THIRTEENTH CONGRESS OT THE REPUBLIC ) 
OF THE PIXLIPPINES 
1 
First Regular Session 
1 
gr@;?“ &%%?E 
SENATE 
r- r 
S. B. No. 
Introduced by Senator LUISA “LOI” P. EJERCITO ESTRADA 
EXPLANATORY NOTE 
The Constitution, Article II, 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 earnestly 
solicited. 
LUISA P. EJER~ITO ESTRADA 
Senator 


THIRTEENTH CONGRESS OF THE REPUBLIC ) 
0 
4UN 
OF THE PHILIPPINES 
) 
First Regular Session 
) 
S E N A T E  
’ 
S. B. No. 
Introduced by Senator Luisa “LOI” P. Ejercito Estrada 
AN ACT 
TO REGULATE PESTICIDE CHEMICAL RESIDUES IN FOOD 
Be it enacted by the Senate and the House of Representatives of the Philippines in 
Congress assembled: 
ARTICLE I 
PRELIMINARY PROVISIONS 
SECTION 1. Short Title. - This Act may be cited as the “Pesticide Food Safety 
Act.” 
SEC. 2. Declaration of Policy.- 
It is 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: 
(AY‘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 he product thereof 
(c) 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, and ingredient which will artificially 
accelerate the dying of plant tissue. 
(B)“Defoliant” means any substance or mixture of substances intended for 
causing the laves 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; 
(D) “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 defected. 
(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 II 
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; or 
(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. - 
(a) Authority - In General - The Adn-@istrator may promulgate regulations 
establishing, modifjring, or revoking a tolerance for a pesticide chemical 
residue- 
(1) in response to a petition filed under Article El, Section 22; or 
(2) on the initiative of the Administrator under Article III, Section 29. 
(b) Expiration Date - A regulation under this paragraph may provide for an 
expiration date for the tolerance. 
(e) 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 be established for a pesticide chemical residue shall be 
revoked or modified unless the risk to human health fi-om dietary 
exposure to the pesticide chemical residue is negligible. 
(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 able to identifjr 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; 
(c) the variability of individual sensitivities and the sensitivities of population 
subgroups to the adverse effects from such residue; and 
(d) 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 100 times less than the no observable effect 1eveI 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, demonstrate will cause no adverse effect. 
SEC. 10. Tolerances, Nonthreshold Pesticides. - If the Administrator is not able 
to identifjr a level at which a pesticide chemical residue will not cause or contribute to 
any known or anticipated harm to human health or of 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, in 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 is accordance with good 
manufacturing practice. 
SECTION 11. Tolerances, Exposure, Except as provided in Section 12, in 
determining &eta y 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 he 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 - Administrator may calculate dietary exposure to a food based on 
reliable data that provide the Administrator which a valid statistical basis to 
identifjr the percentage of the food in which the pesticide chemical residue 
actually occurs. 
(b) Percentage - Such percentage shall not 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. 
(c) Reevaluation - The Administrator shall reevaluate he determination under this 
Act every 2 years aRer 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 ofthe age 0 tol; 
(b) children of the age 1 to 2; 
(c) children of the age 2 to 3; 
(d) children of the age 3 to 4; 
(e) children of the age 4 to 5; 
(9 children of the age 6 to 10; 
(g) other population groups that have been identified by the Administrator to have 
special food consumption patterns 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 unavoidable persist in the 
environment and contaminate food, the Administrator shall establish a 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 he 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 
establish 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 
(2) except as provided in clause (b), such method is the best available, 
practical method. 
(b) Special Rule - If the Administrator determines that a practical method of 
analysis for a pesticide chemical residue is not available, the Administrator 
shall identifjr 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. 
(c) 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 pefiormed 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) In General - The Administrator may promulgate regulations establishing or 
revoking an exemption from the requirement for a tolerance for a pesticide 
chemical residue- 
(1) in response to a petition filed under Section 22; or 
(b) Expiration Date - Such a regulation may provide for an expiration date for the 
exemption. 


SEC. 18. Exemptions, Standard, Authority and Risk Standard. - 
(a) 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. 
(b) 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 health of individuals in the population groups 
set out in Section 13 from dietary exposure to such residue. 
(c) Tolerance - No exemption nay 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) 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; 
(b) 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 
(c) consider the exposure to be the level of exposure that would occur if -- 
(1) 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; 
(2) all other sources of dietary exposure to such residue described in 
paragraph (b) occur; and 


, 
(3) human exposure to the pesticide chemical residue at he 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, afier 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 IU 
PETITIONS AND ACTION ON THE INITIATIVE OF THE ADMINISTRATOR 
SEC. 
22. General Rule for Petitions. - 
Any person may file with the 
Administrator a petition proposing the issuance of a regulation establishing, modifjring, 
or revoking a tolerance or exemption for a pesticide chemical residue. 
SEC. 23: Requirements for Petitions to Established a Tolerance Exemption - . 
(A)Contents - A petition under Section 22 to established a tolerance or exemption 
for a pesticide chemical residue shall contain -- 
(1) 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 
(11) the additional exposure to such residue that would result if 
the requested tolerance or exemption were granted; 
(2) a proposed tolerance for such residue, if a tolerance is proposed; 
(3) the name, chemical identity, and composition of the pesticide chemical 
that produces such residue; 
(4) reports of test 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 investigation; 
(5) data showing the amount, fiequency, method, and time of application of 
such pesticide chemical; 
(6) reports of test 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; 
(7) 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 Section 15 and 21; 
(8) reports of investigations conducted on the effects of processing methods 
used to produce food on the level and identity of such pesticide chemical 
residue; 
(9) 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 


