FIFTEENTH CONGRESS )
REPUBLIC OF THE PHILIPPINES )
FIRST REGULAR SESSION )

HOUSE OF REPRESENTATIVES

Introduced by Representative Rufus B. Rodriguez and
Representative Maximo B. Rodriguez, Jr.

2579

House Bill No._

EXPLANATORY NOTE

The Constitution, under Article Il Section 15 provides that, “The State
shall protect and promote the right to health of the people and instill health
consciousness among them.”

There is no law that regulates the use of pesticide chemicals on food
despite the hazardous effects pesticide chemicals may have on the food we
consume. In accordance with the above-quoted constitutional mandate, this bill
provides for a method whereby the State regulates the use of pesticide
chemicals on food.

Considering the foregoing, the early passage of this proposed measure is
eamestly solicited.

MAXIMO B.

Me JR.


FIFTEENTH CONGRESS )
REPUBLIC OF THE PHILIPPINES )
FIRST REGULAR SESSION )

HOUSE OF REPRESENTATIVES

Introduced by Representative Rufus B. Rodriguez and
Representative Maximo B. Rodriguez, Jr.

House Bill No. 2579

AN ACT
TO REGULATE PESTICIDE CHEMICAL RESIDUES IN FOOD

Be it enacted by the Senate and House of Representatives of the Philippines in
Congress assembled:

ARTICLE!
PRELIMINARY PROVISIONS

SECTION 1. Short Title. This Act may be cited as the “Pesticide Food
Safety Act’.

SEC 2. Declaration of Policy. itis the policy of the State to protect and
promote the right to health of the people and instill health consciousness among
them. To this end, the State shall regulate the usage of pesticide chemicals in
the processing of food

SEC 3. Definition of Terms. As used in this Act, the following terms shall
mean:

(A) “Pesticide Chemical” means-

(1) (a) any substance or mixture of substances intended for preventing,
destroying, repelling, or mitigating any pest; and

(b) any substance or mixture of substances intended for use as a
plant regulator, defoliant or desiccant;

(2) (a) in the case of a pesticide other than a plant regulator, defoliant, or
dessicant, an ingredient which will prevent, destroy, repel, or mitigate
any pest;

(b) in the case of a plant regulator, an ingredient which, through
Physiological action, will accelerate or retard the rate of growth or rate


of maturation or otherwise alter the behavior of ornamental or crop
plants or the product thereof,

(0) in the case of a defoliant, an ingredient which will cause the leaves
or foliage to drop from a plant; and

(d) in the case of a desiccant, an ingredient which will artificially
accelerate the dying of plant tissue.

(8) “Defoliant” means any substance or mixture of substances intended
for causing the leaves or foliage to drop from a plant, with or without
causing abscission;

(C) “Desiccant" means any substance or mixture of substances intended
for artificially accelerating the dying of plant tissues;

(0) ‘Pesticide Chemical Residue” means a residue in or on food of —
(1) any pesticide chemical; or
(2) any other substance that is present in the commodity or food as
a result of the metabolism or other degradation of a pesticide
chemical, regardless of whether the residue may be detected.

(E) “Processed Food” means any food that has been subjected to
Processing from a raw agricultural commodity;

(F) “Administrator” means the Administrator of the National Food
Authority;

(G) “Secretary” means the Secretary of Agriculture.

ARTICLE It
TOLERANCE AND EXEMPTION FOR PESTICIDE CHEMICAL RESIDUE

SEC 4. Requirement for Tolerance or Exemption. -

(a) General Rule - Any pesticide chemical residue shall be deemed
unsafe unless —

1) a tolerance for such residue is in effect under this Act and
the quantity of such residue is within the limits of such
tolerance; and,

2) an exemption for such residue is in effect under this Act and
exemption such residue complies with such exemption.

(b) Effect of a Tolerance or Exemption - While a tolerance or from the
requirement for a tolerance is in effect under this section for a


pesticide chemical residue with respect to any food shall not by
reason of bearing or containing any amount of such residue be
considered to be adulterated if such residue on such food complies
with such tolerance or exemption.

SEC 5. Tolerances. —

(@)

(b)

©

Authority - In General - The Administrator may promulgate

regulations establishing, modifying, or revoking a tolerance for a

pesticide chemical residue

(1) in response to a petition filed under Article Ill, Section 22: or

(2) on the initiative of the Administrator under Article Ill, Section
29.

Expiration Date - A regulation under this paragraph may provide for

an expiration date for the tolerance.

Separate Tolerances - The Administrator may establish a separate

tolerance under subparagraph (a) for a pesticide chemical residue

with respect to food at each of the following times:

(1) At the time the food is harvested,

(2) At the time the food is purchased at retail; and

(3) After the food is processed.

