Pesticide Program Dialogue Committee Meeting Summary
Note: This information is provided for reference purposes only. Although the information provided here was accurate and current when first created, it is now outdated.
OCTOBER 22-23, 1997
Opening Remarks by James Aidala, Associate Assistant Administrator for Prevention, Pesticides and Toxic Substances -- Appreciate efforts to be here, especially this time of year. Marion Moses, Jose Amador, Henry Anderson, Bob Harness, Gordon Hassing, Stanley Meiburg, and Terri Ninteman are unable to be here. A few substitutes are here: Ed Behrens (Procter & Gamble), Richard Pont (EPA, Region IV) and Jay Vroom (ACPA). Agenda is full; we would prefer to have fewer topics, but included some issues of special interest to several PPDC members and some areas where the Agency wants more public feedback. First session includes summary of progress made during the first year of FQPA implementation, including list of actual decisions made since passage of FQPA, and impact of FQPA on registration and reregistration in order to meet the new safety standards. Next will be hearty and robust discussion about the consumer brochure. We know this issue is important not only to the Agency but also to many members of Committee. A draft of the brochure was distributed prior to the meeting; this draft does not represent Agency policy and is not set in stone. Rather, it is a slice of the issues for discussion purposes and we want feedback. We will then discuss the Consumer Labeling Initiative, followed by a discussion on Inerts. The final session today will be a presentation by Ramona Trovato of EPA's Office of Children's Health Protection. On the second day, we will be joined by Dr. Lynn Goldman, the Assistant Administrator, to discuss some of the case studies that describe what we're doing differently under FQPA with endpoints focussed on protection of children. We want to discuss the thinking processes we have gone through, especially regarding the additional uncertainty factor (sometimes 10X, 3X or none). After that, we will have a discussion with ILSI by Dr. Jeff Foran who will report back on their meeting this week on organophosphates/common mechanism of toxicity. The next session will be on minor uses whereby Dan Botts and others will present a proposal; however, a fuller discussion will be reserved for a later PPDC meeting. Then Keith Pitts and Al Jennings will discuss the new Office of Pest Management at USDA. The next session will cover some issues recently taken to the Scientific Advisory Panel -- in utero cancer testing and exposure assessment methodologies for residential scenarios. We'll also have discussion about another topic recently taken to the SAP -- antimicrobial products, i.e., products impregnated with pesticides such as cutting boards, sponges, toys, etc.
This is an important time for FQPA -- I refer to as FQPA entering
adolescence (growing pains, training wheels are off, etc.
Important time for public input from committee and the public.
Dan Barolo recently left OPP and is working on special 90-day
project on information systems for Deputy Administrator. Meanwhile,
the program has been left to capable hands of Mr. Stephen
Johnson, Acting Office Director, who is also the permanent
Deputy Director of the program. There will be a rotation of
acting Deputy Office Directors, beginning with Anne Lindsay
who is here today.
Stephen Johnson, Acting Director, Office of Pesticide Programs -- Pleased to be here and note that a renewed PPDC charter has been approved for two more years. Membership nominations received great response and we have forwarded our recommendations to Deputy Administrator Fred Hansen. Some current memberships will expire; many others will be renewed, and new members added for two-year terms. As terms expire every Fall, we will add new members. Also, we have a public comment period set aside each day or comments can be submitted in writing. Our first agenda topic is an update on FQPA implementation by Lindsay Moose.
SESSION I -- Update on FQPA Implementation and Year-End Status Report for FY 1997 Lindsay Moose, Field and External Affairs Division -- (provided review of the Food Quality Protection Act of 1996--Status of Implementation at the end of Fiscal Year 1997) beginning with a summary of the Act's major provisions: new safety standard for all pesticide residues in food; special protections for infants and children; endocrine disruptors screening and testing program; tolerance assessment and reassessment; minor use pesticides; right-to-know; reduced-risk pesticides; pesticide registration and reregistration renewal; and antimicrobial pesticides. In addition to discussion policies and procedures underway, the document also includes future activities planned. The bulk of the document provides a detailed account of regulatory decisions made since FQPA was passed (August 1996 through September 30, 1997), e.g., registration of conventional pesticides, biologicals and antimicrobials, as well as Section 18 actions and reregistration eligibility documents (REDS) (Appendix A). Also discussed will be specific instances where FQPA made an impact, e.g., cases requiring additional restrictions or, in some cases, denials of requested actions (Appendix B).
In March 1997, we published an Implementation Plan for FQPA, and within the Plan we outlined some guiding principles -- sound science, health-based approaches to food safety, promoting safer/effective pest control methods, openness, and accountability. Some highlights describing how we followed this plan include the development last year of the interim decision logic which has enabled us to make decisions involving the uncertainty factor (10X), common mechanism and aggregate exposure. The tolerance reassessment schedule developed last August will require reassessment of the worst first, with all existing tolerances completed within 10 years. For all tolerances that have been set since FQPA passed, we have used the FQPA criteria, including consideration of special sensitivity for infants and children. With regard to promoting safer/effective pest control methods, in September 1997 we published final guidance for submission of applications for reduced risk pesticides to encourage the development, registration and use of lower-risk pesticide products. We have been very active in our Pesticide Environmental Stewardship Program, both with addition of partners and supporters, and we have been active in awarding grants.
With regard to the principle of openness, last Fall we established an advisory committee, the Food Safety Advisory Committee (FSAC), to discuss, among other things, the interim decision logic, as well as reduced risk, minor uses, right-to-know, and other topics we continue to bring to the public through this advisory committee. There have been a number of meetings, workshops and other advisory committee meetings (e.g., Endocrine Disruptors Screening and Testing Program (EDSTAC)) to keep people informed and to provide a means for input by those who are directly affected by these issues. The final guiding principle is accountability. Through the efforts of this committee, FSAC, EDSTAC, SAP and others, we are bringing issues to the public and hope to establish greater communications with our constituencies.
Another topic worth noting in the our FQPA Implementation Plan update is the activities underway in the Antimicrobial program, whereby the backlog has been reduced by 80% since January 1, 1997, and a plan is underway to completely eliminate the rest of the backlog. In summary, the Implementation Plan update is a one-stop place to find summary information about milestones in the statute, numbers of decisions made, and a reference document we will keep up-to-date.
Steve Johnson noted that the appendix lists decisions made, including many controversial ones where we denied Section 18's, eliminated uses, etc. These are real results of FQPA impact. Many of the chemicals are still in reregistration and tolerance reassessment.
Jim Aidala noted that where something was able to be approved, it was put through FQPA analysis; however, information could change given, e.g., a new petition to add a use or new information that arrives in other ways. For these pesticides, it will be easier next year to go through the analysis again.