(1O)such other data and idormation (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 45 days of 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 the 
Administrator 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 noti@ the petitioner of such 
determination. 
(b)Contents - A notice published under this section shall - 
(1) 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; 
(2) include the summary required by Section 23 (a)(l); and 
(3) provide at least 30 days for comments on the petition . 
SEC. 25. Action. - The Administrator shall within 270 days of the publication of 
a notice under Section 24 (a) with respect to a petition and after giving due consideration 
to the petition, any comments on the petition and any other information available to the 
Administrator - - 


(a) issue a final regulation in accordance with the petition establishing a tolerance 
or exemption for the pesticide chemical residue; 
(b) 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 
(c) issue an order denying the petition. 
SEC. 26. Action on Petition, Modification or Revocation. - 
(a) Notice. - Within 45 days of 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 shall provide at least 30 days 
for comments on the petition. 
(b) Action - the Administrator shall 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 modi.fying or 
revoking a tolerance or exemption for the pesticide chemical residue; 
(2) issue a proposed regulation modifjring 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) General Rule - Upon his own initiative, the Administrator may issue a final 
regulation establishing, modifjring, or revoking a tolerance or exemption for a 
pesticide chemical residue; 
(b) Notice - Before issuing a final regulation under paragraph (a), the 
Admidstrator 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 States the reasons for the 
finding in the notice of final regulation. 
SEC. 30. Action on Petition Eflective Dute. - 
(a) General Rule - Except as provided in paragraph (b), a final regulation issued 
under Section 24, 25, 26, 27, 28 and 29 shall take effect upon publication. 
(a) Delay- 
(1) General Rule - If a regulation issued under Section 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 effective day of the regulation to permit the tolerance or 
exemption to remain in effect at the level in effect immediately before 
such regulation in 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 Section 24,25, 26, 27, 28 and 29; and 
(B)if dietary exposure to the pesticide chemical residue in or on the foods 
described in clause (A) meets the negligible risk standard prescribed 
by Section 6 under the period of delay of the effective date. 
(2)Period of Delay - If the Administrator finds that delay of the effective 
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. 3 1. Actions on Petition, Special Data Requirements. - 
(a) Deternfination 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 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 -- 
(1) 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 


(2) the data contained in the petition are insufficient requirements of Section 
23 
(b) 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 - 
(1) within 30 days of a determination under Section 4, initiate an action under 
Section 29 to modi@ 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) a 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 
3 l(b)(2), the Administrator shall publish an order - 
(a) requiring one or more interested persons to notifl the administrator that such 
person will submit the required data; 
(b) 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 
(d) establishing deadlines for the actions described in paragraphs (a) and (c). 


, 
. 
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 a deadline in the order is not met, the tolerance or exemption 
is revoked, effective 45 days after the date the deadline is not met. Immediately aRer 
such deadline is not met. Immediately afker such deadline is not met, the administrator 
shall publish a notice of the revocation. 
SEC. 34. Action of Petition, Special Data Requirements, Edension of request. 
(a) 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 - 
(1) 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 fiom 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) 
(d) Delay - If a tolerance or exemption is revoke under Section 31(b)(l), the 
Administrator may delay the effective date under Section 3O(b). 
(e) Evaluation of Data - within 90 days of 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 date 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 1 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 for the protection of health or the 
environment or for specific law enforcement purposes; or 
(c) any officer or employees 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 
(d) 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. - 
(a) 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. 
(b) Request - To obtain access to such data, a person shall, not later than thirty 
(30) days afier 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. 
(c) 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. 
(d) 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 afier the 
petitioner making the objection has been notified that access has been granted. 
(e) 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. - 
(a) Aflirmation - 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 - 
(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 of 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. 
(b) Miliate - 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 
comment to the Administrator on such petition. 
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. 
(a) In General - Data made available under Section 36 may be examined at an 
ofice 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. 


(b) Record - The Administrator shall maintain a record of the persons who 
A copy of such record shall be sent on request to the person 
inspect data. 
who submitted the data. 
(c) 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 
60 days aRer 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 shall 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 fiom 
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 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; 
(b) require, by regulation, that any person who, before the date of the enactment 
of this Act, distributed in commerce as a pesticide chemical, a pesticide 
chemical that is not 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 chemicaI 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 fknctions of the Administrator under this Section 
may be conditioned upon the payment of such fees. Such regulations may fbrther 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. 
(b) 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. 
(c) 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 responsibility for 
deciding issues of law. 
SEC. 51. 
Judicial Review, Attorney’s Fees. Any petitioner who prevails in a 
proceeding brought under this Act shall be entitled to recover reasonable attorney’s fees 
and expenses (including expert witness fees.) 
ARTICLE 111 
EVALUATION OF EXISTING PESTICIDE CHEMICAZ, RESIDUE TOLERANCES 
AND EXEMPTIONS 
SEC. 52. Evaluation. - Within one (1) year of 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 
(c) the data are insufficient to determine if the tolerance or exemption meets such 
requirements. 


SEC. 53. Sufficient Data. - 
(a) 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. 
(b) 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 1 year of the date of such finding, 
modi@ or revoke the tolerance. 
SEC. 54. Insufficient Data, General Rule, Submission of Data. - If, 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) within 2 years of 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; 
(b) within 4 years of 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; 


A 
c 
(c) within 6 years of 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 7 years of 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 ANKYSIS 
SEC. 56. Procedure- 
(a) Determination - Within 180 days of 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 identirjling 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 within 
3 years of the date of the issuance of the notice. 
(c) 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 shall by regulation require the payment of 
such fees as will in the aggregate judgement of the Administrator, sufficiently 
supplement over a reasonable term to provide, equip and maintain an adequate system for 
the implementation of this Act. 


P 
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, 
G Wviolet sleeII/pesticide food safety act