SEC 6. Standard for Tolerance. —

(a) General Rule -

(1) a tolerance may established for a pesticide chemical
residue;
(2) the tolerance for a pesticide chemical residue shall be

revoked or modified unless the risk to human health
from dietary exposure to the pesticide chemical residue
is negligible.

(b) Negligible Risk - For purposes of this paragraph, a risk to human

health from dietary exposure to a pesticide chemical residue is
negligible only if dietary exposure to the residue is reasonably certain
to cause no harm to human health and the tolerance for such residue
meets the requirements of safety.


SEC 7. Tolerances Level. If the Administrator is abie to identify a level at
which a pesticide chemical residue will not cause or contribute to any known or
anticipated harm to human health, the Administrator may establish or leave on
effect a level for a tolerance for such residue only if the Administrator finds that
such tolerance will provide an ample margin of safety, for each population group
set out in Section 13,

SEC 8. Tolerances, Threshold Pesticides, Considerations. The level
described in Section 7 shall be based on consideration of —

(a) the nature of the toxic effects caused by such residue and
data regarding the prevalence of the same effects caused by
other chemicals;

(b) the validity, completeness, and the reliability of the data about
the pesticide chemical residue;

© the variability of individual sensitivities and the sensitivities of
Population subgroups to the adverse effects from such
residue; and

@ the possibility that human susceptibility to such adverse

effects is significantly greater than that of test animals.

SEC 9. Tolerances, Threshold Pesticides, Margin of Safety. A margin of
Safety for a level of a pesticide chemical residue is not ample unless human.
exposure per unit of body measurement to the pesticide chemical residue and
other chemicals that cause the same effect, is at least one hundred (100) times
less than the no observable effect level in animals on which the pesticide
chemical residue was tested, and, if human data are available, at least 10 times
less than the no observable effect is the level of exposure to a pesticide
chemical that reliable data derived from exposure of humans or animals to the
pesticide chemical, and demonstrate to cause no adverse effect.

SEC 10. Tolerances, Nonthreshold Pesticides. If the Administrator is not
able to identify a level at which a pesticide chemical residue will not cause or
Contribute to any known or anticipated harm to human health or if the
Administrator finds that a pesticide chemical residue causes cancer in animals or
humans, the Administrator may establish a level in effect for such residue only if
the Administrator finds that such level —

(a) will not cause or contribute to, individuals exposed to such
pesticide chemicals residue, a lifetime risk of an adverse human
health effect that occurs at a rate of one in a million or a risk of an
adverse human health effect that occurs at a rate of one
conservative risk assessment models;


(b) _ is the lowest level reasonably required to allow the accomplishment
of the physical or other technical effect for which the use of the
pesticide chemical residue is removed to the extent possible in
accordance with good manufacturing practice.

SEC 11. Tolerances, Exposure. Except as provided in Section 12, in
determining dietary exposure to a pesticide chemical residue, the Administrator
shall —

(a)(1) use only reliable statistically significant data regarding the dietary
exposure to persons who have consumed the food for which the tolerance
for the residue is proposed or is in effect;

(2) take into account all other tolerances in effect for the same pesticide
chemical residue; and

(3) take into account all other sources (including drinking water if data
demonstrating widespread or significant regional contamination in drinking
water are available) of dietary exposure to the same pesticide chemical
residue; and

(b) consider the exposure to be the level of exposure that would occur if:
(1) all food for which the tolerance for the pesticide chemical residue is
proposed or in effect, has amounts of the pesticide chemical residue
equal to the tolerance proposed or in effect;

(2) all other sources of dietary exposure to such residue described in
clause (a)(3) occur; and

(3) human exposure to the pesticide chemical residue at the tolerance
level occurs for a period to a lifetime.

SEC 12. Tolerances, Special Exposure Rule. -

(a) Data - The Administrator may calculate dietary exposure to a food
based on reliable data that provide the Administrator with a valid
statistical basis to identify the percentage of the food in which the
pesticide chemical residue actually occurs.

(b) Percentage - Such percentage shall not be less than the
percentage of the food consumed in an appropriate locality,
identified by the Administrator, which percentage represents the
highest level of exposure to such residue in the Philippines.

(©) Reevaluation - The Administrator shall reevaluate the
determination under this Act every 2 years after the determination.
If, under such a reevaluation, the Administrator finds that the
determination is not justified, the Administrator shall promptly issue


a regulation requiring that the tolerance involved be set on the
basis of the new determination.

SEC 13. Tolerances, Population Covered. In determining if the dietary
exposure to a pesticide chemical residue is negligible, the Administrator shall
evaluate the risk to -

(a) infants of the age 0 to 1:
(©) children of the age 1 to 2;
(6) children of the age 2 to 3;
(d) children of the age 3 to 4;
(e) children of the age 4 to 5;
(f) children of the age 6 to 10;

(g) other population groups that have been identified by the Administrator
to have special food consumption pattems or for which data are
sufficient to demonstrate special food consumption patterns; and

(h) the entire population, who consume food with such chemical residue.