In response to a question about the criteria for the decisions listed in Appendix B (Pesticide Decisions Impacted by FQPA), Steve Johnson noted that the list reflects Section 18's that were rejected; expiring tolerances with significant issues; new uses where FQPA impact was noted, e.g., sulfentrazone is new use and had a "children's" issue, etc. Thus, the list is not reflective of all decisions made, but those that were closely affected by FQPA. Jim Aidala noted that the list was an attempt to reflect how pesticide decisions were impacted by FQPA; it's not an exhaustive list for all decisions.
Jay Vroom noted that the list is valuable and wanted to know if it's possible to put together a list of pending decisions and those in the queue for both new active ingredients and new uses for old products and then track these. Ag community is increasingly concerned about backlogs; entire picture would be helpful. Jim Aidala noted that would be helpful. Jay Vroom also noted that in January 1997, ACPA surveyed its members looking forward three to five years in terms of new compounds and new uses anticipated; we would like to work with EPA and the PPDC to look at ways to anticipate workload and the challenges to the system we may not have traditionally anticipated.
Polly Hoppin asked for clarification of worst first and how long it will take to review and take actions. Lindsay Moose noted that these would include those scenarios where we feel exposure plus hazard would be greatest. The schedule lays out organophosphates, carbamates and most, but not all B-2 carcinogens in the first group. The law requires us to do 33% in the first three years. Depending on how the issue of common mechanism evolves, there may be others added to that group. Jim Aidala noted that the specific schedule developed before the ILSI report would have OP's individual assessments, or science chapters as we call them, completed this fiscal year, but this may change depending on the outcome of the ILSI report.
Ralph Lightstone expressed concern about worker safety and wanted to know if there was a way to flag the most labor-intensive crops and track the impact of the decisions on the farm labor-intensive crops where there are high exposures on the occupational side. Jim Aidala noted there are also other ways to accomplish this; for example, under RED development, we may decide that upon completion of the risk assessment that some risk mitigation that we required is due to dietary, occupational, or something else, or perhaps we might turn down a Section 18 because of occupational concerns. Another way to assess our actions would be to look at those foods heavily consumed by children and to have a way to show what we have done to protect children. Perhaps these do not need to be in our annual updates, but these are good suggestions and there should be something to answer the questions, what have you done about worker risk, kid risk, etc.
SESSION II -- Right-to-Know/Communications, Charles Franklin,
Field and External Affairs Division and Work Group Co-Chair
It's a challenging mandate to provide input to the full PPDC Committee on EPA's efforts to develop communications materials on pesticide residues in food. FQPA requirements are straightforward, but interpretation is challenging -- risk/benefits of pesticide use on food, any actions taken by EPA to establish benefits-based tolerances under FQPA, along with a listing of relevant commodities and alternatives to those commodities, and options for further reducing exposure to pesticide residues on foods -- are key areas. We want to share where we are today and get feedback. Real divergence of opinion was noted.
Since May 1997, we've talked with Workgroup members through past PPDC meetings and during conference calls. As a result, we have developed draft messages and text; collected and circulated existing consumer research information; conducted consumer interviews on general attitudes towards pesticides; and developed drafts incorporating some of these earlier findings. Despite differences, some clear guiding principles were agreed upon -- keep document short and to the point; focus on the core FQPA-mandated elements; maintain balance of the document to avoid undermining its credibility; underscore the importance of fruit and vegetable consumption; and seek consumer input, in addition to PPDC stakeholders. Some unresolved areas include: exposure reduction measures, e.g., loss of nutrition from peeling fruits and vegetables; organic alternatives; point of origin; and whether we should we cover issues such as removing skin/fat from meat and poultry and whether we should also provide information on microbial issues; etc. Also unresolved is how much should the brochure discuss the Federal Government's role; addressing the possibility of future benefits-based tolerances; and space and design constraints of a consumer brochure.
Consumer research was conducted with 56 consumers in four cities with focus on basic attitudes and awareness regarding food safety and pesticide use. Microbial contamination was number one concern with regard to fish/meat. Once pesticides were raised, respondents wanted to know more, especially about how to reduce their risk. Interest was also expressed about knowing more about alternatives to foods with pesticides. Few were aware of EPA's role in regulating pesticides (most thought it was the responsibility of USDA and FDA).
In January 1998, we expect to issue a draft in the Federal Register for broad public comment. Comprehensive printing and distribution strategy for the final document needs to be developed with focus on getting material distributed to 41,000 franchise and independent supermarket stores.
Richard Wiles noted the process has been amazing and turned him into the "good cop" at EWG. To review, EWG initially opposed the production of this brochure if there were no benefits-based tolerances, because we felt, and still do, that the purpose of this brochure is not to discuss the wonderfulness of the food supply, but rather to inform consumers of pesticides that exceed the standards of the Act -- that's the primary purpose of this section of the Act. We argued this before the Workgroup and still hold that belief. The draft brochure bears out all our worst fears -- starting with the cover -- from our point of view, and note this is the toned-down version, it pretty much makes a mockery of this whole issue by portraying pesticides in food as a washing and peeling party with the family. The attempt is to make it look fun and get the consumer interested. It's well-intentioned, but from our point of view, it makes a mockery of a very serious issue, which is the risk of pesticides in the food supply. A glaring problem is that the brochure implies that the standards of FQPA are, in fact, in effect. If you read this, you would think that there is this law in effect that requires the Government to protect infants and children from pesticides. That law is not really in effect. It has not been implemented yet in any comprehensive way. That's why we're here -- to ensure that it is. But to imply to the consumer that everything is fine and we just did this little brochure to tell you about pesticides risk and benefits is not really honest. Perhaps in a decade, we will have the law implemented the right way. For balance, there is a whole column on the wonderfulness of food and pesticides, and then only about one sentence on the hazards. There are many other things you could say about hazards that would be factual and would lead to a much more balanced brochure. Also, there is a gratuitous comment about plants producing their own pesticides, which is true but could be misinterpreted (do tomatoes produce parathion?). This needs to be better explained or taken out. Tips for reducing pesticides has an obvious omission -- a recommendation to buy organic. There's firm opposition on the other side to any mention of organic, as though there is some huge mystery as to whether or not organic produce has less synthetic pesticides on it. Organic produce is the only food out there that you can guarantee -- I did not say none -- has less pesticides in general than conventional food. The notion that we can't come to agreement on that indicates some sort of denial on the part of certain people. To include language that we should look for food grown using alternative methods when there is no single certification program out there anywhere that anyone accepts on alternative methods highlights that problem. The statement that "you can reduce and often eliminate pesticide residues" is flat out not true. You can reduce, but "often eliminate" is not true, unless you use some fancy scrubbing compounds, e.g., you would scrub strawberries with a toothbrush -- not very practical. Stressing the importance of hand washing may be important for children but does not necessarily have a place here. In sum, those are some of our comments. We will continue to work in the process to get some included, but feel we have a long way to go before we get to a brochure that meets the intent of the Act which is to inform people about benefits-based tolerances, which don't exist. If we are not going to do that, then we have a long way to go to achieve balance -- talk about risk, fix the cover, lots of word smithing, etc.
