volatilization,
sorption, hydrolysis, biodegradation, and photolysis of the pesticide.
The VVWM has the ability to vary its volume on a daily scale and to
include sediment burial (unlike its predecessor EXAMS) although these
feature are only used for higher tiered assessments.
Multiple year pesticide concentrations in the water column are
calculated from the simulations as the annual daily peak, maximum
annual 96-hour average, maximum annual 21-day average, maximum annual
60-day average, and annual average. The upper 10th percentile
concentrations (except annual average) are compared against
ecotoxicological and human health levels of concern (LOC). For a more
detailed description of the parameters, validations and assessments for
VVWM, see our information on aquatic models (https://www.epa.gov/
pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-
assessment).
Tier 1 Rice Model
The Tier 1 Rice Model (version 1.0) is used to estimate surface
water exposure from the use of pesticides in rice paddies. This
screening-level model provides short- and long-term concentrations that
can be used for both aquatic ecological risk assessments and drinking
water exposure assessments. Guidance for using the Tier 1 Rice Model
can be found on our models page (https://www.epa.gov/pesticide-science-
and-assessing-pesticide-risks/models-pesticide-risk-assessment).
Pesticide in Flooded Application Model (PFAM)
Compared to the Tier 1 Rice Model, PFAM allows for a more advanced
estimate of surface water exposure from the use of pesticides in
flooded fields such as rice paddies and cranberry bogs. Some of the
advanced features incorporated into PFAM include specifications for
water and pest management practices, degradation data for soil and
aquatic environments and post-processing information of discharged
paddy waters to a stream. Additional information concerning PFAM can be
found on our models page (https://www.epa.gov/pesticide-science-and-
assessing-pesticide-risks/models-pesticide-risk-assessment).
Aquatic Bioaccumulation Model
EPA uses the model KABAM version 1.0 (Kow (based) Aquatic
Bioaccumulation Model) to estimate potential bioaccumulation of
hydrophobic organic pesticides in freshwater aquatic food webs and
subsequent risks to mammals and birds via consumption of contaminated
aquatic prey. The model can also be used to estimate pesticide
concentrations in fish tissues consumed by humans. KABAM is composed of
two parts: (1) a bioaccumulation model estimating pesticide
concentrations in aquatic organisms and (2) a risk component that
translates exposure and toxicological effects of a pesticide into risk
estimates for mammals and birds consuming contaminated aquatic prey.
The users manual and executable file for KABAM can be found on our
models page (https://www.epa.gov/pesticide-science-and-assessing-
pesticide-risks/models-pesticide-risk-assessment).
Ground Water Models
SCI-GROW
After the passage of the Food Quality Protection Act (FQPA) of
1996, the EPA developed SCI-GROW (Screening Concentration in
Groundwater) as a screening-level tool to estimate drinking water
exposure concentrations in groundwater resulting from pesticide use
(Barrett, 1997). As a screening tool, SCI-GROW provides conservative
estimates of pesticides in groundwater, but it does not have the
capability to consider variability in leaching potential of different
soils, weather (including rainfall), cumulative yearly applications or
depth to aquifer. If SCI-GROW-based assessment results indicate that
pesticide concentrations in drinking water exceed levels of concern,
the ability to refine the assessment is limited. At the present time,
SCI-GROW is considered a legacy model for EPA and has been largely
replaced by PRZM-GW.
PRZM-GW
In 2004, the EPA and the Pest Management Regulatory Agency (PMRA)--
Canada initiated a project to evaluate advanced methods for estimating
pesticide concentrations in groundwater. The goals of this project were
to identify a common computer model for estimating pesticide
concentrations in groundwater and to develop common procedures for
determining model input parameters from soil survey data, pesticide
environmental fate studies, and pesticide use information. After
evaluating 19 modeling programs, EPA and PMRA selected a modified
version of PRZM as the North American Free Trade Agreement (NAFTA)
regulatory tool for estimating concentrations of pesticides in ground
water. Concurrently, EPA consulted with the FIFRA Scientific Advisory
Panel (SAP) twice in 2005 on the development of a groundwater
conceptual model and the use of PRZM-GW to implement the conceptual
model.
Figure 2 depicts the general groundwater scenario concept for
estimating pesticide concentrations in drinking water as implemented in
PRZM-GW. This conceptual model is based on a rural drinking water well
beneath an agricultural field (a high pesticide use area), which draws
water from an unconfined, high water-table aquifer.
Figure 2: General Groundwater Scenario Concept for Estimating Pesticide
Concentrations in Drinking Water As Implemented in PRZM-GW
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
The depth of the well is site-specific (i.e., scenario specific).
The well extends into a shallow unconfined aquifer and has a well-
screen that starts at the top and continues down into the aquifer. The
length of the well-screen represents the region of the aquifer where
drinking water is collected. The well-screen length is well-specific
and can be adjusted. Processes included in the conceptual model that
influence pesticide transport through the soil profile include water
flow, chemical specific dissipation and transportation parameters
(i.e., degradation and sorption), and crop specific factors, including
transpiration, pesticide interception and management practices.
After developing the conceptual model for PRZM-GW, EPA compared its
performance in estimating drinking water concentrations of pesticides
with targeted and non-targeted groundwater monitoring data. Data from
prospective ground water monitoring studies (detailed site
investigations of pesticide leaching into vulnerable aquifers) were
important in the development and evaluation of the PRZM-GW model. After
an extensive evaluation, EPA determined that PRZM-GW was an effective
tool for establishing upper bound pesticide concentrations in
groundwater for national and site-specific assessments.
Initially, EPA implemented PRZM-GW using a Tier I procedure that
involves simulation of 30 to 100 years of pesticide applications at
labeled maximum application rates in defined scenarios that represent
the most vulnerable types of aquifers utilized as drinking water
sources. These studies showed that the primary pesticide-specific
inputs affecting PRZM-GW exposure estimates are the application rate
and timing, the aerobic soil degradation rate, the linear adsorption
coefficient, and the hydrolysis rate. For volatile pesticides such as
fumigants, a volatilization routine can also be incorporated in the
model run.
After evaluating PRZM-GW as an effective tool for establishing Tier
I screening assessments, EPA developed refinement strategies for using
PRZM-GW for Tier II groundwater assessments. These refinement
strategies can include consideration of representative scenarios,
additional fate parameters, annual application retreatment, well
setbacks, and representative exposure durations of concern. In the
future, OPP may consider additional strategies to facilitate such
refinements. For more information, refer to EPA's Guidance for Using
PRZM-GW in Drinking Water Exposure Assessments (https://www.epa.gov/
pesticide-science-and-assessing-pesticide-risks/przm-gw-version-107-
guidance-using-przm-gw-drinking).
References
Barrett, M. 1997. Initial Tier Screening of Pesticides for
Groundwater Concentration Using the SCI-GROW Model. U.S. Environmental
Protection Agency. Washington, D.C.
Burns, L. 2004. Exposure Analysis Modeling System (EXAMS) (https://
www.epa.gov/exposure-assessment-models/exams-version-index). User's
manual and system documentation. Ecosystems Research Division. U.S.
Environmental Protection Agency. Athens, GA. EPA/600/R-081. September
2000. Revision G.
Carousel, R.F., J.C. Imhoff, P.R. Hummel, J.M. Cheplick, A.S.
Donigian, and L.A. Suarez. 2005. U.S. Environmental Protection Agency.
Athens, GA. Pesticide Root Zone Model (PRZM)-3. PRZM: a model for
predicting pesticide and nitrogen fate in the crop root and unsaturated
soil zones. 3.12.2 ed.
NRCS, 2003. National Engineering Handbook Section 4: Hydrology.
Natural Resources Conservation Service, U.S. Department of Agriculture,
Washington D.C.
Wischmeier, W.H., and D.D. Smith. 1978. Predicting rainfall erosion
losses--a guide to conservation planning. Agriculture Handbook 537,
U.S. Department of Agriculture, Washington, D.C., USA.
Contact Us (https://www.epa.gov/pesticide-science-and-assessing-
pesticide-risks/forms/contact-us-about-pesticide-science-and) to ask a
question, provide feedback, or report a problem.
[Accessed September 8, 2016]
[attachment 7]
[http://www.ecfr.gov/cgi-bin/text-
idx?SID=3f455fd5338126f4f8c99664dbbbe1b2
&mc=true&node=ap40.24.127_127.a&rgn=div9]
e-CFR data is current as of September 2, 2016.
Electronic Code of Federal Regulations
Title 40: Protection of Environment
Part 127--NPDES Electronic Reporting
Subpart C--Responsibilities of EPA and States, Tribes, and Territories
Authorized to Implement the NPDES Program
Appendix A to Part 127--Minimum Set of NPDES Data
The following two tables identify the minimum set of NPDES data
that authorized states, tribes, territories must enter or transfer to
EPA's national NPDES data system as well as what NPDES-regulated
entities must electronically report to the designated initial recipient
(authorized NPDES program or EPA) [see 40 CFR 127.2(b)]. Authorized
NPDES programs will be the data provider in the event the regulated
entity is covered by a waiver from electronic reporting. Use of these
two tables ensures that there is consistent and complete reporting
nationwide, and expeditious collection and processing of the data,
thereby making it more accurate and timely. Taken together, these data
standardizations and the corresponding electronic reporting
requirements in 40 CFR parts 3, 122, 123, 124, 125, 127, 403, and 503
are designed to save the NPDES authorized programs considerable
resources, make reporting easier for NPDES-regulated entities,
streamline permit renewals (as permit writers typically review previous
noncompliance events during permit renewal), ensure full exchange of
NPDES program data between states and EPA to the public, improve
environmental decision-making, and protect human health and the
environment.
Authorized NPDES programs may also require NPDES regulated entities
to submit more data than what is listed in this appendix. The
authorized NPDES program can require NPDES regulated entities to submit
these ``non-appendix A'' data on paper, electronically, or attachments
to electronic notices and reports filed in compliance with this part.
Instructions: Table 1 of this appendix provides the list of data
sources and minimum submission frequencies for the ten different NPDES
Data Groups. Table 2 of this appendix provides the data that must be
electronically reported for each of these NPDES Data Groups. The use of
each data element is determined by identifying the number(s) in the
column labeled ``NPDES Data Group Number'' in Table 2 and finding the
corresponding ``NPDES Data Group Number'' in Table 1. For example, a
value of ``1'' in Table 2 means that this data element is required in
the electronic transmission of data from the NPDES program to EPA (Core
NPDES Permitting, Compliance, and Enforcement Data). Likewise, a value
of ``1 through 10'' in Table 2 means that this data element is required
in all ten NPDES data groups. NPDES regulated entities that have no
historical record (e.g., ``greenfield'' facilities) do not need to
provide data elements that rely on historical data elements. For the
purposes of this appendix, the term `sewage sludge' [see 40 CFR
503.9(w)] also refers to the material that is commonly referred to as
`biosolids.' EPA does not have a regulatory definition for biosolids
but this material is commonly referred to as sewage sludge that is
placed on, or applied to the land to use the beneficial properties of
the material as a soil amendment, conditioner, or fertilizer. EPA's use
of the term `biosolids' in this appendix is to confirm that information
about beneficially used sewage sludge (a.k.a. biosolids) is part of the
data collected in this appendix.
Table 1--Data Sources and Regulatory Citations \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
NPDES Data
group No. \2\ NPDES data group Program area Data provider Minimum frequency \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
1 Core NPDES Permitting, Compliance, and All NPDES Program Authorized NPDES Within 40 days of the completed activity or within 40
Enforcement Data [40 CFR parts 122, Sectors Program days of receipt of a report from a regulated entity
123, 403, 503] [see 127.23(a)(1)]. However, the frequency associated
with any particular permittee may be considerably less
[e.g., once every five years for most permit
information].
2 General Permit Reports [Notices of All NPDES Program NPDES Permittee Prior to obtaining coverage under a general permit or
Intent to discharge (NOIs); Notices of Sectors consideration for permit exclusion or waiver from
Termination (NOTs); No Exposure permitting, and permit coverage termination. General
Certifications (NOEs); Low Erosivity permits are generally issued once every five years.
Waivers and Other Waivers from
Stormwater Controls (LEWs)] [40 CFR
122.26(b)(15), 122.28 and 124.5]
3 Discharge Monitoring Reports [40 CFR Most NPDES NPDES Permittee At least annual, more frequent submissions may be
122.41(l)(4)] Program Sectors required by the permit.
4 Sewage Sludge/Biosolids Annual Program Sewage Sludge/ NPDES Regulated Annual.
Reports [40 CFR part 503] Biosolids Sewage Sludge/
Biosolids
Generator and
Handler
5 Concentrated Animal Feeding Operation CAFO CAFO Annual.
(CAFO) Annual Program Reports [40 CFR
122.42(e)(4)]
6 Municipal Separate Storm Sewer System MS4 NPDES Permittee Year two and year four of permit coverage (Small MS4),
(MS4) Program Reports [40 CFR Annual (Medium and Large MS4).
122.34(g)(3) and 122.42(c)]
7 Pretreatment Program Reports [40 CFR Pretreatment POTW Pretreatment Annual.
403.12(i)] Control
Authority,
Approval
Authority for
SIUs in
Municipalities
Without Approved
Pretreatment
Programs
8 Significant Industrial User Compliance Pretreatment Significant Bi-Annual.
Reports in Municipalities Without Industrial User
Approved Pretreatment Programs [40 CFR
403.12(e) and (h)]
9 Sewer Overflow Event Reports [40 CFR Sewer Overflows NPDES Permittee Within 5 days of the time the permittee becomes aware of
122.41(l)(6) and (7)] the sewer overflow event (health or environment
endangerment), Monitoring report frequency specific in
permit (all other sewer overflow events).
10 CWA section 316(b) Annual Reports [40 CWA section NPDES Permittee Annual.
CFR part 125, subpart J] 316(b)
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\1\ Entities regulated by a NPDES permit will comply with all reporting requirements in their respective NPDES permit.
\2\ Use the ``NPDES Data Group Number'' in this table and the ``NPDES Data Group Number'' column in Table 2 of this appendix to identify the source of
the required data entry. EPA notes that electronic systems may use additional data to facilitate electronic reporting as well as management and
reporting of electronic data. For example, NPDES permittees may be required to enter their NPDES permit number (``NPDES ID''--NPDES Data Group 1 and
2) into the applicable electronic reporting system in order to identify their permit and submit a Discharge Monitoring Report (DMR-NPDES Data Group
3). Additionally, NPDES regulated entities may be required to enter and submit data to update or correct erroneous data. For example, NPDES permittees
may be required to enter new data regarding the Facility Individual First Name and Last Name (NPDES Data Group 1 and 2) with their DMR submission when
there is a facility personnel change.
\3\ The applicable reporting frequency is specified in the NPDES permit or control mechanism, which may be more frequent than the minimum frequency
specified in this table.
Table 2--Required NPDES Program Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
NPDES data
CWA, regulatory (40 CFR), or other group No.
Data name Data description citation (see Table
1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Basic Facility Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
[Note: As indicated in the ``CWA, Regulatory, or Other Citation'' column, some of these data elements apply to Significant Industrial Users (SIUs)
and Categorical Industrial Users (CIUs) that discharge (including non-domestic wastewater delivered by truck, rail, and dedicated pipe or other means
of transportation) to one or more POTWs and to regulated entities or locations that generate, process, or receive biosolids or sewage sludge.]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Facility Type of Ownership The unique code/description identifying the type of 122.21, 122.21(j)(6), 122.21(q), 1, 2, 4,
facility (e.g., state government, municipal or water 122.28(b)(2)(ii), 403.8(f), 403.10, and 7.
district, Federal facility, tribal facility). This data 403.12(i), 503.18, 503.28, 503.48
element is used by EPA's national NPDES data system to
identify the facility type (e.g., POTW, Non-POTW, and
Federal)
Facility Site Name The name of the facility 122.21, 122.21(j)(6), 122.21(q), 1, 2, 4,
122.28(b)(2)(ii), 122.44(j), 403.8(f), and 7.
403.10, 403.12(i), 503.18, 503.28,
503.48
Facility Site Address The address of the physical facility location 122.21, 122.21(j)(6), 122.21(q), 1, 2, 4,
122.28(b)(2)(ii), 122.44(j), 403.8(f), and 7.
403.10, 403.12(i), 503.18, 503.28,
503.48
Facility Site City The name of the city, town, village, or other locality, 122.21, 122.21(j)(6), 122.21(q), 1, 2, 4,
when identifiable, within which the boundaries (the 122.28(b)(2)(ii), 122.44(j), 403.8(f), and 7.
majority of) the facility site is located. This is not 403.10, 403.12(i), 503.18, 503.28,
always the same as the city used for USPS mail delivery 503.48
Facility Site State The U.S. Postal Service (USPS) abbreviation for the 122.21, 122.21(j)(6), 122.21(q), 1, 2, 4,
state or state equivalent for the U.S. where the 122.28(b)(2)(ii), 122.44(j), 403.8(f), and 7.
facility is located 403.10, 403.12(i), 503.18, 503.28,
503.48
Facility Site Zip Code The combination of the 5-digit Zone Improvement Plan 122.21, 122.21(j)(6), 122.21(q), 1, 2, 4,
(ZIP) code and the 4-digit extension code (if 122.28(b)(2)(ii), 122.44(j), 403.8(f), and 7.
available) where the facility is located. This zip code 403.10, 403.12(i), 503.18, 503.28,
match the ``Facility Site City'' or the city used for 503.48
USPS mail delivery
Facility Site Tribal Land Indicator The EPA Tribal Internal Identifier for every unit of 122.21, 122.21(q), 122.28(b)(2)(ii), 1, 2, and
land trust allotment (``tribal land'') within Indian 503.18, 503.28, 503.48 4.
Country (i.e., Federally recognized American Indian and
Alaska Native tribal entities). This unique identifier
will identify whether the facility is on tribal land
and the current name of the American Indian tribe or
Alaskan Native entity. This unique identifier is
different from the Bureau of Indian Affairs tribal code
and does not change when a Tribe changes its name
Facility Site Longitude The measure of the angular distance on a meridian east 122.21, 122.21(q), 122.28(b)(2)(ii), 1, 2, and
or west of the prime meridian for the facility. The 503.18, 503.28, 503.48 4.
format for this data element is decimal degrees (e.g.,
^77.029289) and the WGS84 standard coordinate system.
This data element will also be used to describe the two-
dimensional area (polygon) regulated by a municipal
storm sewer system (MS4) NPDES permit through use of
multiple latitude and longitude coordinates. For MS4
the polygon data should provide a reasonable estimate
of the MS4 boundaries. This data element can also be
system generated when the Facility Site Address,
Facility Site City, and Facility Site State data
elements can be used to generate accurate longitude and
latitude values. (Note: ``Post Office Box'' addresses
and ``Rural Route'' addresses are generally not
geocodable)
Facility Site Latitude The measure of the angular distance on a meridian north 122.21, 122.21(q), 122.28(b)(2)(ii), 1, 2, and
or south of the equator for the facility. The format 503.18, 503.28, 503.48 4.
for this data element is decimal degrees (e.g.,
38.893829) and the WGS84 standard coordinate system.
This data element will also be used to describe the two-
dimensional area (polygon) regulated by a municipal
storm sewer system (MS4) NPDES permit through use of
multiple latitude and longitude coordinates. This data
element can also be system generated when the Facility
Site Address, Facility Site City, and Facility Site
State data elements can be used to generate accurate
longitude and latitude values. (Note: ``Post Office
Box'' addresses and ``Rural Route'' addresses are
generally not geocodable)
Facility Contact Affiliation Type The affiliation of the contact with the facility (e.g., 122.21, 122.21(j)(6), 122.21(q), 1, 2, 4,
``Owner,'' ``Operator,'' or ``Main Contact''). This is 122.28(b)(2)(ii), 403.8(f), 403.10, and 7.
a unique code/description that identifies the nature of 403.12(i), 503.18, 503.28, 503.48
the individual's affiliation to the facility
Facility Contact First Name The given name of an individual affiliated with this 122.21, 122.21(j)(6), 122.21(q), 1, 2, 4,
facility 122.28(b)(2)(ii), 403.8(f), 403.10, and 7.
403.12(i), 503.18, 503.28, 503.48
Facility Contact Last Name The surname of an individual affiliated with this 122.21, 122.21(j)(6), 122.21(q), 1, 2, 4,
facility 122.28(b)(2)(ii), 403.8(f), 403.10, and 7.
403.12(i), 503.18, 503.28, 503.48
Facility Contact Title The title held by an individual in an organization 122.21, 122.21(j)(6), 122.21(q), 1, 2, 4,
affiliated with this facility 122.28(b)(2)(ii), 403.8(f), 403.10, and 7.
403.12(i), 503.18, 503.28, 503.48
Facility Contact E-Mail Address The business e-mail address of the designated individual 122.21, 122.21(j)(6), 122.21(q), 1, 2, 4,
affiliated with this facility 122.28(b)(2)(ii), 403.8(f), 403.10, and 7.
403.12(i), 503.18, 503.28, 503.48
Facility Organization Formal Name The legal name of the person, firm, public organization, 122.21, 122.21(j)(6), 122.21(q), 1, 2, 4,
or other entity that operates the facility. This name 122.28(b)(2)(ii), 403.8(f), 403.10, and 7.
may or may not be the same name as the facility. The 403.12(i), 503.18, 503.28, 503.48
operator of the facility is the legal entity that
controls the facility's operation rather than the
facility or site manager. This data element should not
use a colloquial name. This field is optional for MS4
permittees
--------------------------------------------------------------------------------------------------------------------------------------------------------
Basic Permit Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
[Note: As indicated in the ``CWA, Regulatory, or Other Citation'' column, some of these data elements also apply to Significant Industrial Users
(SIUs) and Categorical Industrial Users (CIUs) that discharge (including non-domestic wastewater delivered by truck, rail, and dedicated pipe or
other means of transportation) to one or more POTWs and to regulated entities or locations that generate, process, or receive biosolids or sewage
sludge.]
--------------------------------------------------------------------------------------------------------------------------------------------------------
NPDES ID This is the unique identifier for the NPDES permit or 122.2, 122.21, 122.21(j)(6), 122.21(q), 1, 2, 3, 4,
control mechanism for NPDES regulated entities or 122.28(b)(2)(ii), 122.34(g)(3), 5, 6, 7,
Unpermitted ID for an unpermitted facility. This data 122.41(l)(4)(i), 122.41(l)(6) and (7), 8, 9, 10.
elements is used for compliance monitoring activities, 122.41(m)(3), 122.42(c), 122.42(e)(4),
violation determinations, and enforcement actions. This 123.26, 123.41(a), 125.96, 125.97(g),
data element also applies to Significant Industrial 125.98, 125.138(b), 401.14, 403.10,
Users (SIUs) and Categorical Industrial Users (CIUs) 403.12(e), 403.12(h), 403.12(i),
that discharge (including non-domestic wastewater 503.18, 503.28, 503.48
delivered by truck, rail, and dedicated pipe or other
means of transportation) to one or more POTWs in states
where the POTW is the Control Authority
Master General Permit Number The unique identifier of the master general permit, 122.2, 122.21, 122.21(j)(6), 122.21(q), 1, 2.
which is linked to a General Permit Covered Facility. 122.28(b)(2)(ii), 122.34(g)(3),
This data element only applies to facilities regulated 122.41(l)(4)(i), 122.41(l)(6) and (7),
by a master general permit 122.41(m)(3), 122.42(c), 122.42(e)(4),
123.26, 123.41(a), 403.10, 403.12(e),
403.12(h), 403.12(i), 503.18, 503.28,
503.48
Permit Type The unique code/description identifying the type of 122.2, 122.21, 122.21(j)(6), 122.21(q), 1, 2.
permit [e.g., NPDES Individual Permit, NPDES Master 122.28(b)(2)(ii), 403.10
General Permit, General Permit Covered Facility, State
Issued Non-NPDES General Permit, Individual IU Permit
(Non-NPDES), Individual State Issued Permit (Non-
NPDES)]
Permit Component This will identify one or more applicable NPDES 122.2, 122.21, 122.21(j)(6), 122.21(q), 1, 2.
subprograms (e.g., pretreatment, CAFO, CSO, POTW, 122.28(b)(2)(ii), 403.10
biosolids/sewage sludge, stormwater) for the permit
record. This field is only required when the permit
includes one or more NPDES subprograms
Permit Issue Date This is the date the permit was issued. The date must be 122.46 1.
provided in YYYY-MM-DD format where YYYY is the year,
MM is the month, and DD is the day
Permit Effective Date This is the date on which the permit is effective. The 122.46, 122.21, 122.21(j)(6), 1.
date must be provided in YYYY-MM-DD format where YYYY 122.21(q), 403.10
is the year, MM is the month, and DD is the day
Permit Modification/Amendment Date This is the date on which the permit was modified or 122.62, 122.63, 403.10 1.
amended. The date must be provided in YYYY-MM-DD format
where YYYY is the year, MM is the month, and DD is the
day
Permit Expiration Date This is the date the permit will expire. The date must 122.46, 122.21, 122.21(j)(6), 1.
be provided in YYYY-MM-DD format where YYYY is the 122.21(q), 403.10
year, MM is the month, and DD is the day
Permit Termination Date This is the date the permit was terminated. The date 122.64, 403.10 1.
must be provided in YYYY-MM-DD format where YYYY is the
year, MM is the month, and DD is the day
Permit Major/Minor Status Indicator This code/description identifies the permit status as 122.2 1.
``Major'' or ``Nonmajor'' (a.k.a. ``Minor''). This data
element is initially system generated and defaults to
``Minor''. The most recent permit status is copied when
the permit is reissued
Permit Major/Minor Status Start Date The date that the permit became its current Major/Minor 122.2 1.
status. Initially system-generated to match effective
date. The date must be provided in YYYY-MM-DD format
where YYYY is the year, MM is the month, and DD is the
day
Permit Application Total Design Flow This is the design flow rate that a permitted facility 122.21, 122.28(b)(2)(ii), 403.10(f) 1, 2.
was designed to accommodate, in millions of gallons per
day (MGD). This is only required for wastewater
treatment plants
Permit Application Total Actual Average This is the annual average daily flow rate that a 122.21,122.28(b)(2)(ii), 122.41, 1, 2.
Flow permitted facility will likely accommodate at the start 403.10(f)
of its permit term, in MGD. This is only required for
wastewater treatment plants
Complete Permit Application/NOI Received This is the date on which the complete application for 122.21, 122.28(b)(2)(ii), 403.10(f) 1.
Date an individual NPDES permit was received or a complete
Notice of Intent (NOI) for coverage under a master
general permit was received. The date must be provided
in YYYY-MM-DD format where YYYY is the year, MM is the
month, and DD is the day. This data element can be
system generated when the complete NOI is
electronically received by the NPDES program
Permit Application/NOI Received Date This is the date on which the application for an 122.21, 122.28(b)(2)(ii), 403.10(f) 1.
individual NPDES permit was received or a Notice of
Intent (NOI) for coverage under a master general permit
was received. The date must be provided in YYYY-MM-DD
format where YYYY is the year, MM is the month, and DD
is the day. This data element can be system generated
when the NPDES permit application or NOI is
electronically received by the NPDES program
Permit Status This is a unique code/description that identifies the 122.21, 122.21(j)(6), 122.21(q), 1.
permit status (e.g., Effective, Expired, 122.64, 122.46, 403.10(f)
Administratively Continued, Pending, Not Needed,
Retired, Denied, and Terminated). This is system
generated for all statuses except ``Not Needed,'' which
must be user entered
Master General Permit Industrial These are the one or more unique codes/descriptions that 122.21, 122.21(j)(6), 122.21(q), 1.
Category identify the one or more industrial categories covered 122.28(b)(2)(ii), 403.10(f)
by the master general permit. This field is required
for master general permits only
Permit Issuing Organization Type This is the type of organization issuing a permit (e.g., 122.21, 122.21(j)(6), 122.21(q), 1.
County, Federal, Local, Municipal, Regional, State, 123.41, 403.10(f)
Tribal)
DMR Non-Receipt Turns non-receipt tracking for compliance monitoring 123.45, 403.10(f) 1.
submissions [e.g., discharge monitoring reports (DMRs)]
``on'' or ``off'' for non-major permits (a.k.a.
``minors''). This field is always ``on'' for major
permits. This data element is initially system
generated (defaults to ``on'') and the most recent
value is copied when the permit is reissued. . . . This
data element will also be used to track non-receipt
tracking of periodic compliance monitoring data [40 CFR
403.12(e) and (h)] for Significant Industrial Users
(SIUs) and Categorical Industrial Users (CIUs) that
discharge (including non-domestic wastewater delivered
by truck, rail, and dedicated pipe or other means of
transportation) to one or more POTWs in states where
EPA or the State is the Control Authority)
DMR Non-Receipt Start Date This is the date on which the permit's ``on'' or ``off'' 123.45, 403.10(f) 1.
period for DMR Non-Receipt tracking status began.
Initially system-generated to match effective date. The
date must be provided in YYYY-MM-DD format where YYYY
is the year, MM is the month, and DD is the day. This
data element will also be used to track non-receipt
tracking of periodic compliance monitoring data [40 CFR
403.12(e) and (h)] for Significant Industrial Users
(SIUs) and Categorical Industrial Users (CIUs) that
discharge (including non-domestic wastewater delivered
by truck, rail, and dedicated pipe or other means of
transportation) to one or more POTWs in states where
EPA or the State is the Control Authority)
Reportable Noncompliance Tracking Turns reportable noncompliance (RNC) tracking ``on'' or 123.45, 403.10(f) 1.
``off'' for non-major permits (a.k.a. ``minors''). This
data element is initially system generated (defaults to
``on'') and the most recent value is copied when the
permit is reissued
Reportable Noncompliance Tracking Start This is the date on which the permit's ``on'' or ``off'' 123.45, 403.10(f) 1.
Date period for Reportable Noncompliance Tracking status
began. Initially system-generated to match effective
date. The date must be provided in YYYY-MM-DD format
where YYYY is the year, MM is the month, and DD is the
day
Applicable Effluent Limitations The applicable effluent limitations guidelines and new 122.21, 122.21(j)(6), 122.21(q), 1.
Guidelines source performance standards in the NPDES permit (e.g., 122.44, 403.10(f)
part 414--Organic chemicals, plastics, and synthetic
fibers point source category). This data element also
applies to SIUs and CIUs that discharge (including non-
domestic wastewater delivered by truck, rail, and
dedicated pipe or other means of transportation) to one
or more POTWs in states where the POTW is the Control
Authority
Permit Compliance Tracking Status This is a unique code/description that indicates whether 122.21, 122.21(j)(6), 122.21(q), 1.
the permit is currently ``on'' or ``off'' for 123.45, 403.10(f)
compliance tracking purposes. This data element is
initially system generated (defaults to ``on'') and the
most recent value is copied when the permit is reissued
Permit Compliance Tracking Status Start This is the date on which the permit's ``on'' or ``off'' 122.21, 122.21(j)(6), 122.21(q), 1.
Date period for compliance tracking status began. Initially 123.45, 403.10(f)
system-generated to match effective date. The date must
be provided in YYYY-MM-DD format where YYYY is the
year, MM is the month, and DD is the day
RNC Status (Manual) The status of reportable noncompliance (RNC) as it was 122.21, 122.21(j)(6), 122.21(q), 1.
entered by the regulatory authority for the official 123.45, 403.10(f)
Quarterly Noncompliance Report (QNCR) or NPDES
Noncompliance Report (NNCR). This data element can also
be revised by the regulatory authority
RNC Status (Manual) Year The year associated with the RNC Status (Manual) being 122.21, 122.21(j)(6), 122.21(q), 1.
reported. This data element is used for the official 123.45, 403.10(f)
Quarterly Noncompliance Report (QNCR) or NPDES
Noncompliance Report (NNCR). This data element can also
be revised by the regulatory authority
RNC Status (Manual) Quarter The quarter associated with the RNC Status (Manual) 122.21, 122.21(j)(6), 122.21(q), 1.
being reported. This data element is used for the 123.45, 403.10(f)
official Quarterly Noncompliance Report (QNCR) or NPDES
Noncompliance Report (NNCR). This data element can also
be revised by the regulatory authority
Associated NPDES ID Number If applicable, the unique identifier for each NPDES 122.2, 122.21, 122.21(j)(6), 122.21(q), 1 through
Permit that is related to another NPDES Permit. For 122.28(b)(2)(ii), 122.41(l)(4)(i), 5, 7, 8,
example, this data element identifies the recipient 122.41(l)(6) and (7), 122.41(m)(3), and 9.
POTW's NPDES ID for each satellite collection system, 122.42(e)(4), 123.26, 123.41(a),
the suppliers of biosolids and sewage sludge to a land 503.18, 503.28, 503.48
application site, and the one or more NPDES IDs for
other permitted operators at the same construction site
or industrial facility. This data element does not
apply to municipal storm sewer systems (MS4s) as other
data elements create linkages between these entities
Associated NPDES ID Number Reason The unique code/description that identifies the reason 122.2, 122.21, 122.21(j)(6), 122.21(q), 1 through
for the association between two NPDES IDs (e.g., ETP = 122.28(b)(2)(ii), 122.41(l)(4)(i), 5, 7, 8,
Effluent Trade Partner, APR = Associated Permit Record, 122.41(l)(6) and (7), 122.41(m)(3), and 9.
SIP = Switched To An Individual Permit, SGP = Switched 122.42(e)(4), 123.26, 123.41(a),
To A General Permit. This data element does not apply 503.18, 503.28, 503.48
to municipal storm sewer systems (MS4s) as other data
elements create linkages between these entities
Receiving POTW ID This data element will identify for each Significant 122.21, 122.21(j)(6)[,] 1, 2, and
Industrial Users (SIUs) and Categorical Industrial 7.
Users (CIUs) the unique identifier of the one or more
POTWs receiving the discharge. This includes non-
domestic wastewater delivered by truck, rail, and
dedicated pipe or other means of transportation to the
one or more receiving POTWs. This data element only
applies to SIUs and CIUs and will link the industrial
discharger to the one or more receiving POTWs
SIC Code The one or more four-digit Standard Industrial 122.21, 122.21(j)(6), 122.21(q), 1, 2, and
Classification (SIC) codes that represent the economic 122.28(b)(2)(ii), 403.10(f), 7.
activities of the facility. This data element also 403.12(e), 403.12(h), 403.12(i),
applies to SIUs and CIUs that discharge (including non- 503.18, 503.28, 503.48
domestic wastewater delivered by truck, rail, and
dedicated pipe or other means of transportation) to one
or more POTWs in states where the POTW is the Control
Authority. A value of ``4952'' can be system generated
for POTWs and TWTDS
SIC Code Primary Indicator This data element will identify the primary economic 1, 2, and 7.
activity, SIC code, of the facility. This data element
is required for electronic data transfer between state
and EPA systems. This data element also applies to SIUs
and CIUs that discharge (including non-domestic
wastewater delivered by truck, rail, and dedicated pipe
or other means of transportation) to one or more POTWs
in states where the POTW is the Control
Authority122.21, 122.21(j)(6), 122.21(q),
122.28(b)(2)(ii), 403.10(f), 403.12(e), 403.12(h),
403.12(i), 503.18, 503.28, 503.48
NAICS Code The six-digit North American Industry Classification EPA SIC/NAICS Data Standard, Standard 1, 2, and
System (NAICS) code/description that represents the No. EX000022.2, 6 January 2006, Office 7.
economic activity of the facility. This field is of Management and Budget, Executive
optional if the ``SIC Code'' data element is provided Office of the President, Final
for the facility Decision on North American Industry
Classification System (62 FR 17288),
403.10(f)
NAICS Code Primary Indicator This data element will identify the primary economic EPA SIC/NAICS Data Standard, Standard 1, 2, and
activity, NAICS code, of the facility. This data No. EX000022.2, 6 January 2006, Office 7.
element is required for electronic data transfer of Management and Budget, Executive
between state and EPA systems. This field is optional Office of the President, Final
if the ``SIC Code'' data element is provided for the Decision on North American Industry
facility Classification System (62 FR 17288),
403.10(f)
Permittee Mailing Address The mailing address of the permit holder 122.21, 122.21(j)(6), 122.21(q), 1, 2.
122.28(b)(2)(ii), 403.10(f)
Permittee Organization Formal Name The legal, formal name of the organization that holds 122.21, 122.21(j)(6), 122.21(q), 1, 2.
the permit 122.28(b)(2)(ii), 403.10(f)
Permittee City The name of the city, town, or village where the mail is 122.21, 122.21(j)(6), 122.21(q), 1, 2.
delivered for the permit holder 122.28(b)(2)(ii), 403.10(f)
Permittee State The U.S. Postal Service abbreviation that represents the 122.21, 122.21(j)(6), 122.21(q), 1, 2.
state or state equivalent for the U.S. for the permit 122.28(b)(2)(ii), 403.10(f)
holder
Permittee Zip Code The combination of the 5-digit Zone Improvement Plan 122.21, 122.21(j)(6), 122.21(q), 1, 2.
(ZIP) code and the 4-digit extension code (if 122.28(b)(2)(ii), 403.10(f)
available) that represents the geographic segment that
is a sub-unit of the ZIP Code assigned by the U.S.
Postal Service to a geographic location for the permit
holder
Residual Designation Determination Code Under section 402(p)(2)(E) and (6) and 40 CFR 122.26(a)(9)(i)(C) and (D) and CWA 1.
122.26(a)(9)(i)(C) and (D), the authorized NPDES section 402(p)
program or the EPA Regional Administrator may
specifically designate stormwater discharges as
requiring an NPDES permit. In this `residual
designation' process the NPDES permitting authority
regulates stormwater discharges based on: (1) Wasteload
allocations that are part of ``total maximum daily
loads'' (TMDLs) that address the pollutant(s) of
concern in the stormwater discharges [see 40 CFR
122.26(a)(9)(i)(C)]; or (2) the determination that the
stormwater discharge, or category of stormwater
discharges within a geographic area, contributes to a
violation of a water quality standard or is a
significant contributor of pollutants to waters of the
United States [see 40 CFR 122.26(a)(9)(i)(D)]. This
data element is the unique code/description that
identifies the main basis for this residual designation
determination. This data element only applies to
stormwater permits
Electronic Reporting Waiver Type The unique code/description that identifies whether the 123.26, 123.41(a) and CWA section 308 1.
authorized NPDES program has granted the permittee a
waiver from electronic reporting in compliance with
this part (1 = temporary waiver; 2 = permanent waiver).
This data element should be left blank if the permittee
does not have a waiver from electronic reporting in
compliance with this part
Electronic Reporting Waiver Expiration This is the expiration date for a temporary waiver from 123.26, 123.41(a) and CWA section 308 1.
Date electronic reporting in compliance with this part. This
data element should be left blank if the permittee has
a permanent waiver from electronic reporting or if the
permittee does not have a waiver from electronic
reporting in compliance with this part
Electronic Submission Type (General This is the unique code/description for each general 123.26, 123.41(a) and CWA section 308 1.
Permit Reports) permit report submitted by the facility or entity.
Notices, certifications, and waiver requests covered by
this data element are listed in Table 1 in this
appendix (i.e., NPDES Data Group 2). This data element
describes how each submission was electronically
collected or processed by the initial recipient [see
127.2(b)]. For example, these unique codes/descriptions
include: (1) NPDES regulated entity submits NPDES
program data using an EPA electronic reporting system;
(2) NPDES regulated entity submits NPDES program data
using an authorized NPDES program electronic reporting
system; (3) NPDES regulated entity has temporary waiver
from electronic reporting and submits NPDES program
data on paper to the authorized NPDES program who then
electronically uses manual data entry to electronically
process these data; (4) NPDES regulated entity has a
permanent waiver from electronic reporting and submits
NPDES program data on paper to the authorized NPDES
program who then electronically uses manual data entry
to electronically process these data; (5) NPDES
regulated entity has an episodic waiver from electronic
reporting and submits NPDES program data on paper to
the authorized NPDES program who then electronically
uses manual data entry to electronically process these
data; (6) NPDES regulated entity submits NPDES program
data on paper in a form that allows the authorized
NPDES program to use of automatic identification and
data capture technology to electronically process these
data; (7) NPDES regulated entity submits NPDES program
data using another electronic reporting system (e.g.,
third-party). This data element can sometimes be system
generated (e.g., incorporated into an electronic
reporting tool). This data element does not identify
the electronic submission type of other reports (NPDES
Data Groups = 3 through 10 in Table 1), which is
tracked by the ``Electronic Submission Type (Compliance
Monitoring Activity)'' data element
NPDES Data Group Number This is the unique code/description that identifies the 122.2, 122.21, 122.21(j)(6), 122.21(q), 1.
types of NPDES program data that are required to be 122.28(b)(2)(ii), 122.34(g)(3),
reported by the facility. This corresponds to Table 1 122.41(l)(4)(i), 122.41(l)(6) and (7),
in this appendix (e.g., 3 = Discharge Monitoring Report 122.41(m)(3), 122.42(c), 122.42(e)(4),
[40 CFR 122.41(l)(4)]). This data element can be system 123.26, 123.41(a), 403.10, 403.12(e),
generated. This data element will record each NPDES 403.12(h), 403.12(i), 503.18, 503.28,
Data Group that the facility is required to submit. For 503.48 and CWA section 308
example, when a POTW is required to submit a Discharge
Monitoring Report, Sewage Sludge/Biosolids Annual
Program Report, Pretreatment Program Report, and Sewer
Overflow/Bypass Event Report, the values for this data
element for this facility will be 3, 4, 7, and 9. The
following general permit reports will have the
following values for this data element: 2a = Notice of
Intent to discharge (NOI); 2b = Notice of Termination
(NOT); 2c = No Exposure Certification (NOE); and 2d =
Low Erosivity Waiver or Other Waiver from stormwater
Controls (LEW)
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Narrative Conditions and Permit Schedules Information
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[Note: As indicated in the ``CWA, Regulatory, or Other Citation'' column, these data elements also apply to Significant Industrial Users (SIUs)
and Categorical Industrial Users (CIUs) that discharge (including non-domestic wastewater delivered by truck, rail, and dedicated pipe or other means
of transportation) to one or more POTWs in states where EPA or the State is the Control Authority].
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Permit Narrative Condition Code The unique code/description that identifies the type of 122.47, 403.10(f) 1.
narrative condition
Permit Narrative Condition Number This number uniquely identifies a narrative condition 122.47, 403.10(f) 1.
and its elements for a permit
Permit Schedule Date The date on which a permit schedule event is due to be 122.47, 403.10(f) 1.
completed and against which compliance will be
measured. The date must be provided in YYYY-MM-DD
format where YYYY is the year, MM is the month, and DD
is the day
Permit Schedule Actual Date The date on which the permittee achieved the schedule 122.47, 403.10(f) 1.
event. The date must be provided in YYYY-MM-DD format
where YYYY is the year, MM is the month, and DD is the
day
Required Report Received Date The date on which the regulatory authority receives a 122.47, 403.10(f) 1.
report from the permittee indicating that a scheduled
event was completed (e.g., the start of construction)
or the date on which the regulatory authority received
the required report. The date must be provided in YYYY-
MM-DD format where YYYY is the year, MM is the month,
and DD is the day
Permit Schedule Event Code The unique code/description indicating the one or more 122.47, 403.10(f) 1.
events with which the permittee is scheduled to comply
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Permitted Feature Information
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[Note: These `Permitted Feature' data elements are only required to be submitted for permits that require limits or outfall monitoring for
stationary point sources. Additionally, as indicated in the ``CWA, Regulatory, or Other Citation'' column, some of these data elements apply to
Significant Industrial Users (SIUs) and Categorical Industrial Users (CIUs) that discharge (including non-domestic wastewater delivered by truck,
rail, and dedicated pipe or other means of transportation) to one or more POTWs in states where EPA or the State is the Control Authority].
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Permitted Feature Application Actual The average flow that a permitted feature will actually 122.21, 122.28(b)(2)(ii), 403.10(f) 1, 2.
Average Flow (MGD) discharge or transmit, in MGD, at the start of its
permit term. This data element does not apply to
regulated entities that do not discharge (e.g., some
biosolids/sewage sludge generators) and entities that
only discharge stormwater. This data element may also
not apply to some intermittent dischargers
Permitted Feature Identifier (Permit) The identifier assigned for each location at which 122.21, 122.28(b)(2)(ii), 403.10(f) 1, 2.
conditions are being applied (e.g., external outfall).
This data element also identifies cooling water intake
structures
Permitted Feature Type The code/description that uniquely identifies the type 122.21, 122.28(b)(2)(ii), 403.10(f) 1, 2.
of permitted feature (e.g.[,] external outfall, sum,
intake structure, cooling water intake structure)
Receiving Waterbody Name for Permitted The name of the waterbody that is or will likely receive 122.21, 122.28(b)(2)(ii) 1, 2.
Feature the discharge from each permitted feature
Permitted Feature Longitude The measure of the angular distance on a meridian east 122.21, 122.28(b)(2)(ii) 1, 2.
or west of the prime meridian for the permitted
feature. The format for this data element is decimal
degrees (e.g., ^77.029289) and the WGS84 standard
coordinate system
Permitted Feature Latitude The measure of the angular distance on a meridian north 122.21, 122.28(b)(2)(ii) 1, 2.
or south of the equator for the permitted feature. The
format for this data element is decimal degrees (e.g.,
38.893829) and the WGS84 standard coordinate system
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Limit Set Information
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[Note: These `Limit Set' data elements are only required to be submitted for permits that require limits or outfall monitoring for stationary
point sources. Additionally, as indicated in the ``CWA, Regulatory, or Other Citation'' column, these data elements apply to Significant Industrial
Users (SIUs) and Categorical Industrial Users (CIUs) that discharge (including non-domestic wastewater delivered by truck, rail, and dedicated pipe
or other means of transportation) to one or more POTWs in states where EPA or the State is the Control Authority].
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Limit Set Designator The alphanumeric field that is used to designate a 122.45, 403.10(f) 1.
particular grouping of parameters within a limit set
Limit Set Type The unique code/description identifying the type of 122.45, 403.10(f) 1.
limit set (e.g., scheduled, unscheduled)
Modification Effective Date (Limit Set) The effective date of the permit modification that 122.45, 403.10(f) 1.
updated or created a limit set. The date must be
provided in YYYY-MM-DD format where YYYY is the year,
MM is the month, and DD is the day
Modification Type (Limit Set) The type of permit modification that updated or created 122.45, 403.10(f) 1.
this limit set (e.g., major modification, minor
modification, permit authorized change)
Initial Monitoring Date The date on which monitoring starts for the first 122.45, 403.10(f) 1.
monitoring period for the limit set. This date will be
blank for unscheduled limit sets. The date must be
provided in YYYY-MM-DD format where YYYY is the year,
MM is the month, and DD is the day
Initial DMR Due Date The date that the first compliance monitoring submission 122.45, 403.10(f) 1.
(e.g., DMR) for the limit set is due to the regulatory
authority. This date will be blank for unscheduled
limit sets. The date must be provided in YYYY-MM-DD
format where YYYY is the year, MM is the month, and DD
is the day. This data element will also be used to
track non-receipt tracking of periodic compliance
monitoring data [40 CFR 403.12(e) and (h)] for
Significant Industrial Users (SIUs) and Categorical
Industrial Users (CIUs) that discharge (including non-
domestic wastewater delivered by truck, rail, and
dedicated pipe or other means of transportation) to one
or more POTWs in states where EPA or the State is the
Control Authority)
Number of Report Units The number of months covered in each compliance 122.45, 403.10(f) 1.
monitoring period (e.g., monthly = 1, semi-annually =
6, quarterly = 3)
Number of Submission Units The number of months between compliance monitoring 122.45, 403.10(f) 1.
submissions (e.g., monthly = 1, semi-annually = 6,
quarterly = 3). This data element will be blank for
unscheduled limit sets For example, if the permittee
was required to submit monthly reports every quarter,
the number of report units would be one (i.e., monthly)
and the number of submission units would be three
(i.e., three months of information in each submission).
Limit Set Status The status of the limit set (e.g., active, inactive). subpart C of 122, 403.10(f) 1.
Limit sets will not have violations generated when a
limit set is inactive unless an enforcement action
limit is present
Limit Set Status Start Date The date that the Limit Set Status started. The date 123.45, 403.10(f) 1.
must be provided in YYYY-MM-DD format where YYYY is the
year, MM is the month, and DD is the day
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Limit Information
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[Note: These `Limit' data elements are only required to be submitted for permits that require limits or outfall monitoring for stationary point
sources. Additionally, as indicated in the ``CWA, Regulatory, or Other Citation'' column, some of these data elements apply to Significant Industrial
Users (SIUs) and Categorical Industrial Users (CIUs) that discharge (including non-domestic wastewater delivered by truck, rail, and dedicated pipe
or other means of transportation) to one or more POTWs in states where EPA or the State is the Control Authority].
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Monitoring Location Code The unique code/description of the monitoring location 122.45, 403.10(f) 1.
at which sampling should occur for a limit parameter
Limit Season Number Indicates the season of a limit and is used to enter 122.45, 403.10(f) 1.
different seasonal limits for the same parameter within
a single limit start and end date
Limit Start Date The date on which a limit starts being in effect for a 122.45, 403.10(f) 1.
particular parameter in a limit set. The date must be
provided in YYYY-MM-DD format where YYYY is the year,
MM is the month, and DD is the day
Limit End Date The date on which a limit stops being in effect for a 122.45, 403.10(f) 1.
particular parameter in a limit set. The date must be
provided in YYYY-MM-DD format where YYYY is the year,
MM is the month, and DD is the day
Change of Limit Status Indicator The unique code/description that describes circumstances subpart C of 122, 403.10(f) 1.
affecting limits, such as formal enforcement actions or
permit modifications
Limit Stay Type The unique identifier of the type of stay applied to a 122.45, 403.10(f) 1.
limit (e.g., X, Y, Z), which indicates whether the
limits do not appear on the compliance monitoring
report (e.g., DMR) at all, are treated as monitor only,
or have a stay value in effect during the period of the
stay
Limit Stay Start Date The date on which a limit stay begins. The date must be 124.19, 403.10(f) 1.
provided in YYYY-MM-DD format where YYYY is the year,
MM is the month, and DD is the day
Limit Stay End Date The date on which a limit stay is lifted. The date must 124.19, 403.10(f) 1.
be provided in YYYY-MM-DD format where YYYY is the
year, MM is the month, and DD is the day
Reason for Limit Stay The text that represents the reason a stay was applied 124.19, 403.10(f) 1.
to a permit
Stay Limit Value The numeric limit value imposed during the period of the 124.19, 403.10(f) 1.
stay for the limit; if entered, during the stay period,
the system will use this limit value for calculating
compliance, rather than the actual limit value that was
stayed
Limit Type The unique code/description that indicates whether a 122.45, 403.10(f) 1.
limit is an enforceable, or alert limit (e.g., action
level, benchmark) that does not receive effluent
violations
Enforcement Action ID The unique identifier for the enforcement action that 122.45, 403.10(f) 1.
imposed the enforcement action limit; this data element
helps uniquely tie the limit record to the final order
record
Final Order ID The unique identifier for the Final Order that imposed 122.45, 403.10(f) 1.
the Enforcement Action limit; this data element ties
the limit record to the Final Order record in the
database
Modification Effective Date The effective date of the permit modification that 122.62, 403.10(f) 1.
created this limit. The date must be provided in YYYY-
MM-DD format where YYYY is the year, MM is the month,
and DD is the day
Modification Type The type of permit modification that created this limit 122.62, 403.10(f) 1.