SEC 14. Tolerances, Unavoidable Persistence. If a tolerance or an
exemption from the requirement for a tolerance for a pesticide chemical is
revoked and the Administrator finds the pesticide chemical residue will
unavoidably persist in the environment and contaminate food, the Administrator
shall establish 2 new tolerance under Section 29 for the pesticide chemical
residue. The level permitted by the tolerance shall not be greater than the lowest
level that permits only such unavoidable levels to remain in food. The
Administrator shall evaluate any such tolerance at least once a year to determine
whether modification of such tolerance is necessary so that the tolerance
provides only for the level of the pesticide chemical residue that is unavoidable.

SEC 15. Tolerances, Practical Method of Analysis. —

(a) General Rule - A tolerance for a pesticide chemical residue
shall not be established or allowed to remain in effect unless
the Administrator determines, after consultation with the
Secretary, that —

(1) _ there is a method for detecting and measuring the levels of
such pesticide chemical residue in or on a food that will
detect the residue at the level established by the tolerance:
and,


(b)

(2)

except as provided in clause (b), such method is the best
available, practical method.

Special Rule - If the Administrator determines that a practical
method of analysis for a pesticide chemical residue is not
available, the Administrator shall identify the best available
method that is designed to identify the lowest detectable
amount of the pesticide chemical residue. The Administrator
shall, every 2 years after the date of the determination under
this paragraph, reevaluate the determination.

Practical Method - A method shall be considered practical for
purposes of this Act only if it is a multi-residue method that can
be performed by the Secretary on a routine basis as part of
‘surveillance and compliance sampling of foods for pesticide
chemical residues with the personnel, equipment, and other
resources available to the Secretary, or, if no multiresidue
method is available, only if it can be so performed by the
Secretary.

SEC 16. Tolerances, Consistent Application. The Administrator shall
issue guidelines providing for the consistent application of the requirements in

Sections 6 to 15.

SEC 17. Exemptions, Authority. —

(a)

(b)

In General - The Administrator may promulgate regulations
establishing or revoking an exemption from the requirement
for a tolerance for a pesticide chemical residue in response
to a petition filed under Section 22;

Expiration Date - Such a regulation may provide for an
expiration date for the exemption.

SEC 18. Exemptions, Standard, Authority and Risk Standard. -

(a)

(b)

Establishment - An exemption may be established for a
pesticide chemical residue if such residue is not a human or
animal carcinogen and otherwise present no risk to human
health, including the health of individuals in the population
groups set out in Section 13 from dietary exposure to such
residue.

Revocation - An exemption shall be revoked unless the
residue is not a human or animal carcinogen and the residue
does not present any risk to human health, including the


co)

health of individuals in the population groups set out in
Section 13 from dietary exposure to such residue.

Tolerance - No exemption may be established or allowed to
remain in effect for a pesticide chemical residue for which
there is in effect a tolerance.

SEC 19. Exemptions, Exposure. For purposes of Section 18, in
determining dietary exposure to a pesticide chemical residue, the Administrator

shall-

(a)

()

(°)

(1)

(2)

(3)

use only reliable, statistically significant data regarding the
dietary exposure resulting from the consumption of the food
for which the exemption for such residue is proposed or is in
effect;

take into account all other exemptions in effect for such
residue and all other sources (including drinking water if data
demonstrating widespread or _ significant __regional
contamination in drinking water are available) of dietary
exposure to such residue; and

consider the exposure to be the level of exposure that would
occur if —

all the food, for which the tolerance for such residue is
proposed or in effect, has amounts of such residue
equal to the tolerance proposed or in effect,
respectively;

all other sources of dietary exposure to such residue
described in paragraph (b) occur; and

human exposure to the pesticide chemical residue at
the tolerance level occurs for a period equal to a
lifetime.

SEC 20. Exemptions, Practical Methods of Analysis. An exemption to a
pesticide chemical residue shall not be established or allowed to remain in effect
unless the Administrator determines, after consultation with the Secretary, that
there is a method for detecting and measuring the levels of such pesticide
chemical residue on a food and that such method is the best available, practical
method, as defined in Section 15.

SEC 21. Exemptions, Consistent Application. The Administrator shall

issue guidelines providing for the consistent application of the requirements in
Sections 17 to 20.


ARTICLE IV

PETITIONS AND ACTION ON THE INITIATIVE OF THE ADMINISTRATOR

a)

SEC 22. General Rule for Petitions. Any person may file with the
Administrator a petition proposing the issuance of a regulation establishing,
modifying, or revoking a tolerance or exemption for a pesticide chemical residue.

