Recordkeeping Requirements for Certified Applicators of Federally Restricted Use Pesticides; Proposed Rules

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]

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