(e.g., major, minor, permit authorized change)
Limit Parameter Code The unique code/description identifying the parameter 122.41(j), 403.10(f) 1.
being limited and/or monitored
Limit Months The months that the limit applies 122.46, 403.10(f) 1.
Limit Value Type The indication of the limit value type (e.g., Quantity 122.45(f), 403.10(f) 1.
1, Concentration 2)
Limit Quantity or Concentration Units The unique code/description representing the unit(s) of 122.45(f), 403.10(f) 1.
measure applicable to quantity or concentration limits
as entered by the user
Statistical Base Code The unique code/description representing the unit of 122.45(d), 403.10(f) 1.
measure applicable to the limit and compliance
monitoring activity (e.g., DMR) values entered by the
user (e.g., 30-day average, daily maximum)
Optional Monitoring Code The code/description that indicates when monitoring is 122.45, 403.10(f) 1.
optional but not required (e.g., DMR Non-Receipt
violation generation will be suppressed for optional
monitoring)
Limit Value Qualifier The unique code identifying the limit value operator 122.45, 403.10(f) 1.
(e.g., ``<'', ``='', ``>'')
Limit Value The actual limit value number from the Permit or 122.45, 403.10(f) 1.
Enforcement Action Final Order
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Sewage Sludge/Biosolids Information on NPDES Permit Application or Notice of Intent
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[Note: As indicated in the ``CWA, Regulatory, or Other Citation'' column, these data elements apply to Treatment Works Treating Domestic Sewage
whose sewage sludge use or disposal practices are regulated by part 503.]
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Biosolids/Sewage Sludge Management The unique code/description that identifies whether the 122.21(q), 122.28(b)(2)(ii), 503.18, 1, 2, and
Facility Type facility was issued a permit as a biosolids/sewage 503.28, 503.48 4.
sludge generator, processor, or end user (e.g., land
application site, surface disposal site, incinerator).
For the Sewage Sludge/Biosolids Annual Report this data
element is also the unique code/description that
identifies an off-site facility or location receives
biosolids or sewage sludge from this facility. This
data element is also required for the Sewage Sludge/
Biosolids Annual Report
Biosolids or Sewage Sludge Treatment The one or more unique codes/descriptions that 122.21(q)(6), 122.28(b)(2)(ii) 1, 2.
Processes (Permit) identifies the biosolids or sewage sludge treatment
process or processes at the facility. For example, this
may include treatment processes in the following
categories: preliminary operations (e.g., sludge
grinding and degritting), thickening (concentration),
stabilization, anaerobic digestion, aerobic digestion,
composting, conditioning, disinfection (e.g., beta ray
irradiation, gamma ray irradiation, pasteurization),
dewatering (e.g., centrifugation, sludge drying beds,
sludge lagoons), heat drying, thermal reduction, and
methane or biogas capture and recovery
Biosolids or Sewage Sludge Form (Permit) The one or more unique codes/descriptions that identify 122.21(q)(6), 122.28(b)(2)(ii) 1, 2.
the nature of each biosolids and sewage sludge material
generated by the facility in terms of whether the
material is a biosolid or sewage sludge and whether the
material is ultimately conveyed off-site in bulk or in
bags. The facility will separately report the form for
each biosolids or sewage sludge management practice and
pathogen class
Biosolids or Sewage Sludge Management The one or more unique codes/descriptions that identify 122.21(q)(6), 122.28(b)(2)(ii) 1, 2.
Practice (Permit) the type of biosolids or sewage sludge management
practice or practices (e.g., land application, surface
disposal, incineration) used by the facility. The
facility will separately report the practice for each
different form of biosolids and sewage sludge generated
by the facility and pathogen class
Biosolids or Sewage Sludge Pathogen The one or more unique codes/descriptions that identify 122.21(q)(6), 122.28(b)(2)(ii) 1, 2.
Class (Permit) the pathogen class or classes (e.g., Class A, Class B,
Not Applicable) for biosolids or sewage sludge
generated by the facility. The facility will separately
report the pathogen class for each biosolids or sewage
sludge management practice used by the facility and for
each biosolids or sewage sludge form
Biosolids or Sewage Sludge Vector The one or more unique codes/descriptions that identify 122.21(q)(6), 122.28(b)(2)(ii) 1, 2.
Attraction Reduction Options (Permit) the option(s) used by the facility for vector
attraction reduction. See a listing of these vector
attraction reduction options at 40 CFR 503.33(b)(1)
through (11). The facility will separately report the
vector attraction reduction options for each biosolids
or sewage sludge management practice used by the
facility and for each biosolids or sewage sludge form
as well as by each biosolids or sewage sludge pathogen
class
Biosolids or Sewage Sludge Pathogen The one or more unique codes/descriptions that identify 122.21(q)(6), 122.28(b)(2)(ii) 1, 2.
Reduction Options (Permit) the option(s) used by the facility to control pathogens
(e.g., Class A--Alternative 1, Class A--Alternative 2,
Class A--Alternative 3, Class A--Alternative 4, Class
A--Alternative 5, Class A--Alternative 6, Class B--
Alternative 1, Class B--Alternative 2, Class B--
Alternative 3, or pH Adjustment (Domestic Septage). The
facility will separately report the pathogen reduction
options for each biosolids or sewage sludge management
practice used by the facility and by each biosolids or
sewage sludge form as well as by each biosolids or
sewage sludge pathogen class
Biosolids or Sewage Sludge Amount This is the amount (in dry metric tons) of biosolids or 122.21 (q), 122.28(b)(2)(ii) 1, 2.
(Permit) sewage sludge applied to the land, prepared for sale or
give-away in a bag or other container for application
to the land, or placed on an active sewage sludge unit
in the preceding 365-day period. This identification
will be made for each biosolids or sewage sludge
management practice used by the facility and by each
biosolids or sewage sludge form as well as by each
biosolids or sewage sludge pathogen class
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Animal Feeding Operation Information on NPDES Permit Application or Notice of Intent
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Facility CAAP Designation A unique code (e.g., ``Yes'', ``No'') to indicate 122.21(i)(2), 122.24, 122.25, 1, 2.
whether the facility includes Concentrated Aquatic 122.28(b)(2)(ii)
Animal Production (CAAP)
Facility CAFO Type The unique code/description that identifies whether the 122.21(i)(1), 122.23, 122.28(b)(2)(ii) 1, 2.
facility includes a small, medium or large Concentrated
Animal Feeding Operation (CAFO)
CAFO Designation Date The date on which the facility is designated as a small 122.23 1.
or medium Concentrated Animal Feeding Operation (CAFO).
The date must be provided in YYYY-MM-DD format where
YYYY is the year, MM is the month, and DD is the day
CAFO Designation Reason The reason(s) the State Director or the Regional 122.23(c) 1.
Administrator used to designate an animal feeding
operation as a small or medium CAFO. [Ed note: Large
and medium CAFO definitions are in 40 CFR 122.23(b)].
This text field can include the following factors: (1)
the size of the AFO and the amount of wastes reaching
waters of the United States; (2) the location of the
AFO relative to waters of the United States; (3) the
means of conveyance of animal wastes and process waste
waters into waters of the United States; (4) the slope,
vegetation, rainfall, and other factors affecting the
likelihood or frequency of discharge of animal wastes
manure and process waste waters into waters of the
United States; and (5) other relevant factors
CAFO Animal Types The unique code/description that identifies the animal 122.21(i)(1)(v), 122.28(b)(2)(ii) 1, 2.
type(s) at the facility (e.g., beef cattle, broilers,
layers, swine weighing 55 pounds or more, swine
weighing less than 55 pounds, mature dairy cows, dairy
heifers, veal calves, sheep and lambs, horses, ducks,
turkeys, other)
CAFO Animal Maximum Numbers The estimated maximum number of each type of animal in 122.21(i)(1)(v), 122.28(b)(2)(ii) 1, 2.
open confinement or housed under roof (either partially
or totally) which are held at the facility for a total
of 45 days or more in a 12 month period
CAFO Animal Maximum Numbers in Open The estimated maximum number of each type of animal in 122.21(i)(1)(v), 122.28(b)(2)(ii) 1, 2.
Confinement open confinement which are held at the facility for a
total of 45 days or more in a 12 month period
CAFO MLPW The unique code/description that identifies the type of 122.21(i)(1)(viii), 122.28(b)(2)(ii) 1, 2.
CAFO manure, litter, and process wastewater generated
by the facility i.e., in a 12 month period
CAFO MLPW Amounts The estimated amount of CAFO manure, litter, and process 122.21(i)(1)(viii), 122.28(b)(2)(ii) 1, 2.
wastewater generated by the facility i.e., in a 12
month period
CAFO MLPW Amounts Units The unit (e.g., tons, gallons) for the estimated maximum 122.21(i)(1)(viii), 122.28(b)(2)(ii) 1, 2.
amount of CAFO manure, litter, and process wastewater
generated by the facility i.e., in a 12 month period
CAFO MLPW Transferred The estimated maximum amount of CAFO manure, litter, and 122.21(i)(1)(ix), 122.28(b)(2)(ii) 1, 2.
process wastewater generated by the facility i.e., in a
12 month period that is transferred to other persons.
The units for this data element will be the same as the
units for the ``CAFO MLPW Amounts'' data element
Total Number of Acres Available for Land Total number of acres under the control of the applicant 122.21(i)(1)(vii), 122.28(b)(2)(ii) 1, 2.
Application that are available for land application of CAFO manure,
litter, and process wastewater
CAFO MLPW Containment and Storage Type The unique code/description describing the one or more 122.21(i)(1)(vi), 122.28(b)(2)(ii) 1, 2.
types of CAFO manure, litter, and process wastewater
containment and storage (e.g., lagoon, holding pond,
evaporation pond, anaerobic lagoon, storage lagoon,
evaporation pond, aboveground storage tanks,
belowground storage tanks, roofed storage shed,
concrete pad, impervious soil pad, other) at the
facility
CAFO MLPW Containment and Storage The estimated maximum capacity of each CAFO manure, 122.21(i)(1)(vi), 122.28(b)(2)(ii) 1, 2.
Maximum Capacity Amounts litter, and process wastewater containment and storage
type at the facility
CAFO MLPW Containment and Storage The unit for the estimated maximum capacity of each CAFO 122.21(i)(1)(vi), 122.28(b)(2)(ii) 1, 2.
Maximum Capacity Amounts Unit manure, litter, and process wastewater containment and
storage type at the facility (e.g., gallons)
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Construction and Industrial Stormwater Information [from the permitting authority derived from the No Exposure Certification, Low Erosivity Waiver, and
Other Waiver From Stormwater Controls (see Exhibit 1 to 40 CFR 122.26(b)(15)]
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No Exposure Certification Approval Date This is the date on which the No Exposure Certification 122.26(g) 1.
(NOE) was authorized by the NPDES permitting authority.
Submission of a No Exposure Certification means that
the facility does not require NPDES permit
authorization for its stormwater discharges due to the
existence of a condition of ``no exposure.'' A
condition of no exposure exists at an industrial
facility when all industrial materials and activities
are protected by a storm resistant shelter to prevent
exposure to rain, snow, snowmelt, and/or runoff and the
operator complies with all requirements at 40 CFR
122.26(g)(1) through (4). This date is provided by the
permitting authority. The date must be provided in YYYY-
MM-DD format where YYYY is the year, MM is the month,
and DD is the day
Low Erosivity Waiver or Other Waiver The NPDES Stormwater Phase II Rule allows NPDES Exhibit 1 to 40 CFR 122.26(b)(15) 1.
From Stormwater Controls Approval Date permitting authorities to accept low erosivity waivers
and other waivers from stormwater controls (LEWs) for
small construction sites. The waiver process exempts
small construction sites (disturbing under five acres)
from NPDES permitting requirements when the rainfall
erosivity factor is less than five during the period of
construction activity as well as other criteria [see
Exhibit 1 to 40 CFR 122.26(b)(15)]. This is the date
when the NPDES permitting authority granted such
waiver, based on information from the entity requesting
the waiver; this date is provided by the permitting
authority. The date must be provided in YYYY-MM-DD
format, where YYYY is the year, MM is the month, and DD
is the day
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Construction Stormwater Information on NPDES Permit Application, Notice of Intent, or Waiver Request [including construction activity requiring permit
coverage under 40 CFR 122.26(b)(14)(x)]
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Total Area of the Site This is an estimate of the total area of the 122.26(c)(1)(ii)(B) 1.
construction site at the time of permit application (in
acres). This data element is only required for
individual construction stormwater permit applications.
Values under 5 acres will be reported to the nearest \1/
10\ of an acre or nearest \1/4\ acre. Authorized NPDES
programs will have the discretion to choose whether
permittees should report to the nearest \1/10\ of an
acre or nearest \1/4\ acre for values under 5 acres
Total Activity Area (Construction) This is the estimate of the total area of the 122.26, 122.28(b)(2)(ii) 1, 2.
construction activities at the time of permit
application or filing of notice of intent to be covered
under a general permit (in acres). Areas of
construction activity include areas of clearing,
grading, and/or excavation and areas of construction
support activity (e.g., concrete or asphalt batch
plants, equipment staging yards, material storage
areas, excavated materials disposal areas, borrow
areas). Values under 5 acres will be reported to the
nearest \1/10\ of an acre or nearest \1/4\ acre.
Authorized NPDES programs will have the discretion to
choose whether permittees should report to the nearest
\1/10\ of an acre or nearest \1/4\ acre for values
under 5 acres
Post-Construction Total Impervious Area This is the estimate of total impervious area of the 122.26(c)(1)(ii)(E) 1.
site after the construction addressed in the permit
application is completed (in acres). This estimate is
made at the time of the permit application. This data
element is only required for individual construction
stormwater permit applications. Values under 5 acres
will be reported to the nearest \1/10\ of an acre or
nearest \1/4\ acre. Authorized NPDES programs will have
the discretion to choose whether permittees should
report to the nearest \1/10\ of an acre or nearest \1/
4\ acre for values under 5 acres
Proposed Stormwater Best Management This is the one or more unique codes that list the most 122.26(c)(1)(ii)(C) 1.
Practices for Construction Activities important proposed measures, including best management
practices, to control pollutants in stormwater
discharges from construction activities. This data
element includes temporary structural measures (e.g.,
check dams, construction road stabilization, silt
fences), vegetative measures (e.g., mulching, seeding,
sodding, straw/hay bale dikes), and permanent
structures (e.g., land grading, riprap slope
protection, streambank protection). This data element
field is only required for individual construction
stormwater permit applications
Post-Construction Stormwater Best This is the one or more unique codes that list the most 122.26(c)(1)(ii)(D) 1.
Management Practices for Construction important proposed long-term measures and permanent
Activities structures to control pollutants in stormwater
discharges, which will occur after the completion of
construction operations. The codes for this data
element include long-term control measures (e.g.,
cleaning and removal of debris after major storm
events, harvesting vegetation when a 50 percent
reduction in the original open water surface area
occurs, sediment cleanout, repairing embankments, side
slopes, and control structures) and permanent
structures (e.g., land grading, riprap slope
protection, streambank protection, ponds, wetlands,
infiltration basins, sand filters, filter strips). This
data element is only required for individual
construction stormwater permit applications
Soil and Fill Material Description This is a text field describes the nature of fill 122.26(c)(1)(ii)(E) 1.
material and existing data describing soils or the
quality of the discharge. This data element is only
required for individual construction stormwater permit
applications
Runoff Coefficient of the Site (Post- This is an estimate of the overall runoff coefficient of 122.26(c)(1)(ii)(E) 1.
Construction) the site after the construction addressed in the permit
application is completed. This data element is only
required for individual construction stormwater permit
applications
Estimated Construction Project Start The estimated start date for the construction project 122.26, 122.28(b)(2)(ii) 1, 2.
Date covered by the NPDES permit. The date must be provided
in YYYY-MM-DD format where YYYY is the year, MM is the
month, and DD is the day
Estimated Construction Project End Date The estimated end date for the construction project 122.26, 122.28(b)(2)(ii) 1, 2.
covered by the NPDES permit. The date must be provided
in YYYY-MM-DD format where YYYY is the year, MM is the
month, and DD is the day
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Industrial Stormwater Information on NPDES Permit Application [excluding construction activity requiring permit coverage under 40 CFR 122.26(b)(14)(x)]
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Total Surface Area Drained (Industrial) This is an estimate of the total surface area drained at 122.26(c)(1)(i)(B) 1.
the facility at the time of permit application (in
acres). This data field is only required for individual
industrial stormwater permit applications. Values under
5 acres will be reported to the nearest \1/10\ of an
acre or nearest \1/4\ acre. Authorized NPDES programs
will have the discretion to choose whether permittees
should report to the nearest \1/10\ of an acre or
nearest \1/4\ acre for values under 5 acres
Total Impervious Surface Area This is the estimate of the total impervious area at the 122.26(c)(1)(i)(B) 1.
(Industrial) facility at the time of permit application (in acres).
This data element is only required for individual
industrial stormwater permit applications. Values under
5 acres will be reported to the nearest \1/10\ of an
acre or nearest \1/4\ acre. Authorized NPDES programs
will have the discretion to choose whether permittees
should report to the nearest \1/10\ of an acre or
nearest \1/4\ acre for values under 5 acres
Proposed Stormwater Best Management This is the one or more codes that identify the 122.26(c)(1)(i)(B) 1.
Practices (Industrial) structural and non-structural control measures
(including treatment) to control pollutants in
stormwater discharges from industrial activities. This
data element includes long-term measures (e.g., good
housekeeping of waste-handling and waste-storage areas,
collecting debris and yard material, proper management
of vehicle wash and equipment maintenance areas) and
permanent structures (e.g., covers, pads, diversion
berms or channels, vegetative buffer strips, erosion
prevention and sediment control such as land grading,
riprap slope protection, streambank protection) to
control pollutants in stormwater discharges. This data
element is only required for individual industrial
stormwater permit applications
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Municipal Separate Storm Sewer System (MS4) Information on NPDES Permit Application or Notice of Intent
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MS4 Permit Class The unique code/description that identifies the size of 122.26, 122.28(b)(2)(ii) 1, 2.
the MS4 permit holder (e.g., Phase I = large or medium
MS4s, Phase II = small MS4s)
Unique Identifier for Each Municipality The unique identifier for each municipality covered 122.21(f), 122.26(d) 122.28(b)(2)(ii), 1, 2, 6.
Covered Under MS4 Permit under MS4 permit. Use of this identifier allows for 122.34(g)(3), and 122.42(c)
greater geographic resolution for the MS4 components
being tracked. This unique identifier does not change
over time. Use of this unique identifier is similar to
how the `Permitted Feature Identifier (Permit)' data
element is used to distinguish between permitted
features
MS4 Public Education Program The one or more unique codes/descriptions that 122.21(f), 122.26(d)(2)(iv)(A)(6), 1, 2.
identifies the educational materials the permittee (B)(5) and (6), and (D)(4);
intends to distribute or equivalent outreach activities 122.28(b)(2)(ii), 122.34(b)(1),
the permittee will implement to inform the target 122.34(d)(1)(i)
audience about the impacts of stormwater discharges and
the steps the public can take to reduce stormwater
pollutants
MS4 Measurable Goals Associated With The one or more unique codes/descriptions that 122.34(d)(1)(ii), 122.28(b)(2)(ii) 1, 2.
Public Education Program identifies measurable goals associated with the public
education programs including, as appropriate, the
months and years in which the permittee will undertake
required actions, including interim milestones and the
frequency of the action. This data element only applies
to Phase II MS4s
MS4 Public Involvement and Participation The one or more unique codes/descriptions that 122.21(f), 122.26(d)(2)(iv), 1, 2.
Program identifies how the permittee intends to involve the 122.28(b)(2)(ii), 122.34(b)(2),
public and at minimum comply with State, Tribal, and 122.34(d)(1)(i)
local public notice requirements to implement its
public involvement and participation program
MS4 Measurable Goals for the Public The one or more unique codes/descriptions that 122.28(b)(2)(ii) 122.34(d)(1)(ii) 1, 2.
Involvement and Participation Program identifies the measurable goals associated with the
public involvement and participation program including,
as appropriate, the months and years in which the
permittee will undertake required actions, including
interim milestones and the frequency of the action.
This data element only applies to Phase II MS4s
MS4 Illicit Discharge Detection and The one or more unique codes/descriptions that identify 122.21(f), 122.26(d)(1)(iii)(B), 1, 2.
Elimination how the permittee will comply with Illicit Discharge 122.26(d)(2)(i)(B) and (C),
Detection and Elimination requirements, including (at a 122.26(d)(2)(iv)(B), 122.28(b)(2)(ii),
minimum): (1) The status of the permittee's storm sewer 122.34(b)(3)(ii)(A)-(D),
system map showing the location of all outfalls and 122.34(d)(1)(i)
names and locations of all waters of the U.S. that
receive discharges from those outfalls; (2) the status
of the ordinance or other regulatory mechanism to
prohibit non-stormwater discharges into the permittee's
MS4; (3) the procedures and actions the permittee takes
to enforce the prohibition of non-stormwater discharges
to the permittee's MS4; (4) the status of the program
that identifies the procedures and actions the
permittee will take to detect and address non-
stormwater discharges, including illegal dumping, to
the permittee's MS4; and (5) the status of procedures
and actions the permittee will take to inform public
employees, businesses and the general public of hazards
associated with illegal discharges and improper
disposal of waste
MS4 Measurable Goals Associated With The one or more unique codes/descriptions that 122.34(d)(1)(ii) 1, 2.
Illicit Discharge Detection and identifies the measurable goals associated with the
Elimination Program illicit discharge detection and elimination program,
including, as appropriate, the months and years in
which the permittee will undertake required actions,
including interim milestones and the frequency of the
action. This data element only applies to Phase II MS4s
MS4 Construction Site Stormwater Runoff The one or more unique codes/descriptions that identify 122.21(f), 122.26(d)(2)(iv)(D), 1, 2.
Control how the permittee will comply with the Construction 122.28(b)(2)(ii), 122.34(b)(4)(ii),
Site Runoff Control requirements, including (at a 122.34(d)(1)(i)
minimum): (1) status of the ordinance or other
regulatory mechanism to require erosion and sediment
controls, including sanctions to ensure compliance; (2)
status of requirements for construction site operators
to implement appropriate erosion and sediment control
BMPs and control waste at the construction site that
may cause adverse impacts to water quality; (3) status
of procedures for site plan review that incorporate
consideration of potential water quality impacts; (4)
status of procedures for receipt and consideration of
information submitted by the public; and (5) status of
procedures for site inspection and enforcement of
control measures
MS4 Measurable Goals Associated with the The one or more unique codes/descriptions that identify 122.34(d)(1)(ii) 1, 2.
Construction Site Stormwater Runoff the measurable goals associated with the construction
Control Program program, including, as appropriate, the months and
years in which the permittee will undertake required
actions, including interim milestones and the frequency
of the action. This data element only applies to Phase
II MS4s
MS4 Post-Construction Stormwater The one or more unique codes/descriptions that identify 122.21(f), 122.26(d)(2)(iv)(A)(2), 1, 2.
Management In New Development And how the permittee will comply with the Post- 122.28(b)(2)(ii), 122.34(b)(5),
Redevelopment Construction Stormwater Management in New Development 122.34(d)(1)(i)
and Redevelopment requirements, including (at a
minimum): (1) Status of ordinance or other regulatory
mechanism to address post-construction runoff from new
development and redevelopment projects; (2) how the
permittee plans to address stormwater runoff from new
development and redevelopment projects that disturb a
minimum of greater than or equal to one acre (including
if the permittee requires on-site retention of
stormwater; and (3) status of a plan to ensure adequate
long-term operation and maintenance of BMPs for
controlling runoff from new development and
redevelopment projects
MS4 Measurable Goals Associated with the The one or more unique codes/descriptions that identify 122.34(d)(1)(ii) 1, 2.
Post-Construction: Stormwater the measurable goals associated with the post-
Management Program construction program, including, as appropriate, the
months and years in which the permittee will undertake
required actions, including interim milestones and the
frequency of the action. This data element only applies
to Phase II MS4s
MS4 Pollution Prevention/Good The one or more unique codes/descriptions that identify 122.21(f), 122.26(d)(2)(iv)(A)(1), (2) 1, 2.
Housekeeping for Municipal Operations how the permittee will comply with the Pollution and (3), 122.28(b)(2)(ii),
Program Prevention/Good Housekeeping requirements 122.34(b)(6)(i), 122.34(d)(1)(i)
MS4 Additional Measures The one or more unique codes/descriptions that identify 122.28(b)(2)(ii), 122.34(b), 122.34(d) 1, 2.
any other additional measures that are required by the 122.44(d)(1)(vii)(B)
permit such as controls to be consistent with the
assumptions and requirements of any available wasteload
allocation prepared by a state and approved by EPA.
This data element is optional if there are no MS4
additional measures
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POTW Information on NPDES Permit Application or Notice of Intent
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Name of Collection System This is the unique name of each collection system that 122.1(b) and 122.21(j)(1)(iv), 1, 2.
provides flow to the permittee. This includes 122.28(b)(2)(ii)
unincorporated connector districts and satellite
collection systems, which are sanitary sewers owned or
operated by another entity that conveys sewage or
industrial wastewater to this permittee. This data
element applies to POTWs
Owner Type of Collection System The unique code/description that identifies the 122.1(b) and 122.21(j)(1)(iv), 1, 2.
ownership type for each unique collection system that 122.28(b)(2)(ii)
provides flow to the permittee (e.g., municipality
owned, privately owned). This includes unincorporated
connector districts and satellite collection systems.
This data element applies to POTWs
Collection System Identifier This is the NPDES permit number (``NPDES ID'') for each 122.1(b) and 122.21(j)(1)(iv), 1, 2.
unique collection system that provides flow to the 122.28(b)(2)(ii)
permittee. If there is no NPDES permit number for the
collection system this data element will be a unique
identifier for each collection system that provides
flow to the permittee. This includes unincorporated
connector districts and satellite collection systems.
This data element applies to POTWs
Population of Collection System This is the estimated population for each unique 122.1(b) and 122.21(j)(1)(iv), 1, 2.
collection system that provides flow to the permittee. 122.28(b)(2)(ii)
This includes unincorporated connector districts and
satellite collection systems. This data element applies
to POTWs
Percentage of Collection System That Is For each unique collection system that provides flow to 122.1(b) and 122.21(j)(1)(iv) and 1, 2.
a Combined Sewer System the permittee, this is the estimated percentage of the (vii), 122.28(b)(2)(ii)
collection system that is a combined sewer system. This
includes unincorporated connector districts and
satellite collection systems. This estimated percentage
is calculated separately for each unique collection
system that provides flow to the permittee and is based
on the service population of each unique collection
system. This data element applies to POTWs
POTW Wastewater Treatment Technology This data element describes the level of wastewater 122.21(j)(3)(iii), 122.28(b)(2)(ii) and 1, 2.
Level Description treatment technology [e.g., raw discharge (no CWA section 516
treatment), primary treatment, secondary wastewater
treatment, advanced treatment] used at the facility.
This data element only applies to POTWs
POTW Wastewater Disinfection Technology The one or more unique codes/descriptions that describe 122.21(j)(3)(iii), 122.28(b)(2)(ii) 1, 2.
the types of disinfection technology that are used at
the facility (e.g., chlorination, ozonation,
ultraviolet disinfection). This data element will also
use a code/description to identify if this facility is
using dechlorination, which may be required if the
facility uses chlorination for disinfection. This data
element only applies to POTWs
POTW Wastewater Treatment Technology The one or more unique codes/descriptions that describe 122.21(j)(2)(ii)(A), 122.28(b)(2)(ii) 1, 2.
Unit Operations the wastewater treatment technology unit operations and CWA section 516
(e.g., grit removal, flow equalization, complete mix
activated sludge secondary treatment, trickling filter,
facultative lagoon, biological nitrification) used at
the facility. This data element is required for POTWs
that have a design flow capacity equal to or above 10
million gallons per day (MGD) and is optional for POTWs
with a design flow capacity below 10 MGD
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Combined Sewer Overflow Information
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[Note: All Phase II and post-Phase II combined sewer system NPDES permittees are required to complete and implement a long-term CSO control plan
(LTCP) as described in EPA's Combined Sewer Overflow (CSO) Control Policy (19 April 1994; 59 Federal Register 18688-18698). These data will be
updated by the authorized NPDES program on a timely basis as changes occur with the combined sewer system and the LTCP as well as with the POTW's
implementation and compliance with the LTCP.]
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Long-Term CSO Control Plan Permit This data element uses a unique code/description that 122.41(h), 122.43, 123.41(a) and CWA 1.
Requirements and Compliance identifies whether the permit requires the permit section 402(q)(1), Combined Sewer
holder to complete and implement a LTCP and whether the Overflow (CSO) Control Policy (59 FR
permit holder is in compliance with these permit 18688-18698, 19 April 1994)
requirements
Nine Minimum CSO Controls Developed This data element uses a unique code/description to 122.41(h), 122.43, 123.41(a) and CWA 1.
identify by number each of the nine minimum control section 402(q)(1), Combined Sewer
measures outlines in the CSO Control Policy that the Overflow (CSO) Control Policy (59 FR
permit holder has implemented in compliance with the 18688-18698, 19 April 1994)
applicable permit and/or enforcement mechanism. These
unique codes are: (1) Proper operation and regular
maintenance programs for the sewer system and the CSOs;
(2) Maximum use of the collection system for storage;
(3) Review and modification of pretreatment
requirements to assure CSO impacts are minimized; (4)
Maximization of flow to the publicly owned treatment
works for treatment; (5) Prohibition of CSOs during dry
weather; (6) Control of solid and floatable materials
in CSOs; (7) Pollution prevention; (8) Public
notification to ensure that the public receives
adequate notification of CSO occurrences and CSO
impacts; and (9) Monitoring to effectively characterize
CSO impacts and the efficacy of CSO controls. For
example, if the permit holder has only developed the
``Maximum use of the collection system for storage''
minimum control measure then the permitting authority
will record ``2'' for this data element. Likewise, if
the permit holder has developed all nine minimum
control measures then permitting authority will record
1, 2, 3, 4, 5, 6, 7, 8, and 9 for this data element
Nine Minimum CSO Controls Implemented This data element uses a unique code/description to 122.41(h), 122.43, 123.41(a) and CWA 1.
identify by number each of nine minimum control section 402(q)(1), Combined Sewer
measures outlined in the CSO Control Policy that the Overflow (CSO) Control Policy (59 FR
permit holder has implemented in compliance with the 18688-18698, 19 April 1994)
applicable permit and/or enforcement mechanism. These
unique codes are: (1) Proper operation and regular
maintenance programs for the sewer system and the CSOs;
(2) Maximum use of the collection system for storage;
(3) Review and modification of pretreatment
requirements to assure CSO impacts are minimized; (4)
Maximization of flow to the publicly owned treatment
works for treatment; (5) Prohibition of CSOs during dry
weather; (6) Control of solid and floatable materials
in CSOs; (7) Pollution prevention; (8) Public
notification to ensure that the public receives
adequate notification of CSO occurrences and CSO
impacts; and (9) Monitoring to effectively characterize
CSO impacts and the efficacy of CSO controls. For
example, if the permit holder has only developed the
``Maximum use of the collection system for storage''
minimum control measure then the permitting authority
will record ``2'' for this data element. Likewise, if
the permit holder has developed all nine minimum
control measures then permitting authority will record
1, 2, 3, 4, 5, 6, 7, 8, and 9 for this data element
LTCP Submission and Approval Type This data element uses a unique code/description to 122.41(h), 122.43, 123.41(a) and CWA 1.
identify whether the most recent version of the LTCP section 402(q)(1), Combined Sewer
was received and approved by the permitting authority Overflow (CSO) Control Policy (59 FR
(e.g., most recent version of the LTCP was submitted by 18688-18698, 19 April 1994)
permit holder and was approved by the permitting
authority, most recent version of the LTCP was
submitted by permit holder but has not yet been
approved by permitting authority, permit holder is
required to submit a revised LTCP but the permitting
authority has not yet received the revised LTCP from
the permit holder, permit holder has not yet submitted
a LTCP)
LTCP Approval Date This data element identifies the date when the 122.41(h), 122.43, 123.41(a) and CWA 1.
permitting authority approved the most current version section 402(q)(1), Combined Sewer
of the LTCP. This data element will be updated for each Overflow (CSO) Control Policy (59 FR
revision to the LTCP. The date must be provided in YYYY- 18688-18698, 19 April 1994)
MM-DD format where YYYY is the year, MM is the month,
and DD is the day
Enforceable Mechanism and Schedule to This data element uses a unique code/description to 122.41(h), 122.43, 123.41(a) and CWA 1.
Complete LTCP and CSO Controls identify whether the permit holder is on an enforceable section 402(q)(1), Combined Sewer
schedule to complete all required LTCP and CSO controls Overflow (CSO) Control Policy (59 FR
and the type of enforcement mechanism 18688-18698, 19 April 1994)
Actual Date Completed LTCP and CSO This data element identifies the date by which the 122.41(h), 122.43, 123.41(a) and CWA 1.
Controls permit holder completed construction and implementation section 402(q)(1), Combined Sewer
of all currently required LTCP and CSO controls. This Overflow (CSO) Control Policy (59 FR
data element will be updated for each revision to the 18688-18698, 19 April 1994)
LTCP and CSO controls. The date must be provided in
YYYY-MM-DD format where YYYY is the year, MM is the
month, and DD is the day
Approved Post-Construction Compliance This data element uses a unique code/description to 122.41(h), 122.43, 123.41(a) and CWA 1.
Monitoring Program indicate whether the permit holder is currently section 402(q)(1), Combined Sewer
implementing an approved post-construction compliance Overflow (CSO) Control Policy (59 FR
monitoring program 18688-18698, 19 April 1994)
Other CSO Control Measures with This data element uses a unique code/description to 122.41(h), 122.43, 123.41(a) and CWA 1.
Compliance Schedule identify whether the permit holder has other CSO section 402(q)(1), Combined Sewer
control measures specified in a compliance schedule, Overflow (CSO) Control Policy (59 FR
beyond those identified in the nine minimum controls, 18688-18698, 19 April 1994)
long-term CSO control plan (LTCP), or a plan for sewer
system separation
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Pretreatment Information on NPDES Permit Application or Notice of Intent (this includes permit application data required for all new and existing POTWs
[40 CFR 122.21(j)(6)]
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[Note: These data will be added or updated through the Annual Pretreatment Program Report, see 40 CFR 403.12(i), as needed. It is also important
to note that the `Associated NPDES ID Number' identifies the receiving POTW's NPDES permit number for each industrial user.]
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Pretreatment Program Required Indicator The unique code/description that describes whether the 122.28(b)(2)(ii), 122.44(j) 1.
permitted municipality is required to develop or
implement a pretreatment program (in accordance with 40
CFR 403)
Pretreatment Program Approval or The date the pretreatment program was approved or 122.28(b)(2)(ii), 403.8(a) and (b), 1.
Modification Date substantially modified. This data element can be system 403.11
generated by carrying forward the most recent date
(approval or modification). The date must be provided
in YYYY-MM-DD format where YYYY is the year, MM is the
month, and DD is the day
Pretreatment Program Modification Type The unique code describing the type of substantial 122.28(b)(2)(ii), 403.8(a) and (b), 1.
modification to a POTW Pretreatment Program, which 403.11, 403.18
includes the initial start of a pretreatment program
Industrial User Type The unique code/description that identifies the type of 122.21(j)(6), 122.28(b)(2)(ii), 1, 2, 7.
each industrial user discharging to a POTW [e.g., 122.44(j), 403.12(i)
Significant Industrial User (SIU), Standard Categorical
Industrial Users (CIU), Non-Significant Categorical
Industrial User (NSCIU), and Middle Tier Categorical
Industrial User (MTCIU)]. This data element is at the
permit or control mechanism level and is required for
each SIU, CIU, NSCIU, and MTCIU. This data element also
applies to SIUs and CIUs that discharge non-domestic
wastewater by truck, rail, and dedicated pipe or other
means of transportation to one or more POTWs
Significant Industrial User Subject to The unique code (e.g., ``Yes'', ``No'') that identifies 122.21(j)(6), 122.28(b)(2)(ii), 1, 2, 7.
Local Limits for each Significant Industrial User (SIU) or 122.44(j), 403.12(i)
Categorical Industrial User (CIU) discharging to a POTW
(including non-domestic wastewater delivered by truck,
rail, and dedicated pipe or other means of
transportation) whether the SIU is subject to local
limits
Significant Industrial User Subject to The unique code (e.g., ``Yes'', ``No'') that identifies 122.21(j)(6), 122.28(b)(2)(ii), 1, 2, 7.
Local Limits More Stringent Than for each Categorical Industrial User (CIU) discharging 122.44(j), 403.12(i)
Categorical Standards to a POTW (including non-domestic wastewater delivered
by truck, rail, and dedicated pipe or other means of
transportation) whether the CIU is subject to one or
more local limits that are more stringent than the
applicable categorical standards
Applicable Categorical Standards This data element will identify for each Categorical 122.21(j)(6), 122.28(b)(2)(ii), 1, 2, 7.
Industrial User (CIU) discharging to a POTW (including 122.44(j), 403.12(i)
non-domestic wastewater delivered by truck, rail, and
dedicated pipe or other means of transportation) the
applicable categorical standard(s) by its 40 CFR part
number (e.g., Metal Finishing--part 433, Electrical and
Electronic Components--Part 469). This data element
will track the one or more applicable categorical
standards even when the CIU is subject to one or more
local limits that are more stringent than the
applicable categorical standards
Significant Industrial User Wastewater This data element will identify for each Significant 122.21(j)(6), 122.28(b)(2)(ii), 1, 2.
Flow Rate Industrial User (SIU) or Categorical Industrial User 122.44(j)
(CIU) that is discharging to a POTW (including non-
domestic wastewater delivered by truck, rail, and
dedicated pipe or other means of transportation) the
estimated maximum monthly average wastewater flow rate
(in gallons per day)
Industrial User Causing Problems at POTW The unique code/description that identifies for each 122.21(j)(6), 122.28(b)(2)(ii), 1, 2.
Significant Industrial User (SIU) or Categorical 122.44(j)(2)(ii), 403.5(c)
Industrial User (CIU) whether it caused or contributed
to any problems (including upset, bypass, interference,
pass-through) at a POTW within the past four and one-
half calendar years. EPA regulations require the
Control Authority to develop and enforce local limits
when the discharge from an IU causes or contributes to
any problems (including upset, interference, and
bypass) at the receiving POTW's effluent discharge or
biosolids/sewage sludge management. This data element
also applies to SIUs and CIUs that discharge non-
domestic wastewater by truck, rail, and dedicated pipe
or other means of transportation to one or more POTWs
Receiving RCRA Waste The unique code/description that identifies whether a 122.21(j)(7), 122.28(b)(2)(ii), 1, 2.
POTW has received RCRA hazardous waste by truck, rail, 122.44(j)
or dedicated pipe within the last three calendar years
Receiving Remediation Waste The unique code/description that identifies whether the 122.21(j)(7), 122.44(j) 1, 2.
POTW has received RCRA or CERLCA waste from off-site
remedial activities within the last three calendar
years
Control Authority Identifier This data element identifies the one or more Control 122.28(b)(2)(ii), 122.44(j) 1, 2.
Authorities for each Significant Industrial User (SIU)
or Categorical Industrial User (CIU). When the Control
Authority is a POTW this data element will use the
POTW's NPDES ID. There will also be a unique identifier
for each state and EPA Region for SIUs and CIUs when
they are the Control Authority
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Cooling Water Intake Information on NPDES Permit Application or Notice of Intent
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Cooling Water Intake Applicable Subpart The unique code/description that identifies the 122.21(r), 122.28(b)(2)(ii), subparts 1, 2.
regulatory subpart the facility is subject to [e.g., 1 I, J, and N of 125, 401.14, and CWA
= New Facility under 40 CFR part 125, subpart I, 2 = section 316(b)
New Offshore Oil and Gas Facility under 40 CFR part
125, subpart N, 3 = Existing Facility under 40 CFR part
125, subpart J, 4 = BPJ Facility under 40 CFR
125.80(c), 40 CFR 125.90(b), 40 CFR 125.130(c), or 40
CFR 401.14]
Design Intake Flow for Cooling Water Design Intake Flow (DIF) means the value, in units of 122.21(r), 122.28(b)(2)(ii), 125.80, 1, 2.
Intake Structure(s) million gallons per day (MGD), assigned to each cooling 125.86, 125.90, 125.92, 125.95,
water intake structure design that corresponds to the 125.131, 125.136, 401.14, and CWA
maximum instantaneous rate of flow of water the cooling section 316(b)
water intake system is capable of withdrawing from a
source waterbody. The facility's DIF may be adjusted to
reflect permanent changes to the maximum flow
capability of the cooling water intake system to
withdraw cooling water, including pumps permanently
removed from service, flow limit devices, and physical
limitations of the piping. DIF does not include values
associated with emergency and fire suppression capacity
or redundant pumps (i.e., back-up pumps). For new
facilities this is the design maximum flow capacity of
the cooling water intake structure. See 40 CFR 125.83
and 125.92. This data element will be reported for each
cooling water intake structure, which will have a
``Permitted Feature ID.'' Specific monitoring protocols
and frequency of monitoring will be determined by the
Director
Actual Intake Flow for Cooling Water This actual flow value, in units of MGD, is intended to 122.21(r), 122.28(b)(2)(ii), 1, 2.
Intake Structure(s) represent on-the-ground intake flow for each cooling 125.86,125.92(a), 125.95, 125.136,
water intake structure at the facility, as opposed to 401.14, and CWA section 316(b)
the DIF, which is based on maximum design flow intake.
For existing facility, Actual Intake Flow (AIF) means
the average flow rate of water withdrawn on an annual
basis by each cooling water intake structure over the
past three years. After October 14, 2019, AIF means the
average flow rate of water withdrawn on an annual basis
by each cooling water intake structure over the
previous five years. Actual intake flow is measured at
a location within the cooling water intake structure
that the Director deems appropriate. The calculation of
actual intake flow includes days of zero flow. AIF does
not include flows associated with emergency and fire
suppression capacity. See 40 CFR 125.92. This data
element will be reported for each cooling water intake
structure, which will have a ``Permitted Feature ID.''
Specific monitoring protocols and frequency of
monitoring will be determined by the Director
Location Type for Cooling Water Intake The unique code/description that identifies the location 122.21(r), 122.28(b)(2)(ii), 125.86, 1, 2.
Structure and description for each cooling water intake structure 125.95, 125.136, 401.14 and CWA
[e.g., 1 = shoreline intake description (flushed, section 316(b)
recessed), 2 = intake canal, 3 = embayment, bank, or
cove, 4 = submerged offshore intake, 5 = near-shore
submerged intake, 6 = shoreline submerged intake, 7 =
Offshore Velocity Cap (800 foot minimum distance from
shoreline), 8 = other]. Each cooling water intake
structure will have its own ``Permitted Feature ID''
Actual Through-Screen Velocity This is the actual through-screen velocity (in feet/ 122.21(r), 122.28(b)(2), 125.86, 1, 2.
second) of the water intake through the screen for each 125.94, 125.95, 125.136, 401.14 and
cooling water intake structure at an existing facility. CWA section 316(b)
This is the measured average intake velocity as water
passes through the structural components of a screen
measured perpendicular to the screen mesh during normal
operations. See 40 CFR 125.94. This data element will
be reported for each cooling water intake structure,
which will have a ``Permitted Feature ID.'' Specific
monitoring protocols and frequency of monitoring will
be determined by the Director
Source Water for Cooling Purposes The unique code/description that describes the one or 122.21(r), 122.28(b)(2)(ii), 125.86, 1, 2.
more source water for cooling purpose for each cooling 125.95, 125.136, 401.14 and CWA
water intake structure [e.g., 1 = Ocean, 2 = Estuary, 3 section 316(b)
= Great Lake, 4 = Fresh River, 5 = Lake/Reservoir, 6 =
contract or arrangement with an independent supplier
(or multiple suppliers)]. Each cooling water intake
structure will have its own ``Permitted Feature ID''
Cooling Water Intake Structure Chosen The unique code/description to indicate the one or more 122.21(r)(6), 122.28(b)(2)(ii), 125.84, 1, 2.
Compliance Method compliance method selected for each cooling water 125.85, 125.94, 125.134, 125.135,
intake structure based on EPA's CWA section 316(b) 401.14 and CWA section 316(b)
regulations or based on BPJ. For new facilities for
example, Track I, Track II, alternative requirements,
etc. For existing facilities, which of the 40 CFR
125.94(c) compliance options were chosen and reported
as part of 40 CFR 122.21(r)(6), whether the facility
has chosen to comply on an intake basis or facility
wide, or whether alternative requirements were
requested. Facilities have the option to comply on a
facility wide or on an intake basis. Each cooling water
intake structure will have its own ``Permitted Feature
ID''
Source Water Baseline Biological For new and existing facilities, a unique code/ 122.21(r)(4), 122.28(b)(2), 125.86, 1, 2.
Characterization Data: Threatened or description that identifies whether there are Federally- 125.95, 125.136, 401.14 and CWA
Endangered Status listed threatened or endangered species (or relevant section 316(b)
taxa) that might be susceptible to impingement and
entrainment at the facility's cooling water intake
structures. This unique code/description will also
identify whether designated critical habitat is in the
vicinity of facility's cooling water intake structure
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CWA section 316(a) Thermal Variance Information on NPDES Permit Application or Notice of Intent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Thermal Variance Request Type The unique code/description that describes the thermal 125, subpart H and CWA section 316(a) 1.
variance request submitted by the discharger (e.g., 1 =
new request, 2 = renewal request)
Public Notice of Section 316(a) Requests This is the unique code that describes whether the NPDES 124.57, 125, subpart H and CWA section 1.
permitting authority included the information required 316(a)
under 40 CFR 124.57(a) in the public notice regarding
the CWA section 316(a) request
Thermal Variance Granted Date This is the most recent date when the NPDES permitting 1.
authority granted or renewed a CWA section 316(a)
variance for the controlling NPDES permit. The date
must be provided in YYYY-MM-DD format where YYYY is the
year, MM is the month, and DD is the
day122.28(b)(2)(ii), subpart H of 125 and CWA section
316(a)
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Compliance Monitoring Activity Information (General)
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Compliance Monitoring Identifier The unique identifier for the compliance monitoring 123.26, 123.41(a) and CWA section 308 1.
activity performed by the authorized NPDES program and
EPA (e.g., inspections). This data element can be
system generated
Permitted Feature Identifier (Compliance The unique identifier for the permitted feature 122.34(g)(3), 122.41(l)(4)(i), 1, 3, 4, 6,
Monitoring Activity) number(s) entered by the user for the inspected or 122.41(l)(6) and (7), 122.41(m)(3), 8, and 9.
monitored permitted feature(s). This data element will 123.26, 123.41(a), 122.42(c),
use the same number used by `Permitted Feature 403.12(e), 403.12(h) and CWA section
Identifier (Permit)' data element for each compliance 308
monitoring activity permitted feature. This will
provide a unique link between each compliance
monitoring activity permitted feature and the
corresponding NPDES permitted feature. This data
element can be left blank if the compliance monitoring
activity does not involve a permitted feature. For
Sewer Overflow/Bypass Event Reports this data element
will identify the permitted feature(s), if any, for
each Sewer Overflow/Bypass Identifier. The POTW can
leave this data element blank on the Sewer Overflow/
Bypass Event Report if the sewer overflows are caused
by an extreme weather event (e.g., hurricane) that
floods the entire sewer system and are too numerous to
count. This data element applies to compliance
monitoring activities performed by the authorized NPDES
program and EPA (e.g., inspections) as well as
compliance monitoring reports submitted by the NPDES
regulated entity (e.g., DMRs, program reports)
Electronic Submission Type (Compliance This is the unique code/description for each report 123.26, 123.41(a) and CWA section 308 1.
Monitoring Activity) submitted by the NPDES regulated entity. Report
submissions covered by the data element are listed in
Table 1 in this appendix (i.e., NPDES Data Groups 3
through 10). This data element describes how each
submission was electronically collected or processed by
the initial recipient [see 127.2(b)]. For example,
these unique codes/descriptions include: (1) NPDES
regulated entity submits NPDES program data using an
EPA electronic reporting system; (2) NPDES regulated
entity submits NPDES program data using an authorized
NPDES program electronic reporting system; (3) NPDES
regulated entity has temporary waiver from electronic
reporting and submits NPDES program data on paper to
the authorized NPDES program who then electronically
uses manual data entry to electronically process these
data; (4) NPDES regulated entity has a permanent waiver
from electronic reporting and submits NPDES program
data on paper to the authorized NPDES program who then
electronically uses manual data entry to electronically
process these data; (5) NPDES regulated entity has an
episodic waiver from electronic reporting and submits
NPDES program data on paper to the authorized NPDES
program who then electronically uses manual data entry
to electronically process these data; (6) NPDES
regulated entity submits NPDES program data on paper in
a form that allows the authorized NPDES program to use
of automatic identification and data capture technology
to electronically process these data; (7) NPDES
regulated entity submits NPDES program data using
another electronic reporting system (e.g., third-
party). This data element can sometimes be system
generated (e.g., incorporated into an electronic
reporting tool). This data element does not identify
the electronic submission type of general permit
reports (NPDES Data Group = 2 in Table 1), which is
tracked by the ``Electronic Submission Type (General
Permit Reports)'' data element. This data element
applies to information submitted by NPDES regulated
entities and does not apply to compliance monitoring
information generated by authorized NPDES programs and
EPA (e.g., inspection data)
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Compliance Monitoring Activity Information (General Data Generated from Authorized NPDES Programs and EPA)
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Compliance Monitoring Activity Actual The actual date on which the compliance monitoring 123.26, 123.41(a) and CWA section 308 1.
End Date activity ended. For example, the date of an authorized
NPDES program inspection of a facility can be used for
this data element. The date must be provided in YYYY-MM-
DD format where YYYY is the year, MM is the month, and
DD is the day
Compliance Monitoring Activity The unique code/description that identifies each 123.26, 123.41(a) and CWA section 308 1.
compliance monitoring activity taken by the authorized
NPDES program (e.g., inspection, investigation,
information request, offsite records review)
Compliance Monitoring Type The unique code/description that identifies each 123.26, 123.41(a) and CWA section 308 1.
compliance monitoring activity type taken by a
regulatory Agency (e.g., audit, biomonitoring, case
development, diagnostic, evaluation, reconnaissance
with sampling, reconnaissance without sampling,
sampling)
Biomonitoring Test Type The unique code/description that identifies the type of 123.26, 123.41(a) and CWA section 308 1.
biomonitoring inspection method (e.g., acute, chronic,
or flow through) and sample type (e.g., grab,
composite). This data element supplements the
Compliance Monitoring Type data element. This data
element only applies to compliance monitoring
activities that involve biomonitoring
Compliance Monitoring Action Reason The unique code/description that identifies the reason 123.26, 123.41(a) and CWA section 308 1.
for the initiation of the compliance monitoring
activity (e.g., Agency Priority, Citizen Complaint/Tip,
Core Program)
Was this a State, Federal or Joint This data element identifies if the inspection is a 123.26, 123.41(a) and CWA section 308 1.