SEC 23. Requirements for Petitions to Establish a Tolerance Exemption —
Contents - A petition under Section 22 to establish a tolerance or
exemption for a pesticide chemical residue shall contain —

1)

2)
3)

4)

5)

6)

an information summary of the petition and of the data, information,
and arguments submitted or cited in support of the petition,
including —

a) a summary of the reports required under clause (4) respecting
the safety of the pesticide chemical residue; and

b) a characterization of

1. the exposure to the pesticide chemical residue
due to any tolerance or exemption already
granted for such residue; and

2. the additional exposure to such residue that would
result if the requested tolerance or exemption
were granted;

a proposed tolerance for such residue, if a tolerance is proposed;

the name, chemical identity, and composition of the pesticide
chemical that produces such residue;

reports of tests and investigations made with respect to the safety
of such pesticide chemical, including complete information as to
the methods and controls used in conducting such tests and
investigations;

data showing the amount, frequency, method, and time of
application of such pesticide chemical;

reports of tests and investigations made with respect to the nature
and amount of the pesticide chemical residue that is likely to
remain in or on food when ready for sale to consumers, including a
description of the analytical methods used;


72)

8)

9)

10)

a description of methods for detecting and measuring the levels of
such pesticide chemical residue in or on the food, which methods
meet the requirements of Sections 15 and 21;

reports of investigations conducted on the effects of processing
methods used to produce food on the level and identity of such
pesticide chemical residue;

if the petition is for a pesticide chemical residue that is described in
Sections 7, 8 and 9, all relevant data bearing on the physical or
other technical effect the pesticide chemical involved is intended to
have and the quantity of the pesticide chemical residue required to
accomplish such effect; and

such other data and information (including a sample of the
pesticide chemical from which the pesticide chemical residue is
derived) as the Administrator may require to support the petition.

(B) Information Available to Administrator - If information or data required by
this section are available to the Administrator, the person submitting the
petition may, in lieu of submitting the information or data, cite the
availability of the information data.

SEC 24. Action on Petitions, Notice. -

(a) In General - Within forty five (45) days from the filing of the petition under
Section 22 for the establishment of a tolerance or an exemption, the
Administrator shall determine if the petition complies with the
requirements of Section 23. If the Administrator finds requirements to be
sufficiently complied with, he shall publish a notice of the filing of the
petition. If the Administrator determines that the petition does not comply

with such requirements, the Administrator shall notify the petitioner of
such determination.

(b) Contents - A notice published under this section shall —

(1)

(2)
@)

announce the availability of a complete description of the analytical
methods available to the Administrator for the detection and
measurement of the pesticide chemical residue with respect to
which the petition is filed;

include the summary required by Section 23 (a)(1); and

provide at least 30 days for comments on the petition .

SEC 25. Action. The Administrator shall within 270 days from the
Publication of a notice under Section 24 (a) with respect to a petition and after


giving due consideration to the petition, any comment on the petition and any
other information available to the Administrator —

(a)

(b)

(©)

issue a final regulation in accordance with the petition establishing
a tolerance or exemption for the pesticide chemical residue;

issue a proposed regulation establishing a tolerance or exemption
for the pesticide chemical residue, which tolerance or exemption is

different from the tolerance or exemption requested in the petition;
or

issue an order denying the petition

SEC 26. Action on Petition, Modification or Revocation. —

(a)

(b)

Notice. - Within forty five (45) days from the filing of a petition
under Section 22 for the modification or revocation of a
tolerance or exemption, the Administrator shall publish a notice
of the filing of the petition. Such notice shall contain the full
petition or a summary of the petition and shail provide at least
30 days for comments on the petition.

Action - the Administrator shall within 270 days of publication of
the notice under Section 24(a) and after giving due
consideration to the petition, any comments on the petition, and
any other information available to the Administrator —

(1) issue a final regulation in accordance with the petition
modifying or revoking a tolerance or exemption for the
pesticide chemical residue;

(2) issue a proposed regulation modifying or revoking a
tolerance or exemption for the pesticide chemical residue,
which tolerance or exemption is different from the
modification or revocation requested in the petition; or

(3) issue and order denying the petition.

SEC 27. Actions on Petition, Comments and Final Regulations. If the
Administrator issues a proposed regulation under Section 25(b) or Section
26(b)(2), the Administrator shall allow at least 30 days for comments on such
proposed regulations.

The Administrator shall issue a final decision within 180 days of the date
of the publication of the proposed regulations.


SEC 28. Action on Petition Priorities. The Administrator shall give priority
to petitions for the establishment of a tolerance for a pesticide chemical residue
that appears to pose a significantly lower risk to human health from dietary
exposure than pesticide chemical residues that have tolerances in effect for the
same or similar uses.

