[Federal Register Volume 59, Number 66 (Wednesday, April 6, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-8093]
[[Page Unknown]]
[Federal Register: April 6, 1994]
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Part X
Department of Agriculture
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Agricultural Marketing Service
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7 CFR Part 110
Recordkeeping Requirements for Certified Applicators of Federally
Restricted Use Pesticides; Proposed Rules
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 110
[SD-94-001 PR]
RIN No. 0581-AA39
Recordkeeping Requirements for Certified Applicators of Federally
Restricted Use Pesticides
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Agricultural Marketing Service, United States Department
of Agriculture, proposes to revise its regulations in 7 CFR Part 110,
governing recordkeeping of federally restricted use pesticides by
certified applicators. The regulations governing recordkeeping of
federally restricted use pesticides by certified applicators were
published on April 9, 1993, and became effective on May 10, 1993. Since
that time, issues have been raised regarding the regulations. A lawsuit
was filed challenging the substance of limited portions of the
regulations. The changes specified in the proposed rule would clarify
certain provisions of the regulations, ensure consistency with the
objectives of section 1491 of the Food, Agriculture, Conservation, and
Trade Act of 1990, and provide for a more pragmatic approach to the
implementation of the Pesticide Recordkeeping Program.
DATES: Comments must be received on or before June 6, 1994.
ADDRESSES: Written comments concerning this proposal should be sent to
Bonnie L. Poli, Docket Manager, USDA-AMS, Science Division, 8700
Centreville Road, suite 200, Manassas, Virginia 22110, and should refer
to the docket title and number located in the heading of this document.
All comments submitted in response to this proposal will be available
for public inspection in Room 3507, South Agriculture Building, 14th &
Independence Avenues, SW., between the hours of 9 a.m. and 4 p.m.,
Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Bonnie Poli, Chief, Pesticide Records
Branch, Science Division, AMS, 8700 Centreville Road, suite 200,
Manassas, VA 22110, 703-330-7826.
SUPPLEMENTARY INFORMATION:
Executive Order 12866 and Regulatory Flexibility Act
This rule has been determined to be non-significant for purposes of
Executive Order 12866 and therefore has not been reviewed by OMB.
This proposed rule also has been reviewed under the Regulatory
Flexibility Act (5 U.S.C. 601 et. seq.). This proposed rule will (1)
clarify certain definitions within the regulations; (2) clarify the
availability of pesticide record information to facilitate medical
treatment or first aid; (3) clarify the utilization and release of
pesticide record information by licensed health care professionals; (4)
modify the time period by which the information required by the
regulations shall be officially recorded, and (5) ensure uniformity in
recording the location of pesticide applications by removing the
distinction between recording spot applications and other applications
of federally restricted use pesticides. We do not anticipate that any
of these proposed changes will result in any significant additional
economic impact on certified (private and commercial) applicators of
federally restricted use pesticides.
Under these circumstances, the Administrator of the Agricultural
Marketing Service has determined that this action will not have a
significant economic impact on a substantial number of small entities.
Executive Order 12778
This proposed rule has been reviewed under Executive Order 12778,
Civil Justice Reform. If adopted, this proposed rule: (1) Will not
preempt any state or local laws, regulations, or policies, unless they
present an irreconcilable conflict with this rule; (2) will not have
any retroactive effect; and (3) will not require administrative
proceedings before parties may file suit challenging this rule.
Paperwork Reduction Act
In accordance with section 3507 of the Paperwork Reduction Act of
1980 (44 U.S.C. 3507), the recordkeeping provisions included in this
proposed rule have been approved by the Office of Management and Budget
(OMB), number 0581-0164. The proposed rule does not change the data
elements required for a record or the collection of information.
Background
As part of the Food, Agriculture, Conservation, and Trade Act of
1990 (Pub.L. 101-624; 7 U.S.C. 136i-1), hereinafter referred to as the
FACT Act, Congress mandated the establishment, by the Secretary of
Agriculture in consultation with the Administrator of the Environmental
Protection Agency, of requirements for recordkeeping by all certified
applicators of federally restricted use pesticides.