(State/Federal) Inspection? joint inspection by [F]ederal, [S]tate, [T]ribal, or
territorial personnel. Only one value for this data
element may be used for each compliance monitoring
activity [e.g., State, Federal, Joint (State/Federal)]
Programs Evaluated The unique code/description for the one or more programs 123.26, 123.41(a) and CWA section 308 1.
evaluated or related to the compliance monitoring
activity (e.g., NPDES Base Program, Biosolids/Sewage
Sludge, Pretreatment, and MS4)
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Compliance Monitoring Activity Information (Program Data Generated from Authorized NPDES Programs and EPA)
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Deficiencies Identified Through the This is the unique code/description that that identifies 123.26, 123.41(a), 123.45 and CWA 1.
Biosolids/Sewage Sludge Compliance each deficiency in the facility's biosolids and sewage section 308
Monitoring sludge program (40 CFR part 503) for each compliance
monitoring activity (e.g., inspections, audits) by the
regulatory authority. This data element includes unique
codes to identify when the facility failed to comply
with any applicable permit requirements or enforcement
actions. The values for this data element will
distinguish between noncompliance and significant
noncompliance (SNC)
Deficiencies Identified Through the MS4 This is the unique code/description that that identifies 123.26, 123.41(a), 123.45 and CWA 1.
Compliance Monitoring each deficiency in the MS4's program to control section 308
stormwater pollution for each compliance monitoring
activity (e.g., inspections, audits) by the regulatory
authority. This data element includes unique codes to
identify when the MS4 failed to comply with any
applicable permit requirements or enforcement actions.
The values for this data element will distinguish
between noncompliance and significant noncompliance
(SNC)
Deficiencies Identified Through the This is the unique code/description that that identifies 123.26, 123.41(a), 123.45, 403.10, and 1.
Pretreatment Compliance Monitoring each deficiency in the POTW's authorized pretreatment CWA section 308
program for each pretreatment compliance monitoring
activity (e.g., inspections, audits) by the regulatory
authority. The values for this data element will
distinguish between noncompliance and significant
noncompliance (SNC). These unique codes include: (1)
Failure to enforce against pass through and/or
interference; (2) failure to submit required reports
within 30 days; (3) failure to meet compliance schedule
milestones within 90 days; (4) failure to issue/reissue
control mechanisms to 90% of SIUs within 6 months; (5)
failure to inspect or sample 80% of SIUs within the
past 12 months; and (6) failure to enforce standards
and reporting requirements
Deficiencies Identified Through the This is the unique code/description that that identifies 122.41(h), 122.41(l)(6) and (7), 1.
Sewer Overflow/Bypass Compliance each deficiency in the POTW's control of combined sewer 122.43, 123.26, 123.41(a), and CWA
Monitoring overflows, sanitary sewer overflows, or bypass events sections 308 and 402(q)(1)
for each compliance monitoring activity (e.g.,
inspections, audits) by the regulatory authority. This
data element includes unique codes to identify when a
POTW has failed to provide 24-hour notification to the
NPDES permitting authority or failed to submit the
Sewer Overflow/Bypass Event Report within the required
5-day period. This data element also includes unique
codes to identify when the POTW failed to comply with
any applicable long-term CSO control plan, permit
requirements, or enforcement actions. The values for
data element will distinguish between noncompliance and
significant noncompliance (SNC)
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Compliance Monitoring Activity Information (AFO/CAFO Program Data Generated from Authorized NPDES Programs and EPA)
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Animal Types (Inspection) The unique code/description that identifies the animal 122.23, 123.26, 123.41(a), and CWA 1.
type(s) at the facility at the time of inspection section 308
(e.g., beef cattle, broilers, layers, swine weighing 55
pounds or more, swine weighing less than 55 pounds,
mature dairy cows, dairy heifers, veal calves, sheep
and lambs, horses, ducks, turkeys, other)
Animal Numbers (Inspection) The number of each type of animal in open confinement or 122.23, 123.26, 123.41(a) and CWA 1.
housed under roof (either partially or totally) which section 308
are held at the facility at the time of inspection
Animal Numbers in Open Confinement The number of each type of animal in open confinement 122.23, 123.26, 123.41(a) and CWA 1.
(Inspection) which are held at the facility at the time of section 308
inspection
MLPW Containment and Storage Type The one or more types of containment and storage (e.g., 122.23, 123.26, 123.41(a) and CWA 1.
(Inspection) anaerobic lagoon, roofed storage shed, storage ponds, section 308
underfloor pits, above ground storage tanks, below
ground storage tanks, concrete pad, impervious soil
pad, other) at the facility at the time of inspection
MLPW Containment and Storage Type Within The one or more unique codes/descriptions that 122.23, 123.26, 123.41(a) and CWA 1.
Design Capacity (Inspection) identifies whether or not the facility is operating section 308
within the design capacity for each type of containment
and storage used by the facility for MLPW at the time
of inspection
AFO/CAFO Unauthorized Discharges A unique code (e.g., ``Yes'', ``No'') that indicates 122.23, 123.26, 123.41(a) and CWA 1.
(Inspection) whether there evidence of unauthorized discharge(s) of section 308
pollutants from the facility's production area and/or
land application area(s) to a water of the U.S.
Permit Requirements Implementation The unique code/description that identifies whether or 122.23, 123.26, 123.41(a) and CWA 1.
(Inspection) not the facility is properly implementing its NPDES section 308
permit requirements, including the applicable Nutrient
Management Plan (NMP) or other nutrient management
planning, at the time of inspection
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Compliance Monitoring Activity Information (Discharge Monitoring Report, and Pretreatment Periodic Compliance Reports for Significant Industrial Users
(SIUs) and Categorical Industrial Users (CIUs) when EPA or the State is the Control Authority)
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[Note: Authorized NPDES programs will identify in the applicable NPDES permits will identify whether MS4 regulated entities are required to
submit DMRs.]
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Limit Set Designator (Compliance The unique identifier tying the compliance monitoring 122.41(l)(4)(i), 123.26, 123.41(a), 3, 6, 8.
Monitoring Activity) activity (e.g., DMR submission) to the corresponding 403.12(e), 403.12(h)
Limit Set record
Parameter Code (Compliance Monitoring The unique code/description identifying the parameter 122.41(l)(4)(i), 123.26, 123.41(a), 3, 6, 8.
Activity) reported on the compliance monitoring activity (e.g., 403.12(e), 403.12(h)
DMR submission)
Monitoring Location Code (Compliance The unique code/description that identifies the 122.41(l)(4)(i), 123.26, 123.41(a), 3, 6, 8.
Monitoring Activity) monitoring location at which the sampling occurred for 403.12(e), 403.12(h)
a compliance monitoring activity parameter (e.g., DMR
submission)
Limit Season Number (Compliance The unique identifier tying the compliance monitoring 122.41(l)(4)(i), 123.26, 123.41(a), 3, 6, 8.
Monitoring Activity) activity (e.g., DMR submission) to the Limit Season 403.12(e), 403.12(h)
Number of the corresponding limit. This data element is
necessary as a parameter can have different seasonal
limits within a single limit start and end date
Monitoring Period End Date (Compliance The monitoring period end date for the values covered by 122.41(l)(4)(i), 123.26, 123.41(a), 3, 6, 8.
Monitoring Activity) the compliance monitoring activity (e.g., DMR 403.12(e), 403.12(h)
submission). The date must be provided in YYYY-MM-DD
format where YYYY is the year, MM is the month, and DD
is the day
No Data Indicator (NODI) (Compliance The unique code/description that indicates the reason 122.41(l)(4)(i), 123.26, 123.41(a), 3, 6, 8.
Monitoring Activity) that ``No Discharge'' or ``No Data'' was reported on 403.12(e), 403.12(h)
the compliance monitoring activity (e.g., DMR
submission) (e.g., B = Below Detection Limit, C = No
Discharge)
Value (Compliance Monitoring Activity) The number value reported on the compliance monitoring 122.41(l)(4)(i), 123.26, 123.41(a), 3, 6, 8.
activity (e.g., DMR form) 403.12(e), 403.12(h)
Quantity or Concentration Units The unique code/description that identifies the one or 122.41(l)(4)(i), 123.26, 123.41(a), 3, 6, 8.
(Compliance Monitoring Activity) more units of measure that are applicable to quantity 403.12(e), 403.12(h)
or concentration limits and measurements as entered on
the compliance monitoring activity (e.g., DMR
submission). This field is optional if the units are
the same as the limit units
Value Received Date (Compliance The date the compliance monitoring value was received by 122.41(l)(4)(i), 123.26, 123.41(a), 1.
Monitoring Activity) the regulatory authority (e.g., DMR submission). The 403.12(e), 403.12(h)
date must be provided in YYYY-MM-DD format where YYYY
is the year, MM is the month, and DD is the day
Value Type (Compliance Monitoring The unique code/description identifying a value type 122.41(l)(4)(i), 123.26, 123.41(a), 3, 6, 8.
Activity) (e.g., Quantity 1, Quantity 2, Concentration 1, 403.12(e), 403.12(h)
Concentration 2, Concentration 3) on a compliance
monitoring activity (e.g., DMR submission)
Value Qualifier (Compliance Monitoring The unique code identifying the qualifier for the 122.41(l)(4)(i), 123.26, 123.41(a), 3, 6, 8.
Activity) reported value (e.g., ``<'', ``='', ``>'') on a 403.12(e), 403.12(h)
compliance monitoring activity (e.g., DMR submission).
This field is optional if the qualifier is ``=''
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Compliance Monitoring Activity Information (Periodic Program Reports)
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Program Report Received Date The date the program report was received. The date must These are data elements that are common 1.
be provided in YYYY-MM-DD format where YYYY is the to reports required in parts 122, 123,
year, MM is the month, and DD is the day 403, and 503
Program Report Event ID The unique identifier for each program report These are data elements that are common 1.
submission. This will provide for unique tracking of to reports required in parts 122, 123,
program report submissions. This data element can be 403, and 503
system generated
Start Date of Reporting Period (Program The start date of the reporting period for the program These are data elements that are common 4, 5, 6, 7,
Report) report. The date must be provided in YYYY-MM-DD format to reports required in parts 122, 123, 9, 10.
where YYYY is the year, MM is the month, and DD is the 403, and 503
day. For the Sewer Overflow/Bypass Event Report this is
the start or best estimate of the start date for each
Sewer Overflow/Bypass Identifier
End Date of Reporting Period (Program The end date of the reporting period for the program These are data elements that are common 4, 5, 6, 7,
Report) report. The date must be provided in YYYY-MM-DD format to reports required in parts 122, 123, 9, 10.
where YYYY is the year, MM is the month, and DD is the 403, and 503
day. For the Sewer Overflow/Bypass Event Report this is
the end or best estimate of the end date for each Sewer
Overflow/Bypass Identifier
NPDES Data Group Number (Program Report) This data element identifies the NPDES Data Group for These are data elements that are common 4 through
each program report submission. This corresponds to to reports required in parts 122, 123, 10.
Table 1 in this appendix (e.g., 7 = Pretreatment 403, and 503
Program Reports [40 CFR 403.12(i)]).This data element
also applies to Significant Industrial User Compliance
Reports in Municipalities Without Approved Pretreatment
Programs [40 CFR 403.12(e) and (h)], which is NPDES
Data Group Number 8 (Table 1 in this appendix). This
can be a system generated data element
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Compliance Monitoring Activity Information (Data Elements Specific to Sewage Sludge/Biosolids Annual Program Reports)
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Biosolids or Sewage Sludge Treatment The one or more unique codes/descriptions that identify 503.18, 503.28, 503.48 4.
Processes the biosolids or sewage sludge treatment process or
processes at the facility. For example, this data
element uses codes to identify treatment processes in
the following categories: preliminary operations (e.g.,
sludge grinding and degritting), thickening
(concentration), stabilization, anaerobic digestion,
aerobic digestion, composting, conditioning,
disinfection (e.g., beta ray irradiation, gamma ray
irradiation, pasteurization), dewatering (e.g.,
centrifugation, sludge drying beds, sludge lagoons),
heat drying, thermal reduction, and methane or biogas
capture and recovery
Biosolids or Sewage Sludge Analytical The one or more unique codes/descriptions that identify 503.8(b), 503.18, 503.28, 503.48 4.
Methods each of the analytic methods used by the facility to
analyze enteric viruses, fecal coliforms, helminth ova,
Salmonella sp., and other regulated parameters. For
example, EPA requires facilities to monitor for the
certain parameters, which are listed in Tables 1, 2, 3,
and 4 at 40 CFR 503. 13 and Tables 1 and 2 at 40 CFR
503.23. This data element stores each analytic methods
used by the facility only once for each annual report
(not for each parameter measurement)
Biosolids or Sewage Sludge Form The one or more unique codes/descriptions that identify 503.18, 503.28, 503.48 4.
the nature of each biosolids and sewage sludge material
generated by the facility in terms of whether the
material is a biosolid or sewage sludge and whether the
material is ultimately conveyed off-site in bulk or in
bags. The facility will separately report the form for
each biosolids or sewage sludge management practice or
practices used by the facility and pathogen class
Biosolids or Sewage Sludge Management The one or more unique codes/descriptions that identify 503.18, 503.28, 503.48 4.
Practice the type of biosolids or sewage sludge management
practice or practices (e.g., land application, surface
disposal, incineration) used by the facility. The
facility will separately report the management practice
for each biosolids or sewage sludge form and pathogen
class. This data element will also identify the
management practices used by surface disposal site
owners/operators (see 40 CFR 503.24)
Biosolids or Sewage Sludge Pathogen The one or more unique codes/descriptions that identify 503.18, 503.28, 503.48 4.
Class the pathogen class or classes [e.g., Class A, Class B,
Not Applicable (Incineration)] for biosolids or sewage
sludge generated by the facility. The facility will
separately report the pathogen class for each biosolids
or sewage sludge management practice used by the
facility and by each biosolids or sewage sludge form
Biosolids or Sewage Sludge Amount This is the amount (in dry metric tons) of biosolids or 503.18, 503.28, 503.48 4.
(Program Report) sewage sludge applied to the land, prepared for sale or
give-away in a bag or other container for application
to the land, or placed on an active sewage sludge unit.
This identification will be made for each biosolids or
sewage sludge management practice used by the facility
and by each biosolids or sewage sludge form as well as
by each biosolids or sewage sludge pathogen class
Biosolids or Sewage Sludge Pathogen The one or more unique codes/descriptions that identify 503.18, 503.28, 503.48 4.
Reduction Options the options used by the facility to control pathogens
(e.g., Class A--Alternative 1, Class A--Alternative 2,
Class A--Alternative 3, Class A--Alternative 4, Class
A--Alternative 5, Class A--Alternative 6, Class B--
Alternative 1, Class B--Alternative 2, Class B--
Alternative 3, or pH Adjustment (Domestic Septage). The
facility will separately report the pathogen reduction
options for each biosolids or sewage sludge management
practice used by the facility and by each biosolids or
sewage sludge form as well as by each biosolids or
sewage sludge pathogen class
Biosolids or Sewage Sludge Vector The one or more unique codes/descriptions that identify 503.18, 503.28, 503.48 4.
Attraction Reduction Options the options used by the facility for vector attraction
reduction. See a listing of these vector attraction
reduction options at 40 CFR 503.33(b)(1) through (11).
The facility will separately report the vector
attraction reduction options for each biosolids or
sewage sludge management practice used by the facility
and by each biosolids or sewage sludge form as well as
by each biosolids or sewage sludge pathogen class
Biosolids or Sewage Sludge Monitored This is the biosolids or sewage sludge parameter that is 503.18, 503.28, 503.48 4.
Parameter monitored by the facility. If there is more than one
class, then the facility will separately report each
monitored parameter for each biosolids or sewage sludge
management practice used by the facility and by each
biosolids or sewage sludge form. EPA requires
facilities to monitor for the certain parameters, which
are listed in Tables 1, 2, 3, and 4 at 40 CFR 503. 13
and Tables 1 and 2 at 40 CFR 503.23, pathogens (e.g.,
fecal coliform, Salmonella sp., enteric viruses,
helminth ova), and vector attraction reduction
parameters (e.g., specific oxygen uptake rate, and
total, fixed, and volatile solids)
Biosolids or Sewage Sludge Monitored This is the value of the Biosolids or Sewage Sludge 503.18, 503.28, 503.48 4.
Parameter Value Monitored Parameter
Biosolids or Sewage Sludge Monitored This is the measurement unit (e.g., mg/kg) associated 503.18, 503.28, 503.48 4.
Parameter Units with the Biosolids or Sewage Sludge Monitored Parameter
Value
Biosolids or Sewage Sludge Monitored This is the end date of the monthly monitoring period 503.18, 503.28, 503.48 4.
Parameter End Date for the biosolids or sewage sludge sampling (e.g., 1/31/
2015 for biosolids or sewage sludge monitoring data in
January 2015). This data element is used to track the
frequency of biosolids or sewage sludge monitoring in
the reporting period (e.g., annual, quarterly, bi-
monthly, or monthly). For example, see Table 1 of 40
CFR 503.16 (Land Application), Table 1 of 40 CFR 503.26
(Surface Disposal)
Biosolids or Sewage Sludge--Surface This data element is applicable to facilities that use 503.23, 503.28 4.
Disposal Maximum Allowable Pollutant an active surface disposal sites (e.g., monofills,
Concentration surface impoundments, lagoons, waste piles, dedicated
disposal sites, and dedicated beneficial use sites)
without a liner. This data element identifies the
maximum allowable pollutant concentration for each of
the three pollutants: Arsenic, chromium, and nickel (in
units of mg/kg). This data element will use Tables 1
and 2 of 40 CFR 503.23 or the procedures identified in
40 CFR 503.23(b)
Biosolids or Sewage Sludge--Land This data element is applicable to facilities that use 503.18, 503.28 4.
Application or Surface Disposal land application and/or an active surface disposal site
Deficiencies (e.g., monofills, surface impoundments, lagoons, waste
piles, dedicated disposal sites, and dedicated
beneficial use sites). This data element uses one or
more unique codes/descriptions to identify all
deficiencies in the biosolids or sewage sludge program
within the reporting period. For example, this data
element uses a unique code/description to identify when
a biosolids or sewage sludge pollutant concentration
exceed a ceiling concentration (e.g., Table 1 of 40 CFR
503.13 for facilities utilizing land application). This
data element also uses a unique code/description to
identify when the facility failed to properly collect
and analyze its biosolids or sewage sludge in
accordance with the approved analytical methods
(including appropriate method holding times). This data
element also uses a unique code/description to identify
deficiencies with pathogen reduction and/or vector
attraction reduction. For facilities that use an active
surface disposal site this data element will use a
unique code/description to identify any deficiencies in
meeting the applicable surface disposal requirements
[see 40 CFR 503.24(a) through (n)]
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Compliance Monitoring Activity Information (Data Elements Specific to CAFO Annual Program Reports)
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CAFO Animal Types (Program Report) The unique code/description that identifies the 122.42(e)(4)(i) 5.
permittee's applicable animal sector(s) in the previous
12 months. This includes (but not limited to) beef
cattle, broilers, layers, swine weighing 55 pounds or
more, swine weighing less than 55 pounds, mature dairy
cows, dairy heifers, veal calves, sheep and lambs,
horses, ducks, and turkeys
CAFO Animal Maximum Number (Program The estimated maximum number of each type of animal in 122.42(e)(4)(i) 5.
Report) open confinement or housed under roof (either partially
or totally) which are held at the facility for a total
of 45 days or more in the previous 12 months
CAFO Animal Maximum Number in Open The estimated maximum number of each type of animal in 122.42(e)(4)(i) 5.
Confinement (Program Report) open confinement which are held at the facility for a
total of 45 days or more in the previous 12 months
CAFO MLPW (Program Report) The unique code/description that identifies the type of 122.42(e)(4)(ii) 5.
CAFO manure, litter, and process wastewater generated
by the facility i.e., in the previous 12 months
CAFO MLPW Amounts (Program Report) The estimated total amount of CAFO manure, litter, and 122.42(e)(4)(ii) 5.
process wastewater generated by the facility in the
previous 12 months
CAFO MLPW Amounts Units (Program Report) The unit (e.g., tons, gallons) for the estimated total 122.42(e)(4)(ii) 5.
amount of CAFO manure, litter, and process wastewater
generated by the facility i.e., in the previous 12
months
CAFO MLPW Transferred (Program Report) The estimated total amount of CAFO manure, litter, and 122.42(e)(4)(iii) 5.
process wastewater generated by the facility i.e., in
the previous 12 months that is transferred to other
persons. The units for this data element will be the
same as the units for the ``CAFO MLPW Amounts (Program
Report)'' data element
Total Number of Acres for Land Total number of acres for land application covered by 122.42(e)(4)(iv) 5.
Application Covered by the Nutrient the current nutrient management plan
Management Plan (Program Report)
Total Number of Acres Used for Land The total number of acres under control of the CAFO and 122.42(e)(4)(v) 5.
Application (Program Report) used for land application in the previous 12 months
Discharge Type (Program Report) The unique code/description that identifies for each 122.42(e)(4)(vi), 412 5.
discharge from the permittee's production area in the
previous 12 month whether a 25-year, 24-hour rainfall
event was the cause for the discharge. These data are
optional if permittee uses a Discharge Monitoring
Report (DMR) to provide the permitting authority with
information on their discharges
Discovery Dates of Discharges from The date of each discharge from the permittee's 122.42(e)(4)(vi) 5.
Production Area (Program Report) production area in the previous 12 months. The date
must be provided in YYYY-MM-DD format where YYYY is the
year, MM is the month, and DD is the day. These data
are optional if permittee uses a Discharge Monitoring
Report (DMR) to provide the permitting authority with
information on their discharges
Duration of Discharges from Production The estimated duration time (in hours) of each discharge 122.42(e)(4)(vi) 5.
Area (Program Report) from the permittee's production area in the previous 12
months. These data are optional if permittee uses a
Discharge Monitoring Report (DMR) to provide the
permitting authority with information on their
discharges
Approximate Volume of Discharge from The approximate volume (in gallons) of each discharge 122.42(e)(4)(vi) 5.
Production Area (Program Report) from the permittee's production area in the previous 12
months. These data are optional if permittee uses a
Discharge Monitoring Report (DMR) to provide the
permitting authority with information on their
discharges
Whether NMP Approved or Developed by The unique code/description that identifies whether the 122.42(e)(4)(vii) 5.
Certified Planner (Program Report) current version of the NMP was approved or developed by
a certified nutrient management planner
CAFO MLPW Nitrogen Content (Program The nitrogen content of CAFO manure, litter, and process 122.42(e)(4)(viii) 5.
Report) wastewater used or generated by the facility i.e., in
the previous 12 months
CAFO MLPW Phosphorus Content (Program The phosphorus content of CAFO manure, litter, and 122.42(e)(4)(viii) 5.
Report) process wastewater used or generated by the facility
i.e., in the previous 12 months
CAFO MLPW Nitrogen or Phosphorus Units The unit(s) (e.g., lbs/tons, lbs/1,000-gallons) for the 122.42(e)(4)(viii) 5.
(Program Report) nitrogen and phosphorus content of CAFO manure, litter,
and process wastewater used or generated by the
facility i.e., in the previous 12 months
CAFO MLPW Nitrogen or Phosphorus Form The form (e.g., total nitrogen, ammonium-nitrogen, total 122.42(e)(4)(viii) 5.
(Program Report) phosphorus) for the nitrogen and phosphorus content of
CAFO manure, litter, and process wastewater used or
generated by the facility i.e., in the previous 12
months
Field Identification Number (Program A unique field number to which CAFO MLPW was applied in 122.42(e)(4)(viii) 5.
Report) the previous 12 months. This data element will be used
when the term ``for each field'' is used in the CAFO
Annual Program Report
Actual Crop(s) Planted for Each Field Actual crop(s) planted for each field 122.42(e)(4)(viii) 5.
(Program Report)
Actual Crop Yield(s) for Each Field Actual crop yield(s) for each field 122.42(e)(4)(viii) 5.
(Program Report)
Actual Crop Yield(s) for Each Field The unit(s) for the actual crop yield(s) for each field 122.42(e)(4)(viii) 5.
Units (Program Report) (e.g., bushels per acre)
Method for Calculating Maximum Amounts The unique code/description that identifies whether the 122.42(e)(4)(viii) 5.
of Manure, Litter, and Process CAFO used the Linear Approach [40 CFR 122.42(e)(5)(i)]
Wastewater (Program Report) or the Narrative Rate Approach [40 CFR
122.42(e)(5)(ii)]
CAFO MLPW Land Application For Each The unique code/description that identifies for each 122.42(e)(4)(viii) 5.
Field (Program Report) field the type of CAFO manure, litter, and process
wastewater i.e., in the previous 12 months and used for
land application
CAFO MLPW Land Application Maximum The maximum amount of CAFO manure, litter, and process 122.42(e)(4)(viii) 5.
Amount For Each Field (Program Report) wastewater for each field in the previous 12 months and
used for land application. The maximum amounts of CAFO
manure, litter, and process wastewater is calculated in
accordance with procedures in the Linear Approach [40
CFR 122.42(e)(5)(i)(B)] or the Narrative Rate Approach
[40 CFR 122.42(e)(5)(ii)(D)]
CAFO MLPW Land Application Actual Amount The actual amount of CAFO manure, litter, and process 122.42(e)(4)(viii) 5.
For Each Field (Program Report) wastewater for each field in the previous 12 months and
used for land application
CAFO MLPW Land Application For Each The unit (e.g., tons, gallons) for the maximum and 122.42(e)(4)(viii) 5.
Field Unit (Program Report) actual amount of CAFO manure, litter, and process
wastewater for each field in the previous 12 months and
used for land application
Nitrogen Soil Test Measurement For each field used for land application, the results of 122.42(e)(4)(viii) 5.
(Narrative Rate Approach) (Program the most recent soil nitrogen analysis for any soil
Report) test taken in the preceding 12 months (i.e., amount of
nitrogen in the soil). This data element is only
applicable to facilities using the Narrative Rate
Approach as described in 40 CFR 122.42(e)(5)(ii)
Phosphorus Soil Test Measurement For each field used for land application, the results of 122.42(e)(4)(viii) 5.
(Narrative Rate Approach) (Program the most recent soil phosphorus analysis for any soil
Report) test taken in the preceding 12 months (i.e., amount of
phosphorus in the soil). This data element is only
applicable to facilities using the Narrative Rate
Approach as described in 40 CFR 122.42(e)(5)(ii)
Soil Test Measurement Form (Narrative The form (e.g., total nitrogen, ammonium-nitrogen, total 122.42(e)(4)(viii) 5.
Rate Approach) (Program Report) phosphorus) for each soil test measurement. This data
element is only applicable to facilities using the
Narrative Rate Approach as described in 40 CFR
122.42(e)(5)(ii)
Soil Test Measurement Unit(s) (Narrative The unit(s) for the amounts of nitrogen and/or 122.42(e)(4)(viii) 5.
Rate Approach) (Program Report) phosphorus for any soil test results. This data element
is only applicable to facilities using the Narrative
Rate Approach, as described in 40 CFR 122.42(e)(5)(ii)
Nitrogen Amount of Any Supplemental For each field used for land application, provide the 122.42(e)(4)(viii) 5.
Fertilizer Applied (Program Report) amount of nitrogen in supplemental fertilizer applied
in the previous 12 months. This data element is only
applicable to facilities using the Narrative Rate
Approach as described in 40 CFR 122.42(e)(5)(ii)
Phosphorus Amount of Any Supplemental For each field used for land application, provide the 122.42(e)(4)(viii) 5.
Fertilizer Applied (Program Report) amount of phosphorus in supplemental fertilizer applied
in the previous 12 months. This data element is only
applicable to facilities that are using the Narrative
Rate Approach as described in 40 CFR 122.42(e)(5)(ii)
Supplemental Fertilizer Applied Units The unit(s) for the amount(s) of nitrogen and/or 122.42(e)(4)(viii) 5.
(Program Report) phosphorus in any supplemental fertilizer applied in
the previous 12 months (e.g., ppm, pounds per acre).
This data element is only applicable to facilities
using the Narrative Rate Approach, as described in 40
CFR 122.42(e)(5)(ii)
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Compliance Monitoring Activity Information (Data Elements Specific to Municipal Separate Storm Sewer System Program Reports)
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[Note: The MS4 permit may require one report for each unique governmental entity or one report per permit].
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MS4 Reliance on Other Government This is a unique code (e.g., ``Yes'', ``No'') that 122.26(d)(2)(vii), 122.34(g)(3)(v) 6.
Entities Status identifies whether the permittee relies on another
unique governmental entity to satisfy any of the permit
requirements
MS4 Reliance on Other Government For each MS4 permit component this data element 122.34(g)(3)(i) and (v), 122.35(a) and 6.
Entities: Permit Component Status identifies the responsible government entity. This data 122.42(c)
element uses the `Unique Identifier for Each
Municipality Covered Under MS4 Permit' data element.
Use of this identifier allows for greater geographic
resolution for the MS4 components being tracked. This
unique identifier does not change over time. The number
identifies the entity taking responsibility for
complying with each MS4 permit component
MS4 Permit Components Descriptions and The one or more codes/descriptions that identify for 122.34(g)(3) and 122.42(c) 6.
Measurable Goals each unique municipality all of the permitted
components and measurable goals that are included in
the MS4 permit. For Phase II MS4s, these components
will be pre-populated from the BMPs each Phase II MS4
permittee indicated it will implement in its NOI or
permit application. The groupings of these MS4
components will include public education and outreach
on stormwater impacts; public involvement/
participation; illicit discharge detection and
elimination; construction site stormwater runoff; post-
construction stormwater management in new development
and redevelopment; and pollution prevention/good
housekeeping for municipal operations
Changes to MS4 Permit Components and The one or more codes/descriptions that describe for 122.34(g)(3)(iv) and 122.42(c) 6.
Measurable Goals each unique municipality any changes made to MS4 permit
components (e.g., BMPs) during the reporting period
Status of Compliance with each Minimum The unique code (e.g., ``Yes'', ``No'') that identifies 122.34(g)(3) and 122.42(c) 6.
Control Measure if the permittee has completed each measureable goal
associated with each MS4 permit component
Progress and Summary of Results with This is a text summary describing the permittee's 122.34(g)(3) and 122.42(c) 6.
Each Minimum Control Measure compliance and progress toward meeting each measurable
goal including a summary of results for each unique
municipality
MS4 Enforcement Action Type For each unique municipality covered under a Phase I MS4 122.34(g)(3) and 122.42(c) 6.
permit, this data element identifies the one or more
types of enforcement actions taken during the past
reporting period (e.g., notice of violations, stop work
orders, administration orders, administrative fines,
civil penalties, criminal actions). The unique
municipality covered under the MS4 permit will identify
``No Authority'' for this data element if the
municipality does not have the authority to conduct
enforcement actions. This data element is optional for
Phase II MS4s
MS4 Enforcement Action Number For each unique municipality covered under a Phase II 122.34(g)(3) and 122.42(c) 6.
MS4 permit and for each MS4 Enforcement Action Type,
this data element identifies the number of enforcement
actions taken by responsible MS4 Municipal Enforcement
Agency. The unique municipality covered under the MS4
permit will identify ``No Authority'' for this data
element if the municipality does not have the authority
to conduct enforcement actions. For Phase II MS4s this
data element will be the total number of enforcement
actions taken during the reporting period
MS4 Municipality Enforcement Agency For each unique municipality covered under the MS4 122.34(g)(3) and 122.42(c) 6.
permit and for each MS4 Enforcement Action Type, this
data element identifies the corresponding MS4 Municipal
Enforcement Agency by its unique municipality number
(``Unique Identifier for Each Municipality Covered
Under MS4 Permit''). This data element is only required
for permittees that have co-permittees under their
unique MS4 permit
MS4 Industrial Stormwater Control The one or more unique codes/descriptions that identify 40 CFR 122.26(d)(2)(i)(A, B, C, E, and 6.
how the MS4 permittee will comply with industrial F) and 40 CFR 122.26(d)(2)(ii) and
stormwater control requirements, including (at a (iv)(A)(5) and (iv)(C), 122.42(c)
minimum): (1) Status of the ordinance or other
regulatory mechanism to control the contribution of
pollutants by stormwater discharges associated with
industrial activity, including authority to carry out
all inspection, surveillance and monitoring procedures
necessary to determine compliance and noncompliance,
and including sanctions to ensure compliance; (2)
status of the MS4 permittee industrial stormwater
inventory, which identifies facilities with industrial
activities and assesses the quality of the stormwater
discharged from each facility with an industrial
activity; (3) status of program to monitor and control
pollutants in stormwater discharges from municipal
landfills, hazardous waste treatment, disposal and
recovery facilities, industrial facilities that are
subject to Toxics Release Inventory (TRI) reporting
requirements (Emergency Planning and Community Right-To-
Know Act Section 313), and industrial facilities that
are contributing a substantial pollutant loading to the
MS4; and (4) status of monitoring program for
discharges associated with industrial facilities. This
data element is optional for Phase II MS4s
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Compliance Monitoring Activity Information (Data Elements Specific to Pretreatment Program Reports, SIU Periodic Compliance Reports in Municipalities
without an Approved Pretreatment Program)
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[Note: These data elements do not apply to the development, evaluation, or compliance monitoring activities supporting wastewater surcharge
rates.]
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SNC Published A unique code (e.g., ``Yes'', ``No'') that identifies 403.8(f)(2)(viii), 403.12(i)(2) 7.
for each Significant Industrial User (SIU) and Non-
Significant Categorical Industrial Users (NSCIU) in SNC
whether the Control Authority published a public notice
within the reporting period
SNC with Pretreatment Enforceable The unique code/description that identifies for each 403.8(f)(2)(viii), 403.12(i)(2) 7.
Compliance Schedule Status Significant Industrial User (SIU) and Non-Significant
Categorical Industrial User (NSCIU) in SNC whether the
industrial user in SNC is subject to one or more
enforceable compliance schedules within the reporting
period
Local Limits Adoption Date This is the most recent date on which the Control 122.44(j)(2)(ii), 403.5(c), 403.8(f)(4) 7.
Authority adopted new local limits within the reporting and (5), 403.12(i)(4)
period. The date must be provided in YYYY-MM-DD format
where YYYY is the year, MM is the month, and DD is the
day. The Control Authority can leave this data element
blank on the Pretreatment Program Report if the Control
Authority did not adopt any new local limits within the
reporting period
Local Limits Evaluation Date This is the most recent date on which the Control 122.44(j)(2)(ii), 403.5(c), 403.8(f)(4) 7.
Authority completed an evaluation on the potential need and (5), 403.12(i)(4), 403.8(f)(4)
for local limits within the reporting period. The date
must be provided in YYYY-MM-DD format where YYYY is the
year, MM is the month, and DD is the day. The Control
Authority can leave this data element blank on the
Pretreatment Program Report if the Control Authority
did not evaluate any local limits within the reporting
period
Local Limits Pollutants This is the list of the pollutants for which the Control 403.5(c), 403.12(i)(4) 7.
Authority adopted local limits. The Control Authority
will only need to enter each pollutant once no matter
how many treatment works are managed by the Control
Authority. The Control Authority can leave this data
element blank on the Pretreatment Program Reports if
the Control Authority did not change the pollutants for
which the Control Authority derived local limits
POTW Discharge Contamination Indicator The one or more unique codes/descriptions that identify 403.8(f), 403.12(i) 7.
(Program Report) any problems (e.g., pass-through, interference,
violation of NPDES permit limits) with the receiving
POTW's effluent discharge within the reporting period.
See 40 CFR 403.3(k) and (p). EPA regulations require
the Control Authority to develop and enforce local
limits when the discharge from an IU causes or
contributes to any problems at the receiving POTW
POTW Biosolids or Sewage Sludge The one or more unique codes/descriptions that identify 403.8(f), 403.12(i) 7.
Contamination Indicator (Program any problems (e.g., interference with the use or
Report) disposal of biosolids or sewage sludge, violation of
NPDES permit requirements or EPA's regulations at 40
CFR part 503) with the receiving POTW's biosolids or
sewage sludge within the reporting period. See 40 CFR
403.3(k). EPA regulations require any Control Authority
that must develop a Pretreatment Program also to
develop and enforce local limits to ensure that the
discharge from an IU does not cause or contribute a
disruption of biosolids' use or disposal at the
receiving POTW
Industrial User Control Mechanism Status A unique code/description that identifies whether the 403.3(k), 403.5(c), 403.8(f), 403.12(i) 7.
Industrial User is subject to an effective Control
Mechanism within the reporting period
Industrial User Control Mechanism The date when the active Control Mechanism for the 403.8(f)(1)(iii)(B)(1), 403.12(i) 7.
Effective Date Industrial User became effective. The date must be
provided in YYYY-MM-DD format where YYYY is the year,
MM is the month, and DD is the day
Industrial User Control Mechanism The date when the active Control Mechanism for the 403.8(f), 403.12(i) 7.
Expiration Date Industrial User will expire. The date must be provided
in YYYY-MM-DD format where YYYY is the year, MM is the
month, and DD is the day
SNC With Pretreatment Standards or This data element will identify for each Significant 403.8(f), 403.12(i) 7.
Limits (Program Report) Industrial User (SIU) and Non-Significant Categorical
Industrial User (NSCIU) whether the IU was in
Significant Non-Compliance (SNC) with any pretreatment
standard or local limits applicable to the industrial
user's discharge within the reporting period
SNC With Pretreatment Standards or This data element will identify for each Significant 403.8(f), 403.12(i) 7.
Limits Pollutants (Program Report) Industrial User (SIU) and Non-Significant Categorical
Industrial User (NSCIU) the pollutants that related to
the industrial user's Significant Non-Compliance (SNC)
status with any applicable pretreatment standard or
local limits within the reporting period
SNC With Reporting Requirements (Program This data element will identify for each Significant 123.26, 123.41(a), 123.45, 403.8(f), 1, 7.
Report) Industrial User (SIU) and Non-Significant Categorical 403.10, 403.12(i)
Industrial User (NSCIU) whether the IU was in
Significant Non-Compliance (SNC) with reporting
requirements (including baseline monitoring reports,
notice of potential problems, periodic self-monitoring
reports, notice of change in Industrial User discharge,
hazardous waste notification and BMP certification)
within the reporting period
SNC with Other Control Mechanism This data element will identify for each Significant 123.26, 123.41(a), 123.45, 403.8(f), 1, 7.
Requirements (Program Report) Industrial User (SIU) and Non-Significant Categorical 403.10, 403.12(i)
Industrial User (NSCIU) whether the IU was in
Significant Non-Compliance (SNC) with any other control
mechanism requirements within the reporting period.
This data element does not include instances of SNC
that relate to the industrial user's applicable
discharge standards or local limits or reporting
requirements
Listing of Months in SNC This data element will identify for each Significant 123.26, 123.41(a), 123.45, 403.8(f), 1, 7.
Industrial User (SIU) and Non-Significant Categorical 403.10, 403.12(i)
Industrial User (NSCIU) the month or months the IU is
in SNC within the reporting period. These data must be
provided in YYYY-MM format where YYYY is the year and
MM is the month
Number of Industrial User Inspections by This data element will identify for each Significant 403.8(f), 403.12(i) 7.
Control Authority Industrial User (SIU) the number of inspections
conducted by the Control Authority within the reporting
period
Number of Industrial User Sampling This data element will identify for each Significant 403.8(f), 403.12(i) 7.
Events by Control Authority Industrial User (SIU) the number of complete sampling
events conducted by the Control Authority within the
reporting period
Number of Required Industrial User Self- This data element will identify for each Significant 403.8(f), 403.12(i) 7.
Monitoring Events Industrial User (SIU) the number of required self-
monitoring sampling events within the reporting period
that must be reported to the Control Authority
Actual Number of Industrial User Self- This data element will identify for each Significant 403.8(f), 403.12(i) 7.
Monitoring Events Industrial User (SIU) the actual number of self-
monitoring sampling events within the reporting period
submitted to the Control Authority
Types of Industrial User Enforcement This data element will identify for each Significant 403.8(f), 403.12(i) 7.
Action Industrial User (SIU) the type(s) of formal enforcement
action(s) (e.g., formal notices of violation or
equivalent actions, administrative orders, civil suits,
criminal suits) issued by the Control Authority within
the reporting period. The Control Authority can also
optionally use this data element to track informal
actions that they issued within the reporting period
Number of Industrial User Enforcement This data element will identify for each Significant 403.8(f), 403.12(i) 7.
Actions Industrial User (SIU) and for each type of enforcement
action the total number of formal enforcement actions
issued by the Control Authority within the reporting
period. The Control Authority can also optionally use
this data element to track informal actions that they
issued within the reporting period
Industrial User Cash Civil Penalty For civil judicial Enforcement Actions, the dollar CWA section 309 7.
Amount Assessed amount of the penalty assessed against each Significant
Industrial User (SIU) and Non-Significant Categorical
Industrial User (NSCIU) within the reporting period as
specified in the final entered Consent Decree or Court
Order. For Administrative Enforcement Actions, it is
the dollar amount of the penalty assessed in the
Consent/Final Order
Industrial User Cash Civil Penalty For civil judicial Enforcement Actions, the dollar CWA section 309 7.
Amount Collected amount of the penalty collected from each Significant
Industrial User (SIU) and Non-Significant Categorical
Industrial User (NSCIU) within the reporting period.
For Administrative Enforcement Actions, it is the
dollar amount collected of the penalty assessed in the
Consent/Final Order
Industrial User POTW Discharge The one or more unique codes/descriptions that identify 123.26, 123.41(a), 123.45, 403.5(c), 1, 7.
Contamination Indicator (Program for each Significant Industrial User (SIU) and Non- 403.8(f), 403.10, 403.12(i)
Report) Significant Categorical Industrial User (NSCIU) whether
the Industrial User caused or contributed to any
problems (e.g., pass-through, interference, violation
of NPDES permit limits) with the receiving POTW's
effluent discharge in the previous reporting period.
See 40 CFR 403.3(k) and (p). EPA regulations require
the Control Authority to develop and enforce local
limits when the discharge from an IU causes or
contributes to any problems e.g., at the receiving POTW
Industrial User Biosolids or Sewage The one or more unique codes/descriptions that identify 123.26, 123.41(a), 123.45, 403.5(c), 1, 7.
Sludge Contamination Indicator (Program for each Significant Industrial User (SIU) and Non- 403.8(f), 403.10, 403.12(i)
Report) Significant Categorical Industrial User (NSCIU) whether
the Industrial User caused or contributed to any
problems (e.g., interference with the use or disposal
of biosolids or sewage sludge, violation of NPDES
permit requirements or EPA's regulations at 40 CFR part
503) with the receiving POTW's biosolids or sewage
sludge in the previous reporting period. See 40 CFR
403.3(k). EPA regulations require the Control Authority
to develop and enforce local limits when the discharge
from an IU causes or contributes to any problems e.g.,
at the receiving POTW
Industrial User Wastewater Flow Rate This data element will identify for each Significant 403.8(f), 403.12(e), 403.12(h), 7, 8.
(Program Report) Industrial User (SIU) and Non-Significant Categorical 403.12(i)
Industrial User (NSCIU) the maximum monthly average
wastewater flow rate (in gallons per day) in the
previous reporting period
Middle-Tier Significant Industrial User The unique code/description that identifies for each 123.26, 123.41(a), 123.45, 403.10, 1, 7.
Reduced Reporting Status Middle-Tier Significant Industrial User (MTSIU) whether 403.12(e)(3), 403.12(i)(2)
the Control Authority has granted reduced reporting
requirements in accordance with 40 CFR 403.12(e)(3)
Non-Significant Categorical Industrial The unique code/description that identifies for each Non- 123.26, 123.41(a), 123.45, 403.10, 1, 7.
User (NSCIU) Certification Submitted to Significant Categorical Industrial User (NSCIU) whether 403.12(i)(2), 403.12(q)
Control Authority the facility has reported its required annual
compliance certification to the Control Authority
within the reporting period
Notification of Changed Discharge The unique code (e.g., ``Yes'', ``No'') that identifies 403.8(f), 403.12 (i), 403.12(j) 1, 7.
Submission for each Significant Industrial User (SIU) and Non-
Significant Categorical Industrial User (NSCIU) whether
the Industrial User submitted a notification within the
reporting period to the Control Authority of a
substantial change in the volume or character of
pollutants in their discharge, including the listing or
characteristic hazardous wastes for which the
Industrial User previously submitted notice
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Compliance Monitoring Activity Information (Data Elements Specific to Sewer Overflow/Bypass Event Reports)
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[Note: These data elements apply to sewer overflows and bypass events at POTWs. These data elements do not apply to industrial facilities. This
report uses the `Permitted Feature Identifier (Compliance Monitoring Activity)' data element to identify the location of each sewer overflow or
bypass at a permitted feature. Each bypass location should be permitted and have an identifier in the `Permitted Feature Identifier (Permit)' data
element. This report will also identify the location of each sewer overflow at an unpermitted feature.]
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Sewer Overflow/Bypass Identifier This data element will allow the reporting of multiple 122.41(l)(4), (6), and (7) and 3, 9.
sewer overflows or bypasses on one report. Each 122.41(m)(3)
individualized sewer overflow or bypass will be given a
unique identifier (e.g., 1, 2, 3, and so on) for each
Sewer Overflow/Bypass Event Report. This field can be
system generated to accommodate one or more individual
sewer overflows or bypasses. If the sewer overflows are
caused by an extreme weather event (e.g., hurricane)
that floods the entire sewer system the POTW can use
this data element to indicate that the number of sewer
overflows cannot be tabulated as they are too numerous
to count
Sewer Overflow Longitude for Unpermitted This data element is required for each Sewer Overflow/ 122.41(l)(4), (6), and (7) 3, 9.
Feature (Sewer Overflow/Bypass Event Bypass Identifier without a corresponding identifier in
Report) the `Permitted Feature Identifier (Permit)' data
element, which is reported on the NPDES permit
application or Notice of Intent for NPDES permit
coverage. This data element is the measure of the
angular distance on a meridian east or west of the
prime meridian for the sewer overflow location. The
format for this data element is decimal degrees (e.g.,
^77.029289) and the WGS84 standard coordinate system.
The `Permitted Feature Identifier (Compliance
Monitoring Activity)' data element is used to identify
the location of each sewer overflow at a permitted
feature. If the sewer overflow is associated with a
private residence the longitude of the nearest
collection system structure (e.g., manhole) can be used
for this data element to the extent that reporting is
required. The POTW can leave this data element blank on
the Sewer Overflow/Bypass Event Report if the sewer
overflows are caused by an extreme weather event (e.g.,
hurricane) that floods the entire sewer system and are
too numerous to count. This data element can also be
system generated if the Sewer Overflow/Bypass Event
Report collects the street location of the sewer
overflow and the street location can be used to
generate an accurate longitude value. (Note: ``Post
Office Box'' addresses and ``Rural Route'' addresses
are generally not geocodable)
Sewer Overflow Latitude for Unpermitted This data element is required for each Sewer Overflow/ 122.41(l)(4), (6), and (7) 3, 9.
Feature (Sewer Overflow/Bypass Event Bypass Identifier without a corresponding identifier in
Report) the `Permitted Feature Identifier (Permit)' data
element, which is reported on the NPDES permit
application or Notice of Intent for NPDES permit
coverage. This data element is the measure of the
angular distance on a meridian north or south of the
equator for the sewer overflow location. The format for
this data element is decimal degrees (e.g., ^77.029289)
and the WGS84 standard coordinate system. The Permitted
Feature Identifier (Compliance Monitoring Activity)
data element is used to identify the location of each
sewer overflow at a permitted feature. If the sewer
overflow is associated with a private residence the
latitude of the nearest collection system structure
(e.g., manhole) can be used for this data element to
the extent that reporting is required. The POTW can
leave this data element blank on the Sewer Overflow/
Bypass Event Report if the sewer overflows are caused
by an extreme weather event (e.g., hurricane) that
floods the entire sewer system and are too numerous to
count. This data element can also be system generated
if the Sewer Overflow/Bypass Event Report collects the
street location of the sewer overflow and the street
location can be used to generate an accurate longitude
value. (Note: ``Post Office Box'' addresses and ``Rural
Route'' addresses are generally not geocodable)
Type of Sewer Overflow/Bypass (Sewer A unique code/description that identifies the type of 122.41(l)(4), (6), and (7) and 3, 9.
Overflow/Bypass Event Report) sewer overflow or bypass (e.g., CSO or SSO from the 122.41(m)(3)
POTW's collection system, anticipated bypass from the
treatment works, unanticipated bypass from the
treatment works) for each Sewer Overflow/Bypass
Identifier. For bypass events the permittee will also
use this data element to identify if any NPDES effluent
limitations were violated as a result of the bypass
Type of Sewer Overflow/Bypass Structure A unique code/description that identifies the type of 122.41(l)(4), (6), and (7) and 3, 9.
sewer overflow or bypass structure (e.g., manhole, CSO 122.41(m)(3)
outfall) for each Sewer Overflow/Bypass Identifier. The
POTW can leave this data element blank on the Sewer
Overflow/Bypass Event Report if the sewer overflows are
caused by an extreme weather event (e.g., hurricane)
that floods the entire sewer system and are too
numerous to count
Sewer Overflow/Bypass Cause The one or more unique codes/descriptions that best 122.41(l)(4), (6), and (7) and 3, 9
represent the likely cause of the sewer overflow or 122.41(m)(3)
bypass (e.g., broken pipe, fats/oil/grease, mechanical
failure, pump station electrical failure, wet weather,
vandalism) for each Sewer Overflow/Bypass Identifier.
Duration of Sewer Overflow/Bypass Estimated duration of the sewer overflow or bypass (in 122.41(l)(4), (6), and (7) and 3, 9.
(hours) (Sewer Overflow/Bypass Event hours) for each Sewer Overflow/Bypass Identifier. If 122.41(m)(3)
Report) the discharge has not been corrected, this is the best
professional judgment from the sewer owner or in the
case of a bypass, the treatment plant owner, of the
time the sewer overflow or bypass is expected to
continue. The POTW can leave this data element blank on
the Sewer Overflow/Bypass Event Report if the sewer
overflows are caused by an extreme weather event (e.g.,
hurricane) that floods the entire sewer system and are
too numerous to count
Sewer Overflow/Bypass Discharge Volume Best professional judgment from the sewer owner on the 122.41(l)(4), (6), and (7) and 3, 9.
(gallons) (Sewer Overflow/Bypass Event estimated number of gallons of sewer overflow or bypass 122.41(m)(3)
Report) for each Sewer Overflow/Bypass Identifier. If the
discharge has not been corrected, this is the best
professional judgment from the sewer owner or in the
case of a bypass, the treatment plant owner, of the
volume of overflow or bypass prior to cessation. The
POTW can leave this data element blank on the Sewer
Overflow/Bypass Event Report if the sewer overflows are
caused by an extreme weather event (e.g., hurricane)
that floods the entire sewer system and are too
numerous to count
Receiving Waterbody Name for Unpermitted This data element identifies the receiving waterbody 122.41(l)(4), (6), and (7) 3, 9.