Jim Aidala noted that some people may have different drafts but that the organic issue was to be bracketed -- fully recognizing that the issue was not agreed upon by Committee members and others.
Richard Wiles noted that the organic issue is a "do or die" issue. It is ridiculous that you can't acknowledge that organic produce has less pesticides on it. If we have to draw the line, it's definitely going to be there.
Larry Elworth reiterated statutory mandate to all three agencies involved. He asked for clarification of 41,000 grocery stores which was explained to be large grocery stores and not all the smaller "quicky" marts. He noted that the best way to protect children from pesticides is to prevent them from playing with products stored under the kitchen sink -- that it would be more appropriate and useful to refer to pesticide "residues." Noting a desire to look specifically at the report language, he expressed agreement with Richard Wiles regarding whether the brochure is necessary or useful in the absence of benefits-based tolerances.
Jim Aidala noted the statutory language says something like there will be an annual pamphlet; it will describe, for example, ways to reduce your risk from pesticides, and any benefits-based tolerances.
Larry Elworth noted that the process being used looked expensive. With respect to organics, he had no objection to including, but felt it poses interesting issue for organics industry. He noted that the general public perception of people who are not familiar with the proposed USDA rule assume that organic means no pesticides whatsoever. I wonder how the organics industry feels about saying "don't have as much residues or pesticide use" as other products, but obviously the implication is that there are pesticides used.
Carolyn Brickey agreed that it is important to include the words
"buy organic" as an alternative under the Tips section,
and feels it would be ridiculous to debate it. It can be worded
to avoid concern about natural pesticides, but it makes sense
that a recommendation like this be included in a document
like this. I was personally shocked when I read the draft
and noted it was not there. With regard to benefits-based
tolerances, I feel some wordsmithing is necessary under the
section on Government's role, which currently sounds like
there are not any and there are not going to be any. In general,
there are lots of places where wordsmithing is needed and
that, on balance, it is not a balanced document. The cover
is not very dignified and not befitting the subject it is
Jay Vroom noted he has something in common with Richard Wiles in that he was voted the bad cop at ACPA which is roughly analogous with being the good cop at EWG. He expressed disappointment that there was not a meeting with the Work Group in the morning as previously planned to further refine the document. Balance is in the eyes of the beholder. He expressed concerns about referencing "buy organic" as an advertising mechanism and definition of what organic means and is there space to discuss it in the brochure. He would hope to have a further discussion of this topic at the next meeting of the WorkGroup. He noted that while it is important and smart for the Agency to use consumer interviews and focus groups to get input, that it is a fundamental mistake to write this brochure by way of trying to measure public opinion winds are blowing. Smart people who know the facts need to make the final calls as this language is brought together. It is important to listen to consumers and to understand their concerns, what type of language resonates with them, etc., so that we are all communicating as clearly as possible. ACPA provided written comments on this to the Agency.
Steve Balling commented that any language about organic include clarification that organic includes naturally-occurring pesticides because there is a very serious sense not only among consumers but also in the media that organic means pesticide-free, which is wrong. The title of the brochure includes "food safety" and to most consumers, the connotation of food safety is microbiological -- noting recent recognition of the problems with microbes and pathogens in food. It really is a pesticide residues brochure and should be so titled.
Ralph Lightstone commented that the brochure, as currently written, and without benefits-based tolerances, does not give credibility to the government and would not be very useful without that information. Under Government's role section where it says EPA considers the public's "overall exposure," you need to say "except the exposure at work."
Beth Marshall noted she liked the draft of the brochure and felt it met the law's requirements. Regarding organics, she was one of the Work Group members who felt it would be irresponsible to not mention this in the brochure. She felt the language discussing using fewer pesticides and alternative practices was ok and was what people who look for organic produce are looking for. She agreed that the words pesticide residues are a more accurate description of the brochure. The paragraph which discusses how in certain cases the law allows EPA to approve pesticides which may not meet the health standard was something that would likely lead a consumer to ask more questions. This is about consumer choices -- there is a significant minority of consumers out there who are concerned about pesticide residues on their food and that significant minority would find this brochure acceptable.
Richard Wiles stated it would be okay to have a statement that indicates organic includes pesticides as long as we clarify the difference between those pesticides and the ones we are talking about. People get the difference. The organic industry should be ok with that.
Robert Lake noted that he agreed with the sentiment that the brochure should address pesticide residues. After sharing copies of the brochure with others at FDA who are very much involved with the President's food safety initiative, they felt the title of the brochure would be confusing to people because the food safety initiative has a microbiological focus rather than a pesticide residue focus. With regard to organic, while it's true that organic foods will have in general less pesticides, it is not true that they will be safer from a microbiological standpoint. Again, if organic is to be a part of a brochure, then the title food safety will be more confusing.
Jim Aidala noted that most people don't distinguish between EPA and FDA and agreeing that we call the brochure something else, that perhaps there should be something more we should refer folks to -- in addition to the information on the back of the pamphlet.
Robert Lake noted that one component of the Food Safety Initiative is public education and perhaps there is something that could be referenced about this effort -- perhaps a document or something that could be referenced.
Robert Lake further clarified that there are actually two food safety initiatives underway. One has been underway over the course of the last year and involves FDA, USDA, EPA, CDC and others. The principle focus is pathogens in food and a whole range of topics -- booklet from FDA is available on this. Issues cover surveillance, inspection, public education, research, risk assessment and others. In large measure, it's a budgetary initiative with money -- it's one step away from being approved, e.g., FDA food program will get $20 million (it's in conference and both Houses agreed to that and $4 million for our Center for Veterinary Medicine). There's also money for CDC and for USDA. Again, focus is pathogens in food and various approaches to try to reduce that risk -- from surveillance/inspections to public education. The other initiative has a special focus on fruits and vegetables which was recently announced. There are special concerns about pathogens on fresh fruits and vegetables, with component focussed on imported ones (noting recent problems with cyclospora on raspberries from Guatemala). This initiative has broad focus, both foreign and domestic, to give guidance to growers on what they can do to reduce the risk of pathogens on fresh fruits and vegetables. There is also a legislative component to strengthen FDA's authority over imported foods, which is a newer initiative that does not have money associated with it; however, the President has talked about it and refers to it and it is referred to as a food safety initiative. Thus, there is strong White House press involving multiple agencies regarding pathogens, and it's important to not confuse these efforts with what we are discussing here.
Jim Aidala noted that in FQPA we were able to secure some ability to impose civil penalties in some situations for pesticide violations, which was a huge step forward and something we can hopefully build on as part of the Administration's effort to enhance food safety enforcement authority.