SEC 29. Action on Petition on the Initiatives by the Administrator. -

(a)

(b)

General Rule - Upon his own initiative, the Administrator may
issue a final regulation establishing, modifying, or revoking a
tolerance or exemption for a pesticide chemical residue;

Notice - Before issuing a final regulation under paragraph (a),
the Administrator shall issue a notice of proposed rulemaking
and provide a period of not less than 30 days for public
comment on the proposed regulation unless the Administrator
finds that it would be contrary to the public interest to issue the
notice and provide the period and state the reasons for the
finding in the notice of final regulation

‘SEC 30. Action on Petition, Effectivity Date. -

@)

(b)
(ty

General Rule - Except as provided in paragraph (b), a final
regulation issued under Sections 24, 25, 26, 27, 28 and 29
shall take effect upon publication.

Delay -

General Rule - If a regulation issued under Sections 24,
25, 26, 27, 28 and 29 revokes or modifies a tolerance
for a pesticide chemical residue or revokes an
exemption for a pesticide chemical residue, the
Administrator may, delay the effectivity date of the
regulation to permit the tolerance or exemption to
remain in effect at the level in effect immediately before
‘such regulation is issued only—

(a) for foods that on the date of the publication
of the regulation, contain such pesticide
chemical residue in an amount that is not
more than the amount that could legally be
applied on the date the Administrator
acted under Sections 24,25, 26, 27, 28
and 29; and,

() if dietary exposure to the pesticide
chemical residue in or on the foods
described in clause (A) meets the


(2)

negligible risk standard prescribed by
Section 6 under the period of delay of the
effectivity date.

Period of Delay - if the Administrator finds that delay of
the effectivity date of such a revocation or modification
is consistent with the public health, the Administrator
may delay such date under Section 5 for each type of
food that contains such pesticide chemical residue, for
the period that is required for such food to be sold to
consumers in the course of the usual practice for
persons engaged in the production processing,
transportation, storage, and distribution of the type of
food.

SEC 31. Actions on Petition, Special Data Requirements. —

(a)

(b)

q)

(2)

(1)

Determination of Inadequate Data - The Administrator shall
take the action described in Sections 5 to 16 if a tolerance or
exemption is in effect for a pesticide chemical residue and the
Administrator determines that the data contained in the
petition, which had been submitted, under Section 22 for
establishment of the tolerance or exemption under this Act are
not adequate to support the continuation of such tolerance or
‘exemption because —

based on the data contained in the petition and other
data available to the Administrator, the Administrator
determines that dietary exposure to such pesticide
chemical residue may present a risk to human health
that is greater than the standard prescribed by Sections
6 to 15 and Sections 18, 19 and 20; or

the data contained in the petition are insufficient
requirements of Section 23

Action by Administrator - When the Administrator makes the
determination described in paragraph (a) with respect to a
tolerance or exemption for a pesticide chemical residue, the
Administrator shall —

within 30 days of a determination under Section 4,
initiate an action under Section 29 to modify or revoke
the tolerance or exemption so that the tolerance or
exemption meets the standard prescribed by Sections
6 to 15 or Sections 18, 19 and 20, and within 1 year of
such determination issue a final regulation to complete
‘such action; and


2) within 30 days of the date of a determination under
Section 4(a\(2) require the submission of data to
support —

(a) the existing tolerance or exemption; or

(b) 2 new tolerance or exemption for such residue that
meets the standard prescribed by Sections 6 to 15 or
Sections 18, 19 and 20.

SEC 32. Action on Petition, Special Data Requirements, Submission of
Required Data. - When the Administrator requires the submission of data under
Section 31(b)(2), the Administrator shall publish an order —

(@ requiring one or more interested persons to notify the
administrator that such person will submit the required data;

() describing the type of data required to be submitted;

C) describing the reports required to be made during and after
the collection of the data; and

@ establishing deadiines for the actions described in paragraphs
(a) and (0).

SEC 33. Action on Petition, Special Data Requirements, Deadlines.
Except as provided in Section 34, if an order is issued under Section 32 with
respect to a tolerance or exemption and 2 deadiine in the order is not met, the
tolerance or exemption is revoked, effective 45 days after the date the deadline
is not met. Immediately after such deadline is not met, the administrator shall
publish a notice of the revocation.

SEC 34. Action on Petition, Special Data Requirements, Extension of
request.

(@) Request - Any person may request the Administrator to issue
an order to extend the deadline established under Section
32(d) before expiration of the deadline;

(b) Grant of Request - The Administrator may grant such a request
only if —

(0) the person submitting the request notified the
Administrator pursuant to Section 32(a) in compliance
with the deadline established under Section 32(c); and


(2) the Administrator finds that _ extraordinary
circumstances beyond the control of such person
prevented such persons from submitting the required
data.