Feature (Sewer Overflow/Bypass Event name for each Sewer Overflow/Bypass Identifier that
Report) does not have a corresponding value in the `Permitted
Feature Identifier (Permit)' data element. This data
element will use the best professional judgment of the
sewer owner to identify the name of the waterbody that
is or will likely receive the discharge from each Sewer
Overflow/Bypass Identifier. The POTW can leave this
data element blank on the Sewer Overflow/Bypass Event
Report if the sewer overflows are caused by an extreme
weather event (e.g., hurricane) that floods the entire
sewer system and are too numerous to count
Wet Weather Occurrence for Sewer The unique code (e.g., ``Yes'', ``No'') that represents 122.41(l)(4), (6), and (7) and 3, 9.
Overflow/Bypass Status the best professional judgment of the sewer owner, or 122.41(m)(3)
in the case of a bypass, the treatment plant owner,
regarding whether the sewer overflow or bypass, by
Sewer Overflow/Bypass Identifier, occurred during wet
weather
Corrective Actions Taken or Planned for The unique code/description that describes the steps 122.41(l)(4), (6), and (7) and 3, 9.
Sewer Overflow/Bypass (Sewer Overflow/ taken or planned to reduce, eliminate, and prevent 122.41(m)(3)
Bypass Event Report) reoccurrence of future sewer overflows or bypasses for
each Sewer Overflow/Bypass Identifier and the related
impacts to health and the environment. This data
element can be used to identify the portion of the
sewer overflow or bypass that was contained and
recovered prior to any discharge to waters of the U.S.
This data element will also identify if any monitoring
of the receiving waterbody was done during and/or after
the sewer overflow or bypass to gauge the potential
impact to health and the environment. The POTW can
leave this data element blank on the Sewer Overflow/
Bypass Event Report if the sewer overflows are caused
by an extreme weather event (e.g., hurricane) that
floods the entire sewer system and are too numerous to
count
Type of Potential Impact of Sewer The unique code/description that describes the type of 122.41(l)(4), (6), and (7) and 3, 9.
Overflow/Bypass (Sewer Overflow/Bypass potential health or environmental impact(s) (e.g., 122.41(m)(3)
Event Report) beach closure) for each Sewer Overflow/Bypass
Identifier. Under 40 CFR 122.41(l)(6), ``the permittee
shall report any noncompliance which may endanger
health or the environment.'' This data element provides
information regarding the nature of such potential
endangerment. The POTW can leave this data element
blank on the Sewer Overflow/Bypass Event Report if the
sewer overflows are caused by an extreme weather event
(e.g., hurricane) that floods the entire sewer system
and are too numerous to count
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Compliance Monitoring Activity Information (Data Elements Specific to CWA section 316(b) Annual Reports)
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[Note: Where the Director requires additional measures to protect Federally-listed threatened or endangered species or critical habitat pursuant
to 40 CFR 125.94(g), the Director shall require reporting associated with those measures [see 40 CFR 125.97(g)]. The following data elements
correspond to this reporting requirement. These data elements are only required for facilities that are required to report on their additional
measures to protect Federally-listed threatened or endangered species or critical habitat.]
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CWA Section 316(b) Biological For existing facilities, a listing of each Federally- 125.96, 125.97(g), 125.98, 125.138(b), 10.
Monitoring--Species Name (Program listed threatened or endangered species (or relevant 401.14 and CWA section 316(b)
Report) taxa) for all life stages that might be susceptible to
impingement and entrainment at the facility's cooling
water intake structure(s). Specific monitoring
protocols and frequency of monitoring will be
determined by the Director
CWA Section 316(b) Biological For existing facilities, the number of each Federally- 125.96, 125.97(g), 125.98, 125.138(b), 10.
Monitoring--Species Number (Program listed threatened or endangered species (or relevant 401.14 and CWA section 316(b)
Report) taxa) that might be susceptible to impingement and
entrainment at the facility's cooling water intake
structure(s). Specific monitoring protocols and
frequency of monitoring will be determined by the
Director
CWA Section 316(b) Biological For existing facilities, a unique code/description that 125.96, 125.97(g), 125.98, 125.138(b), 10.
Monitoring--Threatened or Endangered identifies for each Federally-listed threatened or 401.14 and CWA section 316(b)
Status (Program Report) endangered species (or relevant taxa) whether the
species is threatened, endangered, or is an otherwise
protected species that might be susceptible to
impingement and entrainment at the facility's cooling
water intake structure(s). Specific monitoring
protocols and frequency of monitoring will be
determined by the Director
CWA Section 316(b) Biological For existing facilities, the number of each Federally- 125.96, 125.97(g), 125.98, 125.138(b), 10.
Monitoring--Species Impinged and listed threatened or endangered species (or relevant 401.14 and CWA section 316(b)
Entrained (Program Report) taxa) impinged and entrained per year by the facility's
cooling water intake structure(s). Specific monitoring
protocols and frequency of monitoring will be
determined by the Director
CWA Section 316(b) Biological For existing facilities, a text summary of the measures 125.96, 125.97(g), 125.98, 125.138(b), 10.
Monitoring--Applicable Measures to taken by the permittee to protect designated critical 401.14 and CWA section 316(b)
Protect Designated Critical Habitat habitat in the vicinity of impingement and entrainment
(Program Report) at the facility's cooling water intake structure(s)
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Information Common to Violations, Enforcement Actions, and Final Orders
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[Note: Single Event Violation (SEV) data elements are mandatory for construction stormwater inspections that identify CWA violations that result
in a regulatory authority taking a formal enforcement action. SEV data elements are optional for other construction stormwater inspections.]
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Violation Code The unique code/description that identifies each type of 123.45 and CWA section 309 1.
violation that has occurred at the facility (e.g., D80
= Required Monitoring DMR Value Non-Receipt, E90 =
Effluent Violation, C20 = Schedule Event Achieved
Late). This includes single event violations (SEVs) and
violations that are system generated based upon DMRs,
schedules, etc.
Violation Date This is the date of the violation, which varies 123.45 and CWA section 309 1.
depending on the type of violation. The date must be
provided in YYYY-MM-DD format where YYYY is the year,
MM is the month, and DD is the day. This data element
may be system generated and does not apply to single
event violation dates
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Violation Information
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Agency Identifying the Single Event The unique code/description that identifies the agency 123.26, 123.41(a), 123.45 1.
Violation (SEV) that identified the single event violation (SEV)
Single Event Violation Start Date The date the single event violation (SEV) began. If the 123.26, 123.41(a), 123.45 1.
SEV occurred on one date, this data element is optional
as this date can be system generated to equal ``Single
Event Violation End Date'' when left blank. The date
must be provided in YYYY-MM-DD format where YYYY is the
year, MM is the month, and DD is the day
Single Event Violation End Date The date the single event violation (SEV) ended. This 123.26, 123.41(a), 123.45 1.
field will be left blank to denote an ongoing or
unresolved SEV. The date must be provided in YYYY-MM-DD
format where YYYY is the year, MM is the month, and DD
is the day
RNC Detection Code The unique code/description that identifies the type of 123.26, 123.41(a), 123.45 1.
reportable noncompliance (RNC) detected by the
regulatory authority
RNC Detection Date The date that reportable noncompliance (RNC) was 123.26, 123.41(a), 123.45 1.
detected. This date may vary according to the type of
violation detected. The date must be provided in YYYY-
MM-DD format where YYYY is the year, MM is the month,
and DD is the day
RNC Resolution Code The unique code/description that identifies the 123.26, 123.41(a), 123.45 1.
reportable noncompliance (RNC) status (e.g.,
noncompliant, resolved pending, waiting resolution,
resolved) for each violation. This data element can be
entered manually or system generated
RNC Resolution Date The date reportable noncompliance (RNC) was marked to 123.26, 123.41(a), 123.45 1.
its current resolution status. This data element is
entered manually. The date must be provided in YYYY-MM-
DD format where YYYY is the year, MM is the month, and
DD is the day
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Enforcement Action Information
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[Note: NPDES authorized programs will only need to share criminal action information with EPA when the criminal case is concluded.]
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Enforcement Action Identifier The unique identifier for each enforcement action. For 123.27, 123.41(a), and CWA section 309 1.
EPA enforcement actions, this field will be have three
components, each separated by a hyphen (e.g., 04-2014-
4509). These three components are: (1) the EPA Region
responsible for the enforcement action as identified by
the EPA Region code (e.g., 04); (2) the four-digit
fiscal year during which the enforcement action is
initiated (e.g., 2014); and (3) a four-digit, user-
assigned sequence number between 0001 and 9999 (e.g.,
4509). States will be able to use this same structure,
or they will be able to use a different structure of
their choosing provided that the first two characters
of the identifier constitute the state code (e.g.,
Alabama = ``AL'')
Enforcement Action Forum This identifies the forum of the formal enforcement 123.27, 123.41(a), and CWA section 309 1.
action (e.g., administrative formal, judicial). This
can be system generated
Enforcement Action Type The unique code/description that identifies the type for 123.27, 123.41(a), and CWA section 309 1.
each formal or informal enforcement action. This code/
description identifies, for example, whether the
enforcement action is a civil judicial referral, a
notice of violation, an administrative penalty order,
administrative order, or criminal prosecution
Programs Violated (Enforcement Action) The unique code/description that identifies each program 123.27, 123.41(a), and CWA section 309 1.
(e.g., pretreatment, biosolids/sewage sludge, MS4s,
Core NPDES program) associated with each enforcement
activity
Enforcement Action Sub-activity Type A unique code/description that identifies the type for 123.27, 123.41(a), and CWA section 309 1.
each sub-activity associated with each enforcement
activity (e.g., COMPS = compliance achieved, MECDJ =
motion to enforce consent agreement, AHRG =
administrative hearing, AMNCA = amended complaint).
Some of these sub-activities are system required and
some can be system generated. Data on sub-activities
that are not milestones are optional
Enforcement Action Sub-activity The date on which the sub-activity was completed. This 123.27, 123.41(a), and CWA section 309 1.
Completion Date data element is required for each sub-activity
provided. The date must be provided in YYYY-MM-DD
format where YYYY is the year, MM is the month, and DD
is the day. Some of these dates can be system generated
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Final Order Information
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[Note: These data elements are linked to the ``Enforcement Action Identifier''. NPDES authorized programs will only need to share criminal action
information with EPA when the criminal case is concluded.]
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Final Order Identifier The unique identifier for each final order. This data 123.27, 123.41(a), and CWA section 309 1.
element can be system generated
Final Order Type A unique code that identifies the legal process used by 123.27, 123.41(a), and CWA section 309 1.
the authorized NPDES program to settle the enforcement
action (e.g., administrative compliance order, an
administrative penalty order, consent decree, Federal
facility agreement, criminal conviction or plea
agreement)
Final Order Issued/Entered Date For a judicial enforcement action this is the date the 123.27, 123.41(a), and CWA section 309 1.
Clerk of the Court stamps the document after it is
signed by the presiding Judge. For an administrative
formal enforcement action this is the date the Final
Order was issued. For a criminal enforcement action,
this is the date the sentence was imposed. The date
must be provided in YYYY-MM-DD format where YYYY is the
year, MM is the month, and DD is the day
NPDES Closed Date The date of closure for each NPDES final order. The date 123.27, 123.41(a), and CWA section 309 1.
must be provided in YYYY-MM-DD format where YYYY is the
year, MM is the month, and DD is the day
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Penalty Information
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[Note: These data elements are linked to the ``Enforcement Action Identifier''. NPDES authorized programs will only need to share criminal action
information with EPA when the criminal case is concluded.]
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Penalty Amount Assessed For civil judicial enforcement actions, the dollar 123.27, 123.41(a), and CWA section 309 1.
amount of the penalty assessed against the defendant(s)
as specified in the final entered Consent Decree or
Court Order. For administrative enforcement actions, it
is the dollar amount of the penalty assessed in the
Consent Decree or Final Order. For criminal enforcement
actions, it is the dollar amount of the fine agreed to
by the defendant or sentenced by the Court and should
include fields for prison time, probation, home
confinement or monitoring periods, restitution, and
special assessments
Penalty Amount Collected For civil judicial enforcement actions, the dollar 123.27, 123.41(a), and CWA section 309 1.
amount of the penalty collected from the defendant(s).
For administrative enforcement actions, it is the
dollar amount collected of the penalty assessed in the
Consent Decree or Final Order. For criminal enforcement
actions, it is the dollar amount of the fine paid by
the defendant as well as restitution and special
assessments
Supplemental Environmental Project The unique identifier for each supplemental 123.27, 123.41(a), and CWA section 309 1.
Identifier environmental project. This data element can be system
generated
Supplemental Environmental Project The assessed cost, in dollars, of the one or more of the 123.27, 123.41(a), and CWA section 309 1.
Amount defendant's Supplemental Environmental Projects (SEPs).
This is the dollar amount that is assessed either in
addition to civil penalties or in lieu of civil
penalties. This data element is only required if there
is a SEP and may be entered at a later date when the
data is available
Supplemental Environmental Project This text field summarizes the Supplemental 123.27, 123.41(a), and CWA section 309 1.
Description Environmental Projects (SEPs) that the respondent has
completed in response to an enforcement action. This
data element is only required if there is a SEP and may
be entered at a later date when the data is available
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Compliance Schedule Information
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[Note: These data elements are linked to the ``Enforcement Action Identifier''.]
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Compliance Schedule Number This number that in combination with the Compliance 123.27, 123.41(a), and CWA section 309 1.
Schedule Type and NPDES ID uniquely identifies a
compliance schedule
Compliance Schedule Type The unique code/description that identifies the type of 123.27, 123.41(a), and CWA section 309 1.
compliance schedule (e.g., an administrative formal
action = ``A'', a judicial action = ``J'')
Compliance Schedule Description The unique code/description that identifies each type of 123.27, 123.41(a), and CWA section 309 1.
condition or requirement (e.g., best management
practices plan development) for the compliance schedule
Compliance Schedule Event Code The unique code/description that identifies each event 123.27, 123.41(a), and CWA section 309 1.
that is added within a compliance schedule
Compliance Schedule Due Date The date the compliance schedule event is scheduled to 123.27, 123.41(a), and CWA section 309 1.
be completed (i.e., the due date). The date must be
provided in YYYY-MM-DD format where YYYY is the year,
MM is the month, and DD is the day
Compliance Schedule Actual Date The actual date on which the compliance schedule event 123.27, 123.41(a), and CWA section 309 1.
was completed or achieved. The date must be provided in
YYYY-MM-DD format where YYYY is the year, MM is the
month, and DD is the day
Compliance Schedule Report Received Date The date the regulatory agency received the report 123.27, 123.41(a), and CWA section 309 1.
required by the compliance schedule report. The date
must be provided in YYYY-MM-DD format where YYYY is the
year, MM is the month, and DD is the day
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes:
(1) The NPDES program authority may pre-populate these data elements and other data elements (e.g., Federal Registry System ID) in the NPDES electronic
reporting systems in order to create efficiencies and standardization. For example, the NPDES program authority may configure their electronic
reporting system to automatically generate NPDES IDs for control mechanisms for new facilities reported on a Pretreatment Program Report [40 CFR
403.12(i)]. Additionally, the NPDES program authority can decide whether to allow NPDES regulated entities to override these pre-populated data.
(2) The data elements in this table conform to EPA's policy regarding the application requirements for renewal or reissuance of NPDES permits for
discharges from municipal separate storm sewer systems (see 61 FR 41698; 6 August 1996).
(3) The data elements in this table are also supported by the Office Management and Budget approved permit applications and forms for the NPDES program.
(4) These data will allow EPA and the NPDES program authority to link facilities, compliance monitoring activities, compliance determinations, and
enforcement actions. For example, these data will provide several ways to make the following linkages: linking violations to enforcement actions and
final orders; linking single event violations and compliance monitoring activities; linking program reports to DMRs; linking program reports to
compliance monitoring activities; and linking enforcement activities and compliance monitoring activities.
[attachment 8]
USDA Comments on Draft Final WPS Rule
Submitted July 8, 2015
USDA Background
A healthy and strong agricultural workforce is one of the key
factors in the success of American agriculture. The labor force,
whether employed in greenhouses, fields, orchards, nurseries, or other
productive agricultural enterprises, like employees in other
industries, should be aware of all activities in their workplace,
particularly when there is potential occupational exposure directly to
pesticides or their residues, so that they can take appropriate
measures to minimize those risks. Agricultural employers have a
responsibility to ensure that people working at an agricultural
enterprise have the protections of a safe workplace. The accountability
of worker protection is not one-sided. To be successful, the labor
force and the employer share equally in the responsibility. USDA
supports strong agricultural worker protection standards as they are
essential to successful, modern agriculture.
Comments on EPA Worker Protection Standard Final Rule
USDA did not reference its comments by page number and line,
because changing the display settings for the tracked changes in the
draft final rule USDA received from EPA resulted in varying page and
line number alignments. To prevent confusion, USDA is referencing its
comments by unit and subunit number for the preamble, and by section
and subsection for the draft final rule.
Comments on the Preamble
1. USDA. The draft final rule has an overall weakness in a number
of places in the document in the manner in which EPA justifies
positions it takes in the document. This weakness is a lack of
evidenced-based scientific data. In these cases, the positions
presented by EPA could have be greatly strengthened to make the draft
final rule more compelling in its justification for their proposed
changes to the 1992 Worker Protection Standards. With the lack of
evidenced-based scientific data, some of EPA's positions tend to appear
as opinions rather than factual determinations. Examples of language in
the draft final rule that demonstrate this lack of evidenced-based
scientific data are listed below:
(a) II.D.: ``Even if the lack of quantitative data impairs
the reliability of estimates of the total number of chronic
illnesses avoided, it is reasonable to expect that the proposed
changes to the WPS will reduce pesticide exposure, and thereby
reduce the incidence of chronic disease resulting from
pesticide exposure.''
(b) IV.B.2.: ``Although EPA cannot quantify the specific
reduction in incidents from any single change to the
regulation, taken together, EPA estimates that the final rule
will result in an annual reduction of between 540 and 1,620
acute, health-related incidents.''
(c) V.H.2.: ``2. Benefits. While EPA can estimate the costs
of the changes to pesticide safety training for workers and
handlers, quantifying the benefits is more difficult.
Nonetheless, as explained in the NPRM, it is reasonable to
expect that more frequent training would lead to better
retention of information by workers and handlers, ultimately
resulting in fewer incidents of pesticide exposure and illness
in workers and handlers, improved decontamination procedures,
reduced take-home exposure, and better protection of
children.''
EPA Response. The preamble discusses the best evidence and data
that are available, including a detailed analysis of occupational
pesticide incidents for the four most recent years in the SENSOR-
Pesticides database. EPA believes the statements in the preamble--
including the ones USDA cited--are accurate, and that the evidence and
data adequately support these revisions to the WPS. EPA is not aware of
any additional data sources that address the specific scenarios covered
by the regulations and is interested in learning about any evidence-
based scientific data that USDA has seen. EPA's decisions on training
were based partially on the widely accepted idea that training people
on worker safety decreases the number of incidents even though there is
little research in how the training quantitatively translates to fewer
incidents. As stated in Unit IV.B.2 of the preamble, EPA has seen a
significant reduction in the number of estimated incidents since the
1992 rule even though EPA cannot determine the impact of each
individual requirement in the rule, as well as other changes in
agriculture, on that reduction in incidents.
2. Unit IV.B.2. (``Surveillance data'')
USDA. Consider rewriting to improve clarity. The original statement
is ``Another example of potentially avoidable exposure is spray drift;
labeling prohibits application that contacts other persons and handlers
should be instructed to apply pesticides in a manner that does not
contact other persons, but incidents continue to occur.'' Consider
revising to say: ``Another example of potentially avoidable exposure is
spray drift. Labeling instructs handlers to apply pesticides in a
manner that does not contact other persons, but incidents continue to
occur.''
EPA Response. EPA has made this change to the preamble by revising
it as follows: ``. . . Another example of potentially avoidable
exposure is spray drift. l Labeling prohibits application that contacts
other persons and instructs handlers must to apply pesticides in a
manner that does not contact other persons, but pesticide drift
continues to cause exposure incidents.''
3. Unit V.D. (``Expand the Content of Worker and Handler Pesticide
Safety Training'')
USDA. USDA is concerned that the draft final rule does not include
any estimate for how much additional time, if any, will be required to
teach the expanded content of Worker and Handler Pesticide Safety
Training. Without these time estimates, one cannot compare the training
times for the expanded content for workers or handlers versus the
typical time needed to teach the current pesticide safety training
covering specific content. The time required for training is a
significant driver of costs to effectively implement the draft final
rule. This apparent increase in training time needed to provide the
expanded content appears to put in question EPA's marginal costs
estimates of Impact on Jobs (page 10) of a typical farmworker to
increase only $5/year and the marginal cost for a more skilled
pesticide handler to increase only $50 per year. The ``Economic
Analysis of the Agricultural Worker Protection Standard Revisions'' did
not dispel this concern, because the analysis was based on the current
training time of 30 minutes per sessions without an analysis of how
long the ``expanded'' training sessions will require. This would also
put into question EPA's estimate (Costs and Benefits of Revisions to
Pesticide Safety Training, page 53) of $62 to $80 per agricultural
establishment per year.
EPA Response. In the Economic Assessment, Unit 3.3.1 Pesticide
Safety Training, Step 1 Calculate Baseline Costs, EPA provides an
estimate of 30 minutes for a full training session for workers under
the current rule. In the second paragraph on page 57, and under Table
3.3-7 on page 57, EPA provides the estimate of 45 minutes for worker
safety training with the expanded content, an increase of 15 minutes of
training time.
For the handler training baseline, please refer to Table 3.3-3 for
the estimate of 45 minutes. Handler safety training covers more
material than worker safety training. EPA estimated that the additional
content in the final rule will result in an additional 15 minutes for
handler training, and EPA includes that estimate in the narrative in
the economic analysis.
The 15 minute estimate for the increases in worker and handler
training time is based on the length and content of current training
videos.
4. Unit V.H.1. (``Costs and Benefits of Revisions to Pesticide
Safety Training: Costs'')
The expanded training is good from a safety standpoint and is
necessary. However, it does not appear that the economic analysis
addresses the impact of the time spent for training on worker/handler
income particularly if the training is performed at the field prior to
a work day. For many laborers, wages are earn based on their volume of
work and not on the hours worked. Are they paid for the time spent
training or does the time spent training significantly impact their
earned wages for that day?
EPA Response. EPA does not require employers to pay workers for
their time spent in training, although some employers do pay workers
for that time. This is addressed in the EA as follows:
Training, Step 1 Calculate Baseline Costs: ``Action is
required by two actors, the WPS farm, which provides or
arranges the training, and the workers, who take the training.
We consider these actors separately, although we assume the WPS
farm incurs the training costs and implicitly pays the worker
to take the training at the same wage he or she earns doing
field work. However, some workers may bear the opportunity cost
of taking the training. Workers who are hired to harvest fruits
and vegetables are often paid by the quantity harvested; thus,
time spent in training is time they are not earning pay.''
Because EPA estimates that under the final rule worker training will
last 45 minutes, workers who are not paid for by the hour would incur
an average opportunity cost of less than $10 annually due to the
training requirement.
5. Unit VII.A.2. (``Hazard Information--Location and Accessibility:
Final rule'')
USDA. Please define the term ``valid'' in this context and describe
how an employer will be able to determine that the request and
employee's signature is authentic. [In regards to the following
sentence: ``When the employer is presented a valid request, the
employer must provide a copy of, or access to, all of the requested
information that is applicable within 15 working days from the receipt
of the request.'']
EPA Response. In this context, the term ``valid'' was used to mean
the request contains all of the required information. The agricultural
employer is required to provide the information only when the
designated representative presents a complete request. However, for
clarity, EPA will replace ``valid'' with more descriptive language.
Specifically, the sentence in Unit VII.A.2 has been revised as follows:
``When the employer is presented a valid request that contains all of
the necessary information specified in the regulations, the employer
must provide a copy of, or access to, all of the requested information
that is applicable within 15 working days from the receipt of the
request.''
The employer will have access to the employee's signature in
training records. The pesticide use information is not confidential
Personally Identifiable Information, and it should be readily provided
to anyone with a plausible claim to be a designated representative. See
170.401(d)(1) for details.
6. Unit VII.B.3. (Paragraph on ``Comments on inconsistencies in
information between labels and SDSs'')
It is surprising that EPA is not acknowledging that it is common
for SDSs to show PPE requirements that are different from the pesticide
labels, since the two documents are intended for different audiences.
EPA states here that since the label is not required to be posted, they
do not ``expect issues with a perception of conflict between labeling
and SDSs.'' USDA questions whether this is correct. Many Forest Service
employees have reported finding differences between the PPE listed in
the SDSs compared to the label. At a minimum, EPA should address this
issue in the preamble.
EPA Response. EPA's intention with requiring agricultural employers
to display the Safety Data Sheets (SDSs) is to provide farmworkers and
handlers with information regarding chronic, developmental and
reproductive toxicity that is usually found on SDSs and not the label.
Much of the technical information on SDSs, such as the chemical and
physical properties of the pesticide, is designed for use by multiple
professionals such as manufacturers, transporters, medical personnel
and firefighters.
EPA maintains our position that we do not anticipate issues with a
perception of conflict between labeling and SDSs. First, many SDSs
include a reference to the pesticide label in the section on exposure
controls and personal protection. Second, the persons who would wear
PPE are handlers who are trained that they must follow labeling
instructions, including those regarding PPE. However, EPA has amended
the preamble to clarify that pesticide applicators and handlers must
always follow the instructions on the labeling regardless of any
differences between information on the labeling and the SDS, and will
make a point of including in future training materials warnings against
reliance on SDS provisions regarding PPE.
EPA has adjusted the response to this comment in Unit VII.B.3 of
the preamble as follows: ``. . . The SDS provides succinct information
about the known health hazards of the product that typically is not
presented as part of the product label or labeling. Such information
can be invaluable to medical professionals for the diagnosis and
treatment of certain pesticide-related illnesses and injuries. Because
EPA is not requiring the employer to display the labeling, EPA does not
expect issues with a perception of conflict between labeling and SDSs.
The persons who would wear PPE are handlers who receive more thorough
training than ordinary workers. If pesticide handlers encounter
conflicting information on labeling and SDSs, such as the PPE
identified, they should know that they must follow the instructions on
the pesticide labeling, as they are trained to do. For information on
OSHA's adoption of the Globally Harmonized System of Classification and
Labeling of Chemicals for SDSs and the pesticide product labeling . .
.''
7. Unit XVIII.E. (``Equivalency provisions'' and
``Clarifications'')
There are two subsections labeled ``E.'' The second one, ``E.
Clarifications'' should be relabeled ``F. Clarifications''.
EPA Response. The correction has been made.
Comments on the Rule 8. 170.305
a. USDA. The definition for ``agricultural plant'' depends on the
definition for ``commercial production,'' and the definition for
``commercial production'' depends on the definition for ``agricultural
plant.'' Similar issues exist in the definitions of ``agricultural
establishment'' and ``farm,'' ``forest operation,'' and ``nursery.''
USDA recommends resolving these circular dependencies by defining at
least one of the terms in each pair independently.
EPA Response. EPA agrees that these definitions are somewhat
circular, and while EPA is not convinced that serious confusion would
result, EPA has eliminated some definitions and revised others to
address USDA's concern. The terms ``commercial production,'' ``farm,''
``nursery,'' and ``forest operation'' appear only in the definition
section and are not used elsewhere in the regulation. Accordingly, EPA
will delete these definitions and merge their substantive content into
the definitions of ``agricultural establishment'' and ``agricultural
plant,'' as follows:
``Agricultural establishment'' means any farm, forest
operation, or nursery engaged in the outdoor or enclosed space
production of agricultural plants. An establishment that is not
primarily agricultural is an agricultural establishment if it
produces agricultural plants for transplant or use (in part or
their entirety) in another location instead of purchasing the
agricultural plants. ``Agricultural plant'' means any plant, or
part thereof, grown, maintained, or otherwise produced for
commercial purposes, including growing, maintaining or
otherwise producing plants for sale or trade, for research or
experimental purposes, or for use in part or their entirety in
another location. ``Agricultural plant'' includes, but is not
limited to, grains, fruits and vegetables; wood fiber or timber
products; flowering and foliage plants and trees; seedlings and
transplants; and turf grass produced for sod. ``Agricultural
plant'' does not include pasture or rangeland used for grazing.
b. USDA. The definition of ``handler employer'' is very broad,
because it includes both agricultural employers and commercial
pesticide handler employers (CPHEs), even in a situation where both are
simultaneously present on the agricultural establishment. This causes
significant concerns and confusion as to who is ultimately responsible
for providing the protections in Subpart F (see additional comments on
Subpart F below).
As currently written, a ``handler employer'' is anyone who employs
any handler, as well as self-employed handlers. The definition of
``handler employer'' uses the verb ``to employ,'' which is also defined
in 170.305, as ``to obtain, directly or through a labor contractor,
the services of a person in exchange for a salary or wages . . .
without regard to who may pay or who may receive the salary or wages''
(emphasis added). This definition in turn uses the term ``labor
contractor,'' whose definition would include any CPHE hired by an
agricultural employer to provide handlers. Reading these definitions
together, it becomes clear that agricultural employers can be ``handler
employers'' even when they do not directly employ a single handler,
because they are employing handlers through a labor contractor/CPHE.
In a situation where an agricultural employer hires a CPHE, who in
turn hires handlers, both the agricultural employer and the CPHE meet
the definition of ``handler employer,'' since both employ handlers
under the WPS definition of ``employ'': the CPHE does so ``directly,''
while the agricultural employer does so ``through a labor contractor''
(i.e., the CPHE). In other words, a handler that is directly employed
by a commercial pesticide employer handler is simultaneously
``employed'' by both the CPHE and the agricultural employer, leading to
confusion over who has ultimate responsibility.
A solution to this problem would be to change the definition of
``labor contractor'' to explicitly exclude CPHEs: ``Labor contractor
means a person, other than a commercial pesticide handler employer, who
employs workers and handlers to perform tasks . . . '' [The reference
to handlers in the definition for ``labor contractor'' could then be
eliminated, since any person employing handlers is a CPHE, and no
longer a labor contractor.] For handlers, this change would have the
practical effect of limiting the meaning of the word ``employ'' to just
a direct employment relationship. As a result, each handler would only
have a single handler employer (i.e., his or her direct employer). For
workers who are not handlers, agricultural employers would still
``employ'' anyone engaged directly or through a labor contractor.
EPA Response. EPA agrees that the current definitions of labor
contractor and commercial pesticide handler employer contain some
problematic language that could result in potential confusion and/or
conflict regarding agricultural employer and commercial pesticide
handler employer duties under the rule. EPA has made the suggested
changes to the final rule with minor modifications to address the fact
that some labor contractors do bring handlers on to agricultural
establishments. EPA believes the revised text below clarifies that
CPHEs are responsible for the handlers they employ and agricultural
employers would no longer be considered employers of CPHE handlers for
the purposes of the WPS, without overlooking the fact that some
handlers are hired by agricultural employers through labor contractors
and not CPHEs.
Commercial pesticide handler employer means any person, other than
an agricultural employer, who employs any handler to perform handler
activities on an agricultural establishment. A labor contractor who
does not provide pesticide application services or supervise the
performance of handler activities, but merely employs laborers who
perform handler activities at the direction of an agricultural or
handler employer, is not a commercial pesticide handler employer.
Employ means to obtain, directly or through a labor contractor, the
services of a person in exchange for a salary or wages, including
piece-rate wages, without regard to who may pay or who may receive the
salary or wages. It includes obtaining the services of a self-employed
person, an independent contractor, or a person compensated by a third
party, except that it does not include an agricultural employer
obtaining the services of a handler through a commercial pesticide
handler employer or a commercial pesticide handling establishment.
Labor contractor means a person, other than a commercial pesticide
handler employer, who employs workers or handlers to perform tasks on
an agricultural establishment for an agricultural employer.
c. USDA. USDA is further concerned that EPA's definitions of
``employ'' and ``agricultural employer'' are not consistent with common
legal definitions of these terms. Common law, tax law, and certain
court decisions interpreting related statutes such as the Fair Labor
Standards Act and the Seasonal Agricultural Worker protection Act,
Aimable v. Long and Scott Farms, 20 F.3d 434 (1994), make a clear
distinction between an employer/employee relationship and other, less
direct working arrangements, such as independent contractors. USDA
encourages EPA to assign WPS responsibilities in accordance with these
more traditional and accepted definitions of ``employer'' and ``to
employ''.
EPA Response. EPA disagrees. EPA acknowledges that its use of the
term ``employ'' in the WPS is more aligned with popular usage than with
the common law and tax law uses of the term, but notes that the
definition of ``agricultural employer'' in the existing WPS has been
used since 1992 without significant conflict or confusion with similar
terms. USDA's objection pertains to the existing WPS definition of
``agricultural employer'' to the same degree as it does to the draft
final rule's definitions of ``employ'' and ``agricultural employer,''
and EPA declines to change this fundamental and longstanding WPS
principle.
d. USDA. EPA included in the definition of ``outdoor production''
the phrase ``. . . or in the case of forest operations, a natural
forest''. Ignoring the question of what an ``unnatural'' forest would
be, USDA is unsure why this phrase is needed at all. As this is written
one could say that any planted forest is then not subject to WPS. There
are other occurrences in the preamble (pages 202, 204, and perhaps
others).
EPA Response. EPA agrees that the inclusion of the term ``natural
forest'' in the definition of ``outdoor production'' creates confusion
and is not needed. EPA has made the following change to the definition
of ``outdoor production'' to address USDA's comments:
Outdoor production means production of an agricultural plant in an
outside area that is not enclosed or covered in any way that would
obstruct the natural air flow.
e. USDA. In addition, most golf courses have nursery greens located
next to, or near, the golf course. Posting agricultural exclusion
zones, etc. could disrupt golfing activities. USDA requests
clarification of how nursery greens are considered. If they are covered
by this rule, did EPA consider the costs to golf courses which may have
nurseries?
EPA Response. Golf courses that have operations considered
nurseries on their establishment (e.g., they are growing turf/greens in
a nursery area for use in replacing turf on the playing areas of the
golf course, or they are growing ornamentals in a greenhouse for
planting on the golf course) have always been covered by the WPS, and
compared to the existing WPS, the coverage of golf courses that have
nurseries on their establishment is not changed by the amendments in
this final rule. EPA has included an excerpt from the 1995 WPS guidance
which clarifies this coverage below. Since there are no posting
requirements associated with application exclusion zones, EPA does not
see this as an issue. Additionally, EPA understands that most golf
course pesticide applications are conducted when the public is not
using the course, and this should be similar with applications to a
nursery operation on the golf course. EPA expects this practice should
minimize any potential impact to golf course operations due to WPS
requirements. EPA considered the cost to golf courses that operate
nurseries; the costs would be accounted for under the costs of the WPS
revisions on nursery operations.
14-24 Production of agricultural plants for other than direct sale
IGW Question: What is the scope of the WPS with respect to
establishments producing agricultural plants for other than
direct sale, i.e., in-house use?
IGW Answer: There is no exception for agricultural plants
produced for other than direct sale, i.e., in-house use. The
WPS covers an agricultural establishment if (1) a WPS-labeled
agricultural pesticide is used on the establishment, (2)
workers or handlers are employed by or on the agricultural
establishment, (3) the establishment is a farm, forest,
nursery, or greenhouse, as defined in the WPS, and (4) the
establishment or the activity is not covered by one of the
exceptions specifically described in the rule, Section 170.102
(b).
For instance, the following operations are covered by the
WPS: Production of hay or feed grown for livestock on dairy
farms, cattle ranches, or other livestock operations; sod
farms, greenhouses, or nurseries operated by golf courses; and
greenhouses and nurseries operated by theme parks, hotel
chains, botanical gardens, and state and local governments.
(Note: Pasture and rangeland used for grazing are excluded.)
(March 15, 1995)
f. USDA. Including ``arranging for the application of the
pesticide'' in the definition of ``use, as in `to use a pesticide' ''
is superfluous and gives the impression of expanding the WPS--and the
related state enforcement actions--far beyond the actual agricultural
establishment to reach off-site administrators involved only in pre-
application tasks. USDA recommends removing the reference to
``arranging for the application of the pesticide.''
EPA Response. EPA also received several similar comments from
states, growers, agricultural associations and pesticide manufacturer
associations objecting to the proposed definition of ``use.'' Most
commenters objected to the definition of use because they did not
support inclusion of ``arranging for application of the pesticide'' as
part of the definition of ``use,'' and they said they believed that
this language would greatly expand the scope of the WPS and would be
unreasonable and unnecessary. EPA disagrees with comments that say the
proposed definition for the term ``use'' could or will expand the scope
of the WPS because this language has been in 170.9(a) of the WPS
since the rule first became effective in 1992. Moreover, EPA has not
been made aware of any instances where this definition of ``use'' has
resulted in an unreasonable or inappropriate outcome. EPA believes that
``arranging for application of the pesticide'' is appropriately part of
the definition of ``use'' for the purposes of the WPS because in
production agriculture, the individual who physically ``uses'' a
pesticide almost always does so at the direction of another person who
has substantially greater control over the circumstances of the use.
Thus the WPS is designed so that when an agricultural or handler
employer arranges for the application of a pesticide by a handler
employee, it triggers certain WPS duties that are properly the
responsibility of the agricultural or handler employer. For instance,
once the agricultural employer arranges for a pesticide application by
a commercial pesticide handling establishment, the commercial pesticide
handler employer must provide the agricultural employer with certain
information about the intended application before the application takes
place (so the employer will be able to fulfill WPS notification
requirements and protect workers during application, etc.). In such
circumstances, it is reasonable and appropriate that the handler
employer should be held responsible for the pre-application information
exchange even though the application has not commenced and even though
the handler employer personally never physically applies the pesticide.
Therefore, since EPA has not been made aware of any instances where the
existing interpretation of the term ``use'' has resulted in
unreasonable difficulties for growers, states or the agricultural
industry, EPA has moved the definition for the term ``use'' into the
definitions section of the rule without any changes from the proposal.
8.1 ``Administration of Conservation Programs'' was not included in
the proposed rule. This NAICS code includes the administration of
recreational areas and weather forecasting administration, geologic
survey program administration, preservation of natural resources,
recreational areas, erosion control, etc. USDA would like an expansion
on the rationale for their inclusion into the worker protection
standard. Furthermore, the entirety of this NAICS code's government
population, appears not to be addressed in the Economic Analysis and,
therefore, the impact on this sector may not have been included.
EPA Response. EPA did not receive comments from the entities listed
under this NAICS code, and does not believe that the WPS applies to
them. EPA has removed the reference from the preamble, per USDA's
request.
9. 170.309(c) and 170.313(c) minimum age
USDA. As in previous reviews, USDA opposes changing the minimum age
for handlers and early-entry workers proposed by EPA and defer this
decision to the States. U.S. agricultural workers operate under a
variety of Federal requirements, including those of the Environmental
Protection Agency and the U.S. Department of Labor. States also have
minimum age requirements for users of pesticides. The U.S. Department
of Labor has already set Federal minimum age limits for people who are
18 years old or younger when working with pesticides. The current
regulatory system allows for States to increase age requirements and
most states have already exercised this right based on their unique
circumstances. USDA believes the current Federal-state system is
working in this regard. The need for added regulation is not apparent
and should be weighed against state discretion and current state and
Federal laws.
Please see the following as posted by the Department of Labor at
http://www.dol.gov/elaws/esa/flsa/docs/hazag.asp. (Italics added for
emphasis.)
Prohibited Occupations for Agricultural Employees
The child labor rules that apply to agricultural employment
depend on the age of the young worker and the kind of job to be
performed. The rules are the same for all youth, migrant
children as well as local resident children. In addition to
restrictions on hours, the Secretary of Labor has found that
certain jobs in agriculture are too hazardous for anyone under
16 to perform.
Once a young person turns 16 years old, he or she can do
any job in agriculture.
A youth 14 or 15 years old can work in agriculture, on any
farm, but only in non-hazardous jobs. ? A youth 12 or 13
years of age can only work in agriculture on a farm if a
parent has given written permission or if a parent is
working on the same farm as his or her child, and only in
non-hazardous jobs.
If the youth is younger than 12, he or she can only work
in agriculture on a farm if the farm is not required to pay
the Federal minimum wage. Under the FLSA, ``small'' farms
are exempt from the minimum wage requirements. ``Small''
farm means any farm that did not use more than 500 ``man-
days'' of agricultural labor in any calendar quarter (3-
month period) during the preceding calendar year. ``Man-
day'' means any day during which an employee works at least
one hour. If the farm is ``small,'' workers under 12 years
of age can only be employed with a parent's permission and
only in non-hazardous jobs.
Hazardous Occupations
The Secretary of Labor has found that the following
agricultural occupations are hazardous for youths under 16
years of age. No youth under 16 years of age may be
employed at any time in any of these hazardous occupations
in agriculture (HO/A) unless specifically exempt.
Exemptions (*) will apply to HO/A #1 through #6 under
limited circumstances. (None of the exemptions apply to
pesticides.)
HO/A #9 Handling or applying agricultural chemicals if
the chemicals are
classified under the Federal Insecticide, Fungicide and
Rodenticide Act as
Toxicity Category I--identified by the word ``Danger''
and/or ``Poison'' with
skull and crossbones; or Toxicity Category II--identified
by the word ``Warn-
ing'' on the label. (Handling includes cleaning or
decontaminating equip-
ment, disposing of or returning empty containers, or
serving as a flagman
for aircraft applying agricultural chemicals.)
USDA requests that EPA work with DOL to unify their regulations so that
those working in agriculture have clear guidance as to Federal minimum
age requirements for agricultural workers. The States have regulations
in place that are consistent with DOL--or more restrictive--based on
the needs of individual States.
EPA Response. EPA notes that a majority of the comments received
encouraged the Agency to implement a minimum age of 18 for handlers and
early-entry workers.
EPA welcomes input from DOL to ensure no avoidable conflict between
the WPS and FLSA. However, the statutory criteria for regulating under
FIFRA and the child labor provisions of FLSA are different. While EPA
will defer to DOL regarding the scope of its authority under FLSA, it
does not appear that DOL has the discretion to use the FLSA section 12
child labor provisions to protect children 16 or older working in
agriculture. FIFRA does not contain such a limitation, and EPA believes
that pesticide handling in agriculture and entry to a treated area when
a restricted-entry interval (REI) is in effect (``early-entry
workers'') by persons under the age of 18 is inconsistent with the
FIFRA statutory standard.
Moreover, where DOL exercises its FLSA child labor authorities in
regard to children employed in agriculture, its focus is on protecting
the child worker (see 29 U.S.C. 213(c)(4)). EPA's mandate under FIFRA
is significantly broader, requiring EPA to prevent unreasonable adverse
effects of pesticides to workers, other persons, and the environment,
and these are put at risk when agricultural pesticides are applied by
persons with immature judgment and risk-taking behaviors. Inasmuch as
FLSA and FIFRA have different purposes and different scopes, it is not
surprising that they should produce different regulatory outcomes.
DOL's standard and the WPS differ in the types of pesticides
covered. DOL's restrictions on pesticide use in agricultural employment
applies only to pesticides with high acute toxicity (toxicity
categories I and II). The WPS applies to all agricultural use
pesticides, some of which may pose a variety of other risks. Pesticides
that are extremely toxic to other species, or that are powerful
carcinogens or mutagens, may nevertheless have low acute human
toxicity, and therefore be classified in toxicity categories III and
IV. Such pesticides can pose significant risks to the handler,
bystanders, and the environment if not used properly.
To the extent that DOL's standard does protect children from
agricultural pesticides, it only protects children as pesticide
applicators. DOL's standard does not cover early-entry workers at all,
though they face increased risks from entering an area treated with
pesticides before the residue levels have fallen to a level unlikely to
cause unreasonable adverse effects.
In sum, EPA disagrees with USDA's request that EPA should defer to
the states or the FLSA and not establish any age-related restrictions
on pesticide handling or early-entry activities. EPA has the
responsibility under FIFRA to regulate the use of pesticides to avoid
unreasonable adverse effects, apart from any requirements established
by other Federal or state laws.
10. 170.311(b)(6)
a. USDA: The new requirement to maintain application information
and SDSs for 2 years is onerous and without foreseeable benefit. Acute
toxic effects would be the most likely triggering need to get this
information to a worker. EPA should have considered a longer
application information posting time (45 days, 60 days) rather than a
2-year record retention.
EPA Response. EPA believes that workers in agriculture and
pesticide regulatory agencies should have access to application and
exposure information, and believes that two years is a reasonable
compromise between access and the burdens of record retention. Acute
pesticide illnesses are the most common triggering effects; however,
chronic illnesses are potentially linked to pesticide exposure, and
workers and handlers may present such illnesses and should have access
to the exposure or hazard information. Under OSHA, records of exposure
to hazardous chemicals are required to be retained for 30 years, and
access to those must be provided to workers, even if they are no longer
employed by the employer. Once the record is created and filed, there
is little cost to maintaining it. In addition, employers may choose to
keep the information at the central posting display for the required
retention period of two years from the date of application, providing
that the information remains legible and all other requirements are
met.
b. USDA: USDA expresses concern over the increased burden placed on
agricultural employers due to a significant expansion and complexity of
record-keeping requirements. As written, agricultural employers will
bear the sole responsibility in providing records and responses to
workers, their designated representatives, plus states and Federal
enforcement. Agricultural employers already must keep records under
OSHA, including The Migrant and Seasonal Agricultural Worker Protection
Act (MSPA), Field Sanitation Standards under the Occupational Safety
and Health Act, and Agricultural Employers under the Fair Labor
Standards Act (FLSA). USDA is further concerned over agricultural
employers' liability resulting from small procedural mistakes stemming
from the added recording-keeping requirements under FIFRA.
EPA Response. EPA responded to comments from agricultural interests
opposing the proposed record-keeping on the basis of burden by
examining the purpose and need for the records. As a result, EPA
eliminated from the final rule the requirement for documenting oral
notification to workers for early-entry. The review found that
collection of the application information and the SDS are necessary for
hazard communications. The remaining records were found to be necessary
for employers to demonstrate compliance with aspects of the regulation.
USDA expresses concern for employers' liability from small
procedural mistakes. Small procedural mistakes are typically addressed
with a warning notice, rather than monetary penalties. After
implementation, there will be a period of compliance assistance. During
this period, EPA and state regulatory agencies will work with
agricultural interests to ensure understanding of the rule requirements
and how to comply with them, thereby minimizing ``small procedural
mistakes.''
c. USDA. Under OSHA, there are already considerations for
``designated representatives'' for farm accidents, farm chemical
hazards, wages, etc. which can be confusing if there is a separate
``designated representative'' under FIFRA for pesticide hazard
communication records. OSHA provides a process for expiration,
revocation of ``designated representatives,'' and whether the
designated representative can be a union representative, worker group
representative, etc. for records and in what circumstances the
designated representative can accompany an inspection. The WPS language
does not specify how many authorized representatives a worker may have.
The time to process multiple authorizations, confirm signatures and
make changes will incur added costs to agricultural employers and
should be included in the Economic Analysis.
EPA Response. EPA believes the WPS final rule is clear regarding
the identification and function of the designated representative. The
representative must provide, in writing, the designation from the
worker or handler. The information that the employer must provide is
limited to the application records and the SDS that were displayed
while the worker or handler was on the establishment. EPA's designated
representative requirement is modeled on OSHA's rule at 29 CFR
1910.1020. EPA is aware that California and Texas regulations include
employee representatives' access to information for farmworkers.
Comments from the Texas Department of Agriculture encouraged EPA to
require the designation in writing and to limit access to records to
the timeframe of 2 years.
Under the final rule, while a worker may have multiple authorized
representatives, EPA expects a single individual could be the
designated representative under both sets of regulations, thereby
minimizing confusion and burden for the employer. The final rule does
not provide access to inspections for the designated representative.
The Economic Analysis has been updated to provide an estimate of
the costs of processing requests on a per-request basis, and includes
the cost of verifying the validity of the request. Please refer to
comment #30 for details.
d. USDA. USDA believes the total costs for record-keeping should
include the following: set-up costs to establish a record-keeping
system (if one has not already been established; costs to develop
internal record forms; printing costs for paper records); computer
software/system costs (for electronic records); storage costs; disposal
costs of records with sensitive information; maintenance costs for
records beyond the two-year minimum for longer-term employees. Did EPA
consider all these in its cost estimates for record-keeping, especially
for small businesses and government agencies?
EPA Response. As USDA noted previously in this comment (10.b.),
agricultural employers must comply with record-keeping under
requirements from other Federal agencies. Therefore, EPA believes that
establishments will have record-keeping systems in place as a result of
complying with the cited requirements. EPA estimates the following
costs: paper, time to collect information and signatures, and storage.
The records required by EPA do not include information that would
ordinarily be considered private or sensitive (note that the draft
final rule does not require employers to record workers' birthdates),
therefore, there is no need to dispose of those in any particular
manner. Finally, as there is not a requirement to retain records beyond
the two year timeframe regardless of a worker or handler's continued
employment, such cost is not necessary to assess.
11. 170.311(b)(7)-(9)
a. USDA. Compared to the proposed rule's ``authorized
representative,'' EPA has now coined and defined the term ``designated
representative'' and added additional language. Regardless of terms,
EPA's definition of ``designated representative'' still raises serious
concerns for USDA. We also remind EPA of the concerns expressed by key
stakeholders that are detailed below in response to reading the
proposed rule. USDA is concerned that EPA has not seriously considered
their concerns. We also note that there was only one public comment in
support of this concept during the proposed rule period which was far
outnumbered by those written in opposition.
Minor Crop Farmer Alliance (MCFA)
``The current proposed definition of `authorized representative' is
overly broad and would be very difficult to manage to ensure
information that is worker specific is protected. The information
necessary to provide support for workers who seek treatment for
potential health related impacts is already provided in the current WPS
regulations. The proposed definition is open-ended and subject to
serious abuse. The representative of a worker seeking information under
the provision of the WPS should be limited to family members or medical
personnel with a legitimate need for information.''
National Association of State Departments of Agriculture (NASDA)
``Authorized representative: We request EPA remove `Authorized
representative' from the proposed rule. We recognize at least one state
has this provision included in its state regulations, and we understand
the inclusion has led to a range of complications and on-going
litigation that does nothing to forward the purpose of the WPS or
facilitate a sound regulatory framework. If mandated in the Code of
Federal Regulations, the new provision will lead to numerous
complications for both the state regulatory agency and the regulated
community in trying to comply with the proposed WPS rule, even if the
designation is required in writing, while protecting against liability
in responding to fraudulent claims or interests seeking to utilize this
provision for non-WPS purposes. We oppose this proposal.''
Association of American Pesticide Control Officials (AAPCO)
``Authorized employee representative--A person designated by the
worker or handler, orally or in writing, to request and obtain any
information that the employer is required to provide upon request to
the worker or handler.