Al Jennings commented on organic and microbiological concerns
and noted that the term organic almost universally means the
use of manure fertilizers. He asked whether the Work Group
discuss the potential increase in microbiological risk that
might be due to organic -- is it real and is it something
reasonable to discuss further.
Charles Franklin noted that they did not discuss this. The discussion about organic focussed on whether there was a definition for organic and did the public know this. Jim Aidala noted that USDA's standards for organics was about to come out, as part of the 1990 Farm Bill requirements.
Larry Elworth further discussed the Government's role section
and indicated there are some useful things to be raised in
this section, e.g., reviewing pesticides that don't meet the
current standards, etc. He encourages a straightforward discussion
about each Agency's responsibilities.
Steve Balling commented over lack of understanding by public regarding EPA's role in establishing pesticide standards and also that public probably does not really care. It's probably not terribly important to use valuable space in the brochure to describe these things; provide them 800 numbers.
Richard Wiles agreed that the brochure should be a lot more hard-hitting. He read some words from ACPA's home page which he felt sounds similar to the brochure. "Pesticides are tightly regulated and controlled by the Federal and State governments. Before they can be used by farmers, crop protection products undergo extensive research..." We should instead be saying something like these things are regulated to protect public health, and the reason we have this brochure is to inform you of situations where we did not meet that test. There are a couple of compounds that don't meet that public health standard, such as ... Since we don't have any of those, it gets to be academic. Less fluff and more hard hitting information will be more useful.
Steve Balling noted that the brochure should indicate eat "canned" fruits and vegetables. (Laughter)
Polly Hoppin noted that most don't care who does what in Government, but rather what gets done. She noted the following sequence of points made in different places in the brochure: (1) there's a new law that protects people; (2) FDA and USDA check samples and don't allow food to be sold that exceeds those limits; (3) if EPA allows pesticides that don't meet the new health and safety standards, they must list them; (4) there are no pesticides that don't meet the new health and safety standards and therefore, none are listed. The impression created by that sequence of points is that there are no pesticides out there that exceed the new standard -- that is protective of children. It seems that with the objective to be clear and accurate that we have a problem for the next few years with the logic of the progression of those points. If we proceed with the brochure before the "worst first" pesticides are reassessed, we need to be more specific about roles and the lag time between putting out the standard and the tolerance reassessment process.
Richard Pont noted that he did not think a brochure would satisfy all sides and asked how grocery retailers received the concept of this brochure, noting that not all grocery stores sell organic food and may be concerned about a brochure that steers consumers away from foods that may contain pesticide residues. He noted further that we should try to determine whether grocers would actually use the brochure. He also noted that there is valuable information we should try to get to consumers, addressing pesticide risk and benefits.
Steve Johnson noted that while we are required to produce the brochure that grocers are not required to put it out. Charles Franklin further noted a meeting had been held earlier in the year with Food Marketing Institute (FMI) to discuss this issue, and that FMI was represented on the PPDC Work Group. He noted the current focus on microbial food safety. Produce was noted by FMI as the number one or two reason consumers select grocery stores. FMI would be concerned about any literature that would raise questions about the safety or quality of produce. Jim Aidala further noted that this will be an annual publication. For example, should there be a benefits-based tolerance, it would in effect require a new pamphlet. The issue of updating the pamphlet to reflect changes needs to be thought about.
Dan Botts noted that there are many other places beside the farm where produce may come into contact with pesticides that may end up as residues on the surface or contained in the product, whether it's crack and crevice treatments in the facilities itself, or fumigation after harvest in storage facilities or other locations, etc. The implication in the draft brochure is that farmers are the only ones responsible for using pesticides is not true. From all the data I have seen, the farmgate residue is less than detectable in a lot of cases, and very much below the tolerance level in most others -- the point of which is the closest to the consumer the pesticide comes into contact with, the greater the risk of a larger residue. In fairness of balance, this issue should be discussed in this document. Secondly, and this relates to canned versus fresh, when you first read the draft brochure, you assume all the risk comes from eating fresh fruits and vegetables because that's where all the directions are for minimizing exposure which is not necessarily the case. More attention should be paid to the balance.
Beth Marshall noted that organic is not simply a lifestyle choice; rather, it is a product and a good many people make a very nice living growing and selling organic produce. Some grocers may see this as an opportunity to develop a market for a product they can sell and make a profit. Secondly, this is a very small first step in public education and will not have an earth-shaking effect on the future of anybody's market -- largely because of the restrictions placed by the law on how this has to be done.
Jay Vroom questioned whether the Agency had thought about cost of this effort to taxpayers, and whether other efforts (e.g., FDA pamphlets) could be piggybacked somehow to reach the same 41,000 supermarkets. Recognition is due FDA and USDA for groundwork already done in other areas and are there synergies out there where the vehicle to get this out does not need to be reinvented, to make better use of taxpayer resources.
Steve Johnson acknowledged FDA's USDA's proactive roles and that we would look for ways t capitalize on that. While this niche was not really being addressed by these other Federal agencies, it's a good point to keep in mind.
Ed Behrens asked whether the brochure would be bilingual and noted that the formatting and cover should reflect more diversity in order to reach the socioeconomic groups in the U.S.
Richard Wiles noted that with respect to benefits-based tolerances and how you address them, that this draft version implies that the law is in place and there are no tolerances that exceed the health standard -- that has to be clarified. Another option that we proposed, which did not fly, was that since the Agency is well aware of many carcinogens that exceed the one in a million standard of the law when you don't look at kid's risk, those are obviously going to be over when you do look at kids. There's your list and you could do it that way. The Agency's response was that these have not been officially "re-jiggered" under FQPA, which is fair enough. However, if that's the Agency's position, it needs to be clear that we have not done any of this.
A PPDC member noted that it appears difficult to develop a brochure through Committee process -- that the Agency should try to capture the spirit of what is said and not the detail. Readability and attractiveness to consumers should be kept in mind. The Agency may want to consider this version as an executive summary for a larger brochure that could be obtained by calling EPA or through a website.
