[Federal Register Volume 87, Number 56 (Wednesday, March 23, 2022)]
[Notices]
[Pages 16500-16501]
[FR Doc No: 2022-06134]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2016-0022]

Bay Area Compliance Laboratories Corporation: Request for Renewal
of Recognition

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Notice.

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SUMMARY: In this notice, OSHA announces Bay Area Compliance
Laboratories Corporation (BACL), application requesting renewal of
recognition as a Nationally Recognized Testing Laboratory (NRTL).

DATES: Submit comments, information, and documents in response to this
notice, or requests for an extension of time to make a submission, on
or before April 7, 2022.

ADDRESSES: Submit comments by any of the following methods:
    Electronically: You may submit comments and attachments
electronically at: https://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov. Documents in the docket are
listed in the http://www.regulations.gov index; however, some
information (e.g., copyrighted material) is not publicly available to
read or download through the website. All submissions, including
copyrighted material, are available for inspection through the OSHA
Docket Office. Contact the OSHA Docket Office at<PHONE_NUMBER> (TTY
(877) 889-5627) for assistance in locating docket submissions. Please
note: While OSHA's docket office is continuing to accept and process
submissions by regular mail, due to the COVID-19 pandemic, the Docket
Office is closed to the public and not able to receive submissions to
the rulemaking record by express delivery, hand delivery, and messenger
service.
    Instructions: All submissions must include the agency name and OSHA
docket number for this Federal Register notice (OSHA-2016-0022). OSHA
places comments and other materials, including any personal
information, in the public docket without revision, and these materials
will be available online at http://www.regulations.gov. Therefore, the
agency cautions commenters about submitting statements they do not want
made available to the public or submitting comments that contain
personal information (either about themselves or others) such as Social
Security numbers, birth dates and medical data.
    Extension of comment period: Submit requests for an extension of
the comment period on or before April 7, 2022 to the Office of
Technical Programs and Coordination Activities, Directorate of
Technical Support and Emergency Management, Occupational Safety and
Health Administration, U.S. Department of Labor, 200 Constitution
Avenue NW, Room N-3655, Washington, DC 20210, or by fax to (202) 693-
1644.

FOR FURTHER INFORMATION CONTACT: Information regarding this notice is
available from the following sources:
    Press inquiries: Contact Mr. Frank Meilinger, Director, OSHA Office
of Communications, U.S. Department of Labor, telephone:<PHONE_NUMBER>;
email: [email protected].
    General and technical information: Contact Mr. Kevin Robinson,
Director, Office of Technical Programs and Coordination Activities,
Directorate of Technical Support and Emergency Management, Occupational
Safety and Health Administration, U.S. Department of Labor, phone:
(202) 693-2110 or email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    OSHA recognition of a NRTL signifies that the organization meets
the requirements in section 1910.7 of title 29, Code of Federal
Regulations (29 CFR 1910.7). Recognition is an acknowledgment that the
organization can perform independent safety testing and certification
of the specific products covered within its scope of recognition and is
not a delegation or grant of government authority. As a result of
recognition, employers may use products properly approved by the NRTL
to meet OSHA standards that require testing and certification. OSHA
maintains an informational web page for each NRTL that details its
scope of recognition available at http://www.osha.gov/dts/otpca/nrtl/index.html.
    OSHA processes applications by a NRTL for renewal of recognition
following requirements in appendix A to 29 CFR 1910.7. OSHA conducts
renewals in accordance with the procedures in 29 CFR 1910.7, Appendix
A, paragraph II.C. In accordance with these procedures, NRTLs submit a
renewal request to OSHA, not less than nine months or no more than one
year, before the expiration date of its current recognition. The
submission includes a request for renewal and any additional
information the NRTL wishes to submit to demonstrate its continued
compliance with the terms of its recognition and 29 CFR 1910.7. If OSHA
has not conducted an on-site assessment of the NRTL's headquarters and
key sites within the past 18 to 24 months, it will schedule the
necessary on-site assessments prior to the expiration date of the
NRTL's recognition. Upon review of the submitted material and, as
necessary, the successful completion of the on-site assessment, OSHA
announces its preliminary decision to grant or deny renewal in the
Federal Register and solicit comments from the public. OSHA then
publishes a final Federal Register notice responding to any comments
and renewing the NRTL's recognition for a period of five years, or
denying the renewal of recognition.
    BACL initially received OSHA recognition as a NRTL on April 6, 2017
(82 FR 16856) for a five-year period that ends on April 6, 2022. BACL
submitted a timely request for renewal, dated July 7, 2021 (OSHA-2016-
0022-0013), and retains its recognition pending OSHA's final decision
in this renewal process. The current address of the BACL facility
recognized by OSHA and included as part of the renewal request is:
     Bay Area Compliance Laboratories Corporation, 1274
Anvilwood Avenue, Sunnyvale, California 94089.

II. Notice of Preliminary Findings

    OSHA is providing notice that BACL is applying for renewal of its
recognition as a NRTL. This renewal covers BACL's existing NRTL scope
of recognition. OSHA evaluated BACL's application for renewal and
preliminarily determined that BACL can continue to meet the
requirements prescribed by 29 CFR 1910.7 for recognition. Accordingly,
OSHA is making a preliminary determination that it does not need to
conduct an additional on-site review of BACL's facility based on its
evaluations of BACL's application and all other available information.
This information includes OSHA's most recent audit of BACL's NRTL
recognized site during this recognition period, and the satisfactory
resolution of non-conformances with the requirements of 29 CFR 1910.7.
This preliminary finding does not constitute an interim or temporary
approval of the request.
    OSHA welcomes public comment as to whether BACL meets the
requirements of 29 CFR 1910.7 for renewal of its recognition as a NRTL.
Comments should consist of pertinent written documents and exhibits.

Commenters needing more time to comment must submit a request in
writing, stating the reasons for the request. OSHA must receive the
written request for an extension by the due date for comments. OSHA
will limit any extension to 30 days unless the requester justifies a
longer period. OSHA may deny a request for an extension if it is not
adequately justified. To obtain or review copies of the publicly
available information in BACL's application and other pertinent
documents (including exhibits), as well as all submitted comments,
contact the Docket Office, Room N-3653, Occupational Safety and Health
Administration, U.S. Department of Labor, at the above address; these
materials also are available online at http://www.regulations.gov under
Docket No. OSHA-2016-0022.
    OSHA staff will review all comments to the docket submitted in a
timely manner and, after addressing the issues raised by these
comments, will make a recommendation to the Assistant Secretary on
whether to grant BACL's application for renewal. The Assistant
Secretary will make the final decision on granting the application and,
in making this decision, may undertake other proceedings prescribed in
Appendix A to 29 CFR 1910.7.
    OSHA will publish a public notice of this final decision in the
Federal Register.

III. Authority and Signature

    James S. Frederick, Deputy Assistant Secretary of Labor for
Occupational Safety and Health, 200 Constitution Avenue NW, Washington,
DC 20210, authorized the preparation of this notice. Accordingly, the
agency is issuing this notice pursuant to 29 U.S.C. 657(g)(2),
Secretary of Labor's Order No. 8-2020 (85 FR 58393, September 18,
2020), and 29 CFR 1910.7.

    Signed at Washington, DC, on March 15, 2022.
James S. Frederick,
Deputy Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2022-06134 Filed 3-22-22; 8:45 am]
BILLING CODE 4510-26-P


2    about.

          3              We can't look at any one issue as

          4    isolated, because environment, economics,

          5    health, healthcare, tourism, agriculture are

          6    all linked together whether we recognize it

          7    or not and what affects one area will affect

          8    the others and when one area suffers, we all

          9    suffer.