AAPCO does not support the definition as proposed. An authorized
representative should be designated in writing for a specific worker or
handler and for a specific event or time period within the last 2 years
from the date of request (due to record retention requirements). The
information required to be provided to the authorized representative,
and the purpose of the request or intended use of the information,
should be clearly specified as noted in the above comments.''
EPA [R]esponse. In response to the many comments concerning the
identification of the designated (authorized) representative, EPA has
clarified the requirements for the designation: it must be in writing,
include the name and signature of the requesting employee, describe the
specific information being requested, the date of the designation, and
directions for sending the information if so desired. These
requirements largely meet the AAPCO recommendation. In addition, the
employer has 15 days to provide the information. EPA believes requiring
the identification of the designated representative in writing
addresses the concerns raised for the legitimacy of the designated
representative and clarity of the request, while continuing to allow
access to important pesticide exposure information for workers and
handlers that they may be reluctant to request of their employer.
One public comment states that the emergency provisions of the
current rule provide adequate support for workers. However, under the
rule, only employees seeking emergency assistance while on the
establishment are so protected. Additionally, employees should have
access to the information if they are concerned for their exposure but
do not show symptoms.
USDA states that only a single public comment supports the
authorized representative concept; however, EPA has found several
comments in support of the authorized representative, stating that the
requirement would enable a worker or handler access to important
information for medical purposes.
b. USDA has the following additional comments on this section
These requirements for providing application data to the worker or
handler, treating medical personnel, or a designated representative do
not spell out the timeframe for which records can be produced based on
170.311(b)(6) (two year application information retention
requirement). Each of subsections should include the phrase ``within
the last two years'' to clarify that after two years there is no
expectation that such records would have been retained.
EPA should be clear on the differences between a ``designated
representative'' and a person acting under the direction of medical
personnel. Who are those ``persons''? While the two could be the same
person, it is possible that in an emergency situation, the requirements
for requesting the information as outlined may not be expedient.
EPA Response. EPA has clarified in those sections that the
information is accessible for only that period of time after it is
collected and retained.
USDA has also expressed concern that it is not clear who may access
the information as a person acting under the direction of treating
medical personnel. In consultation with USDA, EPA has revised the
language to clarify that treating medical personnel and persons working
under their supervision are to be given access to the information.
c. USDA. Allowing oral requests to the employer by workers and
handlers for pesticide application information and safety data sheets
is not consistent with the EPA's new posting requirements that prohibit
oral notification to workers of pesticide applications due to
difficulty in recalling oral information, difficulty communicating
orally if language barriers exist and the lack of verification of an
oral notification. For these same reasons, oral notification to
employers should be replaced with written notification. USDA encourages
EPA to meet with stakeholders representing employers and farmworkers to
best balance the oral versus written requests and the mechanism for
collecting the written statement to designate the representative.
EPA Response. USDA finds inconsistency between (1) the option for
workers and handlers to orally request hazard information from their
employer and (2) the requirement for the employer to post areas treated
with a pesticide with an REI of greater than 48 hours. EPA does not
agree that these requirements need to be consistent with each other.
While it would be more convenient for employers to get a written
request for the hazard communication information, in the interest of
promoting access to workers and handlers who may not be literate and
could not provide a written request, allowing oral requests facilitates
the flow of information and outweighs the convenience for the employer.
Posting a treated area under an REI as a visual warning is intended to
provide an ongoing reminder to workers not to enter the area, because
they may forget the oral notification given, or there may be confusion
about which field is treated.
Regarding USDA's comment about the mechanism for collecting the
written request to designate the representative, the written
information can be hand delivered, mailed, provided to the employer as
an attachment to an e-mail, or any other way seen as appropriate. Oral
identification of the designated representative is not sufficient.
12. 170.313
USDA. This section creates responsibilities for commercial
pesticide handler employers (CPHEs) toward ``each handler'' or ``any
handler,'' without limiting the CPHE's responsibility to only the
handlers employed by the given CPHE. This may lead to difficulties and
unintended consequences when multiple CPHEs are operating on the same
agricultural establishment, or when an agricultural employer chooses to
employ some handlers directly while contracting for additional handlers
through a CPHE.
Regarding subsection (b), how is a CPHE supposed to ensure that
handlers employed by a different CPHE or handlers employed directly by
the agricultural employer receive the protections required by the WPS?
Regarding subsection (c), how is a CPHE supposed to ensure that
handlers employed by a different CPHE or handlers employed directly by
the agricultural employer are at least 18 years old?
The same line of questioning also applies to subsections (d), (e),
(f), (g), (h), and (k). A CPHE will not likely be able to follow these
requirements with regards to handlers that are not employed by him or
her and thus are not within his or her supervisory control. USDA
recommends clarifying that for purposes of 170.313, the term
``handler'' is limited to handlers employed by the CPHE (i.e., the
CPHE's ``own'' handlers).
In addition, if EPA makes the changes to the definition of ``labor
contractor'' in 170.305 suggested above, EPA should remove references
to labor contractors in this section. This is because any contractor
who employs handlers will no longer be both a ``labor contractor'' and
a CPHE, but only a CPHE instead.
EPA Response. EPA does not believe that a CPHE has responsibilities
for handlers other than its own handler employees because the required
employer-employee relationship that triggers WPS responsibilities does
not exist for handlers that are not employed by the CPHE. However, in
the interest of providing greater clarity in the, EPA has clarified in
the rule in 170.313 that the commercial pesticide handler employer
duties are only applicable for handlers they directly employ. The
revised reg text is included below:
170.313 Commercial pesticide handler employer duties.
``Commercial pesticide handler employers must:
(a) Ensure that any pesticide is used in a manner
consistent with the pesticide product labeling,
including the requirements of this part, when applied
on an agricultural establishment by a handler employed
by the commercial pesticide handling establishment.
(b) Ensure each handler employed by the commercial
pesticide handling establishment and subject to this
part receives the protections required by this part.
(c) Ensure that any handler employed by the
commercial pesticide handling establishment is at least
18 years old.
(d) Provide to each person, including labor
contractors, who supervises any handlers employed by
the commercial pesticide handling establishment,
information and directions sufficient to ensure that
each handler receives the protections required by this
part. Such information and directions must specify the
tasks for which the supervisor is responsible in order
to comply with the provisions of this part.
(e) Require each person, including labor contractors,
who supervises any handlers employed by the commercial
pesticide handling establishment, to provide sufficient
information and directions to each handler to ensure
that the handler can comply with the provisions of this
part.
(f) Ensure that before any handler employed by the
commercial pesticide handling establishment uses any
equipment for mixing, loading, transferring, or
applying pesticides, the handler is instructed in the
safe operation of such equipment.
(g) Ensure that, before each day of use, equipment
used by their employees for mixing, loading,
transferring, or applying pesticides is inspected for
leaks, obstructions, and worn or damaged parts, and any
damaged equipment is repaired or is replaced.
(h) Ensure that whenever a handler who is employed by
the commercial pesticide handling establishment will be
on an agricultural establishment, the handler is
provided information about, or is aware of, the
specific location and description of any treated areas
where a restricted-entry interval is in effect, and the
restrictions on entering those areas.
(i) Provide the agricultural employer all of the
following information before the application of any
pesticide on an agricultural establishment:
(1) Specific location(s) and description of
the area(s) to be treated.
(2) The date(s) and start and estimated end
times of application.
(3) Product name, EPA registration number,
and active ingredient(s).
(4) The labeling-specified restricted-entry
interval applicable for the application.
(5) Whether posting, oral notification or
both are required under 170.409.
(6) Any restrictions or use directions on the
pesticide product labeling that must be
followed for protection of workers, handlers,
or other persons during or after application.
(j) If there are any changes to the information
provided in 170.313(i)(1), 170.313(i)(4),
170.313(i)(5), 170.313(i)(6) or if the start time for
the application will be earlier than originally
forecasted or scheduled, ensure that the agricultural
employer is provided updated information prior to the
application. If there are any changes to any other
information provided pursuant to 170.313(i), the
commercial pesticide handler employer must provide
updated information to the agricultural employer within
two hours after completing the application. Changes to
the estimated application end time of less than one
hour need not be reported to the agricultural employer.
(k) Provide emergency assistance in accordance with
this paragraph. If there is reason to believe that a
handler has experienced a potential pesticide exposure
during his or her employment by the commercial
pesticide handling establishment or shows symptoms
similar to those associated with acute exposure to
pesticides during or within 72 hours after his or her
employment by the commercial pesticide handling
establishment, and needs emergency medical treatment,
the commercial pesticide handler employer must do all
of the following promptly after learning of the
possible poisoning or injury:
(1) Make available to that person
transportation from the commercial pesticide
handling establishment, or any agricultural
establishment on which that handler may be
working on behalf of the commercial pesticide
handling establishment, to an operating medical
care facility capable of providing emergency
medical treatment to a person exposed to
pesticides.
(2) Provide all of the following information
to the treating medical personnel:
(i) Copies of the applicable safety
data sheet(s) and the product name(s),
EPA registration number(s) and active
ingredient(s) for each pesticide
product to which the person may have
been exposed.
(ii) The circumstances of
application or use of the pesticide.
(iii) The circumstances that could
have resulted in exposure to the
pesticide.
(l) Ensure that persons directly employed by the
commercial pesticide handling establishment do not
clean, repair, or adjust pesticide application
equipment, unless trained as a handler under 170.501.
Before allowing any person not directly employed by the
commercial pesticide handling establishment to clean,
repair, or adjust equipment that has been used to mix,
load, transfer, or apply pesticides, the commercial
pesticide handler employer must provide all of the
following information to such persons:
(1) Notice that the pesticide application
equipment may be contaminated with pesticides.
(2) The potentially harmful effects of
exposure to pesticides.
(3) Procedures for handling pesticide
application equipment and for limiting exposure
to pesticide residues.
(4) Personal hygiene practices and
decontamination procedures for preventing
pesticide exposures and removing pesticide
residues.
(m) Provide any records or other information required
by this part for inspection and copying upon request by
an employee of EPA or any duly authorized
representative of a Federal, State or Tribal government
agency responsible for pesticide enforcement.''
Please note that EPA has not removed the references to labor
contractors in this section. This is because the rule must still
address the possibility that a CPHE could hire handler labor through a
labor contractor and the CPHE must be responsible for providing handler
protections to individuals hired through a contractor. The final rule
has been revised so that a CPHE is no longer considered a labor
contractor under the WPS, and therefore the CPHE handlers will not be
considered employees of the agricultural establishment when hired
through the CPHE, but it recognizes that a CPHE may use labor
contractors.
13. 170.315 Whistleblower
General comment: Because agricultural employers must already comply
with OSHA regulations on health and safety, USDA seeks a broad inter-
agency discussion on whistleblower rights of workers. OSHA already
investigates whistleblower complaints under seven environmental
statutes, and established procedures are already in place for OSHA
investigations. Is there a way to take advantage of existing OSHA
investigative standards, regulatory processes and whistleblower
investigative procedures for farm accidents, labor, chemical hazards,
dust, wages, migrant housing, sanitation, drinking water, etc.? This
would also take advantage of existing state whistleblower laws and
regulations. Both growers and workers would benefit as there will be
one Federal body to place whistleblower complaints and an existing
regulatory process and infrastructure. One can therefore expect
farmworkers, agricultural employers and labor contractors to experience
reduced regulatory confusion.
EPA Response. EPA is interested in meeting with OSHA regarding
their whistleblower procedures and standards. The final WPS has adopted
language consistent with OSHA's approach to providing whistleblower
protections, and it makes sense to have similar processes for
investigations. However, as it is not clear that OSHA can adequately
enforce the WPS whistleblower provisions, EPA is not prepared to cede
that responsibility to OSHA. Although OSHA jurisdiction covers most
areas of agriculture, they do not cover pesticide use or establishments
with fewer than 11 workers, i.e., the majority of the farms subject to
the WPS.
14. 170.401(a) and 170.501(a) Annual Training
USDA. After reviewing the public comments and conferring with state
Departments of Agriculture, USDA finds that annual training for workers
and handlers will place an excessive burden on states and growers,
without any evidence of increased protections for workers. USDA
recommends that training should be required at most every two years.
Moreover, USDA urges that EPA confer with their state regulatory
partners regarding the feasibility of annual training with respect to
the ability of state and extension service personnel at local
universities to enforce or provide training on an annual basis. USDA
has noted letters of concern dated August 15, 2014, in the docket from
the Association of American Pest Control Officials (AAPCO) and the
National Association of State Departments of Agriculture (NASDA).
Federalism and resource issues were raised by NASDA. Also, per the
Louisiana AgCenter August 18, 2014, Docket Letter to EPA, ``In
Louisiana, we already retrain workers and handlers every three years.
This is a dramatic change requiring annual training rather than every
five years. This would increase the cost of the program and limit
opportunities to attend training sessions. What is the funding source
to support this increase in the frequency of training events?''
Finally, the Forest Service's experience with mandatory annual
training is that such training becomes robotic and less useful over
time. USDA is concerned that an annual training requirement will add
costs without any appreciable benefit or increase in safety. Annual
training for handlers is required in California, but probably not too
many other places.
EPA Response. EPA is sensitive to the concerns of agricultural
employers regarding the potential burden of annual training. Many
comments linked the concern for burden with EPA's proposal to eliminate
one segment of trainers, certified applicators, from qualifying as
trainers of workers. Based on the comments in support of allowing
certified applicators to train workers, EPA reassessed the ability of
certified applicators to provide worker training and has retained
certified applicators as trainers in the final rule. EPA believes that,
with the addition of certified applicators as trainers, there are
adequate resources to provide worker safety training. Please refer to
the USDA comment 18 from this document:
``USDA is very supportive of expanding the class of persons
qualified to train workers and handlers compared to the
proposed rule, and is especially in favor of allowing certified
applicators to train workers (170.401) and handlers (170.501).
This is particularly important to provide adequate numbers of
trainers without severely straining cooperative extension
trainer resources required to meet the annual training
requirement in the draft final rule. USDA also supports that
EPA retained the ability to use as trainers those who are so
identified at the state level as qualified trainers. That
allows the Forest Service in California to utilize registered
professional foresters as trainers; something that was fought
for in the past in state regulations.''
Safety training is well recognized as an important factor to reduce
workplace incidents. Despite the absence of studies on this subject, it
is reasonable to attribute to the 1992 WPS the significant reduction in
agricultural pesticide exposure incidents dating from the
implementation of rule. Although EPA cannot attribute the reduction in
incidents to particular provisions in the WPS, we think the rule has
contributed significantly to this reduction, and EPA expects the number
of incidents to be further reduced upon implementation of the
amendments contained in this rule.
15. 170.401(c)(1) [comment cross-referenced from EA]
USDA. Due to the added training topics and other requirements, USDA
does not believe that the estimated 45 minutes of training include
ample time to thoroughly cover added topics and take questions. To
allow for at least 5 minutes per training topic (11 for workers and 13
for handlers) and at least 15 minutes for questions the estimated
training time should be adjusted to 1.5 hours. This is still a
conservative estimate and does not take into account the added time
required when a translator is used.
EPA Response. Many of the topics listed for training content are
self-explanatory and do not require substantial elaboration. Current
EPA training videos take about 30 minutes per session, including
questions. While questions and answers from workers can be
unpredictable in quantity and length, based on past experience EPA
estimates that the training with added content will not take longer (on
average) than 45 minutes.
EPA recognizes there are many different languages in the workforce.
The EA considers only new burdens that would result from the amendments
to the existing WPS. Sections 170.130(c) and 170.230(c) of the existing
WPS include the same requirement that training be conducted ``in a
manner workers can understand.''
16. 170.401(c)(3)
USDA. EPA states that after the effective date, ``training programs
required under this section must include, at a minimum, all of the
topics listed in 170.401(c)(i)-(xvi) . . .'' This is followed by a
list of 23 points numbered from (i) to (xxiii). If only the first 16,
up to (xvi), should be included in future training, there is no reason
to include the remaining 7 points in the rule. Alternatively, if all 23
points should be included in future training, then the language should
be corrected to include ``all of the topics listed in 170.401(c)(i)-
(xxiii) . . .''
Most of the points listed in 170.401(c)(3), including (ii)-(xv)
and (xix)-(xxii), sound like topics for training, as they should.
However, there are a few points, notably (i), (xvi)-(xviii), and
(xxiii), that sound like restated or new requirements placed on
agricultural employers. Unlike the other points, these five points
include ``agricultural employer'' as the subject together with
commanding verbs such as ``are required,'' ``must not,'' ``must,'' and
``are prohibited.'' This could easily lead to confusion if these points
are misinterpreted as binding requirements, rather than training
topics.
In addition to being generally misleading, two of these five points
include statements that are incorrect. First, (i) states that
agricultural employers are required to ``provide pesticide safety
training,'' (emphasis added) when in fact agricultural employers are
merely required to ``ensure that each worker has been trained'' (
170.401(a), emphasis added), meaning that workers can be trained by a
third party. Second, (xvi) states that agricultural employers are
required to ``provide workers information about the location of safety
data sheets,'' when in fact agricultural employers must display the
safety data sheets ``at a place on the agricultural establishment where
workers and handlers are likely to pass by or congregate'' and must
allow workers ``access to the location of the information'' (
170.311(b)), but there is no express requirement to provide workers
information about this location.
USDA recommends that at a minimum, the language in (i) and (xvi) be
corrected to properly reflect the requirements placed on agricultural
employers in the WPS. EPA should also consider rewording all of the
five points in question--(i), (xvi)-(xviii), and (xxiii)--to make it
clear that these are merely topics for training, and not new
requirements.
EPA Response. EPA appreciates the correction, and has included all
the points in the citation at 170.401(c)(3). EPA will revise the
language at 170.401(c)(3)(i), (xvi)-(xviii), and (xxiii) to clarify
their intent as training points.
Regarding 170.401(c)(3)(i), USDA's comment is correct; the
employer is required only to ensure that the worker or handler has been
trained. Therefore, EPA has adjusted the language to reflect that
distinction. However, the comment stating that there is not a
requirement for employers to inform workers and handlers of the
location of the safety data sheets that reflects the training point at
170.401(c)(3)(xvi) is incorrect; please refer to 170.403(a) and
170.503(b)(1) that instruct the employer to inform their employees of
the location(s) of the safety data sheets.
17. 170.401(c)(3)(i)
USDA. Add the phrase ``in writing'' after ``designate'' to make it
clear to workers that such designation must be in writing.
EPA Response. This change has been made. The rule text at
170.401(c)(3)(i) has been revised as follows:
(i) Agricultural employers are required to provide workers
with information and protections designed to reduce work-
related pesticide exposures and illnesses . . . A worker may
designate in writing a representative to request access to
pesticide application and hazard information.
18. 170.401(c)(4) and 170.501(c)(4) certified applicators
USDA. USDA is very supportive of expanding the class of persons
qualified to train workers and handlers compared to the proposed rule,
and is especially in favor of allowing certified applicators to train
workers (170.401) and handlers (170.501). This is particularly
important to provide adequate numbers of trainers without severely
straining cooperative extension trainer resources required to meet the
annual training requirement in the draft final rule. USDA also supports
that EPA retained the ability to use as trainers those who are so
identified at the state level as qualified trainers. That allows the
Forest Service in California to utilize registered professional
foresters as trainers; something that was fought for in the past in
state regulations.
EPA Response. None required.
19. 170.401(d) National Data Base for trained workers and
handlers
USDA. USDA reminds EPA of the comments submitted by key stakeholder
groups that have responsibilities for record-keeping:
a. Association of American Pest [sic] Control Officials (AAPCO)
AAPCO supports record-keeping of employee training. We recommend
that the date of birth be removed as a requirement from the record, as
this will complicate use of the record, since the birth date can be
considered confidential information. The employer must verify age by
other means (license, immigration documentation, etc.) for personnel
purposes that are maintained separately. We recommend that the Agency
provide a template for record-keeping that can be provided as a
convenience for employers, but not make use of the template a
requirement. The records should be kept by the agricultural employer.
EPA Response. EPA was convinced by concerns raised by states
regarding the confidentiality issues with personally identifiable
information, and has removed the requirement for a record of the
birthdate in the training record.
EPA plans to develop an optional form that employers may use to
collect training records.
USDA.
b. Association of American Pest [sic] Control Officials (AAPCO)
AAPCO has serious concerns about the requirement in
170.101(d)(2). The possibility for use of fraudulent records is real,
and verification of the training record could require significant
resources by state lead agency personnel, or may be impossible if the
record is provided by an out of state trainer. AAPCO recommends that
EPA develop a national data base that can be used by certified trainers
to enter information, coupled with a national card with a scannable bar
code. State lead agencies can access the data base to verify the
training record. State lead agencies should not be expected to rely on
the employee-provided record to verify training.
National Association of State Departments of Agriculture (NASDA)
We encourage EPA to consult with NASDA, SFIREG, AAPCO, and the
regulated community to discuss and review the benefits and drawbacks of
developing a central repository for basic training information
submitted to and retained by EPA.
EPA Response. Please refer to the notice of proposed rulemaking
Unit VII B, 79 FR 15444, page 15463, for a discussion of the advantages
and disadvantages of a centralized database for training records. EPA
declined to propose requirements that would centralize the recorded
information because it would burden employers to enter the data, and
the requirement for on-site records for inspection purposes would
remain. EPA continues to believe that the costs of such a scheme would
outweigh its expected benefits. Although there are potential uses for a
centralized database of trained workers and handlers, EPA believes that
it would require significant resources committed to ensure data
quality. Giving workers and handlers a copy of their training records
on their request should provide workers and handlers a simple way to
demonstrate prior training to a new employer.
20. 170.405(a)
USDA. USDA is concerned how helicopter or fixed wing applications
can possibly meet this standard without de facto buffers. A pilot would
otherwise have to be constantly scanning a distance of 100 from the
aircraft in all directions looking for some errant person; which is a
huge safety issue in itself. This essentially means that a 100 buffer
remains with aerial applications.
EPA Response. The provision in 170.405(a) establishes a
requirement on the agricultural employer, not the applicator (handler).
Specifically, an agricultural employer must not allow or direct a
worker or other person to remain in the treated area or application
exclusion zone within the boundaries of the establishment until
application is complete. This is a relatively small extension of the
current requirement in 170.110(a) for agricultural employers to keep
workers and others out of a treated area during application on farms
and forests. The final rule will cover a slightly larger area from
which the agricultural employer must exclude workers and other persons
but only while the application equipment is treating that specific
section of the treated area. For the example of an aerial application,
there would be an additional 100 area along the side of the treated
area from which people must be excluded, but only while the helicopter
or airplane is treating that edge of the field. Once the aircraft has
left the edge of the field, workers and other persons must be excluded
of only the treated area, as is currently required.
As explained in Unit IX.B.2, EPA notes that the application
exclusion zone is not a ``buffer,'' a term that typically is used to
describe an area that cannot be sprayed. The application exclusion zone
is simply an area around active application equipment that moves with
the application equipment as the application progresses. Under the
final rule, a pesticide can be applied in an application exclusion
zone, and the requirement for agricultural employers is to keep workers
and other people out of this zone (which is a specified distance from
the application equipment, not the edge of the treated area) during the
pesticide application.
For additional information, see the response to question 26.
21. 170.409(b)(3)(ii)--forestry signs
USDA. The requirement to post outdoor production areas at all
normal access points, or roads, or trails, or if no access points, at
corners of the units can be problematic in forestry. Is a skid trail or
a landing considered a road or access point? What if no roads or trails
access the unit? Posting the corners makes no sense in such a case, as
those would be essentially invisible anyway. EPA may want to reconsider
posting requirements related to forestry regulations.
EPA Response. The requirement in the final rule is that ``the signs
must be visible from all reasonably expected points of worker entry to
the treated area, including at least each access road, each border with
any worker housing area within 100 of the treated area and each
footpath and other walking route that enters the treated area.'' EPA
does not believe the application of this proposal to forestry
operations is unique or substantially from its application to large
fields or orchards that may not have definitive points of entry. In the
situation described above, the draft final rule would require the
employer to consider whether the ``skid trail'' or landing is a
reasonably expected point of worker entry; if so, then it must be
posted. Where there are no reasonably expected points of worker entry,
the draft final rule provides that ``signs must be posted in the
corners of the treated area or in any other location affording maximum
visibility.'' If as USDA suggests, the geography of a particular
treated area makes posting the corners irrelevant, then the employer
should post the locations providing maximum visibility for workers
entering the treated area.
EPA intends that the final rule should apply to these situations in
the same manner as described in the existing WPS IGW guidance that
addresses this topic (a copy of the WPS IGW guidance applicable to this
issue is included below). It is worth noting that EPA intends to
revisit all the existing WPS IGW guidance Q&As and will retain those
that are still applicable, and will revise any guidance that is still
necessary but needs to be updated to reflect changes in the final rule.
EPA would be glad to work with USDA to revise the existing WPS IGW
guidance related to posting such types of fields/forests to make sure
it adequately addresses forestry concerns.
13-10 Posting areas with unlimited entry points
Question: If a treated area has unlimited entry points, how
often should treated-area warning signs be posted to be
``visible from all usual points of entry?'' Every 100?
Answer: The rule requires that signs be visible at all usual
points of worker entry, including at least each access road,
each border with any labor camp adjacent to the treated area,
and each footpath and other walking route that enters the
treated area. If there are many usual points of entry, then
signs must be visible from all usual points of entry. When
there are no usual points of worker entry, signs must be posted
in the corners of the treated area or a location affording
maximum visibility. In areas where there are unlimited points
of entry, the agricultural employer must determine the usual
points of entry and make signs visible from those points of
entry. (March 7, 1995)
22. 170.411(b) Decon water--1 gallon/worker
USDA. Requiring a gallon of water at the beginning of the work
shift for every worker entering a treated unit for a period lasting 30
days after the REI could be problematic in forestry applications. If
the water is always located in the worker's vehicle, it is probably not
a major issue, although carrying extra canteens in the vehicle will be
a change in procedures.
EPA Response. Since the WPS requirement for the quantity of
decontamination water for workers in the final rule is merely a
codification of an existing WPS IGW policy that clarified what a
``sufficient'' amount of water per worker was, EPA does not believe
this change should represent a significant burden compared to the
existing rule. Since this is water that only has to be available at the
area where decontamination supplies are provided, or at the nearest
point of vehicular access, the provision will not result in workers
having to carry any water on their persons. It will only necessitate
that the required amount of water per worker be available at the area
where decontamination supplies are provided, or at the nearest point of
vehicular access. Additionally, EPA believes the current exceptions in
the rule for the location of decontamination supplies provide adequate
flexibility to agriculture and forestry to accommodate the range of
situations.
23. 170.411(d) and 170.509(c)--define nearest place of
vehicular access
USDA. The term ``nearest place of vehicular access,'' which is
where decontamination supplies must be stored when workers or handlers
are working in remote areas, is not defined in the WPS. This location
depends on whether one considers just regular automobiles that travel
on paved or well-maintained unpaved roads; or also tractors and all-
terrain vehicles that can travel where regular automobiles cannot; or
even helicopters, drones, and other aircraft. Is there a general
standard for what ``nearest place of vehicular access'' means, or does
it depend on which vehicles the agricultural employer or handler
employer happens to have available at the time? USDA recommends the EPA
include a definition of ``nearest place of vehicular access'' in
170.305.
EPA Response. EPA does not believe it is necessary to define the
phrase ``nearest place of vehicular access'' because the term is
sufficiently clear in its meaning without further explanation. USDA is
correct that the nearest place of vehicular access would be dependent
on the type of vehicle in use for the situation, and because it is not
practical to describe all situations, EPA believes it is appropriate to
use a general term that can be easily interpreted. In the 20 years of
WPS implementation and taking questions from regulators and the
regulated community, EPA is not aware of any serious disagreement
related to the meaning of the phrase ``nearest place of vehicular
access'', and feels that trying to define the term may reduce the
existing flexibility in the rule afforded by the current approach.
24. Subpart F, 170.501-170.509 Conflict between ``handler
employer'' and ``CPHE employer''
USDA. Subpart F assigns a host of responsibilities regarding
handlers to the ``handler employer.'' As noted in the comments on
170.305, the definition of ``handler employer'' is currently so broad,
that at any given moment there could be two or more ``handler
employers'' responsible for the same handler (i.e., the agricultural
employer and one or more commercial pesticide handler employers).
This dual responsibility is very problematic. Is each requirement
in Subpart F supposed to be carried out in duplicate? This would mean
that both the agricultural employer and the commercial pesticide
handler employer would have to independently check the handler's
training status (and keep the corresponding records), age, and
knowledge of relevant information; both would have to ensure that
handlers using highly toxic pesticides or fumigants within enclosed
spaces are monitored regularly; and both would have to provide PPE and
decontamination supplies to the handler. This approach would be
ridiculously wasteful. At the same time, it is questionable whether
splitting responsibility between the agricultural employer and the
commercial pesticide handler employer would lead to better results,
since the two parties would have to coordinate extensively to determine
who will cover each requirement.
USDA recommends that EPA address this problem by making the changes
to the definition of ``labor contractor'' in 170.305 suggested above,
which would have the practical effect of changing the definition of
``handler employer'' to mean only the handler's direct employer,
whether that is an agricultural employer or a commercial pesticide
handler employer.
EPA Response. EPA believes it has made the revisions to the rule
text necessary to address USDA's concerns in this area. Please see
EPA's responses to comments 8b and 12.
25. 170.501(c)(3)(xiv) training for handlers--error in reg text
USDA. This section requires that the training for handlers include
the following point: ``Handler employers must post treated areas as
required by this rule.'' However, under 170.309(h) and 170.409, it
is the agricultural employer--not the handler employer--who is required
to display information and signs related to pesticide applications and
worker entry restrictions. USDA recommends that EPA resolve this
discrepancy.
EPA [R]esponse. EPA corrected the text of the final rule to refer
to the agricultural employer.
26. 170.505(b)--AEZ--handler suspend application if person in
zone, even when outside the property
USDA. This section requires that handlers suspend pesticide
application when individuals are present in the application exclusion
zone. Unlike in 170.405(a)(2), there is no exception if the
individuals are outside the boundaries of the agricultural
establishment, for example on a neighboring property or on a public
right-of-way. USDA recommends that the language in 170.505(b) should
be adjusted to match 170.405(a)(2): ``. . . the handler performing
the application must immediately suspend a pesticide application if any
worker or other person [other than another handler] is in the
application exclusion zone described in 170.405(a)(1) that is within
the boundaries of the establishment . . .'' The agricultural employer
has no control over individuals outside of the agricultural
establishment, and this should be recognized by not requiring automatic
suspension of application in situations where individuals beyond the
boundaries of the establishment might peripherally encroach on an
application exclusion zone. It should be noted that 170.505(a)
already requires the handler to ``ensure that no pesticide is applied
so as to contact, directly or through drift, any worker or other person
[other than another handler].'' This renders superfluous the additional
restriction in 170.505(b) requiring suspension when the application
exclusion zone is encroached outside the establishment.
EPA Response. EPA disagrees that the application exclusion zone
should be limited to the boundaries of the agricultural establishment
for the requirement in 170.505(b) for a handler to suspend
application if a worker or other person is in the application exclusion
zone.
EPA agrees with USDA that labels and 170.210(a) already require
handlers to apply in a way so pesticides do not contact a worker or
another person. However, these provisions appear inadequate because
drift from pesticide applications continues to cause human exposure
incidents. EPA also agrees that an agricultural employer has no control
over individuals outside the establishment, which is why the
requirement for agricultural employers in 170.405(a) is limited to
the boundaries of the agricultural establishment. However, the handler
who is applying the pesticide does have the ability to temporarily
suspend an application and restart it after the worker or person leaves
the area. Handlers who are applying should already be doing this so
they do not contact a worker or other person during application. As
stated by the National Agricultural Aviation Association in their
comments on the proposed rule, ``It is standard operating procedure for
aerial applicators to temporarily avoid making passes adjacent to such
[rural] roads if workers happen to be passing by in vehicles or on
foot.''
27. 170.507 [comment cross-referenced from EA] Respirator
Requirement costs and update terminology
USDA. The discussion of costs associated with respirator fit tests
could be clarified by providing additional information on the types of
pesticides that are assumed to require respirators, the frequency those
pesticides are applied (every year or less frequently), and the number
of farms likely to apply those pesticides.
Consistent use of terminology: USDA commends the change of
terminology from dust/mist filtering respirator to filtering facepiece
respirator. Use of the OSHA terminology prevents confusion and
contributes to more cohesive standards across agencies. USDA suggests
the addition of this term to 170.205 to reflect the definition
provided by OSHA in 29 CFR 1910.134 (b) (quoted below) for further
clarity.
``Filtering facepiece respirator means a negative pressure
particulate respirator with a filter as an integral part of the
facepiece or with the entire facepiece composed of the
filtering medium.''
EPA Response. EPA disagrees that a detailed discussion of the
respirator cost analysis is needed in the Federal Register. Those
details are included in the economic analysis.
EPA appreciates USDA's comments on changing terminology from dust/
mist respirators to filtering facepiece respirators. The final WPS rule
only uses the term filtering facepiece respirator in the preamble; it
does not appear in the reg text itself. Therefore, EPA has added OSHA's
definition of filtering facepiece respirator to Unit XV.A.3 of the
preamble as follows: ``. . . Many farmworker advocacy organizations and
some PPE manufacturers asserted that EPA should also apply the proposed
standards for fit testing, training, and medical monitoring to users of
filtering facepiece respirators in addition to the other respirator
types (e.g., tight fitting elastomeric facepieces). Commenters
suggested that filtering facepiece respirators are widely used and
covered by OSHA's respirator requirements, and that their exclusion
would result in inadequate protection for many pesticide handlers. OSHA
defines a filtering facepiece as `a negative pressure particulate
respirator with a filter as an integral part of the facepiece or with
the entire facepiece composed of the filtering medium' in 29 CFR
1910.134(b).''
28. 170.509(b) and (d) decon water in forestry
a. USDA. Requiring 3 gallons of water per handler at the beginning
of the work shift will be problematic, especially if added to the eye
wash requirement of 6 gallons of water for mixer/loaders using
pesticides requiring protective eyewear. When using backpack
applicators, each handler is at some point a mixer/loader (loading from
a batch tank into the backpack, most commonly). A crew of 8 applicators
could then potentially need 72 gallons of water to be carried each day.
This seems excessive. It is clear that each handler requires 3 gallons
of water at the start of the shift for decontamination, but in such a
circumstance as described, would a crew of 8 each need 6 gallons for
eye flushing, or would one quantity of 6 gallons meet the requirement?
This could be clarified.
EPA Response. Section 170.509(d) requires an emergency eye wash
system at the mixing/loading site immediately available to the handler
when a handler is mixing or loading a product whose labeling requires
protective eyewear for handlers. Only one emergency eye wash system
(that meets the WPS requirements) is required at a mixing/loading site
regardless of how many handlers are mixing or loading at that site. EPA
has revised Unit XII.C.3 of the preamble as follows to clarify this:
``. . . The final rule allows employers to provide either at least 6
gallons of water in containers suitable for providing a gentle eye
flush for about 15 minutes, or a system capable of delivering gently
running water at a rate of 0.4 gallons per minute for at least 15
minutes to satisfy the requirement. One emergency eye wash system is
required at a mixing/loading site when a handler is mixing or loading a
product whose labeling requires protective eyewear to handlers,
regardless of how many handlers are mixing or loading at that site.''
The final rule retains the existing requirement for water to be of ``a
quality and temperature that will not cause illness or injury.''
b. USDA. May this water be drafted from local natural surface
waters (woodland stream)? May the requirement be met by pre-positioning
6 gallons at the nearest place of vehicular access outside any treated
area or area subject to a restricted-entry interval? Clarification
invited.
EPA Response. The water in an emergency eye wash system can be
drawn from local natural surface waters if the handler employer has
determined the water meets the standard of being ``of a quality and
temperature that will not cause illness or injury when it contacts the
skin or eyes or if it is swallowed'' as required in 170.509(b)(1). An
emergency eye wash system at the nearest place of vehicular access
would not satisfy the requirement of 170.509(d)(1) unless it is ``at
the mixing/loading site immediately available to the handler.''
29. 170.601(a)(1)(xii)--mistake in numbering in reg text
USDA. This point references 170.605(a) through (c) and (e)
through (k). However, the rule as currently written does not include a
170.605(k), only (a) through (j). EPA likely meant to write
170.605(a) through (c) and (e) through (j).
EPA Response. This change has been made to the rule text.
USDA Comments on EPA Worker Protection Standard Economic Analysis
30. 170.311 Display Requirements for Pesticide Application and
Hazard Information
a. USDA. The economic analysis does not account for provision of
safety data sheet and information about the application to the worker
or a designated representative within 15 days of request for such
material. In addition, there is no cost assumed for mailing this
material to the designated representative. There is no estimate of the
expected number of requests for this information by workers or their
representatives. These costs should be included.
EPA Response. These costs have now been included in the EA (Section
3.3.2) and Appendix B (Section 2, Tables B.2.a-2 and B.2.a-5). EPA
calculates that the cost of responding to a request from a current
employee to be about $3.50 and the cost of responding to a request from
a former employee to be about $14, including mailing costs. It does not
seem likely that costs would vary substantially whether the request
comes directly from an employee or from a designated representative.
The number of requests is subject to a great deal of uncertainty;
however, California and Texas have similar provisions and have not
suggested that the issue arises frequently. For purposes of the EA, EPA
has assumed that current employees may request hazard information once
for every 20 applications made while one in 100 former employees may
make a request.
b. USDA. The economic analysis assumes all farms have double-sided
copies when it estimates 3.3 pages are required to store the Safety
Data Sheet, reported to be 6.7 pages on average (Table B.2.b.1 Cost per
Final Rule, WPS Farms, Information on Pesticide Applications, p. 17,
Appendix B).
EPA Response. That is correct.
c. USDA. The period over which these records must be made available
to the worker is unclear. The cost of retaining these records over time
should be included and as well as the period over which they must be
retained.
EPA Response. Records must be retained for two years
(170.311(b)(6)). Retention costs are the cost of the folder used to
store the documents, and are included in the EA.
31. 170.401 Training Requirements for Workers
a. USDA. Due to the added training topics and other requirements,
USDA does not believe that the estimated 45 minutes of training include
ample time to thoroughly cover added topics and take questions. To
allow for at least 5 minutes per training topic (11 for workers and 13
for handlers) and at least 15 minutes for questions the estimated
training time should be adjusted to 1.5 hours. This is still a
conservative estimate and does not take into account the added time
required when a translator is used.
EPA Response. EPA's experience with the training material, as well
as information provided in comments, suggest that current training
sessions are about 30 minutes in length. One respondent to a
questionnaire by the National Council of Agricultural Employers
indicated that in the past year they spent about 2,100 hours training
4,400 workers, or slightly less than 30 minutes per worker. See EPA's
response to Comment 15, above.
b. USDA. The Economic Analysis does not take into consideration the
cost of a translator for training. Though a translator is not required
by the regulation, it does suggest the use of a translator in order to
ensure that training is carried out ``in a manner workers understand''
(citation). These costs could be incorporated by estimating a
reasonable probability of the number of trainings that will require a
translator. Since EPA plans to develop training materials in several
languages, the probability of requiring a translator could be estimated
based on which languages and dialects would not be covered by those
materials.
EPA Response. The EA considers only new burdens that would result
from the amendments to the existing WPS. Sections 170.130(c) and
170.230(c) of the existing WPS include the same requirement that
training be conducted ``in a manner workers can understand''.
c. USDA. Small farms bear a disproportionately larger cost for the
new training requirements than large farms. The economic analysis
Appendix B states that worker training costs will result in an increase
of 85% over baseline costs for small-small WPS farms, and increase by
75% for medium-small WPS farms and large-small WPS farms with less than
10 employees, 48% for large-small farms with 10 or more employees, and
42% for large WPS farms. It would be clearer if costs were summarized
for each of these farm size categories for each of the rule provisions
throughout the economic analysis.
EPA Response. USDA appears to have misunderstood the information in
Appendix B. The percentage changes reported do not refer to increases
in overall costs, only the change in the number of trainings needed.
For example, the Appendix states that ``Small-small farms (revenue/year
less than $10,000) are assumed to hold an average of 1.2 training
sessions per year, an increase of 85% over the baseline.'' That is, the
number of training sessions increases from an average of 0.65 sessions
to 1.2 sessions, an absolute increase of 0.55 sessions. EPA assumes a
large farm (revenue %$750,000) with more than 10 workers will increase
the average number of training sessions from 4.5 sessions to 6.4, an
absolute increase of 1.9 sessions.
EPA has provided a summary of costs by farm size throughout the
analysis and provided an analysis of overall impacts to small farms,
defined by the Small Business Administration as entities with revenue
less than $750,000. Because this definition implies that 95% of all
U.S. farms, and almost 80% of farms affected by the WPS, are small, EPA
also provides a more detailed analysis to examine the impacts across
the distribution of small farms.
d. USDA. The cost per farm of training workers or handlers appears
to assume that only 1 training record per training needs to be retained
by the farm (Table B.1.b.3. Cost under Final Rule, cost per WPS farm by
size, Worker Training). For both large and small WPS farms, the
economic analysis assumes retention of only one copy per training
event. If a worker requests a copy, USDA assumes that only the worker's
information will be provided and not the records of other workers who
also attended the training. If EPA assumes the employer will provide
records for all workers attending training (for example on the same
sign-in sheet) when one worker requests their training record, the
impact of this provision on privacy requirements should be included in
the analysis. If privacy constraints prevent sharing records of other
workers, the cost of record retention at the farm level should reflect
the cost of providing individual records.
EPA Response. EPA's goal is to make the process of confirming
training as easy as possible. The record of the training can be as
simple as a paper with the following information:
(i) The trained worker's printed name and signature.
(ii) The date of the training.
(iii) Information identifying which EPA-approved training materials
were used.
(iv) The trainer's name and documentation showing that the trainer
met the requirements of 170.401(c)(4) at the time of
training.
(v) The agricultural employer's name.
As the draft final rule does not require the collection of any
personally identifiable information, no personally identifiable
information would be included in the record. For a worker to confirm to
a subsequent employer that he or she has recently completed the
pesticide safety training, a copy of the training record would have the
information needed for the subsequent employer's records.
e. USDA. As part of their preliminary research, EPA conducted a
Small Business Administration Review Panel (SBAR Panel or Panel). In
almost every written comment they received, small business owners urged
them to keep a grace period for employee training. Since EPA conducted
a SBAR Panel, USDA would like to see an acknowledgment that these
issues were taken into consideration. Though most of the commenters did
not see many real cost added with removing (or decreasing) the grace
period, they did indicate that workers would have to be hired sooner
and thus paid for days where the employer received no work. If the time
lost from work is considered in the benefits section regarding
healthcare, then time lost from work due to training and paperwork must
be considered in the costs.
EPA Response. EPA thinks the elimination of the grace period is not
likely to lead employers to hire workers and pay them for no work.
Rather, EPA anticipates that employers may have to provide additional
training sessions (see response 31.c.). The opportunity cost of time
for the worker to attend a safety training is included in the estimated
cost of the revisions.
f. USDA. The elimination of the grace period and the requirement
that all workers be trained ``in manner workers understand'' creates
the potential for discrimination on the basis of language and literacy.
Economic analysis should discuss the probability that workers who speak
the language used by the employer or by on-site trainers will be used
more frequently when training is required by temporary or seasonal
workers immediately prior to performing a field or handler task. If a
farm must train workers immediately before any allowable exposure to
pesticides, the most easily trained workers will be more likely to be
used in job situations where exposure could occur, at least initially.
EPA Response: EPA notes that the requirement for training to be
provided in a manner that the worker can understand is not new. EPA has
not received comment regarding discriminatory practices related to
language as a result of the WPS.
32. 170.507 Personal Protective Equipment
a. USDA. Consistent use of terminology: USDA commends the change of
terminology from dust/mist filtering respirator to filtering facepiece
respirator. Use of the OSHA terminology prevents confusion and
contributes to more cohesive standards across agencies. USDA suggests
the addition of this term to 170.205 to reflect the definition
provided by OSHA in 29 CFR 1910.134 (b) (quoted below) for further
clarity.
``Filtering facepiece respirator means a negative pressure
particulate respirator with a filter as an integral part of the
facepiece or with the entire facepiece composed of the
filtering medium.''
Costs and benefits: In the cost estimate for the addition of
filtering facepiece respirators the Agency assumes that all employers
will use the suggested online medical evaluation (introduced in lines
3388-3394 of the rule preamble) from the outset. While the use of
online medical evaluations would be the most cost-effective option for
employers, assuming that employers will be able to use this method of
evaluation in the first years of implementation does not seem likely.
This is especially true for rural areas where broadband access is not
available on every farm operation. Though online medical evaluations
will likely be used by some employers, the estimated probability seems
high for the first year. The probability of using an off-site medical
evaluation is much more likely in the first year with a decreasing
probability within the first five years as employers learn more about
their available options.
EPA Response. EPA does not agree with USDA's reasoning. Employers
are unlikely to forego cost-effective options, even initially. EPA
plans significant outreach and is confident that private interests,
including crop advisors and pesticide dealers, will engage in similar
programs. According to the 2012 Census of Agriculture almost 70% of
U.S. farms have Internet access and most have high-quality service,
including broadband or DSL. Less than 10% of farms rely on dial-up
connections.
b. USDA. Additionally, the time estimate for an off-site medical
evaluation (Table 3.3-34) should use the same estimate as the follow-up
medical exam ($72.12). The analysis must also take into consideration
the lost wages and travel time associated with visiting a medical
professional considering that most farm operations are located in rural
areas where access to a licensed medical professional may increase time
and travel. The time should at least reflect the time allotted to the
evaluation, but should also include at least 30 minutes of travel time.
Please see table below for an example of suggested edits.
Table 3.3-34. Costs under Final Rule, Large WPS Farm, Respirator Fit
Test
------------------------------------------------------------------------
annual
Action/ unit time/ frequency
Material (j) wage/price wj quantity Prob (jDi) cost
Hr,i,j/Mr,i,j
------------------------------------------------------------------------
Time for $20.04/hr 1.5 hour 0.535 $16.08
medical
evaluation
Off-site $72.17 1 0.535 $38.61
evaluation
On-line $27.00 1 0.134 $3.62
evaluation
Time for $20.04/hr 2 hour 0.134 $5.36
follow-up
exam \1\
Follow-up $72.17 1 0.134 $9.66
medical
exam \1\
Time for fit $20.04/hr 1.5 hour 0.535 $16.09
test,
with travel
Fit test and $50.00 1 0.535 $26.76
training
Employer $33.44/hr 1 hour 0.535 $17.90
manage-
ment
Collect/Store $33.44/hr 4 min 0.535 $1.19
docu-
mentation
-------------
costr,i,aP $135.27
------------------------------------------------------------------------
Source: EPA estimation. See text for data sources. Numbers may not sum
due to rounding. 1 EPA assumes approximately 25 percent of handlers
taking the medical evaluation will be referred for a more complete
medical examination.
EPA Response. EPA does not agree with USDA's reasoning that
employers will select a more costly response to the regulatory burden.
Further, if they choose to skip the screening evaluation for a complete
medical evaluation e.g., because of a previously scheduled physical
examination, there would be no need for an on-line (screening)
evaluation or subsequent follow-up evaluation.
c. USDA. In the Economic Analysis for the rule, EPA explains that
it derives costs for respirator fit tests from the assumption that each
farm will only have one handler that will need to be fit tested and
that only 40 percent of farms will likely use pesticides that require
respirators.
``Accounting for the fact that not all farms will use
pesticides every year, EPA estimates about 40 percent of large
farms and large-small farms will use a product requiring a
respirator. A farm is unlikely to need more than one handler
when using these products, so for ease we calculate costs at
the farm level. Further, some handlers will undergo fit testing
because the requirement has been incorporated onto some product
labels, for example, various soil fumigants.'' (Economic
Analysis 3.3.6)
With the addition of filtering facepiece respirators, USDA does not
believe this estimate is accurate. First, though only one handler may
be involved in pesticide use at a time, this does not imply that there
is only one handler on the farm that will need to be fit tested. The
number of handlers per farm that need fit tests should be estimated
based on small versus large WPS farms.
Second, the assumption that only 40 percent of farms will use
pesticides that require respirators seems low considering the addition
of filtering facepiece respirators (which are required for a much
larger number of pesticides than chemical cartridge respirators (NIOSH
23-C)). USDA urges EPA to gather further data on the number of
pesticide labels that require respirators (including filtering
facepiece respirators) and use that data to re-estimate the cost of
respirator fit tests.
EPA Response. EPA notes that USDA is quoting the baseline
estimation of cost, where about 40% of the larger farms ultimately use
a product requiring a respirator and the employer provides the handler
with instruction on fit and use. Under the final rule, EPA assumes that
over half of the larger farms will arrange for a handler to be tested.
d. USDA. The discussion of costs associated with respirator fit
tests could be clarified by providing additional information on the
types of pesticides that are assumed to require respirators, the
frequency those pesticides are applied (every year or less frequently),
and the number of farms likely to apply those pesticides. The economic
analysis could be strengthened by providing a more detailed explanation
for the assumption that under the baseline and final rule, 60% of crop-
producing farms use pesticides requiring respirators with an annual use
at 40% of these farms. In Appendix A, 76% of crop-producing WPS farms
are estimated to use pesticides. It is unclear whether the 60% estimate
requiring respirators includes pesticides requiring only the filtering
facepiece respirators as well as pesticides requiring other types of
respirators. The baseline calculation for the cost of fit tests at WPS
farms assumes 40.4% of these farms will have a handler undergo a fit
test with 3% of these baseline fit tests consistent with OSHA
requirements. The final rule calculations assume 53.5% of large and
13.4% of large-small WPS farms have handlers undergoing fit tests. EPA
should present the baseline percentage of WPS farms where handlers
undergo fit tests in terms of large and large-small WPS farms to allow
direct comparison between the two scenarios.
EPA Response. EPA does not think further discussion is warranted.
As noted in the EA, ``Pesticides bearing label requirements for
respirators are not common, but there are a few commonly used
pesticides with the requirement.'' The requirement is product-specific
and may apply to the mixer/loader and/or to the applicator. In the end,
EPA assumes that 75% of large and large-small primarily crop farms
(farms with annual revenue of $750,000 or more and farms with annual
revenue between $100,000 and $750,000, respectively) will account for
virtually all respirator use subject to the WPS. According to data from
the 2012 Census of Agriculture, farms primarily producing crops (NAICS
111) in these size ranges account for about 67% of all crop acreage in
the U.S., but about 80% of all herbicide and insecticide treated
acreage and over 90% of all acres treated with fungicides or plant
growth regulators.
e. USDA. The family farms fit test calculation needs further
clarification. The economic analysis references Appendix A for the
number of family farms by category (large, large-small, etc.). Appendix
A does not discuss family farms explicitly--by back-calculating from
the existing tables you could derive the number of family farms but
this adds some uncertainty and the values do not match those reported
in the economic analysis (18,949 large family farm and 141,753 large-
small family farms). Further explanation or support is needed for the
assumption that 40% of family farms producing crops use a pesticide
requiring a respirator.