(c) Extension - If the administrator issues an order extending a
deadline-

(1) the Administrator may extend the deadline for a period
no longer than such time as is necessary for such
person to submit the data; and,

2) the Administrator shall establish a new deadline in
accordance with Section 32(d)

(¢) Delay - If a tolerance or exemption is revoked under Section
31(b)(1), the Administrator may delay the effectivity date under
Section 30(b);

) Evaluation of Data - within 90 days from the date of the receipt
of data under Section 32 the Administrator shall evaluate such
data and determine whether action is required under Section
29 with respect to the tolerance or exemption, for the pesticide
chemical residue for which the data were submitted so that
such tolerance meets the negligible risk standard prescribed
under Sections 6 to 15 or Sections 18, 19 and 20. if the
Administrator determines that action under Section 29 is
required, the Administrator shall complete such action within 4
year of the date of such determination.

SEC 35. Confidentiality of Data. Data submitted to the Administrator in

support of a petition under Section 22, which data have not previously been
made available to the public without restriction, shall upon request of the
petitioner, be considered as entitled to confidential treatment by the
Administrator until publication of a regulation or order under Sections 24 to 28 in
response to the petition unless disclosure of such data is required by Section 24
(a)(Z)(B) or Section 36 is allowed by Section 35.

SEC 36. Confidentiality of Data Disclosure. Data that are entitled to
confidential treatment under Section 34 until publication of a regulation or order
under Sections 24 to 28 may be revealed to —

(a) either House of Congress or any committee or sub-committee
of such House to the extent of matter within the jurisdiction of
the committee or subcommittee;

(b) any officer or employee of the State in connection with the
Official duties of such officer or employee under any law of the


()

State for the protection of health or the environment or for
specific law enforcement purposes; or

contractors with the State authorized by the Administrator to
examine such data in the carrying out of contracts under such
statutes under such security requirements as the Administrator
may provide.

SEC 37. Access to Data in Support of Petition, General Rule. -

@

(b)

©

@

Public Access - If data in support of a petition are submitted to
the Administrator, the Administrator before acting on such
petition, shall provide, in accordance with this subsection,
public access to health and safety data that are submitted or
cited in support of such petition.

Request - To obtain access to such data, a person shall, not
later than thirty (30) days after the publication under Section
24 of a notice of the filing of a petition, send by certified mail to
the Administrator and to the petitioner a request for such
access and the affirmation required by Section 37.

Grant of Request. - The Administrator shall grant such request
unless, within 15 days after the receipt by the Administrator of
such request and affirmation, the petitioner submits to the
Administrator an objection to the request asserting that the
affirmation is inaccurate and other reasons for the objection.

Objection. - If an objection to a request is submitted to the
Administrator within such 15-day period, the Administrator
shall resolve such objection within 5 days after receipt of the
objection. If the Administrator determines to grant the request,
access shall not be permitted until 5 days after the petitioner
making the objection has been notified that access has been
granted.

Denial of Request. - If access to data is denied, comments on
the petition for which such data were submitted or cited shall
be filed within 30 days after the decision of the Administrator
denying access.

SEC 38. Access to Data In Support of Petition, Restriction. -

@

Affirmation - Data referred to in Section 37 may be made
available only to person who provides an affirmation (and such
supporting evidence as the Administrator may require) that —


(a)

(b)

(1) states that the person is not engaged in, and is neither
employed by, nor acting (directly or indirectly) on behalf
of, any other person, or affiliate of, a person, engaged in
the production, sale or distribution of a pesticide

chemical;

(2) identifies any business, employer or other person, if
any, on whose behalf the person is requesting access to
the data; and

(3) states that the person will not intentionally or recklessly
violate this section.

() Affiliate - For purposes of this paragraph, an affiliate of a

person is a person who directly or indirectly, through one or
more intermediaries controls or is controlled by or is under
common control with the other person.

SEC 39. Access To Data In Support of Petition, Comments. -

(a) General Rule. - Data supporting a petition may be made
available under Section 36 to a person only for the purpose of
permitting the person to submit comments on such petition to
the Administrator. Such comments may reasonably quote data
submitted to the Administrator. No person, including the
Administrator, may make such comments publicly before the
decision of the Administrator on the petition for which such
data were submitted or after such decision if the petition is
denied.

(b) Restrictions. - A person who obtains data (directly or
indirectly) under Section 36 may not publish, copy or transfer
the data to any other person to obtain approval to sell,
manufacture or distribute a pesticide chemical anywhere in the
world.