         10              I was a young child in New Jersey

         11    and many of you might be surprised to know

         12    that New Jersey, though it's called the

         13    Garden State, was once a beautiful garden.

         14    And the same pressures a long time ago that

         15    befell the farmers there are befalling you

         16    guys here.  The increased development,

         17    increase in taxes, a lot of pressures that

         18    make viable farming very difficult.

         19              As a member of the Environmental

         20    Justice Committee, however, of the dioceses

         21    of Venice, we've looked at water quality

         22    issues and realized that Florida has unique

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          1    environmental concerns with this sandy soil

          2    and the high water table.

          3              What caught our attention a few

          4    years ago, that kind of stopped us from what

          5    we were working on, and looked at, was the

          6    reports of birth defects.  And I know that

          7    we've read the Collier County Health

          8    Department report and we understand that one

          9    cannot, on paper, necessarily show the links,

         10    but we know that these three women in

         11    particular were in the same general vicinity

         12    at the same general time, and I think it's

         13    pretty easy to make a connection there.

         14              It also bespeaks of the problem

         15    with overspray and drift and reentry periods.

         16    So they may not have been in the field that

         17    you could document at a given time, but the

         18    problem is very real.

         19              As the commission, we recommend

         20    best management practices, integrated pest

         21    management.  We'd like to see minimum use of

         22    pesticides.  Someone mentioned about over

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          1    time that the soil becomes so full of

          2    nematodes and various pests, but just like

          3    our bodies, when we overuse antibiotics then

          4    we can't have natural control.  Natural

          5    agents are no longer effective.

          6              So we would like to encourage

          7    whatever requirements, and I'm not going to

          8    speak to the buffer zone only because I've

          9    heard some of your comments today, but the

         10    requirements for safety, particularly, like I

         11    said, with the reentry and the drift and

         12    overspray, the personal protection, eye

         13    washing stations, and you've all said that

         14    you've done a good job of education, and I

         15    appreciate that very much.

         16              So I do want to say too that the

         17    incidents the other lady mentioned reporting

         18    -- a lot of the workers are migratory.  They

         19    are not in the same place year after year.

         20    It's very difficult to track and document the

         21    incidence of skin lesions and so forth, but

         22    we know that many of the workers come home at

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          1    night and have to undress, leave their

          2    clothing outside -- not because of body odor

          3    but because of intense pesticide.  And so we

          4    know that it's very much a problem.  Thank

          5    you.

          6              THE MODERATOR:  I scared 24 off, so

          7    25 is up.

          8              MR. OBERN:  My name is Chuck Obern,

          9    C&B Farms.  We are here talking about

         10    reducing risks with fumigants.  I think the

         11    best description of what we're trying to do

         12    is how we tried to get to this place this

         13    morning.

         14              With all the one-way streets, the

         15    detours, and dead ends, we both have to deal

         16    with them.  So I think we understand where

         17    we're trying to go.  There's lots of

         18    challenges to get to where we want to go.

         19              I'm a specialty vegetable producer

         20    who needs and requires fumigants, especially

         21    metam sodium, because of the many different

         22    crops that I grow which do not have labeled

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          1    herbicides.

          2              We use open-bed and plastic

          3    mulches.  Set-back requirements would reduce

          4    my farmable acreage from 5 to 25 percent

          5    depending on what buffer zone is required.

          6              One of my questions is, what are we

          7    going to do with the buffered land?  Can't

          8    use it.  We've got to have fumigants to farm.

          9    So what do I do?  Pay taxes on a piece of

         10    land that I can't use?

         11              We have not had any issues on the

         12    farm with worker safety or bystanders, and I

         13    don't foresee any problems.  I think

         14    education is the key with all affected

         15    parties.  It's of ultimate importance that we

         16    communicate with everybody that's affected

         17    with fumigants.

         18              A simple guide -- bilingual -- for

         19    use of the product would go a long way to

         20    help reduce any possible risks.  I'm also a

         21    farm worker.  I live right in the middle of

         22    my fields.  So does my family -- my wife, my

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          1    daughter.  We're there 24/7.  If I felt like

          2    I was hurting or exposing somebody, I would

          3    be one of the first ones to feel it.  I'm not

          4    going to take that risk.  I'm not going to

          5    expose any of the people who live on the farm

          6    or any of my neighbors to accept the same

          7    risk.

          8              I think it's important that we

          9    understand that farmworkers are employees.

         10    We have worker compensation insurance.

         11    Employee has the right to get workers'

         12    compensation.  So I would dare say that

         13    almost every case that there was has been

         14    reported, because worker compensation doesn't

         15    discriminate, it's for all the employees.

         16              I would like to just reiterate many

         17    of the things that have been discussed many

         18    times.  This is not California.  We don't

         19    have mountains, we don't have inversions, we

         20    don't have many of their conditions.  A lot

         21    of the issues that have been brought up by

         22    this panel and the information has been

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          1    developed in California.  Please, let's use

          2    some information from our localities, our

          3    soil types.  We get 72 inches of rain a year.

          4              I think we need to apply good Ag

          5    practices by all farmers, but I believe most

          6    of the farmers do.  We need to reduce

          7    exposure by taking into account wind,

          8    climate, temperature, soil, moisture.

          9              The amount of area to be treated

         10    depends not only on what a schedule is, but

         11    what Mother Nature gives us.  If we get a

         12    2-inch rain or like the other day we had a

         13    4-inch rain, you have to stay out of the

         14    fields for two days.  So, what are we going

         15    to do in those instances?  We need to keep

         16    them in mind.

         17              The use of VIF plastics is in

         18    vogue, but they're expensive.  We're in a

         19    global market.  We need to be careful.  VIF

         20    does work.

         21              What happens if no fumigant is

         22    used?  Well, we're going to go out of

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          1    business.  We can't compete with the global

          2    market.  I also ask for an extension for 60

          3    days on this comment period so as much of the

          4    information can be reviewed.

          5              Thank you very much.

          6              THE MODERATOR:  Did Lisa leave?

          7    Number 26, Lisa, did you leave?

          8              Please come in the lineup when its

          9    time for you to talk.  Thank you.

         10              MS. BUTLER:  My name is Lisa

         11    Butler.  I'm an attorney with Florida Rural

         12    Legal Services Farmworker Project.  Thank you

         13    for the opportunity to provide you comments

         14    today.  My focus is going to be not on the

         15    bystander exposure, but instead on

         16    suggestions that I have to mitigate worker

         17    exposure while they're working in the fields

         18    during what commonly is referred to in

         19    Florida as a plasticking operation, talking

         20    about methyl bromide.

         21              And I think by way of background,

         22    the first thing I would like to point out is

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          1    the reality for fieldworkers is very

          2    different than I think what maybe you've

          3    heard snippets of it already, but four field

          4    workers who were working in a plasticking

          5    operation with methyl bromide.  There are

          6    routinely problems of these workers not

          7    having had any training as to how to protect

          8    themselves from pesticide exposure, not

          9    having had any training to bring them up to

         10    handler level.

         11              And in addition when they're

         12    working in the plasticking operations, I have

         13    had numerous reports over the -- I've worked

         14    here for 10 years now, but for five years

         15    I've started looking at methyl bromide cases

         16    and I've had numerous reports that workers

         17    are receiving some level of direct exposure

         18    to methyl bromide while they're working in

         19    these plasticking operations and I have a

         20    couple of incidents I'd like to describe to

         21    you in a minute.

         22              But I think that belies the fact

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          1    that you have people saying from the

          2    enforcement sector that there are no

          3    incidents.