EPA Response. EPA acknowledges that Appendix A does not contain
information on so-called family farms, i.e., those farms that do not
report hired labor. However, EPA has provided the exact numbers used
within the analysis.
f. USDA. The values used in the baseline analysis for respirator
fit tests at WPS farms are not consistent between the main economic
analysis and its explanatory [A]ppendix B (See Table 3.3.32. Baseline
Costs, per Large and Large-Small WPS Farm, Respirator Fit, Economic
Analysis versus Table B-6.a.3. Baseline Cost, per WPS Farm, Respirator
Fit, Appendix B). Likewise, the values reported in Appendix B for the
number of large (79,434) and small-large (141,753) WPS farms do not
appear in Appendix A where the reader is referred for further
information. Since the population of WPS farms affected by the rule is
assumed to only include crop-producing farms, it is assumed that these
values represent crop-producing farms hiring labor (shown in Table
A.1.10 of Appendix A). Further explanation would strengthen the
economic analysis.
EPA Response. EPA acknowledges that Appendix B was in error and
revised the tables and explanations.
g. USDA. In the cost estimate (p. 90, Economic Analysis) for the
addition of filtering facepiece respirators the Agency assumes that all
employers will use the suggested online medical evaluation (introduced
in lines 3388-3394 of the rule preamble) from the outset. While the use
of online medical evaluations would be the most cost-effective option
for employers, assuming that employers will be able to use this method
of evaluation in the first years of implementation does not seem
likely. This is especially true for rural areas where broadband access
is not available on every farm operation. Though online medical
evaluations will likely be used by some employers, the estimated
probability seems high for the first year. On-line medical evaluations
are currently offered only in Spanish and English. Workers speaking
other languages will need off-site medical evaluations. The probability
of using an off-site medical evaluation is much more likely in the
first year with a decreasing probability within the first five years as
employers learn more about their available options.
EPA Response. EPA does not agree with USDA's reasoning. Employers
are unlikely to forego cost-effective options, even initially. EPA
plans significant outreach and is confident that private interests,
including crop advisors and pesticide dealers, will engage in similar
programs. According to the 2012 Census of Agriculture almost 70% of
U.S. farms have Internet access and most have high-quality service,
including broadband or DSL. Less than 10% of farms rely on dial-up
connections. EPA does not see language as a significant barrier for
employers and handlers.
h. USDA. The cost of the off-site medical evaluation used in the
economic analysis is based on a single provider--Affordable Safety
Training, offered in English and Spanish. A quick review of on-line
medical evaluations for fit testing shows a range of products from the
$25 for McHaney and Associates to $27 for Affordable Safety Training to
$28 for a 3M on-line medical evaluation. These products are only
offered in English and Spanish. If these medical evaluation materials
need to be provided in other languages, there is no cost considered for
this in the economic analysis. The Affordable Safety Training web site
offers a fit test kit for $140 using Bitrex and $139.95 using
saccharin. The economic analysis cites the cost for a fit test as
ranging between $80 and $140 for an employer administered test.
EPA Response. EPA agrees that there are multiple options of similar
price. Fit test kits come in a range of prices with smoke tests
typically costing less than other options. EPA does not see language as
a significant barrier for employers and handlers.
i. USDA. The economic analysis does not include costs accounting
for circumstances requiring the same person to repeat the fit test for
a different class of respirator which may involve additional
measurements. The medical evaluation questionnaire required by OSHA
lists two separate categories of respirators. A worker/handler would
need an additional fit test and evaluation if required to use another
class of respirator. The analysis also does not consider agricultural
establishments where the same person is not the handler for all
pesticides or for the entire year. Seasonal workers may not remain at
an establishment for the entire period where pesticides requiring
respirators may be applied.
EPA Response. EPA does not think the cost of a medical screen would
be significantly increased if the handler seeks testing for different
classes of respirators. Multiple respirators could be tested at an off-
farm site or tested using the same test kit.
33. 170.601 Exemptions--family farms
a. USDA. Family farm exemption is too narrow: The exemption for
family farms applies to any agricultural establishment that is wholly
owned by an individual, or where all of the owners of the establishment
are members of the same immediate family. This definition is narrower
than the definition used by ERS in the Agricultural Resource Management
Survey (ARMS). The ERS definition is more flexible and requires only
that the majority of the business is owned by the operator and
individuals related to the operator by blood, marriage, or adoption,
including relatives that do not live in the operator's household. Using
this definition, ERS finds around 97% of all farms are family farms
based on data from ARMS.
Findings from the 2013 ARMS survey indicate that 97.6 farm are
family farms, using the ERS definition. Family farms are organized as
individually owned, partnerships, corporations and other types of legal
status (trust, estate, cooperative). The largest category of ownership
in family farms is individual ownership (91.5%). Partnerships account
for 4.4 %, corporations for 3.3 % and other types of legal status for
0.8 %. Family farms that are not individually owned account for 173,434
farms.
It is unclear how many of the farms considered family farms in the
economic analysis would meet the definition required in the
agricultural establishment exemption. The EPA should estimate how many
of the crop producing family farms would be not be eligible for the
exemption and thus should be counted in population of farms that must
comply with the WPS standard. If ownership type is distributed
similarly between crop producing family farms and all family farms, as
many as 8% of crop producing farms may not be eligible for the
exemption.
EPA Response. To determine the number of farms that would be
impacted by revisions to the WPS, EPA considered all farms hiring labor
as reported in the 2012 Census of Agriculture. Since farms may describe
in their Census report as hired labor persons who would qualify for the
WPS immediate family exemption, EPA has probably overestimated of the
number of farms and workers/handlers affected by the WPS.
b. USDA. The definition of immediate family is too narrow. In
regard to establishing a minimum age for handlers and workers
performing early-entry tasks, the final rule requires that handlers and
workers performing early-entry tasks be at least 18 years old, rather
than the proposed minimum age of 16 years old. This minimum age does
not apply to an adolescent working on an establishment owned by an
immediate family member. (EPA WPS FR page. 7). EPA has finalized the
definition of ``immediate family'' as limited to the owner's spouse,
parents, stepparents, foster parents, father-in-law, mother-in-law,
children, stepchildren, foster children, sons-in-law, daughters-in-law,
grandparents, grandchildren, brothers, sisters, brothers-in-law, and
sisters-in-law (EPA WPS FR page 169).
The EPA should reconsider the definition of immediate family. The
proposed definition would not allow the exemption to youth who would
work for a more distant family member such as an uncle. This definition
would also not allow the exemption to youth whose parents are farm
operators, but not owners. The Department of Labor (DOL) has exemptions
for youth in the child labor requirements in agricultural occupations
under the Fair Labor Standards Act. The Act states: ``A child of any
age may be employed by his or her parent or person standing in place of
the parent at any time in any occupation on a farm owned or operated by
that parent or person standing in place of that parent'' (http://
www.dol.gov/whd/regs/compliance/childlabor102.pdf). EPA should revise
their definition of immediate family, or the exemption itself to be
more consistent with rules enforced by DOL.
EPA Response. Under the owner and immediate family exemption in the
existing WPS, establishments that qualify must be either wholly owned
by the individual, or all owners of the establishment must be members
of the same immediate family. While EPA is proposing to expand the
types of familial relationships that would be considered ``immediate
family'' under the WPS, EPA did not consider and does not plan to
further expand the exemption to allow farms that are majority owned by
family members to qualify. EPA did not propose such a change to the
requirement and has not received comments from the public indicating
that the current requirement for the establishment to be wholly owned
by an individual or persons who are all members of the same immediate
family is too restrictive.
[attachment 9]
August 18, 2014
Hon. Gina McCarthy,
Administrator,
U.S. Environmental Protection Agency,
Washington, D.C.
Re: Agricultural Worker Protection Standard Revisions; Docket ID #EPA-
HQ-OPP-2011-0184
Dear Administrator McCarthy:
Migrant Clinicians Network (MCN) welcomes this important
opportunity to comment on the proposed revisions to the Agricultural
Worker Protection Standard (WPS). MCN is a national clinical
organization with over 10,000 health care provider constituents
dedicated to health justice for the mobile under-served, including
migrant and immigrant farmworkers and their families. MCN states
unequivocally that farmworker occupational safety and health is a
critical health priority. Since our inception in 1984 we have worked to
eliminate health disparities among farmworkers. In particular we have
focused on occupational health disparities, as the work and lifestyle
that accompanies this vulnerable population places migrants at higher
risk for injuries and other health problems. We have worked to address
pesticide exposure on a number of levels, including our national
program to improve clinical practices regarding the recognition and
management of pesticide poisonings, in partnership with the U.S.
Environmental Protection Agency (EPA).
We write to support many aspects of the proposed WPS that foster
worker health and safety for an estimated 2 million workers across the
United States who harvest our food. Additionally, we highlight areas of
the proposed regulation that need to be strengthened to better protect
farmworkers from pesticide exposure. These vulnerable workers, the
majority of whom are immigrants from Mexico and other Latin American
countries, have limited English proficiency, low educational
attainment, and poverty-level incomes. They are also the most
overexposed population to pesticides.
Economic analysis of the proposed rule: In its economic analysis in
support of the proposed rule, EPA acknowledges that many acute
pesticide incidents are underreported and adjusts its calculation
regarding costs and benefits to account for the unreported costs of
acute pesticide incidents. (79 Fed. Reg. No. 53 at 15449). MCN supports
EPA's acknowledgement of underreported pesticide incidents. MCN
provides training to clinicians to recognize the signs and symptoms of
pesticide exposures and underscores the importance of reporting
pesticide poisonings to the appropriate state agencies. Once trained,
clinicians have repeatedly acknowledged that they likely have
misdiagnosed and/or failed to report pesticide exposures. In 2014, over
\1/2\ the clinicians participating in MCN trainings stated they were
unfamiliar with the pesticide reporting requirements in their state and
did not know which agency to contact to report pesticide poisonings.
MCN's Chief Medical Officer, Ed Zuroweste, M.D., has worked in the
field of migrant health for over 30 years as a frontline physician,
medical director of a migrant health center and a clinical consultant
assessing health center performance. He has trained and provided
technical assistance to thousands of clinicians. He states, ``I have
yet to meet an experienced clinician who has not admitted that he or
she misdiagnosed or failed to report a pesticide exposure.'' A survey
of environmental medicine content in U.S. medical schools found that 75
percent of schools require only about seven hours of study in
environmental medicine over four years.\1\ Of the clinicians MCN
trained in 2014, 45 percent had less than one hour of training in
environmental and occupational health. It is not surprising that
clinicians are unprepared to accurately recognize and manage (including
report) pesticide exposure. Clinicians are also challenged in making an
accurate diagnosis and reporting exposures as there are few readily
accessible confirmatory clinical tests for pesticide poisoning.\2\
Clinicians undoubtedly resist reporting to public health agencies
unless diagnosis is certain and reporting is mandated. Although 30
states have rules requiring some form of clinician reporting of
pesticide exposure and illness, only 12 states have a surveillance
program to act on these reports.3-4 Underreporting is also
due to many workers not seeking medical attention for overexposures as
they do not understand their rights and fear losing their jobs.
---------------------------------------------------------------------------
\1\ Schenk M., Popp S.M., Neale A.V., Demers R.Y. Environmental
medicine content in medical school curricula. Acad. Med. 1996 May;
71(5): 499-501.
\2\ American Public Health Association. APHA Policy Statement
20108: Requiring Clinical Diagnostic Tools and Biomonitoring of
Exposures to Pesticides. Washington, D.C.: American Public Health
Association. 2010. Available at: http://www.apha.org/advocacy/policy/
policysearch/default.htm?id=1400. Accessed August 4, 2014.
\3\ National Institute for Occupational Health and Safety.
Pesticide-related illness and injury surveillance: a how-to guide for
state-based programs. DHHS (NIOSH) Publication Number 2006-102.
Washington, D.C.: National Institute for Occupational Health and
Safety; 2005. Available at: http://www.cdc.gov/niosh/docs/2006-102/
pdfs/2006-102.pdf. Accessed August 15, 2014.
\4\ Centers for Disease Control and Prevention. Pesticide Injury
Surveillance: Sentinel Event Notification System for Occupational Risk
(SENSOR) Program. July 2014. Available at http://www.cdc.gov/niosh/
topics/pesticides/overview.html. Accessed on August 16, 2014.
---------------------------------------------------------------------------
MCN agrees with EPA that the full costs of occupational illness
related to pesticide exposure include not only costs in medical care
and lost productivity to workers and handlers in acute incidents, but
also the long-term costs from the health effects of chronic exposure to
pesticides. There is an extraordinary cost to workers, farmers and our
society for occupational illness and injury both in the short term and
long term in terms of medical care, lost work days, lost wages, and
potential workers' compensation insurance premiums for an occupational
injury or illness. While the cost of illness and injury as a result of
work-related pesticide exposure is challenging to determine, when
occupational illness and injury are assessed across industries, the
cost is more than $250 billion a year. In fact, occupational injuries
and illnesses are the second costliest medical condition behind
cardiovascular disease and ahead of cancer.\5\ In addition, EPA is
correct to consider the costs of illness related to exposures to
farmworkers' families due to the pesticides that are brought home on
workers' clothes, skin and hair.
---------------------------------------------------------------------------
\5\ Leigh J.P. Economic burden of occupational injury and illness
in the United States. Milbank Q. 2011; 89(4): 728-72.
---------------------------------------------------------------------------
Preparing and Equipping Clinicians to Protect Workers: MCN applauds
EPA's recognition that clinicians play an important role in worker
protection. We urge EPA to help clinicians to improve their recognition
and management of pesticide exposure by supporting the development of
clinical diagnostic tools, and providing training and technical
assistance for clinicians. This need is underscored in recommendations
outlined in the 2011 Agency for Toxic Substances and Disease Registry's
National Conversation on Public Health and Chemical Exposures Action
Agenda. It states: ``Clinicians need a set of skills and tools for (1)
diagnosing, treating, and intervening to prevent chemical exposures,
(2) providing information about chemical exposures to their patients
and communities, and (3) participating in surveillance for chemical
exposures and health effects.'' \6\ The National Strategies for Health
Care Providers: Pesticide Initiative, established in 1998 by EPA and
the U.S. Departments of Health and Human Service, Agriculture, and
Labor, also aims to improve the training of health care providers in
the recognition, diagnosis, treatment, and prevention of pesticide
poisonings among those who work with pesticides.\7\
---------------------------------------------------------------------------
\6\ Agency for Toxic Substances and Disease Registry, National
Conversation on Public Health and Chemical Exposures Action Agenda.
2011. Available at: http://www.atsdr.cdc.gov/nationalconversation/
action_agenda.html. Accessed August 5, 2014.
\7\ US Environmental Protection Agency, National Strategies for
Health Care Providers: Pesticide Initiative. Available from http://
www.epa.gov/oppfead1/safety/healthcare/healthcare.htm#Cooperative.
Accessed August 18, 2014.
---------------------------------------------------------------------------
EPA relies on data from surveillance systems such as the SENSOR
Pesticide Program in order to make decisions about pesticides once they
are on the market. These systems rely in large part on reports
submitted by healthcare providers. A well trained clinician, who
receives education to recognize the signs and symptoms of pesticide
exposures as well as information about where to report, is the first
step to improve reporting. As important are clinical diagnostic tools
to confirm a clinical impression and to help provide the objective
confirmation of the work relatedness of an illness. Confirmatory
diagnostic tests are essential to providing the information clinicians
need to treat overexposed workers and handlers and to ultimately
provide EPA with the data necessary to understand the health effects of
registered pesticides. The Agency for Toxic Substances and Disease
Registry, National Conversation on Public Health and Chemical Exposures
Action Agenda also calls for clinical diagnostic tools and states: ``To
more fully prepare healthcare providers to address chemical exposures,
validated clinical diagnostic tools similar to blood lead testing are
needed.'' \8\ The American Public Health Association echoes this
recommendation as well.\9\ MCN calls for clinical diagnostic tools to
monitor pesticide exposure. Providing clinicians with the clinical
diagnostic tools they need to make the most accurate diagnosis possible
should be a central part of worker protection and it is glaringly
absent in the proposed rule.
---------------------------------------------------------------------------
\8\ Agency for Toxic Substances and Disease Registry, National
Conversation on Public Health and Chemical Exposures Action Agenda.
2011. Available at: http://www.atsdr.cdc.gov/nationalconversation/
action_agenda.html. Accessed August 5, 2014.
\9\ American Public Health Association. APHA Policy Statement
20108: Requiring Clinical Diagnostic Tools and Biomonitoring of
Exposures to Pesticides. Washington, D.C.: American Public Health
Association; 2010. Available at: http://www.apha.org/advocacy/policy/
policysearch/default.htm?id=1400. Accessed August 4, 2014.
---------------------------------------------------------------------------
Hierarchy of Controls for Occupational Health and Safety: MCN urges
EPA to apply the standard and universally accepted public health best
practice for control of worker exposure to chemicals--the industrial
hygiene ``hierarchy of controls.'' Under the hierarchy of controls,
risk reduction is based on the following preferred order of controls:
elimination, substitution with less hazardous materials, engineering
controls (such as closed systems), warnings, administrative control,
and personal protective equipment.\10\ MCN is concerned that the
revised WPS largely relies on the least protective measures for
workers--PPE and administrative controls such as training and record
keeping.
---------------------------------------------------------------------------
\10\ American National Standards Institute--American Industrial
Hygiene Association Z10-2005 Occupational Health and Safety Management
Systems. 2005; as described in Manuele, F. ANSI/AIHA Z10-2005: The new
benchmark for safety management systems. February 2006. Available from:
http://www.asse.org/publications/standards/z10/docs/25-33Feb2006.pdf.
Accessed August 5, 2014.
---------------------------------------------------------------------------
Annual Training and Record Keeping: MCN supports annual pesticide
safety training for farmworkers and pesticide handlers as well as a
record-keeping system to document when these trainings take place. An
informed workforce is an important first step in worker protection.
Annual training will reinforce important pesticide safety practices and
information to help workers better protect themselves and their
families from pesticide overexposure. Studies indicate that workers who
have been trained in the preceding year retain more information from
new training than those whose previous training is more than two years
old; that workers maintain information but begin to show some drop-off
at five months; and that knowledge gains are correlated with improved
self-reported use of PPE.11-13 Pedagogically, it is
unreasonable to expect a workforce characterized by limited formal
education and low levels of literacy to retain training content beyond
one year. Training requirements to protect agricultural workers and
handlers should be comparable to those required by OSHA regulations
that require employers to provide annual training to protect employees
from chemical hazardsin the workplace.
---------------------------------------------------------------------------
\11\ Anger W.K., Patterson L., Fuchs M., Will L.L., Rohlman D.S.
Learning and recall of Worker Protection Standard (WPS) training in
vineyard workers. J. Agromedicine. 2009; 14(3): 336-44. doi: 10.1080/
10599240903042057.
\12\ LePrevost C.E., Storm J.F., Asuaje C.R., Arellano C., Cope
W.G. Assessing the effectiveness of the Pesticides and Farmworker
Health Toolkit: A curriculum for enhancing farmworkers' understanding
of pesticide safety concepts. J. Agromedicine. 2014; 19(2): 96-102.
doi: 10.1080/1059924X.2014.886538.
\13\ Levesque D.L., Arif A.A., Shen J. Effectiveness of pesticide
safety training and knowledge about pesticide exposure among Hispanic
farmworkers. J. Occup. Environ. Med. 2012 Dec.; 54(12): 1550-6. doi:
10.1097/JOM.0b013e3182677d96.
---------------------------------------------------------------------------
Training Content: MCN supports expanding the content of the
required training for workers and handlers, underscoring the importance
of including the proposed topics of worker rights, emergency assistance
and ways to minimize paraoccupational exposures or pesticide ``take
home'' exposures. Additionally, we call for EPA to emphasize training
regarding the possible reproductive health effects of pesticide
exposure. We also recommend that EPA be mindful of the needs of workers
and some handlers due to low literacy and limited English language when
revising the training standards. The training should be provided in
meaningful interactive formats that include training in a language that
the individual understands.
Training Grace Period: MCN supports the elimination of a grace
period for worker training. Any training grace period severely
undermines the intent of the WPS. An untrained worker is more
vulnerable to pesticide overexposure and should not be put at risk.
OSHA standards require employers in almost all industries to notify
their workers of the hazards that may be encountered in the workplace
before the work begins. Agriculture should be held to the same standard
when it comes to exposure to hazardous chemicals.
Minimum Age--MCN supports the establishment of a minimum age of 18
rather than the proposed minimum age limit of 16 for pesticide handlers
and early-entry workers. Children younger than 18 are still developing
both physically and mentally and high levels of exposure to pesticides
could have life-long health effects. Furthermore, most minors do not
have the maturity to follow all label instructions or take the
necessary precautions to ensure their safety and the safety of other
workers.14-15 Children working in other industries are
prohibited from engaging in high hazard tasks.\16\ Children employed in
agriculture should be afforded the same protections as children working
in other hazardous industries.
---------------------------------------------------------------------------
\14\ Salazar M.K., Napolitano M., Scherer J.A., and McCauley L.A.
Hispanic adolescent farmworkers' perceptions associated with pesticide
exposure. West J. Nurse Res. 2004; 26(2): 146-166.
\15\ Steinberg L. Cognitive and affective development in
adolescence. Trends in Cognitive Science. 2005; 9(2): 69-74.
\16\ US Department of Labor. Labor Regulations, Orders and
Statements of Interpretation. 29 CFR 570. Available from http://
www.ecfr.gov/cgi-bin/
textidx?c=ecfr&sid=48d6ee3b99d3b3a97b1bf189e1757786&rgn=div5&
;view= text&node=29:3.1.1.1.31&idno=29Accessed August 4, 2014.
---------------------------------------------------------------------------
Hazard Communication--MCN does not support the EPA's proposal to
eliminate the current requirement for a central posting location for
pesticide application information. We do support EPA's clarification
that this information, in addition to the Safety Data Sheets (SDSs) and
labeling for pesticide applications, must be made available to workers'
representatives such as clinicians, attorneys and union
representatives. Particularly in the case of workers injured by
pesticides, it is critical for workers' representatives to be able to
obtain accurate, timely information about the pesticides to which
workers may have been exposed. However, specific information about the
pesticides applied and the hazards they pose must be made available to
workers universally, in advance of pesticide applications. Such
information should be available in nonemergency situations and it
should not require any type of request from the worker or worker
representative. Workers may not understand that they have the right to
request such information. If workers do understand, many will be
reluctant (for fear of job loss) or unable due to language barriers to
ask their employer for the information.
Additionally, we recommend requiring availability of SDSs in
Spanish as well as English both in a central location and
electronically using a smart phone scan code. SDSs in Spanish and other
written languages should now be readily available, because format and
basic content of SDSs has been harmonized internationally to comply
with Globally Harmonized System requirements. Labels should also be
made available electronically, as well as at a central location and
provided in Spanish and other languages when available.
Monitoring Handler Exposure to Cholinesterase Inhibiting
Pesticides: We support medical monitoring of pesticide handlers who
mix, load or apply Toxicity Category I or II organophosphates or N-
methyl carbamates. Monitoring programs have been successfully
implemented for 40 years in California and over 10 years in Washington
State, substantially helping to prevent overexposure of handlers. These
biomonitoring programs have been critical in reducing overexposure by
removing workers from ongoing exposure and identifying flaws in the
system of worker protection.17-18
---------------------------------------------------------------------------
\17\ Ames R.G., Brown S.K., Mengle D.C., et al. Cholinesterase
activity depression among California agricultural pesticide
applicators. Am. J. Ind. Med. 1989; 15(2): 143-150.
\18\ Hofmann J.N., Keifer M.C., De Roos A.J., et al. Occupational
determinants of serum cholinesterase inhibition among organophosphate-
exposed agricultural pesticide handlers in Washington state. Occup.
Environ. Med. 2010;67:375-386.
---------------------------------------------------------------------------
We strongly disagree with EPA's decision not to implement such a
program nationwide based on its determination that these programs are
``reactive, catching incidents after they occur rather than working to
stop them from happening.'' This analysis contradicts some of the very
basic tenets of public health. Medical monitoring programs are
essential preventive measures, which successfully stop handlers from
being overexposed by identifying subclinical evidence of exposure,
prompting review of primary prevention practices. Medical monitoring is
common in other industries and OSHA has promulgated over 25 specific
standards for medical screening of workers exposed to hazardous
substances.\19\ Pesticide handlers deserve the same protections that
are afforded to workers in other industries. MCN recommends that EPA
expeditiously explore a national requirement for cholinesterase
monitoring for pesticide handlers mixing, loading or applying Category
I or II organophosphates or N-methyl carbamates, and that the
Washington State requirements provide a model.
---------------------------------------------------------------------------
\19\ Occupational Safety and Health Administration. General
Industry. Medical Screening and Surveillance. 29 CFR 1910. Available
from https://www.osha.gov/SLTC/medicalsurveil
lance/. Accessed August 5, 2014.
---------------------------------------------------------------------------
Emergency Assistance: MCN supports the EPA's proposal to clarify
when employers must make transportation to a medical facility available
to workers and handlers. However, transportation should be made
available within 3-4 minutes if the injury is life-threatening or 15
minutes if it is not life-threatening upon learning of an exposure, and
not within 30 minutes. We support the proposal to require employers to
provide to the worker, handler or the treating medical personnel the
relevant SDS and pesticide label, or all of the pertinent information
in an alternate form (as opposed to waiting for it to be requested). In
certain circumstances, employers should be required to document the
time and length of the exposure and report it to the worker and
clinician.
Respirator Training and Fitting: We support requiring employers of
pesticide handlers to comply with OSHA-equivalent training on
respirator use, fit-testing of respirators, and medical evaluation
requirements whenever a respirator is required by the labeling.
However, the rule should also include the OSHA requirement for each
employer to adopt a worksite-specific respiratory protection program to
address in detail how respirators are properly selected, cleaned,
stored, repaired, and replaced. Furthermore, we disagree with EPA's
decision to exclude dust or mist filtering masks, since a majority of
pesticides with label requirements for handlers to wear respirators
only require dust/mist filtering respirators. Medical evaluation, fit-
testing and training should be required for all types of dust/mist
filtering respirators.
Decontamination Supplies: We support the EPA recommendation to
require employers to provide decontamination supplies that include one
gallon of water per worker for routine washing and emergency eye
flushing, soap, and single use towels and at least three gallons of
water per worker for decontamination for workers performing tasks in an
entry-restricted area. We also recommend that EPA require further
decontamination supplies including shower facilities onsite. We
recommend following the American National Standards Institute standard
(Z358.1-2009) for emergency eyewash and shower equipment and require an
emergency shower that can deliver water at 20 gallons per minute for 15
minutes.\20\
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\20\ American National Standards Institute. American National
Standard Z358.1-2009 for Emergency Eyewashes and Shower Equipment.
Available at: http://webstore.ansi.org/
RecordDetail.aspx?sku=ANSI%2fISEA+Z358.1-2009. Accessed August 6, 2015.
Described in Bradley Corporation. A Guide to the ANSI Z358.1-2009
Standard for Emergency Eyewashes and Shower Equipment. 2012. Available
from https://www.bradleycorp.com/download/2081/4002.pdf. Accessed
August 6, 2014.
---------------------------------------------------------------------------
Contaminated Personal Protective Equipment: MCN supports the EPA
proposal to require employers to render contaminated PPE unusable
before properly disposing of PPE that cannot be decontaminated
according to the manufacturer's instructions. Such measures will
prevent adverse health effects resulting from the wearing of
contaminated garments.
Closed Systems for Mixing and Loading: MCN supports the EPA
proposal to clarify the criteria for closed systems by adopting the
California standards for system design. However, EPA should go further
and adopt, at a minimum, the California standards requiring the use of
closed systems for highly-toxic categories of pesticides. As noted
above, under the industrial hygiene hierarchy of controls, engineering
controls are preferred over PPE. It therefore is appropriate for EPA to
require the engineering control of a closed system rather than PPE as
the primary protection for pesticide handlers. Closed systems are
already used extensively in California, and for some pesticides and
certain types of uses across the country. The proper use of closed
transfer systems for mixing and loading pesticides reduces the
potential for human exposure from spills, splashes and blowing, and
this type of engineering control--rather than PPE--should be the first
line of defense against pesticide exposure.
Drift Protections: MCN supports the EPA proposal to require
handlers to cease application if someone other than a trained and
properly equipped handler enters treated or surrounding areas. We also
support the establishment of entry-restricted areas adjacent to the
treated areas in farms and forests. But, as proposed, these protections
apply only to fields on the farm that was sprayed. This safeguard
should extend to workers in harm's way who work at a neighboring
establishment. Though modest in scope, the proposed entry-restricted
areas are a step in the right direction to protect workers and others
in the immediate vicinity of pesticideapplications.
Early Entry Restrictions: MCN believes that early reentry for
fieldwork should only be allowed in true agricultural emergencies.
Worker protection during early reentry is largely dependent upon proper
use of PPE. Many of the tasks involved with early reentry, such as
moving irrigation pipes and performing hand labor tasks, may be
cumbersome with required PPE. Given the nature of the tasks as well as
the potential for escalating heat stress with PPE, there is potential
for improper use or no use of PPE. The proposed improvements in
training and age restriction cannot adequately mitigate these risks. In
addition, we oppose the relaxing of the early reentry restriction for
irrigators, allowing early reentry even if the need for irrigation
could have been foreseen before the pesticide application. Irrigators
are at high risk of pesticide poisoning because they tend to work long
hours. They also often work alone with no coworker to assist in calling
for help in case of pesticide or heat illness.
Notification about Restricted Entry Intervals (REIs): MCN
recommends that EPA continue to require on the sign the wording ``Keep
Out'' and not change it to ``Entry Restricted.'' While this semantic
change may be technically more accurate, it is far more difficult for
most people to understand. According to a standard readability program,
``Entry Restricted'' tests at a Grade 13 reading level. By contrast,
``Keep Out'' tests at Grade 0, meaning that it should be easily
understood by most six-year-olds.\21\
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\21\ Tested using The Readability Test Tool on August 16, 2014
available from http://read-able.com/.
---------------------------------------------------------------------------
In conclusion, MCN applauds EPA for proposing to strengthen the WPS
and for attempting to bring the WPS more closely into line with
protections offered to workers in other industries. EPA can better
protect the health and well-being of farmworkers MCN strongly urges EPA
to act affirmatively on our recommendations to further strengthen the
WPS.
Sincerely,
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Amy K. Liebman, M.P.A., M.A.,
Director of Environmental and Occupational Health,
512.579.4535
[email protected]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Karen Mountain, M.B.A., M.S.N., R.N.,
Chief Executive Officer.
[attachment 10]
August 17, 2014
Hon. Gina McCarthy,
Administrator,
U.S. Environmental Protection Agency,
Washington, D.C.
Re: Agricultural Worker Protection Standard Revisions; Proposed Rule
Docket ID # EPA-HQ-OPP-2011-0184
Dear Administrator McCarthy,
Thank you for the opportunity to comment on the proposed revisions
to the Worker Protection Standard. The Farmworker Advocacy Network is a
statewide network of organizations that work to improve living and
working conditions of farmworkers and poultry workers in North
Carolina.
Farmworker Advocacy Network is pleased that the U.S. EPA has
proposed many improvements to the WPS, which we believe will improve
pesticide safety on the job for the 2+ million workers across the U.S.
who harvest our food. There are several areas in which we believe that
improvements that would strengthen the rule's effectiveness in
preventing unnecessary pesticide exposure for migrant and seasonal
farmworkers in North Carolina and across the U.S.
We are concerned that the proposed rules fall short in several key
areas:
The proposed Minimum Age of 16 to work as a pesticide
handler, or as an early re-entry worker, is inappropriate and
unsupported by the scientific literature. We urge you most
strongly to adopt a minimum age of 18.
The proposal to eliminate Central Posting does not solve the
need for better hazard communication. We recommend retaining
central posting, particularly for greenhouse and nursery
workers, as well as implementing more robust field posting to
address gaps in Hazard Communications.
Our comments and rationale on these items and several others are
included below. You will find citations on the last page.
Minimum Age
The proposed minimum age of 16 to work as a pesticide handler, or
as an early re-entry worker [ 170.9(c), 170.13(c) and 170.303)], is
inappropriate and unsupported by the scientific literature. It is
widely opposed by farmworkers, health care providers, and public health
advocates. We strongly recommend a minimum age of 18.
Pesticide handlers and early re-entry workers are at high risk of
pesticide exposure. Working with pesticides is not appropriate work for
youth because:
Teens' bodies are still developing. The brain and
reproductive system in particular undergo significant
development during the teen years.i-ii Many
pesticides are highly toxic to the brain and to the
reproductive system.iii Exposing immature,
developing systems to pesticides can do long-term harm.
Exposure to pesticides can increase the risk of chronic
diseases such as cancer iv and Parkinson's
Disease.v The likelihood of developing such diseases
later in life increases with additional years of exposure.
Teens are capable of many jobs, but they are not yet mature
enough to handle highly-hazardous chemicals like pesticides.
Studies have shown that teens perceive themselves as less
vulnerable to harm, and therefore do not follow the same safety
precautions as adults--even when they have received the same
trainings.vi-vii
Pesticide poisoning surveillance data show that youth are
more likely than adults to be injured by pesticides on the
job.viii
In every other industry, 16 and 17 year-olds are not allowed
to work with hazardous chemicals.ix There is no
compelling reason to treat farmworker youth differently or
afford them a lesser level of protection on the job.
EPA proposed a minimum age of 16, based on the higher cost of
increasing the minimum age to 18. For a cost differential of only $10
per year for an average farm, EPA has proposed to promulgate a standard
that would put over 89,000 16- and 17-year-old farmworker teens at
elevated risk of pesticide exposure, affording them a lesser level of
protection from chemical hazards than they would receive at any other
job.
There is simply no viable reason to afford farmworker children a
lesser degree of protection, as the U.S. Department of Labor does
through its Hazardous Orders. FIFRA allows EPA to regulate child labor
in agriculture more broadly than DOL can under the FLSA, and thus EPA
can reach different results about when children ages 16 to 18 can do
agricultural work involving the handling of pesticides. For DOL to
regulate child labor, it must make a finding of particular hazard or
detriment to health [29 U.S.C. 203(l)]; whereas EPA can regulate the
use of pesticides to avoid ``unreasonable risk,'' broadly understood [7
U.S.C. 136(bb)]. Because allowing children ages 16 and 17 to work as
pesticide handlers would pose ``unreasonable risks,'' EPA is mandated
by FIFRA to prohibit this practice as part of the Worker Protection
Standard. The FLSA does not preempt more protective standards in other
Federal laws. Regulations adopted by DOL under the authority of the
FLSA provide that ``Nothing in this subpart shall authorize non-
compliance with any Federal or State law, regulation, or municipal
ordinance establishing a higher standard. If more than one standard
within this subpart applies to a single activity the higher standard
shall be applicable'' [29 CFR 570.50].
Since the founding of EPA's Office of Children's Health Protection
in 1997, EPA has repeatedly restated its commitment to protect children
as ``fundamental to EPA's core mission.'' x Advancing a rule
that explicitly allows adolescents to work with high-risk materials is
at odds with that mission, and out of step with protections for youth
working in every other industry nationwide.
Hazard Communications
EPA has proposed doing away with the current requirement for a
central posting location for pesticide application information, while
requiring that employers make the SDS and labeling for pesticide
applications available to workers or their representatives upon request
[ 170.11(b)]. We support EPA's clarification that this information
must be made available to workers' representatives (whether medical
providers, attorneys, union representatives, etc.). Particularly in the
case of workers injured by pesticides, it is critical for workers'
representatives to be able to obtain accurate, timely information about
the pesticides to which workers may have been exposed. However,
specific information about the pesticides applied and the hazards they
pose must be made available to workers universally, in advance of
pesticide applications. Anything less is a step backward in Hazard
Communications.
The proposal to maintain pesticide use records for 2 years is a
significant improvement over the current 30-day requirement. North
Carolina adopted a 2-year record retention requirement in 2009 in the
wake of the Ag-Mart case [02 NCAC 9L.1402]. However, we urge the
Agency to go further in adopting a 5-year interval, which would
coincide with the statute of limitations for civil violations (28
U.S.C. 2462). The cost difference for growers in maintaining records
for five years vs. two years would be negligible.
However, the proposal omits any record-keeping of worker re-entry
into treated areas. In the 2006 Ag-Mart case in North Carolina, one of
the major points at issue was whether workers were sent into fields
before the re-entry interval (REI) had expired. EPA should require that
employers record the date, time and field location of worker re-entry
into treated areas, and should require that those records be maintained
for five years (coinciding with the statute of limitations for civil
violations). The act of recording worker re-entry into recently-treated
fields could also serve as a deterrent that makes employers more aware
of REIs and less likely to endanger workers' health by sending them
into recently-treated areas too soon.
Notification to Workers and Handlers
EPA is proposing requiring employers to post warning signs
regarding the application of a pesticide that has an REI greater than
48 hours (for outdoor production), or 4 hours (for enclosed space
production) [ 170.109(a)(1)(i) and 170.109(a)(1)(ii)]. We believe
that this change could reduce occupational pesticide illnesses.
However, the 48-hour limit seems excessive, since as EPA notes in its
proposal, people have difficulty remembering what they have been told
orally. We recommend requiring both posting signs and oral warnings for
all pesticide applications, or at a minimum for those pesticides with
an REI of 12 hours or more. The most effective way to convey important
information is through multiple routes, i.e., oral and written.
Training
We strongly support the proposal to require annual training of
workers and handlers [ 170.101(a) and 170.201(a)]. This is the
current practice in California, and anecdotally many growers in North
Carolina report using annual training as well. Annual training will
decrease the likelihood that workers fail to receive critical pesticide
safety training on the job. We also support the record-keeping and
verification proposals [ 170.101(d) and 170.201(d)] to help employers
and workers track compliance with the training requirement.
However, the training grace period of two days [ 170.309], while
an improvement over the current rule, still puts workers at serious
risk when they begin at a new workplace. We recommend eliminating the
grace period and requiring that pesticide safety training take place
before any worker is put at risk of exposure on the job. There is
currently no grace period in California, and in most other industries
OSHA requires that employers provide safety training before employees
begin work with potentially hazardous materials, as EPA notes in the
proposal package [29 CFR 1910.1200(h)]. There is no compelling reason
that the standard should be different for farmworkers.
We strongly support the proposal that qualified trainers should
provide WPS training to workers. However, the standard should be the
same for pesticide handlers. [ 170.101(c)(4) and 170.201(c)(4)]. We
question the agency's logic in deciding that for trainers of handlers,
simple Certified Applicator status is adequate to provide an effective
training, when that status is not adequate for trainers of workers--
especially because handlers are arguably at higher risk of exposure.
All trainings--whether for workers or handlers--should be provided by
someone who has proven competency in adult education techniques, in the
language of the trainees, and cultural competence to convey the
information effectively to the target audience. A high-quality
nationwide train-the-trainer program can ensure these competencies.
It is absolutely critical that workers be well-trained in pesticide
safety. However, it is at least as important to ensure that the
employer understand clearly the hazards of the pesticides being used
and her/his obligations to protect workers. The WPS places a lopsided
emphasis on training and information provision to workers, who have no
control over the circumstances in which pesticides are used. The
employer is the one responsible for compliance with the rule, and in
control of whether the conditions for compliance exist, such as
adequate PPE, decontamination supplies, etc. The rule needs a specific
mandate for Employers and labor contractors/crew leaders to receive
regular training on pesticide hazards and their obligations under the
WPS. A proactive approach to training employers and crew leaders could
help improve compliance rates, ease the transition to the changes in
the WPS, create safer work conditions, and place the emphasis on
compliance where it belongs--with the employer.
Prevention of Take-Home Exposure
Training workers in preventing take-home exposure is key for better
protecting the health and safety of workers' children and other family
members [ 170.101(c)(2) through (3)]. However, workers will be
severely challenged to actually carry out prevention of take-home
exposure, since employers do not have to provide a place for workers to
change and store clean clothes, wash clothes or take a shower before
leaving the workplace. EPA must do more to ensure that workers can
actually act [and] carry out the precautions and behavior changes in
which they are trained.
For example, EPA did not choose to propose that employers provide a
place to shower before leaving work. How can workers be reasonably
expected to shower before returning home if no shower is provided? On
the [E]ast [C]oast, many migrant workers are housed in barracks or
trailers provided by their employers. The current migrant housing
standard in North Carolina requires employers to provide only 1 working
shower head per 10 workers, meaning that after work many workers are
forced to wait in long lines to remove pesticide residues. The North
Carolina migrant housing standard does not require washing machines, or
a ride to the local laundromat--only one ``laundry tub'' per 30 people
for washing work clothes [NCGS 95-222:229]. Workers cannot be
reasonably expected to wash work clothes regularly and separately from
other laundry under such conditions. We recommend that EPA require
employers to provide such facilities at the worksite that would enable
compliance with safety training:
Showers with separate stalls or privacy screens;
A changing area with lockers to store clean clothes; and
Washing machines designated for work clothes, or regular
access to a nearby laundromat or other similarly-equipped
facility.
Training workers on these safety topics is futile without the
facilities to actually comply.
As EPA moves forward with this new rule and begins to consider
implementation and training, we hope that you will reach out to us for
assistance. Developing and field-testing strong new training and
compliance materials will be key to this rule's success in both
preventing hazardous pesticide exposure for workers and their families,
and minimizing the challenges of compliance for growers. Farmworker
Advocacy Network's members stand ready to assist you.
Thank you for the opportunity to provide comments on the proposal
to revise the agricultural Worker Protection Standard. We congratulate
EPA for taking this major step forward, and look forward to working
with you to ensure pesticide safety in the workplace.
Sincerely,
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Melinda Wiggins, Executive Director, Student Action with Farmworkers.
On behalf of Farmworker Advocacy Network.
[References]
i Lebel and Beaulieu. ``Longitudinal Development of
Human Brain Wiring Continues from Childhood into Adulthood.'' The
Journal of Neuroscience, July 27, 2011. 31(30): 10937-10947.
ii Medline Plus, ``Adolescent Development.'' U.S.
National Library of Medicine, National Institutes of Health. http://
www.nlm.nih.gov/medlineplus/ency/article/002003.htm (accessed 3/17/
2014).
iii Roberts and Reigart. ``Chapter 21: Chronic Effects''
in Recognition and Management of Pesticide Poisonings, Sixth Edition.
2013. U.S. EPA Publication number 735K13001.
iv Bassil, et al. ``Cancer health effects of pesticides:
Systematic review'' Canadian Family Physician. October 2007 vol. 53 no.
10 1704-1711.
v Kamel, et al. ``Pesticide Exposure and Self-reported
Parkinson's Disease in the Agricultural Health Study'' Am. J.
Epidemiol. 2007; 165: 364-374.
vi Salazar, et al. 2004. ``Hispanic Adolescent
Farmworkers' perceptions associated with pesticide exposure.'' West J.
Nurse Res. 26(2): 146-166.
vii Steinberg, 2005. ``Cognitive and affective
development in adolescents.'' Trends in Cognitive Sciences, February
2005 vol. 9 no. 2 69-74.
viii Calvert, et al. 2003. ``Acute pesticide poisoning
among agricultural workers in the United States 1998-2005.'' Am. J.
Ind. Med. 51(12): 883-898.
ix ``Youth & Labor: Hazardous Jobs'' United States
Department of Labor. http://www.dol.gov/dol/topic/youthlabor/
harzardousjobs.htm (accessed 3/17/2014).
x U.S. EPA Office of Children's Health Protection
website. http://www.yosemite.epa.gov/ochp/ochpweb.nsf/content/
homepage.htm (accessed 4/25/2014).
[attachment 11]
August 14, 2014
Hon. Gina McCarthy,
Administrator,
U.S. Environmental Protection Agency,
Washington, D.C.
Re: Agricultural Worker Protection Standard Revisions; Docket ID # EPA-
HQ-OPP-2011-0184
Dear Administrator McCarthy:
Thank you for the opportunity to comment on the proposed revisions
to the Worker Protection Standard. I write on behalf of the American
Public Health Association, a diverse community of public health
professionals who champion the health of all people and communities.
APHA and its 53 affiliated state and regional public health
associations represent 50,000 public health professionals. APHA brings
a 140+ year perspective from all fields of public health, including
occupational health and safety, environmental health, children's health
and immigrant health. APHA firmly believes that the occupational health
and safety of workers is a public health priority, and we have a long
history of supporting measures to protect workers and improve
occupational health and safety.
We write to support many aspects of the proposed WPS that foster
worker health and safety for an estimated 2 million workers across the
United States who harvest our food. These workers, the majority of whom
are immigrants from Mexico and other Central American countries, are
the most overexposed population to pesticides.
Prevention of occupational disease, injury and exposure is
fundamental to worker health and safety. APHA believes the protection
of agricultural workers and their families, immigrant workers,
including farmworkers, and workers exposed to pesticides is a critical
public health concern and believes stronger, protective measures are
urgently needed.1-5
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\1\ American Public Health Association. APHA Policy Statement 96-
06: The Precautionary Principle and Chemical Exposure Standards for the
Workplace. 1996. Available at: www.apha.org/advocacy/policy/
policysearch/default.htm?id=124. Accessed August 4, 2014.
\2\ American Public Health Association. APHA Policy Statement 2005-
4: Occupational Health and Safety Protections for Immigrant Workers.
2005. Available at: http://www.apha.org/advocacy/policy/policysearch/
default.htm?id=1318. Accessed August 4, 2014.
\3\ American Public Health Association. APHA Policy Statement
20108: Requiring Clinical Diagnostic Tools and Biomonitoring of
Exposures to Pesticides. Washington, D.C.: American Public Health
Association; 2010. Available at: http://www.apha.org/advocacy/policy/
policysearch/default.htm?id=1400. Accessed August 4, 2014.
\4\ American Public Health Association. APHA Policy Statement
201110: Ending Agricultural Exceptionalism: Strengthening Worker
Protection in Agriculture through Regulation, Enforcement, Training,
and Improved Worksite Health and Safety. American Public Health
Association; 2011. Available at: http://www.apha.org/advocacy/policy/
policysearch/default.htm?id=1420. Accessed August 4, 2014.
\5\ American Public Health Association. APHA Policy Statement 2005-
06: Reducing occupational exposure to benzene in workers and their
offspring. Available at: http://www.apha.org/advocacy/policy/
policysearch/default.htm?id=1322. Accessed August 4, 2014.
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More importantly, we wish to underscore the standard and
universally accepted public health best practice for control of worker
exposure to chemicals--the industrial hygiene ``hierarchy of
controls.'' Under the hierarchy of controls, risk reduction is based on
the following preferred order of controls: elimination, substitution
with less hazardous materials, engineering controls (such as closed
systems), warnings, administrative control, and personal protective
equipment.\6\ While we commend the U.S. Environmental Protection Agency
for proposing to strengthen the WPS, we are concerned that the revised
WPS largely relies on the least protective measures for workers--PPE
and administrative controls. We therefore urge EPA to apply the
hierarchy of controls principle to strengthen protections for
farmworkers.
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\6\ American National Standards Institute--American Industrial
Hygiene Association Z10-2005 Occupational Health and Safety Management
Systems. 2005; as described in Manuele, F. ANSI/AIHA Z10-2005: The new
benchmark for safety management systems. February 2006. Available from:
http://www.asse.org/publications/standards/z10/docs/25-33Feb2006.pdf.
Accessed on August 5, 2014.
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We also emphasize the public health benefit of preventing injury,
illness and exposure. While there are costs associated with the
protection of this important and vulnerable workforce, there is also an
extraordinary cost to workers, farmers and our society for occupational
illness and injury in terms of medical care, lost work days, lost
wages, and potential workers' compensation insurance premiums for an
occupational injury or illness. At the price of more than $250 billion
a year, occupational conditions are the second costliest medical
condition behind cardiovascular disease and ahead of cancer.\7\ The
cost of illness and injury as a result of work-related pesticide
exposure is challenging to assess. This is largely due to the current
weaknesses in our regulations, formal and informal exclusions from the
workers' compensation systems, challenges in clinically confirming the
diagnosis of pesticide poisonings, lack of understanding regarding
incident reporting as well as patchwork surveillance systems.
Additionally, many workers do not report overexposures as they do not
understand their rights and fear losing their jobs. Prevention policies
and programs are cost-effective, reduce health care costs, and can
improve productivity.
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\7\ Leigh J.P. Economic burden of occupational injury and illness
in the United States. Milbank Q. 2011; 89(4): 728-72.
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Detailed below are the areas of the rule that we strongly support,
and those areas in need of strengthening in order to better protect
farmworkers.
Training Frequency--APHA supports annual pesticide safety training
for farmworkers and pesticide handlers. An informed workforce is an
important first step in worker protection. Annual training will
reinforce important pesticide safety practices and information to help
workers better protect themselves and their families from pesticide
overexposure. Studies indicate that workers who have been trained in
the preceding year retain more information from new training than those
whose previous training is more than two years old; that workers
maintain information but begin to show some drop-off at five months;
and that knowledge gains are correlated with improved self-reported use
of PPE.8-10 Pedagogically, it is unreasonable to expect a
workforce characterized by limited formal education and low levels of
literacy to retain training content beyond one year. Moreover, workers
in most other industries receive annual safety training and farmworkers
deserve the same protection.
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\8\ Anger W.K., Patterson L., Fuchs M., Will L.L., Rohlman D.S.
Learning and recall of Worker Protection Standard (WPS) training in
vineyard workers. J. Agromedicine. 2009; 14(3): 336-44. doi: 10.1080/
10599240903042057.
\9\ LePrevost C.E., Storm J.F., Asuaje C.R., Arellano C., Cope W.G.
Assessing the effectiveness of the Pesticides and Farmworker Health
Toolkit: a curriculum for enhancing farmworkers' understanding of
pesticide safety concepts. J. Agromedicine. 2014; 19(2): 96-102. doi:
10.1080/1059924X.2014.886538.
\10\ Levesque D.L., Arif A.A., Shen J. Effectiveness of pesticide
safety training and knowledge about pesticide exposure among Hispanic
farmworkers. J. Occup. Environ. Med. 2012 Dec.; 54(12): 1550-6. doi:
10.1097/JOM.0b013e3182677d96.
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Training Content--APHA supports expanding the content of the
required training for workers and handlers, underscoring the importance
of including the proposed topics of worker rights, emergency assistance
and ways to minimize paraoccupational exposures or pesticide ``take
home'' exposures. Additionally, we call for the EPA to emphasize
training regarding the possible reproductive health effects of
pesticide exposure. We also recommend that EPA be mindful of the needs
of workers and some handlers due to low income, low literacy and
limited English language when revising the training standards. The
training should be provided in meaningful interactive formats that
include training in a language that the individual understands.
Training Grace Period--APHA supports the elimination of a grace
period for worker training. Any training grace period severely
undermines the intent of the WPS. An untrained worker is more
vulnerable to pesticide overexposure and should not be put at risk.