SEC 40. Access to Data in Support of Petition, Procedure. —

In General - Data made available under Section 36 may be
examined at an office of the Department of Environment and
Natural Resources or an appropriate State agency under the
conditions prescribed by this Article and may not be removed from
‘such office.

Record - The Administrator shall maintain a record of the persons
who inspect data. A copy of such record shall be sent on request to
the person who submitted the data.


©) Basis for comments. - Once access to data supporting a petition is
granted, the data may be examined and notes may be taken for
use in developing comments on the petition. Such comments on
the petition shall be filed within sixty (60) days after the decision of
the Administrator granting access, unless the comment period is
extended by the Administrator.

SEC 41. Access to Data after Decision. When the Administrator takes
final action on a petition submitted under Section 22 or on the initiative of the
Administrator under Section 29, the Administrator shall make available to the
public the administrative record of the decision, including the data relied upon for
the decision.

SEC 42. Existing Pesticide Chemical Residues; Pesticides Chemical
Residues Under Regulations. Regulations establishing tolerances for pesticide
chemical residues under this Article or exemptions for pesticide chemical
residues under this Article on or before the date of the enactment of this Act shail
be deemed to be tolerances or exemptions issued under this Act and shall be
‘subject to modification or revocation under Sections 22 to 33.

SEC 43. Generally Recognized as Safe Pesticide Chemical Residues;
General Rule. Pesticide chemical residues that do not have tolerances or
exemptions from tolerances under this Act because the residues are generally
recognized as safe under this Act shall, until the expiration of the period
prescribed by Section 45, not be considered unsafe solely because the
chemicals do not have such a tolerance or exemption.

SEC 44. Generally Recognized as Safe Pesticide Chemical Residues,
List. Not later than ninety (90) days after the date of the enactment of this Act,
the Administrator shall —

(a) publish a list of all pesticide chemical residues that the
Administrator has determined are generally recognized on the
day before the date of the enactment of this Act, as safe under
this Act;

() require, by regulation, that any person who, before the date of
the enactment of this Act, distributed a pesticide chemical that
is mot on the list described in paragraph (a), and that such
person determined is generally recognized as safe under this
Act, shall -

(1) report to the Administrator the identity of such
pesticide chemical; and


(2) report to the Administrator the data that supports the
claim that the pesticide chemical is so safe.

SEC 45. Generally Recognized as Safe Pesticide Chemical Residues,
Determination of the Administrator. Not later than 270 days after the enactment
of this Act, the Administrator shall determine if each pesticide chemical reported
to the Administrator in accordance with Section 44 is generally recognized as
safe. If the Administrator determines, by order, that such pesticide chemical is
generally recognized as safe, the residue of such pesticide chemical shall be
considered a pesticide chemical residue subject to modification or revocation
under Sections 22 to 33.

SEC 46. Food and Drug Administration Monitoring of Pesticide Chemical
Residues. —

(a) Sampling. - The Secretary shall conduct surveillance and
compliance sampling of food for pesticide chemical residues to
determine if the pesticide chemical residues are in compliance
with this Act. In carrying out this paragraph, the Secretary shall
give priority to foods that contain pesticide chemical residues
included in a notice under paragraph (b).

(b) Notification. - The Administrator shall notify the Secretary of
the pesticide chemical residues that the Administrator
determines, in the administration of this Section —

(1) are above the standard prescribed by Section 6; or

(2) are not above such standard but that may under certain
circumstances reach or exceed such standard.

SEC 47. Fees. The Administrator shall, by regulation, require the
payment of such fees as will in the aggregate, in the judgment of the
Administrator, be sufficient over a reasonable term to provide, equip and
maintain an adequate service for the performance of the functions of the
Administrator under this Act. Under such regulations, the performance of the
services or other functions of the Administrator under this Section may be
conditioned upon the payment of such fees. Such regulations may further
provide that the continuation in effect of a tolerance or exemption shall be
conditioned upon the payment of an annual fee and for waiver or refund of fees
in whole or in part when, in the judgment of the Administrator, such waiver or
refund is equitable and not contrary to the purposes of this Article.

SEC 48. Judicial Review. Any person (including a person without an
economic interest) who may be adversely affected by a final regulation or order
issued under Sections 24, 29, 33, 43, 44 and 45 may obtain judicial review of


such regulation or order by filing a petition requesting that the regulation or order
be set aside in whole or in part in the Court of Appeals within 60 days after
publication of the regulation or order.

SEC 49. Judicial Review of Data. —

(a) In General - Any person (including a person without
economic interest) may obtain judicial review, of the
adequacy of the data made available by the Administrator
under Section 41 to support the issuance of a tolerance or
‘exemption for a pesticide chemical residue, by filing a petition
for the review of data in the Court of Appeals.