Applicator certification programs are administered by EPA, other
Federal Agencies, and States. A restricted use pesticide, as
distinguished from a general use pesticide, is one that has been
classified as such under the Federal Insecticide, Fungicide, and
Rodenticide Act (FIFRA, at 7 U.S.C. 136a(d)(1)(C)). EPA regulations
issued under FIFRA, further provide that restricted use pesticides may
be applied only by, or under the supervision of, a certified
applicator. Applicator certification requirements are provided in the
EPA regulations (40 CFR 171).
A certified applicator may be a commercial applicator or a private
applicator. A private applicator is one who uses or supervises the use
of any restricted use pesticide for purposes of producing any
agricultural commodity: (1) On property that is owned or rented by the
applicator, or the employer of the applicator; or (2) if applied
without compensation other than trading of personal services between
producers of agricultural commodities, on the property of another
person. A commercial applicator is one who uses or supervises the use
of a restricted use pesticide for any purpose or on any property other
than as provided under the definition of a private applicator.
On April 9, 1993, final regulations were published in the Federal
Register, ``Recordkeeping Requirements for Certified Applicators of
Federally Restricted Use Pesticides.'' These regulations went into
affect on May 10, 1993. USDA proceeded to implement a national program
for recordkeeping of federally restricted use pesticides. One of USDA's
first goals was to inform certified pesticide applicators of their
responsibilities under the new regulations.
Early in the implementation phase of the USDA recordkeeping
program, State regulatory agencies and others raised issues involving
specific interpretations of the regulations. A lawsuit was filed
against the Secretary of Agriculture and the Administrator of the
Environmental Protection Agency by the National Coalition Against the
Misuse of Pesticides and others. The lawsuit challenged the substance
of limited portions of the final regulations promulgated by USDA. After
careful consideration of the issues raised by the lawsuit and a
thorough review of the regulations, we agreed to propose changes to the
regulations for the reasons set forth below.
Proposed Amendments to Sec. 110.2 Definitions
Concerns were raised that the regulation's definition of ``medical
emergency'' was too restrictive and could hinder the medical treatment
by licensed health care professionals of an individual(s) who may have
been exposed to a federally restricted use pesticide. It was pointed
out that some particular pesticide exposures could require immediate
medical treatment or first aid, but would not meet the criteria of the
current definition. It is not the intent of USDA to limit medical
treatment of an individual(s) who may have been exposed to a restricted
use pesticide. Because reactions to some pesticide exposures could
require treatment immediately and not fit the current definition of
``medical emergency,'' USDA is proposing to amend the definition of
``medical emergency'' to read as follows:
Medical Emergency. A medical emergency shall be defined as a
situation that requires immediate medical treatment or first aid.
Questions also were raised concerning the definition of ``licensed
health care professional.'' There was some confusion as to whether
medically trained individuals who had been certified by a State, such
as medical technicians on an ambulance or emergency response vehicle,
met the definition. USDA wishes to clarify that individuals that have
been licensed or certified by a State to provide medical treatment are
considered to be ``licensed health care professionals.'' Therefore,
individuals such as physicians, nurses, physician assistants, or
emergency medical technicians, licensed or certified by a State to
provide medical treatment, would fall into the definition of ``licensed
health care professionals.'' However, individuals who have been
certified only to provide first aid or cardiopulmonary resuscitation
(CPR) through organizations such as the American Red Cross would not be
``licensed health care professionals.''
In order to clarify this definition, USDA is proposing to amend the
definition of ``licensed health care professional'' to read as follows:
Licensed health care professional. A physician, nurse, emergency
medical technician, or other qualified individual, licensed or
certified by a State to provide medical treatment.
Proposed Amendment to Sec. 110.3(a)(6)--Spot Applications
The reduced requirements for recording information for spot
applications were intended to provide private certified applicators
with an incentive to record small spot applications on noxious weeds or
similar type applications, without recording each location, due to the
usually small amount of pesticide associated with a spot treatment.