          4              There are incidents and they are

          5    not being captured and as Jeannie Economos

          6    testified from the Farmworker Association, a

          7    vast majority of the farmworker population

          8    doing the field work in Florida is Hispanic,

          9    is not English-literate and the vast majority

         10    are undocumented and are very intimidated and

         11    frightened about making complaints.  So, we

         12    have huge amounts of underreporting.

         13              The other thing that is apparent as

         14    far as your information goes is we do not

         15    have any good documentation, as it stands, of

         16    what the actual levels of exposure are for

         17    workers in the fumigant applications in

         18    Florida and we would urge you to take every

         19    step that you can to ensure that that data is

         20    gathered.

         21              Air monitoring is something that we

         22    believe should be done in every application

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          1    to ensure that, for example, with methyl

          2    bromide, you're not exceeding five parts per

          3    million or whatever the ratio is.

          4              Now, apart from that factual

          5    predicate which other workers can testify to,

          6    there are some specific steps that I believe

          7    would mitigate risks for workers.  One

          8    question is whether they're feasible, but

          9    first I'd like you to hear the story of a

         10    client of mine who could not be here today.

         11              He was working on a plasticking

         12    tractor in a pepper operation within the past

         13    two years.  Part of his job was to simply

         14    unroll the plastic.

         15              He'd had no training to work as

         16    pesticide handler.  He simply was doing this

         17    job.  Over the course of the day he began to

         18    feel dizzy and ill and the crew leader said

         19    go sit in the pickup truck.  He sat in the

         20    pickup truck.  At the end of the day, he went

         21    home.  He went at 1:00 in the morning to the

         22    emergency room with severe lung burns from

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          1    inhaling methyl bromide.

          2              There was no apparent accident, but

          3    he clearly had an injury which was documented

          4    by a medical authority.  A complaint was made

          5    to Department of Agriculture about this

          6    incident.  It proceeded through a workers'

          7    compensation claim.  Now, a year and a half

          8    later, we still have an individual who has

          9    respiratory problems and kidney problems.

         10              So, what I'd like you to evaluate

         11    and DACS, Department of Agriculture drew the

         12    conclusion that they could find no connection

         13    between methyl bromide and the injury this

         14    worker sustained.  We believe that that

         15    represents why you have underreporting of

         16    injuries.  There is --

         17              THE MODERATOR:  Time's up.

         18              MS. BUTLER:  I'm sorry.  I'll

         19    submit my written recommendations.

         20              MR. OSHAB:  My name is Terry Oshab.

         21    I work with Intergrow.  We're an agriculture

         22    supply company.  My area of expertise is, it

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          1    use to be called plastics, I think any more

          2    we're going to pretty much call it tarps,

          3    because there is a evolvement of the

          4    different types of films out there,

          5    incorporate metallization in different types

          6    of nylons.

          7              I've been laying plastic for, you

          8    know, a good solid 20 years now in a lot of

          9    different locations, both domestically and

         10    offshore, and I know you've heard this a lot,

         11    but I would like to encourage tests be done

         12    in Florida.

         13              My experience in laying plastics in

         14    Central America, in California, Texas,

         15    Arizona, Mexico, there is a difference in

         16    everywhere.  So, I think if you don't do the

         17    tests, whether you're looking at getting the

         18    information from, you're doing a disservice.

         19              I've been involved with a lot of

         20    trials with Dr. Jim Gilreath and Dr. Dan

         21    Chellemi of the USDA and in doing so we've

         22    developed some very good parameters on the

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          1    barrier films.  We've got some good

          2    documentation on how they work, how they

          3    respond to the methyl bromide and how it

          4    escapes through the films, measured in the

          5    French standard, which is grams per meter,

          6    squared per hour.

          7              I think you need to take that into

          8    consideration, based on your study that you

          9    put up here, regarding buffer zones and the

         10    parts per million and how far away they were.

         11    I think a lot of that can be looked at by

         12    changing the different types of tarps.  I

         13    would encourage you to do that.

         14              Anything I can do to assist you,

         15    I'd be glad to do it.  If you need to get any

         16    of the specific materials, Dr. Jim Gilreath

         17    works with us sometimes as a consultant.  I'm

         18    sure we'd would be glad to, you know, work

         19    with you if you want to get some more

         20    information regarding how these different

         21    tarps could work in conjunction with what

         22    we're all trying to get at, which is a safe

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          1    way to use fumigants.

          2              With the films, we've got a lot of

          3    different ways for testing, we set up a

          4    laboratory in Leesburg called Miller Nelson

          5    Analytical.  They do independent film

          6    samples, where they run them through an

          7    orifice, run methyl bromide through one side,

          8    test the vapor as it goes through the plastic

          9    and measures the backside so we have a very

         10    accurate analysis of the vapor transmission

         11    rate of the materials.

         12              We do that with any film before we

         13    take it to the fields to understand on a

         14    laboratory setting, how it works.  When we

         15    get to the field we have a piece of equipment

         16    called photoionization detector, which tests

         17    for volatile organic compounds.  In a

         18    nutshell, all the chemicals that you put up

         19    there, we can test it with a correction

         20    factor and get the parts per million of how

         21    much of it is contained in the bed or how

         22    much of it is escaping around the perimeter.

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          1              So we have those types of equipment

          2    in-house which we use readily so that when we

          3    go to the field and we're looking at these

          4    different alternatives or looking at the

          5    different rates of reduction, which we've cut

          6    back tremendously over the last three to five

          7    years, and results that we're getting from

          8    it, we have an accurate parts per million

          9    analysis of these programs.

         10              And I would suggest to you that if

         11    any way we can be of benefit, we would be

         12    glad to do it, but I think that your

         13    information, as seen out here today, has been

         14    a little bit outdated, based on the fact that

         15    you're not taking in the current types of

         16    material that we are using.

         17              Don't get up.  Thank you very much.

         18              THE MODERATOR:  Thank you.  That

         19    was pleasant.  Number 28, Jenny Hasley?

         20    Okay, Number 29?

         21              MR. McRIARTY:  Name is Jim

         22    McRiarty, an industrial hygienist,

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          1    toxicologist, have a little bit of experience

          2    with air monitoring as well.  But just on

          3    this aspect, okay, your fumigation manual,

          4    okay, is a good thing, but I think you need

          5    some serious input from both the registrants

          6    and applicators, okay, here.  And need a

          7    possibly -- well, some of these things are

          8    mixed together.

          9              You need one manual for mixtures

         10    and then another separate manual for the

         11    different straight materials.  Time of

         12    application, you can't restrict that too much

         13    because time of application is both day and

         14    period of a day.

         15              All right, in some cases time of

         16    day will be useful or day, like on a weekend

         17    you might want to use a weekend to apply

         18    around the school or you know, or something

         19    like that or extend the holiday on a school

         20    in order to get a job in.

         21              At the beginning of the

         22    re-registration process EPA made a big deal

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          1    about level playing field for all the soil

          2    fumigants, but here I see in the recommended

          3    risk mitigation measures you're comparing

          4    fetal development, eye irritation, eye

          5    irritation and inhalation studies.  You're

          6    not comparing the -- you know, those

          7    effects -- it's fine picking a study for a

          8    final effect.

          9              Pick your target populations that

         10    are experiencing those effects, at the same

         11    time incorporate in the proportion of the

         12    population that will be experiencing any

         13    effect, okay, the duration of time they would

         14    be experiencing effect.  Make the playing

         15    field even.  You have a very uneven

         16    distribution here when you're setting up.

         17              Eye irritation is going to be

         18    developed by every individual, okay.