(o) ‘Scope of Review - Review in a proceeding initiated under the
preceding Section shall be limited to whether the data under
review are adequate to demonstrate that the tolerance or
exemption supported by such data meets the standards
required by Section 6 or Sections 18, 19 and 20 and
interpreted by the guidelines issued under Section 16 or 21.

() Burden of Proof - In any such proceeding the Administrator
‘shall have the burden of proof on all issues.

SEC 50. Judicial Review, Court Responsibility. In any action seeking
judicial review of actions under this Act, the court shall have the principal
Fresponsibility for deciding issues of law.

SEC 51. Judicial Review, Attorney's Fees. Any petitioner who prevails in
@ proceeding brought under this Act shall be entitled to recover reasonable
attomey’s fees and expenses (including expert witness fees.)

ARTICLE Ill
EVALUATION OF EXISTING PESTICIDE CHEMICALS, RESIDUE
TOLERANCES AND EXEMPTIONS

SEC 52. Evaluation. Within one (1) year from the date of the enactment
of this Act, the Administrator shall, for each pesticide chemical residue that has a
tolerance or exemption in effect, evaluate all available data with respect to the
safety of such pesticide chemical residue and the nature and amount of such
residue remaining in or on foods and determine if —

(a) the tolerance or exemption meets the requirements under this Act;


(b) the tolerance or exemption does not meet such requirements; or

(©) the data are insufficient to determine if the tolerance or exemption
meets such requirements.

SEC 53. Sufficient Data. —

(a)

(b)

Acceptable Risk Data - If, with respect to any pesticide
chemical residue that is evaluated under Section 4, the
Administrator finds that data for the pesticide chemical residue
are sufficient to determine that the requirements for tolerance
or exemption for the pesticide chemical residue are met, the
‘Administrator shall publish such finding.

Unacceptable Risk Data. - If, with respect to any pesticide
chemical residue that is evaluated under Section 52, the
Administrator finds that data for the pesticide chemical residue
are sufficient to determine that the tolerance or exemption for
the pesticide chemical residue does not meet the required
standard, the Administrator shall, within one (1) year of the
date of such finding, modify or revoke the tolerance.

SEC 54. Insufficient Data, General Rule, Submission of Data. |f, with
respect to any pesticide chemical residue that is evaluated under Section 52, the
Administrator determines that the data are insufficient to determine whether the
tolerance or exemption meets the prescribed requirements, the Administrator
shall establish a schedule for the submission of data in accordance with the
prescribed requirements.

SEC 55. Insufficient Data, Determinations. The Administrator shall -

(a)

(b)

©

within two (2) years from the date of the enactment of this Act,
make such a determination respecting a tolerance or
exemption standard for at least 30 percent of the tolerances or
exemptions in effect for pesticide chemical residues in
existence on such date;

within four (4) years from the date of the enactment of this Act,
make such a determination for at least 60 percent of the
tolerances or exemptions in effect for pesticide chemical
residues in existence on such date;

within six (6) years from the date of the enactment of this Act,
make such a determination for at least 90 percent of the
tolerances or exemptions in effect for pesticide chemical
residues in existence on such date; and


(d) within seven (7) years from the date of the enactment of this
Act, make such a determination for 100 percent of the
tolerances or exemptions in effect for pesticide chemical
residues in existence on such date.

ARTICLE IV
REVIEW OF EXISTING METHODS OF ANALYSIS

SEC 56. Procedure -

(a) Determination - Within one hundred eighty (180) days from the
date of the enactment of this Act, the Administrator shall
determine, for each method of detecting and measuring levels
of pesticide chemical residues, whether the prescribed
requirements have been met.

(b) Notice - The Administrator shall issue a notice identifying each
pesticide chemical for which there is such a method that does
not meet such requirements. Any such method that does not
meet such requirements shall comply with the requirements
within three (3) years from the date of the issuance of the
notice.

© Revocation - if upon the expiration of such 3-year period, a
method does not meet such requirements, then any tolerance
or exemption in effect for the pesticide chemical residue
subject to such method shall be considered revoked.

SEC 57. Fees. - The Administrator shail by regulation require the payment
of such fees as will in the aggregate judgment of the Administrator, sufficiently
‘supplement over a reasonable term to provide, equip and maintain an adequate
system for the implementation of this Act.

SEC 58. Separability Clause. if any provision, or part hereof, is held
invalid or unconstitutional, the remainder of the law or the provision not
otherwise affected shall remain valid and subsisting

SEC 59. Repealing Clause. Any law, presidential decree or issuances,
executive order, letter of instruction, administrative order, rule or regulation
contrary to or inconsistent with the provisions of this Act is hereby repealed,
modified or amended accordingly.


SEC 60. Effectivity Clause. This Act shall take effect fifteen (15) days
after the publication in at least two (2) newspapers of general circulation

Approved.