Minimum Age--APHA supports the establishment of a minimum age of 18
rather than the proposed minimum age limit of 16 for pesticide handlers
and early-entry workers. Children younger than 18 are still developing
both physically and mentally, and high levels of exposure to pesticides
could have life-long health effects. Furthermore, most minors do not
have the maturity to follow all label instructions or take the
necessary precautions to ensure their safety and the safety of other
workers.11-12 Children working in other industries are
prohibited from engaging in high hazard tasks.\13\ Children employed in
agriculture should be afforded the same protections as children working
in other hazardous industries.
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\11\ Salazar M.K., Napolitano M., Scherer J.A., and McCauley L.A.
Hispanic adolescent farmworkers' perceptions associated with pesticide
exposure. West J. Nurse Res. 2004; 26(2): 146-166.
\12\ Steinberg L. Cognitive and affective development in
adolescence. Trends in Cognitive Science. 2005; 9(2): 69-74.
\13\ U.S. Department of Labor. Labor Regulations, Orders and
Statements of Interpretation. 29 CFR 570. Available from http://
www.ecfr.gov/cgi-bin/text-
idx?c=ecfr&sid=48d6ee3b99d3b3a97b1bf189e1757786&rgn=div5&vie
w=text& node=29:3.1.1.1.31&idno=29. Accessed August 4, 2014.
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Hazard Communication--APHA does not support EPA's proposal to
eliminate the current requirement for a central posting location for
pesticide application information. We support EPA's clarification that
this information, in addition to the Safety Data Sheets and labeling
for pesticide applications, must be made available to workers'
representatives such as clinicians, attorneys and union
representatives. Particularly in the case of workers injured by
pesticides, it is critical for workers' representatives to be able to
obtain accurate, timely information about the pesticides to which
workers may have been exposed. However, specific information about the
pesticides applied and the hazards they pose must be made available to
workers universally, in advance of pesticide applications. Such
information should be available in nonemergency situations and it
should not require any type of request from the worker or worker
representative. Workers may not understand that they have the right to
request such information. If workers do understand, many will be
reluctant (for fear of job loss) or unable due to language barriers to
ask their employer for the information.
Additionally, we recommend requiring availability of SDSs in
Spanish as well as English both in a central location and
electronically using a smart phone scan code. SDSs in Spanish and other
written languages should now be readily available, because format and
basic content of SDSs has been harmonized internationally to comply
with Globally Harmonized System requirements. Labels should also be
made available electronically, as well as at a central location and
provided in Spanish and other languages when available.
Monitoring Handler Exposure to Cholinesterase Inhibiting
Pesticides--APHA supports medical monitoring of pesticide handlers who
mix, load or apply Toxicity Category I or II organophosphates or N-
methyl carbamates. Monitoring programs have been successfully
implemented for 40 years in California and over 10 years in Washington
State, substantially helping to prevent overexposure of handlers. We
strongly disagree with EPA's decision not to implement such a program
nationwide based on its determination that these programs are
``reactive, catching incidents after they occur rather than working to
stop them from happening.'' This analysis contradicts some of the very
basic tenets of public health. Medical monitoring programs are
essential preventive measures, which successfully stop handlers from
being overexposed by identifying subclinical evidence of exposure,
prompting review of primary prevention practices. Medical monitoring is
common in other industries and OSHA has promulgated over 25 specific
standards for medical screening of workers exposed to hazardous
substances.\14\ Pesticide handlers deserve the same protections that
are afforded to workers in other industries.
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\14\ Occupational Safety and Health Administration. General
Industry. Medical Screening and Surveillance. 29 CFR 1910. Available
from https://www.osha.gov/SLTC/medicalsurveil
lance/. Accessed on August 5, 2014.
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Clinical Diagnostic Tools and Monitoring Workers for Pesticide
Exposure--APHA believes biomonitoring is critical to protecting
agriculture workers from over exposure to pesticides.\15\ Health care
providers have few clinical diagnostic tools readily available to help
to better recognize and manage pesticide exposures. Additional
information offered by a confirmatory diagnostic test is essential in
providing information clinicians need to treat overexposed workers and
handlers and to ultimately provide EPA with frontline data necessary to
understand the health effects of registered pesticides. Providing
clinicians with the clinical diagnostic tools they need to make the
most accurate diagnosis possible should be a central part of worker
protection, a feature that is glaringly absent in the proposed rule.
The Agency for Toxic Substance and Disease Registry, National
Conversation on Public Health and Chemical Exposures Action Agenda,
also calls for clinical diagnostic tools and states: ``To more fully
prepare healthcare providers to address chemical exposures, validated
clinical diagnostic tools similar to blood lead testing are needed.''
\16\
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\15\ American Public Health Association. APHA Policy Statement
20108: Requiring Clinical Diagnostic Tools and Biomonitoring of
Exposures to Pesticides. Washington, D.C.: American Public Health
Association; 2010. Available at: http://www.apha.org/advocacy/policy/
policysearch/default.htm?id=1400. Accessed August 4, 2014.
\16\ Agency for Toxic Substance and Disease Registry, National
Conversation on Public Health and Chemical Exposures Action Agenda.
2011. Available at: http://www.atsdr.cdc.gov/nationalconversation/
action_agenda.html. Accessed August 5, 2014.
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Emergency Assistance--APHA supports EPA's proposal to clarify when
employers must make transportation to a medical facility available to
workers and handlers. However, transportation should be made available
within 3-4 minutes if the injury is life-threatening or 15 minutes if
it is not life-threatening upon learning of an exposure, and not within
30 minutes. We support the proposal to require employers to provide to
the worker, handler or the treating medical personnel the relevant SDS
and pesticide label, or all of the pertinent information in an
alternate form (as opposed to waiting for it to be requested). In
certain circumstances, employers should be required to document the
time and length of the exposure and report it to the worker and
clinician.
Informed and Prepared Clinicians--APHA applauds EPA's recognition
that clinicians play an important role in worker protection. In
addition to requiring employers to provide treating medical personnel
with pertinent pesticide exposure information, we urge EPA to consider
further measures. EPA should help clinicians to improve their
recognition and management of pesticide overexposure by (1) supporting
the development of clinical diagnostic tools, and (2) providing
training and technical assistance for clinicians. A survey of
environmental medicine content in U.S. medical schools found that 75
percent of schools require only about seven hours of study in
environmental medicine over four years.\17\ Not surprisingly,
clinicians are often unprepared to recognize, manage, or help prevent
exposure-related illness. APHA echoes the recommendation outlined in
the ATSDR National Conversation on Public Health and Chemical Exposures
Action Agenda that ``Clinicians need a set of skills and tools for (1)
diagnosing, treating, and intervening to prevent chemical exposures,
(2) providing information about chemical exposures to their patients
and communities, and (3) participating in surveillance for chemical
exposures and health effects.'' \18\
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\17\ Schenk M., Popp S.M., Neale A.V., Demers R.Y. Environmental
medicine content in medical school curricula. Acad. Med. 1996 May;
71(5): 499-501.
\18\ Agency for Toxic Substance and Disease Registry, National
Conversation on Public Health and Chemical Exposures Action Agenda.
2011. Available at: http://www.atsdr.cdc.gov/nationalconversation/
action_agenda.html. Accessed August 5, 2014.
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Respirator Training and Fitting--APHA supports requiring employers
of pesticide handlers to comply with OSHA-equivalent training on
respirator use, fit-testing of respirators, and medical evaluation
requirements whenever a respirator is required by the labeling.
However, the rule should also include the OSHA requirement for each
employer to adopt a worksite-specific respiratory protection program to
address in detail how respirators are properly selected, cleaned,
stored, repaired, and replaced. Furthermore, we disagree with EPA's
decision to exclude dust or mist filtering masks, since a majority of
pesticides with label requirements for handlers to wear respirators
only require dust/mist filtering respirators. Medical evaluation, fit-
testing and training should be required for all types of dust/mist
filtering respirators.
Decontamination Supplies--APHA supports the EPA recommendation to
require employers to provide decontamination supplies that include one
gallon of water per worker for routine washing and emergency eye
flushing, soap, and single use towels and at least three gallons of
water per worker for decontamination for workers performing tasks in an
entry-restricted area. We also recommend that EPA require further
decontamination supplies including shower facilities onsite. We
recommend following the American National Standard Institute standard
(Z358.1-2009) for emergency eyewash and shower equipment and require an
emergency shower that can deliver water at 20 gallons per minute for 15
minutes.\19\
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\19\ American National Standards Institute . American National
Standard Z358.1-2009 for Emergency Eyewashes and Shower Equipment.
Available at: http://webstore.ansi.org/
RecordDetail.aspx?sku=ANSI%2fISEA+Z358.1-2009. Accessed August 6, 2014.
Described in Bradley Corporation. A Guide to the ANSI Z358.1-2009
Standard for Emergency Eyewashes and Shower Equipment. 2012. Available
from https://www.bradleycorp.com/download/2081/4002.pdf. Accessed
August 6, 2014.
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Contaminated Personal Protective Equipment--APHA supports the EPA
proposal to require employers to render contaminated PPE unusable
before properly disposing of PPE that cannot be decontaminated
according to the manufacturer's instructions. Such measures will
prevent adverse health effects resulting from the wearing of
contaminated garments.
Closed Systems for Mixing and Loading--APHA supports the EPA
proposal to clarify the criteria for closed systems by adopting the
California standards for system design. However, EPA should go further
and adopt, at a minimum, the California standards requiring the use of
closed systems for highly-toxic categories of pesticides. As noted
above, under the industrial hygiene hierarchy of controls, engineering
controls are preferred over PPE. It therefore is appropriate for EPA to
require the engineering control of closed system as the primary
protection for pesticide handlers rather than PPE. Closed systems are
already used extensively in California, and for some pesticides and
certain types of uses across the country. The proper use of closed
transfer systems for mixing and loading pesticides reduces the
potential for human exposure from spills, splashes and blowing, and
this type of engineering control--rather than PPE--should be the first
line of defense against pesticide exposure.
Drift Protections--APHA supports the EPA proposal to require
handlers to cease application if someone other than a trained and
properly equipped handler enters treated or surrounding areas. We also
support the establishment of entry-restricted areas adjacent to the
treated areas in farms and forests. But, as proposed, these protections
apply only to fields on the farm that was sprayed. This safeguard
should extend to workers in harm's way who work at a neighboring
establishment. Though modest in scope, the proposed entry-restricted
areas are a step in the right direction to protect workers and others
in the immediate vicinity of pesticide applications.
Early Entry Restrictions--APHA believes that early reentry for
fieldwork should only be allowed in true agricultural emergencies.
Worker protection during early reentry is largely dependent upon proper
use of PPE. Many of the tasks involved with early reentry such as
moving irrigation pipes and performing hand labor tasks may be
cumbersome with required PPE. Given the nature of the tasks as well as
the potential for escalating heat stress with PPE, there is potential
for improper use or no use of PPE. The proposed improvements in
training and age restriction cannot adequately mitigate these risks. In
addition, we oppose the relaxing of the early reentry restriction for
irrigators, allowing early reentry even if the need for irrigation
could have been foreseen before the pesticide application. Irrigators
are at high risk of pesticide poisoning because they tend to work long
hours. They also often work alone with no coworker to assist in calling
for help in case of pesticide or heat illness.
In conclusion, APHA strongly urges you to adopt these
recommendations to strengthen the WPS. EPA can better protect the
health and well-being of farmworkers by bringing the WPS more closely
into line with protections offered to workers in other economic
sectors.
Sincerely,
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Georges C. Benjamin, M.D.,
Executive Director.
[attachment 12]
August 15, 2014
Hon. Gina McCarthy,
Administrator,
U.S. Environmental Protection Agency,
Washington, D.C.
Re: Docket ID No. EPA-HQ-OPP-2011-0184, Agricultural Worker Protection
Standard Revisions
Dear Administrator McCarthy:
Our firm represents and submits these comments on behalf of the
Coalition of Florida Farmworker Organizations (CoFFO) of Florida City,
Florida. CoFFO is a statewide organization whose main objective is to
enhance the living and working conditions of migrant and seasonal
farmworkers and the rural poor in Florida.
These comments are submitted in response to the Environmental
Protection Agency's (``EPA'') proposed regulatory changes to the Worker
Protection Standard Revisions, 79 Fed. Reg. 15444, 15449 (proposed Mar.
19, 2014) While the proposed rule makes important improvements to the
outdated and inadequate current version of the worker protection
standards, it falls short in a number of respects in providing maximum
feasible protection to farmworkers and their families. Notably, the
proposed rule leaves farmworkers with considerably fewer protections
against exposure to dangerous chemicals and toxic substances in the
workplace than those enjoyed by nonagricultural workers.
The EPA worker protection standards are of great importance to the
estimated 250,000 workers employed in Florida's fields, groves,
greenhouses, nurseries and forests. Because of its hot, humid
subtropical climate, Florida uses a greater quantity of pesticides per
acre than any other state. The use of pesticides, herbicides and
fungicides is greatest in the state's nurseries, which employ an
estimated 100,000 workers, a disproportionate number of whom are women
of child-bearing age, and where the risks of exposure are increased by
the contained or enclosed work areas.
Worker surveys indicate that pesticide misuse is widespread in
Florida. Nearly \1/2\ (48.3%) of over 400 crop workers in south Florida
surveyed in 1980 reported that they had been directly sprayed with
agricultural chemicals at least once while working. See Danger in the
Field: The Myth of Pesticide Safety, Florida Rural Legal Services, Inc.
(May 1980), at 1.\1\ However, relatively few pesticide incidents are
reported to the state Department of Agriculture and Consumer Services,
and those that are reported rarely result in meaningful sanctions to
employers who misuse pesticides. See Indifference to Safety: Florida's
Investigations into Pesticide Poisoning of Farmworkers, Farmworker
Justice Fund and Florida Legal Services (February 1998). Enhanced
protections and increased worker training are important in addressing
these longstanding problems.
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\1\ There is evidence that these problems have not abated since the
adoption of the Worker Protection Standards. In 2005, 84 employees of
Ag-Mart Produce, Inc., one of the nation's largest grape tomato
producers, were interviewed following the widely-reported incidence of
three of its employees bearing children with severe birth defects.
Nearly \1/4\ (22%) of the respondents reported being sprayed directly
during the prior month, with 40% claiming during that same period that
they were exposed to pesticides through drift. See Ag-Mart worker
survey, Florida Legal Services (June 2005).
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The proposed rules should be based on several fundamental
principles:
Federal WPS standards should not be less than state standards.
At a minimum, the Worker Protection Standards should be at least as
stringent as state law. In the past, variances between the WPS and
Florida law have led to confusion among both farmworkers and their
employers. The proposed rule should adopt as an absolute floor state
requirements regarding pesticide use. For example, Florida law
prohibits minors (under 18) from handling pesticides. See
450.061(2)(c), Fla. Stat. (``No minor under 18 years of age . . . shall
be employed or permitted to suffer to work in any of the following
places of employment . . . [i]n and around toxic substances or
corrosives, including pesticides or herbi-
cides . . .'')
Protections against exposure to pesticides [for] farmworkers should
be no less than corresponding OSHA provisions regarding use of toxic
substances in nonagricultural workplaces.
Based on years of studies and its regulatory experience, the
Occupational Safety and Health Administration (OSHA) has established
detailed standards regarding the use of toxic substances in the
workplace. No principled reason exists for the WPS to provide
farmworkers with lower level of protection than required for
nonagricultural workers under the OSHA regulations.\2\ Unfortunately,
the proposed regulations fall short of the OSHA minimums in a number of
important respects. Among other things:
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\2\ We commend the agency for those portions of the proposed
regulations that bring the protection of farmworkers into conformity
with those extended to other workers. For example, the proposed
regulation requires annual retraining of workers, similar to the
mandates of OSHA with respect to nonagricultural workers regularly
exposed to chemical hazards. Similarly, the proposed rule allowing for
the authorized representatives of farmworkers to obtain pesticide
information is consistent with the rights workers have to obtain
information regarding occupational hazards under the OSHA. See 29 CFR
1910.1020(e)(1) (allowing access to a worker or his ``designated
representative,'' defined as ``any individual or organization to whom
an employee gives written authorization to exercise a right of
access,'' and providing that a collective bargaining agent may obtain
such records without written authorization).
Mandated closed systems are required by OSHA in many
situations and similar requirements should be required for the
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mixing of pesticides.
The protections in the proposed regulations are noticeably
less than those required under OSHA'[s] respiratory protection
program for dust- and mist-filtering respirators.
Emergency showers should be available in the work area when
there is bodily contact with pesticides, as is required by the
OSHA.
In instances of suspected pesticide exposures, the proposed
regulations provide employers with a 30 minute grace period
before arranging for medical care. OSHA requires that workers
be immediately transported to a health care facility in such
situations, and the same protocol should be followed with
respect to farmworkers displaying symptoms of pesticide
poisoning.
OSHA requires that workers be provided training regarding
hazardous chemicals in the workplace before employment begins.
The proposed regulations provide a grace period of several days
during which a farmworker can be employed prior to receiving
training regarding pesticides. There is no principled basis for
denying farmworkers the same right to pre-employment training
that is extended to nonagricultural workers.
Farmworkers who seek to assert or enforce their rights under
the WPS are not afforded the same protections against
retaliation as workers have under the Occupational Safety and
Health Act.
While proposed rule represents a marked improvement over the
current regulations regarding record-keeping and record
retention, it stops stop well short of the obligations imposed
by the OSHA regulations. As part of its effort to ``detect[],
treat[] and prevent[] . . . occupational disease,'' see 29 CFR
1910.1020(a), OSHA requires that records of employee exposure
be maintained for at least 30 years. See 29 CFR
1910.1020(d)(ii). There is no reason that pesticide application
records should be retained for any shorter period, especially
given that many of the long-term effects of pesticide poisoning
do not manifest themselves for many years after the exposure.
Furthermore, the proposed regulation is silent as to charges
for providing the information available to workers. Consistent
with the OSHA regulations, the proposed regulation should
expressly provide that this information will be provided to the
farmworker or his representative free of charge, as is the case
under the OSHA regulations. See 29 CFR 1910.1020(e)(1)(iii).
Information must be made available in a manner that is accessible
to and easily understood by farmworkers.
While the proposed regulations increase workers' access to
information regarding pesticide applications, they omit provisions that
would greatly enhance the usefulness of this information to
farmworkers. Notably, the proposed regulation does not require the
basic application information be provided in any foreign language. For
the enhanced disclosures to be meaningful, it is imperative that the
information be conveyed in a fashion that is comprehensible to the
workers. The vast majority of farmworkers in both Florida and
nationwide speak little or no English. See Daniel Carroll, et al.,
Changing Characteristics of U.S. Farm Workers: 21 Years of Findings
from the National Agricultural Workers Survey (May 12, 2011), at 10
(finding that 62% of current farmworkers speak little or no English).
Other farmworker protective laws require that essential information be
provided in the worker's native language. See Migrant and Seasonal
Agricultural Worker Protection Act, 29 U.S.C. 1821(g) and 29 CFR
500.78 (requiring information regarding job terms and housing
conditions to be disclosed in writing in a language in which the worker
is fluent). There is no reason to require an employer to disclose the
wages and job terms to a worker in his native tongue while not also
requiring vital health information regarding pesticide applications to
be provided in the vernacular.
The proposed regulation removes the current requirement that
mandates posting of pesticide application information in a central
location. Posting in this fashion eliminates the need for a farmworker
to confront his employer with a request for data, greatly reducing the
chances of retaliation. We urge that the current posting requirements
be retained. Farmworkers are reluctant to approach their employers to
request information because of the widespread practice of retaliation
against farmworkers perceived as potential troublemakers. See, e.g.,
Fanette v. Steven Davis Farms, LLC, 2014 WL 2961239, at *16 (N.D. Fla.,
July 1, 2014); Castillo v. Case Farms of Ohio, Inc., 96 F. Supp. 2d
578, 631 (W.D. Tex. 1999), Bertrand v. Jorden, 672 F. Supp. 1417, 1425
(M.D. Fla. 1987).
Thank you for your consideration of our views.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Gregory S. Schell,
Attorney at Law.
[attachment 13]
Received May 5, 2014
April 29, 2014
Hon. Gina McCarthy,
Administrator,
U.S. Environmental Protection Agency,
Washington, D.C.
RE: Docket Number: EPA-HQ-OPP-2011-0184 (Pesticides; Agricultural
Worker Protection Standard Revisions)
Dear Administrator McCarthy:
On behalf of Telamon Corporation I am writing to express our
organization's strong support for the proposed revisions to the Worker
Protection Standard for Agricultural Pesticides (WPS). We deeply
appreciate your consideration of our comments.
With the support of a grant from the United States Department of
Labor through the National Farmworker Jobs Program (NFJP), we provide
critical job training to migrant and seasonal farmworkers to help them
secure more stable and self- and family-sustaining employment. In doing
so, our organization actively seeks to engage eligible members of this
population by going into communities, often before and after working
hours and on weekends, to make them aware of the opportunities we
provide. We then work closely with program participants to help them
complete training and find gainful employment that provides for them a
more stable future. We are proud of the success we have had in this
work and that of the program in its entirety. Nationally, NFJP
continues to be one of the highest performing training programs at the
Labor Department.
Because of our extensive, close work with farmworkers, we believe
that we know better than most about just how important these WPS
revisions are to farmworkers. Our organization fully supports these
changes because of the greater protections they will bring to the
vulnerable migrant and seasonal farmworker population. In particular,
we are especially happy to see the following changes proposed:
Yearly trainings for farmworkers. As you know, current
regulations require training only every five years. Again,
because of our work with farmworkers, we see firsthand the
turnover in this population. As a result, we consistently find
farmworkers who have received little, if any, pesticide-safety
training.
Added emphasis on take-home exposure for farmworker
families. Several years ago, our member organization, the
Association of Farmworker Opportunity Programs (AFOP),
developed a curriculum to educate farmworkers about the dangers
of pesticide residue on clothing and equipment returned to the
home at the end of each work day. Using excellent low-literacy
materials to communicate this message, AFOP members have
trained thousands of farmworkers on limiting this take-home
exposure, greatly benefitting workers' families. While AFOP is
pleased with that impact, it knows that many tens of thousands
more suffer in ignorance of this threat to their homes and
families.
Actions to reduce spray drift, especially near farmworker
housing, schools, and playgrounds. Spray drift is also a danger
farmworkers face routinely. While we acknowledge the common use
of pesticides, we also recognize the simple precautions
proposed by this new rule will better protect farmworkers from
overspray and fumes.
More stringent requirements for treated areas and improved
notification for early-entry workers. Again, we see these as
common sense precautions that will help preserve the health and
safety of laborers.
Making available to farmworkers or their advocates
(including medical personnel) information specific to the
pesticide application, including the pesticide label and Safety
Data Sheets. Working with farmworkers firsthand, we see
consistently the barriers they face in working in the United
States agricultural sector. Oftentimes, an inability to speak
or understand the English language makes it difficult for these
workers to communicate effectively with employers and
understand sufficiently the information provided them.
Accordingly, making this critical information available to
advocates, including medical personnel, will allow these
laborers to call on a family friend to communicate and better
explain matters on their behalf. Importantly, it will also
allow doctors, nurses and first-responders to better understand
the nature of injuries through ready access to pesticide
information.
On the topic of minimum age for pesticide handling, we understand
the revisions would allow for a person as young as 16 years of age to
handle pesticides. AFOP believes that 18 years of age would be a more
appropriate age for that kind of work, and will state so in its
comments. AFOP will also work with its collegial advocacy groups and
the medical community to better demonstrate why the age change is
warranted.
In closing, we would like to thank you for putting forward these
important changes, and look forward to their quick adoption.
Sincerely,
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Don Kuchnicki,
State Director.
[attachment 14]
[http://www.statutes.legis.state.tx.us/Docs/AG/htm/AG.125.htm]
Texas Agriculture Code
Title 5. Production, Processing, and Sale of Horticultural Products
Subtitle G. Workplace Chemicals
Chapter 125. Agricultural Hazard Communication Act
Sec. 125.001. Declaration of Purpose. The legislature finds that
the health and safety of persons living and working in agricultural
areas in the state may be improved by providing access to information
regarding certain hazardous chemicals to which they may be exposed
either during their normal employment activities, during emergency
situations, or as a result of proximity to the use of those chemicals.
The legislature also finds that, because of the conditions of
agricultural employment, there is a unique situation regarding certain
agricultural laborers that makes it necessary to establish formal
procedures to provide access to information regarding certain hazardous
chemicals and to assure those laborers that there will be no
retaliation by the employer for the exercise of rights under this
chapter. This chapter is intended to assure that accessibility to
information regarding chemicals covered by this chapter be provided to
agricultural laborers who may be exposed to those chemicals in
agricultural workplaces, to certain emergency service organizations
responsible for dealing with chemical hazards during emergency
situations when those chemicals are in close proximity to residential
areas, and to the department to make the information available to the
general public through specific procedures.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988.
Sec. 125.002. Definitions. In this chapter:
(1) ``Agricultural laborer'' means a person who plants,
cultivates, harvests, or handles an agricultural or
horticultural commodity in its unmanufactured state as
determined by rule of the department, and includes an
agricultural laborer who handles a chemical covered by this
chapter. Office workers, cooks, maintenance workers, security
personnel, and nonresident management are not agricultural
laborers, except for purposes of a gross annual payroll
determination, unless their job performance routinely involves
potential exposure to chemicals covered under this chapter.
Farm and ranch laborers working solely with livestock and
persons working solely in the retail sales component of a
business are not agricultural laborers for purposes of this
chapter.
(2) ``Chemical name'' means the scientific designation of a
chemical in accordance with the nomenclature system developed
by the International Union of Pure and Applied Chemistry
(IUPAC) or the Chemical Abstracts Service (CAS) rules of
nomenclature, or a name that will clearly identify the chemical
for the purpose of conducting a hazard evaluation.
(3) ``Common name'' means any designation of identification
such as code name, code number, trade name, brand name, or
generic name used to identify a chemical other than by its
chemical name.
(4) ``Chemical manufacturer'' means an employer in Standard
Industrial Classification (SIC) Codes 20 through 39.
(5) ``Designated representative'' means the individual or
organization to whom an agricultural laborer gives written
authorization to exercise the laborer's rights under this
chapter. A designated representative is not required to reveal
the name of the agricultural laborer he represents if the
department has reviewed the laborer's written authorization,
certifies that the representative has that authorization, and
determines that the agricultural laborer would be entitled to
the information the designated representative is seeking to
obtain. A recognized or certified collective bargaining agent
shall be treated automatically as a designated representative
without regard to written authorization from a laborer.
(6) ``Distributor'' means any business, other than a chemical
manufacturer or importer, that supplies chemicals covered by
this chapter to other distributors or to purchasers.
(7) ``Expose'' or ``exposure'' means that an agricultural
laborer is subjected to a chemical covered by this chapter in
the course of employment through any route of entry, including
inhalation, ingestion, skin contact, or absorption, and
includes potential, possible, or accidental exposure.
(8) ``Fire chief'' means the elected or paid administrative
head of a fire department as defined in Chapter 125 (http://
www.statutes.legis.state.tx.us/
GetStatute.aspx?Code=AG&Value=125), Acts of the 45th
Legislature, Regular Session, 1937 (Article 6243e (http://
www.statutes.legis.state.tx.us/
GetStatute.aspx?Code=CV&Value=6243e), Vernon's Texas Civil
Statutes).
(9) ``Label'' means any written, printed, or graphic material
displayed on or affixed to containers of chemicals covered by
this chapter.
(10) ``Material safety data sheet'' (``MSDS'') means a
document containing chemical hazard and safe handling
information that is prepared in accordance with the
requirements of the Occupational Safety and Health
Administration (OSHA) standard for that document or, in the
case of a chemical labeled under the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. Section 136 et seq.)
for which an MSDS is both unavailable and not required under
the Federal OSHA's hazard communication standard, a product
label or other equivalent document with precautionary
statements, such as hazards to humans and domestic animals, and
environmental, physical, or chemical hazards, including warning
statements.
(11) ``Work area'' means a room, defined space, or field
where chemicals covered by this chapter are stored or used and
where agricultural laborers may be present.
(12) ``Workplace'' means a geographical location containing
one or more work areas.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988.
Sec. 125.003. Application. (a) This chapter applies only to the
following employers who annually use or store any one of the chemicals
covered by this chapter in excess of 55 gallons or 500 pounds or an
amount that the department determines by rule for certain highly toxic
or dangerous chemicals covered by this chapter:
(1) employers who themselves or through labor agents hire
agricultural laborers to perform seasonal or migrant work and
whose gross annual payroll for those laborers is $15,000 or
more; and
(2) employers who themselves or through labor agents hire
agricultural laborers for purposes other than seasonal or
migrant work and whose gross annual payroll for those laborers
is $50,000 or more.
(b) This chapter applies only to the following chemicals:
(1) chemicals labeled under the Federal Insecticide,
Fungicide, and Rodenticide Act (7 U.S.C. Section 136 et seq.);
and
(2) fertilizers with chemicals that are listed or defined as
hazardous chemicals in 29 CFR Section 1910.1200(c) or
1910.1200(d)(3), including those listed or defined in
subsequent comparable regulations.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988.
Sec. 125.004. Workplace Chemical List. (a) An employer covered by
this chapter shall compile and maintain a workplace chemical list on a
form prescribed by the department that contains the following
information by crop for each chemical covered by this chapter that is
actually used or stored annually in the workplace in excess of 55
gallons or 500 pounds or an amount that the department determines by
rule for certain highly toxic or dangerous chemicals covered by this
chapter:
(1) the product name used on the MSDS and container label and
the Environmental Protection Agency registration number, if
applicable;
(2) the date and crop on which the chemical was applied or
used; and
(3) the work area in which the chemical is actually stored or
used.
(b) The employer shall update the workplace chemical list as
necessary but not less frequently than annually.
(c) The workplace chemical list may be prepared for the workplace
as a whole or for each work area and must be readily available to
agricultural laborers and their designated representatives. New or
newly assigned agricultural laborers shall be made aware of the
workplace chemical list before working with chemicals covered by this
chapter or in a work area containing those chemicals.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988.
Sec. 125.005. Workplace Chemical List Form, Maintenance, and
Access. (a) The department shall prescribe forms for workplace chemical
lists required by this chapter with places to indicate the crop, the
product name of the chemical that is applied to the crop or that is
stored, and the location and date of its application, use, or storage,
as appropriate.
(b) An employer covered by this chapter shall maintain one form for
each crop, work area, or workplace as a whole, as appropriate, and
shall add information to the form as different chemicals are applied,
used, or stored.
(c) The employer shall attach relevant information to the form,
including MSDSs.
(d) The employer shall keep the forms and attachments accessible
and available for copying and shall store them in a location suitable
to preserve their physical integrity.
(e) The employer shall keep the forms and attachments under this
chapter for 30 years. However, the department shall provide by rule
that an employer may file with the department annually the forms and
attachments, including an estimate of the total amount of each chemical
listed on the form that was used. The department shall categorize and
cross-reference the data on the forms in a manner to preserve the data
for future medical use. An employer who files the forms and attachments
with the department under rules adopted under this section is not
required to preserve the forms.
(f) If it is determined after a hearing conducted under Section
12.032 (http://www.statutes.legis.state.tx.us/
GetStatute.aspx?Code=AG&Value=12.032) that an employer has repeatedly
failed to maintain the forms and attachments as required, the
department may require the employer to file the documents with the
department. In addition, the person may be subject to any applicable
penalties provided by this chapter.
(g) If agricultural activities for which forms and attachments are
maintained cease at a workplace, the forms and attachments shall be
filed with the department, and the department shall retain the
information for 30 years. If an employer covered by this chapter is
succeeded or replaced in that function by another person, the person
who succeeds or replaces the employer shall retain the forms as
provided by Subsection (e) of this section but is not liable for
violations committed by the former employer under this chapter or rules
adopted under this chapter, including violations relating to the
retention and preservation of forms and attachments.
(h) Except as otherwise provided by this section, the employer
shall show the forms and attachments, on request, to an employee,
designated representative, treating medical personnel, or a member of
the community. The designated representative or treating medical
personnel are not required to identify the employee represented or
treated. If the employer has filed the forms and attachments with the
department, the employer shall inform the requestor of that fact.
(i) If a designated representative or member of the community
desires a copy of a form and attachments and the employer refuses to
provide a copy, that person shall notify the department of the request
and the employer's refusal. Within two working days, the department
shall request that the employer provide the department with all
pertinent copies. The employer shall provide copies of the form and
attachments to the department within 24 hours after the department's
request if a designated representative desires the copies, and within
14 days after the department's request if a member of the community
desires the copies.
(j) The employer may not refuse to provide the forms and
attachments to an employee or treating medical personnel.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988. Amended by Acts 1995, 74th Leg., ch. 419, Sec. 3.25, eff.
Sept. 1, 1995.
Sec. 125.006. Material Safety Data Sheets. (a) Chemical
manufacturers and distributors shall provide appropriate MSDSs to
purchasers in this state of chemicals covered by this chapter.
(b) Employers covered by this chapter shall maintain the most
current MSDS received from manufacturers or distributors for each
purchased chemical covered by this chapter. If an MSDS has not been
provided by the manufacturer or distributor for chemicals on the
workplace chemical list at the time the chemicals are received at the
workplace, the employer shall request one in writing from the
manufacturer or distributor in a timely manner. This chapter does not
require an employer who is not a chemical manufacturer to create an
MSDS.
(c) The department may require any person who has or obtains a
registration for a pesticide under Sections 76.041-76.048 of this code
to provide with the registration a copy of the most current and
complete MSDS for that pesticide.
(d) The department by rule may require chemical manufacturers to
submit MSDSs for chemicals covered by this chapter, excluding chemicals
covered by Subsection (c) of this section.
(e) All MSDSs in the files of the department are public records.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1.
Sec. 125.007. Labels. (a) Existing labels on incoming containers of
chemicals covered by this chapter may not be removed or defaced.
(b) Agricultural laborers may not be required to work with a
chemical covered by this chapter from an unlabeled container except for
a portable container intended for the immediate use of the laborer who
performs the transfer.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988.
Sec. 125.008. Emergency Information. (a) Employers covered by this
chapter and other entities who normally store products labeled under
the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C.
Section 136 et seq.) in an amount in excess of 55 gallons or 500 pounds
or an amount the department determines by rule for certain highly toxic
or dangerous chemicals covered by this chapter within \1/4\ mile of a
residential area composed of three or more private dwellings shall
provide to the fire chief of the fire department having jurisdiction
over the storage place, in writing, the names and telephone numbers of
knowledgeable representatives of the employer or other entity storing
the product who can be contacted for further information or contacted
in case of an emergency.
(b) Each employer, on request, shall provide a copy of the
workplace chemical list to the fire chief having jurisdiction over the
storage place. The employer shall notify the fire chief of any
significant changes that occur in the workplace chemical list.
(c) The fire chief having jurisdiction over the storage place or
his representative, on request, shall be permitted to conduct on-site
inspections of the chemicals on the workplace chemical list for the
sole purpose of preparing fire department activities in case of an
emergency.
(d) Employers shall provide to the fire chief having jurisdiction
over the storage place, on request, a copy of the MSDS for any chemical
on the workplace chemical list.
(e) On request, the fire chief having jurisdiction over the storage
place shall make the workplace chemical list and MSDSs available to
members of the fire department having jurisdiction over the workplace
and to other personnel outside the fire department who are responsible
for preplanning emergency activities, but may not otherwise distribute
the information without approval of the employer.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988.
Sec. 125.009. Training Program Provided By Department. (a) The
department in conjunction with the Texas Agricultural Extension Service
shall develop an on-going training program for agricultural laborers.
The program must provide information the department considers
appropriate, and must include:
(1) information on interpreting labels and MSDSs and the
relationship between those two methods of hazard communication;
(2) information on the proper storage, acute and chronic
effects, and safe handling of chemicals covered by this
chapter;
(3) information on protective clothing and equipment and
first aid treatment to be used with respect to the chemicals
covered by this chapter; and
(4) general safety instructions on the handling, cleanup
procedures, and disposal of chemicals covered by this chapter.
(b) The department shall provide the training program in counties
with a hired farm labor work force of 2,000 or more, according to the
most recent United States Census of Agriculture. The department by rule
may determine to provide the training program in additional counties
with a significant farm labor work force or based on other relevant
factors. In all other counties, the county office of the Texas
Agricultural Extension Service shall provide the training program.
(c) The department or the county office of the Texas Agricultural
Extension Service, as appropriate, shall notify agricultural laborers
on a regular basis of the training program by public service
announcements given by the media and shall contact in writing
charitable, public, religious, and health care provider organizations
to announce the training program to agricultural laborers in the county
served by the organization.
(d) In addition to the Texas Agricultural Extension Service, the
department may develop the training program in conjunction with the
Texas Department of Health, other appropriate state agencies, clinics,
hospitals, and other health care providers in counties in which the
training program will be conducted, and organizations representing
employers, organizations representing employees, and organizations
representing manufacturers of chemicals covered by this chapter.
(e) The department shall prepare and make available to employers
appropriate training materials for employers covered by this chapter
and their managers and labor contractors.
(f) To help cover production costs, the department may charge not
more than $10 plus the cost of a blank videotape from a person desiring
to purchase the videotaped training program.
(g) The department or the county office of the Texas Agricultural
Extension Service, as appropriate, shall provide to each agricultural
laborer who completes the training program a card evidencing
participation in the program. An employer may not refuse to hire an
agricultural laborer solely because the laborer does not have a card
issued under this subsection. An employer who refuses to hire an
agricultural laborer for that reason is not entitled to the 14 days'
written notice provided by Section 125.016(d) (http://
www.statutes.legis.state.tx.us/GetStatute.aspx?Code=AG&
Value=125.016) of this code.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988.
Sec. 125.010. Crop Sheet Developed By Department. (a) The
department shall develop crop sheets that contain the following
information:
(1) the kinds of chemicals typically used on a particular
crop;
(2) the typical time a chemical is applied to a particular
crop;
(3) general safety information, including information on
general hygiene, clothing, contact with chemicals, medical
symptoms, pregnancy, and other relevant safety data;
(4) a notice of the training programs and the counties in
which the programs will be conducted;
(5) the availability of MSDSs for chemicals used on a
particular crop;
(6) the means of locating emergency medical information;
(7) agricultural laborers' rights under this chapter;
(8) the name and telephone number of the person to contact
for information under this chapter;
(9) the appropriate telephone number for emergency
information; and
(10) any other safety or health-related information the
department considers relevant.
(b) The information on the crop sheet must be printed in English
and Spanish, except that the information required by Subsections (a)(1)
and (a)(2) of this section is required to be printed only in English.
The department may provide crop sheets printed in other languages
commonly used by agricultural laborers who work with a particular crop.
(c) The department shall develop the crop sheets in conjunction
with the Texas Department of Health, the Texas Agricultural Extension
Service, other appropriate state agencies, and clinics, hospitals, and
other health care providers in counties in which training programs are
provided by the department under Section 125.009 (http://
www.statutes.legis.state.tx.us/GetStatute.aspx?Code=AG&Value=125.009)
of this code.
(d) Annually, the department shall:
(1) provide appropriate crop sheets to clinics, hospitals,
and other health care providers that serve agricultural
laborers and that are located in counties in which the training
program is provided; and
(2) provide to an employer covered by this chapter one crop
sheet for each crop grown by that employer.
(e) The director of the Texas Feed and Fertilizer Control Service
under Section 63.003 (http://www.statutes.legis.state.tx.us/
GetStatute.aspx?Code=AG&Value=
63.003) of this code shall provide to the department the information
that is needed by the department under Subsection (a) of this section
for the fertilizers that are covered by this chapter.
(f) For purposes of developing crop sheets under this chapter and
complying with other provisions of this chapter, nursery stock, stored
grain, and other logical groupings may be considered a single crop as
determined by rules adopted by the department.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988.
Sec. 125.011. Crop Sheet Provided By Employer. (a) An employer
covered by this chapter shall provide crop sheets to each agricultural
laborer pertaining to the crops that laborer will be working with if:
(1) the laborer does not have a card issued under Section
125.009(g)
(http://www.statutes.legis.state.tx.us/
GetStatute.aspx?Code=AG&Value=
125.009) of this code; or
(2) the laborer requests the crop sheets.
(b) An employer who is required under Subsection (a) of this
section to provide crop sheets to an agricultural laborer shall ensure
that the information on a crop sheet required by Sections
125.010(a)(3), (a)(4), and (a)(10) (http://
www.statutes.legis.state.tx.us/GetStatute.aspx?Code=AG&Value=125.010)
of this code that pertains to the crops with which the laborer will be
working is read to the laborer at least once each work season. When the
crop sheet is read, the employer or the employer's agent shall inform
the laborer of the date on which chemicals covered by this chapter were
last applied or are scheduled to be applied to the field or to other
areas in which the laborer will be working and shall inform the laborer
of the time on which the reentry period, if any, expired for chemicals
covered by this chapter that have been applied.
(c) If an employer is required under Subsection (b) of this section
to read a crop sheet to an agricultural laborer, the employer or a
person designated by the employer shall read the appropriate crop
sheets on the first day of each work season or on the day the laborer
begins employment with that employer, whichever is later.
(d) In addition to the crop sheet, the department shall require an
employer to offer to the agricultural laborer, on the day on which the
laborer is given his first pay for that work season, basic safety and
health-related information approved by the department. That information
shall be available to the employers free of charge.
(e) An employer who does not provide or read the crop sheets as
required by this section is not entitled to the 14 days' written notice
provided by Section 125.016(d) (http://www.statutes.legis.state.tx.us/
GetStatute.aspx?Code=AG&Value=125.016) of this code.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988.
Sec. 125.012. Protective Clothing. An employer covered by this
chapter shall provide any protective clothing or device that is
recommended by the MSDS, crop sheet, or department rule and that is in
addition to the standard long-sleeved shirt, long pants, boots or
shoes, and socks normally provided by the agricultural laborer.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988.
Sec. 125.013. Rights of Agricultural Laborers. (a) Agricultural
laborers employed by employers covered by this chapter who may be
exposed to chemicals covered by this chapter shall be informed of the
exposure and shall have access to the workplace chemical list and MSDSs
for those chemicals. Laborers, on request, shall be provided a copy of
a specific MSDS. In addition, laborers shall receive training on the
hazards of the chemicals and on measures they can take to protect
themselves from those hazards and shall be provided with appropriate
personal protective equipment as required by this chapter. These rights
are guaranteed on January 1, 1988.
(b) An employer covered by this chapter may not discharge, cause to
be discharged, otherwise discipline, or in any manner discriminate
against an agricultural laborer because the laborer has made an
inquiry, filed a complaint, assisted an inspector of the department who
may make or is making an inspection under Section 125.016 (http://
www.statutes.legis.state.tx.us/GetStatute.aspx?Code=AG&Value=
125.016) of this code, instituted or caused to be instituted any
proceeding under or related to this chapter, testified or is about to
testify in such a proceeding, or exercised any rights afforded under
this chapter on behalf of the laborer or on behalf of others. Pay,
position, seniority, or other benefits may not be lost as the result of
the exercise of any right provided by this chapter.
(c) Any waiver by an agricultural laborer of the benefits or
requirements of this chapter is against public policy and is void. Any
employer's request or requirement that a laborer waive any rights under
this chapter as a condition of employment is a violation of this
chapter.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988.
Sec. 125.014. Department Rules; Outreach Program. (a) The
department may adopt rules and administrative procedures reasonably
necessary to carry out the purposes of this chapter.
(b) The department shall develop and provide to each employer
covered by this chapter a suitable form of notice providing
agricultural laborers with information regarding their rights under
this chapter.
(c) As part of an outreach program, the department shall develop
and distribute a supply of informational leaflets on employers' duties,
agricultural laborers' rights, the public's ability to obtain
information under this chapter, the outreach program, and the effects
of chemicals covered by this chapter.
(d) The department may contract with a public institution of higher
education or other public or private organizations to develop and
implement the outreach program.
(e) The department shall publicize the availability of information
to answer inquiries from agricultural laborers, employers, or the
public in this state concerning the effects of chemicals covered by
this chapter.
(f) In cooperation with the department, an employer covered by this
chapter may provide an outreach program in the community.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988.
Sec. 125.015. Liability Under Other Laws. (a) The provision of
information to an agricultural laborer does not in any way affect the
liability of an employer with regard to the health and safety of a
laborer or other person exposed to chemicals, nor does it affect the
employer's responsibility to take any action to prevent the occurrence
of occupational disease as required under any other provision of law.
(b) The provision of information to an agricultural laborer does
not affect any other duty or responsibility of a manufacturer,
producer, or formulator to warn ultimate users of a chemical under any
other provision of law.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988.
Sec. 125.016. Complaints, Investigations, and Penalties. (a)
Complaints received in writing from agricultural laborers or their
designated representatives relating to alleged violations of this
chapter by employers covered by this chapter shall be investigated in a
timely manner by the department as provided by this section.
(b) Officers or representatives of the department, on presentation
of appropriate credentials, have the right of entry into any workplace
at reasonable times to inspect and investigate complaints for purposes
of determining compliance with this chapter.
(c) The department shall complete an investigation of a complaint
not later than 90 days after the date on which the complaint is filed.
A hearing shall be conducted under Section 12.032 (http://
www.statutes.legis.state.tx.us/GetStatute.aspx?Code=
AG&Value=12.032) and an enforcement order issued, if appropriate, not
later than 90 days after the date on which the investigation is
completed. If it is necessary to commence an action relating to an
alleged violation, the action must be commenced not later than 60 days
after the date on which the investigation is completed.
(d) After providing at least 14 days' written notice and an
opportunity for a public hearing, the department may issue an
enforcement order requiring any employer or chemical manufacturer
covered by this chapter to comply with this chapter or rules adopted
under this chapter. A public hearing held under this subsection is a
contested case under Chapter 2001 (http://
www.statutes.legis.state.tx.us/GetStatute.aspx?Code=GV&Value=2001),
Government Code, and may be appealed under that chapter. In the case of
a medical emergency, the department may issue an enforcement order
immediately and shall provide the opportunity for a hearing on the
order within 10 days after the date on which the order is issued.
(e) In the case of a medical emergency, the department may sue in
the name of the State of Texas to enjoin any violation of this chapter
or a rule adopted or enforcement order issued by the department under
this chapter.
(f) If required under this chapter, employers who knowingly
disclose false information or negligently fail to disclose a hazard are
subject to a civil penalty of not more than $5,000 per violation. This
section does not affect any other right of an agricultural laborer or
any other person to receive compensation for damages under other law.
(g) If required under this chapter, employers who proximately cause
an injury to an individual by knowingly disclosing false hazard
information or knowingly failing to disclose hazard information are
subject to a criminal fine of not more than $25,000. This section does
not affect any other right of an agricultural laborer or any other
person to receive compensation for damages under other law.
(h) The department may request the attorney general to represent
the department in any legal proceeding authorized under this chapter.
An action for civil or criminal penalties or injunctive relief shall be
brought in the county in which the alleged violation occurred or is
occurring.
(i) Each violation of this chapter or a rule adopted under this
chapter constitutes a separate offense.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49),
eff. Sept. 1, 1995; Acts 1995, 74th Leg., ch. 419, Sec. 3.26,
eff. Sept. 1, 1995.
Sec. 125.017. Compliance With Hazard Communication Act. (a) If an
employer is required to comply with Chapter 502 (http://
www.statutes.legis.state.tx.us/GetStatute.aspx?Code=HS&Value=502),
Health and Safety Code and with this chapter, the employer is required
to comply with only the Hazard Communication Act. However, if an
agricultural laborer is not covered under the Hazard Communication Act,
the employer shall comply with this chapter for those laborers not
covered by the Hazard Communication Act.
(b) If an employer is covered by both the Hazard Communication Act
and this chapter, the employer is required to furnish a workplace
chemical list under only one of those laws.
Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1,
1988. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 284(92),
eff. Sept. 1, 1991.
[Accessed September 8, 2016]
[attachment 15]
[http://www.cdpr.ca.gov/docs/legbills/calcode/030302.htm#a67231]
California Code of Regulations (Title 3. Food and Agriculture)
Division 6. Pesticides and Pest Control Operations
Chapter 3. Pest Control Operations
Subchapter 3. Pesticide Worker Safety
Article 2. General Safety Requirements
6723.1. Application-Specific Information For Handlers.
(a) The operator of property used for the commercial or research
production of an agricultural plant commodity shall display, at a
central location, the following application-specific information while
employees are employed to handle pesticides:
(1) Identification of the treated area;
(2) Time and date of the application;
(3) Restricted entry interval; and
(4) Product name, EPA registration number, and active
ingredients.
(b) The information shall be displayed within 24 hours of the
completion of an application and include all applications that have
been made to any treated field on the agricultural establishment within
\1/4\ mile of where employees will be working. Once displayed, the
information shall remain displayed until the area no longer meets the
definition of a treated field or handler employees will no longer be on
the establishment, whichever occurs earlier.
(c) The original or copies of documents otherwise required to be
maintained by this chapter may be used to meet the requirements of this
Section provided they contain the information required by this Section.
Note: Authority cited: Section 12981, Food and Agricultural
Code.
Reference: Sections 11501, 12973, 12980, and 12981, Food and
Agricultural Code.
6761. Hazard Communication for Field Workers.
(a) Whenever employees are working as field workers in a treated
field, the employer shall display at the worksite, a copy of a
completed written Hazard Communication Information for Employees
Working in Fields (Pesticide Safety Information Series leaflet A-9). In
the event that fieldworkers gather at a central location prior to
transportation to the worksite, the Pesticide Safety Information Series
leaflet A-9 may instead be displayed at that central location.
Pesticide Safety Information Series leaflet A-9 shall be written by the
department in English and Spanish. Upon request, the employer shall
read to the requesting employee, in a language understandable to that
employee, Pesticide Safety Information Series leaflet A-9. Pesticide
Safety Information Series leaflets are available from the Department.
(b) The operator of the property shall maintain in a central
location at the workplace accessible to employees, including the
employees of labor contractors, who enter a treated field, the
following:
(1) pesticide use records specified in section 6624(b), (c),
(d) and (e) for pesticides that have been applied to the field
within the last two years;
(2) a Safety Data Sheets (SDS), as specified in Title 8,
California Code of Regulations, section 5194, for each
pesticide listed in the pesticide use records referred to in
subsection (b)(1). If the SDS is not provided by the registrant
of a pesticide, the operator of the property shall:
(A) within 7 working days of a request for a SDS from
an employee, employee representative or employee's
physician, make written inquiry to the registrant of
the pesticide, asking that a SDS be sent to the
operator of the property. If the operator of the
property has made a written inquiry within the last 12
months as to whether the pesticide is subject to the
requirement for a SDS or the operator of the property
has made a written inquiry within the last 6 months
requesting new, revised or later information on the
SDS, the operator of the property need not make
additional written inquiry. A copy of the written
inquiry shall immediately be sent to the person
requesting the SDS;
(B) notify the requester of the availability of the
SDS or provide a copy of the SDS to the requester
within 15 days of receipt of the SDS from the
registrant; and
(C) if a response has not been received from the
registrant within 25 working days of the date the
inquiry was made, send the department a copy of the
inquiry with a notation that no response has been
received. The operator of the property is not precluded
from obtaining and providing the SDS utilizing other
more expedient methods in lieu of those provided in
this subsection.