         19    However, fetal development is only going to

         20    be experienced by -- if someone had to take a

         21    wild guess -- 25 percent or less of the

         22    population, females in child-bearing ages and

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          1    then reduce that to the duration of gestation

          2    that they're in, where they would be affected

          3    by a chemical, okay.  And then they have to

          4    be present in that offsite area where they're

          5    going to be there, so again it's a reduction

          6    in the potential thing of exposure from one

          7    who has irritation to one who is possibly

          8    pregnant.

          9              All right, the other portion was in

         10    regards to your site-specific fumigation

         11    management plans.  They're probably a good

         12    thing, all right, but they do need to be very

         13    flexible, so you have changes in weather,

         14    changes in conditions that can be done.  If

         15    that flexibility is built in when they are

         16    done, then they can be reviewed with an eye

         17    towards those various things.

         18              However, you're also going on the

         19    other side and saying you have responsible

         20    parties.  By pointing out the responsible

         21    parties, you're putting liabilities right

         22    around their neck and if you want somebody to

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          1    review those plans, they then put even more

          2    liability on those reviewers.  So without

          3    indemnification of those reviewers or those

          4    reviewers being in a governmental position

          5    you have no chance of getting them reviewed.

          6              I'm done.

          7              MS. HERNANDEZ:  Hi, my name is

          8    Laura Hernandez and I come from Homestead,

          9    Florida.  I'm going to talk about my own

         10    experience.

         11              In 1978, I started working in

         12    agriculture in Alabama in potato.  In 1979, I

         13    got pregnant and my son, I was working on the

         14    tomato and my son come with the slow learner

         15    disability.

         16              I went to the doctor and the doctor

         17    said that it was related to the chemicals.

         18    But he couldn't be more specific, you know,

         19    that it was directly for that.

         20              He recommend me to change job, so I

         21    start working in the clinic, a CHI as a

         22    health promoter, and working in the CHI I saw

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          1    a lot of my friends, they were working in the

          2    agriculture, losing their babies, having

          3    miscarriage, childs born with birth defects.

          4              I remember this case that there was

          5    this baby with a frog-face and we asked the

          6    hospital to make a study to see if it was

          7    related to the chemical, if they found any

          8    residues of pesticides in the body.  And they

          9    ask us for $900 to do the autopsy and do a

         10    little study, when we collect door by door to

         11    bury this baby.

         12              Other cases is, you know, that my

         13    first son and then for two years I work with

         14    the clinic.  After the clinic, five years

         15    back, I went to the agriculture and now my

         16    younger son has the same problem and I was

         17    working in Tifton, Georgia in tomato as a

         18    crew leader, work in picking tomatoes, and I

         19    have the same problems, my son has the same

         20    DSL, learning disability.

         21              And so the last person that I hear

         22    was a friend of mine, that her husband die in

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          1    the field, drinking water, and he was very

          2    sick, you know, with the chemicals.  And he

          3    was attending the doctors and so the doctors

          4    like I say, you know, that is very expensive

          5    to study if it was the pesticide.

          6              And the Everglades migrant comes

          7    south of Florida City in Dade County, two or

          8    three babies was dying as I —————— that.  And

          9    the Everglades migrant come now is --

         10    Everglades Community Association is in the

         11    middle of fields.

         12              In 1980s, it was toilets.  And so

         13    in the night they -- the plane would spray it

         14    and like I said, every season when the

         15    migrants were working we have two or three

         16    crib deaths, baby dying with -- and like I

         17    said, if you have a report every year from

         18    the CHI clinic in Dade County you're going to

         19    see there is a lot of migrant farmworker

         20    people sick with the chemicals.  And I work

         21    in that, so I know.  That's all.

         22              THE MODERATOR:  Thank you.  Number

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          1    31?  31?  32?

          2              SPEAKER:  ———————— the Pesticide

          3    Action Network North America.  ————————————

          4    ————————————————————————————————.

          5              THE MODERATOR:  One moment please?

          6    Can you give us one moment so I could get a

          7    translator?

          8              SPEAKER:  Okay.

          9              SPEAKER:  (Speaking Spanish)

         10              THE INTERPRETER:  (Simultaneously,

         11    while the Speaker speaks)  I want to talk

         12    about the exposure, you know, to pesticides

         13    that daily workers have when they're on the

         14    field because I've heard today that the

         15    exposure to pesticide is something that it's

         16    due to ————————.  Technically the workers

         17    have heard different stories.  It's not that

         18    it's due to ——————————.  It's the application

         19    workers.

         20              Now, I'm going to talk about

         21    specifically because that's the way they do

         22    it and not that they do it everyday.  They're

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          1    exposed 10 to 12 hours during the season

          2    where the pesticides are supplied.  It's

          3    around two months.

          4              Twenty-five to thirty workers work

          5    in a block.  And the opportunities due to the

          6    kind of job they do is that it's constant

          7    during day because they need to cut the

          8    plastic when they're injecting and they're

          9    putting it underneath the tarp, you know, so

         10    they have different times and they do it

         11    during the day, so there are 25 to 30 workers

         12    and they're exposed too, depending on where

         13    they are because the fumes, they escape.

         14              Though the studies should consider

         15    all the parts involved and all this different

         16    situations it may be inhalation, direct

         17    contact, ocular contact, you know, birth

         18    defects, if somebody is working there while

         19    pregnant, and long term effects, you know,

         20    it's not only exposure, acute exposure in

         21    fact because sometimes the gas comes out in

         22    higher measures because they're working

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          1    continuously during the day and they are

          2    exposed to those fumes for two months or

          3    during the time that the season, so it's also

          4    important.

          5              I have to say again, you know, what

          6    she said before that workers don't report

          7    because they actually, don't do it for

          8    several reasons and you were already told.

          9              It's important to monitor the air

         10    where the workers are to be able to --

         11              SPEAKER:  Oh, I'm sorry, I'm

         12    talking too fast.  Yeah.

         13              THE INTERPRETER:  She needs to get

         14    closer to the mic.  I can't hear her.

         15              SPEAKER:  (Speaking Spanish)

         16              THE INTERPRETER:  -- certain

         17    conditions of the air, you know, so when that

         18    person is working.  Also the method of

         19    applying the tarp, you know, it's the way

         20    they -- how work is explained, you know how

         21    they do it, you know when they -- you have to

         22    think in another way.  Things that something

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          1    that's very serious, the way that they -- the

          2    workers are being exposed.

          3              Well, the protection gear, that

          4    equipment -- it generate -- it's missing,

          5    they don't have it.  And talking about that

          6    equipment, it's not practical, it's not --

          7    due to the weather conditions in Florida,

          8    it's too hot.  You know, workers have said

          9    that even if they had it, you know, they

         10    don't have it though, but they only have the

         11    little things they have, maybe they won't be

         12    able to use it for more than half an hour

         13    because of the weather conditions.

         14              And training also, training is not

         15    for everybody and some people get trained,

         16    although others don't.  And there are several

         17    incidents -- people -- anecdotes, you know,

         18    people who didn't know that they were working

         19    on the field, well, after the -- it was --

         20    the land was fumigated and they sit down on

         21    the plastic for three minutes and they get

         22    burned.

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          1              So we see that they were still

          2    there, the pesticide was there.  And also air

          3    monitoring on the site, but it's also

          4    important to monitor the air in the

          5    community.  Because air quality, it's very

          6    important for people who live there because

          7    there are children there and we need to

          8    insure that that air quality is good, so

          9    that's what we're asking for, so we want for

         10    people to have access to that information.

         11    Air monitoring, so the community could have

         12    their own monitoring system.

         13              Thank you very much.

         14              THE MODERATOR:  Spanish speakers

         15    with numbers, if you could meet with the

         16    translator a few minutes before you get up to

         17    talk it would speed things up.  We've already

         18    made arrangements for a couple of other

         19    speakers.  If there is anyone else, please

         20    see the translator.  Number 32?  Number 33.