Concerns were raised that the spot application record provision does
not require a specific location for each spot application, which could
be important information for the purpose of providing first aid or
medical treatment. USDA has reviewed the spot application provision and
agrees that, in some instances, the location of spot applications could
be valuable information when needed to determine if a pesticide
exposure could have occurred in a field or area. Therefore, we are
proposing to delete Sec. 110.3(a)(6). Under the proposed regulations,
spot applications would be required to be recorded in the same manner
as are other applications of federally restricted use pesticides. This
would provide field or area locations which could be utilized to help
determine if an individual could have been exposed to a federally
restricted use pesticide.
Proposed Amendment to Sec. 110.3(b)--Time for Making an Official Record
USDA has reevaluated the 30 day time period allowed certified
applicators to make an official record after concerns were expressed
regarding the accuracy of the records for both collecting information
for a pesticide use data base and for medical treatment if application
information was not required to be recorded for 30 days. USDA
recognizes the importance of compiling accurate pesticide use data and
believes that data recorded in a shorter time period would be more
accurate. USDA also reexamined existing State requirements for making
official records of pesticide applications for private and commercial
certified applicators. We found that many State regulations require
applicators to have records available ``upon request'' which, in some
situations, could be interpreted to be immediately after an
application. Therefore, to assure more accurate information for both
medical treatment and accuracy of collected data on pesticide use, USDA
proposes to change the time period from 30 days to 7 days. USDA
considers the proposed 7 day requirement adequate to allow the private
certified applicator time to make an accurate official record without
causing an undue hardship in peak production periods. This proposed
requirement also is less stringent than similar existing State
requirements for recordkeeping in many States.
Additionally, concerns were raised regarding the certified
applicator's responsibility to provide federally restricted use
pesticide information concerning a specific application prior to the
time to make an official record for purposes of providing medical
treatment. USDA interprets the current regulations to require certified
applicators to provide the record information for purposes of providing
medical treatment or first aid, in accordance with the provisions of
Sec. 110.5(a), whether or not the time to make an official written
record has elapsed. Nonetheless, in order to make this clear, we
propose to add explicit language to this effect. The proposed amendment
would read as follows:
The information required in this section shall be recorded
within seven (7) days following the pesticide application. However,
whether or not the written record has been completed, the certified
applicator shall provide the information to be recorded in
accordance with the provisions of Sec. 110.5(a) of this part.
Proposed Amendments to Sec. 110.5(a)--Availability of Records to
Facilitate Medical Treatment
Questions also have been raised concerning the availability of
records to facilitate medical treatment. Concern was expressed that the
current regulations could hinder access to record information if a
strict interpretation was applied to the need for the licensed health
care professional to personally make the record information request.
USDA never intended to prevent an individual acting under the direction
of the attending licensed health care professional from requesting
record information. We are aware that, in some instances, the attending
licensed health care professional may rely on a person acting under
his/her direction to make the contacts necessary to obtain the
pesticide record information. However, the regulations also presume the
request for pesticide record information is supported by indications of
pesticide exposure and the need for medical treatment or first aid. For
example, the attending licensed health care professional, such as a
registered nurse, may determine that the pesticide record information
will be necessary to treat the patient, and instruct someone under his/
her direction, to obtain the record information.
In order to clarify the availability of pesticide record
information to facilitate medical treatment, USDA proposes to amend
Sec. 110.5(a) to read as follows:
When a licensed health care professional, or an individual
acting under the direction of the attending licensed health care
professional, determines that any record of the application of
restricted use pesticide required to be maintained under Sec. 110.3
of this part is necessary to provide medical treatment or first aid
to an individual who may have been exposed to the restricted use
pesticide for which the record is or will be maintained, the
certified applicator required to maintain the record shall promptly
provide the record information and any available label information.
If it is determined by a licensed health care professional, or an
individual acting under the direction of the attending licensed
health care professional, to be a medical emergency, the record
information of the restricted use pesticide, relating to the medical
emergency, shall be provided immediately.