(c) The operator of the property shall inform his or her employees,
before they are allowed to enter a treated field, of the location and
availability of any records and other documents required by subsections
(a) and (b). If the employees are employed by a labor contractor, the
operator of the property shall inform the labor contractor of the
location, or changed location, of the records and other documents. The
labor contractor shall provide that information to his or her
employees. If the location of the records and other documents changes,
the operator of the property and the labor contractor shall promptly
inform his or her employees of the new location. The employer,
including the labor contractor, shall also inform their employees that
they, their physicians and their representatives have a right of access
to the information and that the employees are protected against
discharge or other discrimination due to the exercise of their rights
under this section.
(d) The operator of the property shall provide, upon request of his
or her employee, an employee of a labor contractor, employee
representative, or an employee's physician, access to any records,
documents and information required to be maintained by this chapter.
Access shall be granted as soon as possible and not to exceed 48 hours
from the date of the request.
Informational Note: Other requirements relating to hazard
communication can be found in sections 6602, 6618, 6619, 6724,
6726, 6738, 6744, 6764, 6766, 6770, 6771, and 6776.
Note: Authority cited: Section 12981, Food and Agricultural
Code.
Reference: Sections 12980 and 12981, Food and Agricultural
Code; and 29 Code of Federal Regulations, Part 1910.1200.
6761.1. Application-Specific Information for Fieldworkers.
(a) The operator of property used for the commercial or research
production of an agricultural plant commodity shall display at a
central location the following application-specific information, while
fieldworkers are employed to work in treated fields on the operator's
property:
(1) Identification of the treated field;
(2) Time and date of the application;
(3) Restricted entry interval;
(4) Product name(s), U.S. EPA registration number(s), and
active ingredient(s); and
(5) Spray adjuvant product name(s) and California
registration number(s) if applicable.
(b) The information must be displayed when the operator of the
property receives notice of the completion of an application and before
any fieldworkers are allowed to enter the treated field. The
information must include all applications that have been made to any
field on the operator's property. The information must remain displayed
until the area no longer meets the definition of a treated field or
fieldworkers will no longer be on the operator's property, whichever
occurs earlier.
(d) * The operator of the property and any employer with
fieldworkers hired to work on the operator's property, shall display,
at the worksite or at a central location where fieldworkers gather, a
description of the location of the application-specific information
display whenever their fieldworkers are working in a treated field. The
description of the location must be specific enough for fieldworkers to
find and have unimpeded access to the displayed application-specific
information. The location description must be included in the
appropriate section of, or as an attachment to, the Hazard
Communication Information for Employees Working in Fields (Pesticide
Safety Information Series leaflet A-9) pursuant to section 6761(a).
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* Editor's note: the entries on the California Government website
are reproduced herein as is. Technically, paragraph (d) should follow
paragraph (c).
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(c) * The original or copies of documents otherwise required to be
maintained by this chapter may be used to meet the requirements of this
Section, provided they contain the information required by this
Section.
Note: Authority cited: Section 12981, Food and Agricultural
Code.
Reference: Sections 11501, 12973, 12980, and 12981, Food and
Agricultural Code.
[Accessed September 8, 2016]
[attachment 16]
[http://www.ecfr.gov/cgi-bin/text-
idx?c=ecfr&sid=d452215d50193ecd758dc85
dc47b5e7c&rgn=div8&view=text&node =29:6.1.1.1.1.1.1.20&idno=29]
e-CFR data is current as of September 8, 2016.
29 CFR Labor
Subtitle B--Regulations Relating to Labor (Continued)
Chapter XVII--Occupational Safety and Health Administration, Department
of Labor (Continued)
Part 1910--Occupational Safety and Health Standards (Continued)
Subpart Z--Toxic and Hazardous Substances
1910.1020 Access to employee exposure and medical records.
(a) Purpose. The purpose of this section is to provide employees
and their designated representatives a right of access to relevant
exposure and medical records; and to provide representatives of the
Assistant Secretary a right of access to these records in order to
fulfill responsibilities under the Occupational Safety and Health Act.
Access by employees, their representatives, and the Assistant Secretary
is necessary to yield both direct and indirect improvements in the
detection, treatment, and prevention of occupational disease. Each
employer is responsible for assuring compliance with this section, but
the activities involved in complying with the access to medical records
provisions can be carried out, on behalf of the employer, by the
physician or other health care personnel in charge of employee medical
records. Except as expressly provided, nothing in this section is
intended to affect existing legal and ethical obligations concerning
the maintenance and confidentiality of employee medical information,
the duty to disclose information to a patient/employee or any other
aspect of the medical-care relationship, or affect existing legal
obligations concerning the protection of trade secret information.
(b) Scope and application. (1) This section applies to each general
industry, maritime, and construction employer who makes, maintains,
contracts for, or has access to employee exposure or medical records,
or analyses thereof, pertaining to employees exposed to toxic
substances or harmful physical agents.
(2) This section applies to all employee exposure and medical
records, and analyses thereof, of such employees, whether or not the
records are mandated by specific occupational safety and health
standards.
(3) This section applies to all employee exposure and medical
records, and analyses thereof, made or maintained in any manner,
including on an in-house of contractual (e.g., fee-for-service) basis.
Each employer shall assure that the preservation and access
requirements of this section are complied with regardless of the manner
in which the records are made or maintained.
(c) Definitions--(1) Access means the right and opportunity to
examine and copy.
(2) Analysis using exposure or medical records means any
compilation of data or any statistical study based at least in part on
information collected from individual employee exposure or medical
records or information collected from health insurance claims records,
provided that either the analysis has been reported to the employer or
no further work is currently being done by the person responsible for
preparing the analysis.
(3) Designated representative means any individual or organization
to whom an employee gives written authorization to exercise a right of
access. For the purposes of access to employee exposure records and
analyses using exposure or medical records, a recognized or certified
collective bargaining agent shall be treated automatically as a
designated representative without regard to written employee
authorization.
(4) Employee means a current employee, a former employee, or an
employee being assigned or transferred to work where there will be
exposure to toxic substances or harmful physical agents. In the case of
a deceased or legally incapacitated employee, the employee's legal
representative may directly exercise all the employee's rights under
this section.
(5) Employee exposure record means a record containing any of the
following kinds of information:
(i) Environmental (workplace) monitoring or measuring of a
toxic substance or harmful physical agent, including personal,
area, grab, wipe, or other form of sampling, as well as related
collection and analytical methodologies, calculations, and
other background data relevant to interpretation of the results
obtained;
(ii) Biological monitoring results which directly assess the
absorption of a toxic substance or harmful physical agent by
body systems (e.g., the level of a chemical in the blood,
urine, breath, hair, fingernails, etc[.]) but not including
results which assess the biological effect of a substance or
agent or which assess an employee's use of alcohol or drugs;
(iii) Material safety data sheets indicating that the
material may pose a hazard to human health; or
(iv) In the absence of the above, a [chemical] inventory or
any other record which reveals where and when used and the
identity (e.g., chemical, common, or trade name) of a toxic
substance or harmful physical agent.
(6)(i) Employee medical record means a record concerning the health
status of an employee which is made or maintained by a physician,
nurse, or other health care personnel or technician, including:
(A) Medical and employment questionnaires or histories
(including job description and occupational exposures),
(B) The results of medical examinations (pre-employment, pre-
assignment, periodic, or episodic) and laboratory tests
(including chest and other X-ray examinations taken for the
purposes of establishing a base-line or detecting occupational
illness, and all biological monitoring not defined as an
``employee exposure record''),
(C) Medical opinions, diagnoses, progress notes, and
recommendations,
(D) First aid records,
(E) Descriptions of treatments and prescriptions, and
(F) Employee medical complaints.
(ii) ``Employee medical record'' does not include medical
information in the form of:
(A) Physical specimens (e.g., blood or urine samples) which
are routinely discarded as a part of normal medical practice;
or
(B) Records concerning health insurance claims if maintained
separately from the employer's medical program and its records,
and not accessible to the employer by employee name or other
direct personal identifier (e.g., [S]ocial [S]ecurity [N]umber,
payroll number, etc.); or
(C) Records created solely in preparation for litigation
which are privileged from discovery under the applicable rules
of procedure or evidence; or
(D) Records concerning voluntary employee assistance programs
(alcohol, drug abuse, or personal counseling programs) if
maintained separately from the employer's medical program and
its records.
(7) Employer means a current employer, a former employer, or a
successor employer.
(8) Exposure or exposed means that an employee is subjected to a
toxic substance or harmful physical agent in the course of employment
through any route of entry (inhalation, ingestion, skin contact or
absorption, etc.), and includes past exposure and potential (e.g.,
accidental or possible) exposure, but does not include situations where
the employer can demonstrate that the toxic substance or harmful
physical agent is not used, handled, stored, generated, or present in
the workplace in any manner different from typical non-occupational
situations.
(9) Health Professional means a physician, occupational health
nurse, industrial hygienist, toxicologist, or epidemiologist, providing
medical or other occupational health services to exposed employees.
(10) Record means any item, collection, or grouping of information
regardless of the form or process by which it is maintained (e.g.,
paper document, microfiche, microfilm, X-ray film, or automated data
processing).
(11) Specific chemical identity means the chemical name, Chemical
Abstracts Service (CAS) Registry Number, or any other information that
reveals the precise chemical designation of the substance.
(12)(i) Specific written consent means a written authorization
containing the following:
(A) The name and signature of the employee authorizing the
release of medical information,
(B) The date of the written authorization,
(C) The name of the individual or organization that is
authorized to release the medical information,
(D) The name of the designated representative (individual or
organization) that is authorized to receive the released
information,
(E) A general description of the medical information that is
authorized to be released,
(F) A general description of the purpose for the release of
the medical information, and
(G) A date or condition upon which the written authorization
will expire (if less than one year).
(ii) A written authorization does not operate to authorize the
release of medical information not in existence on the date of written
authorization, unless the release of future information is expressly
authorized, and does not operate for more than one year from the date
of written authorization.
(iii) A written authorization may be revoked in writing
prospectively at any time.
(13) Toxic substance or harmful physical agent means any chemical
substance, biological agent (bacteria, virus, fungus, etc.), or
physical stress (noise, heat, cold, vibration, repetitive motion,
ionizing and non-ionizing radiation, hypo- or hyperbaric pressure,
etc.) which:
(i) Is listed in the latest printed edition of the National
Institute for Occupational Safety and Health (NIOSH) Registry
of Toxic Effects of Chemical Substances (RTECS), which is
incorporated by reference as specified in 1910.6; or
(ii) Has yielded positive evidence of an acute or chronic
health hazard in testing conducted by, or known to, the
employer; or
(iii) Is the subject of a material safety data sheet kept by
or known to the employer indicating that the material may pose
a hazard to human health.
(14) Trade secret means any confidential formula, pattern, process,
device, or information or compilation of information that is used in an
employer's business and that gives the employer an opportunity to
obtain an advantage over competitors who do not know or use it.
(d) Preservation of records. (1) Unless a specific occupational
safety and health standard provides a different period of time, each
employer shall assure the preservation and retention of records as
follows:
(i) Employee medical records. The medical record for each
employee shall be preserved and maintained for at least the
duration of employment plus thirty (30) years, except that the
following types of records need not be retained for any
specified period:
(A) Health insurance claims records maintained
separately from the employer's medical program and its
records,
(B) First aid records (not including medical
histories) of one-time treatment and subsequent
observation of minor scratches, cuts, burns, splinters,
and the like which do not involve medical treatment,
loss of consciousness, restriction of work or motion,
or transfer to another job, if made on-site by a non-
physician and if maintained separately from the
employer's medical program and its records, and
(C) The medical records of employees who have worked
for less than (1) year for the employer need not be
retained beyond the term of employment if they are
provided to the employee upon the termination of
employment.
(ii) Employee exposure records. Each employee exposure record
shall be preserved and maintained for at least thirty (30)
years, except that:
(A) Background data to environmental (workplace)
monitoring or measuring, such as laboratory reports and
worksheets, need only be retained for one (1) year as
long as the sampling results, the collection
methodology (sampling plan), a description of the
analytical and mathematical methods used, and a summary
of other background data relevant to interpretation of
the results obtained, are retained for at least thirty
(30) years; and
(B) Material safety data sheets and paragraph
(c)(5)(iv) records concerning the identity of a
substance or agent need not be retained for any
specified period as long as some record of the identity
(chemical name if known) of the substance or agent,
where it was used, and when it was used is retained for
at least thirty (30) years; \1\ and
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\1\ Material safety data sheets must be kept for those chemicals
currently in use that are effected by the Hazard Communication Standard
in accordance with 29 CFR 1910.1200(g).
---------------------------------------------------------------------------
(C) Biological monitoring results designated as
exposure records by specific occupational safety and
health standards shall be preserved and maintained as
required by the specific standard.
(iii) Analyses using exposure or medical records. Each
analysis using exposure or medial records shall be preserved
and maintained for at least thirty (30) years.
(2) Nothing in this section is intended to mandate the form,
manner, or process by which an employer preserves a record as long as
the information contained in the record is preserved and retrievable,
except that chest X-ray films shall be preserved in their original
state.
(e) Access to records--(1) General. (i) Whenever an employee or
designated representative requests access to a record, the employer
shall assure that access is provided in a reasonable time, place, and
manner. If the employer cannot reasonably provide access to the record
within fifteen (15) working days, the employer shall within the fifteen
(15) working days apprise the employee or designated representative
requesting the record of the reason for the delay and the earliest date
when the record can be made available.
(ii) The employer may require of the requester only such
information as should be readily known to the requester and which may
be necessary to locate or identify the records being requested (e.g.[,]
dates and locations where the employee worked during the time period in
question).
(iii) Whenever an employee or designated representative requests a
copy of a record, the employer shall assure that either:
(A) A copy of the record is provided without cost to the
employee or representative,
(B) The necessary mechanical copying facilities (e.g.,
photocopying) are made available without cost to the employee
or representative for copying the record, or
(C) The record is loaned to the employee or representative
for a reasonable time to enable a copy to be made.
(iv) In the case of an original X-ray, the employer may restrict
access to on-site examination or make other suitable arrangements for
the temporary loan of the X-ray.
(v) Whenever a record has been previously provided without cost to
an employee or designated representative, the employer may charge
reasonable, non-discriminatory administrative costs (i.e., search and
copying expenses but not including overhead expenses) for a request by
the employee or designated representative for additional copies of the
record, except that
(A) An employer shall not charge for an initial request for a
copy of new information that has been added to a record which
was previously provided; and
(B) An employer shall not charge for an initial request by a
recognized or certified collective bargaining agent for a copy
of an employee exposure record or an analysis using exposure or
medical records.
(vi) Nothing in this section is intended to preclude employees and
collective bargaining agents from collectively bargaining to obtain
access to information in addition to that available under this section.
(2) Employee and designated representative access--(i) Employee
exposure records. (A) Except as limited by paragraph (f) of this
section, each employer shall, upon request, assure the access to each
employee and designated representative to employee exposure records
relevant to the employee. For the purpose of this section, an exposure
record relevant to the employee consists of:
(1) A record which measures or monitors the amount of a toxic
substance or harmful physical agent to which the employee is or
has been exposed;
(2) In the absence of such directly relevant records, such
records of other employees with past or present job duties or
working conditions related to or similar to those of the
employee to the extent necessary to reasonably indicate the
amount and nature of the toxic substances or harmful physical
agents to which the employee is or has been subjected, and
(3) Exposure records to the extent necessary to reasonably
indicate the amount and nature of the toxic substances or
harmful physical agents at workplaces or under working
conditions to which the employee is being assigned or
transferred.
(B) Requests by designated representatives for unconsented access
to employee exposure records shall be in writing and shall specify with
reasonable particularity:
(1) The records requested to be disclosed; and
(2) The occupational health need for gaining access to these
records.
(ii) Employee medical records. (A) Each employer shall, upon
request, assure the access of each employee to employee medical records
of which the employee is the subject, except as provided in paragraph
(e)(2)(ii)(D) of this section.
(B) Each employer shall, upon request, assure the access of each
designated representative to the employee medical records of any
employee who has given the designated representative specific written
consent. [A]ppendix A to this section contains a sample form which may
be used to establish specific written consent for access to employee
medical records.
(C) Whenever access to employee medical records is requested, a
physician representing the employer may recommend that the employee or
designated representative:
(1) Consult with the physician for the purposes of reviewing
and discussing the records requested,
(2) Accept a summary of material facts and opinions in lieu
of the records requested, or
(3) Accept release of the requested records only to a
physician or other designated representative.
(D) Whenever an employee requests access to his or her employee
medical records, and a physician representing the employer believes
that direct employee access to information contained in the records
regarding a specific diagnosis of a terminal illness or a psychiatric
condition could be detrimental to the employee's health, the employer
may inform the employee that access will only be provided to a
designated representative of the employee having specific written
consent, and deny the employee's request for direct access to this
information only. Where a designated representative with specific
written consent requests access to information so withheld, the
employer shall assure the access of the designated representative to
this information, even when it is known that the designated
representative will give the information to the employee.
(E) A physician, nurse, or other responsible health care personnel
maintaining medical records may delete from requested medical records
the identity of a family member, personal friend, or fellow employee
who has provided confidential information concerning an employee's
health status.
(iii) Analyses using exposure or medical records. (A) Each employee
shall, upon request, assure the access of each employee and designated
representative to each analysis using exposure or medical records
concerning the employee's working conditions or workplace.
(B) Whenever access is requested to an analysis which reports the
contents of employee medical records by either direct identifier (name,
address, [S]ocial [S]ecurity [N]umber, payroll number, etc.) or by
information which could reasonably be used under the circumstances
indirectly to identify specific employees (exact age, height, weight,
race, sex, date of initial employment, job title, etc.), the employer
shall assure that personal identifiers are removed before access is
provided. If the employer can demonstrate that removal of personal
identifiers from an analysis is not feasible, access to the personally
identifiable portions of the analysis need not be provided.
(3) OSHA access. (i) Each employer shall, upon request, and without
derogation of any rights under the Constitution or the Occupational
Safety and Health Act of 1970, 29 U.S.C. 651 et seq., that the employer
chooses to exercise, assure the prompt access of representatives of the
Assistant Secretary of Labor for Occupational Safety and Health to
employee exposure and medical records and to analyses using exposure or
medical records. Rules of agency practice and procedure governing OSHA
access to employee medical records are contained in 29 CFR 1913.10.
(ii) Whenever OSHA seeks access to personally identifiable employee
medical information by presenting to the employer a written access
order pursuant to 29 CFR 1913.10(d), the employer shall prominently
post a copy of the written access order and its accompanying cover
letter for at least fifteen (15) working days.
(f) Trade secrets. (1) Except as provided in paragraph (f)(2) of
this section, nothing in this section precludes an employer from
deleting from records requested by a health professional, employee, or
designated representative any trade secret data which discloses
manufacturing processes, or discloses the percentage of a chemical
substance in mixture, as long as the health professional, employee, or
designated representative is notified that information has been
deleted. Whenever deletion of trade secret information substantially
impairs evaluation of the place where or the time when exposure to a
toxic substance or harmful physical agent occurred, the employer shall
provide alternative information which is sufficient to permit the
requesting party to identify where and when exposure occurred.
(2) The employer may withhold the specific chemical identity,
including the chemical name and other specific identification of a
toxic substance from a disclosable record provided that:
(i) The claim that the information withheld is a trade secret
can be supported;
(ii) All other available information on the properties and
effects of the toxic substance is disclosed;
(iii) The employer informs the requesting party that the
specific chemical identity is being withheld as a trade secret;
and
(iv) The specific chemical identity is made available to
health professionals, employees and designated representatives
in accordance with the specific applicable provisions of this
paragraph.
(3) Where a treating physician or nurse determines that a medical
emergency exists and the specific chemical identity of a toxic
substance is necessary for emergency or first-aid treatment, the
employer shall immediately disclose the specific chemical identity of a
trade secret chemical to the treating physician or nurse, regardless of
the existence of a written statement of need or a confidentiality
agreement. The employer may require a written statement of need and
confidentiality agreement, in accordance with the provisions of
paragraphs (f)(4) and (f)(5), as soon as circumstances permit.
(4) In non-emergency situations, an employer shall, upon request,
disclose a specific chemical identity, otherwise permitted to be
withheld under paragraph (f)(2) of this section, to a health
professional, employee, or designated representative if:
(i) The request is in writing;
(ii) The request describes with reasonable detail one or more
of the following occupational health needs for the information:
(A) To assess the hazards of the chemicals to which
employees will be exposed;
(B) To conduct or assess sampling of the workplace
atmosphere to determine employee exposure levels;
(C) To conduct pre-assignment or periodic medical
surveillance of exposed employees;
(D) To provide medical treatment to exposed
employees;
(E) To select or assess appropriate personal
protective equipment for exposed employees;
(F) To design or assess engineering controls or other
protective measures for exposed employees; and
(G) To conduct studies to determine the health
effects of exposure.
(iii) The request explains in detail why the disclosure of
the specific chemical identity is essential and that, in lieu
thereof, the disclosure of the following information would not
enable the health professional, employee or designated
representative to provide the occupational health services
described in paragraph (f)(4)(ii) of this section:
(A) The properties and effects of the chemical;
(B) Measures for controlling workers' exposure to the
chemical;
(C) Methods of monitoring and analyzing worker
exposure to the chemical; and,
(D) Methods of diagnosing and treating harmful
exposures to the chemical;
(iv) The request includes a description of the procedures to
be used to maintain the confidentiality of the disclosed
information; and,
(v) The health professional, employee, or designated
representative and the employer or contractor of the services
of the health professional or designated representative agree
in a written confidentiality agreement that the health
professional, employee or designated representative will not
use the trade secret information for any purpose other than the
health need(s) asserted and agree not to release the
information under any circumstances other than to OSHA, as
provided in paragraph (f)(7) of this section, except as
authorized by the terms of the agreement or by the employer.
(5) The confidentiality agreement authorized by paragraph
(f)(4)(iv) of this section:
(i) May restrict the use of the information to the health
purposes indicated in the written statement of need;
(ii) May provide for appropriate legal remedies in the event
of a breach of the agreement, including stipulation of a
reasonable pre-estimate of likely damages; and,
(iii) May not include requirements for the posting of a
penalty bond.
(6) Nothing in this section is meant to preclude the parties from
pursuing non-contractual remedies to the extent permitted by law.
(7) If the health professional, employee or designated
representative receiving the trade secret information decides that
there is a need to disclose it to OSHA, the employer who provided the
information shall be informed by the health professional prior to, or
at the same time as, such disclosure.
(8) If the employer denies a written request for disclosure of a
specific chemical identity, the denial must:
(i) Be provided to the health professional, employee or
designated representative within thirty days of the request;
(ii) Be in writing;
(iii) Include evidence to support the claim that the specific
chemical identity is a trade secret;
(iv) State the specific reasons why the request is being
denied; and,
(v) Explain in detail how alternative information may satisfy
the specific medical or occupational health need without
revealing the specific chemical identity.
(9) The health professional, employee, or designated representative
whose request for information is denied under paragraph (f)(4) of this
section may refer the request and the written denial of the request to
OSHA for consideration.
(10) When a heath professional employee, or designated
representative refers a denial to OSHA under paragraph (f)(9) of this
section, OSHA shall consider the evidence to determine if:
(i) The employer has supported the claim that the specific
chemical identity is a trade secret;
(ii) The health professional employee, or designated
representative has supported the claim that there is a medical
or occupational health need for the information; and
(iii) The health professional, employee or designated
representative has demonstrated adequate means to protect the
confidentiality.
(11)(i) If OSHA determines that the specific chemical identity
requested under paragraph (f)(4) of this section is not a bona fide
trade secret, or that it is a trade secret but the requesting health
professional, employee or designated representatives has a legitimate
medical or occupational health need for the information, has executed a
written confidentiality agreement, and has shown adequate means for
complying with the terms of such agreement, the employer will be
subject to citation by OSHA.
(ii) If an employer demonstrates to OSHA that the execution of a
confidentiality agreement would not provide sufficient protection
against the potential harm from the unauthorized disclosure of a trade
secret specific chemical identity, the Assistant Secretary may issue
such orders or impose such additional limitations or conditions upon
the disclosure of the requested chemical information as may be
appropriate to assure that the occupational health needs are met
without an undue risk of harm to the employer.
(12) Notwithstanding the existence of a trade secret claim, an
employer shall, upon request, disclose to the Assistant Secretary any
information which this section requires the employer to make available.
Where there is a trade secret claim, such claim shall be made no later
than at the time the information is provided to the Assistant Secretary
so that suitable determinations of trade secret status can be made and
the necessary protections can be implemented.
(13) Nothing in this paragraph shall be construed as requiring the
disclosure under any circumstances of process or percentage of mixture
information which is trade secret.
(g) Employee information. (1) Upon an employee's first entering
into employment, and at least annually thereafter, each employer shall
inform current employees covered by this section of the following:
(i) The existence, location, and availability of any records
covered by this section;
(ii) The person responsible for maintaining and providing
access to records; and
(iii) Each employee's rights of access to these records.
(2) Each employer shall keep a copy of this section and its
appendices, and make copies readily available, upon request, to
employees. The employer shall also distribute to current employees any
informational materials concerning this section which are made
available to the employer by the Assistant Secretary of Labor for
Occupational Safety and Health.
(h) Transfer of records. (1) Whenever an employer is ceasing to do
business, the employer shall transfer all records subject to this
section to the successor employer. The successor employer shall receive
and maintain these records.
(2) Whenever an employer is ceasing to do business and there is no
successor employer to receive and maintain the records subject to this
standard, the employer shall notify affected current employees of their
rights of access to records at least three (3) months prior to the
cessation of the employer's business.
(i) Appendices. The information contained in appendices A and B to
this section is not intended, by itself, to create any additional
obligations not otherwise imposed by this section nor detract from any
existing obligation.
Appendix A to 1910.1020--Sample Authorization Letter for the Release
of Employee Medical Record Information to a Designated
Representative (Non-Mandatory)
I, ____ (full name of worker/patient), hereby authorize ____
(individual or organization holding the medical records) to release to
____ (individual or organization authorized to receive the medical
information), the following medical information from my personal
medical records:
------------------------------------------------------------------------
-------------------------------------------------------------------------
------------------------------------------------------------------------
(Describe generally the information desired to be released)
I give my permission for this medical information to be used for
the following purpose:
------------------------------------------------------------------------
-------------------------------------------------------------------------
------------------------------------------------------------------------
but I do not give permission for any other use or re-disclosure of this
information.
Note: Several extra lines are provided below so that you can place
additional restrictions on this authorization letter if you want to.
You may, however, leave these lines blank. On the other hand, you may
want to (1) specify a particular expiration date for this letter (if
less than one year); (2) describe medical information to be created in
the future that you intend to be covered by this authorization letter;
or (3) describe portions of the medical information in your records
which you do not intend to be released as a result of this letter.)
------------------------------------------------------------------------
-------------------------------------------------------------------------
------------------------------------------------------------------------
------------------------------------------------------------------------
------------------------------------------------------------------------
Full name of Employee or Legal Representative
------------------------------------------------------------------------
-------------------------------------------------------------------------
------------------------------------------------------------------------
Signature of Employee or Legal Representative
------------------------------------------------------------------------
-------------------------------------------------------------------------
------------------------------------------------------------------------
Date of Signature
Appendix B to 1910.1020--Availability of NIOSH Registry of Toxic
Effects of Chemical Substances (RTECS) (Non-Mandatory)
The final regulation, 29 CFR 1910.20, applies to all employee
exposure and medical records, and analyses thereof, of employees
exposed to toxic substances or harmful physical agents (paragraph
(b)(2)). The term toxic substance or harmful physical agent is defined
by paragraph (c)(13) to encompass chemical substances, biological
agents, and physical stresses for which there is evidence of harmful
health effects. The regulation uses the latest printed edition of the
National Institute for Occupational Safety and Health (NIOSH) Registry
of Toxic Effects of Chemical Substances (RTECS) as one of the chief
sources of information as to whether evidence of harmful health effects
exists. If a substance is listed in the latest printed RTECS, the
regulation applies to exposure and medical records (and analyses of
these records) relevant to employees exposed to the substance.
It is appropriate to note that the final regulation does not
require that employers purchase a copy of RTECS, and many employers
need not consult RTECS to ascertain whether their employee exposure or
medical records are subject to the rule. Employers who do not currently
have the latest printed edition of the NIOSH RTECS, however, may desire
to obtain a copy. The RTECS is issued in an annual printed edition as
mandated by section 20(a)(6) of the Occupational Safety and Health Act
(29 U.S.C. 669(a)(6)).
The Introduction to the 1980 printed edition describes the RTECS as
follows:
``The 1980 edition of the Registry of Toxic Effects of
Chemical Substances, formerly known as the Toxic Substances
list, is the ninth revision prepared in compliance with the
requirements of Section 20(a)(6) of the Occupational Safety and
Health Act of 1970 (Public Law 91-596). The original list was
completed on June 28, 1971, and has been updated annually in
book format. Beginning in October 1977, quarterly revisions
have been provided in microfiche. This edition of the Registry
contains 168,096 listings of chemical substances: 45,156 are
names of different chemicals with their associated toxicity
data and 122,940 are synonyms. This edition includes
approximately 5,900 new chemical compounds that did not appear
in the 1979 Registry. (p. xi)
``The Registry's purposes are many, and it serves a variety
of users. It is a single source document for basic toxicity
information and for other data, such as chemical identifiers ad
information necessary for the preparation of safety directives
and hazard evaluations for chemical substances. The various
types of toxic effects linked to literature citations provide
researchers and occupational health scientists with an
introduction to the toxicological literature, making their own
review of the toxic hazards of a given substance easier. By
presenting data on the lowest reported doses that produce
effects by several routes of entry in various species, the
Registry furnishes valuable information to those responsible
for preparing safety data sheets for chemical substances in the
workplace. Chemical and production engineers can use the
Registry to identify the hazards which may be associated with
chemical intermediates in the development of final products,
and thus can more readily select substitutes or alternative
processes which may be less hazardous. Some organizations,
including health agencies and chemical companies, have included
the NIOSH Registry accession numbers with the listing of
chemicals in their files to reference toxicity information
associated with those chemicals. By including foreign language
chemical names, a start has been made toward providing rapid
identification of substances produced in other countries. (p.
xi)
``In this edition of the Registry, the editors intend to
identify `all known toxic substances' which may exist in the
environment and to provide pertinent data on the toxic effects
from known doses entering an organism by any route described.
(p xi)
``It must be reemphasized that the entry of a substance in
the Registry does not automatically mean that it must be
avoided. A listing does mean, however, that the substance has
the documented potential of being harmful if misused, and care
must be exercised to prevent tragic consequences. Thus, the
Registry lists many substances that are common in everyday life
and are in nearly every household in the United States. One can
name a variety of such dangerous substances: prescription and
non-prescription drugs; food additives; pesticide concentrates,
sprays, and dusts; fungicides; herbicides; paints; glazes,
dyes; bleaches and other household cleaning agents; alkalies;
and various solvents and diluents. The list is extensive
because chemicals have become an integral part of our
existence.''
The RTECS printed edition may be purchased from the Superintendent
of Documents, U.S. Government Printing Office (GPO), Washington, D.C.
20402 (202-783-3238).
Some employers may desire to subscribe to the quarterly update to
the RTECS which is published in a microfiche edition. An annual
subscription to the quarterly microfiche may be purchased from the GPO
(Order the ``Microfiche Edition, Registry of Toxic Effects of Chemical
Substances''). Both the printed edition and the microfiche edition of
RTECS are available for review at many university and public libraries
throughout the country. The latest RTECS editions may also be examined
at the OSHA Technical Data Center, Room N2439--Rear, United States
Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210
(202-523-9700), or at any OSHA Regional or Area Office (See, major city
telephone directories under United States Government--Labor
Department).
[53 FR 38163, Sept. 29, 1988; 53 FR 49981, Dec. 13, 1988, as
amended at 54 FR 24333, June 7, 1989; 55 FR 26431, June 28,
1990; 61 FR 9235, Mar. 7, 1996. Redesignated at 61 FR 31430,
June 20, 1996, as amended at 71 FR 16673, Apr. 3, 2006; 76 FR
33608, June 8, 2011]
[Accessed September 8, 2016]
[attachment 17]
[https://www.epa.gov/sap/meeting-materials-december-4-6-2013-
scientific-advisory-panel]
Meeting Materials for the December 4-6, 2013 Scientific Advisory Panel
Topic: Scientific Uncertainties Associated with Corn Rootworm
Resistance Monitoring for Bt Corn Plant Incorporated
Protectants (PIPs)
Available meeting materials are listed below. Visit docket EPA-HQ-
OPP-2013-0490 for additional background materials (http://
www.regulations.gov/#%21docketDetail;D=EPA-HQ-OPP-2013-0490).
You will need Adobe Reader to view some of the files on this page.
See EPA's About PDF page (https://www.epa.gov/home/pdf-files) to learn
more.
Agenda (December 4-6, 2013) (PDF) (https://www.epa.gov/
sites/production/files/2015-06/documents/120413agenda.pdf) (6
pp, 41 K)
Panel Members (December 4-6, 2013) (PDF) (https://
www.epa.gov/sites/production/files/2015-06/documents/
120413panel.pdf) (2 pp, 32 K)
Meeting Minutes (December 4-6, 2013) (PDF) (https://
www.epa.gov/sites/production/files/2015-06/documents/
120413minutes.pdf) (72 pp, 488 K)
Contact Us (https://www.epa.gov/sap/forms/contact-us-about-fifra-
scientific-advisory-panel) to ask a question, provide feedback, or
report a problem.
[Accessed September 8, 2016]
[attachment 18]
Records Management Policy
EPA Classification No.: CIO 2155.3 CIO Approval Date: 02/10/2015
CIO Transmittal No.: 15-005 Review Date: 02/10/2018
Issued by the EPA Chief Information Officer, Pursuant to Delegation 1-
19, dated 07/07/2005
1. Purpose
To advance a focus on overall records management
responsibilities under the Federal Records Act (FRA), as
amended, and other applicable authorities.
To confirm and align principles, responsibilities and
requirements for managing the Environmental Protection Agency's
(EPA's) records to ensure that the Agency is in compliance with
Federal laws and regulations; EPA policies; and best practices
for managing records.
To provide the framework for specific guidance and detailed
operating procedures governing records management.
2. Scope and Applicability
This policy addresses all records made or received by EPA employees
under Federal law or in connection with the transaction of public
business, and preserved or appropriate for preservation as evidence of
EPA functions, organization and activities or because of the value of
the information they contain. This policy applies to all EPA
headquarters, regional, laboratory and other organizations.
3. Audience
The audience for this policy includes all EPA organizations,
officials, and employees; those who oversee contractors and grantees;
and non-EPA employees who manage Agency records, as appropriate.
4. Background
The FRA, as amended, requires all Federal agencies to make and
preserve records containing adequate and proper documentation of their
organization, function, policies, decisions, procedures and essential
transactions. These records are public property and must be managed
according to applicable laws and regulations.
The FRA also requires agencies to establish a records management
program, defined as a planned, coordinated set of policies, procedures,
and activities needed to manage their recorded information. Major
elements include periodically issuing up-to-date records management
directives, properly training those responsible for implementation and
carefully evaluating the results to ensure adequacy, effectiveness and
efficiency.
Records serve a number of purposes including: planning for
administrative and program needs, providing evidence of EPA activities,
protecting legal and financial rights, enabling oversight by Congress
and other authorized agencies, documenting the Agency's history, and
continuing key functions and activities in the event of an emergency or
disaster. Records capture the Agency's institutional memory and
preserve the historical record; they are of critical importance in
ensuring that the organization continues to function effectively and
efficiently. In conformance with the Presidential Memorandum, Managing
Government Records, November 28, 2011, the Agency must ``meet the
executive branch-wide effort to reform records management policies and
practices. [The results will improve] performance and promote openness
and accountability by better documenting agency actions and
decisions.''
5. Authority
a. 44 U.S.C. Chapter 31--Records Management by Federal Agencies
(Federal Records Act) [http://www.archives.gov/about/laws/fed-
agencies.html]
b. 44 U.S.C. Chapter 33--Disposal of Records [http://
www.archives.gov/about/laws/disposal-of-records.html]
c. 44 U.S.C. Chapter 35--Coordination of Federal Information Policy
(Paperwork Reduction Act of 1980, as amended, Paperwork Reduction
Reauthorization Act of 1995, and Government Paperwork Elimination Act)
[http://www.archives.gov/about/laws/fed-information-policy.html]
d. 36 CFR Chapter XII, Subchapter B--Records Management [http://
www.archives.gov/about/regulations/regulations.html]
e. OMB Circular A-123--Management's Responsibility for Internal
Control
[http://www.whitehouse.gov/omb/circulars/a123/a123_rev.html]
f. OMB Circular A-130--Management of Federal Information Resources
[http://www.whitehouse.gov/omb/circulars/a130/a130trans4.html]
g. U.S. EPA, National Security Emergency Preparedness Policy (Order
2040.1A1) [http://intranet.epa.gov/ohr/rmpolicy/ads/orders/2040-
1a1.pdf]
h. U.S. EPA, Uniform Continuity of Operations (COOP) Plan Policy
(Order 2030.1a) [http://intranet.epa.gov/ohr/rmpolicy/ads/orders/2030-
1a.pdf]
i. Federal Emergency Management Agency (FEMA) Federal Preparedness
Circular 65--Federal Executive Branch Continuity of Operations (COOP)
[http://www.fema.gov/pdf/library/fpc65_0604.pdf]
j. Presidential Memorandum, Managing Government Records, November
28, 2011 [http://www.whitehouse.gov/the-press-office/2011/11/28/
presidential-memorandum-managing-government-records]
k. U.S. Environmental Protection Agency, Report on Managing
Government Records, March 27, 2012. [http://intranet.epa.gov/records--
click on ``EPA's Response to Presidential Memo'' under ``Features'']
l. Memorandum for the Heads of Executive Departments and Agencies
and Independent Agencies, from The Office of Management and Budget and
the National Archives and Records Administration, Managing Government
Records Directive, August 24, 2012 [http://www.whitehouse.gov/sites/
default/files/omb/memoranda/2012/m-12-18.pdf]
m. The Presidential and Federal Records Act Amendments H.R. 1233,
signed by President Obama, November 26, 2014.
6. Policy
a. EPA's Responsibility and Commitment
As a regulatory agency charged with protecting human health and the
environment, the EPA is committed to managing the Agency's records
properly to comply with legal requirements and to support the Agency's
mission. Records identification, management and access are essential in
allowing the Agency to meet its mission. The accuracy and consistency
of how records are identified, captured, stored and retrieved provide
the cornerstone to the effective functioning and transparent operation
of the Agency. EPA is required to preserve Agency records in accordance
with applicable statutory and regulatory requirements and to facilitate
access to information by EPA staff, partners, stakeholders and the
public, as appropriate.
The Records Management Policy establishes specific requirements to
effectively and efficiently identify, manage, search, retrieve and
provide access to records throughout their lifecycle.
b. Creating and Receiving Records
According to the FRA, every Federal agency is required to ``make
and preserve records containing adequate and proper documentation of
the organization, functions, policies, decisions, procedures, and
essential transactions of the agency and designed to furnish the
information necessary to protect the legal and financial rights of the
Government and of persons directly affected by the agency's
activities.'' Records contain the information that documents how EPA
carries out its mission. The Agency's past and current work generates
records. Records typically include information which is:
Created in the course of doing Agency business;
Received for action;
Needed to document EPA activities and decisions;
Required to support EPA's financial and other obligations
and legal claims; or
Communicated to assert EPA requirements or guidance.
All EPA staff generate and receive records and are legally required
to maintain them.
Records document the Agency's business and can be found in all
media such as paper, e-mail, instant messaging (IM), text messages,
telephone messages, voice mail messages, presentations, websites,
social media (e.g., Facebook, Twitter, etc.), word processing
documents, spreadsheets, and information systems. If electronic records
are created using any of these media, they need to be transferred to an
electronic records management system.
Not all information created or received constitutes a record. Non-
records include reference material, supplementary or convenience
copies, a draft document or working paper with no substantive comments,
and personal information which is unrelated to EPA business.
Some records are transitory in nature, which means they are of
short-term (180 days or less) interest, including in electronic form,
and have minimal or no documentary or evidential value.
Official Agency business should first and foremost be done on
official EPA information systems. The FRA now prohibits the creation or
sending of a Federal record using a non-EPA electronic messaging
account unless the individual creating or sending the record either:
(1) copies their EPA e-mail account at the time of initial creation or
transmission of the record, or (2) forwards a complete copy of the
record to their EPA e-mail account within 20 days of the original
creation or transmission of the record. These FRA requirements are
designed to ensure that any use of a non-EPA information system does
not affect the preservation of Federal records for FRA purposes, or the
ability to identify and process those records if requested under the
Freedom of Information Act (FOIA), Privacy Act or for other official
business (e.g., litigation, congressional oversight requests, etc.).
EPA strongly discourages the use of personal e-mail or other personal
electronic messaging systems, including text messaging on a personal
mobile device, for sending or receiving Agency records, but to the
extent such use occurs, the individual creating or sending the record
from a non-EPA electronic messaging system must copy their EPA e-mail
account at the time of transmission or forward that record to their EPA
e-mail account within 20 days of creation or sending.
Additionally, EPA discourages the use of text messaging on a mobile
device for sending or receiving substantive (or non-transitory) Agency
records. However, EPA recognizes that some Agency staff perform time-
sensitive work that may, at times, require the creation of substantive
(or non-transitory) records in the form of text messages for emergency
or environmental notification purposes. In those limited instances,
staff must continue to save and manage any text message records related
to their work, as discussed below.
c. Managing Records
Records are managed for the benefit of EPA and its staff, partners,
stakeholders and the public. EPA is committed to maintaining and
converting its records to electronic formats, where practical, to
facilitate moving away from paper toward more effective and efficient
electronic solutions. Non-transitory records should be stored in
approved records management systems with records management
capabilities or registered information management systems associated
with an approved records schedule.
It is important not to use non-EPA systems to conduct Agency
business, since such use could potentially lead to the mismanagement of
Agency records and/or the unauthorized disclosure of Agency
information. In the rare situation when a non-EPA messaging system must
be used and a Federal record is created or received on a non-EPA
messaging system (such as a personal e-mail account or personal mobile
device), pursuant to the FRA, staff must either: (1) copy their EPA e-
mail account at the time of initial creation or transmission of the
record, or (2) forward a complete copy of the record to their EPA e-
mail account within 20 days of the original creation or transmission of
the record. Once the message is sent or forwarded to the EPA messaging
system, you must save the record in an approved EPA electronic records
management system. Once the electronic files have been captured in an
approved EPA records management system, they should be removed from
non-EPA messaging systems, unless there is a specific obligation (such
as a litigation hold) to maintain the files on all systems on which
they appear.
Additionally, e-mails forwarding a news article or Web links from a
personal e-mail account to EPA's system and e-mails from EPA forwarding
a document to a personal e-mail account both create a copy of the e-
mail in EPA's e-mail system. Users can then properly preserve the copy
of the e-mail record in a record-keeping system to meet their
preservation requirements, if needed.
Similarly, users of text messaging, instant messaging or other
transient messaging technologies on EPA information systems are
responsible for ensuring that messages that result in the creation of a
substantive (or non-transitory) Federal records are saved for FRA
purposes and placed in a record-keeping system. For example, if a text
message on an EPA mobile device is received or sent that qualifies as a
substantive (or non-transitory) Federal record, it must be saved into
an approved record-keeping system. In order to comply with this
requirement, you can forward the text message into the EPA system, so
that you may then save it in an approved record-keeping system such as
EZ Email Records. When forwarding the text message from the mobile
device to the EPA e-mail system, be sure to include the time, date,
subject, and sender/recipient of the message whenever possible.
Guidance on how to e-mail a text message from a mobile device to
yourself is available at http://intranet.epa.gov/mobiledevices/pdf/
Instructions-Saving-Text-Messages.pdf.
Instant messages (such as Lync chats) that constitute substantive
(or non-transitory) records should also be saved into an approved
Agency record-keeping system. Guidance on how to save instant messages
(Lync chats) is available at http://intranet.epa.gov/ecms/guides/
im.htm.
d. Access
EPA records must be maintained in an appropriate manner, captured
and organized to ensure timely search and retrieval for internal Agency
use as well as for responses to outside inquiries. Sensitive records
(e.g., sensitive personally identifiable information (SPII), and other
Controlled Unclassified Information (CUI)) must be maintained with
restricted access in accordance with statutory and regulatory
requirements.
e. Implementation
Each office within EPA must establish and maintain a records
management program with the following minimum requirements.
1. Create, receive and maintain records providing adequate and
proper documentation and evidence of EPA's activities.
2. Manage records in any format (e.g., paper, e-mails, IMs, text
messages, electronic documents, spreadsheets,
presentations, images, maps, videos, blogs and other social
media tools that generate communications) in accordance
with applicable statutes, regulations, and EPA policy and
guidance, including records schedules.
3. Maintain electronic records (e.g., e-mails, IMs, text messages,
electronic documents, spreadsheets, presentations, images,
maps, videos, blogs and other social media tools that
generate communications) electronically in an approved
electronic records system. Non-e-mail electronic records,
including electronic records that cannot be forwarded to
and managed as an e-mail record, should be saved in their
native format in an organized way on an EPA network drive
until an approved electronic records management system is
available for desktop records.
4. Transfer or migrate records in paper and legacy electronic
systems to approved or registered information management
systems which are associated with a records schedule for
manual management of disposition where practicable and when
available. The Registry of Environmental Applications and
Databases (READ) often captures information on systems
which have a records schedule and require manual
disposition.
5. Ensure that non-electronic records are managed appropriately in
paper-based official record-keeping systems which
facilitate their preservation, retrieval, use and
disposition, if they are not appropriate for scanning (or
digitization).
6. Maintain records so they can be accessed by staff with a need to
know the information for appropriate business reasons and
maintained for the required retention period.
7. Secure records to protect the legal and financial rights of the
government and persons affected by government activities.
8. Implement a plan to protect essential (vital) records and assess
damage to and recover any records affected by an emergency
or disaster (e.g., financial, legal and emergency operating
records).
9. Ensure that instructions for the management and disposition of
records as specified in the approved records schedules are
followed.
7. Related Documents
a. EPA Records Management Manual [http://www.epa.gov/records/
policy/manual/index.htm]
b. Additional documents, including forms, guidance and other
relevant information are maintained on EPA's records management
website. [http://www.epa.gov/records/]
c. International Standard ISO 15489-1:2001--Information and
documentation--Records management--Part 1: General. [http://
www.iso.org/iso/catalogue--detail?csnumber=31908]
d. International Standard ISO/TR 15489-2:2001--Information and
documentation--Records management--Part 2: Guidelines. [http://
www.iso.org/iso/catalogue_detail.htm?csnumber=35845]
e. NARA Bulletin 2013-03: Guidance for agency employees on the
management of Federal records, including e-mail accounts, and the
protection of Federal records from unauthorized removal. [http://
www.archives.gov/records-mgmt/bulletins/2013/2013-03.html]
f. NARA Bulletin 2013-02: Guidance on a new approach to managing e-
mail records. [http://www.archives.gov/records-mgmt/bulletins/2013/
2013-02.html]
g. NARA Bulletin 2012-02: Guidance on managing content on shared
drives, December 6, 2011. [http://www.archives.gov/records-mgmt/
bulletins/2012/2012-02.html]
h. EPA Privacy Policy, CIO 2151.0 [http://www.epa.gov/privacy1/
policy/2151/index.htm]
i. EPA Guidance, Frequent Questions about E-Mail and Records
[http://www.epa.gov/records/faqs/email.htm]
j. EPA Guidance, Managing Social Media Records--DRAFT--12/05/12
8. Roles and Responsibilities
a. The EPA's Administrator is responsible for creating and
preserving records that adequately and properly document the
organization, functions, policies, decisions, procedures and essential
transactions of EPA. This responsibility is delegated to the Assistant
Administrator (AA) for the Office of Environmental Information (OEI)
and Chief Information Officer (CIO). As mandated by the Presidential
Memorandum of November 28, 2011, the Administrator is also responsible
for designating a Senior Agency Official (SAO) at the Assistant
Secretary level or its equivalent who has direct responsibility for
ensuring that the Agency efficiently and appropriately complies with
all applicable records management statutes, regulations, and NARA
policy, and requirements of the OMB/NARA Directive of August 24, 2012--
Managing Government Records. The Administrator has designated the OEI
AA/CIO as this SAO for records management.
b. OEI is responsible for leadership, planning, overall policy,
guidance and general oversight of records management in the Agency, and
its incorporation into the broader information resources management
framework. OEI is responsible for the following:
1. Incorporating records management requirements and policies into
the Agency's overall information resources management (IRM)
policy and planning.
2. Designating an Agency Records Officer responsible for:
Leading and managing the Agency-wide national records
management program.
Ensuring Agency senior officials are aware of their
programmatic and individual records management
responsibilities and requirements.
Advising EPA on records management issues and developing
Agency-wide records management policies, procedures,
guidance, and training materials.
Coordinating the approval of the Agency's records
schedules and the transfer of records to NARA.
Coordinating records management issues with other Federal
agencies, including Federal oversight agencies such as the
Office of Management and Budget (OMB), NARA, and the
General Services Administration (GSA).
Providing technical advice and training to all Agency
organizations on establishing and maintaining effective
records management programs.
Evaluating record-keeping practices to determine the
effectiveness of the program.
Obtaining NARA's Certificate in Federal Records
Management.
3. Promulgating and communicating Agency-wide policies and guidance
that reflect records management missions and goals and
incorporate Federal requirements.
4. Designating other records management staff as required by
regulations or as deemed necessary.
5. Assigning overall responsibility for the records management
aspects of centrally provided information technology
infrastructure, including local area network applications.
6. Ensuring senior Agency officials are aware of their records
management responsibilities.
7. Conducting periodic evaluations of records management programs
within the Agency as part of the Agency's IRM review and
oversight program.
c. Assistant Administrators, Chief Financial Officer, General
Counsel and Regional Counsel, Inspector General, Regional
Administrators and Laboratory/Center/Office Directors are responsible
for the following:
1. Being an advocate for records management in their organization.
2. Personally demonstrating the importance of records management and
ensuring their organization is aware of the importance of
and processes for managing records.
3. Demonstrating their commitment to the proper management of
records in their organization through appropriate means
(e.g., sending out messages, being present during days
devoted to records management, encouraging managers and
staff to take records training).
4. Designating a Records Liaison Officer (RLO) accountable to the
Information Management Official (IMO) or other official
designated to oversee the program. The IMO or other
official designated to oversee the program reports to the
Assistant Administrators, Chief Financial Officer, General
Counsel, Inspector General, Regional Administrators and
Laboratory/Center/Office Directors on a quarterly basis.
5. Ensuring the RLO has adequate skills, resources, time and
appropriate authority to perform the job.
6. Overseeing the implementation of a records management program
within their area of responsibility to accomplish the
objectives identified in Federal regulations and EPA
policies and procedures. Minimum program components include
responsibilities for:
Identifying record-keeping requirements for major
programmatic and administrative records.
Ensuring that records are identified, proper records
schedules are assigned, and the records are properly
stored.