SESSION III -- Consumer Labelling Initiative (CLI) and Inerts
Amy Breedlove, Field and External Affairs Division
Consumer Labelling Initiative began March 1996, with publication in Federal Register requesting comments on labels, etc. Goals are to foster pollution prevention, empower consumer choice, and improve consumer understanding of safe use, environmental, and health information on household consumer product labels. Focus is on indoor insecticides, outdoor pesticides and household hard surface cleaners. Participation includes EPA, States (e.g., Vermont, California and Maryland), other Federal agencies (e.g., FDA, FTC and CPSC), in addition to environmental/public interest groups (e.g., Waste Watch, Citizens for a Better Environment, Working Group on Community Right to Know), consumers, and industry representatives (those interested in the project and those committed to be partners). Two phases to CLI. Phase I had three components: qualitative consumer research (135 indepth interviews in five major cities); a literature review of all relevant publications and reports; and a review of comments solicited through the Federal Register notice. All Phase I recommendations and findings were published in the Phase I Report, September 1996. Findings were in three areas: labeling issues not requiring further validation; labeling issues requiring further development or statistical validation; and education, policy, and coordination issues. Those issues not requiring further validation were: broader use of common names for active ingredients instead of, or in addition to, chemical names; inclusion on labels of phone numbers for general or emergency information (if necessary, EPA encourages the use of the National Pesticide Telecommunications Network number); and change heading "inert ingredients" to "other ingredients" because many people did not understand what inert meant. These recommendations were implemented in Pesticide Regulation Notices 97-4, -5, and -6, published in September 1997. Issues not needing further validation include: use of the heading "first aid" instead of "statements of practical treatment" and revision of first aid statements (preliminary language tested with consumers and poison control centers and revised languaged included in quantitative survey. Revisions will likely be published in a PR Notice. The bulk of issues were those requiring further development or statistical validation: validation done by consumer survey which will test consumer comprehension, attitudes, and behavior regarding labels. Over 12,000 copies will be distributed to screened recipients and the results will be used as the basis for new label changes. The survey is being directed and funded by the CLI's industry partners. Issues needing additional policy planning include such topics as how to present health and safety and ingredient information meaningfully and how to revise storage and disposal instructions so they're useful to consumers and flexible enough to meet different local recycling and disposal programs. Phase II also covers education and coordination issues: we will conduct a more detailed literature review on topics related to questions being asked in the quantitative survey, and we will form a product label consumer education task force which will recommend and implement consumer education activities that emphasize the importance of reading the label. Also, during Phase II we will continue to work on labeling policy coordination and development with other Federal State and international agencies, and we will continue use of CLI research process in other types of EPA policy work, where appropriate. We plan to take steps to address differences between agricultural community and consumers' label needs, and we consider possibly standardizing messages on product labels beyond pesticides (e.g., format, elements of message, etc.). Current activities include following: National Family Opinion survey organization is developing the quantitative survey with input from all CLI participants; and research on current storage and disposal laws and practices. North American Hazardous Materials Management Association will meet in November 1997 where we hope to get additional information about storage, disposal and recycling issues of pesticide containers. We're forming various CLI issue groups, forming the education task forces, and addressing the standardized message concept on product labels (CLI Team is also represented on several international groups looking at this same concept). Interested persons in CLI are encouraged to contact Amy Breedlove.
Carolyn Brickey questioned whether the process being used for the opinion survey could be piggybacked with consumer brochure issues -- to save resources. EPA agreed to look into this.
Ralph Lightstone asked whether any of the surveys dealt with whether there is understanding among the terms, warning, caution and danger. EPA responded yes, noting that there is a lot of misunderstanding between these terms. EPA also noted it would look at possibly a visual indication of the toxicity level on the label.
Ralph Lightstone further asked about whether there will be any
discussion of chronic effects disclosure on labels. For example,
there is contrast between the Material Safety Data Sheet and
label for the same product where the MSDS sheet might say
this causes cancer, birth defects or liver damage, and the
label says none of that. EPA noted that the CLI itself has
questions related to consumer's desire to have this type of
information on the label. Based on the interviews thus far,
many people did not seem overly interested in that information.
We are trying to get a better feel for this by putting it
in the survey. Ralph Lightstone further noted the example
of women of child-bearing age who are likely to be interested
in possible reproductive effects.
Larry Elworth asked how the Agency would measure the results of this effort through GPRA (Government Performance and Results Act). Amy Breedlove noted some effort in this regard -- the quantitative survey will provide a good base of current practices and procedures so that in a couple of years, EPA can re-interview and remeasure to see where we're at. Jim Aidala further noted that the Agency will also try to keep better track of incidents to see if consumers really understand the terms warning or caution.
PPDC member questioned international activities -- whether these were governmental, ISO, or a range of things. Amy Breedlove noted that at the moment it was primarily ISO, and Julie Lynch is most active participant. Anne Lindsay noted a related effort with OECD and entire UN system, in a long-running project called harmonization of classification and labeling of not just pesticide products, but all chemical consumer products. Those that are regulated in this country by CPSC, FDA, OSHA MSDS' -- they're trying to reach agreement this year on triggers which might lead to specific labelling requirements. Assuming that is achieved internationally, they will then turn their attention to what should be the words on labels -- signal words, types of phrase, etc. Big debates regarding when to use hazard information versus risk information. You may know that a chemical has an effect but given the way it is formulated and used, the risk may be very small. Thus, do you provide a warning on hazard or do you not because the risk is not there. Goal is to achieve basic agreement by 2000; then individual countries will likely take quite a few years to implement. Much flexibility on the implementation end as to where you start -- possibly start with focus on chemicals in transport and not so much at the consumer level.
Jay Vroom noted that the label is primarily a device for litigation and asked whether there have been any concerns raised and were they insurmountable barriers in some areas, especially as you look to move this effort to agricultural products in terms of label understandability and improvement. What can be done to break down some of those barriers to make that easier.Amy Breedlove noted that so far it has not been an issue with consumer labels, but that the Agency has not dealt enough with the ag side yet. Whenever issues arise, we will include OGC.
Jay Vroom noted increasing momentum behind electronic communication between registrants and the Agency, and electronic label possibly down the road. Given the fact that it might enable industry to save resources for re-labeling products when label changes if we were able to do a point-of-purchase electronically-generated label, and ensure greater accuracy and up-to-date information, has the Agency factored any of this into its work? Jim Aidala noted that the real emphasis of CLI has been more on homeowners and consumers and not ag retail, but that eventually it will grow.