         21              MR. SCHIELER:  My name is Damien

         22    Schieler.  I'm an independent consultant and

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          1    I've been involved in -- speak-up?  Turn the

          2    mic up, is that better?  Okay, start over.

          3    Do I get the 4 minutes?

          4              Okay.  My name is Damien Schieler

          5    for the record.  I am an independent

          6    consultant in the Ag Industry.  I've been

          7    involved in agriculture for 32 years.

          8    Started out actually applying methyl bromide

          9    down there, cutting the plastic, riding the

         10    rigs, fumigating flowers -- I did that for

         11    roughly 15 years and then probably ended up

         12    with another 15 years as an Ag distributor

         13    involved in plastic culture, fumigation

         14    materials, and other farm chemicals.

         15              So I have been there, I've been in

         16    the trenches, been there a long time.  I've

         17    overseen and personally fumigated probably in

         18    the area of 15,000 acres, personally oversaw

         19    or sold product, worked on rigs to make sure

         20    they were calibrated properly, in proper

         21    working condition, and solved problems out in

         22    the field on probably another 50,000 or

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          1    60,000 acres.

          2              Yes, I have been exposed at times.

          3    And it is a problem, but it is something you

          4    need to deal with.  I guess what I'm trying

          5    to say is, as far as the exposure, of course

          6    I can't get pregnant, but I haven't had any

          7    problems siring kids either and they are well

          8    and healthy today.

          9              Education is very important in the

         10    handling, safe handling of chemicals and safe

         11    use and application of those chemicals.

         12              Over the past 32 years I've seen

         13    tremendous strides, not only in the labeling

         14    but also in the education, not only of the

         15    applicators but also the workers.  We have a

         16    WPS system, the train-a-trainer system,

         17    pesticide reviews.  Agriculture has lost a

         18    lot of chemicals over the last 20 years,

         19    particularly in the last 10.

         20              These are important chemicals.

         21    Yes, there's good reasons for losing some of

         22    these products, but also it puts the American

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          1    farmer at a disadvantage competing in this

          2    world market.  Those things need to be taken

          3    into consideration.

          4              The fact that we have set-backs,

          5    yes.  Set-backs are reasonable.  Our farming

          6    community is very reasonable.  They are much

          7    more up-to-date on the environment today,

          8    they are much more sensitive.  They are good

          9    stewards to the land.  They have to be

         10    because they live there and they earn a

         11    living off of that land, the same as farm

         12    workers or any and most other people in

         13    agriculture.

         14              Today the American farmer is

         15    disappearing.  We're seeing more and more

         16    corporate operations.  Again, I think it's

         17    got good and bad aspects to it.  On the good

         18    aspect, under corporate environments you're

         19    going to see more enforced pesticide handling

         20    procedure correctly, more training.  Those

         21    things are out there, it needs to be done.

         22              Set-backs, yes, they're reasonable,

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          1    but they need to be reasonable.  They can't

          2    be at half a mile, or three-quarters of a

          3    mile.  Look at what some of the charts are

          4    showing.  We'll lose 99 percent of the

          5    strawberry production in Florida if we go to

          6    the full extent of some of the possibilities

          7    of set-backs.

          8              Again, I'm not going to go over a

          9    lot of things that have been discussed today

         10    because they have talked well, brought up a

         11    lot of statistics.  I'm here to just testify

         12    as a person who has worked in agriculture,

         13    that agriculture is important to the state,

         14    it is important to this country.  And a lot

         15    of things are happening in this country to

         16    put the farmer in a disadvantage and make it

         17    more difficult for this country to be self-

         18    sustaining and, well, I guess that's what I

         19    have to say.

         20              So, thank you very much for

         21    listening to us.  I would urge you to extend

         22    the public comment period, because there is a

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          1    lot of data.  I think there still needs to be

          2    some testing done to confirm some of the

          3    things with different environments -- and

          4    please take that into consideration.  Thank

          5    you for your time.  Have a good day.

          6              MR. VENANGO:  My name is Ale

          7    Venango, director of farming for East Coast

          8    Brokers and Packers.  We operate about 7,000

          9    acres of tomatoes on east coast of United

         10    States, grown in Florida and Virginia.

         11              The buffer zones?  Anything over

         12    100 feet will be devastating, especially, in

         13    our Virginia operation.  Those fields are

         14    small.  There are houses around them, and now

         15    a 300-foot buffer zone in that state would

         16    knock out probably 75 percent of our

         17    production area.

         18              And as far as the small amounts, if

         19    you got 7,000 acres of plastic to lay in a

         20    year, you lay 20 acres a day, you're not

         21    going to make it.  That's the reason we try

         22    to lay more plastic, because we have to.  We

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          1    have to make our planting schedules.

          2              Moving from one field to another

          3    involves moving 7 to 8 pieces of equipment

          4    that's at least 21-feet wide, on a public

          5    highway.  That creates a whole another set of

          6    problems for you.  Virginia Highway Patrol

          7    have a lot to say about that.  So will

          8    Florida.

          9              The relocation of people is very

         10    difficult to do.  Even I have had people call

         11    when they felt they had a problem and I tried

         12    to relocate them, and it is very difficult to

         13    do.

         14              So, and lowering the rates.  We

         15    have lowered the rates.  We have gone to the

         16    heavier plastic and the rates are down to the

         17    low that I can see it impacting.  I see more

         18    nematodes.  I see more —————————— moving in

         19    on us, so we're about as low as we can go at

         20    this point, as far as lowering that.

         21              The PPE?  All for keeping everybody

         22    safe and training people, but I'm really

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          1    concerned about the PPE getting so cumbersome

          2    in the heat and hot weather that they are not

          3    able to work.  And you will have to shuttle a

          4    lot of people in and out of the area, and

          5    expose a lot more people to the fumigant if

          6    possible.

          7              So as far as the comment area, the

          8    time, I think we need more time and I would

          9    also like to encourage you to the

         10    implementation of these new regulations, if

         11    there is any way that we can phase them in,

         12    without it all coming down on us at one time,

         13    because you're only one agency.

         14              We have a meeting like this with

         15    the FDA on Tuesday, and I'm sure there will

         16    be somebody standing in line for the next

         17    week.  So, you know, we're complying with at

         18    least ten to a dozen different agencies.

         19    You're not the only one.  And everybody has

         20    some little something that they want and it

         21    is not that big, but you add it all together,

         22    it gets real big.

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          1              Thank you.

          2              MR. FRANCIS:  Good afternoon.  My

          3    name is Bruce Francis and I represent

          4    Weyerhaeuser Company, southern regeneration

          5    business, and I too thank you for this time

          6    to address this panel.  Weyerhaeuser

          7    Company's southern regeneration business is a

          8    division of their southern timberlands.  We

          9    operate four tree seedling nurseries in the

         10    southeast United States, providing bareroot

         11    pine and hardwood seedlings as well as

         12    containerized seedlings for reforestation.

         13              Since this business began in 1969,

         14    we've produced an excess of 5.5 billion

         15    seedlings that have been planted in the

         16    southeast U.S.  Currently, we produce over

         17    250 million seedlings a year.  Of this, only

         18    30 percent is used internally.  The rest goes

         19    to third-party customers that range from

         20    investment management organizations to forest

         21    industry to private land owners.

         22              Currently, we primarily use methyl

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          1    bromide and chloropicrin injected under tarp.

          2    We've been working the formulations down to

          3    minimum use to achieve our objectives, and

          4    we've have actually begun some limited

          5    production use of Telone chloropicrin under

          6    tarp, as an alternative to MBC.