Proposed Amendments to Sec. 110.5(b)--Release of Record Information by
licensed Health Care Professionals
Under the current regulations, licensed health care professionals
may release record information obtained through Sec. 110.5(a) only when
necessary to provide medical treatment or first aid to an individual
who may have been exposed to the restricted use pesticide for which the
record is maintained. Concerns were raised that some confusion could
exist among licensed health care professionals as to the extent to
which they could share or utilize pesticide record information.
Concerns were expressed that licensed health care professionals, or an
individual acting under the direction of the attending licensed health
care professional, could be reluctant to release pesticide record
information to other medical professionals, who may need to be
consulted, to provide proper medical treatment.
Issues also were raised concerning the release of the record
information as it relates to pesticide poisoning incident reports, and
the need to assure licensed health care professionals that they could
release pesticide record information for this purpose. Some States
require pesticide poisoning incident reporting to a designated State or
county agency. For example, California has a law that requires
physicians to submit a pesticide poisoning incident report to the
California Worker Health and Safety Division. Additionally, in States
which do not require the filing of a pesticide poisoning incident
report, physicians or other medical professionals are encouraged to
report incidents to the local poison control centers. These local
poison control centers then may send data to the Toxic Exposure
Surveillance System of the American Association of Poison Control
Centers (AAPCC) database, which provides an annual compilation of
poisoning statistics from around the United States. USDA believes the
release of pesticide record information for this purpose is
appropriate.
USDA also recognizes that a licensed health care professional may
deem it necessary under their responsibility to a code of medical
ethics to utilize pesticide record information to prevent additional
poisoning or injuries. For example, as a result of treating an
individual who had been exposed to a federally restricted use
pesticide, the licensed health care professional may feel it necessary
to release the record information to the proper State or county
authorities in order to remove workers from an area where pesticide
exposure could be occurring.
Therefore, in order to clarify the circumstances under which the
federally restricted use pesticide information can be utilized and
released, and who has authority to release this information, USDA
proposes to amend Sec. 110.5(b) to read as follows:
A licensed health care professional, or an individual acting
under the direction of the attending licensed health care
professional, may utilize and release record or record information
obtained under paragraph (a) of this section when necessary to
provide medical treatment or first aid to an individual or
individuals who may have been exposed to the restricted use
pesticide for which the record is or will be maintained. Further
utilization and release of such record or record information is
limited to licensed health care professionals who may use it: (1) To
submit pesticide poisoning incident reports to appropriate State or
Federal agencies, or (2) where consideration of medical ethics may
necessitate such utilization and release.
Proposed Amendments to Sec. 110.7--Penalties
Several State pesticide regulatory agencies had questions in regard
to the penalty provision in Sec. 110.7 of the current regulations.
These agencies interpreted this section to provide that the
Administrator, or his designee, would have discretion to reduce the
penalty for a second violation of the regulations to less than $1,000
if it was determined that the certified applicator made a good faith
effort to comply with the regulations, but, that the Administrator, or
his designee, would not have discretion to reduce the penalty to less
than $1,000 for other subsequent offenses.
USDA has reexamined this issue and agrees that the current language
could be unclear. We, therefore, propose to amend the penalty section
to eliminate any ambiguity. We are proposing that all offenses
subsequent to the first offense would be subject to a fine of not less
than $1,000, except that the penalty shall be less than $1,000 if the
Administrator, or his designee, determines that the certified
applicator made a good faith effort to comply with the regulations.
This proposed change follows the language of the statute and provides
the Administrator, or his designee, flexibility in assessing penalties
for all subsequent offenses, not just the second offense.
Therefore, USDA proposes to amend Sec. 110.7 to read as follows:
Section 1491(d) of the Food, Agriculture, Conservation, and
Trade Act of 1990 provides that the Secretary shall be responsible
for enforcement of section 1491 (a), (b), and (c) of the Food,
Agriculture, Conservation, and Trade Act of 1990. Therefore, as
provided in section 1491(d) of the Food, Agriculture, Conservation,
and Trade Act of 1990, any certified applicator who violates the
requirements of 7 U.S.C. 136i-1 (a), (b), or (c) shall be subject to
a civil penalty of not more than $500 in the case of the first
offense, and in the case of subsequent offenses, be subject to a
fine of not less than $1,000 for each violation, except that the
penalty shall be less than $1,000 if the Administrator, or his
designee, determines that the certified applicator made a good faith
effort to comply with this Part.