SESSION III -- Enhancing Availability of Inert Ingredient
Cameo Smoot, Field and External Affairs Division
FIFRA statute makes distinction between active and inert ingredients; active ingredients are required to be listed on the label while inerts are not. This statutory definition has lead the Agency to treat inerts differently by not requiring their disclosure on the label. Other issues involve trade secret protections. Frequently, pesticide registration applicants claim confidentiality for a number of their inert ingredient identities. The exception to this regulatory scheme is the 1987 inert list policy which was created to reduce the adverse effects from use of pesticide products containing toxic inert ingredients. The policy establishes four categories of inert ingredients, List 1 being inerts of toxicological concern, List 2 as inerts potentially toxic with a high priority for testing, List 3 as inerts of unknown toxicity, and List 4 as inerts of minimal concern. The hammer of the 1987 policy was to disclose the identity of List 1 ingredient inerts on the label. EPA views the 1987 policy successful because it has had an impact on use of Lists 1 and 2 inert ingredients. Since 1987, there has been over a 70% reduction in the use of List 1 inert ingredients in pesticide products, and during the same period, there has been about a 15% reduction in use of List 2 inerts. OPP continues to be strongly committed to reducing the use of toxic inert ingredients in pesticide products. Over the past year, the program has been involved in a number of ongoing activities related to the 1987 policy. In response to a data call in-notice, two of the eight List 1 inert ingredients are under review. Isophorone -- toxicological data submitted to demonstrate that the basis for inclusion on List 1 is not warranted for human risk assessment. Rhodamine B -- residue data submitted to demonstrate that no human dietary exposure would result from use in seed treatment applications. Four data waiver requests were submitted and are under consideration (phenol, nonylphenol, diethyhexyl phtalate, and dioctyl adipate). The seventh List 1 inert, formaldehyde, is under review in the reregistration process, and the eight List 1 inert, hydroquinone, will be reviewed in the reregistration of acrolein. Looking at List 2 inerts, EPA has drafted a Federal Register notice to remove a number of chemicals from both Lists 2 and 3 that are no longer used in pesticide products. EPA continues to review data on List 2 inerts to determine if any of these meet the triggers for inclusion on List 1 or could be reclassified to List 4. Reviews have primarily focused on phthalate esters and glycol ethers. All List 3 inerts are being reviewed by OPPT's Structure Activity Team through literature review and various modeling approaches used to predict the effects of these chemicals on human health and the environment. Reviews for about 90% of the List 3 inert ingredients are complete and the remaining are expected to be done in new two months. OPP is examining List 3 inerts to determine if sufficient data are now available to permit reclassification to either List 1 or List 4 status. Also, OPP has considered a number of inerts for exemption under the 25(b) rule. A Federal Register notice on this is undergoing internal review.
EPA wants to enhance public access to pesticide information
while protecting trade secret information. We propose four-prong
approach to look at the administrative forms and procedures
as we process information coming into the Agency, as we enter
era of electronic data, etc. As we turn around information
quickly for the public, we are looking at ways to put flags
on that information -- creating a way to distinguish between
CBI and non-CBI information. We're looking at expanding the
scope of the 1987 policy by looking at other potential candidates
from other hazardous substances lists, i.e., OSHA, TRI, and
other lists that may be suggested by this group. We're also
looking at the regulatory framework from other agencies that
deal with disclosure, labeling, protection of CBI, etc. We're
looking at the Cosmetic Labeling
Act, to look at possible categorization of chemicals as possibly something to be used if the recipient claims CBI, and yet we still want to disclose additional information to consumers. We're also looking at recommendations from CLI -- other alternatives to disclosure other than label disclosure, e.g., 1-800 numbers to direct consumers to more information. When Phase II of CLI is completed, we will know more about the possible direction we could choose.
Ralph Lightstone questioned whether the petition to move Rhodamine B from List 1 (based on dietary exposure) considered occupational exposure. Kerry Leifer clarified that the Agency was not looking to remove it from List 1; rather, the Agency was responding to a data call-in notice in which the registrant was attempting to show there was no risk from its use in seed treatment products. Other than dietary exposure, it's used in an enclosed system and there should not be occupational exposure. Jim Aidala noted that this would need to be verified.
Ralph Lightstone asked whether there has been any movements from Lists 2 and 3 to List 1 since 1987. Kerry Leifer noted that a few chemicals were moved in 1989 to List 1. Jim Aidala further summarized the effort as sorting out List 2 as up or out -- if meets criteria, go to List 1 or drop to something lower. Partially, because of our expansion of right to know under EPCRA, OPPT went through the pesticide chemicals and ingredients, and by the end of this year being complete with the structure activity relationship analysis of List 3. Again, they should be either elevated or dropped down. Steve Johnson noted that regardless of which inert list, the Agency would prefer to see all inert or other ingredients listed on the label. It makes good common sense as right to know. Jim Aidala noted sensitive issue of percentages as trade secret information. Example of possible way to handle this would be to follow the method used for cosmetics, or by listing names. People who may be allergic to ingredients will want to know.
Richard Wiles provided comments on behalf of the Northwest Coalition for Alternatives to Pesticides regarding inerts. [A copy of NCAP's comments were filed with EPA's docket on PPDC (Docket #00439).] The comments were organized under three headings: EPA's current inert policy is inconsistent; EPA's information about inerts is incomplete and inaccurate; and, full disclosure of inert ingredients on product labels will benefit both EPA and the public.
Jim Aidala noted that the Agency met recently with NCAP to discuss the points raised.
Larry Elworth asked for further clarification about seed treatment and dietary exposure. Kerry Leifer explained that the company data provided is residue data which purports to show that there is no uptake of Rhodamine B in the edible portions of the crop; therefore, there would be no dietary exposure concerns. Rhodamine B is no longer used in any other products other than seed treatments. Larry Elworth further asked whether there was a standard response about whether it's food or non-food use. Kerry Leifer responded that seed treatments are food use. The company is trying to show is that there would be no residues in the edible portions of the crop. Jim Aidala noted that both actives and inerts need tolerances if ...the question about this substance listed as an inert per se will be evaluated the same way as an active ingredient. In other words, does a seed treatment need a tolerance, whether it's an active or inert.
Steve Johnson responded to request for clarification regarding Section 25(b) exemptions to note that following the last 25(b) process, several individuals came to the Agency claiming their registered active ingredients or inerts should be considered for exemption. We have pulled together these lists and included other products or chemicals we feel may be appropriate under 25(b) and an internal work group is reviewing to determine whether they would be appropriate as 25(b) candidates. Experience to date would have us eliminate 50-60% as candidates. Whatever list is developed would go through formal notice and comment.
Carolyn Brickey requested clarification about EPA's plan to implement the provisions of the NCAP lawsuit. Jim Aidala noted the Agency was looking at specific procedural things being looked at. Carolyn Brickey further noted that given the TSCA review of List 3 that more chemicals would end up on List 2 and wanted to know how the Agency would deal with a larger number of chemicals on List 2. She asked whether we would test these and how would we deal with them. Kerry Leifer noted that the Agency would move them to either List 1 or List 4. Steve Johnson noted that, as with the 1987 policy, the direction would be to do the listing as well as require more extensive testing if they want to maintain it as an inert ingredient. List 1 would be on the label. Regardless of the lists, the Agency encourages companies to voluntarily list all inert or other ingredients on the label.
Anne Lindsay further noted the Agency is very mindful about seeking cheaper, better ways to do things, especially with the inerts policy. If we started with a huge testing program, it would be vastly resource intensive -- not just for the regulated community but for the Agency as well, and would distract us from some of the higher priorities on our plate. We're trying to find cheap but reliable ways to get those things which should be on List 1, get full disclosure, voluntarily as much as possible, minimizing testing needed, and anything that can be moved to List 4A based on adequate information. Ultimately, we want to do away with List 2 and List 3.
Jay Vroom asked about FQPA requirement where there is residue of an inert or its metabolite or degradate -- how does this overlay what has just been discussed. Secondly, is there a role for NAPIAP or some other economic analysis expert group in government to look at the potential impacts as we lose inerts. What happens if you follow the progression in terms of economic impacts, efficacies of some finally formulated agricultural products -- should industry be thinking about this and projecting down the line?