          7              Since 1979, we've been actively

          8    engaged and spent close to $2 million in

          9    assessing biological and chemical

         10    alternatives to methyl bromide use for soil

         11    fumigation, both independently and with the

         12    Southern Forestry Nursery Cooperative and

         13    Oregon State University Nursery Cooperative.

         14              In 1994, Weyerhaeuser Company

         15    sponsored an alternative methyl bromide

         16    conference in Olympia, Washington and

         17    actually received a commendation from the EPA

         18    for the investigation and case study of

         19    alternatives to fumigants.

         20              The options to ensure the safety

         21    and enhance compliance are performed to some

         22    degree as required by federal regulations or

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          1    their good management practices, and we don't

          2    see these as being overly burdensome.  Issues

          3    such as the site fumigation management plans,

          4    good management practice that can become

          5    burdensome with overzealous bureaucracy.

          6    Defining responsibilities, record keeping,

          7    reporting, and tracking, all are good

          8    responsible agricultural practices.

          9              The mitigation measures that

         10    concern us are buffer zones, sealing methods,

         11    timing of application, application block

         12    limitations, respiratory protection, tarp

         13    cutting and removal, entry restriction and

         14    application method.

         15              All of our nurseries were

         16    originally built in remote areas with no

         17    occupied structures nearby.  There has been

         18    residential encroachment over the years

         19    around several of our nurseries.  And

         20    although we've never had an instance where

         21    nursery operations including soil fumigation

         22    have had a negative impact on bystanders, we

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          1    have gone ahead and purchased land where

          2    possible to protect our boundaries.

          3              Fixed minimum/maximum buffer zones,

          4    because they are a one-size-fits-all

          5    solution, are unworkable, because of the

          6    amount of land they will force out of

          7    production.

          8              The scenario, geographic and site-

          9    specific buffer zones still are highly

         10    problematic, because of all the variables

         11    involved.  We do recognize that they begin to

         12    provide flexibility for actual conditions on

         13    the ground and not drawn in an office.

         14    However, buffer zones of over 100 feet will

         15    still result in the loss of production acres

         16    of one or more of our nurseries.

         17              We currently use high density

         18    tarps, but that's a significant part of the

         19    fumigation cost structure.  VIF or metalized

         20    tarps are currently not feasible, due to

         21    inability to glue seams properly.  And if

         22    these technical difficulties are overcome we

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          1    need to continue to test to see if the costs

          2    can be offset by reduced fumigant use.

          3              Fumigation block is performed by an

          4    independent contractor.  Often more than one

          5    field is treated in a contract.  Any time you

          6    split a field into segments you lose

          7    efficiency and add cost.

          8              As far as respiratory protection,

          9    we support and follow the respiratory

         10    protection requirements provided by the

         11    manufacture's label, including type and fit

         12    testing and do not see a need for added

         13    regulation.

         14              Thank you.

         15              MR. McROLL:  I'm Dean McRoll, the

         16    regeneration manager for Rainier.  And I

         17    wanted to kind of put a face on this thing

         18    today with this graph I put up here.  We grow

         19    as far as tree seedlings for our 1.7 million

         20    acres in the southeast.  Earlier there was a

         21    slide about the impact of the forest

         22    industry.  Even though Georgia is called the

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          1    Peach State, forestry is the biggest business

          2    in the state of Georgia, a $20 billion a year

          3    impact on the state of Georgia.

          4              Just tell you a little bit about

          5    it, this is oldest forestry nursery in the

          6    south under original ownership.  Just this

          7    last year we celebrated our 50th anniversary.

          8    We had a rather big deal with that.  A lot of

          9    local dignitaries, six of our state

         10    representatives and senators and U.S.

         11    Congressman Jack Kingston saw fit to show up

         12    for our celebration.

         13              We're also an integral part of our

         14    community here.  Over the last five years,

         15    we've had 351 school children here at our

         16    nursery for visits.  And each one of those

         17    children has walked away with a tree of their

         18    own and our simulator.  I'll tell you some

         19    real good stories about the children and

         20    their trees.

         21              My major concern is with these

         22    buffer zones, and that's why I did these

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          1    slide.

          2              For many years we've applied

          3    fumigation in this setting without ever

          4    having a worker or bystander issue.  All of

          5    our operational fumigation that is completed

          6    under solid tarp.  We typically fumigate

          7    about 25 acres or less.  All fumigation is

          8    done by a contractor.

          9              Almost all fumigation is completed

         10    in October for sowing that will not occur

         11    until next April.  And you can see on this

         12    slide, the white fields -- this was a photo

         13    at the end of October -- those were done, and

         14    there's no one who reenters those fields

         15    until April of next year.

         16              So there are no worker issues with

         17    this, and we do leave our fumigation tarps --

         18    it is a solid tarp -- we leave them and we're

         19    not pressed for time.  We leave them on for

         20    an extended period of time.

         21              But we do use time of the day

         22    applications for those areas where we are

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          1    impacted on our borders.  It's worked well

          2    for us.  They're right here on this map.

          3    There are 18 offsite occupied home or

          4    businesses within 600 feet of our fields.

          5    Temporarily relocating this number of

          6    households will be rather difficult if not

          7    impossible.  But three of these just happen

          8    to be businesses, which the one at the very

          9    top is a funeral home.  So, relocating those

         10    will be, I think, even more difficult.

         11              If we go even further out up to the

         12    half-mile limit, if you go at the top -- and

         13    it is not on this photo -- you encompass a

         14    large trailer park and we approach almost 50

         15    units.

         16              To leave these fields untreated

         17    would not be a practical solution.  Studies

         18    have shown that without fumigation less than

         19    half of our seedlings produced would be

         20    plantable, and the costs for these seedlings

         21    would increase substantially.

         22              And I'm a bit concerned, based on

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          1    some of the earlier presentations, that we

          2    don't have enough data on solid tarp forest

          3    fumigation to make some of the decisions that

          4    we are making on this.  We need more data on

          5    this.

          6              It is my opinion that our present

          7    fumigation system works well.  I don't think

          8    that the more restrictive applications are

          9    going to improve.  We all know the benefits

         10    of trees -- clean water, clean air -- and I

         11    was telling somebody earlier today, our

         12    company has lost 64,000 acres in the fires

         13    here in this past two months.  And while the

         14    bright spot of that is that it's good for my

         15    business -- I felt good about that -- I'm not

         16    feeling so good about what I'm hearing today.

         17              Thank you.

         18              THE MODERATOR:  37?  38?

         19              MR. ROMERO:  Good afternoon.  My

         20    name is Pedro Jesus Romero.  I'm here talking

         21    as a member of the community, and I thank you

         22    for giving me the opportunity to express

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          1    myself.  But I find it very sad for the time

          2    chosen for this meeting, which is at the same

          3    time that most of the workers whose health is

          4    affected by these chemicals and this

          5    poisoning affect of the fumigants and that

          6    these workers have already left the area, and

          7    have no opportunity to offer their testimony.

          8              I heard a lot about these safety

          9    zones and how to reduce them, to make them

         10    smaller.  But I haven't heard anything about

         11    the dangers that these chemicals are causing

         12    to the ozone layer, its protection.

         13              Neither I haven't heard about the

         14    one —————————— protocol where 160 countries

         15    agree to phase out the use of methyl bromide.

         16    If its destructive effect go as far as the

         17    stratosphere, what can make you believe that

         18    it is not going to go beyond the safety

         19    zones?  Why could it be safe for all of us?

         20              I just want to finish with

         21    something.  Please, let's look to alternative

         22    safer method for the agriculture, so to

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          1    balance the ecological system and the health

          2    of the earth for future generations to come.