List of Subjects in 7 CFR Part 110
Pesticide and pests, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble 7 CFR, part 110 is
proposed to be amended as follows:
PART 110--RECORDKEEPING ON RESTRICTED USE PESTICIDES BY CERTIFIED
APPLICATORS; SURVEYS AND REPORTS
1. The authority citation for part 110 would continue to read as
follows:
Authority: 7 U.S.C. 136a(d)(1)(c); 7 U.S.C. 136i-1; 7 U.S.C.
450; 7 CFR 2.17, 2.50.
2. In Sec. 110.2, the definition for licensed health care
professional is amended by adding the phrase ``or certified''
immediately following ``licensed.''
3. In Sec. 110.2, the definition for medical emergency is revised
to read as follows:
Sec. 110.2 Definitions.
* * * * *
Medical emergency. A medical emergency shall be defined as a
situation that requires immediate medical treatment or first aid.
* * * * *
4. In Sec. 110.3, paragraph (a)(6) is removed and paragraph (b) is
revised to read as follows:
Sec. 110.3 Records, retention, and access to records.
* * * * *
(b) The information required in this section shall be recorded
within seven (7) days following the pesticide application. However,
whether or not the written record has been completed, the certified
applicator shall provide the information to be recorded in accordance
with the provisions of Sec. 110.5(a) of this part.
* * * * *
5. Section 110.5 is revised to read as follows:
Sec. 110.5 Availability of records to facilitate medical treatment.
(a) When a licensed health care professional, or an individual
acting under the direction of the attending licensed health care
professional, determines that any record of the application of
restricted use pesticide required to be maintained under Sec. 110.3 of
this part is necessary to provide medical treatment or first aid to an
individual who may have been exposed to the restricted use pesticide
for which the record is or will be maintained, the certified applicator
required to maintain the record shall promptly provide the record
information and any available label information. If it is determined by
a licensed health care professional, or an individual acting under the
direction of the attending licensed health care professional, to be a
medical emergency, the record information of the restricted use
pesticide, relating to the medical emergency, shall be provided
immediately.
(b) A licensed health care professional, or an individual acting
under the direction of the attending licensed health care professional,
may utilize and release record or record information obtained under
paragraph (a) of this section when necessary to provide medical
treatment or first aid to an individual or individuals who may have
been exposed to the restricted use pesticide for which the record is or
will be maintained. Further utilization and release of such record or
record information is limited to licensed health care professionals who
may use it:
(1) To submit pesticide poisoning incident reports to appropriate
State or Federal agencies; or
(2) Where considerations of medical ethics may necessitate such
utilization and release.
6. Section 110.7 is revised to read as follows:
Sec. 110.7 Penalties.
Section 1491(d) of the Food, Agriculture, Conservation, and Trade
Act of 1990 provides that the Secretary shall be responsible for
enforcement of section 1491 (a), (b), and (c) of the Food, Agriculture,
Conservation, and Trade Act of 1990. Therefore, as provided in section
1491(d) of the Food, Agriculture, Conservation, and Trade Act of 1990,
any certified applicator who violates the requirements of 7 U.S.C.
136i-1 (a), (b), or (c) shall be subject to a civil penalty of not more
than $500 in the case of the first offense, and in the case of
subsequent offenses, be subject to a fine of not less than $1,000 for
each violation, except that the penalty shall be less than $1,000 if
the Administrator, or his designee, determines that the certified
applicator made a good faith effort to comply with this Part.
Dated: March 30, 1994.
Lon Hatamiya,
Administrator.
[FR Doc. 94-8093 Filed 4-5-94; 8:45 am]
BILLING CODE 3410-02-P