Steve Johnson noted the Agency evaluates inerts for tolerance setting similar to any other active ingredient. Frequently, we note in many cases, there are many requests for waivers for various studies -- because of the intended use of the inert that appears to not result in the need for a food tolerance. Steve Johnson responded to second question noting that not many have focussed on inerts and potential impacts. It's time to look at it -- possibly NAPIAP, but not sure. If List 3 inerts get moved up, need to focus on data and information needed to maintain an acquisition or whether there are alternatives on List 4, or are there new inert compounds under development.
Jim Aidala further commented that FQPA did not change the law significantly here -- under the previous statute, there were requirements for residue on food. Industry and others need to identify whether there would be a significant impact. Our experience in the past has been that reengineering towards safer products, safer solvents, etc., have been solutions that are there. We would encourage this and, to my knowledge, we have not heard of any essential product that positively needs a particular inert and therefore cannot be used. He further noted that if the requirement is listing, it does not mean you can't have it, means you need to list it.
Regarding the TSCA review to comply with the lawsuit, Carolyn Brickey requested being notified about steps to be undertaken and where things are moving to change the list. The Agency agreed to provide this information.
SESSION IV -- Presentation by EPA's Office of Children's
Ramona Trovato, Office of Children's Health Protection
In 1988, Congress asked the National Academy of Sciences to investigate pesticides in the diets of infants and children, and in 1993, NAS published its report which suggested changes in the way EPA deals with risk assessments, including consideration of children's health factors in evaluating environmental risks. That resulted in a 1995 policy by EPA which made it explicit for kids to be considered in all Agency risk assessments for all regulations. Shortly thereafter, FQPA was passed, which expanded EPA's testing authority. In the same year the Safe Drinking Water Act amendments were published which also required that affected subpopulations be explicitly considered in the setting of drinking water MCL's. In that same year, Carol Browner came out with her national agenda which identified a number of areas to be worked on. It specifically focussed on protecting kids or how to deal with kids issues at EPA. In 1997, a Presidential Executive Order came out which said that all Federal agencies need to consider kids explicitly in conducting risk assessments for all significant regulations. For EPA, our General Counsel's office was asked to clarify timing for when the Executive Order's requirements kick in, which was April 1997. Anything that was a significant regulation from an economic point of view had to be considered. We don't have any on the books ongoing right now and we're not aware of any in the hopper. This applies to all rules, not just FQPA.
In 1997, we set up the Office of Children's Health Protection with about 12 people and a small budget. Our primary focus is to work with the program offices and regions to understand how best to protect children and infants in all of the Agency's actions -- from rulemaking, to permitting, to Superfund site clean-up, or communications documents. The office will only exist for five years -- by that time, the Office will have worked with the programs and regions to the extent that we're not needed any more, i.e., considering the risk to kids will be the practice of the Agency and a separate office will not be needed. Thus far, within the Agency, there has not been any problem with this plan.
Phil Landrigan is on-board one day a week or every other week. He is the Senior Advisor to the Administrator on children's health issues and he advises the office and the Administrator on what he thinks are the appropriate next steps for the Agency to undertake. He was instrumental in getting the cancer conference set up and wants to hold a risk assessment workshop, probably in March, whereby experts in risk assessment both in Government and outside can discuss the best way to conduct risk assessments for kids. EPA does not have a lot of guidance on how to conduct risk assessments for kids. The cancer guidelines that were proposed over a year ago do not have anything on kids. This is a big focus for our office. We also hope to have a conference this summer on learning disabilities. He also plays close attention to activities of the program offices and provides his opinion. Meetings with OPP are planned shortly about the setting of pesticide tolerances and the 10X factor. We're talking with the drinking water program about the best way to notify pregnant women and to parents of kids when MCL's are exceeded in drinking water systems because there is a public notification requirement.
Many of you recognize why children are important and different from adults -- pound for pound they breathe more air, drink more water and eat more food than adults, and they play closer to the ground and probably consume more dirt than adults. For some of these reasons, we feel kids need to be considered as an affected subpopulation as we do risk assessments. The Executive Order requires some specific items. A government-wideTask Force headed by Carol Browner and Donna Shalala was set up and held its first meeting on October 9, with good turn out by other involved Departments and White House agencies. Three work groups were established: one to coordinate activities and to cover legislative issues that the Administration might want to consider, and this group will be co-chaired by Dick Jackson and myself (Ramona Trovato). A research work group is to look at what research is already being collected, data gaps, and what the research agenda should be for the entire Federal government on kids issues, and will be co-chaired by Ken Olden of HHS and Bill Farland of EPA's Research and Development office. The third committee is on program implementation dealing with kids issues -- what are we already doing now, what seems to be successful, what are the kinds of partnerships should we building -- whether with States, local governments, foundations, private sector organizations, etc., to best protect kids health. That will be co-chaired by Jerry Clifford, Acting Regional Administrator in Region VI, and Barry Johnson of ATSDR. The Task Force will not meet again until April 1998; and hopefully, we will have completed enough work and have more products to offer at that time.
For EPA's national agenda that Carol Browner issued September 1996, it requires that all standards set by EPA are protective of any heightened risks faced by kids. The best way to address this issue is to change the Agency's risk assessment guidances, and there are many across the Agency. We've just started discussions with various folks around the Agency to determine the most appropriate way to build in a consideration of kids as people move forward with a risk assessment. We're supposed to develop a research strategy for EPA and ORD's Bill Farland is in charge of this effort. We were supposed to develop a new and comprehensive policy to deal with cumulative and simultaneous exposures to kids. In July, the Agency came out with a cumulative risk assessment guidance, Phase I Planning and Scoping document, that begins to address that. It looks at cumulative risk to everybody and it will work for kids as well. We're supposed to expand community right to know for families. We're not certain what that means. As we talked to folks who wrote the National Agenda, they asked how we get information out to parents, pediatricians, school nurses teachers, and teachers, so they know best how to protect kids. We also want to get information directly to parents, e.g., second-hand smoke is correlated with a higher incidence of SIDS; we want to make parents aware of this so that they will stop smoking around infants. Everyone knows that UV rays are causing more cancer and there is a "safe sun" program in EPA's Office of Air and Radiation to educate parents about putting hats on kids or having them play outside during parts of the day when the sun is not quite as strong as mid-day, which is typically when recess is held. We also want to encourage and expand educational efforts with healthcare providers and environmental professionals. We are looking to include in the medical school curriculum for pediatricians or perhaps all doctors a piece on environmental health because doctors are not typically trained to ask questions about exposures such as house painting. Finally, we are going to look at the funding issues to address kid's health. Funding has increased about five-fold in terms of dealing with kids issues in the Agency since 1996. A big chunk is the $5 million that EPA is putting into the Centers for Excellence for Children's Health. Other efforts include setting up a Federal Advisory Committee. We're seeking names from environmental groups, citizens organizations, industry, pediatricians, nurses, folks good at outreach and people who understand communications across different cultures. We're trying to keep size to 30-35. Names have been submitted to the Administrator for consideration. Administrator Browner also committed in the national agenda to identify five existing regulations to take a second look at to see if they need to be redone to protect kids. This will be a primary topic of consideration for the Federal Advisory Committee -- the idea being that over the 27 years since EPA began, did we write any regulations that if we rewrote today would they be more protective or would we change them at all in order to consider children as a specifically affected subpopulations. A Federal Register notice has been issued soliciting the nominations. Some folks have suggested that we may want to pick a chemical and then look at the regulations for that chemical around the Agency (perhaps three or four) to see if we want to change them, e.g., lead, mercury or nitrogen. Others have suggested that we pick five regulations that seem to be the most likely to cause an effect in kids. We're still open to that and we have not made a decision.