          3              Thank you.

          4              THE MODERATOR:  Number 39.

          5              SPEAKER:  (Spanish spoken)

          6              THE INTERPRETER:  I work for the

          7    association, and I've come from Homestead and

          8    we train people.  We have been basically

          9    trained to how to protect themselves against

         10    pesticides.  During the training sessions, we

         11    hear the testimonies of the people.

         12              Well, the chemicals are always

         13    there.  They are before the harvest and after

         14    the harvest and that some of the people that

         15    work there they get shortness of breath, and

         16    they are afraid to report because some of

         17    them don't even speak English, so they are

         18    afraid to report.  Some of them are from

         19    Guatemala and they don't even speak English.

         20    So that's what is going on at the present

         21    time.

         22              I think that is very important and

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          1    that what we have talked to, and stay here

          2    and we should follow up everything we have

          3    said so far, because training is very

          4    important and people are talking also about

          5    equipment.  So I think that if you have

          6    equipment available for your workers, I think

          7    that you care about their health.  So that's

          8    why I think it is important that we could

          9    follow up.

         10              But I also know about employers

         11    that put their employees to work without any

         12    training and working with chemicals without

         13    any training and they don't have any kind of

         14    equipment.

         15              We in our association, we train the

         16    workers how to work safely and also we give

         17    them this brochure and I'm going to give you

         18    this brochure so you could have it.

         19              Now, we'll allow for this to have

         20    some follow-up.  Thank you so much.

         21              THE MODERATOR:  Number 40.

         22              SPEAKER:  (Spanish spoken)

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          1              THE INTERPRETER:  Well, my name is

          2    Christo Va Kalsara.  I first started working

          3    in the '80s -- 1980 -- and my first job was

          4    cutting plastic, cutting the tarps, and

          5    taking care of that section.

          6              Well, after a while, many years

          7    after, I started itching, my whole body

          8    started itching.  My nose, my ears, my eyes.

          9    I had watery eyes that had a lot of water and

         10    then phlegm and at night, especially at

         11    night, a lot of saliva.

         12              Well, we work many hours.  We

         13    actually work from 8 to 10 hours, you know,

         14    and we are exposed to pesticides and also the

         15    gas that comes out of the tarp when we work

         16    with plastics.

         17              I stopped working there like eight

         18    years ago, but I now have symptoms still,

         19    because I'm kind of shaky and it looks like

         20    Parkinson's disease, but it is not

         21    Parkinson's.  It's just the results of my

         22    performance there.

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          1              THE MODERATOR:  Thank you.  Number

          2    41.

          3              SPEAKER:  (Spanish spoken.)

          4              THE INTERPRETER:  Good afternoon.

          5    My name is Norveto Humanis.  I'm a member of

          6    the coalition of Amakali (?) workers.  I'm

          7    here representing my companions who, like

          8    myself, work picking tomatoes in Amakali.

          9              And I'm a worker and I have lived

         10    and worked in these conditions firsthand in

         11    my own flesh and blood, and I have worked

         12    with the plastic and I have cut the plastic

         13    and when you lift it up, you start to

         14    immediately cry and the mucus starts coming

         15    out of your nose.  And you're very much

         16    affected by these chemicals.

         17              And I'm not against these chemicals

         18    in and of themselves, because we know that

         19    without them we can't produce the plants.

         20    But what I'm here to say is that we need to

         21    take steps so that these chemicals will not

         22    affect human beings the way that they are

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          1    doing right now.

          2              And I'm here not only to talk about

          3    what happens to the men in the fields, but

          4    also the women, and in particular the ones

          5    who are pregnant.  And like a lot of people

          6    have said here today, it's true that women

          7    working in the fields who are pregnant have

          8    had babies that have come out deformed and

          9    missing parts of their bodies.

         10              And even when we are working

         11    normally on a day to day basis, when we are

         12    reaching into the plant and spreading it

         13    apart to be able to grab the tomatoes, we

         14    feel those chemicals coming out from those,

         15    the machines that have sprayed on those

         16    plants, and we feel the burning sensation and

         17    everything.

         18              And there in the course of the work

         19    day when we want to stop for a few minutes

         20    and eat something, there are fields where

         21    there isn't even water for us to wash our

         22    hands with.  So many times we have to go wash

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          1    our hands in a ditch which is also

          2    contaminated with the same chemicals.  For

          3    these reasons, this is why there's a lot of

          4    workers in our community of Amakali who are

          5    sick right now.

          6              And so today I'm here to ask you

          7    people on the table, what you are going to do

          8    to defend our rights and our health, and

          9    because obviously a lot of the people in this

         10    room are here to defend their interest and

         11    their production and that's fine, but we also

         12    want to make people remember that we are also

         13    a part of this, and we are also human beings,

         14    and we need our rights and our health to be

         15    looked after also.

         16              And I come from Oaxaca, Mexico, and

         17    a lot of times people demand that the

         18    products that we provide be organic and free

         19    of chemicals.  And why is that here in this

         20    country things are allowed to be made with so

         21    many chemicals in them?  And I think this is

         22    something that's bad, not only for the health

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          1    of workers, but also for also for consumers.

          2              And I just ask all the people up

          3    there on the table to keep all these things

          4    in mind, and that there are many of us

          5    workers in Amakali who are being severely

          6    affected by all these chemicals.  And I hope

          7    that everything that we talked about today in

          8    this dialog will produce something favorable

          9    for us as the workers.

         10              Thank you.

         11              MR. ONESS:  Good afternoon and

         12    thank you.  I'll speak English instead of my

         13    native language as we don't have an

         14    interpreter.  It's a little bit of a joke, to

         15    have some humor here.  My name is Oness, and

         16    I'm going to speak for myself.

         17              I want to mention four items

         18    briefly, but before, what is most important

         19    is that EPA extends the comment time period.

         20    There are many so-called stakeholders that

         21    are not represented here, especially in the

         22    environment and community, grassroots

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          1    community, that is very much affected from a

          2    lot of agriculture and forest chemicals and

          3    fumigants.

          4              Briefly I want to mention I'm a

          5    Native American biologist, and since the age

          6    of 14 I have worked in agriculture and

          7    horticulture.  And I will tell you, part of

          8    the reason why I'm in a wheel chair is

          9    because I was contaminated years ago as a

         10    teenager in my youth long before EPA cared

         11    about, or was supposed to care about, health

         12    and the environment and social justice.

         13              I spent 6 years as a university

         14    biologist, specifically as a field biologist

         15    doing environmental monitoring impact

         16    assessment of pesticides and agriculture in

         17    forestry, and I worked under the soil

         18    scientist, Dr. Struckmeyer, and anyone that

         19    knows much about pesticides and soils, knows

         20    that he is one of the primary authors of that

         21    subject in university curriculum.

         22              And so I'm qualified to speak about

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          1    the few biological impacts I'm going to

          2    briefly mention.  But my concern is that --

          3    and it was expressed by, I believe it was the

          4    representative of the Florida Department of

          5    Agriculture -- that many government agencies

          6    including yours, EPA, does not have the

          7    scientific, or financial, or staff resources

          8    to do real, serious environment monitoring.

          9              I am very concerned about the

         10    so-called Growers Certification Project.

         11    I've seen first hand that a lot of the so-

         12    called training programs are nothing more

         13    than almost weekend barbecues, where a lot of

         14    the growers really do not have field training

         15    manuals, do not have competent people

         16    instructing their staff or workers.

         17              And when you compound that problem

         18    with a lot of workers who are not English

         19    speakers, who perhaps might be undocumented,

         20    what the attorney said here earlier, which I

         21    don't know her, but I can tell you as a

         22    journalist covering this issue for many

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          1    years, that she's absolutely correct that

          2    there are many incidents that happen

          3    throughout the southeast that do not go

          4    reported.