We're also working on an inventory of Agency activities to determine what is already going on throughout the Agency to protect kids. We hope to have our FACA meet in early December. In all cases, we will work with the program offices because that's where the expertise and responsibility lies. There is also an international component to this. An agreement was signed in Miami and then Denver at meetings on kids issues internationally -- these dealt with risk assessments and standard setting, lead, protecting kids from microbiological contaminants in drinking water, compiling an international inventory of research activities on endocrine disruptors, reducing air pollution and improving indoor air quality and educating people about risks to kids from second-hand smoke.
Beth Marshall noted that two areas are not mentioned in the literature -- exposure to kids from pesticides in schools and in lawn care products. In both instances, kids are more likely to be exposed than adults, and I know there have been incidents, particularly in schools, where pesticides were used that had effects on children.
Jim Aidala noted this issue will be covered as part of our residential/non-dietary exposure as we go through the list. Anne Lindsay noted the Agency already has an IPM in Schools brochure (one of our most popular brochures). During the coming year, we're working on a community-based demonstration project with a specific school in the area to do some hands-on IPM work. Ramona Trovato noted that the Agency also had a product called ATools for Schools@ which has been delivered to about 20,000 schools which contains additional information from the Pesticide Program on conducting IPM in schools. Implementation of IPM seems to be more effective when we add a small amount of grant money to the schools.
Polly Hoppin noted that the Task Force mentioned previously with Browner and Shalala is viewed by both EPA and HHS as a good opportunity to work more closely together on these issues, i.e., HHS has extensive programs in a number of childhood diseases for which environmental agents may be causal or exacerbating factors -- asthma being an excellent example. So, the opportunity to link up our asthma outcome work with additional information on the exposure side that, for instance, will be generated under the Clean Air Act rules is a very exciting opportunity from HHS' standpoint, and we're pleased to have the Office of Children's Health established that will do that more effectively. There is an Environmental Health Policy Committee (HPC) which includes many of HHS' institutes and agencies -- National Institute for Environmental Health Sciences, Centers for Disease Control, Agency for Toxic Substances and Disease Registry. Many of these people are formally involved as work group co-chairs under the Task Force, but the HPC has established a subcommittee on children's health and one of the priority areas for this cross-Agency work is pesticides. HHS intends to integrate the initiative on children's environmental health with its broader initiative on children's health.
Ramona Trovato noted that all activities being worked on in the kids office will go through the existing Agency structures, e.g., risk assessment issues will be worked through the Science Policy Council. Likewise for regulations. An economically-significant regulation must consider whether children were an affected subpopulation before it can be released by EPA.
Richard Wiles noted that we would hope that FQPA could serve as a model for the Agencywide risk assessment. FQPA is a very unsung law -- few people outside of this room realize the sweeping nature of the changes that are called for in this law. It's a good model about what the Agency should be doing. He noted that EWG may have some recommendations for the five regulations to be reviewed --perhaps a pesticide or two, or an existing set of food tolerances.
Ramona Trovato noted that the Office of Pesticide Programs is thinking the same way. Regarding FQPA as a model, we have visited all offices at EPA and we raised FQPA in our discussions. At EPA's Board of Children's Health Protection (consisting of Deputy Office Directors and above) we raised issue of how to deal with risk assessments and kids -- FQPA has been raised as a place to start. It's not clear at this time where this will end up and there is also the question about whether we can legally apply the same kind of conservative factor in the risk assessments under other statutes.
Jay Vroom asked about yardsticks -- in five, ten or twenty years from now -- that you have laid out so that we know you have been a success. Have these been identified and defined? Secondly, who would keep track of how much the U.S. invests in this process?
Ramona Trovato noted that they're in the process of setting some Agency goals (GPRA), and we're trying to compile in the existing GPRA goals where we already have a focus on kids. It was not ignored before; it just wasn't culled out specially. We also want to look at the HHS "healthy 2000" goals and focus on those. Another way is to focus on whether the Agency's regulations address kids. Whether they say they're not an affected subpopulation and therefore we don't need to go further, or they are an affected subpopulation and this is what we did -- that's an internal measure we're going to look for. Also, we're looking to change the risk assessments to have some inclusion of kids in them. Communications documents is another area. Where there is a separate effect or more pronounced effect on kids, we would like to see the Agency's communications documents have a special section on kids.
Jim Aidala further noted that the Agency's Childrens Office was about 12 people out of the Agency's 18,000 employees. Thus, you'll see the benefits mostly through GPRA goals, e.g., anything from residues from carcinogenic pesticides being reduced to things like, ideally cases of asthma, cancer, neurological effects being reduced. Ramona Trovato noted that they are looking for ways to measure their success.
Jay Vroom noted he viewed most of what was described as tactical measureables and that he was thinking more in terms of childhood cancers, incidents of other childhood disease. Ramona Trovato noted they would do this with HHS because they collect that type of data.
Ralph Lightstone noted that the Fair Labor Standards Act sets the rules for child labor, and agriculture (the floor for allowing legal child labor) is lower than it is in other industries and it is much more widely used (and I'm not even getting into the question of non-legal child labor. There is both legal and nonlegal child labor -- there are lots of children working in agriculture that are exposed to pesticides occupationally. That's not in the FQPA equation and needs to be. It interfaces with the pesticide program and the children's office as an occupational issue.
Ramona Trovato noted they have been talking with OSHA. She further
noted that the response from other Federal agencies has been
very good. The Executive Order goes beyond environmental risks
and includes safety risks -- e.g., airbags, helmits for bikeriding,
Ralph Lightstone noted two ways to get at this concern: through DOL by removing kids. To the extent they don't, then EPA should consider children's presence in regulating substances in the workplace. Ramona Trovato noted the children's office at EPA can be reached by calling 202/260-7778.
Public Comment Period -- No public comments were made.
Meeting adjourned for October 22.