          5              And also those issues that are

          6    reported are primarily acute incidents.  I'm

          7    concerned about long-term chronic impacts of

          8    soil fumigants.  And getting back to what I

          9    said about environmental monitoring, in 1977

         10    the National Academy of Sciences report,

         11    about what constitutes environmental

         12    monitoring and impact assessment, has never

         13    yet even been scientifically continued in,

         14    now, 2007.  So, there's a real serious

         15    problem about environmental monitoring with

         16    federal and state agencies, and to expect

         17    growers or the pesticide industry to do that

         18    is even more absurd.

         19              Last but not least, I was very

         20    upset about the so-called IFIS

         21    representative.  Here is a person being

         22    employed by public money, public state

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          1    university institution, talking about that

          2    there was really little problems or

          3    environmental health impacts, or health

          4    impacts to the environment from soil

          5    fumigants.

          6              And that person should really be

          7    working for the Nuclear Regulatory

          8    Commission, if you believe his statements.

          9              So I was very upset about this idea

         10    of, again, issue of enforcement, issue of

         11    environmental monitoring, issue of safety

         12    training.  There really needs to be a lot

         13    more thought going into this, and it must be

         14    done by forced agency regulations, not

         15    volunteer by the industry.

         16              Last but not least, this is an

         17    issue of environmental justice.  And I really

         18    can't stress upon you the fact that the

         19    Florida's ecosystem is very different from

         20    other places, not just the biological

         21    conditions, but the socioeconomic conditions,

         22    and you really need to really be very

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          1    specific about not letting industry and

          2    agriculture fool you into thinking that the

          3    sky is falling.

          4              You really need to implement buffer

          5    zones.  You really need to implement these

          6    mitigation measures that you were

          7    considering, like residency times, and many

          8    other things.  So I will be presenting things

          9    in written comment.

         10              Thank you.

         11              THE MODERATOR:  Thank you all for

         12    dealing with my iron fist today, not too much

         13    grumbling about that, and I appreciate it,

         14    and we are on time.  Because of that we're

         15    able to hopefully get you out on the road

         16    before it gets too rainy.

         17              There are some wrap-up comments by

         18    the EPA.  I'd like to state again that my

         19    name is Jennifer Julette.  My business cards

         20    and my information are on the back table.  So

         21    if you have any issue with my representation

         22    today, you are welcome to pick up whatever

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          1    you'd like and send a letter, a nastygram

          2    because I cut you off, or send a thank-you.

          3    I like the thank-yous.

          4              So, I'd also like to encourage you

          5    to look at our website and some of the IFIS

          6    recommendations, and what IFIS has been doing

          7    with some of this methyl bromide research.

          8              ———————————————————————————————————

          9    ——————————————————————— quite far away as did

         10    we.  But I think in our case at least we

         11    really feel it was worth it, because we got

         12    to hear from all of you.  We really hope that

         13    you will take seriously our offer, and take

         14    advantage of the opportunity to provide

         15    written comments as well to the docket.

         16              What helps us tremendously is to

         17    have actual data and information that we can

         18    use to document our decisions.  And so,

         19    anything you have at all in that area will be

         20    very helpful, in addition to your ideas about

         21    future research that we might do in the out

         22    years as we move forward on these decisions.

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          1              So again, thank you very much.  We

          2    intend to take all these comments, as I said,

          3    transcribe them, put them in the docket, and

          4    we are going to very carefully consider them.

          5    We are going to extend the comment period.

          6              So, thank you for coming.

          7                   (Whereupon, the PROCEEDINGS were

          8                   adjourned.)

          9

         10

         11

         12                       *  *  *  *  *

         13

         14

         15

         16

         17

         18

         19

         20

         21

         22

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[Federal Register Volume 88, Number 213 (Monday, November 6, 2023)]
[Notices]
[Pages 76218-76219]
[FR Doc No: 2023-24506]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-P-2536]

Determination That FORADIL (Formoterol Fumarate) Inhalation
Powder, 0.012 Milligrams, Was Not Withdrawn From Sale for Reasons of
Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) has
determined that FORADIL (formoterol fumarate) inhalation powder, 0.012
milligrams (mg)/inhalation (inh), was not withdrawn from sale for
reasons of safety or effectiveness. This determination will allow FDA
to approve abbreviated new drug applications (ANDAs) for formoterol
fumarate inhalation powder, 0.012 mg/inh, if all other legal and
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Joe Thomas, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6217, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved; and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act requires FDA to publish a list of
all

approved drugs. FDA publishes this list as part of the ``Approved Drug
Products With Therapeutic Equivalence Evaluations,'' which is known
generally as the ``Orange Book.'' Under FDA regulations, drugs are
removed from the list if the Agency withdraws or suspends approval of
the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA
determines that the listed drug was withdrawn from sale for reasons of
safety or effectiveness (21 CFR 314.162).
    A person may petition the Agency to determine, or the Agency may
determine on its own initiative, whether a listed drug was withdrawn
from sale for reasons of safety or effectiveness. This determination
may be made at any time after the drug has been withdrawn from sale,
but must be made prior to approving an ANDA that refers to the listed
drug (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that
does not refer to a listed drug.
    FORADIL (formoterol fumarate) inhalation powder, 0.012 mg/inh, is
the subject of NDA 020831, held by Novartis Pharmaceuticals Corp., and
initially approved on February 16, 2001. FORADIL is indicated for
treatment of asthma in patients 5 years of age and older as an add-on
to a long-term asthma control medication such as an inhaled
corticosteroid; prevention of exercise-induced bronchospasm (EIB) in
patients 5 years of age and older; and maintenance treatment of
bronchoconstriction in patients with chronic obstructive pulmonary
disease.
    In a letter dated September 30, 2015, Novartis Pharmaceuticals
Corp. notified FDA that FORADIL (formoterol fumarate) inhalation
powder, 0.012 mg/inh, was being discontinued, and FDA moved the drug
product to the ``Discontinued Drug Product List'' section of the Orange
Book. In the Federal Register of June 21, 2018 (83 FR 28856), FDA
announced that it was withdrawing approval of NDA 020831, effective
July 23, 2018.
    K&L Gates LLP submitted a citizen petition dated June 21, 2023
(Docket No. FDA-2023-P-2536), under 21 CFR 10.30, requesting that the
Agency determine whether FORADIL (formoterol fumarate) inhalation
powder, 0.012 mg/inh, was withdrawn from sale for reasons of safety or
effectiveness.
    After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec.  314.161 that FORADIL (formoterol fumarate) inhalation
powder, 0.012 mg/inh, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that FORADIL (formoterol fumarate) inhalation
powder, 0.012 mg/inh, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of FORADIL (formoterol fumarate) inhalation
powder, 0.012 mg/inh, from sale. We have also independently evaluated
relevant literature and data for possible postmarketing adverse events.
We have reviewed the available evidence and determined that this drug
product was not withdrawn from sale for reasons of safety or
effectiveness.
    Accordingly, the Agency will continue to list FORADIL (formoterol
fumarate) inhalation powder, 0.012 mg/inh, in the ``Discontinued Drug
Product List'' section of the Orange Book. The ``Discontinued Drug
Product List'' delineates, among other items, drug products that have
been discontinued from marketing for reasons other than safety or
effectiveness. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also be approved by the Agency as long as they
meet all other legal and regulatory requirements for the approval of
ANDAs. If FDA determines that labeling for this drug product should be
revised to meet current standards, the Agency will advise ANDA
applicants to submit such labeling.

    Dated: November 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24506 Filed 11-3-23; 8:45 am]
BILLING CODE 4164-01-P